UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended February 28, 2026
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission file number: 000-56737
MEDINOTEC, INC.
(Exact name of registrant as specified in its charter)
Nevada
36-4990343
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
Northlands Deco Park | 10 New Market Street | Stand
299 Avant Garde Avenue
North Riding | Johannesburg | South Africa 2169
(Address of principal executive offices) (Zip Code)
+27 87 330 2301
(Registrant’s telephone number, including area
code)
(Former name, former address and former fiscal year,
if changed since last report)
Securities registered under Section 12(b) of the Exchange
Act: None
Securities registered under Section 12(g) of the Exchange
Act: Common Stock, par value $0.001 per share
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a
large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See
the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of
its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
State the aggregate market value of the voting and
non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average
bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed fourth fiscal
quarter: $ 9,157,135
Indicate
the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: 11,755,548
shares as of May 28, 2026.
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Table of Contents
TABLE OF CONTENTS
PART I
PAGE
ITEM 1.
BUSINESS
4
ITEM 1A.
RISK FACTORS
23
ITEM 1B.
UNRESOLVED STAFF COMMENTS
51
ITEM 1C.
CYBERSECURITY
52
ITEM 2.
PROPERTIES
53
ITEM 3.
LEGAL PROCEEDINGS
53
ITEM 4.
MINE SAFETY DISCLOSURES
53
PART II
ITEM 5.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
54
ITEM 6.
[ RESERVED ]
54
ITEM 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
54
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
63
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
63
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
63
ITEM 9A.
CONTROLS AND PROCEDURES
63
ITEM 9B.
OTHER INFORMATION
64
ITEM 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
64
PART III
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
65
ITEM 11.
EXECUTIVE COMPENSATION
69
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
70
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
71
ITEM 14.
PRINCIPAL ACCOUNTING FEES AND SERVICES
74
PART IV
ITEM 15.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
76
ITEM 16.
FORM 10-K SUMMARY
77
SIGNATURES
78
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FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Forward-looking statements include, but are not limited to, statements regarding our future financial performance,
business strategy, product development and commercialization plans, regulatory approvals and clearances (including FDA 510(k) clearances
and EU MDR/CE marking for our current and pipeline products), expansion into the United States and other international markets, manufacturing
scale-up and supply chain capabilities, reduction of customer and geographic concentration risk (particularly reliance on DISA Life Sciences
in South Africa), foreign exchange and currency risks, geopolitical and South Africa-specific risks (including power supply instability,
exchange controls, tariffs, potential changes to AGOA benefits, and political or regulatory developments), strategic acquisitions or partnerships,
intellectual property protection, and other matters relating to our operations and growth. You can identify these forward-looking statements
by words such as “may,” “will,” “should,” “could,” “would,” “expects,”
“plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,”
“predicts,” “potential,” “continue,” the negative of these terms, or other comparable terminology.
These forward-looking statements are based on management’s
current expectations, estimates, projections, and assumptions about future events and are not guarantees of future performance. Actual
results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result
of a number of important factors, risks, and uncertainties, many of which are beyond our control. These factors include, but are not limited
to, those discussed in detail under “Item 1A. Risk Factors” and elsewhere in this report, including:
Our ability to obtain and maintain necessary regulatory
approvals and clearances (including FDA 510(k) clearances for additional products and full compliance with the EU Medical Device Regulation);
The success of our U.S. market entry and commercialization
efforts, including sales growth of the Trachealator, Outflo, and future pipeline products;
Risks associated with our significant customer and
geographic concentration, particularly reliance on DISA Life Sciences in South Africa and related-party distribution arrangements;
Foreign exchange rate volatility, currency controls,
and economic or political instability in South Africa (including load-shedding, BEE requirements, and transfer pricing or exchange control
regulations);
Potential changes in U.S. trade policy, tariffs,
or preferential market access for South African goods (including AGOA benefits);
Manufacturing, supply chain, and quality risks, including
dependence on third-party suppliers and our ability to scale production;
Product development, clinical, and commercialization
risks for our pipeline products;
Intellectual property protection and third-party
infringement claims;
Dependence on key personnel and our ability to attract
and retain qualified employees;
Liquidity, capital requirements, and our ability
to obtain additional financing on acceptable terms; and
General economic, industry, and market conditions,
including competitive pressures from larger medical device companies.
Because we are a smaller reporting company and our
common stock is considered a “penny stock,” we are ineligible to rely on the safe harbor for forward-looking statements provided
by Section 27A of the Securities Act and Section 21E of the Exchange Act to the full extent otherwise available to larger reporting companies.
Forward-looking statements speak only as of the date they are made. We expressly disclaim any obligation or undertaking to update or revise
any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable
law.
You should carefully consider the risk factors described
in Item 1A of this report, as well as the other information contained or incorporated by reference in this report, before making any investment
decision regarding our securities. The occurrence of any of the events described as risk factors or other future events could have a material
adverse effect on our business, results of operations, financial condition, and stock price.
As used in this Annual Report on Form 10-K, unless
the context otherwise requires, the terms the “Company,” “Registrant,” “we,” “us,” “our,”
“Medinotec,” “Medinotec Group of Companies” or “MDNC” refer to Medinotec, Inc., a Nevada corporation,
and its wholly owned subsidiaries.
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Table of Contents
PART I
ITEM 1.
BUSINESS
Company Overview
Medinotec Inc. was registered on April 26, 2021,
in the State of Nevada. With an effective date of April 26, 2022, we acquired DISA Medinotec Proprietary Limited, a South African
corporation, from Minoan Medical Proprietary Limited ("Minoan"), a company incorporated in South Africa, and owner of all the
capital stock of DISA Medinotec Proprietary Limited. We accomplished the acquisition pursuant to the terms and conditions of a Share
Exchange Agreement under common control with Minoan whereby we acquired all the capital stock of DISA Medinotec Proprietary Limited in
exchange for the issuance of stock at par value and the transfer of the outstanding loan account.
This purchase was concluded between Minoan and a local
newly established investment vehicle of Medinotec Inc. called Medinotec Capital Proprietary Limited in South Africa after Medinotec Inc.
registered the company as a shelf company by injecting $10,000 into it on December 18, 2021. Medinotec Capital Proprietary Limited serves
as the acquisition vehicle for Medinotec Inc. on the continent of Africa.
Combined these companies now form the Medinotec Group
of Companies.
We currently generate revenue from two principal sources:
(1) internally designed and manufactured proprietary medical devices and (2) distribution of third-party medical products under exclusive
or non-exclusive agreements in defined territories. Our proprietary products include the Trachealator (a non-occlusive airway dilation
balloon), the Outflo Aortic Valve Dilation Balloon Catheter, and the Cape Cross family of PTCA balloon catheters. We also distribute a
range of cardiology and renal dialysis products on behalf of multinational manufacturers, primarily in South Africa.
Our History
DISA Medinotec Proprietary Limited originated from
DISA Vascular 2015, a South African medical device business focused on vascular technologies. DISA Medinotec has historically developed
and manufactured medical devices, including products used in cardiology and airway-related procedures. The Company’s products are
sold through distributor arrangements in South Africa and certain international markets.
Following the acquisition by Medinotec Inc. through
Medinotec Capital Proprietary Limited, the Group continued operating its medical device manufacturing activities from Johannesburg, South
Africa. The Johannesburg facility includes manufacturing, warehousing, quality, regulatory, and administrative functions.
The Company has appointed distributors and obtained
distribution rights in certain territories, including South Africa, Namibia, Mauritius, the Middle East, Europe, South America, and portions
of Asia. The Company has also taken steps to develop sales channels in the United States following FDA 510(k) clearance for Trachealator
in November 2021 and Outflo in March 2025. The Company continues to evaluate additional regulatory filings and patent applications in
selected territories, subject to commercial feasibility, regulatory requirements, and available resources.
Raw materials and components used in manufacturing
are sourced from local and international suppliers. The Company maintains supplier evaluation procedures and quality processes intended
to support compliance with applicable regulatory and product specifications.
Employees
As of February 28, 2026, the Medinotec Group of Companies
had 48 employees and independent contractors supporting its operations. This consisted of 36 individual full time employees and 12 independent
contractors. The 12 independent contractors include a mix of individual
contractors and companies engaged to support the Group’s sales and commercialization activities.
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Certain of the independent contractors that are companies,
including U.S.-based companies, may in turn employ or engage individual sales representatives who participate in sales-related activities
for the Group’s products. These individuals are employed or engaged by the relevant independent contractor company and are not employees
or individual independent contractors of the Medinotec Group of Companies. Accordingly, where an independent contractor is a company,
that company is counted as one independent contractor in the table below, and any individuals employed or engaged by that company are
not included in the 48-person count.
The Group’s personnel support the following
functions:
Commercial and sales: pricing, customer engagement,
product support, marketing coordination, logistics support, and distributor liaison.
Marketing: product materials, trade show support,
customer communications, and coordination of industry events.
Warehouse and logistics: inbound and outbound
shipments, inventory storage, product handling, and shipment coordination in accordance with applicable quality requirements.
Technical and manufacturing support: maintenance
of manufacturing equipment and technical support for production activities.
Customer service: order support, customer
communication, and coordination of product-related queries.
Back-office and regulatory support: finance,
administration, quality, regulatory affairs, and research and development.
The Company operates in a specialized industry and
seeks to retain personnel with relevant technical, manufacturing, regulatory, commercial, and administrative experience. None of the Company’s
employees are represented by a labor union. The Company has not experienced any work stoppages.
The
table below shows the
approximate number of employees and independent contractors, the employment status as full or part time, and the employer within the Medinotec
Group of Companies. None of our employees are represented by a labor union with respect to their employment with us. We have not experienced
any work stoppages, and we consider our relations with our employees to be good.
Employer
Number of full-time employees
Number of part-time employees
Number of independent contractors
Medinotec Inc.
3
—
12
Medinotec Capital Proprietary Limited*
—
—
—
DISA Medinotec Proprietary Limited
33
—
—
Total
36
—
12
Group Contractors
DISA Medinotec Proprietary Limited holds distribution
arrangements with third-party medical device companies for cardiology and renal dialysis products. These arrangements form part of the
Company’s third-party distribution business and supplement the Group’s internally manufactured product portfolio.
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Certain third-party distribution relationships were
introduced through Minoan Medical Proprietary Limited, which previously acted as distributor before DISA Medinotec assumed responsibility
for the relevant distribution activities. The Company appointed DISA Life Sciences, a South African sub-distributor, to support sales
and marketing activities in South Africa. DISA Life Sciences also distributes certain internally manufactured Medinotec products in South
Africa.
The Company’s principal operating focus remains
the development, manufacture, and commercialization of products for which it owns or controls intellectual property, together with the
distribution of selected third-party products where management believes such arrangements are commercially appropriate.
The Trachealator received FDA 510(k) clearance in
November 2021, permitting the Company to market the product in the United States. As the Company did not have an established U.S. sales
infrastructure at that time, it entered into a relationship with Innovative Outcomes and provided a revolving credit facility of up to
$750,000 to support the development of distribution infrastructure.
During the quarter ended November 30, 2023, the Company
reassessed the relationship after determining that Innovative Outcomes’ focus on the wound care clinic market was no longer aligned
with the Company’s intended focus on niche surgical units. The parties separated their respective distribution activities. The note
receivable remained subject to its original terms and became payable during fiscal 2024. The Company recorded a full impairment allowance
against the receivable as of November 30, 2023 because the receivable was no longer supported by anticipated Trachealator-related revenue
streams. Any future recoveries will be recognized when received, as appropriate.
The Company relies on distributor relationships and
customer relationships to sell its products, particularly in South Africa. Through its distribution arrangements, the Group has access
to a network of sales representatives that service hospitals and healthcare providers in South Africa. The Company may seek to develop
or access similar distribution capabilities in the United States; however, there can be no assurance that it will be able to do so on
commercially acceptable terms or at all.
The Group has historical reliance on two companies
for sales into South Africa: there is reliance on DISA Life Sciences Proprietary Limited (“Disa Life Sciences”) as a customer;
and for exports out of South Africa there was historical reliance on Minoan Medical (a related party). These relationships provide the
Group with more than 100 sales representatives in the South African Market.
DISA Life Sciences remains a significant customer
and distribution partner in South Africa. The Company expects to continue selling products to DISA Life Sciences while it remains commercially
viable to do so. Management’s strategy includes seeking to reduce customer and geographic concentration over time by expanding into
additional markets. There can be no assurance that these efforts will be successful. Regulatory requirements, market acceptance, reimbursement,
competition, pricing pressure, and other barriers to entry may limit or delay the Company’s ability to diversify revenue away from
the South African market and from DISA Life Sciences.
The Medinotec Group of Companies operate in countries
where the market is dominated by certain players, and this creates a sales concentration risk which also causes an accounts receivable
concentration risk.
Seasonality
Sales reflect the cyclical nature of the business,
as the number of procedures incorporating our products does decrease in the summer holiday months of December and January within the South
African market, which is currently the predominant market in the Medinotec Group of Companies.
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Reliance on Other Parties
The Medinotec Group of Companies in the past focused
solely on product development and manufacturing and therefore outsourced its sales function to two companies, namely, Minoan Medical Proprietary
Limited (a related party) and DISA Life Sciences. This was done to preserve funds for R&D and manufacturing and to ensure the products
that are developed are launched effectively.
•
DISA Life Sciences is a South African medical device distributor with an established sales and marketing presence in the South African market. DISA Medinotec entered into the relationship to access existing distribution capabilities rather than building a separate internal sales force for the South African market. DISA Life Sciences uses its own sales personnel and certain subcontractors to support sales within South Africa. Following the Company’s decision to manage exports internally, the DISA Life Sciences relationship primarily relates to sales and distribution within South Africa.
Please refer to the related party footnotes in the
financial statements and as disclosed in the Section of this Annual Report, entitled, “Certain Relationships and Related Transactions,
and Director Independence” where the nature and flow of transactions between related parties have been disclosed in detail.
Our Business Strategy
As we are currently operating in various markets,
the below provides a brief overview of the Company structure as well as each individual entity’s role within the Company:
Medinotec Inc
The company was incorporated in Nevada in April of 2021. Currently, this company houses the directorship and management of the business and owns the subsidiary, Medinotec Capital Proprietary Limited, which in turn wholly owns DISA Medinotec Proprietary Limited. Medinotec Inc. facilitates all sales into the United States.
Medinotec Capital (Pty) Ltd
Medinotec Capital Proprietary Limited was incorporated in South Africa as an investment holding company for the Group’s African operations. It currently holds the Company’s investment in DISA Medinotec Proprietary Limited. The use of a holding company structure assists the Group in managing its African investments, intercompany arrangements, and related transfer pricing considerations.
Disa Medinotec (Pty) Ltd
This is the operational company acquired by Medinotec Capital in March of 2022. This company manufactures and develops the products that are sold to Medinotec Inc. It is a medical device manufacturing and distribution company with distribution channels predominately in South Africa, but also in the Middle East, South America, Europe and portions of Asia, with plans to enter the markets in countries such as Australia, Japan and China that have very strict regulatory approval processes.
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The Company’s business strategy is focused on:
1.
maintaining and expanding its existing product portfolio;
2.
developing internal manufacturing, quality, regulatory, and commercial
capabilities; and
3.
evaluating acquisitions, distribution arrangements, or other strategic
transactions where management believes they may support the Company’s operations or market access.
Our strategy includes investing in the entire value
chain, ranging from the importation of raw materials, manufacturing capabilities and the marketing and selling of products, through to
the distribution of our products to customers via our sales network.
A
high-level overview of our strategy follows in this annual report on Form 10-K ,
which is followed by a discussion on how we implement this strategy.
Operating Capabilities
The Company’s operations include product development,
manufacturing, quality management, regulatory affairs, sales support, and distribution management. Management believes the following operating
capabilities are relevant to the Company’s business:
experience in developing and manufacturing selected
balloon catheter and airway dilation products;
manufacturing operations in South Africa, including
cleanroom production capabilities;
quality management and regulatory processes applicable
to medical device manufacturing;
distributor relationships in South Africa and selected
international markets;
experience with product registration and regulatory
submissions in selected jurisdictions; and
internal technical, quality, regulatory, finance,
and administrative support functions.
These capabilities are subject to the risks described
in Item 1A, including risks relating to regulation, customer concentration, manufacturing, product quality, market acceptance, competition,
and the Company’s ability to obtain additional funding if required.
The Three Pillars of our Strategy
The Company’s strategy is organized around three
areas: (1) maintaining and expanding its proprietary product portfolio, (2) developing internal manufacturing, quality, and regulatory
capabilities, and (3) evaluating acquisitions, distribution arrangements, or other strategic relationships where management believes they
may support the Company’s business.
1.
Innovate and Grow our Product Range
DISA Medinotec Proprietary Limited develops and manufactures
selected medical devices, including products used in cardiology and airway-related procedures. The Company has invested in product development,
intellectual property protection, manufacturing processes, and regulatory submissions for certain products.
The Company currently has commercially available products
and developmental products. Historically, a significant portion of revenue and gross profit has been generated in South Africa. Management’s
strategy includes maintaining the existing South African business while seeking opportunities to commercialize selected products in additional
markets, including the United States and certain other regulated markets, subject to regulatory clearance, distributor arrangements, market
acceptance, pricing, reimbursement, and available resources.
The Company also evaluates changes to existing products
and new product development opportunities where management believes these may be commercially viable and consistent with the Company’s
technical and regulatory capabilities.
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The products are generally targeted at more complex,
specialized surgical cases and are specifically relevant in medical centers of excellence. During 2018, DISA Medinotec Proprietary Limited
recognized the need to become a significant player in manufacturing in reaction to the risk of price sensitivity.
DISA Medinotec Proprietary Limited currently specializes
in niche products within the disciplines of cardiology and respiratory interventions in which we are involved in medical device design,
development, manufacture, all supported by a well-trained and educated sales and distribution channel. The specialty areas include:
•
Interventional Cardiology, which involves surgery performed on the heart and vessels to correct life-threatening conditions. The surgery is performed by minimally invasive intravascular methods depending on the condition to be corrected.
•
Interventional Endolaryngeal Endoscopy, which involves balloon dilation to treat suitable airway stenosis by ENT surgeons and anesthetists.
The Company’s expansion efforts are focused on markets where the
relevant procedures are performed and where the Company believes its products may be commercially viable. These efforts may include:
identifying and appointing distributors;
supporting product training and technical education where appropriate;
obtaining or maintaining required regulatory approvals or registrations;
supporting product adoption by healthcare providers; and
evaluating whether clinical data, publications, or other product information
may support market access.
There can be no assurance that these activities will result in increased
sales, market acceptance, or reduced customer concentration.
In addition, we appointed and trained various distributors
in the Middle East, Europe, portions of Asia and South America, with several training initiatives also held in the USA where FDA approval
have been granted for the Trachealator and Outflo following the 510(k) substantially equivalence process for Class II medical devices.
This has enabled us to start sales in the USA.
Demand for the Company’s products is affected
by procedure volumes, healthcare infrastructure, hospital purchasing patterns, reimbursement, pricing pressure, regulatory requirements,
and broader economic conditions in the markets in which the Company operates. The Company’s current revenue remains concentrated
in South Africa, although management continues to evaluate opportunities in other markets where regulatory and commercial conditions support
market entry.
The United States is an important target market for
the Company because certain of its products have received, or may in the future seek, FDA 510(k) clearance. U.S. sales for fiscal 2026
were $611,860, representing 6% of total sales, compared to $678,105, representing 7% of total sales, in fiscal 2025. The Company’s
ability to increase U.S. revenue will depend on factors including regulatory clearance, product adoption, distributor or sales arrangements,
reimbursement, pricing, competition, and available capital.
Key Market Trends and Our Response to These
Medical device markets are affected by demand for
less invasive procedures, hospital cost controls, reimbursement practices, product innovation, and competition. These factors may create
opportunities for products used in minimally invasive procedures, but they may also increase pricing pressure and require ongoing investment
in product development, regulatory compliance, quality systems, and commercial support.
The Company seeks to respond to these trends by maintaining
its current product portfolio, evaluating product development opportunities, managing manufacturing costs, and supporting regulatory submissions
in selected markets. The Company’s ability to benefit from these trends is subject to market acceptance, regulatory clearance, reimbursement,
competition, and the risks described in Item 1A.
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Major shifts in industry market share have occurred
in connection with product problems, physician advisories, safety alerts, results of clinical trials to support superiority claims, and
publications about products, reflecting the importance of product quality, product efficacy and quality systems in the medical device
industry.
In the current environment of managed care, economically
motivated customers, consolidation among healthcare providers, increased competition, and declining reimbursement rates, we have been
increasingly required to compete on the basis of price. In order to continue to compete effectively, we must continue to create or acquire
advanced technology, incorporate this technology into proprietary product offerings, obtain regulatory approvals in a timely manner, maintain
high-quality manufacturing processes, and successfully market these products.
Government and private sector initiatives to limit
the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies,
comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries in which
the Medinotec Group does business, including the US.
These initiatives put increased emphasis on the delivery
of more cost-effective medical devices and therapies. Government programs, including Medicare and Medicaid, private healthcare insurance
and managed-care plans have attempted to control costs by limiting the amount of reimbursement they will pay for particular procedures
or treatments, tying reimbursement to outcomes, shifting to population health management, and other mechanisms.
Hospitals, which purchase our technology, are also
seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases, limiting the
number of vendors that may participate in the purchasing program. Hospitals are also aligning interests with physicians through employment
and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings resulting from
changes in practice patterns such as device standardization. This has created an increased level of price sensitivity among customers
for our products.
The Company may seek additional distributor
relationships, strategic relationships, or financing arrangements to support its activities in North America and other selected markets.
There can be no assurance that such arrangements will be available on acceptable terms or that they will result in increased revenue.
Our Competitor Landscape
The Medinotec Group of Companies operates in
highly competitive medical device markets characterized by a number of large, multinational players as well as a number of small, regional
or local distributors. Some of the major players include Johnson & Johnson, Boston Scientific, Cook Medical, Cordis, B. Braun, Teleflex,
Medtronic, Merit Medical, Endotec, Conmed and Cadence.
Competition is based on price, consistency
and quality of product, site location, distribution capability, customer service, reliability of supply, breadth of product offering
and technical support. The principal competitive factors in these markets are product features, value-added solutions, reliability, clinical
evidence, reimbursement coverage, and price.
We compete with many companies having significantly
more capital resources, larger research laboratories and more extensive distribution systems. As a smaller company with limited market
share, we are particularly vulnerable to these competitive pressures, especially as we seek to expand commercialization of our proprietary
devices into the highly regulated and competitive United States market. As such, there are no assurances that we will be able to compete
and gain market share.
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2.
Build our Competencies
The Company has invested in its Johannesburg manufacturing facility, including
cleanroom production capacity, laboratory space, packaging areas, sterilization capabilities, and equipment used in the development and
manufacture of selected medical devices. The facility supports activities conducted under the Company’s ISO 13485 Quality Management
System.
The Company’s manufacturing capabilities include processes relevant
to balloon catheter and related device production, including balloon forming, bonding, coating, catheter lamination, packaging, and sterilization-related
activities. These capabilities support the Company’s current products and certain product development activities.
At present, management does not intend to prioritize significant additional
expansion of the production facility. The Company expects to focus available resources on maintaining current operations, supporting regulatory
and quality requirements, product development, and commercial activities.
3.
Make Strategic Bolt-on Acquisitions
While strategic bolt-on acquisitions remain a consideration
in our business plan, we currently have no active due diligence processes underway and no imminent acquisition transactions at this time.
Our Implementation Plan
The Company’s implementation plan is focused on the following operating
priorities:
maintaining manufacturing and quality processes for existing products;
supporting regulatory compliance and product registrations in selected
jurisdictions;
managing distributor and customer relationships in South Africa and selected
international markets;
evaluating product development opportunities that align with the Company’s
technical, regulatory, and financial resources;
managing inventory levels to support expected demand while limiting excess
or obsolete inventory;
managing operating costs and working capital; and
evaluating acquisitions, distribution arrangements, or other strategic
transactions where management believes they may be commercially appropriate.
The Company’s ability to execute this plan depends on, among other
factors, available capital, regulatory approvals, supplier performance, production capacity, customer demand, distributor performance,
reimbursement, competition, and macroeconomic conditions.
Product Distribution
We have appointed various distributors to grow sales
internationally, especially in Europe, North America, South America, Middle East, portions of Asia as well as Namibia and Mauritius.
As of February 28, 2026, the Company was represented
in approximately 45 countries and had 31 appointed distributors globally. Product registrations were received in several additional jurisdictions
during fiscal 2026, while registrations remained pending in certain other jurisdictions. All exports are managed directly from South Africa
by the Company’s export manager.
We have had several training initiatives held in the US where FDA
approval has been granted for both the Trachealator and Outflo following the 510(k) substantially equivalence process for Class II medical
devices
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The Company intends to continue evaluating distributor
arrangements and regulatory requirements in additional markets, including Australia, Japan, and China. Entry into these markets would
be subject to local regulatory approvals, commercial feasibility, distributor arrangements, and available resources.
Through the operating subsidiary DISA Medinotec Proprietary
Limited, we ship our products to customers directly by freight or by air and through our network of in-house and courier partners. Recent
market trends have resulted in more product volumes being transported by high-efficiency road freight.
The Company maintains distribution facilities in Johannesburg,
South Africa and New York, United States of America. These facilities support access to road and air freight routes. The Company evaluates
its distribution arrangements from time to time to manage delivery timing, inventory availability, freight costs, and customer requirements.
Product Manufacturing – Quality Assurance and Regulatory
Requirements
Quality Management
The Company maintains documented procedures and a
Quality Management System (“QMS”) intended to support compliance with ISO 13485, the European Union Medical Device Regulation
2017/745, U.S. FDA 21 CFR 820 regulations, and applicable South African regulatory requirements.
Our QMS is implemented through the Medinotec Group
of Companies’ policies, procedures and work instructions followed and utilized by all departments. We also maintain an active post-market
surveillance program, which enables product performance to be regularly assessed and to be reported to the regulatory authorities if any
incident/malfunction occurs that results in severe injury to the patient or death.
Additionally, we maintain quality standards relevant
to the storage and distribution of our products. These include technical/quality agreements with our suppliers. Since we import raw materials,
all manufacturing of the products is performed in DISA Medinotec South Africa’s clean room facilities, and all instructions and
quality manuals are written to convert a series of raw materials into finished goods against the applicable quality assurance standards
and internal procedures. No manufacturing steps are outsourced at the moment.
Compliance to all procedures is monitored via an internal
audit system and augmented by audits conducted annually by European and American Notified Bodies.
International Quality Regulations
Many of our products require CE marking before they
can be sold in the European Union. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety,
health and environmental protection requirements. Most of our products carry the CE Mark. It is required for products manufactured anywhere
in the world that are then marketed in the European Union.
Most of our products carry the CE Mark, ensuring conformity
to the legal requirements of the European Union. The valid CE certificates for the devices concerned have been issued in compliance with
the Medical Device Directive 93/42/EEC and these devices could initially be placed on the market until May 2024, but an extension has
been granted till the end of 2027 due to the European Notified Bodies being unable to handle the volume of the applications.
The Company is in the process of addressing applicable
requirements under the Medical Device Regulation (MDR) 2017/745. The Trachealator has been certified under this regulation, and technical
files for certain remaining products are under review by DEKRA.
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DEKRA is a global testing, inspection, and certification
organization. In Europe, DEKRA is recognized as a Notified Body for medical devices, meaning it is authorized by the European Union to
assess whether medical devices comply with EU regulations and standards. This involves evaluating the design, manufacturing process, and
quality management systems of medical devices to ensure they meet the required safety and performance criteria before they can be marketed
in the EU. DEKRA's role includes conducting conformity assessments, issuing CE certifications, and performing post-market surveillance
to ensure ongoing compliance.
The Company has obtained FDA 510(k) clearance for
the Trachealator, and U.S. sales have commenced. FDA 510(k) clearance has also been obtained for Outflo, and the company is currently
implementing marketing strategies in the United States with sales expected to commence in fiscal 2027. There can be no assurance as to
the timing or outcome of any pending or future FDA submissions.
In addition, we are subject to numerous and increasingly
stringent environmental laws and regulations concerning, among other things, the generation, handling, storage, transportation, treatment
and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the cleanup of contamination. We
are required to maintain and comply with environmental permits and controls for some of our operations, and these permits are subject
to modification, renewal, and revocation by the issuing authorities. Our environmental compliance may increase in the future because of
changes in environmental laws and regulations or increased manufacturing activities at any of our facilities. We could incur significant
costs or liabilities because of any failure to comply with environmental laws, including fines, penalties, third-party claims, and the
costs of undertaking a clean-up on-site or at a site to which any waste materials were transported. In addition, we are planning to grow
in part by acquisition, and our diligence may not have identified environmental impacts from historical operations at sites we may acquire
in the future. We have an extensive health and safety program. This also stipulates how we handle waste materials and staff safety in
the cleanroom facility. Our health and safety costs are included in our compliance costs.
The Medinotec Group of Companies for the Years Ended
February 28, 2026
February 28, 2025
Compliance cost
$ 362,172
$ 526,603
It should be noted that as we approach market and
sales readiness with our products our compliance costs are increased to facilitate the path to sell products into new territories and
to ensure legal and statutory compliance in these markets. The fluctuations in annual and quarterly compliance costs can be attributed
to these new markets being prepared for sales activities. Compliance costs decreased during fiscal 2026 compared to fiscal 2025, primarily
due to lower audit fees following the change in the Company’s independent registered public accounting firm, as well as higher prior-year
costs associated with seeking FDA approval for OutFlo, which was granted in March 2025.
Medical Device Regulation
Regulatory approvals and market acceptance are material
to the Company’s business. The regulatory approval process for medical devices, including FDA clearance in the United States and
CE/MDR certification in Europe, can be lengthy, costly, and uncertain. If the Company is unable to obtain or maintain required approvals,
clearances, registrations, or certifications, or if approvals are
delayed, the Company may be unable to commercialize certain products or may experience delays in commercialization. Even where regulatory
clearance or certification is obtained, there can be no assurance that the relevant products will achieve market acceptance. See below
and Item 1A. Risk Factors for further discussion of regulatory, compliance, and environmental risks in connection with our medical device
products.
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Regulation of Medical Devices in Europe
Medical devices placed on the market in the European
Economic Area must comply with the Medical Device Regulation (MDR) (EU) 2017/745, which sets out the essential safety and performance
requirements that all devices must meet. Under the MDR, manufacturers must undergo a conformity assessment process (typically involving
an independent accredited Notified Body for higher-risk devices) to demonstrate compliance before the device can be CE-marked and legally
sold throughout the EEA.
The Company maintains CE Mark certification for most
of its products and is progressing toward full compliance with the MDR. The Trachealator has been certified under the MDR, and technical
files for the remaining products are under review by the Notified Body.
Regulation of Medical Devices in South Africa
In South Africa, medical device manufacturing is regulated
by the South African Health Products Regulatory Authority (“SAHPRA”), with guidelines published in the Government Gazette
No. 40480 in 2016, which refer to licensing of medical devices establishments and the registration required to ensure an acceptable level
of safety, quality, and performance. DISA Medinotec Proprietary Limited is registered with SAHPRA and possesses the above-described licenses
and registrations for all our products.
Regulation of Medical Devices in Other Key Markets
Australia, Japan, and China have their own independent
regulatory systems (Therapeutic Goods Administration – TGA; Pharmaceuticals and Medical Devices Agency – PMDA; National Medical
Products Administration – NMPA respectively) and do not automatically accept CE marking or FDA clearance. Separate local registrations,
testing, and compliance requirements apply in these jurisdictions.
The Company is also subject to numerous and increasingly
stringent environmental, health and safety laws and regulations in the jurisdictions in which it operates.
Federal, State, and Foreign Fraud and Abuse
and Physician Payment Transparency Laws.
In addition to FDA restrictions on the marketing and
promotion of our medical devices, other federal, state and foreign laws may restrict our business practices particularly as we expand
commercialization of our products into the United States and other markets where our devices may be reimbursable under government healthcare
programs. These laws include, without limitation, anti-kickback, false claims laws, and physician payment transparency laws.
The federal Anti-Kickback Statute prohibits knowingly
and willfully offering, paying, soliciting, or receiving any remuneration (in cash or in kind) to induce or reward the purchase, order,
or recommendation of any item or service reimbursable, in whole or in part, under Medicare, Medicaid, or other federal healthcare programs.
Violation of the Anti-Kickback Statute can also result in liability under the Civil Monetary Penalties Law (originally enacted as the
Civil Monetary Penalty Act of 1981). Current penalties under the Civil Monetary Penalties Law can reach up to $100,000 per violation plus
three times the amount of the remuneration, as well as exclusion from federal healthcare programs such as Medicare and Medicaid.
The federal False Claims Act prohibits knowingly presenting
or causing to be presented a false or fraudulent claim for payment to the federal government, or knowingly making or using a false record
or statement material to a false or fraudulent claim. Liability can arise even without specific intent to defraud. Private parties may
bring “qui tam” lawsuits on behalf of the government and share in any recovery. Penalties include civil fines ranging from
$14,308 to $28,619 per false claim, plus up to three times the damages sustained by the government, and potential exclusion from federal
healthcare programs. The criminal False Claims Act imposes additional penalties for knowingly presenting a false claim to the government.
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The Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”) also created federal criminal statutes prohibiting schemes to defraud healthcare benefit programs (including
private payers), embezzlement from such programs, and making false statements in connection with the delivery of or payment for healthcare
services.
Many states have similar fraud and abuse laws that
may be broader than their federal counterparts and apply regardless of the payor. In addition, many foreign jurisdictions in which we
operate or plan to operate, including the European Union and South Africa, have analogous laws restricting improper payments and promotional
activities involving healthcare professionals.
The Physician Payments Sunshine Act (now administered
through the federal Open Payments program) requires manufacturers of drugs, biologics, and medical devices covered by Medicare, Medicaid,
or CHIP to report annually to the Centers for Medicare & Medicaid Services certain payments or other transfers of value made to physicians,
teaching hospitals, and other covered recipients. We are subject to these reporting requirements as we commercialize our devices in the
United States. Failure to comply with these transparency and fraud and abuse laws could result in significant civil and criminal penalties,
exclusion from government programs, and reputational harm.
Data Privacy and Security Laws.
In addition to other regulatory requirements, we are
or may become subject to various federal, state, and foreign laws governing the collection, use, disclosure, and protection of personal
information, including protected health information (“PHI”) and other sensitive data. These laws include the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical
Health Act (“HITECH”), the European Union General Data Protection Regulation (“GDPR”), and the California Consumer
Privacy Act of 2018, as amended by the California Privacy Rights Act (“CCPA/CPRA”).
HIPAA establishes national standards for the privacy
and security of PHI. It applies to covered entities (such as healthcare providers and plans) and their business associates (including
contractors or agents that create, receive, maintain, or transmit PHI on behalf of a covered entity). HIPAA requires safeguards to protect
the confidentiality, integrity, and availability of electronically transmitted or stored PHI, restricts the use and disclosure of PHI,
and grants individuals certain rights regarding their health information (such as the right to access or amend records). In the event
of a breach of unsecured PHI, HIPAA mandates notification to affected individuals without unreasonable delay and no later than 60 days
after discovery. Breaches affecting 500 or more individuals must also be reported to the U.S. Department of Health and Human Services
(HHS) and the media. Failure to comply with HIPAA’s privacy and security rules can result in civil monetary penalties of up to $71,000
per violation (adjusted for inflation), with an annual maximum of approximately $2.1 million for identical violations, as well as potential
criminal penalties.
Many states have data privacy and breach notification
laws that are broader than HIPAA or apply regardless of payor. For example, the CCPA/CPRA grants California residents rights to access,
delete, and opt out of the sale of their personal information and creates a private right of action for certain data breaches. Although
exceptions exist for PHI regulated by HIPAA, the CCPA/CPRA may still apply to certain personal data we process outside of covered healthcare
activities.
In the European Economic Area, the GDPR and related
national laws impose strict requirements on the processing of personal data, including special categories of data such as health information.
As we expand operations and potentially process data of EEA individuals (including employees, customers, patients, or clinical trial participants),
we must ensure compliance with GDPR principles such as lawful basis for processing, data minimization, security, and accountability. Violations
of the GDPR can result in fines of up to 4% of global annual turnover or €20 million, whichever is greater.
We maintain policies, procedures, and technical safeguards
designed to protect personal and health information; however, as we commercialize our devices in the United States and other regulated
markets and handle increasing volumes of patient or clinical data, our exposure to these laws will grow.
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Healthcare Reform.
The U.S. and certain foreign jurisdictions continue
to consider or have enacted legislative and regulatory changes to the healthcare system that could affect our ability to sell our products
profitably. Policymakers and payors remain focused on containing healthcare costs while seeking to improve quality and expand access.
These efforts include ongoing cost-containment measures, value-based payment models, and reforms to reimbursement for medical devices.
In the United States, recent initiatives such as the
One Big Beautiful Bill Act of 2025 and the new CMS/FDA RAPID coverage pathway (announced in April 2026) aim to accelerate Medicare reimbursement
for certain breakthrough devices following FDA approval. While these developments could benefit our U.S. commercialization efforts for
products such as the Trachealator and Outflo catheters, broader cost-containment pressures—including site-neutral payments, expanded
use of ambulatory surgical centers, and ongoing scrutiny of device pricing—may limit coverage of or reduce reimbursement for procedures
using our devices. Any such changes could reduce demand for our products or create additional pricing pressure.
In the European Union, the Health Technology Assessment
Regulation (effective since January 2025) requires Joint Clinical Assessments for high-risk medical devices, which may influence national
reimbursement decisions. In South Africa, the phased implementation of National Health Insurance (NHI) continues, with Phase 2 (2026–2028)
focused on centralized purchasing and reimbursement reforms that could affect our local distribution and pricing strategies.
We expect additional state, federal, and foreign healthcare
reform measures to be adopted in the future. Any of these could limit the amounts that governments or private payors will reimburse for
our products or the procedures in which they are used, potentially reducing demand or increasing pricing pressure.
Our Key Products
The Company’s key products include the Trachealator,
the Outflo Aortic Valve Dilation Balloon Catheter, and the Cape Cross family of balloon catheters. Certain additional products remain
in development or are subject to regulatory review. The discussion below summarizes the Company’s principal products and selected
developmental products.
The Trachealator
The Trachealator is a non-occlusive airway dilation
balloon intended for use in selected airway dilation procedures. Tracheal and bronchial stenosis can arise from a number of causes and
may require one or more dilation procedures, depending on the patient and clinical circumstances.
The Trachealator received CE Mark approval in 2019
and FDA 510(k) clearance in November 2021. The product is sold in selected markets, including parts of Europe, the Middle East, South
America, portions of Asia, South Africa, and the United States. In May 2021, the product received a Gold Medal in the Medical Design Excellence
Awards.
The Trachealator received the CE Mark of approval
by a European notifying body (DEKRA). CE Marking is a qualification mandatory for any product to be sold in countries of the European
Union.
The USA recognizes only an FDA approval to accept
products in its market – a 510(k) accreditation that was obtained in November 2021 for the Trachealator and sales has since commenced
in the USA.
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FDA clearance and CE/MDR certification may support
regulatory submissions or market access in certain jurisdictions, but medical device approval requirements differ by country. Some jurisdictions
require additional local registrations, testing, certifications, or quality requirements before a product may be sold. The Company evaluates
market entry requirements on a jurisdiction-by-jurisdiction basis.
For example, Australia (Therapeutic Goods Administration
– TGA), Japan (Pharmaceuticals and Medical Devices Agency – PMDA), and China (National Medical Products Administration –
NMPA) have their own independent regulatory systems and do not automatically accept CE marking or FDA clearance.
The
Trachealator
The Trachealator
Outflo Aortic Valve Dilation Balloon Catheter
The Outflo Aortic Perfusion and Dilation Catheter
is a non-occlusive perfusion balloon to allow the expansion of the aortic valve without impeding the cardiac output.
The product is intended for use in selected procedures
involving post-dilation of an artificial valve in TAVI (Transcatheter Aortic Valve Implantation), where clinically appropriate.
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FDA clearance was obtained on March 11, 2025. Outflo
is currently marketed in South Africa, and marketing activities in the United States commenced during the fourth quarter of fiscal 2026.
Outflo Aortic Valve Dilation Balloon Catheter
The Cape Cross PTCA Catheter
The Company designed and developed the Cape
Cross range of semi-compliant coronary PTCA catheters. The product has obtained CE Mark approval and is sold in South Africa and selected
international markets.
A PTCA catheter is inserted either from the
groin or the arm and threaded through the blood vessels, through the aorta into the heart. The cardiac surgeon and/or interventional cardiologist
will move the catheter to the blocked artery (plaque). The balloon part of the catheter is inflated to open the blockage in the artery,
after which the balloon is deflated, and the entire catheter withdrawn and removed. If this procedure is not effective enough to open
the artery, a coronary stent will be placed inside the diseased area of the artery.
The Cape Cross PTCA Catheter
Cape Cross Non-Compliant (“NC”)
Catheter
The Cape Cross NC Catheter was developed as
a non-compliant balloon catheter for post-dilation procedures. The product has obtained CE Mark approval and is sold in South Africa and
selected international markets. After placement of a stent, a non-compliant balloon catheter
may be used to assist with stent apposition, depending on the clinical circumstances.
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The Cape Cross Non-Compliant (“NC”)
Catheter
The Micro CTO Catheter (Developmental)
The Company has developed a micro CTO (Chronic Total
Occlusion) balloon catheter range with diameters from 0.70 mm to 1.25 mm as a size range extension to the Cape Cross PTCA Catheter.
The product is intended for use in selected coronary
cases involving chronic total occlusions, subject to applicable regulatory approvals or certifications. The technical file was submitted
to the Company’s Notified Body at the end of July 2023 and remains under review.
The process of seeking FDA clearance for the Cape
Cross PTCA catheter range through the 510(k) substantial equivalence process commenced in January 2024. There can be no assurance as to
the timing or outcome of this process.
StaXstop Catheter (Developmental)
The StaXstop Catheter is an epistaxis catheter intended
for use in the management of nasal bleeding. The product remains in the development pipeline and is currently subject to research and
development, testing, pre-production prototyping, and related product validation activities. The Company expects that the product will
require FDA 510(k) clearance before it may be marketed in the United States.
Septus Balloon (Developmental)
The Septus Balloon is a nasal fracture balloon intended
for use in selected nasal procedures. The product remains in the development pipeline and is currently subject to research and development,
testing, and pre-production prototyping activities. Further development, regulatory review, and commercialization assessments will be
required before the product may be marketed in applicable jurisdictions.
Vaultseal Balloon (Developmental)
The Vaultseal Balloon is a balloon product intended
for use in selected gynecological procedures. The product remains in the development pipeline and is currently subject to research and
development, testing, and pre-production prototyping activities. The Company will continue to
evaluate the product’s regulatory pathway, commercial feasibility, and timing of any potential market introduction.
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Product
Development Pipeline
The following distinct and finite developmental phases / stages
are applicable to all our product pipeline, namely:
1)
R&D
2)
Pre-production prototyping
3)
Testing
4)
Production
5)
Clinical trials
6)
MDR/CE Mark accreditation
7)
Local marketing & selling
8)
International sales outside the US
9)
FDA 510 (k) approval
10)
Sales to the United States.
The products described have reached the following stages:
Trachealator:
FDA 510(k) clearance and CE/MDR certification obtained. The Company continues to supply Trachealators to private and academic hospitals throughout the United States.
OutFlo Aortic Valve Dilation Balloon Catheter:
FDA clearance was obtained on March 11, 2025. Outflo is in market in South
Africa, and extensive marketing in the United States has commenced during the fourth quarter of fiscal 2026.
Cape Cross PTCA Catheter:
Application for FDA 510(k) clearance in progress with external consultants. Final submission pending. CE certification under the MDD has been obtained, and is still valid under Regulation (EU) 2023/607. CE certification under the MDR is in progress.
Cape Cross NC Catheter:
Application for FDA 510(k) clearance in progress with external consultants. Final submission pending. CE certification under the MDD has been obtained, and is still valid under Regulation (EU) 2023/607. CE certification under the MDR is in progress.
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Micro CTO Catheter :
R&D, testing, and pre-production prototyping completed. Technical File submitted to the Notified Body in July 2023 and remains under review as of the date of this report.
StaXstop Catheter:
Developmental / Pipeline: An epistaxis catheter - R&D, Testing, Pre-Production Prototyping, Testing, Production, Clinical Trials – FDA 510(k) exempted (Class I product)
Septus Balloon:
Developmental / Pipeline: A nasal fracture balloon – R&D Testing, Pre-Production Prototyping, Testing.
Vaultseal Balloon:
Developmental / Pipeline: A gynae vaginal vault sealing balloon: R&D Testing, Pre-Production Prototyping, Testing.
See Item 1A. Risk Factors for a discussion of risks
associated with product development, clinical trials, and regulatory approvals.
Intellectual Property
The Medinotec Group of Companies currently holds various
product registration certificates and operating licenses, which allow us to operate as an importer of raw materials for the manufacture
of medical devices and an exporter and distributor of these products within the territories we service. We also hold various patents,
trademarks, and other intangible proprietary rights that are considered material to the business and its ability to compete effectively
with other companies.
The Medinotec Group pursues patent protection in selected
jurisdictions where management believes such protection is appropriate for patentable subject matter in its products. The Company also
reviews publicly available third-party patents and patent applications where relevant to its product development and commercialization
activities. These activities are intended to support the Company’s intellectual property position and reduce the risk of infringing
third-party rights, although there can be no assurance that these efforts will be effective.
Due to the Trachealator being fairly new, patent applications
for the Trachealator have been filed in the following countries or regions: USA, European Union, China, Australia, Korea and South Africa.
All other products are either not novel enough to file a patent or not yet developed far enough to start filing processes.
The status of these applications is listed below:
1)
USA:
Patent No. 12,036,376, B2 has been granted on July 16, 2024. This patent is valid until April 28, 2040.
2)
China:
Patent No. 201880086558.2 has been granted on March 31, 2023. This patent is valid until December 12, 2038.
3)
South Korea:
Patent No. 10-2635372 has been granted on February 5, 2024. This patent is valid until September 4, 2040.
4)
European Union:
European
Community Registered Patent No. 18903920.9 / has been granted with effect from March 5, 2025. The patent is valid until March
4, 2045.
5)
South Africa:
Patent No. 2020/02618 has been granted on July 27, 2022. This patent is valid until July 27, 2040.
6)
Australia:
Australian
Registered Patent No. 2018406682 / has been granted on December 12, 2025. The patent is valid until December 11,2038.
No patents have been licensed from third parties.
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Trade Secrets
With respect to some of our products, Medinotec Group
of Companies rely principally on trade secrets, rather than patents, to protect proprietary processes, methods, documentation, and other
technologies, as well as certain other business information.
Although the Medinotec Group of Companies seek patents
from time to time as discussed above, patent protection for other industrial and specialty products requires a costly federal registration
process with an uncertain outcome that would place confidential information in the public domain.
The Company sells to or through hospitals, clinics,
third-party healthcare providers, distributors, governmental healthcare programs, and group purchasing organizations. A significant portion
of the Company’s revenue is generated through distributor relationships, including DISA Life Sciences in South Africa.
Research and Development
All R&D is conducted within the Medinotec Group
of Companies, which employs the necessary engineers, and technical and support personnel. The in-house technical expertise includes biomedical
engineering and product design. The R&D team focuses primarily on developing new products and supporting existing products.
Condition of Physical Assets and Insurance
Parts of the Medinotec Group of Companies are capital
intensive and require ongoing capital investment for the replacement, modernization and/or expansion of equipment and facilities. We therefore
maintain insurance policies against property loss and business interruption and insure against other risks that are typical in the operation
of the business, in amounts that we believe to be reasonable. Where costs are deemed to be commercially unviable, we self-insure. Such
insurance, however, contains exclusions and limitations on coverage, particularly with respect to environmental liability and political
risk. There can thus be no assurance that claims would be paid under such insurance policies in connection with a particular event.
Primary Customers
Medinotec Group of Companies primary customers include
hospitals, clinics, third-party healthcare providers, distributors, and other institutions, including governmental healthcare programs
and group purchasing organizations (“GPOs”). We also benefit from strong and long-standing relationships with customers in
each of the industrial and specialty products end markets we serve.
Third Party Coverage and Reimbursement
Healthcare providers that purchase medical devices
generally rely on third-party payors, including private payors, such as indemnity insurers, employer group health insurance programs and
managed care plans, to reimburse all or part of the cost of the products. As a result, demand for our products is and will continue to
be dependent in part on the coverage and reimbursement policies of these payors.
Possible reductions in, or eliminations of, coverage
or reimbursement by third-party payors, or denial of, or provision of uneconomical reimbursement for new products may affect our customers’
revenue and ability to purchase our products. Any changes in the healthcare regulation, payment or enforcement landscape relative to our
customers’ healthcare services have the potential to significantly affect our operations and revenue.
Additional Information
The public may read and copy any materials the Company
files with the SEC in the SEC’s Public Reference Section, Room 1580, 100 F Street N.E., Washington, D.C. 20549. The public may obtain
information on the operation of the Public Reference Section by calling the SEC on 1-800-SEC-0330. Additionally, the SEC maintains an
Internet site that contains reports, proxy and information statements,
and other information regarding issuers that file electronically with the SEC, which can be found at http://www.sec.gov.
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Item 1A.
Risk Factors.
You should carefully consider the risks described
below, together with all of the other information included in this Annual Report on Form 10-K, before making an investment decision regarding
our securities. The occurrence of any of the following risks, or additional risks and uncertainties not presently known to us or that
we currently deem immaterial, could materially and adversely affect our business, financial condition, results of operations, cash flows
and the trading price of our common stock. In such a case, you may lose all or part of your investment.
SUMMARY OF PRINCIPAL RISK FACTORS
The following is a summary of the principal risks
that could materially and adversely affect our business, financial condition, results of operations and stock price. This summary does
not include every risk we face; a more complete discussion of the risks set forth below appears later in this Item 1A under the corresponding
headings. You should read the full “Risk Factors” section for a more detailed discussion of these and other material risks.
Liquidity, Capital Needs and Dilution Risk
We may require additional capital to fund U.S. commercialization, product development and potential acquisitions. There can be no assurance
that such financing will be available on favorable terms, or at all. Any future equity offerings would dilute existing shareholders, and
our failure to obtain necessary capital could delay or prevent execution of our growth strategy.
Customer and Geographic Concentration Risk
We derive a substantial majority of our revenue from a limited number of customers and geographic markets. In particular, sales to DISA
Life Sciences in South Africa represented approximately 89% of our total revenue for the fiscal year ended February 28, 2026. Any loss
or material reduction in business with DISA Life Sciences, or any disruption in the South African market, would have a material adverse
effect on our revenue, profitability and cash flows.
Regulatory and Product Approval Risk
Our ability to commercialize current and future products in the United States and other major markets depends on obtaining and maintaining
regulatory clearances and approvals, including FDA 510(k) clearance and compliance with the EU Medical Device Regulation (MDR). Delays
in, or failure to obtain, these approvals, or any subsequent product modifications that require new clearances, could prevent or significantly
delay product launches, harm our reputation and materially adversely affect our growth and financial results.
South Africa-Specific Operational and Political
Risks
Our primary manufacturing operations are located in South Africa, exposing us to country-specific risks including frequent load-shedding
and unstable power supply, political instability, Broad-Based Black Economic Empowerment (BEE) requirements that could limit growth or
talent acquisition, stringent exchange controls that may restrict or delay repatriation of funds to the United States, and potential changes
in South African tax, labor or regulatory policy. Any of these factors could disrupt manufacturing, increase costs or impair our ability
to fund U.S. operations.
Geopolitical, Trade and Tariff Risks
We are subject to risks arising from U.S. tariffs on South African goods, potential revocation or modification of AGOA benefits, retaliatory
trade measures, and broader geopolitical tensions (including conflicts involving Iran and global shipping disruptions). These developments
could materially increase our costs, reduce competitiveness in the U.S. market, disrupt supply chains and adversely affect revenue and
margins.
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Dependence on Key Personnel and Founder Control
Our future success depends heavily on the continued service of our founder, CEO and director Dr. Gregory Vizirgianakis and our CFO Pieter
van Niekerk. In addition, Dr. Vizirgianakis and his brother Stavros together control approximately 81% of our voting power. The loss of
either key executive, or any actions by the controlling shareholders that are not aligned with minority shareholders, could materially
harm our business, strategy execution and governance.
Market and Securities Risks
Our common stock trades on the OTCQX and is subject to “penny stock” rules, which may limit liquidity and make it more difficult
for investors to sell shares. The market price of our stock may be highly volatile, and we may be unable to uplist to a national securities
exchange or maintain such a listing if achieved. These factors could result in substantial losses for investors and limit our ability
to raise capital in the future.
Product Development, Competition and Commercialization
Risk
Our growth depends on successfully developing and commercializing new products and line extensions. Many of these products are in the
development pipeline and may never reach market, may fail to obtain regulatory approval or may not achieve commercial acceptance. We also
face intense competition from much larger, well-capitalized medical device companies, which could limit our market share and profitability.
Investing in our securities involves a high degree
of risk. You should carefully review the full discussion of these and other risks in the “Risk Factors” section below before
making an investment decision.
Risks Related to our Financial Position and Need
for Capital
The Medinotec Group of Companies
may need additional financing – any limitation on our ability to obtain such additional financing could have a material adverse
effect on the business, financial condition, and results of operations.
Our expansion plans, particularly the continued commercialization
of our products in the United States (including the Trachealator and Outflo), pursuit of additional FDA 510(k) clearances, and scaling
of manufacturing and regulatory compliance activities, may require additional capital. We may also need capital to operate our business
in response to circumstances caused by the risks described in this report, including customer concentration, foreign exchange volatility,
and South Africa-specific operational challenges.
The raising of additional capital could result in
dilution to stockholders. In addition, there is no assurance that we will be able to obtain additional capital if we need it, or that
if available, it will be available to us on favorable or reasonable terms. Any limitation on our ability to obtain additional capital
as and when needed could have a material adverse effect on the business, financial condition and results of operations.
We may also incur additional indebtedness in
the future. This could have adverse consequences, including the following:
•
making it more difficult for us to satisfy our financial obligations;
•
increasing vulnerability to adverse economic, regulatory and industry conditions;
•
placing us at a disadvantage to our competitors that are less leveraged;
•
limiting the ability to compete and flexibility in planning for, or reacting to, changes in the business and the industry in which we operate;
•
limiting the ability to borrow additional funds for working capital, capital expenditures, acquisitions and general corporate or other purposes; and
•
exposing us to greater interest rate risk since the interest rate on floating rate borrowings is variable.
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Any potential future debt service obligations may
require us to use a portion of the operating cash flow to pay interest and principal on indebtedness instead of for other corporate purposes,
including funding the future expansion of the business, acquisitions, and ongoing capital expenditures, which could impede growth. If
operating cash flow and capital resources are insufficient to service debt obligations, we may be forced to sell assets, seek additional
equity or debt financing or to restructure our debt, which could harm long-term business prospects.
Our failure to comply with the terms of any potential
future debt obligations could also result in an event of default which, if not cured or waived, could result in the acceleration of all
its debt and impact our ability to operate as a going concern.
Management evaluated the Company’s ability to
continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available
funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance
of these financial statements.
Future changes in financial accounting
standards or practices or existing taxation rules or practices may cause adverse or unexpected revenue fluctuations and affect the reported
results of operations within The Medinotec Group of companies.
A change in accounting standards or practices or a
change in existing taxation rules or practices can have a significant effect on our reported results and may even affect our reporting
of transactions completed before the change is effective. This also applies to new standards, practices, and rules.
Changes to existing rules or the questioning of current
practices may adversely affect our reported financial results or the way we conduct our business. The fact that we operate in multiple
territories (including the United States and South Africa) heightens this risk in specific territories.
Risks Relating to Business Operations
Consolidation in the healthcare industry could
have an adverse effect on revenues and results of operations of the Medinotec Group of Companies.
Many healthcare companies, including healthcare systems,
distributors, manufacturers, providers, and insurers, are consolidating or have formed strategic alliances. As the healthcare industry
consolidates, competition to provide goods and services to industry participants will become more intense. Further, this consolidation
creates larger enterprises with greater negotiating power, which they can use to negotiate price concessions or demand more favorable
contract terms.
As a smaller company with limited market share, we
are particularly vulnerable to these dynamics. Our business is already subject to significant price pressure in both our proprietary product
lines and our distribution business. Larger consolidated customers or distributors may demand deeper discounts, volume-based rebates,
or exclusive arrangements that favor our much larger, better-capitalized competitors. If we are forced to reduce our prices or lose existing
distributor relationships (including our significant relationship with DISA Life Sciences) as a result of industry consolidation, our
revenues, gross margins, profitability, and cash flows could be materially and adversely affected.
We believe our low-cost manufacturing base in South
Africa provides some competitive advantage, but there can be no assurance that this advantage will be sufficient to offset the pricing
and contracting leverage held by larger consolidated entities.
Healthcare industry cost-containment measures
could result in reduced sales of the Medinotec Group of Companies medical devices and medical device components.
Most of our customers and the healthcare providers
to whom our customers supply medical devices, rely on third-party payers, including government programs (such as Medicare and Medicaid
in the United States and public healthcare funding in South Africa) and private health
insurance plans, to reimburse some or all the cost of the procedures in which medical devices that incorporate components we manufacture
or assemble are used.
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The continuing efforts of governmental authorities,
insurance companies and other payers of healthcare costs to contain or reduce these costs, through mechanisms such as reduced reimbursement
rates, bundled payments, competitive tender processes, prior-authorization requirements, and value-based purchasing, could lead to patients
being unable to obtain approval for payment from these third-party payers or could cause hospitals and other providers to favor lower-cost
alternatives.
If third-party payer payment approval cannot be obtained
by patients, or if providers face increased pressure to reduce procedure costs, sales of finished medical devices that include our components
(including our proprietary Trachealator, Outflo, and Cape Cross products) may decline significantly. Our customers, including distributors
and hospitals, may reduce or eliminate purchases of our devices in favor of lower-priced competitors. These pressures are particularly
acute in the U.S. market where we are expanding commercialization efforts and in South Africa where a large portion of our current revenue
is generated. The cost-containment measures that healthcare providers are instituting, both in the United States and outside of the United
States, could harm our ability to maintain pricing levels, achieve anticipated sales volumes, and operate profitably.
The continuing development of many of our products
and offerings depends on our maintaining strong relationships with healthcare professionals, and these professionals are external to the
Medinotec Group of Companies.
If we fail to maintain our working relationships with
healthcare professionals, many of our products may not be launched and marketed in line with the needs and expectations of the professionals
who use and support our products, which could cause a decline in earnings and profitability.
The research, development, marketing and sale of many
of our new products — including the Trachealator, Outflo, Cape Cross family, and our development pipeline (Micro CTO Catheter, StaXstop
Catheter, Septus Balloon, and Vaultseal Balloon) — depends on our maintaining working relationships with healthcare professionals.
Physicians, surgeons, and other key opinion leaders assist us as researchers, product consultants, clinical advisors, trainers, inventors,
and public speakers. These relationships are critical for product feedback, clinical validation, surgeon training programs, endorsement,
and adoption in both existing and new markets, particularly as we expand commercialization in the United States.
Any failure to maintain these relationships or to
expand our network to include new professionals in the territories we enter (especially in highly regulated markets such as the United
States), will have a negative impact on our ability to develop, obtain regulatory clearance for, launch, and achieve market acceptance
of our products, which could materially and adversely affect our financial success.
Products in the development pipeline of The
Medinotec Group of Companies may not come to market or fail to commercialize.
We currently have several innovative products in various
stages of the research and development pipeline, including the Micro CTO Catheter (Technical File submitted to our Notified Body in July
2023 and currently under review), as well as the StaXstop Catheter, Septus Balloon, and Vaultseal Balloon (in earlier developmental stages).
However, some of these projects may fail to come to market for a number of reasons, including delays or failure to obtain necessary regulatory
clearances (such as additional FDA 510(k) clearances or full compliance with the EU Medical Device Regulation), competitor products reaching
the market first, lack of economic viability due to high production costs relative to projected sales, insufficient market acceptance
by physicians and hospitals, or unfavorable results from safety, efficacy, or clinical evaluations.
Our growth strategy depends in significant part on
successfully commercializing these and future pipeline products, particularly in the United States and other higher-value regulated markets,
to diversify revenue and reduce our current heavy reliance on South African sales. Any failure to advance these products through regulatory
approval, scale manufacturing, or achieve meaningful market adoption could materially delay or prevent revenue growth, limit our ability
to compete effectively, and adversely affect our business, financial condition, and results of operations.
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The Medinotec Group of Companies operate in
a highly competitive industry and may be unable to compete effectively.
We compete in medical markets throughout the world,
which are characterized by rapid changes resulting from technological advances and scientific discoveries. In the product lines in which
we compete, we face competition ranging from large, multinational companies with multiple business lines and significantly greater financial,
technical, marketing, and distribution resources (such as Johnson & Johnson, Boston Scientific, Medtronic, and others) to small, specialized
manufacturers that offer niche products. Development by other companies of new or improved products, processes, technologies, or the introduction
of lower cost alternatives, including reprocessed products or generic versions when our proprietary products lose their patent protection,
may make existing or planned products less competitive. As a smaller company with limited market share, we are particularly vulnerable
to these competitive pressures, especially as we seek to expand commercialization of our proprietary devices (including the Trachealator,
Outflo, and Cape Cross family) into the highly regulated and competitive United States market.
We believe our ability to compete depends upon many
factors both within and beyond our control, including product performance and reliability, product technology and innovation, product
quality and safety, breadth of product lines, product support services, customer support, cost-effectiveness and price, reimbursement
approval from healthcare insurance providers, and changes to the regulatory environment.
Competition may increase as additional companies enter
our markets or modify their existing products to compete directly with ours. In addition, academic institutions, governmental agencies,
and other public and private research organizations also may conduct research, seek patent protection, and establish collaborative arrangements
for discovery, research, clinical development and marketing of similar products.
These companies and institutions compete with us in
recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. From time
to time we have lost, and may in the future lose, market share in connection with product problems, physician advisories, safety alerts
and publications about our products, which highlights the importance of product quality, product efficacy and quality systems to the business.
In the current environment of managed care, consolidation
among healthcare providers, increased competition, and declining reimbursement rates, we have been increasingly required to compete on
the basis of price. Further, our continued growth and success depend on our ability to develop, acquire and market new and differentiated
products, technologies, and intellectual property. As a result, we also face competition for marketing, distribution, and collaborative
development agreements, establishing relationships with academic and research institutions and licenses to intellectual property.
In order to continue to compete effectively, we must
continue to create, invest in or acquire advanced technology, incorporate this technology into its proprietary products, obtain regulatory
approvals in a timely manner, and manufacture and successfully market our products. Given these factors, we cannot guarantee that we will
be able to compete effectively or continue its current level of success.
Reduction or interruption in supply or
other manufacturing difficulties may adversely affect operations and related product sales within the Medinotec Group of Companies.
The supply of products requires timely delivery and
exact planning due to most of our raw material either being manufactured by suppliers or imported. These suppliers/strategic partners
require a sufficient amount of quality components and materials and are highly exacting and complex, due in part to strict regulatory
requirements.
We have generally been able to obtain adequate supplies
of such finished goods, raw materials, components, and services. However, for reasons of quality assurance, cost effectiveness, or availability,
certain components, raw materials, goods, and services needed to fill our supply chain are obtained from various sole suppliers.
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Although we work closely with our suppliers to ensure
continuity of supply while maintaining high quality and reliability, the supply of these goods, components, raw materials, and services
may be interrupted or insufficient. In addition, due to the stringent regulations and requirements of regulatory agencies, regarding the
manufacture and import/export of our products, we may not be able to quickly establish additional or replacement sources. In addition,
a reduction or interruption in supply, and an inability to develop alternative sources for such supply, could adversely affect our ability
to supply products in a timely or cost-effective manner and could result in lost sales.
Other disruptions in the supply chain process or product
sales and fulfilment systems for any reason, including equipment malfunction, failure to follow specific protocols and procedures, supplier
facility shut-downs, defective raw materials, wars and conflict, natural disasters, power outages (including frequent load-shedding in
South Africa), civil unrest, or other environmental factors, could lead to launch delays, product shortage, unanticipated costs, lost
revenues and damage to our reputation. These risks are particularly relevant to us because our primary manufacturing facility is located
in Johannesburg, South Africa, and we rely on both local and international suppliers for critical inputs. Furthermore, any failure to
identify and address manufacturing problems prior to the release of products to customers could result in quality or safety issues.
These disruptions are exacerbated by global economic
uncertainty and heightened geopolitical tensions, such as the Russian war on Ukraine, between the United States and China as well as Brexit
and conflicts in the Middle East, which can also have an impact on several factors influencing prices, exchange rates, and interest rates,
all of which can affect our business in turn.
In addition, several key components are manufactured
or sterilized at a particular facility, with limited alternate facilities. If an event occurs that results in damage to or closure of
one or more of such facilities, such as the damage caused by natural disasters, power outages, civil unrest, and other factors, we may
be unable to manufacture or sterilize the relevant products at the previous levels or at all. Because of the time required to approve
and license a manufacturing or sterilization facility, a third-party may not be available on a timely basis to replace production capacity
in the event manufacturing or sterilization capacity is lost.
In order to manage any supply chain risk, we have
identified key and crucial components in our manufacturing lines that we deem not to be readily available, and we have vetted 2-3 trusted
suppliers, which we believe mitigates the risk of becoming overly reliant on a specific supplier. Despite this precaution, there is no
assurances that we will be able to secure the materials needed in the event these sources are unable to fulfil orders. Any failure in
the supply chain would result in a lack of inventory and an inability to sell products. For all other non-key materials, we find that
these are readily available from a variety of suppliers and therefore, the risk of sourcing them is minimal or non-existent.
The Medinotec Group of Companies rely on the
proper function, security and availability of our IT systems and data to operate the business, and a breach, cyber-attack or other disruption
to these systems or data could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation,
or competitive position.
We are increasingly dependent on sophisticated IT
systems to operate the business, including to process, transmit and store sensitive data, and many of our products and services include
integrated software and IT that collects data regarding patients or connects to its systems.
Like other multi-national corporations, we could experience,
and in the past have experienced, attempted or actual interference with the integrity of, and interruptions to, our IT systems, as well
as data breaches, such as cyber-attacks, malicious intrusions, breakdowns, interference with the integrity of our products and data or
other significant disruptions.
Furthermore, we rely on third-party vendors to supply
and/or support certain aspects of our IT systems. These third-party systems could also become vulnerable to cyber-attack, malicious intrusions,
breakdowns, interference, or other significant disruptions, and may contain defects in design or manufacture or other problems that could
result in system disruption or compromise the information security of our own systems.
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In addition, we continue to grow in part through new
business acquisitions and, as a result, may face risks associated with defects and vulnerabilities in their systems, or difficulties or
other breakdowns or disruptions in connection with the integration of the acquisitions into its own IT systems.
Our worldwide operations mean that we are subject
to laws and regulations, including data protection and cybersecurity laws and regulations, in many jurisdictions. Any data security breaches,
cyber-attacks, malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation, any
of which could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation or competitive
position.
In addition, our IT systems require an ongoing commitment
of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes
in information processing technology, evolving legal and regulatory standards, the increasing need to protect patient and customer information,
changes in the techniques used to obtain unauthorized access to data and information systems, and the IT needs associated with changing
products and services.
There can be no assurance that the process of consolidating,
protecting, upgrading, and expanding systems and capabilities, continuing to build security into the design of products, and developing
new systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues
will not arise in the future.
If our IT systems, products or services or sensitive
data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer a loss of product functionality.
We could lose existing customers, have difficulty attracting new customers, have difficulty preventing, detecting, and controlling fraud,
be exposed to the loss or misuse of confidential information, have disputes with customers, physicians, and other healthcare professionals,
suffer regulatory sanctions or penalties under federal laws, state laws, or the laws of other jurisdictions, experience increases in operating
expenses or an impairment in our ability to conduct operations, incur expenses or lose revenues as a result of a data privacy breach,
product failure, IT outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to
reputation.
During the years ended February 28, 2026, and February
28, 2025, we did not, to our knowledge, experience any cybersecurity incidents or breaches that materially impacted or are reasonably
likely to materially impact our business, performance or results.
The Medinotec Group of Companies business model
is concentrated around developing countries with higher growth rates, although this model also causes forex risk exposure which may cause
adverse or unexpected revenue fluctuations and affect the reported results of operations.
A significant portion of our manufacturing operations
and supply chain is based in South Africa, where the functional currency is the South African Rand (ZAR). We import a substantial amount
of raw materials and components, many of which are priced or paid in U.S. dollars or other foreign currencies, while a large part of our
current revenue is generated in ZAR (primarily through our South African distribution activities). Our consolidated financial statements
are reported in U.S. dollars. As a result, fluctuations in the ZAR relative to the U.S. dollar and other currencies directly affect our
cost of goods sold, gross margins, and the translated value of our revenue and expenses.
Foreign exchange risk arises when a company engages
in financial transactions denominated in a currency other than the currency where that company is based. Any appreciation/depreciation
of the base currency or the depreciation/appreciation of the denominated currency will affect the cash flows emanating from that transaction.
Our business of import/exports of raw materials and
goods exposes us to foreign exchange risk by having account payables and receivables affected by currency exchange rates. This risk originates
when a contract between us and our suppliers specifies exact prices for goods or services, as well as delivery dates. If a currency’s
value fluctuates between when the contract is signed and the delivery date, it could cause a loss for one of the parties.
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Our business model is concentrated around developing
countries with higher growth rates which causes greater exposure to forex risk which may cause adverse or unexpected revenue fluctuations
and affect the reported results of operations. Usually, the attractive growth rates of these developing countries offset the long term
forex implications of their volatile currencies.
There are three types of foreign exchange risk that
we are exposed to:
•
Transaction risk: This is the risk that we face when we are buying a product from a company located in another country. The price of the product will be denominated in the selling company's currency. If the selling company's currency were to appreciate versus the buying company's currency, then the company doing the buying will have to make a larger payment in its base currency to meet the contracted price.
•
Translation risk: A parent company owning a subsidiary in another country could face losses when the subsidiary's financial statements, which will be denominated in that country's currency, is translated back to the parent company's currency.
•
Economic risk: Also called forecast risk, this refers to when market value is continuously impacted by an unavoidable exposure to currency fluctuations.
We continually assess our foreign exchange risks and
implement varying strategies based on the current economic conditions to implement hedging strategies to mitigate that risk. This usually
involves forward contracts, options, and other exotic financial products that, if done properly, can protect us from unwanted foreign
exchange moves during periods of high volatility. We may also impose a strategy of not hedging due to the costs involved outweighing the
benefits. We then leave exposures unhedged until market conditions and costs justify proceeding with a hedging strategy into the future.
The long-term strategy is to make certain strategic
investments that will generate revenue in first-world, stable currencies to offset the impacts of cost of sales imports in developing
currencies. Material adverse movements in exchange rates could increase our costs, reduce gross margins, cause volatility in our reported
financial results, and materially and adversely affect our business, financial condition, and results of operations.
The Medinotec Group of Companies operate in
countries where the market is dominated by certain players and this creates a sales concentration risk which also causes an accounts receivable
concentration risk.
We have historically relied, and continue to rely
heavily, on a limited number of customers and distributors for a substantial portion of our revenue. In particular, sales to DISA Life
Sciences in South Africa represented approximately 89% of our total revenue for the fiscal year ended February 28, 2026. This high customer
concentration also creates significant accounts receivable concentration risk.
The loss or material reduction in business with DISA
Life Sciences, or any disruption in our South African distribution relationships, would have a material adverse effect on our revenue,
gross profit, cash flows, and overall financial condition. Although we are actively working to diversify our customer base and geographic
revenue mix through expanded U.S. commercialization and new international distributor relationships, there is no assurance that these
efforts will succeed or reduce our concentration risk in the near term. Barriers to entry in new markets, regulatory delays, competitive
pressures, and other factors may prevent or delay successful diversification.
As a result, our business, results of operations,
and financial condition remain highly dependent on the continued success of our relationship with DISA Life Sciences and the stability
of the South African market.
Please refer to the related parties and entities section for
a more detailed discussion on each function and the relationships involved as well as any arm’s length disclosures.
These relationships have the upside of:
•
Developing long-term relationships with fewer large customers
•
Less contractual agreements and overheads per dollar
•
Greater focus on customer service and customer needs
•
Work with large customers similarly to partners
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These relationships also pose the following risks
and downsides:
•
Loss can devastate revenue, profit, and cash flow
•
Holds pricing and negotiating leverage, which can decrease revenue
•
Diverts disproportionate amounts of resources away from smaller customers
•
Causes difficulty diversifying over time
•
Can decrease the value of a company
Due to the nature of the territories that we operate
in, it will be impossible to eliminate concentration risk. However, we do plan to diversify into a larger product basket and increase
our international footprint, either by growing operations into other territories or alternatively acquiring more business share in other
geographical territories.
The Medinotec Group of Companies insurance program
may not be adequate to cover future losses.
We have elected to combine a mix of self-insurance
and insured risks for most of the insurable risks across our company. We made this decision based on cost and availability factors in
the insurance marketplace.
We continue to maintain a directors and officers liability
insurance policy with third-party insurers that provides coverage for our directors and officers. This policy also covers product liability
claims to a limited extent. We also maintain a detailed stock throughput policy to ensure inventory is ensured against losses and fire
risk. All other assets fall into the category of self-insurance.
We continue to monitor the insurance marketplace to
evaluate the value of obtaining insurance coverage for other categories of losses in the future. Although we believe, based on historical
loss trends, that our self-insurance program accruals and existing insurance coverage will be adequate to cover future losses, historical
trends may not be indicative of future losses.
Risks associated with insurance plans include:
•
Insurance costs could increase significantly, or the availability of insurance may decrease, either of which could adversely impact our financial condition;
•
Deductible or retention amounts could increase, or our coverage could be reduced in the future and to the extent losses occur, there could be an adverse effect on our financial results depending on the nature of the loss and the level of insurance coverage we maintained;
•
Insurance may not be available to us at an economically reasonable cost, or our insurance may not adequately cover our liability in connection with claims brought against us; and
•
As our business inherently exposes us to claims, we may become subject to claims for which we are not adequately insured. Unanticipated payment of a large claim may have a material adverse effect on our business.
The absence of sufficient third-party insurance coverage
for other categories of losses increases our exposure to unanticipated claims and these losses could have a materially adverse impact
on the business, results of operations, financial condition, and cash flows.
The Medinotec Group of Companies future growth
is dependent upon the development of new products and line extensions, which requires significant research and development, clinical trials,
and regulatory approvals, all of which are very expensive and time-consuming and may not result in a commercially viable product.
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In order to develop new products and improve current
product offerings through our strategic partnerships with other principals, we focus our research and development programs largely on
the development of, or obtaining the exclusive distribution rights to, next-generation and technology offerings across multiple programs
and opportunities. Our current pipeline includes the Micro CTO Catheter (Technical File submitted to our Notified Body in July 2023 and
currently under review), as well as the StaXstop Catheter, Septus Balloon, and Vaultseal Balloon (in earlier developmental stages).
As a part of the regulatory process of obtaining marketing
clearance from the respective countries’ regulators for new products, we and our strategic partners conduct and participate in numerous
clinical trials with a variety of study designs, patient populations and trial endpoints. Unfavorable or inconsistent clinical data from
existing or future clinical trials conducted by us or partners related to us, by our competitors or by third parties, or the market’s
perception of this clinical data, may adversely impact our ability to obtain product approvals from the regulators, our position in, and
share of, the markets in which we participate and our business, financial condition, results of operations or future prospects.
Our growth strategy depends in significant part on
successfully advancing these pipeline products through regulatory approval and achieving commercial acceptance, particularly in the United
States and other higher-value regulated markets to diversify revenue and reduce our current heavy reliance on South African sales. Any
delays, failures, or unfavorable outcomes in product development, clinical testing, or regulatory processes could materially delay or
prevent revenue growth, limit our ability to diversify away from our current concentration in South Africa, and adversely affect our business,
financial condition, and results of operations.
If the Medinotec Group of Companies fails to
maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which
could harm our operating results, our ability to operate and investors’ views of us.
If we fail to maintain effective internal control
over financial reporting, our ability to report our financial condition and results of operations accurately and on a timely basis could
be adversely affected.
Although management concluded that our internal control
over financial reporting was effective as of February 28, 2026, internal controls can provide only reasonable assurance and may not prevent
or detect all misstatements. During fiscal 2026, we implemented remediation measures to address previously identified material weaknesses.
There can be no assurance that these measures will continue to operate effectively or that additional material weaknesses or other control
deficiencies will not be identified in the future. Any failure to maintain effective internal control over financial reporting could adversely
affect our ability to report our financial condition and results of operations accurately and on a timely basis, which could negatively
affect investor confidence in our reported financial information and adversely affect our business and the market price of our common
stock.
We have limited experience in marketing and
sales and are in the early stages of building our sales channels in the life science market and internationally .
We may not be able to market, sell or distribute our
current and future products effectively enough to support our planned growth. Currently, we sell our products through a combination of
direct sales efforts and partnerships with distributors across all our key markets. During the fiscal year ended February 28, 2026, our
distributors (including DISA Life Sciences, which accounted for approximately 89% of our total revenue) represented the substantial majority
of our sales. We are in the process of broadening and diversifying our sales channels across all markets, particularly as we expand commercialization
of the Trachealator and Outflo in the United States.
In the future, if we fail to maintain good relationships
with, or fail to successfully motivate any of our large distributors, our revenue may decline. If we do not diversify our sales channels
and effectively utilize our direct sales force, we will continue to be susceptible to risks associated with having a large percentage
of revenue concentrated with a limited number of distributors.
Competition for employees capable of selling expensive
medical devices within the pharmaceutical and biotechnology industries is intense. We may not be able to attract and retain personnel
or be able to build an efficient and effective sales organization, which could negatively impact sales
and market acceptance of our products and limit our revenue growth and potential profitability.
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In addition, the time and cost of establishing a specialized
sales, marketing and customer service force for a particular product or service may be difficult to justify considering the revenue projected
to be generated by such additional personnel and resources. We also intend to add additional distribution partners in the life science
market, and if we are unable to do so successfully, it will adversely impact on our ability to increase the revenue from our product offerings.
We rely on distributors for the sale of our products
abroad and are entering into new agreements for the United States. We intend to continue to grow our business internationally and in the
United States and to do so we must attract additional distributors and retain existing distributors to maximize the commercial opportunity
for our products. We exert limited control over existing distributors under our agreements with them, and if their sales and marketing
efforts for our products in their particular region are not successful, our business would be materially and adversely affected. Locating,
qualifying, and engaging additional distribution partners with local industry experience and knowledge will be necessary in at least the
short to mid-term to effectively market and sell our platform in certain countries outside the United States. We may not be successful
in finding, attracting, and retaining distribution partners, or we may not be able to enter into such arrangements on favorable terms.
Most of our distribution relationships are non-exclusive
and permit such distributors to distribute competing products. As such, our distributors may not commit the necessary resources to market
our products to the level of our expectations or may choose to favor marketing the products of our competitors. Some of our distribution
relationships are exclusive where the company is forced to rely on their efforts. Our distribution partners may compete against our inside
sales force for sales opportunities. If current or future distributors do not perform adequately, offer competitive products, compete
with our own sales staff, or we are unable to enter into effective arrangements with distributors in particular geographic areas, we may
not realize long-term international revenue growth.
We rely on a limited number of subcontractors
to manufacture, assemble, package and production test our products, and the failure of any of these third-party subcontractors to deliver
products or otherwise perform as requested could damage our relationships with our customers, decrease our sales and limit our growth.
While we design and market our products and conduct
test development in-house, we do not manufacture, assemble, package and production test the vast majority of components of our products,
and we must rely on third-party subcontractors to perform these services. If these subcontractors do not provide us with high-quality
products, services and production and production test capacity in a timely manner, or if one or more of these subcontractors terminates
its relationship with us, we may be unable to obtain satisfactory replacements to fulfill customer orders on a timely basis, our relationships
with our customers could suffer, our sales could decrease, and our growth could be limited.
In addition, the consolidation of foundry subcontractors,
as well as the increasing capital intensity and complexity associated with fabrication in smaller process geometries has limited the diversity
of our suppliers and increased our risk of a "single point of failure." The lack of diversity of suppliers could also drive
increased prices and adversely affect our results of operations, including our product gross margins.
We currently do not have long-term supply contracts
with any of our third-party subcontractors. Therefore, they are not obligated to perform services or supply products to us for any specific
period, in any specific quantities or at any specific price, except as may be provided in a particular purchase order. None of our third-party
subcontractors has provided contractual assurances to us that adequate capacity will be available to us to meet future demand for our
products. Our subcontractors may allocate capacity to the production of other companies' products while reducing deliveries to us on short
notice. Other customers that are larger and better financed than we are or that have long- term agreements with these subcontractors may
cause these subcontractors to reallocate capacity to those customers, thereby decreasing the capacity available to us.
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Other significant risks associated with relying on
these third-party subcontractors include:
•
reduced control over product cost, delivery schedules and product quality;
•
potential price increases;
•
inability to achieve sufficient production, increase production or test capacity and achieve acceptable yields on a timely basis;
•
increased exposure to potential misappropriation of our intellectual property;
•
shortages of materials used to manufacture products; and
•
capacity shortages.
We distribute commodity medical products on
behalf of multinational manufacturers for a substantial portion of our sales, and our failure to maintain and further develop these relationships
could harm our business.
We act as a distributor on behalf of multinational
firms, and we depend on these third-party contracts for cardiac commodity product inventory to consumers. Our distribution efforts for
these other products, some of which are competitive with our own commodity products such as our Cape Cross NC and Cape Cross products,
currently do and are expected to account for most of our net sales in the near future. These relationships are mostly non-exclusive and
terminable upon a certain number of days’ notice. In particular, our relationship with DISA Life Sciences in South Africa represented
a very significant portion of our total revenue for the fiscal year ended February 28, 2026. The loss of, or business disruption at, one
or more of these firms or a negative change in our relationship with them, or a disruption to any one of our sales channels could have
a material adverse effect on our business. If we do not maintain our relationship with these product suppliers or develop relationships
with other firms for inventory to sell, the growth of our business may be adversely affected, and our business may be harmed. If we are
required to obtain additional or alternative distribution agreements or arrangements in the future, we cannot be certain that we will
be able to do so on satisfactory terms or in a timely manner. Our inability to enter into satisfactory distribution agreements may inhibit
our ability to implement our business plan or to establish markets necessary to expand the distribution of products successfully.
We may not be able to successfully implement our growth
strategy for our own branded products as a result of the distribution efforts we engage in of outside product offerings we distribute
for.
We believe that our future success depends, in part,
on our ability to implement our growth strategy of leveraging our existing brand and products to drive increased sales. Our ability to
implement this strategy depends, among other things, on our ability to:
•
enter distribution and other strategic arrangements with third-party retailers and other potential distributors of our products successfully compete in the product categories in which we choose to operate;
•
successfully compete in the product categories in which we choose to operate;
•
introduce new and appealing products and successfully innovate our existing products;
•
develop and maintain consumer interest in our brand; and
•
increase our brand recognition and loyalty.
We may not be able to implement this growth strategy
successfully. Our planned marketing expenditures may not result in increased total sales or generate sufficient levels of consumer interest
or brand awareness, and our high rates of sales and income growth may not be sustainable over
time. Our sales and results of operations will be negatively affected if we fail to implement our growth strategy or if we invest resources
in a growth strategy that ultimately proves unsuccessful.
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Risks Related to Management, Personnel and Control
Persons
The Medinotec Group of Companies depends on
our senior management personnel and may not be able to retain or replace these individuals or recruit additional personnel, which could
harm our business .
Our future success is substantially dependent on the
continued service of Dr. Gregory Vizirgianakis, our Founder, President, Chief Executive Officer and a member of our board of directors,
and Pieter van Niekerk, our Chief Financial Officer, Treasurer and a member of our board of directors. Dr. Vizirgianakis and Mr. van Niekerk
have extensive experience both with our company and in our industry and are familiar with our business, systems, and processes. Their
loss would be catastrophic to our product offerings and ability to manage our business effectively, as we will likely not be able to find
suitable individuals to replace them on a timely basis or at all.
If the Medinotec Group of Companies are unable
to find, train and retain key personnel, including new showroom employees that reflect our brand image and embody our culture, we may
not be able to grow or sustain our operations.
We depend on several key management, executive, sales
and marketing, and technical personnel. The loss of the services of one or more key employees could delay the achievement of business
objectives. Our success will also depend on our ability to attract and retain additional highly qualified executives, management, sales
and marketing and technical personnel to meet its growth goals. We further face intense competition for qualified personnel, many of whom
are often subject to competing employment offers, and we do not know whether we will be able to attract and retain such personnel.
Our success depends in large part on the continued
service of the senior management team. In particular, the continued service of this group of individuals is critical to our vision, strategic
direction, culture, products, and business plan. We do not maintain key-man insurance for any of the senior management team, and thus
the loss of any of our executives, even temporarily, or any other member of senior management, could harm the business.
The Medinotec Group of Companies’ largest
shareholder, officer and director, Dr. Gregory Vizirgianakis, has substantial control over us and our policies and will be able to influence
corporate matters.
Dr. Gregory Vizirgianakis, our Founder, President,
Chief Executive Officer and a member of our board of directors, and his brother, Stavros Vizirgianakis, also a member of our board of
directors, together control our company with an 81% vote on all matters regarding shareholder approval by virtue of his ownership in our
common stock.
Gregory and Stavros Vizirgianakis have not agreed
to vote their shares together. If they decide to vote together on any matter, they are able to exercise significant influence over our
company, including the election of directors, the approval of significant corporate transactions, and any change of control of our company.
They could prevent transactions, which might be in the best interests of the other shareholders. Their interests may not necessarily be
in the best interests of the shareholders in general. The rest of our shareholders will be considered minority shareholders and these
will have little say in the direction of the Company as a result of their holdings.
The Medinotec Group of Companies’ officers
and directors are located outside of the U.S., so it will be difficult to effect service of process and enforcement of legal
judgments upon our officers and directors.
Our officers and directors are located outside of
the United States and reside in South Africa. As a result, it may be difficult to effect service of process within the
United States and enforce judgments of the US courts obtained against our executive officers and directors. Particularly, our shareholders
may not be able to:
•
Effect service of process in the U.S. on any of our officers and directors;
•
Enforce judgments obtained in U.S. courts against our officers and directors based upon the civil liability provisions of the U.S. federal securities laws;
•
Enforce, in a court outside of the U.S., judgments of U.S. courts based on the civil liability provisions of the U.S. federal securities laws; and
•
Bring an original action in a court in South Africa to enforce liabilities against any of our officers and directors based upon the U.S. federal securities laws.
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The Medinotec Group of companies’ officers
and directors have limited experience managing a public company.
Our officers and directors have limited experience
managing a public company. Consequently, we may not be able to raise any funds or run our public company successfully. Our executive officer’s
and director’s lack of experience of managing a public company could cause you to lose some or all of your investment.
Risk Associated with Legal and Regulatory Matters
The Medinotec Group of Companies are subject
to extensive medical device regulation that may impede or hinder the approval process for our products and, in some cases, may not ultimately
result in approval or may result in the recall or seizure of previously approved products.
The medical technology industry is regulated extensively
by governmental authorities, principally the FDA, and state regulatory agencies with oversight of various aspects of drug and device distribution,
sale, and use. The regulations are very complex, have become more stringent over time, and are subject to rapid change and varying interpretations.
Regulatory restrictions or changes could limit our ability to carry on or expand our operations or result in higher than anticipated costs
or lower than anticipated sales. The FDA and other federal and state governmental agencies regulate numerous elements of our business,
including:
•
product design and development;
•
pre-clinical and clinical testing and trials;
•
product safety;
•
establishment registration and product listing;
•
labeling and storage;
•
marketing, manufacturing, sales, and distribution;
•
pre-market clearance or approval;
•
servicing and post-marketing surveillance, including reporting of deaths or serious injuries and malfunctions that, if they recurred, could lead to death or serious injury;
•
advertising and promotion;
•
post-market approval studies;
•
product import and export; and
•
recalls and field-safety corrective actions.
Before we can market or sell a new regulated product
or a significant modification to an existing product in the United States, we must obtain either clearance under Section 510(k) of the
FDCA, grant of a de novo classification request, or approval of a pre-market approval, or PMA, application from the FDA, unless an exemption
from pre-market review applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially
equivalent” to a legally marketed “predicate” device (in most cases Class II devices, with a few exceptions), with respect
to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. Class III devices approved
under the PMA process cannot serve as predicates. Clinical data are sometimes required to support substantial equivalence. In the de novo
process, the FDA must determine that general and special controls are sufficient to provide reasonable assurance of the safety and effectiveness
of a device, which is low to moderate risk and has no predicate (in other words, the applicant must justify the “down-classification”
to Class I or II for a new product type that would otherwise automatically be placed into Class III, but is lower risk). The PMA process
requires an applicant to demonstrate the safety and effectiveness of the device based on extensive data, including, but not limited to,
technical, preclinical, clinical trial, manufacturing, and labeling data.
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The PMA process is typically required for devices
that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices. Products that are approved
through a PMA application generally need FDA approval before they can be modified. Similarly, some modifications made to products cleared
through a 510(k) may require a new 510(k). The 510(k), de novo, and PMA processes can be expensive and lengthy and require the payment
of significant fees, unless an exemption applies. The FDA’s 510(k) clearance process usually takes from 3 to 12 months, but may
take longer. The FDA’s stated goal is to review de novo classification requests within 150 days, 50% of the time, but in reality
the process for many applicants generally takes even longer, up to a year or more. The process of obtaining a PMA is much more costly
and uncertain than the 510(k) clearance process and generally takes from one to three years, or longer, from the time the application
is submitted to the FDA until an approval is obtained. The process of obtaining regulatory clearances, approvals, and emergency use authorization
to market a medical device can be costly and time-consuming, and we may not be able to obtain these clearances, approvals, or authorizations
on a timely basis, or at all for our proposed products.
If the FDA requires us to go through a lengthier,
more rigorous examination for marketing authorization of our medical devices or future modifications to our medical devices than we had
expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline or to not increase
in line with our forecasts. In addition, the FDA may determine that future products will require the more costly, lengthy, and uncertain
PMA process. Although we do not market any devices under PMA, the FDA may demand that we obtain a PMA prior to marketing certain of our
future products. Further, even with respect to those future products where a PMA is not required, we cannot assure you that we will be
able to obtain the 510(k) clearances with respect to those products.
The FDA can delay, limit, or deny clearance, approval,
or authorization of a device for many reasons, including:
•
we may not be able to demonstrate that our products are safe and effective for their intended users;
•
the data from our clinical trials may be insufficient to support clearance, approval, or authorization; and
•
the manufacturing process or facilities we use may not meet applicable requirements.
In addition, the FDA may change its clearance and
approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval
or clearance of our products under development. Any delay in, or failure to obtain or maintain, clearance or approval for our products
under development could prevent us from generating revenue from these products and adversely affect our business operations and financial
results. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or
other increased scrutiny of us, could dissuade some customers from using our products and adversely affect our reputation and the perceived
safety and efficacy of our product. Failure to comply with applicable regulations could jeopardize our ability to sell our products and
result in enforcement actions such as fines, civil penalties, injunctions, warning letters, recalls of products, delays in the introduction
of products into the market, refusal of the FDA or other regulators to grant future clearances or approvals, and the suspension or withdrawal
of existing clearances or approvals by the FDA or other regulators. Any of these sanctions could result in higher than anticipated costs
or lower than anticipated sales and negatively impact our reputation, business, financial condition and operating results. Furthermore,
any operations or product applications outside of the United States will subject us to various additional regulatory and legal requirements
under the applicable laws and regulations of the international markets we enter. These additional regulatory requirements may involve
significant costs and expenditure and, if we are not able to comply with any such requirements, our international expansion and business
could be significantly harmed.
Failure to obtain clearance or authorization
for our medical devices, or other delays in the development of our medical devices, would adversely affect our ability to grow our business.
Commercialization of our medical devices may require
an Emergency Use Authorization (EUA), FDA clearance of a 510(k) premarket notification submission, or authorization of a de novo submission.
The process for submitting and obtaining FDA clearance of a 510(k), authorization of a de novo submission, or EUA can be expensive and
lengthy. The FDA’s review process can take several months or longer, and we may not be able to obtain FDA clearance, de novo authorization,
or Emergency use Authorization for our medical devices on a timely basis, if at all. The FDA’s refusal of, or any significant delays in receiving
510(k) clearance, de novo authorization, or Emergency use Authorization of our medical devices, would have an adverse effect on our ability
to expand our business.
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FDA approval has been granted for the Trachealator
following the 510(k) substantially equivalence process for Class II medical devices. We have no such FDA clearance with respect to the
Cape Cross PTCA Catheter family, the Cape Cross NC Catheter, or the Micro CTO Catheter (for which the Technical File was submitted in
July 2023 and is currently under review). We have not performed any clinical testing of our medical devices, which will likely be required
before the device can be marketed. Even if a clinical trial is completed, there can be no assurance that the data generated during a clinical
trial will meet the safety and effectiveness endpoints or otherwise produce results that will lead the FDA to grant marketing clearance,
approval, or authorization. In addition, any other delays in the development of our medical devices, for example, unforeseen issues during
product validation, would have an adverse effect on our ability to commercialize our medical devices.
Our growth strategy depends in significant part on
successfully obtaining additional FDA clearances for our pipeline products and launching them in the United States and other regulated
markets. Any failure or material delay in obtaining these clearances could prevent or significantly delay revenue growth, limit our ability
to diversify away from our current concentration in South Africa, and materially and adversely affect our business, financial condition,
and results of operations.
Modifications to our products may require new
510(k) clearances, de novo submissions, or pre-market approvals, or may require us to cease marketing or recall the modified products
until clearances are obtained.
FDA 510(k) clearance has been granted for the Trachealator
(November 2021) and the Outflo Aortic Valve Dilation Balloon Catheter (March 2025). Any modification to a 510(k)-cleared device that could
significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture,
requires a new 510(k) clearance or, possibly, a de novo or PMA. The FDA requires every manufacturer to make this determination in the
first instance, and provides some guidance on decision making, but the FDA may review any manufacturer’s decision at any time. The
FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. If the FDA disagrees with our determination
and requires us to submit new 510(k) notifications, de novo submissions or PMAs for modifications to our previously cleared or approved
products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall
the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.
As we continue to expand commercialization of our
products in the United States and make iterative improvements to existing devices or develop line extensions, the need for new regulatory
submissions could arise frequently. Any requirement to suspend marketing or initiate a recall while awaiting clearance could result in
lost sales, damage to customer relationships, and harm to our reputation, all of which could materially and adversely affect our business,
financial condition, and results of operations.
We may be liable if the FDA or other U.S. enforcement
agencies determine we have engaged in the off-label promotion of our products or have disseminated false or misleading labeling or promotional
materials.
Our promotional materials and training methods must
comply with FDA and other applicable laws and regulations, including laws and regulations prohibiting marketing claims that promote the
off-label use of our products or that make false or misleading statements. Healthcare providers may use our products off-label, as the
FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine. FDA also could conclude that
a performance claim is misleading if it determines that there are inadequate non-clinical and/or clinical data supporting the claim. If
the FDA determines that our promotional materials or training promote of an off-label use or make false or misleading claims, it could
request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance
of an untitled letter, a warning letter, injunction, seizure, civil fines, and criminal penalties. It is also possible that other federal,
state, or foreign enforcement authorities might take action if they determine that our promotional or training materials promote an unapproved
use or make false or misleading claims, which could result in significant fines or penalties. Although our policy is to refrain from statements
that could be considered off-label promotion of our products or false or misleading, the FDA or another regulatory agency could disagree.
Violations of the FDCA may also lead to investigations alleging violations of federal and state health care
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fraud
and abuse laws, as well as state consumer protection laws, which may lead to costly penalties and may adversely impact our business.
Recent court decisions have impacted FDA’s enforcement activity regarding off-label promotion in light of First Amendment Considerations;
however, there are still significant risks in this area, in part due to the potential for False Claims Act exposure. In addition, the
off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and
could result in substantial damage awards against us and harm our reputation.
Healthcare policy changes may have a material
adverse effect on the Medinotec Group of Companies.
In response to perceived increases in healthcare costs
in recent years, there have been and continue to be proposals by several governments, regulators, and third-party payers globally, including
the US federal and state governments, to control these costs and, more generally, to reform healthcare systems.
Certain of these proposals could, among other things,
limit the prices we are able to charge for products or the amounts of reimbursement available for our products, and could also limit the
acceptance and availability of such products. These pressures are particularly relevant to us as we expand commercialization of our proprietary
devices (including the Trachealator and Outflo) into the United States, where reimbursement policies, competitive bidding, value-based
purchasing, and prior-authorization requirements by Medicare, Medicaid, and private payers can significantly influence hospital and physician
purchasing decisions. Similar cost-containment measures in South Africa and other markets where we generate revenue could also reduce
demand or force price concessions.
The adoption of some or all of these proposals could
have a material adverse effect on the business, results of operations, financial condition and cash flows. If we experience decreasing
prices for our goods and services and we are unable to reduce expenses, there may be a materially adverse effect on the business, results
of operations, financial condition and cash flows.
The Medinotec Group of Companies is subject
to environmental laws and regulations and the risk of environmental liabilities, violations, and litigation.
We are subject to numerous US and non-US environmental,
health and safety laws and regulations concerning, among other things, the health and safety of employees; the generation, storage, use
and transportation of hazardous materials; emissions or discharges of substances into the environment; investigation and remediation of
hazardous substances or materials at various sites; chemical constituents in medical products; and end-of-life disposal and take-back
programs for medical devices.
Our operations and those of certain third-party suppliers
involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes.
If we or our suppliers violate these environmental laws and regulations, facilities could be shut down and violators could be fined, criminally
charged, or otherwise sanctioned.
Furthermore, environmental laws outside of the US
are becoming more stringent, resulting in increased costs and compliance burdens. Certain environmental laws also assess liability on
current or previous owners or operators of real property for the costs of investigation, removal or remediation of hazardous substances
or materials at their properties or at properties which they have disposed of hazardous substances. In addition to clean-up actions brought
by governmental authorities, private parties could bring personal injury or other claims due to the presence of, or exposure to, hazardous
substances. The ultimate cost of site clean-up and timing of future cash outflows is difficult to predict, given the uncertainties regarding
the extent of the required clean-up, the interpretation of applicable laws and regulations, and alternative clean-up methods.
The costs of complying with current or future environmental
protection and health and safety laws and regulations, or liabilities arising from past or future releases of, or exposures to, hazardous
substances, may exceed our estimates, or have a material adverse effect on the business, results of operations, financial conditions,
and cash flows.
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Finally, in some jurisdictions around the world, culture
and practice encourages reuse of disposable products when the product is clearly labelled for single use. Such reuse may expose us to
liability in these jurisdictions.
Claims made against the Medinotec Group of Companies
from time to time can result in litigation that could distract management from our business activities and result in significant liability
or damage to our brand.
As a company with expanding operations, we increasingly
face the risk of litigation and other claims against us. We have no such claims at present. Litigation and other claims may arise in the
ordinary course of our business and include employee claims, commercial disputes, landlord-tenant disputes, intellectual property issues,
product-oriented allegations and slip and fall claims. These claims can raise complex factual and legal issues that are subject to risks
and uncertainties and could require significant management time. Litigation and other claims against us could result in unexpected expenses
and liabilities, which could materially affect our operations and our reputation.
In addition, the medical device industry is characterized
by extensive litigation and, from time to time, we are the subject of various claims. Regardless of the outcome, such claims are expensive
to defend and divert management and operating personnel from other business issues. A successful claim or claims against us could result
in payment of significant monetary damages and/or injunctive relief.
The Medinotec Group of Companies’ failure
to comply with laws and regulations relating to reimbursement of healthcare goods and services may subject it to penalties and adversely
impact its reputation, business, results of operations, financial condition and cash flows.
Our devices, products and therapies are purchased
principally by hospitals or physicians that typically bill various third-party payers, such as governmental healthcare programs, private
insurance plans and managed care plans, for the healthcare services provided to their patients.
The ability of customers to obtain appropriate reimbursement
for products and services from third-party payers is critical because it affects which products customers purchase and the prices they
are willing to pay. As a result, our devices, products, and therapies are subject to regulation regarding quality and cost for reimbursement
and regulation of health goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare
fraud.
Many territories have similar laws that apply to reimbursement
by state and other funded programs as well as in some cases to all payers. In certain circumstances, insurance companies attempt to bring
a private cause of action against a manufacturer for causing false claims.
In addition, our strategic investments position the
company as a manufacturer of FDA-approved devices reimbursable by federal healthcare programs. We are thus subject to the Physician Payments
Sunshine Act, which requires us to annually report certain payments and other transfers of value our company makes to US-licensed physicians
or US teaching hospitals. Any failure to comply with these laws and regulations could subject us or our officers and employees to criminal
and civil financial penalties.
We are also subject to risks relating to changes in
government and private medical reimbursement programs and policies, and changes in legal regulatory requirements in the US and around
the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating
to coverage of / or reimbursement for our products by administrators of these systems, could have an impact on the acceptance of and demand
for our products and the prices that customers are willing to pay for them.
Quality problems and product liability claims
could lead to recalls or safety alerts, reputational harm, adverse verdicts or costly settlements, and could have a material adverse effect
on the business, results of operations, financial condition and cash flows.
Quality is extremely important to us and our customers
due to the impact of our products on patients, and the serious and potentially costly consequences of product failure. We are thus exposed
to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices.
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In addition, many products are used in intensive
care settings with seriously ill patients. Component failures, manufacturing nonconformance, design defects, off-label use, or inadequate
disclosure of product-related risks or product related information with respect to our products, if they were to occur, could result in
an unsafe condition or injury to, or death of, a patient.
This could lead to recall of, or issuance of a safety
alert relating to, our products, and could result in product liability claims and lawsuits, including class actions, which could ultimately
result, in certain cases, in the removal from the body of such products and claims regarding costs associated therewith. Due to the strong
brand recognition of Medinotec name and our brands, a material adverse event involving one of our products could result in reduced market
acceptance and demand for all products within that brand and could harm our reputation and ability to market products in the future.
Should we fall short of these standards and our products
become subject to recalls or safety alerts, our reputation could be damaged, we could lose customers and revenue and results of operations
could decline. Our success also depends on the ability to manufacture to exact specifications for precision engineered components, sub-assemblies
and finished devices from multiple materials. If components fail to meet these standards or fail to adapt to evolving standards, our reputation,
competitive advantage, and market share could be harmed.
In certain situations, we may undertake a voluntary
recall of products or temporarily shut down production lines based on performance relative to our own internal safety and quality monitoring
and testing data. Any of the foregoing problems, including future product liability claims or recalls, regardless of their ultimate outcome,
could harm our reputation and have a material adverse effect on the business, results of operations, financial condition, and cash flows.
The Medinotec Group of Companies may not be
able to protect our intellectual property rights effectively.
Patents, trademarks and other intangible proprietary
rights are and will be essential to the business and our ability to compete effectively with other companies. During normal day-to-day
trade, we also rely on trade secrets, know-how, continuing technological innovations, strategic alliances, and licensing opportunities
to develop, maintain and strengthen our competitive position.
We pursue a policy of obtaining patent protection
in both the US and overseas for patentable subject matter of our proprietary devices and attempt to review third-party patents and patent
applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify
licensing opportunities and monitor the patent claims of others.
We also operate in an industry that is susceptible
to significant intellectual property litigation. This litigation is expensive, complex, and lengthy and its outcome is difficult to predict.
Future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and
may significantly divert the attention of our technical and management personnel.
In addition, we may have to take legal action in the
future to protect our patents, trade secrets, or know-how or to assert our intellectual property rights against claimed infringement by
others. Any such legal action could be costly and time consuming and no assurances can be made that any lawsuit will be successful.
The invalidation of key patents or proprietary rights
that we own, or an unsuccessful outcome in lawsuits to protect intellectual property, could have a material adverse effect on the business,
financial condition, and results of operations. In the event that the right to market any of our products is successfully challenged,
or if we fail to obtain a required license or are unable to design around a patent, the business, financial condition, and results of
operations could be compromised.
Security breaches, loss of data and other disruptions
could also compromise sensitive information related to the business, preventing it from accessing critical information or expose us to
liability, which could adversely affect the business and reputation.
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In the ordinary course of business, we collect and
store sensitive data, including patient health information, personally identifiable information about employees, intellectual property,
and proprietary business information. We manage and maintain applications and data utilizing on-site and off-site systems. These applications
and data encompass a wide variety of business-critical information including research and development information, commercial information
and business and financial information.
The secure processing, storage, maintenance, and transmission
of this critical information is vital to operations and business strategy, and we devote resources to protecting such information. Although
we take measures to protect sensitive information from unauthorized access or disclosure, our IT and infrastructure may be vulnerable
to attacks by hackers, viruses, breaches, or interruptions due to employee error or malfeasance, terrorist attacks, hurricanes, fire,
flood, other natural disasters, power loss, computer systems failure, data network failure, internet failure, or lapses in compliance
with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there
could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information
could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement
actions and regulatory penalties.
Changes in tax laws or exposure to additional
income tax liabilities could have a material impact on the Medinotec Group of Companies, the results of operations, financial conditions
and cash flows.
We are subject to income taxes, as well as non-income-based
taxes, in South Africa, and other jurisdictions in which we operate, as well as jurisdictions such as the United States, in which we intend
to have operations. The tax laws in these could change on a prospective or retroactive basis, and any such changes could adversely affect
us and our effective tax rate.
Taxation regulation in territories around the world
can also change very quickly, which may mean that all the implications for businesses may not have been fully thought through by the regulating
authorities before final guidelines and laws are issued. Furthermore, any changes made by tax authorities, together with other legislative
changes, to the mandatory sharing of company information (financial and operational) with tax authorities on both a local and global basis,
could lead to disagreements between jurisdictions with respect to the proper allocation of profits between such jurisdictions. We therefore
continuously monitor changes to tax regulation and double tax treaties between the territories in which we operate. We also maintain a
comprehensive transfer pricing policy to govern the flow of funds between various tax territories.
We are further subject to ongoing tax audits in the
various jurisdictions in which we operate. We regularly assess the likely outcomes of these audits to determine the appropriateness of
our tax provisions. However, there can be no assurance that we will accurately predict the outcomes of these audits, which could have
a material impact on the business, financial condition, results of operations, and cash flows.
While we have recorded reserves for potential payments
to various tax authorities related to uncertain tax positions, the calculation of such tax liabilities involves the application of complex
tax regulations in many jurisdictions. Therefore, any dispute with a tax authority may result in payment that is significantly different
from our estimates. If the payment proves to be less than the recorded reserves, the reversal of the liabilities would generally result
in tax benefits being recognized in the period when we determine the liabilities to be no longer necessary. Conversely, if the payment
proves to be more than the reserves, we would incur additional charges, and these could have a materially adverse effect on the business,
financial condition, results of operations, and cash flows.
The failure to comply with anti-corruption laws
could materially affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.
FCPA and similar anticorruption laws in other jurisdictions
generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining
or retaining business. Because of the predominance of government-administered healthcare systems in many jurisdictions around the world,
many of our customer relationships are with governmental entities and are therefore potentially subject to such laws.
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We also participate in public-private partnerships
and other commercial and policy arrangements with governments around the globe. Global enforcement of anti-corruption laws has increased
in recent years, including investigations and enforcement proceedings leading to assessment of significant fines and penalties against
companies and individuals.
Our international operations create a risk of unauthorized
payments or offers of payments by one of our employees, consultants, sales agents, or distributors. The business maintains policies and
programs to implement safeguards to educate employees and agents on these legal requirements, and to prevent and prohibit improper practices.
However, existing safeguards and any future improvements may not always be effective, and employees, consultants, sales agents, or distributors
may engage in conduct for which we could be held responsible.
In addition, regulators could seek to hold us liable
for conduct committed by companies in which we invest or that we acquire. Any alleged or actual violations of these regulations may subject
us to government scrutiny, criminal or civil sanctions and other liabilities, including exclusion from government contracting, and could
disrupt the business, adversely affect our reputation and result in a material adverse effect on the business, results of operations,
financial condition, and cash flows.
Laws and regulations governing international
business operations could adversely impact the Medinotec Group of Companies.
The US Department of the Treasury’s Office of
Foreign Assets Control (“OFAC”), and the Bureau of Industry and Security at the US Department of Commerce (“BIS”)
administer certain laws and regulations that restrict US persons and, in some instances, non-US persons, in conducting activities, transacting
business with or making investments in certain countries, governments, entities and individuals subject to US economic sanctions.
Our international operations subject us to these laws
and regulations, which are complex, restrict business dealings with certain countries, governments, entities, and individuals, and are
constantly changing. Further restrictions may be enacted, amended, enforced, or interpreted in a manner that materially impacts our operations.
From time to time, certain subsidiaries have limited business dealings in countries subject to comprehensive sanctions.
Certain of our subsidiaries sell medical devices,
and may provide related services, to distributors and other purchasing bodies in such countries. These business dealings represent an
insignificant amount of our consolidated revenues and income but expose us to a heightened risk of violating applicable sanctions regulations.
Violations of these regulations are punishable by civil penalties, including fines, denial of export privileges, injunctions, asset seizures,
debarment from government contracts and revocations or restrictions of licenses, as well as criminal fines and imprisonment.
We have established policies and procedures designed
to assist with compliance with such laws and regulations. However, there can be no assurance that these will prevent us from violating
these regulations in every transaction in which we may engage. As such a violation could adversely affect our reputation, business, financial
condition, results of operations and cash flows.
As an Emerging Growth Company under the Jobs
Act, the Medinotec Group of Companies are permitted to rely on exemptions from certain disclosures requirements.
We qualify as an "emerging growth company"
under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long
as we are an emerging growth company, we will not be required to:
•
have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
•
comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);
•
submit certain executive compensation matters to shareholder advisory votes, such as "say-on-pay" and "say-on-frequency;" and
•
disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive's compensation to median employee compensation.
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In addition, Section 107 of the JOBS Act also provides
that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain
accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits
of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such
new or revised accounting standards.
We will remain an "emerging growth company"
for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed
$1 billion, (ii) the date that we become a "large accelerated filer" as defined in Rule 12b-2 under the Securities Exchange
Act of 1934, which would occur if the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the
last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion
in non-convertible debt during the preceding three year period.
Until such a time, however, we cannot predict if investors
will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
Because we are a “Smaller Reporting Company,”
we may take advantage of certain scaled disclosures available to us, resulting in holders of our securities receiving less company information
than they would receive from a public company that is not a Smaller Reporting Company.
We are a “smaller reporting company” as
defined in the Exchange Act. As a smaller reporting company, we may take advantage of certain of the scaled disclosures available to smaller
reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) our voting and non-voting common
stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or (ii) our annual
revenue is less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates
is less than $700 million measured on the last business day of our second fiscal quarter. To the extent we take advantage of any reduced
disclosure obligations, it may make it harder for investors to analyze the Company’s results of operations and financial prospectus
in comparison with other public companies.
Risks Associated with Political Instability and
Regional Issues
Geopolitical and Trade Risks due to tariffs
and trade wars
Medinotec Inc. operates in a challenging geopolitical
and trade environment that exposes the company to several risks that could adversely affect our financial performance and operations.
The U.S. has recently imposed significant tariffs
on imports from South Africa and other nations, with tariffs ranging up to 30% on a variety of goods, including machinery, vehicles, and
precious metals. This has raised concerns regarding the future of the African Growth and Opportunity Act (AGOA), which has previously
provided preferential trade benefits, including duty-free access to the U.S. market for South African goods. Because our primary manufacturing
operations are located in South Africa and we export medical devices to the United States, any revocation or material reduction of AGOA
benefits, or the continuation or increase of these tariffs, could significantly raise the cost of our U.S.-bound shipments, reduce our
competitiveness in the U.S. market, compress profit margins, and materially adversely affect our revenue and financial results. The U.S.
market is an important part of our growth strategy, particularly for our proprietary products such as the Trachealator and Outflo.
At the May 21, 2025 Oval Office meeting, U.S. President
Donald J. Trump and South African President Cyril Ramaphosa met, but no changes to the imposed tariffs were announced.
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While the South African government is exploring the
possibility of negotiating a bilateral trade agreement with the U.S., the outcome and timeline of these discussions are uncertain. As
a result, the tariffs and the potential loss of AGOA benefits could significantly disrupt our U.S. market strategy and increase the costs
of our exports to the U.S.
The current global trade tensions, including the tariffs
imposed by the U.S., have led to a ripple effect in other markets, including Europe. European governments may respond with retaliatory
tariffs or other trade measures, potentially increasing the cost of medical device products we distribute from European suppliers. These
price increases could have an adverse impact on our business, as we may be unable to offset the rising costs without passing them onto
customers. Since we are locked into agreements with our suppliers for the distribution of their products in South Africa, our ability
to mitigate these cost increases is limited.
South Africa is experiencing significant political
instability, with tensions rising within the ruling coalition government. The potential collapse of the government of national unity and
the uncertainty surrounding fiscal policies, such as increases in VAT or other tax rates, could disrupt business operations. In particular,
such instability may lead to regulatory changes, higher operating costs, or interruptions to our manufacturing activities in South Africa.
While Medinotec Inc. cannot directly influence these
political developments, we are closely monitoring the situation and assessing potential risks to our operations. We are also considering
contingency plans to manage any disruptions that could arise from governmental changes or civil unrest.
While we are not large enough to directly engage with
policymakers, we are actively monitoring developments related to trade tariffs and political instability in South Africa. We will continue
to adapt our strategies based on emerging trends and adjust our risk management approach accordingly.
For our self-manufactured products, we are actively
exploring options to diversify our supply chain, which will help reduce exposure to any disruptions caused by tariff changes or political
instability. However, for our agency business, where we distribute products for multinational medical device companies, we are reliant
on our suppliers and their pricing decisions, which limit our ability to mitigate the impact of potential tariff-induced cost increases.
Despite these efforts, the interconnected nature of
these risks means that their cumulative impact could be more significant than anticipated, potentially affecting our financial results
and operational stability.
South Africa Specific Risk of Unstable Power
Supply
Electricity demand in South Africa is extremely high
and energy plants do not meet the demand. Therefore, there are frequent rolling black outs that are handled by a schedule of “load
shedding” during which the supply and demand of electricity is balanced out to prevent the entire power grid from collapsing. This
results in unstable energy sources and frequent production halts for our company.
DISA Medinotec has a backup generator big enough to
sustain the entire production facility in case of a power outage. In addition, South Africa is also a very solar capable country due to
the weather being warm with sub-tropical like conditions. Therefore, we are looking into solar power as a means to run our production
facilities more efficiently in the longer run.
However, load shedding remains unpredictable and can
still disrupt manufacturing schedules, increase operating costs (including fuel for generators), delay product shipments, and impair our
ability to meet customer demand — particularly as we expand sales in the United States. Any prolonged or severe power instability
could materially and adversely affect our production capacity, supply chain reliability, revenue, and overall financial results.
South Africa Specific Risk of Political instability
May Affect the Medinotec Group of Companies’ ability to operate effectively.
Political instability in the countries in which we
operate, including South Africa, where episodes of violent civil unrest (riots) have further destabilized the country’s economy
and resulted in extensive damage to commercial property, and may cause increased uncertainty about our ability to
exist in this environment. This may adversely affect investor confidence as well as our business planning, operations and our market capitalization.
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This risk extends to global economic uncertainty and
heightened geopolitical tensions, such as those in involved in the Russian war on Ukraine, between the United States and China as well
as Brexit, which can also have an impact on several factors influencing commodity prices, exchange rates, and interest rates, all of which
can affect our business in turn.
Any significant political instability in South Africa
could lead to interruptions in manufacturing, higher operating costs, delays in product shipments, or restrictions on the movement of
goods and capital. These disruptions could materially and adversely affect our ability to meet customer demand (particularly in the United
States), our revenue, profitability, and overall financial condition.
South Africa Specific Risk that Broad-based
Black Economic Empowerment (“BEE”) requirements may restrict growth opportunities and limit the Medinotec Group of Companies’
ability to attract key talent.
In South Africa, the correction of historical inequalities
is regulated by the Broad-based Black Economic Empowerment Act 53 of 2003 and its associated codes. This legislative framework promotes
economic transformation and increased economic participation of Black people in the South African economy. Companies are evaluated on
a scorecard that considers ownership, management control, skills development, enterprise and supplier development, and socio-economic
development.
Failure to meet the requirements of the Act and its
associated codes may limit our ability to qualify for certain government contracts, licenses, or incentives in South Africa. It may also
restrict organic and acquisitive growth opportunities and make it more difficult to attract, recruit, and retain key candidates and suitably
qualified personnel, particularly in technical, engineering, and management roles. Because our primary manufacturing operations and the
majority of our workforce are located in South Africa, non-compliance or lower BEE ratings could materially limit our growth prospects,
increase compliance costs, and adversely affect our ability to compete effectively in the local market. We continue to monitor and work
toward compliance with BEE requirements; however, there can be no assurance that we will be able to meet evolving scorecard targets or
that failure to do so will not have a material adverse effect on our business, financial condition, and results of operations in South
Africa.
South Africa Specific Risk that South African
authorities may disallow or delay a transfer of funds from South Africa to the United States
The Central Reserve Bank of South Africa oversees
the flow of currency in and out of the republic of South Africa and the South African Revenue services oversee all transfer pricing issues.
The Medinotec Group of Companies has transfer pricing bench marking in place for future planned transactions between its South African
subsidiaries and Medinotec Inc., its U.S. parent company, and makes use of an external exchange control advisor to ensure any cross-border
transactions complies with the requirements of both the Reserve Bank and the South African Revenue services.
This is an approval process for the flow of
funds and therefore may cause timing delays to transfer funds cross border but does not mean that it is disallowed entirely. The Company
completed a private placement in May 2022 for approximately $3.3 million, which provided funding for expected U.S. operations. If the
Company’s U.S. business plan takes longer than expected, if operating costs exceed management’s expectations, or if additional
funding is required, the Company may need to obtain additional debt or equity financing. There can be no assurance that such financing
will be available on acceptable terms or at all. We believe that once Medinotec Inc. establishes its own sales network the company is
expected to become self-sustaining. If for some reason there is a time delay and the funding raised during the private placement is not
enough, to realize the business plan of the parent, the operating subsidiary in South Africa would be its only source of cashflow to sustain
the Medinotec Group of Companies.
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Allowable cash flows and their expected timelines
are disclosed in the following table:
Method
Description
Normal Time Delay Experienced
Management fees
Restricted to an amount that the business would need to prove that the services rendered by the Medinotec Group Internationally to the local company is at an arm’s length amount. If this cannot be proven authorities will disallow the charge and in certain instances levy fines and penalties
If these charges are proven to be at arm’s length, flow of funds can happen within a one-week time frame.
Loans
Restricted to arm’s length terms and would need to apply for formal approval to the authorities.
The application may be accepted or declined and would require 6-10 weeks before approval will be obtained.
Dividends
Dividends may be declared from time to time depending on the fact that the company declaring these dividends are liquid and solvent.
Since Medinotec Inc. is the registered owner
of the business in South Africa dividends may be declared at a Board meeting and these can be paid to the parent entity. A dividends withholdings
tax of 20% would apply and the funds may then exit the country.
The timeline to ensure compliance and transfer
the funds will be 2-3 weeks.
It is important to note that the above-mentioned
table is the only three options to externalize funds out of South Africa. The time delays mentioned are based on prior experience and
guidance from expert advisors. The authorities do have the final decision-making powers on any transaction and therefore time delays may
become material and can have a material impact on the business and its ability to function especially when a dispute arises from interactions
with the regulators. Management fees and loans can easily be declined by authorities whereas dividends are less likely to be declined.
Our entire business plan is based on the successful
private placement that was concluded, and this funding is expected to facilitate two years of funding required before any funding would
be needed from the South African subsidiaries, therefore this leaves some time to obtain regulatory approvals in advance if the business
plan roll out in the United States is slower than expected. If the Central Reserve Bank declines or imposes any restrictions including
time delays for approvals for flow of funds it may have a material impact on the business operations of the Group and may delay its roll
out in the American Markets until a follow up capital raise or alternatively debt finance can be obtained on an international level. It
is important to note that this successful raise of money does not guarantee that we will obtain regulatory approval in the USA for product
candidates that fall outside the Trachealator product which already obtained FDA approval in November 2021. In addition to this it also
does not guarantee successful commercializing of any products in the United States of America.
Newly imposed or increased U.S. tariffs, changes
in trade policy, or reduced preferential market access for South African goods may materially impact our U.S. revenue, profit margins
and competitiveness.
The United States has recently imposed increased tariff
measures on certain imported goods, including goods from South Africa, and may further revise tariff rates, trade terms, or import restrictions
in response to broader trade policy objectives or geopolitical developments. In July 2025, the White House announced updated reciprocal
tariff rates applicable from August 1, 2025, including a 30% tariff rate for South Africa. These measures, together with any future revisions,
exemptions, or enforcement actions, may materially affect the landed cost of our products in the United States.
As a company that exports goods from South Africa
into the United States, tariffs or similar import measures may increase the cost of our U.S.-bound shipments, reduce our gross margins,
and impair our competitiveness in the U.S. market. Such measures may also lead to delayed, reduced or cancelled purchase orders from distributors
or customers, require price increases that reduce demand, or necessitate
changes to our sourcing, manufacturing or distribution arrangements.
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In addition, our U.S. market access may be adversely
affected by changes in trade policy, including any reduction in preferential treatment for South African exports, changes in customs or
import procedures, stricter compliance requirements, or increased scrutiny of South African-origin products. Any such developments could
increase our costs, lengthen delivery times, reduce commercial flexibility and adversely affect our revenue and profitability.
We are actively assessing the potential impact of
tariff and trade-policy developments on our operations and financial results and evaluating contingency strategies, including pricing
adjustments, sourcing alternatives and geographic diversification of revenue. However, there can be no assurance that these measures will
be successful or that tariffs, trade restrictions or related policy changes will not materially and adversely affect our business, financial
condition and results of operations.
Geopolitical tensions, including conflict involving
Iran and South Africa’s geopolitical positioning, may materially adversely affect our business, financial condition and results
of operations.
Our business is exposed to geopolitical risk due to
our corporate structure and operating footprint. While Medinotec Inc. is publicly quoted in the United States, our primary operating subsidiary
is based in South Africa, an emerging market and member of BRICS. As a result, we are sensitive to geopolitical developments affecting
both global markets and South Africa specifically.
Conflict involving Iran and related instability in
the Middle East have contributed to volatility in global energy markets, shipping routes, freight pricing, insurance costs and financial
markets. Disruptions affecting the Strait of Hormuz and surrounding trade corridors may increase fuel, transportation, logistics and input
costs, while also contributing to inflationary pressures and currency volatility. Reuters has recently reported disruptions to shipping
and surges in war-risk insurance and oil prices associated with the Iran conflict and Strait of Hormuz instability.
Our reliance on international distribution partners
and cross-border supply chains exposes us to risks arising from trade disruptions, higher shipping costs, supply shortages, delays, sanctions-related
compliance burdens and reduced market access. Escalation of conflict or broader regional instability could impair our ability to efficiently
source, manufacture and supply products to our key markets, including the United States and other international jurisdictions.
South Africa’s geopolitical positioning and
foreign policy stance may further increase our risk exposure. Divergence between South Africa’s international relationships and
the policy positions of the United States or other major trading partners could result in heightened regulatory scrutiny, trade friction,
investor caution, reduced access to capital, tariffs or other restrictions on market access. Recent South African market weakness linked
to renewed U.S.-Iran tensions illustrates how these geopolitical developments may affect the rand and broader financial conditions.
Macroeconomic instability associated with these geopolitical
dynamics, including fluctuations in the South African rand, may also impact our reported financial results, particularly where revenues
and costs are denominated in different currencies. Sustained uncertainty may also reduce healthcare spending, delay procurement decisions
or impair customer demand in certain markets.
c
The duration, scope and outcome of these geopolitical
developments remain highly uncertain. Any escalation or prolonged instability could have a material adverse effect on our supply chain,
operating costs, revenue generation, access to capital and overall financial performance.
Medinotec faces heightened geopolitical and
trade risks due to South African international relations, as potential revocation of AGOA benefits, increased tariffs, and stricter import
regulations on South African goods could significantly impact the cost, compliance, and competitiveness of its U.S.-bound medical exports.
South Africa’s international relations
and foreign policy positioning may affect its trade relationship with the United States and other key markets. Any deterioration in those
relationships could result in reduced preferential market access, increased tariffs, enhanced customs scrutiny, stricter import requirements,
sanctions-related restrictions or other barriers affecting South African exports.
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Because our primary operating subsidiary manufactures
in South Africa and exports products into the United States, our business is particularly exposed to such developments. Increases in tariffs
or changes in import rules may raise the cost of our products in the United States, reduce our competitiveness, compress margins, delay
shipments, increase compliance burdens, or reduce the willingness of U.S. distributors and customers to purchase our products.
These risks may be heightened by broader geopolitical
tensions, diplomatic disagreements, trade negotiations, or changes in U.S. trade policy. Recent U.S. tariff actions applicable to South
African goods illustrate the potential for these developments to materially affect our business.
If any of these events occur, our ability to grow
U.S. revenue, maintain profit margins and expand our international operations could be materially adversely affected.
Risks Relating to Our Securities
If the Medinotec Group of Companies undertakes
future offerings of our common stock, shareholders will experience dilution of their ownership percentage.
Generally, existing shareholders will experience dilution
of their ownership percentage in the company if and when additional shares of common stock are offered and sold. In the future, we may
be required to seek additional equity funding in the form of private or public offerings of our common stock. In the event that we undertake
subsequent offerings of common stock, your ownership percentage, voting power as a common shareholder, and earnings per share, if any,
will be proportionately diluted. This may, in turn, result in a substantial decrease in the per-share value of your common stock.
If a market for our common stock does not develop,
stockholders may be unable to sell their shares
Our common stock is quoted under the symbol “MDNC”
on the OTCQX operated by OTC Markets Group, Inc., an electronic inter-dealer quotation medium for equity securities. We were approved
for trading in March 2023, and we do not have an active trading market. We can provide no assurances that an active trading market will
ever occur, and you may have issues selling your securities in our company.
The Medinotec Group of Companies’ common
stock price may be volatile and could fluctuate widely in price, which could result in substantial losses for investors.
The market price of our common stock is likely to
be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including:
•
new products and services by us or our competitors;
•
government regulation of our products and services;
•
intellectual property disputes;
•
additions or departures of key personnel;
•
sales of our common stock;
•
our ability to integrate operations, technology, products and services;
•
our ability to execute our business plan;
•
operating results below expectations;
•
loss of any strategic relationship;
•
industry developments;
•
economic and other external factors; and
•
period-to-period fluctuations in our financial results.
You should consider any one of these factors to be
material. Our stock price may fluctuate widely as a result of any of the above.
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In addition, the securities markets have from time-to-time
experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market
fluctuations may also materially and adversely affect the market price of our common stock.
If securities analysts do not initiate coverage
or continue to cover the Common Stock or publish unfavorable research or reports about the business, this may have a negative impact on
the market price of the Common Stock of the Medinotec Group of Companies.
The trading market for the Common Stock will depend
on the research and reports that securities analysts publish about our business and us. We do not have any control over these analysts.
There is no guarantee that securities analysts will cover the Common Stock. If securities analysts do not cover the Common Stock, the
lack of research coverage may adversely affect our market price.
If we are covered by securities analysts, and the
stock is the subject of an unfavorable report, the stock price and trading volume would likely decline. If one or more of these analysts
ceases to cover our company or fails to publish regular reports on us, we could lose visibility in the financial markets, which could
cause the stock price or trading volume to decline.
Because we are subject to the “Penny Stock”
rules and our shares are quoted on the over-the-counter bulletin board, the level of trading activity in the Medinotec Group of Companies’
stock may be reduced.
The Securities and Exchange Commission has adopted
regulations which generally define "penny stock" to be any listed, trading equity security that has a market price less than
$5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. The penny stock rules require a broker-dealer,
prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides
information about penny stocks and the risks in the penny stock market. The broker-dealer must also provide the customer with current
bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly
account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules
generally require that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny
stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure
requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to
the penny stock rules which may increase the difficulty Purchasers may experience in attempting to liquidate such securities.
We may be unable to uplist our common stock
to a national securities exchange, or maintain such a listing if achieved, which could adversely affect the liquidity and price of our
common stock.
We intend to pursue an uplisting of our common stock
to a national securities exchange, such as the Nasdaq Capital Market or NYSE American. However, there can be no assurance that we will
satisfy the applicable initial listing requirements, including quantitative and qualitative standards relating to stockholders’
equity, market value of publicly held shares, public float, bid price, number of round lot holders, corporate governance and other criteria.
Even if we satisfy those requirements initially, there can be no assurance that we will be able to maintain continued listing standards
following any uplisting.
Failure to achieve or maintain an uplisting could
reduce investor interest in our common stock, limit trading liquidity, restrict access to certain institutional investors, impair our
ability to raise capital and negatively affect our stock price, valuation and strategic flexibility.
In addition, efforts to achieve an uplisting may require
us to incur substantial additional costs, including accounting, auditing, legal, governance, investor-relations and compliance costs.
We may also seek additional financing in connection with an uplisting or to support operations more generally. Any such financing could
be dilutive to existing stockholders, involve unfavorable terms, or be unavailable when needed.
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Actions taken in pursuit of an uplisting, including
public or private financings, governance changes, structural transactions or other corporate actions, could also increase volatility in
our stock price or otherwise adversely affect existing stockholders. There can be no assurance that any uplisting strategy will be successful
or that the benefits of a listing on a national securities exchange will be realized.
If the Medinotec Group of Companies issues shares
of preferred stock with superior rights to the common stock, it could result in a decrease in the value of our common stock and delay
or prevent a change in control of us.
Our board of directors is authorized to issue up to
20,000,000 shares of preferred stock. Our board of directors has the power to establish the dividend rates, liquidation preferences, voting
rights, redemption and conversion terms and privileges with respect to any series of preferred stock. The issuance of any shares of preferred
stock having rights superior to those of the common stock may result in a decrease in the value or market price of the common stock. Holders
of preferred stock may have the right to receive dividends, certain preferences in liquidation and conversion rights. The issuance of
preferred stock could, under certain circumstances, have the effect of delaying, deferring, or preventing a change in control of us without
further vote or action by the stockholders and may adversely affect the voting and other rights of the holders of common stock.
The Medinotec Group of Companies does not expect
to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.
We do not anticipate paying cash dividends on our
common stock in the foreseeable future. The payment of dividends on our common stock will depend on earnings, financial condition and
other business and economic factors affecting it at such time as the board of directors may consider relevant. If we do not pay dividends,
our common stock may be less valuable because a return on your investment will occur only if our stock price appreciates.
Provisions in the Nevada Revised Statutes and
our Bylaws could make it very difficult for an investor to bring any legal actions against the Medinotec Group of companies’ directors
or officers for violations of their fiduciary duties or could require us to pay any amounts incurred by our directors or officers in any
such actions.
Members of our board of directors and our officers
will have no liability for breaches of their fiduciary duty of care as a director or officer, except in limited circumstances, pursuant
to provisions in the Nevada Revised Statutes and our Bylaws as authorized by the Nevada Revised Statutes. Specifically, Section 78.138
of the Nevada Revised Statutes provides that a director or officer is not individually liable to the company or its shareholders or creditors
for any damages as a result of any act or failure to act in his or her capacity as a director or officer unless it is proven that (1)
the director’s or officer’s act or failure to act constituted a breach of his or her fiduciary duties as a director or officer
and (2) his or her breach of those duties involved intentional misconduct, fraud or a knowing violation of law.
This provision is intended to afford directors and
officers protection against and to limit their potential liability for monetary damages resulting from suits alleging a breach of the
duty of care by a director or officer. Accordingly, you may be unable to prevail in a legal action against our directors or officers even
if they have breached their fiduciary duty of care.
In addition, our Bylaws allow us to indemnify our
directors and officers from and against any and all costs, charges and expenses resulting from their acting in such capacities with us.
This means that if you were able to enforce an action against our directors or officers, in all likelihood, we would be required to pay
any expenses they incurred in defending the lawsuit and any judgment or settlement they otherwise would be required to pay. Accordingly,
our indemnification obligations could divert needed financial resources and may adversely affect our business, financial condition, results
of operations and cash flows, and adversely affect prevailing market prices for our common stock.
Management evaluated the Company’s ability to
continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available
funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance
of these financial statements.
ITEM 1B.
UNRESOLVED STAFF COMMENTS
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This information is not required for smaller reporting
companies.
ITEM 1C.
CYBERSECURITY
Cybersecurity Risk Management and Strategy
We rely on our information technology to operate our
business. As such, we have policies and processes designed to protect our information technology systems, some of which are managed by
third parties, and resolve issues in a timely manner in the event of a cybersecurity threat or incident.
We have designed our business applications and hosting
services to minimize the impact that cybersecurity incidents could have on our business and have identified back-up systems where appropriate.
We seek to further mitigate cybersecurity risks through a combination of monitoring and detection activities, use of anti-malware applications,
employee training, quality audits and communication and reporting structures, among other processes. We engage a third-party consultant
to assist us with our cybersecurity risk management framework, including the monitoring and detection of cybersecurity threats and responding
to any cybersecurity threats or incidents.
The Company maintains an ongoing partnership with
a third-party cybersecurity service provider, which facilitates continuous communication through regular electronic updates and periodic
onsite engagements. This collaboration ensures alignment in key areas of cybersecurity, including threat detection, vulnerability management,
and incident response.
We have implemented internal communication protocols
designed to promptly escalate any cybersecurity incidents to the appropriate personnel responsible for evaluating their significance and
potential materiality. Upon identification of an incident, the matter is assessed in coordination with our cybersecurity service provider.
Relevant information is then communicated to the Board of Directors, which is responsible for determining whether public disclosure is
required under applicable securities laws. This process is intended to support timely and accurate reporting in accordance with the Company’s
disclosure obligations.
We do not currently maintain dedicated cybersecurity
insurance coverage.
Cybersecurity Governance
The Company’s cybersecurity program is supported
by a third-party consultant team, which provides expertise in monitoring, threat detection, and risk mitigation. This team operates under
the oversight of senior leadership, specifically the Chief Executive Officer and an Independent Director with relevant experience. Together,
they are responsible for managing the relationship with the cybersecurity consultants and ensuring that cybersecurity risk management
remains aligned with the Company’s overall strategic objectives and risk tolerance.
Our cybersecurity program is informed by industry-recognized
best practices, including the National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF), which guides our efforts
across key domains such as risk identification, protection, threat detection, incident response, and recovery. This framework helps ensure
consistency and effectiveness in our cybersecurity approach and supports compliance with evolving regulatory expectations.
Cybersecurity oversight is also integrated into the
Company’s broader corporate governance structure. Management provides updates to the Board of Directors at least quarterly, or more
frequently as necessary in response to immediate threats or incidents. These updates cover any material cybersecurity events, as well
as incidents of lesser impact that may indicate emerging risks or operational vulnerabilities. The Board, in exercising its oversight
responsibilities, evaluates the potential impact of such incidents on the Company’s operations, financial condition, and disclosure
obligations.
This governance framework is designed to ensure that
the Company remains responsive to the dynamic cybersecurity landscape, maintains regulatory compliance, and protects the integrity of
its information systems and data assets.
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Our management team is responsible for assessing and
managing our material risks from cybersecurity threats.
Risks from Cybersecurity threats
Although cybersecurity risks have not materially affected
us, including our business strategy, results of operations or financial condition, to date, we face numerous and evolving cybersecurity
threats in our business. For more information about the cybersecurity risks we face, see the risk factor entitled "The Medinotec
Group of Companies rely on the proper function, security and availability of our IT systems and data to operate the business, and a breach,
cyber-attack or other disruption to these systems or data could materially and adversely affect the business, results of operations, financial
condition, cash flows, reputation, or competitive position." in Item 1A. Risk Factors.
During the years ended February 28, 2026 and February
28, 2025, we did not, to our knowledge, experience any cybersecurity incidents or breaches that materially impacted or are reasonably
likely to materially impact our business, performance or results.
ITEM 2.
PROPERTIES
Currently, we do not own any real estate. Our principal
executive offices and manufacturing facility are located at Northlands Business Park at 170-171 Bush Telegraph Avenue, North Riding, Johannesburg,
South Africa. We have entered into a lease for this 8,783 square foot facility. We also rent office space in Melville, New York under
a short-term rental agreement. We believe that our properties are adequate for our current needs, but growth potential may require larger
facilities due to the anticipated addition of personnel.
We do not have any policies regarding investments
in real estate, securities, or other forms of property.
Please refer to related party footnotes in the financial
statements and as disclosed in the Section of this Annual Report, entitled, “Certain Relationships and Related Transactions, and
Director Independence” for the related party effects of the lease.
We are also currently renting office and storage space in Long Island,
New York.
ITEM 3.
LEGAL PROCEEDINGS
From time to time, the Company may become involved
in various legal proceedings in the ordinary course of its business and may be subject to third-party infringement claims.
In the normal course of business, the Company may
agree to indemnify third parties with whom it enters into contractual relationships, including customers, lessors, and parties to other
transactions with the Company, with respect to certain matters. The Company has agreed, under certain conditions, to hold these third
parties harmless against specified losses, such as those arising from a breach of representations or covenants, other third-party claims
that the Company’s products when used for their intended purposes infringe the intellectual property rights of such other third
parties, or other claims made against certain parties. It is not possible to determine the maximum potential amount of liability under
these indemnification obligations due to the Company’s limited history of prior indemnification claims and the unique facts and
circumstances that are likely to be involved in each claim.
From time to time, the Company is subject to various
claims that arise in the ordinary course of business. Management believes that any liability of the Company that may arise out of or with
respect to these matters will not materially affect the financial position, results of operations, or cash flows of the Company.
As of the date of this Annual Report, there is no
known material litigation or claims against the Company.
ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
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PART II
ITEM 5.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information.
Our common stock is qualified for quotation on the
OTCQX under the symbol “MDNC” and has been quoted on the OTC since March 2023. There currently is no liquid trading market
for our common stock. There can be no assurance that a significant active trading market in our common stock will develop, or if such
a market develops, that it will be sustained.
The ability of individual stockholders to trade their
shares in a particular state may be subject to various rules and regulations of that state. A number of states require that an issuer’s
securities be registered in their state or appropriately exempted from registration before the securities are permitted to trade in that
state. Presently, we have no plans to register our securities in any particular state. Further, our shares are subject to the provisions
of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the “penny stock” rule. Section 15(g) sets forth
certain requirements for transactions in penny stocks and Rule 15g-9(d)(1) incorporates the definition of penny stock as that used in
Rule 3a51-1 of the Exchange Act.
Holders
As
of May 28, 2026, we had 58 shareholders of common stock per transfer agent’s shareholder list.
Dividends
The Company has not paid any cash dividends to date
and does not anticipate or contemplate paying any dividends in the foreseeable future. It is the present intention of management to utilize
all available funds for the growth of the Registrant’s business.
Equity Compensation Plan Information
The Company does not currently have an equity compensation
plan in place.
ITEM 6.
[RESERVED]
ITEM 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Results
of Operations for the Years Ended February 28, 2026 and February 28, 2025
Revenue
For the fiscal year ended February 28, 2026, revenue was $9,729,463, compared
to $9,113,607 for the fiscal year ended February 28, 2025, an increase of $615,856, or 7%. This increase was driven primarily by the expansion
of the Company’s distribution business outside the United States, particularly through enhanced partnerships in South Africa that
contributed to higher sales volumes in the Company’s cardiology and dialysis product lines.
Distribution agreement sales outside the United States increased by $569,469
to $8,141,634 for fiscal 2026 from $7,572,165 for fiscal 2025. The increase in these sales reflected, in part, the first full year of
revenue generated under the Company’s renal dialysis distribution agreement in the South African market, which was entered into
during the third quarter of fiscal 2025. Internally designed and manufactured sales outside the United States also increased by $112,632
to $975,969 for fiscal 2026 from $863,337 for fiscal 2025.
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These increases were partially offset by lower internally designed and
manufactured sales in the United States, which decreased by $66,245 to $611,860 for fiscal 2026 from $678,105 for fiscal 2025. Accordingly,
the overall increase in revenue for fiscal 2026 was attributable primarily to stronger sales outside the United States, particularly increased
distribution agreement sales in South Africa, partially offset by lower U.S. sales of internally designed and manufactured products, including
Trachealator, due in part to the timing of customer orders. Management is closely monitoring performance in the United States segment
and has implemented initiatives intended to improve sales performance. The Company expects these efforts, together with the fiscal 2027
launch of OutFlo in the United States market, to support revenue growth in that segment during fiscal 2027, although actual results may
differ depending on customer demand, commercialization progress, market acceptance and other factors.
The Company continues to derive a substantial portion of its revenue from
sales outside the United States, particularly in South Africa, and from a limited number of distribution relationships. While these results
reflect improved market penetration in key markets, future performance remains subject to risks and uncertainties, including customer
and geographic concentration, variability in distributor execution, the timing of customer orders, changes in market demand, and broader
economic conditions. In addition, the Company monitors the effect of foreign currency fluctuations, which may affect both reported revenue
and operating results from period to period.
Management expects established distribution relationships to remain an
important component of revenue generation, while continuing efforts to broaden the Company’s product offering, expand sales of internally
designed and manufactured products, and reduce concentration risk over time.
Seasonality and Operating Patterns
While our business is not subject to pronounced seasonality,
we typically observe modest declines in sales during periods that coincide with regional holidays or extended breaks, particularly in
markets like South Africa. These trends are known and budgeted for as part of our operating planning cycle.
Related Party Transactions
No revenue was generated from related party affiliations
during the fiscal year ended February 28, 2026.
This table indicates the sales per revenue stream
as a breakdown of the total revenue balance:
Medinotec Inc Group Consolidated Years Ended
Feb 28, 2026
$
Feb 28, 2025
$
Outside of United States of America
Internally Designed/Manufactured Sales
975,969
863,337
Distribution Agreement Sales
8,141,634
7,572,165
Sales Generated inside the United States of America
Internally Designed/Manufactured Sales
611,860
678,105
9,729,463
9,113,607
The following table sets forth financial information
by reportable segment for the years ending February 28, 2026 and February 28, 2025:
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1.
Income/(loss) from operations
Inside the United States
Outside the United States
Total
2026
2025
2026
2025
2026
2025
Revenue
611,860
678,105
9,117,603
8,435,502
9,729,463
9,113,607
Cost
of goods sold
(155,214
)
(87,826
)
(4,446,136
)
(4,207,292
)
(4,601,350
)
(4,295,118
)
Gross
profit
456,646
590,279
4,671,467
4,228,210
5,128,113
4,818,489
Selling expenses
(96,906
)
(65,646
)
(1,388,735
)
(47,548
)
(1,485,641
)
(113,194
)
Depreciation expense
—
—
(80,873
)
(73,846
)
(80,873
)
(73,846
)
General
and administrative expenses
(865,855
)
(725,834
)
(1,451,374
)
(622,983
)
(2,317,229
)
(1,348,817
)
Research and development expenses
(54,495
)
(50,000
)
(95,363
)
(41,133
)
(149,858
)
(91,133
)
Income/(loss)
from operations
(560,610
)
(251,201
)
1,655,122
3,442,700
1,094,512
3,191,499
2.
Total Assets
Inside the United States
Outside the United States
Total
2026
2025
2026
2025
2026
2025
Total assets
2,058,119
2,181,184
4,754,769
4,627,789
6,812,888
6,808,973
A major component of total assets is "Cash"
of $2,757,024 for the year ending February 28, 2026 and $2,769,686 for the year ending February 28, 2025. A significant portion of this
is maintained inside the United States in USD of $1,816,626 for the year ending February 28, 2026 and $2,019,628 for the year ending February
28, 2025.
Cost of Goods Sold
For the fiscal year ended February 28, 2026, cost
of goods sold was $4,601,350, compared to $4,295,118 for the fiscal year ended February 28, 2025, an increase of $306,232, or 7%. The
increase in cost of goods sold was primarily attributable to higher sales volumes outside the United States, particularly increased distribution
agreement sales in South Africa, partially offset by lower sales volumes in the United States.
Gross profit was $5,128,113 for fiscal 2026, compared
to $4,818,489 for fiscal 2025, an increase of $309,624, or 6%. Gross margin remained stable at 53% for fiscal 2026 (fiscal 2025: 53%).
The increase in gross profit was driven primarily
by the higher contribution from sales outside the United States. Outside the United States, revenue increased by $682,101 to $9,117,603
for fiscal 2026 from $8,435,502 for fiscal 2025, while cost of sales increased by $238,844 to $4,446,136 from $4,207,292. As a result,
gross profit outside the United States increased by $443,257 to $4,671,467 for fiscal 2026 from $4,228,210 for fiscal 2025. This improvement
reflected increased revenue contribution and a favorable sales mix, including increased distribution agreement sales and higher internally
designed and manufactured sales outside the United States. The improvement was partially offset by the recognition of an inventory obsolescence
provision during fiscal 2026, which increased cost of sales.
Inside the United States, revenue decreased by
$66,245 to $611,860 for fiscal 2026 from $678,105 for fiscal 2025, while cost of sales increased by $67,388 to $155,214 from $87,826.
As a result, gross profit inside the United States decreased by $133,633 to $456,646 for fiscal 2026 from $590,279 for fiscal 2025. The
decrease in gross profit in this segment was primarily attributable to lower revenue, lower selling prices during fiscal 2026, and higher
cost of sales.
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On a consolidated basis, the increase in gross
profit outside the United States was partially offset by the decrease in gross profit inside the United States. Although consolidated
revenue increased by $615,856, cost of sales increased by $306,232, including as a result of the inventory obsolescence provision recognized
during fiscal 2026. As a result, consolidated gross margin remained substantially consistent year over year.
The Company continues to monitor gross margin closely
across both segments. Outside the United States, margins benefited from stronger revenue contribution and sales mix during fiscal 2026.
The strengthening of the South African Rand during fiscal 2026 may also have affected margin trends compared to the prior year. The Company
also continues to monitor the effect of tariffs and other input cost pressures on products sold into the United States, which may adversely
affect margins if not mitigated.
Key Factors Affecting COGS and Gross Margin
• Sales-Driven
Increase in COGS: The rise in COGS is consistent with higher product sales, particularly under third-party distribution agreements, which
resulted in a proportional increase in associated costs.
• Operational
Efficiencies: As the Group matures operationally, efficiencies in manufacturing and sales processes have improved. This ongoing operational
refinement has contributed positively to gross margins through reduced unit costs and optimized workflows.
No related party transactions were recorded in cost
of sales for the fiscal year ended February 28, 2026.
Operating Expenses
For the fiscal year ended February 28, 2026, operating
expenses totaled $4,033,601, an increase from $1,626,990 for the fiscal year ended February 28, 2025.
One of the major components that affect the operating
expenses is the costs of compliance for the business. Certain costs are once off in nature and others will be recurring. This will be
determined after the markets were entered and all regulatory requirements met.
The Medinotec Group of Companies for the Years Ended
Feb 28,
2026
$
Feb 28,
2025
$
Compliance cost
362,172
526,603
The Medinotec Group of Companies for the Years Ended
Feb 28,
2026
$
Feb 28,
2025
$
Depreciation and amortization expense
80,873
73,846
General and administrative expenses
2,317,229
1,348,817
Research and development expenses
149,858
91,133
Selling expenses
1,485,641
113,194
Total operating
expenses
4,033,601
1,626,990
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Key
Drivers of Operating Expense Trends
·
General and Administrative Expenses: General
and administrative expenses increased to $2,317,229 for the year ended February 28, 2026, from $1,348,817 for the year ended February
28, 2025, an increase of $968,412. The increase was driven primarily by the introduction of indirect executive compensation, under which
executives who are not directly employed by the Company are compensated for time spent managing the Company through the entities by which
they are employed. This accounted for approximately $549,498 of general and administrative expense during fiscal 2026. General and administrative
expenses also increased due to higher salary costs associated with the appointment of more qualified full-time staff members in the finance
and research and development departments.
·
Research and Development Expenses: Research and
development expenses increased to $149,858 for the year ended February 28, 2026, from $91,133 for the year ended February 28, 2025, an
increase of $58,725. The increase was primarily attributable to stock-based compensation granted to a physician in exchange for services
rendered. The Company is also currently exploring the development of three new products, namely StaXstop, Septus Balloon and Vaultseal
Balloon. Research and development spending remains modest relative to total operating expenses and continues to be focused on product
opportunities that align with the Company’s existing technical and manufacturing capabilities.
·
Selling Expenses: Selling expenses increased to
$1,485,641 for the year ended February 28, 2026, from $113,194 for the year ended February 28, 2025, an increase of $1,372,447. The increase
was driven primarily by distributor support costs incurred under the Company’s arrangements in the South African market. The Company
agreed to reimburse its distribution partner for a portion of that partner’s expenditure incurred in connection with the sale of
cardiology and dialysis products in South Africa. A substantial portion of these costs related to the distributor’s employee costs
for its sales force, together with other variable expenditure incurred in supporting these sales activities. These distribution costs
amounted to $1,320,115 for fiscal 2026, representing the majority of the increase from fiscal 2025.
·
Depreciation and Amortization Expense: Depreciation
and amortization expense increased modestly to $80,873 for the year ended February 28, 2026, from $73,846 for the year ended February
28, 2025. The Company allocates a portion of depreciation to products manufactured during the period, with the balance recognized in operating
expenses.
Future Operating Expense Growth
Looking forward, the Company expects future operating
expenses to continue to be influenced by regulatory compliance and corporate infrastructure requirements, sales and distribution support
costs, and targeted research and development activities. The Company expects to continue incurring costs associated with operating in
regulated markets, including product registrations, quality and compliance requirements, public company compliance and the personnel needed
to support a growing business. In addition, as the Company continues to expand its distribution activities, particularly outside the United
States, selling expenses may remain elevated due to distributor support costs, sales force-related expenditure and other market development
costs required to support revenue growth. In addition, while R&D expenses will remain relatively modest, the Company's focus will
remain on optimizing manufacturing processes, ensuring that production capabilities are aligned with increased product demand and the
scalability of our operations.
Non-operating income and expenses
Non-operating income and expenses totaled
a net expense of $25,325 for the fiscal year ended February 28, 2026, compared to a net expense of $167,361 for the fiscal year ended
February 28, 2025. The improvement was driven primarily by lower interest expense, partially offset by higher other non-operating expense.
Interest expense decreased to $87,595 for fiscal 2026
from $176,416 for fiscal 2025. The decrease was primarily attributable to lower interest incurred on the loan payable to Minoan Medical,
as fiscal 2026 included interest expense on that loan only through August 31, 2025, when the outstanding balance was settled. Accordingly,
interest expense for fiscal 2026 reflected only a partial year of interest on this borrowing.
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Interest income increased to $71,513 for fiscal 2026
from $8,668 for fiscal 2025, primarily due to higher returns earned on cash balances during the year. Other non-operating expense was
$9,243 for fiscal 2026, compared to other non-operating income of $387 for fiscal 2025.
Net Income
The Medinotec Group of Companies reported net
income of $794,502 for the fiscal year ended February 28, 2026, compared to net income of $2,159,473 for the fiscal year ended February
28, 2025, a decrease of $1,364,971.
The decrease in net income was primarily attributable
to the significant increase in operating expenses during fiscal 2026, which more than offset the increase in gross profit.
As discussed above, revenue and gross profit increased
during the year, driven primarily by stronger sales outside the United States, particularly distribution agreement sales in South Africa.
However, this improvement was more than offset by higher selling expenses, general and administrative expenses and research and development
expenses.
The decrease in net income was partially mitigated
by the improvement in non-operating income and expenses, primarily due to lower interest expense in fiscal 2026 following the settlement
of the Minoan Medical loan on August 31, 2025. In addition, income tax expense was lower in fiscal 2026 than in the prior year. As a result,
although the Company remained profitable for the year ended February 28, 2026, net income declined compared to the prior year.
Liquidity and Capital Resources
As of February 28, 2026, the Company had
total current assets of $6,419,805 and total assets of $6,812,888. Total current liabilities as of February 28, 2026, were $1,101,192.
The Company had working capital of $5,318,613 as of February 28, 2026. In comparison, as of February 28, 2025, the Company had total
current assets of $6,423,186 and total assets of $6,808,973. Total current liabilities as of February 28, 2025 were $1,505,047. Consolidated,
we had working capital of $4,918,139 as of February 28, 2025.
The research and development phase of the
internally designed product lines has largely concluded. Therefore, we expect to see an increase in sales and marketing expenses, primarily
for the rollout in the United States and the expansion of the cardiology distribution contract business in South Africa.
The Company has sufficient cash reserves and
working capital to fund the roll-out in the market of the United States, including new research and development activities, as well as
marketing and sales functions.
We have cash available on hand and believe
that this cash will be sufficient to fund operations and meet our obligations as they come due within one year from the date these Consolidated
Financial Statements are issued. In the event that we do not achieve the revenue anticipated in our current operating plan, management
has the ability and commitment to reduce operating expenses as necessary. The Company’s ability to fund longer-term operations will
depend on its ability to generate revenue, manage operating expenses, and obtain additional capital if required.
As of February 28, 2026, we have no material
capital expenditure commitments. All planned capital projects have been completed, and there are no additional contractual obligations
for plant expansion or equipment purchases. Our manufacturing facility currently operates below its maximum capacity, which allows us
to absorb modest increases in production without significant additional investment. This available capacity enables us to respond efficiently
to changes in customer demand with minimal incremental capital outlay.
We fund our operations and working capital
needs primarily from cash generated by our ongoing business activities. Over the past two fiscal years, our operating cash flows have
been positive and sufficient to meet our cash requirements, and we expect this trend to continue in the near future. We maintain strong
operational controls that allow us to manage our working capital effectively, ensuring liquidity is available for daily operations and
short-term commitments.
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In the longer term, we may require additional
capital to support strategic initiatives, including select product enhancements and potential expansion efforts. While we do not currently
anticipate large-scale capital expenditures, the need for future funding to support ongoing business growth or research and development
(R&D) efforts may arise. As a smaller reporting company with limited R&D activities, we continue to focus our research investments
on incremental product refinements rather than early-stage or speculative development. These expenditures remain modest, as previously
disclosed, and are primarily directed toward refining existing production processes. However, any significant future R&D initiatives
or product development would likely require external funding, either through equity or debt financing.
Liquidity
In terms of liquidity, we currently have sufficient
cash resources to meet our short-term obligations and continue day-to-day operations. We regularly evaluate cash needs based on forecasted
operational demands and have identified no material trends or uncertainties that would cause a significant change in our liquidity position.
Any potential changes in liquidity would likely arise from strategic decisions, such as expansion or increased investment in R&D,
but we expect that cash flows from ongoing operations will continue to provide the necessary funds.
Capital Resources
As of the end of the latest fiscal period,
our capital requirements are primarily focused on sustaining and optimizing existing operations, rather than large-scale growth or capital
expansion. We have no material capital expenditures committed for the near term. However, as our business continues to evolve, we anticipate
that we may seek external financing options, such as equity offerings or debt financing, should the need arise for larger investments
in new products or significant capacity expansion.
While our current capital structure remains
primarily equity-based, we are mindful of changing trends in the availability and cost of capital resources, including any shifts in equity
or debt market conditions that may affect our financing strategy. We continue to explore opportunities to optimize our capital resources,
balancing the need for flexibility with prudent financial management.
Currency Fluctuations and Exchange Rate
Risks
Given the Company’s exposure to various
currencies, particularly the South African Rand and the U.S. Dollar, fluctuations in exchange rates could impact our working capital and
cash reserves. We monitor foreign exchange risks and may take steps to hedge against significant adverse movements. While we have not
implemented any hedging strategy at this time, we will continue to assess the impact of currency fluctuations on our financial position
and operations.
Funding Strategy for Expansion
As part of our growth strategy, the Company
continues to explore opportunities for alternative funding sources, including strategic partnerships, grants, and government incentives,
to support expansion into new markets and product development initiatives. These options could provide additional capital if needed for
larger-scale projects or unforeseen expenditures.
Future Plans and Financing Needs
Looking ahead, we anticipate that any major
strategic initiatives, such as entering new markets or funding larger-scale projects, may require additional capital. We continue to explore
all available financing options to ensure that we can access the necessary resources to fund future growth and innovation. This includes
potential equity or debt offerings, as well as exploring potential partnerships or other arrangements that could provide non-dilutive
funding.
Our audited Consolidated Financial Statements
have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. We received FDA 510(k) approval through the substantially equivalence
process for Class II medical devices for our main product being the Trachealator. During the quarter ending November 30, 2024, the Company
also obtained renal dialysis distribution revenues in South Africa, which significantly contributed to the overall profitability of the
Company in the 2025 fiscal year. With the research and development phase of most products completed, we expect to see an increase in sales
being realized against the sales expenditure incurred, as was the result in the current fiscal year.
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Cash Flows
The following table summarizes our cash flows
from continuing operations for the periods indicated:
2026
2025
Net cash provided by (used in):
Operating Activities
906,798
877,834
Investing Activities
(1,363 )
(89,013 )
Financing Activities
(982,973 )
(894,482 )
Cash flows provided by Operating Activities
Net cash provided by operating activities
before income taxes paid was $952,541 for the fiscal year ended February 28, 2026, compared to $1,144,215 for the fiscal year ended February
28, 2025. After income taxes paid, total cash flows from operating activities were $906,798 for fiscal 2026, compared to $877,834 for
fiscal 2025. Although net income declined to $794,502 from $2,159,473 in the prior year, operating cash flows remained strong.
Operational cash flow benefited from improved
working capital management, including better receivables collection. These benefits were partially offset by an increase in inventory,
an increase in prepayments, and a decrease in accounts payable and accrued expenses. In addition, certain tax liabilities were settled
during the year through a set-off and settlement arrangement by way of reductions in trade receivables, which did not result in cash outflows
by the Company. Under that arrangement, DISA Life Sciences undertook to settle tax liabilities on behalf of DISA Medinotec, with DISA
Medinotec’s trade receivable balance reduced accordingly.
Management believes that these improvements,
alongside efficiencies and sustained revenue momentum, position the Group for continued positive cash flow generation. Non-cash adjustments,
including depreciation and share-based compensation, are minimal in our business.
Cash flows used in Investing Activities
Net cash used in investing activities was
$1,363 for the fiscal year ended February 28, 2026, compared to $89,013 for the fiscal year ended February 28, 2025. Investing cash outflows
in both periods related to payments to acquire property, plant and equipment. The lower cash outflow in fiscal 2026 reflects significantly
reduced capital expenditure compared to the prior year.
Cash flows used in Financing Activities
Cash flows used in financing activities for
the fiscal year ended February 28, 2026, were $982,973, compared to $894,482 for the fiscal year ended February 28, 2025. These outflows
related primarily to the repayment of debt. During fiscal 2026, a significant portion of the Company’s obligations to Minoan Medical
(Pty) Ltd was settled through a non-cash tripartite set-off and settlement arrangement, pursuant to which DISA Life Sciences undertook
to settle the loan payable on behalf of DISA Medinotec, with a corresponding reduction in DISA Medinotec’s trade receivable balance.
Looking ahead, the Company may evaluate additional financing options,
including potential debt or equity issuances, to support its strategic growth objectives. This may include funding expansion into new
markets, increasing production capacity, and scaling marketing and distribution efforts to drive long-term value creation.
Off Balance Sheet Arrangements
As of February 28, 2026, there were no off-balance
sheet arrangements.
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Critical Accounting Estimates
The preparation of the Company’s consolidated
financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported
in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience, current conditions
and various other assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates.
While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the accounting
estimates below are most critical to understanding our financial condition and historical and future results of operations.
Inventories
Inventories are stated at the lower of cost or net
realizable value, with cost determined using the weighted-average method, and consist of raw materials, work-in-process and finished goods.
Inventory cost includes purchased materials, direct labor, machine time and manufacturing overhead.
Management reviews inventory for excess, slow-moving
and obsolete items and records write-downs when the carrying value of inventory is not expected to be recoverable. In performing this
assessment, management considers factors such as inventory age, historical usage, expected future demand, product shelf life and estimated
net realizable value. Because this evaluation requires management to make assumptions about future demand and usage, actual results could
differ from those estimates. However, management does not believe that reasonably likely changes in these assumptions would have a material
effect on the Company’s consolidated financial statements as of February 28, 2026.
There were no material changes during fiscal 2026
in the methodology used to assess inventory valuation or obsolescence.
Deferred Tax Assets and Liabilities
The Company accounts for income taxes using the asset
and liability method, under which deferred tax assets and liabilities are recognized for temporary differences between the financial statement
carrying amounts and the tax bases of existing assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred
tax assets and liabilities are measured using enacted tax rates expected to apply in the periods in which those temporary differences
are expected to reverse.
Management is required to assess whether deferred
tax assets are more likely than not to be realized. In making this assessment, management considers all available positive and negative
evidence, including historical operating results, projections of future taxable income, the reversal of existing taxable temporary differences
and available tax planning strategies. A valuation allowance is recorded when management concludes that it is more likely than not that
some portion or all of a deferred tax asset will not be realized.
This assessment requires significant judgment, particularly
with respect to expectations for future taxable income and the weighing of positive and negative evidence. Changes in these assumptions
or in tax laws could materially affect the amount of deferred tax assets and liabilities recorded in the consolidated financial statements.
There were no material changes during fiscal 2026 in the methodology used to assess deferred tax assets and liabilities.
Recently Issued Accounting Pronouncements
See Note 2 to our Consolidated Financial Statements
included in Part IV, Item 15 of this Annual Report on Form 10-K for more information about recent accounting pronouncements, the timing
of their adoption, and our assessment, to the extent we have made one, of their potential impact on our financial condition and results
of operations.
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ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are not required to provide the information required
by this Item because we are a smaller reporting company.
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements required by this Item 8 are
included in this Annual Report following Item 15 hereof. As a smaller reporting company, we are not required to provide supplementary
financial information.
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that
are designed to ensure that information required to be disclosed in our reports, filed under the Securities Exchange Act of 1934, is recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is
accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to
allow timely decisions regarding required disclosure.
Based on the evaluation performed as of February 28, 2026, our
Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of such date.
Management’s Report on Internal Controls Over Financial
Reporting
Management is responsible for establishing
and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f).
A company’s internal control over financial reporting is a process designed by, or under the supervision of, its Chief Executive
Officer and Chief Financial Officer, and effected by such company’s board of directors, management and other personnel to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles and includes those policies and procedures that:
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
•
provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
•
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not
absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was
required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design
of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate
because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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Management assessed the effectiveness of the Company’s
internal control over financial reporting as of February 28, 2026 based on the criteria established in Internal Control—Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management
concluded that the Company’s internal control over financial reporting was effective as of February 28, 2026.
During fiscal 2026, management implemented and completed
the remediation of the material weaknesses previously identified as of February 28, 2025. These remediation measures were implemented
systematically over the course of the fiscal year and were in place as of February 28, 2026. Specifically, the Company formalized and
documented internal control procedures over material financial reporting cycles, enhanced segregation of duties within the finance function,
implemented additional review and approval controls, established a review and approval process over journal entries recorded in the accounting
records, strengthened controls over expenditures, outgoing payments and banking activities, and adopted a formal Code of Business Conduct
and Ethics.
This annual report does not include an attestation
report of the Company’s independent registered public accounting firm regarding internal control over financial reporting because
such report is not required.
Changes in Internal Control Over Financial Reporting
During the fiscal year ended February 28, 2026, there
were changes in the Company’s internal control over financial reporting that materially affected, or were reasonably likely to materially
affect, the Company’s internal control over financial reporting. These changes included the completion of remediation measures related
to the material weaknesses previously identified as of February 28, 2025, including the formal documentation of internal control procedures
over material financial reporting cycles, enhancements to segregation of duties and review controls within the finance function, the establishment
of a review and approval process over journal entries recorded in the accounting records, strengthened controls over expenditures, outgoing
payments and banking activities, and the adoption of a formal Code of Business Conduct and Ethics.
Limitations on Effectiveness of Controls and Procedures
The effectiveness of any system of internal control
over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing,
operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of
internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not
absolute assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls
may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business, but there can be no assurance
that such improvements will be sufficient to provide us with effective internal control over financial reporting.
ITEM 9B.
OTHER INFORMATION
None.
ITEM 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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PART III
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The following information sets forth the names, ages,
and positions of our current directors and executive officers.
Name
Age
Position(s) and Office(s) Held
Gregory Vizirgianakis
47
President, Secretary, CEO and Director
Pieter van Niekerk
41
CFO, Treasurer and Director
Stavros G. Vizirgianakis
54
Director
Joseph P. Dwyer
70
Director
Athanasios Spirakis
64
Director
Set forth below is a brief description of the background
and business experience of our current executive officers and directors.
Gregory Vizirgianakis
The Company is led by Dr Vizirgianakis as the Chief
Executive Officer, a qualified medical doctor, with a specialty interest in the field of neuroscience. He has many years of experience
in the international and South African health markets. Dr Vizirgianakis is the founding ultimate shareholder of DISA Medinotec Proprietary
Limited and has been involved in several successful entrepreneurial ventures. For the last five years, Dr. Vizirgianakis has been employed
as CEO of Minoan Medical and DISA Medinotec Proprietary Limited.
Aside from that provided above, Dr. Vizirgianakis
does not hold and has not held over the past five years any other directorships in any company with a class of securities registered pursuant
to Section 12 of the Exchange Act or subject to the requirements of Section 15(d) of the Exchange Act or any company registered as an
investment company under the Investment Company Act of 1940.
The Board believes that Dr. Vizirgianakis has the
experience, qualifications, attributes, and skills necessary to serve on the Board based on his experience in healthcare and medical device
businesses, his role as a founding shareholder, and his executive experience with the Company and related businesses.
Pieter van Niekerk
Mr. Pieter van Niekerk is a qualified Chartered
Accountant and the Company's CFO and has been involved in multiple listings on various exchanges in the United States of America and South
Africa. He has 10 years of executive management experience. For the last five years, Mr. van Niekerk has been employed as CFO of Minoan
Medical and DISA Medinotec Proprietary Limited.
Aside from that provided above, Mr. van Niekerk
does not hold and has not held over the past five years any other directorships in any company with a class of securities registered pursuant
to Section 12 of the Exchange Act or subject to the requirements of Section 15(d) of the Exchange Act or any company registered as an
investment company under the Investment Company Act of 1940.
The Board believes that Mr. van Niekerk has the experience,
qualifications, attributes, and skills necessary to serve on the Board based on his financial, accounting, and executive experience, his
role as a founding shareholder, and his experience with the Company and related businesses.
Stavros G. Vizirgianakis
Mr. Vizirgianakis is an investor and
strategic advisor to companies in the medical device field. He currently serves on the Board of Directors at Tally Surgical, Inc.,
Theragenics Corporation, Xtant Medical Holdings, Inc. (NYSE American: XTNT) and Medinotec, Inc. (OTCQX:MDNC). Mr. Vizirgianakis
previously served on the Board of Directors at Bioventus Inc. (Nasdaq: BVS) and Tenaxis Medical. Mr. Vizirgianakis is the former
Chief Executive Officer of medical device company, Misonix, Inc., which he led from 2016 through the company’s acquisition by
Bioventus Inc. in 2021. He previously served as Managing Director of the Medical Devices business at Ascendis Health Limited (JSE:
ASC) from 2014 to 2016. Mr. Vizirgianakis co-founded Surgical Innovations, one of the largest privately-owned medical device
distributors in the African region, which later became part of Ascendis Health Limited. His career in the medical device industry
also includes experience serving as Director of Sales for sub-Saharan Africa at United States Surgical Corporation
and as General Manager of South Africa at Tyco Healthcare. Mr. Vizirgianakis holds a degree in Commerce from the University of South Africa.
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Aside from that provided above, Mr. Vizirgianakis
does not hold and has not held over the past five years any other directorships in any company with a class of securities registered pursuant
to Section 12 of the Exchange Act or subject to the requirements of Section 15(d) of the Exchange Act or any company registered as an
investment company under the Investment Company Act of 1940.
Mr. Vizirgianakis has a degree in commerce
from the University of South Africa. The Board believes Mr. Vizirgianakis’ industry knowledge, sales and marketing experience and
his international business relationships qualify him to serve as a director.
Joseph P. Dwyer
Mr. Dwyer has been serving as the Chief Financial
Officer of Archive360, LLC since June, 2022. He served as Misonix’s Chief Financial Officer from August 2, 2017 through November
2021, and then as a financial consultant to Misonix’s acquirer, Bioventus, through April, 2022. From June 2015 to July 2017, Mr.
Dwyer provided financial consulting and advisory services to various companies, through the firms Dwyer Holdings and TechCXO. Prior thereto,
from November 2012 until June 2015, he was Chief Financial Officer of Virtual Piggy, Inc., a publicly traded technology company. Prior
to joining Virtual Piggy, Mr. Dwyer served as chief financial officer of Open Link Financial, Inc., a privately held company, which provides
software solutions for trading and risk management in the energy, commodity, and capital markets.
During 2011 and 2012, Mr. Dwyer was a member of the
board of directors and chairman of the audit committee and served as interim chief administrative officer of Energy Solutions International,
Inc., a privately held company providing pipeline management software to energy companies and pipeline operators. From 2010 through 2011,
Mr. Dwyer served as chief administrative officer of Capstone Advisory Group, LLC, a privately held financial advisory firm providing corporate
restructuring, litigation support, forensic accounting, expert testimony and valuation services. Mr. Dwyer served as a consultant to Verint
Systems, Inc., a software company listed on the NASDAQ Global Market, from 2009 through 2010, assisting with SEC reporting and compliance.
From 2005 through 2009, Mr. Dwyer served as chief
financial officer and executive vice president of AXS-One Inc., a publicly traded software company. During 2004, Mr. Dwyer served as chief
financial officer of Synergen, Inc., a privately held software company providing energy technology to utilities. Prior to 2004, Mr. Dwyer
also served as chief financial officer and executive vice president of Caminus Corporation, an enterprise application software company
that was formerly listed on the NASDAQ National Market, chief financial officer of ACTV, Inc., a digital media company that was formerly
listed on the NASDAQ National Market, and chief financial officer of Winstar Global Products, Inc., a manufacturer and distributor of
hair care, bath and beauty products until its acquisition by Winstar Communications, Inc. in 1995 when Mr. Dwyer went on to serve as senior
vice president, finance of Winstar Communications.
Aside from that provided above, Mr. Dwyer does not
hold and has not held over the past five years any other directorships in any company with a class of securities registered pursuant to
Section 12 of the Exchange Act or subject to the requirements of Section 15(d) of the Exchange Act or any company registered as an investment
company under the Investment Company Act of 1940.
Mr. Dwyer received his BBA in Accounting from the
University of Notre Dame in 1978 and is licensed as a Certified Public Accountant in the State of New York.
Athanasios Spirakis
Having received two Masters of Science degrees in
Electromechanical & Computer Engineering as well as in Biomedical Engineering in 1984 and 1988 respectively, Mr. Spirakis embarked
in an academic career in 1989 becoming a Senior Lecturer and the Head of the Biomechanics Group at the Department of Biomedical Engineering
of the University of Cape Town.
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During Mr Spirakis’ tenure, besides his academic
outputs in the form of publications, conference presentations, post-graduate students’ supervision and lecturing, Mr. Spirakis undertook
consulting research projects in total Knee and Hip Arthroplasty for Johnson & Johnson (DePuy) and designed orthopedic implants which
were subsequently manufactured by South African & international companies such as Zimmer (now Zimmer-Biomet).
In 1995, Mr. Spirakis left the academic world and
assumed the responsibilities of Research & Development as well as Quality Assurance & Regulatory Affairs Directorships within
Macmed Orthopaedics, a manufacturer of total joint prostheses and spinal implants till the end of 1999.
In 2000 Mr. Spirakis became the Business Development
Director of two sister South African marketing and selling medical devices organizations, namely SA Biomedical and Orthomedics.
The former dealing in medical devices for a large
variety of surgical specialties (Cardiac / Vascular / General Surgery / Arthroscopy / Urology / ENT) and the latter in total joint replacements.
Orthomedics was acquired by J&J in 2008 and Mr. Spirakis continued his involvement as a business development director till 2011 when
he became one of the founders and director of Advanced Orthopaedics.
In 2016 Mr. Spirakis accepted the Chief Executive
Officer position within Elite Surgical, a South African medical devices manufacturer and held it till 2021 when he decided to join Minoan
Medical / Disa Life Sciences as their Chief Operating Officer.
Aside from that provided above, Mr. Spirakis does
not hold and has not held over the past five years any other directorships in any company with a class of securities registered pursuant
to Section 12 of the Exchange Act or subject to the requirements of Section 15(d) of the Exchange Act or any company registered as an
investment company under the Investment Company Act of 1940.
Term of Office
Our directors are appointed for a one-year term to
hold office until the next annual general meeting of our shareholders or until they are removed from office in accordance with our bylaws.
Our officers are appointed by our board of directors and hold office until removed by the board.
Significant Employees
We have no significant employees other than our officer
and director.
Family Relationships
Aside from Gregory Vizirgianakis and Stavros G. Vizirgianakis,
who are brothers, there are no family relationships between or among the directors, executive officers or persons nominated or chosen
by us to become directors or executive officers.
Involvement
in Certain Legal Proceedings.
During the past 10 years, none of our current directors,
nominees for directors or current executive officers has been involved in any legal proceeding identified in Item 401(f) of Regulation
S-K, including:
1. Any petition under the Federal bankruptcy
laws or any state insolvency law filed by or against, or a receiver, fiscal agent or similar officer was appointed by a court for the
business or property of such person, or any partnership in which he or she was a general partner at or within two years before the time
of such filing, or any corporation or business association of which he or she was an executive officer at or within two years before the
time of such filing;
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2. Any conviction in a criminal proceeding
or being named a subject of a pending criminal proceeding (excluding traffic violations and other minor offenses);
3. Being subject to any order, judgment,
or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining
him or her from, or otherwise limiting, the following activities:
i. Acting as a futures commission merchant,
introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person
regulated by the Commodity Futures Trading Commission, or an associated person of any of the foregoing, or as an investment adviser, underwriter,
broker or dealer in securities, or as an affiliated person, director or employee of any investment company, bank, savings and loan association
or insurance company, or engaging in or continuing any conduct or practice in connection with such activity;
ii. Engaging in any type of business practice;
or
iii. Engaging in any activity in connection
with the purchase or sale of any security or commodity or in connection with any violation of Federal or State securities laws or Federal
commodities laws;
4. Being subject to any order, judgment or
decree, not subsequently reversed, suspended or vacated, of any Federal or State authority barring, suspending or otherwise limiting for
more than 60 days the right of such person to engage in any type of business regulated by the Commodity Futures Trading Commission, securities,
investment, insurance or banking activities, or to be associated with persons engaged in any such activity;
5. Being found by a court of competent jurisdiction
in a civil action or by the SEC to have violated any Federal or State securities law, and the judgment in such civil action or finding
by the Commission has not been subsequently reversed, suspended, or vacated;
6. Being found by a court of competent jurisdiction
in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such
civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated;
7. Being subject to, or a party to, any Federal
or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to
an alleged violation of:
i. Any Federal or State securities or commodities
law or regulation; or
ii. Any law or regulation respecting financial
institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution,
civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order; or
iii. Any law or regulation prohibiting mail
or wire fraud or fraud in connection with any business entity; or
8. Being subject to, or a party to, any sanction
or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the
Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))),
or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated
with a member.
Audit Committee
On May 5, 2023, in connection with a requirement for
quotation on the OTCQX markets, our Board of Directors authorized the creation of an Audit Committee. Gregory Vizirgianakis, Athanasios
Spirakis and Joseph P. Dwyer currently serve on the Audit Committee.
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Athanasios Spirakis and Joseph P. Dwyer have been
determined by the Board to be independent directors within the meaning of NASDAQ Rule 5605. Mr. Dwyer was identified and designated by
the Board as an “audit committee financial expert,” as defined by the SEC in Item 407 of Regulation S-K.
The Audit Committee approves the selection of our
independent accountants and meets and interacts with the independent accountants to discuss issues related to financial reporting. In
addition, the Audit Committee reviews the scope and results of the audit with the independent accountants, reviews with management and
the independent accountants our annual operating results, considers the adequacy of our internal accounting procedures, including our
internal control over financial reporting, and considers other auditing and accounting matters including fees to be paid to the independent
auditor and the performance of the independent auditor.
For the fiscal year ending February 28, 2026, the
Audit Committee:
•
Reviewed and discussed the audited financial statements with management, and
•
Reviewed and discussed the written disclosures and the letter from our independent auditors on the matters relating to the auditor’s independence.
Based upon the Audit Committee’s review and discussion of the matters
above, the board of directors authorized inclusion of the audited financial statements for the year ended February 28, 2026 to be included
in this Annual Report on Form 10-K and filed with the Securities and Exchange Commission.
At the 2025 annual meeting of the shareholders, our
shareholders ratified the appointment of Mercurius and Associates LLP as our independent registered public accounting firm for fiscal
year ended 2026.
ITEM 11.
EXECUTIVE COMPENSATION.
The following summary compensation table sets forth
all compensation awarded to, earned by, or paid to the named executive officers paid by us during the years ended February 28, 2026 and
February 28, 2025.
SUMMARY COMPENSATION TABLE
Name
and
principal
position
Year
Salary ($)
Bonus
($)
Stock
Awards
($)
Option
Awards
($)
Non-Equity
Incentive Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All Other
Compensation
($)
Total
($)
Gregory Vizirgianakis
2026
—
—
—
—
—
—
219,799*
219,799
CEO
2025
—
—
—
—
—
—
6,597
6,597
Pieter van Niekerk
2026
—
—
—
—
—
—
109,900*
109,900
CFO
2025
—
—
—
—
—
—
3,958
3,958
Stavros G. Vizirgianakis
2026
—
—
—
—
—
—
219,799*
219,799
Chairman
2025
—
—
—
—
—
—
—
—
Joseph P. Dwyer
2026
—
54,495
—
—
—
—
54,495
Non-executive director
2025
—
—
—
—
—
—
—
—
* Compensation for fiscal 2026 consisted of indirect
executive compensation, as certain executive officers were not employed directly by the Company and the amounts disclosed relate to compensation
arrangements with their employing companies.
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Narrative Disclosure to the Summary Compensation
Table
The Company does not currently employ its executive
officers directly. Instead, compensation for Dr. Gregory Vizirgianakis (CEO) and Mr. Pieter van Niekerk (CFO) is paid indirectly through
arrangements with their employing companies. These indirect payments are reflected in the “All Other Compensation” column
above. Stavros G. Vizirgianakis (Chairman) also received indirect compensation in fiscal 2026 through a related entity.
Joseph P. Dwyer (non-executive director) received
stock awards in fiscal 2026 valued at $54,495 for services rendered.
Although we do not currently compensate our officers
with any regularity, we reserve the right to provide compensation at some time in the future. Our decision to compensate officers depends
on the availability of our cash resources with respect to the need for cash to further business purposes.
Outstanding Equity Awards at Fiscal Year-End
The table below summarizes all unexercised options, stock that has not
vested, and equity incentive plan awards for each named executive officers as of February 28, 2026.
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
OPTION AWARDS
STOCK AWARDS
Name
Number of
Securities
Underlying
Unexercised
Options
Exercisable
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
Equity
Incentive
Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options
Option
Exercise
Price
($)
Option
Expiration
Date
Number
of
Shares
or Units
of
Stock That
Have
Not
Vested
Market
Value
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
($)
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units or
Other
Rights
That Have
Not
Vested
Equity
Incentive
Plan
Awards:
Market or
Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
Gregory Vizirgianakis
-
-
-
-
-
-
-
-
-
Peter van Niekerk
-
-
-
-
-
-
-
-
-
No stock options or other equity awards were outstanding for any named
executive officer or director as of February 28, 2026.
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The following table sets forth, as of May 28, 2026,
the beneficial ownership of our common and preferred stock by each executive officer and director, by each person known by us to beneficially
own more than 5% of our common stock and by the executive officers and directors as a group. Unless otherwise noted, the address of each
beneficial owner is located at Northlands Deco Park | 10 New Market Street | Stand 299 Avant Garde Avenue | North Riding | 2169.
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Title of class
Name and address of beneficial owner (1)
Number of shares - Beneficial ownership
Percent of class (2)
Common
Gregory Vizirgianakis (3)
4,750,179
40.4%
Common
Pieter van Niekerk
401,965
3.4%
Common
Stavros G. Vizirgianakis (4)
4,750,179
40.5%
Common
Joseph P. Dwyer
10,899
0.1%
Common
Athanasios Spirakis
12,073
0.1%
Total of All Directors and Executive Officers (5 persons):
9,925,295
84.43%
More Than 5% Beneficial Owners:
NONE
(1)
As used in this table, "beneficial ownership" means the sole or shared power to vote, or to direct the voting of, a security, or the sole or shared investment power with respect to a security (i.e., the power to dispose of, or to direct the disposition of, a security). In addition, for purposes of this table, a person is deemed, as of any date, to have "beneficial ownership" of any security that such person has the right to acquire within 60 days after such date.
(2)
The percent of class is based on 11,755,548 voting shares as of May 28, 2026.
(3)
Includes 4,750,179 shares of common stock held by Medisol Pty Ltd that Mr. Vizirgianakis has sole voting and investment power.
(4)
Includes 4,750,179 shares held in his name.
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Other than as disclosed below and in “Executive
Compensation,” there have been no transactions involving the Company since the beginning of the last fiscal year, or any currently
proposed transactions, in which the Company was or is to be a participant and the amount involved exceeds $120,000 or one percent of the
average of the Company’s total assets at year-end for the last two completed fiscal years, and in which any related person had or
will have a direct or indirect material interest.
Related Party Summary
Name
Relationship with the Medinotec Group of Companies
Related transactions with the Medinotec Group of Companies
Related Directors with the Medinotec Group of Companies
Related Owners with the Medinotec Group of Companies
Amount for the 2026 fiscal year
Minoan Medical Proprietary Limited
Medical investment company controlled by Dr Gregory Vizirgianakis
Related Party Loan
Dr Gregory Vizirgianakis
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Loan payable - $187
Management fee - $40,000
Account Payable balance - $40,000
71
Table of Contents
Minoan Capital Proprietary Limited
Property investment company controlled by Dr Gregory Vizirgianakis
Related party loan
Rental Expenses
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Loan payable - $314
Lease liability - $14,905
Short-term rental expense - $23,712
Medinotec Capital Proprietary Limited
The African holding company of the Medinotec Group of Companies
Related party loan payable to Minoan Capital
Dr Gregory Vizirgianakis
Pieter van Niekerk
Medinotec Incorporated in Nevada is the 100% ultimate parent entity
n/a
DISA Medinotec Proprietary Limited
The African operating and manufacturing company
Related party loan with Minoan Medical
Operational income and expenses with Minoan Medical
Dr Gregory Vizirgianakis
Pieter van Niekerk
Medinotec Incorporated in Nevada is the 100% ultimate parent entity
n/a
Medinotec Incorporated Nevada
Ultimate parent of Medinotec Capital and DISA Medinotec
All of the above for its related subsidiaries
Dr Gregory Vizirgianakis
Pieter van Niekerk
Joseph P Dwyer
Stavros Vizirgianakis
Athanasios Spirakis
This is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
n/a
Medinotec Group of Companies
The Consolidated group name of Medinotec Incorporated, Medinotec Capital Proprietary Limited and DISA Medinotec Proprietary Limited
above for its related subsidiaries
Dr Gregory Vizirgianakis
Pieter van Niekerk
Joseph P Dwyer
Stavros Vizirgianakis
Athanasios Spirakis
This is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
n/a
72
Table of Contents
Pieter van Niekerk
Chief financial officer of the Medinotec Group of Companies
Transactions relating to mutual entities disclosed above
Related directorships disclosed above
Minority Shareholder in Medinotec Inc
n/a
Gregory Vizirgianakis
Chief Executive officer of the Minoan Group of Companies
Brother of Stavros Vizirgianakis
Transactions relating to mutual entities disclosed above
Related directorships disclosed above
Shareholder in Medinotec Inc and Kingstyle investments.
n/a
Stavros Vizirgianakis
Non-Executive director of the Medinotec Group of companies
Brother of Gregory Vizirgianakis
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
Joseph Dwyer
Non-Executive director of the Medinotec Group of companies
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
Athanasios Spirakis
Independent director of the Medinotec Group of companies
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
a. Rent
DISA Medinotec Proprietary Limited
leases commercial buildings from Minoan Capital Proprietary Limited (“Minoan Capital”). Minoan Capital is owned 100% by the
Chief Executive Officer of the Medinotec Group of Companies, Dr. Gregory Vizirgianakis.
Set forth below is a table showing the
Consolidated entities’ operating lease payments for the year ended February 28, 2026, with Minoan Capital:
February 28,
2026
February 28,
2025
Lease payments
33,774
32,031
The Company incurs monthly rental charges
payable to Minoan Capital for the use of training centre facilities. As no long-term fixed rental agreement exists and the arrangement
is invoiced monthly, the Company does not account for the arrangement as a lease.
Set forth below is a table showing the
Consolidated entities' rental expenses relating to the training centre facilities for the year ended February 28, 2026 and February 28,
2025 with Minoan Capital:
2026
$
2025
$
Rental
expense
23,712
—
73
Table of Contents
Rent is comparable to rent charged for
similar properties in the same relative area. The Consolidated entities do market research of a Minimum and a Maximum rental value within
the area at every renewal of the rental agreement to ensure this is market related, this exercise is undertaken together with a registered
property agent who has the appropriate knowledge of the area.
The Company leases office and warehouse
spaces under a cancelable operating lease agreement with contractual terms from August 1, 2023, to July 31, 2026. The Company is required
to pay property taxes, insurance, and normal maintenance costs for certain of these facilities and will be required to pay any increases
over the base year of these expenses on the remainder of the Company’s facilities.
b. Loan
Loans payable include an unsecured loan
of $187 from Minoan Medical, the prior parent entity of DISA Medinotec in South Africa. This loan was initially obtained to support the
working capital and capital expenditure expansions of DISA Medinotec during its developmental and startup phases. Following the acquisition
of DISA Medinotec on March 2, 2022, the Company assumed this liability.
Under the terms of the loan agreement,
the loan was repayable within three years following the occurrence of an initial public offering, defined in the agreement as the point
at which the business had achieved sufficient growth to list on a national exchange. During this period, the loan accrued interest at
the prevailing South African prime lending rate. At August 31, 2025, the South African prime lending rate was 10.50%. Management believes
the terms of the loan were market-related.
On August 31, 2025, DISA Medinotec, Minoan
Medical and DISA Life Sciences entered into a tripartite set-off and settlement agreement in terms of which DISA Life Sciences undertook
to settle the loan payable on behalf of DISA Medinotec. In accordance with that agreement, DISA Medinotec’s trade receivable balance
with DISA Life Sciences was reduced by a corresponding amount.
During the fiscal year ended February 28,
2026, substantially all amounts previously reflected in loans payable were extinguished through the set-off arrangement described above
and related settlements. As of February 28, 2026, loans payable to Minoan Medical were not material.
Minoan Medical’s ultimate beneficial
owner is Dr. Gregory Vizirgianakis, Chief Executive Officer of the Medinotec group of companies. Prior to the transfer of DISA Medinotec
into the Medinotec group structure, Minoan Medical held Dr. Vizirgianakis’ medical investments and export interests, of which DISA
Medinotec was one.
There is also an unsecured, interest free
loan with no fixed terms of repayment from Minoan Capital.
Minoan Medical and Minoan Capital are related
parties of the Group as the CEO Dr Gregory Vizirgianakis has common control.
ITEM 14.
PRINCIPAL ACCOUNTING FEES AND SERVICES.
Mercurius & Associates LLP served as our independent
registered auditors for the year ended February 28, 2026.
Audit
Fees
Please refer below for the total audit fees for the
Company’s fiscal years ended February 28, 2026 and February 28, 2025, for professional services rendered by our independent auditors
for the audit and review of our financial statements.
February 28,
2026
February 28,
2025
Audit Fees
164,044
159,620
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Table of Contents
Audit Related Fees
There were no fees for audit related services rendered
by our independent auditors for the years ended February 28, 2026 and February 28, 2025, respectively.
Tax Fees
For the Company’s fiscal years ended February
28, 2026 and February 28, 2025, there were no fees for professional services rendered by our independent auditors for tax compliance,
tax advice, and tax planning.
All Other Fees
For the Company’s fiscal years ended February
28, 2026 and February 28, 2025, we were not billed any other fees by our auditors.
75
Table of Contents
PART IV
ITEM 15.
EXHIBIT AND FINANCIAL STATEMENT SCHEDULES.
(a)(1)
FINANCIAL STATEMENTS.
The following documents are included on pages F-1
through F-23 attached hereto and are files as part of this Annual Report on Form 10-K. Reference is made to the Index to Consolidated
Financial Statements on Page F-1.(a)(2) EXHIBITS.
(a)(2)
EXHIBITS
We have filed the exhibits listed on the accompanying
Exhibit Index of this annual report and below in this Item 15:
Incorporated by
Exhibit
Reference
Filed or Furnished
Number
Exhibit Description
Form
Exhibit
Filing Date
Herewith
2.1
Share Exchange Agreement, dated March 2, 2022
S-1
2.1
6/2/2022
3.1
Articles of Incorporation
S-1
3.1
6/2/2022
3.2
Articles of Amendment
S-1
3.3
6/2/2022
3.3
Bylaws
S-1
3.3
6/2/2022
4.1
Unsecured Revolving Promissory Note, dated September 16, 2022
S-1/A
4.1
11/2/2022
4.2
Description of Registrant’s Securities
10-K
4.2
7/5/2024
10.1
Lease Agreement dated January 28, 2020 between Minoan Capital and DISA Medinotec Proprietary Limited
S-1/A
10.1
8/4/2022
10.2
Exclusive Distribution Agreement dated March 1, 2020 between Disa Life Sciences Proprietary Limited and DISA Medinotec Proprietary Limited
S-1/A
10.2
8/4/2022
10.3
Letter of Offer, dated April 26, 2021 with Gregory Vizirgianakis
S-1/A
10.3
8/30/2022
10.4
Letter of Offer, dated April 26, 2021 with Peter van Niekerk
S-1/A
10.4
8/30/2022
10.5
Letter of Offer, dated June 13, 2021 with Stavros Vizirgianakis
S-1/A
10.5
8/30/2022
10.6
Letter of Offer, dated June 13, 2021 with Joseph P Dwyer
S-1/A
10.6
8/30/2022
10.7
Loan Certificate dated Mary 1, 2017
S-1/A
10.7
8/30/2022
76
Table of Contents
21.1
List of Subsidiaries Medinotec Capital Proprietary Limited and DISA Medinotec Proprietary Limited
10-K
21.1
5/30/2023
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended .
X
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
X
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350.
X
101.INS
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
X
101.SCH
Inline XBRL Taxonomy Extension Schema Linkbase Document.
X
101.CAL
Inline XBRL Taxonomy Calculation Linkbase Document.
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline XBRL Taxonomy Label Linkbase Document.
X
101.PRE
Inline XBRL Taxonomy Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
ITEM 16.
10-K SUMMARY
None
77
Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d)
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Gregory Vizirgianakis
Chief Executive Officer and Director
Gregory Vizirgianakis
(Principal Executive Officer)
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Pieter van Niekerk
Chief Financial Officer and Director
Pieter van Niekerk
(Principal Financial Officer and Principal Accounting Officer)
Pursuant to the requirements of the Securities Exchange
Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates
indicated.
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Gregory Vizirgianakis
Chief Executive Officer and Director
Gregory Vizirgianakis
(Principal Executive Officer)
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Pieter van Niekerk
Chief Financial Officer and Director
Pieter van Niekerk
(Principal Financial Office and Principal Accounting Officer)
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Stavros G. Vizirgianakis
Director
Stavros G. Vizirgianakis
DATE
SIGNATURE
TITLE
May 28, 2026
/s/ Joseph P. Dwyer
Director
Joseph P. Dwyer
78
Table of Contents
ITEM 15
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
MEDINOTEC, INC.
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED FEBRUARY 28, 2026 AND FEBRUARY
28, 2025
CONTENTS
Page
Report of Independent Registered Public Accounting Firm
Report for the year ended February 28, 2026 – Mercurius & Associates LLP - Firm ID: 3223
F-1
Consolidated Balance Sheets as of February 28, 2026 and February 28, 2025
F-3
Consolidated Statements of Operations and Comprehensive Income/ (Loss) for the Years Ended February 28, 2026 and February 28, 2025
F-4
Consolidated Statements of Stockholders’ Equity for the Years Ended February 28, 2026 and February 28, 2025
F-5
Consolidated Statements of Cash Flows for the Years Ended February 28, 2026 and February 28, 2025
F-6
Notes to Consolidated Financial Statements
F-7
79
Table of Contents
Report of Independent
Registered Public Accounting Firm
To the Shareholders and Board of Directors
of Medinotec Inc. and its subsidiaries
Opinion on the Consolidated Financial
Statements
We have audited the accompanying consolidated
balance sheets of Medinotec Inc. and its subsidiaries (collectively, the “Company”) as of February 28, 2026 and 2025, the
related consolidated statements of Operations, Comprehensive Income/ (Loss), Stockholders’ Equity and Cash flows, for each of the
two years in the period ended February 28, 2026, and the related notes (collectively referred to as the "consolidated financial statements").
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
as of February 28, 2026 and 2025, and the results of its operations and its cash flows for each of the two years in the period ended February
28, 2026, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are
the responsibility of the Company’s management. Our responsibility is to express an opinion on the company’s consolidated
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
F- 1
Table of Contents
Critical Audit Matter
Critical Audit matters are matters
arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated
to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated
financial statements and (2) involved our especially challenging, subjective or complex judgments. We determined that there are no critical audit matters.
/s/ Mercurius
& Associates LLP
We have served as the Company’s auditor
since 2024
New
Delhi, India
Date: May 28, 2026
F- 2
Table of Contents
Consolidated Balance Sheets for the Medinotec Group of Companies
as of February 28, 2026 and February 28, 2025
2026
$
2025
$
Assets
Current Assets
Cash
2,757,024
2,769,686
Accounts receivable, net of allowances
2,352,474
2,612,440
Inventory
1,236,373
988,341
Other current assets
73,934
52,719
Total Current Assets
6,419,805
6,423,186
Note receivable
—
—
Property, plant and equipment, net of accumulated depreciation
331,346
348,486
Deferred tax asset
48,857
—
Operating right-of-use asset
12,880
37,301
Total Assets
$ 6,812,888
$ 6,808,973
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable and accrued liabilities
1,086,287
1,476,987
Operating lease liability, current portion
14,905
28,060
Total current Liabilities
1,101,192
1,505,047
Long Term Liabilities
Loans payable
501
940,277
Deferred tax liabilities
—
80,124
Operating lease liability, net of current portion
—
12,696
Total Liabilities
1,101,693
2,538,144
Equity
Capital stock $.001 par value; shares
authorized 200,000,000; 11,755,548 shares issued and outstanding (2025: 11,733,750)
11,756
11,734
Capital stock additional paid in capital
3,405,359
3,296,391
Retained earnings
1,712,617
918,115
Accumulated other comprehensive income
581,463
44,589
Total Equity
5,711,195
4,270,829
Total Liabilities and Equity
$ 6,812,888
$ 6,808,973
The accompanying notes are an integral part of these
audited consolidated financial statements.
F- 3
Table of Contents
Consolidated Statements of Operations and Comprehensive Income/ (Loss)
for the Medinotec Group of Companies for the Years Ended February 28, 2026 and February 28, 2025
2026
$
2025
$
Revenue
9,729,463
9,113,607
Cost
of goods sold
( 4,601,350 )
( 4,295,118 )
Gross
profit
5,128,113
4,818,489
Operating expenses
Selling expenses
( 1,485,641 )
( 113,194 )
Depreciation and amortization expense
( 80,873 )
( 73,846 )
General and
administrative expenses
( 2,317,229 )
( 1,348,817 )
Research and development expenses
( 149,858 )
( 91,133 )
Total
operating expenses
( 4,033,601 )
( 1,626,990 )
Income
from operations
1,094,512
3,191,499
Non operating income and expenses
Interest income
71,513
8,668
Interest expense
( 87,595 )
( 176,416 )
Other income/(expenses)
( 9,243 )
387
Total non-operating income and expenses
( 25,325 )
( 167,361 )
Income/(loss) before income taxes
1,069,187
3,024,138
Income taxes
Current income taxes
( 398,703 )
( 737,389 )
Deferred income taxes
124,018
( 127,276 )
Net income/(loss)
794,502
2,159,473
Net earnings/ (loss) per share, basic and diluted:
0.07
0.18
Weighted average shares used in computing net loss per share, basic and diluted
11,755,548
11,733,750
Net income/(loss)
794,502
2,159,473
Other comprehensive income/(loss)
Foreign currency translation gain/(loss)
536,874
( 55,815 )
Other comprehensive income/(loss)
536,874
(55,815 )
Comprehensive income/(loss)
1,331,376
2,103,658
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 4
Table of Contents
Consolidated Statements of Stockholders’ Equity for the
Years Ended February 28, 2026 and February 28, 2025
Common Stock
Common Stock Additional Paid in Capital
Shares
Amount
$
Amount
$
Retained Earnings/(Accumulated Deficit)
$
Accumulated Comprehensive Income
$
Total
$
Balance March 1, 2024
11,733,750
11,734
3,296,391
( 1,241,325 )
100,371
2,167,171
Net income for the period
—
—
—
2,159,473
—
2,159,473
Other comprehensive income / (loss)
—
—
—
—
( 55,815 )
( 55,815 )
Reclassification
adjustment
—
—
—
( 33 )
33
—
Balance February 28, 2025
11,733,750
11,734
3,296,391
918,115
44,589
4,270,829
Balance March 1, 2025
11,733,750
11,734
3,296,391
918,115
44,589
4,270,829
Net income for the period
—
—
—
794,502
—
794,502
Other comprehensive income / (loss)
—
—
—
—
536,874
536,874
Issuance of common stock
21,798
22
108,968
—
—
108,990
Balance February 28, 2026
11,755,548
11,756
3,405,359
1,712,617
581,463
5,711,195
The accompanying notes are an integral part of these
audited consolidated financial statements.
F- 5
Table of Contents
Consolidated Statements of Cash Flows for the Years Ended February 28,
2026 and February 28, 2025
2026
$
2025
$
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
794,502
2,159,473
Adjustments to reconcile net income to net cash from operating activities:
Depreciation
80,873
73,846
Foreign currency
translation loss, unrealized
( 16,554 )
( 5,765 )
Deferred income taxes and tax credits
( 124,018 )
127,276
Provision for income taxes
398,703
737,389
Provision
for inventory obsolescence
38,350
—
Provision for doubtful debt
27,352
—
Common stock issued for services
108,990
—
Operating lease liability
( 30,256 )
( 32,030 )
(Increase)/Decrease in prepayments
7,200
( 11,944 )
(Increase)/Decrease in receivables
259,965
( 2,039,246 )
(Increase)/Decrease in inventories
( 248,032 )
( 91,639 )
Increase/(Decrease) in accounts payable and accrued expenses
( 344,534 )
226,855
Net cash flow from operations
952,541
1,144,215
Tax paid
( 45,743 )
( 266,381 )
TOTAL CASH FLOWS FROM OPERATING ACTIVITIES
906,798
877,834
CASH FLOWS FROM INVESTING ACTIVITIES:
Payments to acquire property, plant, and equipment
( 1,363 )
( 89,013 )
TOTAL CASH FLOWS USED BY INVESTING ACTIVITIES
( 1,363 )
( 89,013 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of long-term debt
26
797
Repayment of debt
( 982,998 )
( 895,279 )
TOTAL CASH FLOWS USED BY FINANCING ACTIVITIES
( 982,973 )
( 894,482 )
OTHER ACTIVITIES:
Effect of exchange rate on cash and cash equivalents
64,876
66,437
Net decrease in cash and cash equivalents
( 12,662 )
( 39,224 )
Cash and cash equivalents at beginning of period
2,769,686
2,808,910
Cash and cash equivalents at end of period
2,757,024
2,769,686
Supplemental disclosures
Interest income
71,513
73,468
Interest expense
( 87,595 )
( 176,416 )
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 6
Table of Contents
Notes to Consolidated Financial Statements
1. Description of Business
Medinotec Inc. is a US-based company with
a primary investment and operations in DISA Medinotec Proprietary Limited (“DISA Medinotec”), a South African medical device
manufacturing and distribution company, which in management’s opinion is a global leader in tracheal non-occlusive airway dilation
technology and medical device design. “The Company” consists of Medinotec Inc. in Nevada, with primary operations in the United
States in Long Island, New York, and its wholly owned subsidiaries, Medinotec Capital Proprietary Limited and DISA Medinotec, of which
both are incorporated in South Africa. Combined, the Company has experience in establishing facilities for the manufacturing and design
of niche medical devices and establishing international distribution networks to commercialize these devices.
The Company is seeking to expand sales
and distribution operations into the United States of America and other markets.
The Company’s audited consolidated
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company received FDA 510(k) approval through the substantial equivalence process for
Class II medical devices for its main product, the Trachealator, in November 2021. FDA 510(k) approval was received for the new Outflo
product in March 2025.
2. Significant Accounting Policies
a. Nature of business/basis of preparation
Basis of presentation
The consolidated financial statements
are prepared in accordance with generally accepted accounting principles in the United States.
Emerging Growth Company (EGC) status
The Company is an “emerging growth
company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart our Business Startups Act of 2012, (the
“JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other
public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in its periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and
shareholder approval of any golden parachute payments not previously approved.
b. Foreign currency translation
i. Translation
of foreign subsidiary
The accounts of the foreign subsidiaries
are translated into U.S. dollars. Assets and liabilities are translated at year-end exchange rates and income and expense accounts are
translated at average exchange rates in effect during the year. Translation adjustments
resulting from fluctuations in the exchange rates are recorded in accumulated other comprehensive income, a separate component of stockholders'
equity.
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Exchange gains or losses incurred foreign
exchange currency transactions conducted by one of the Company’s operations in a currency other than the operation’s functional
currency are reflected in other revenue/(expenses).
ii. Exposed
to currency variations in subsidiary
The primary operations and functional
currency of both Disa Medinotec (Pty) Ltd and Medinotec Capital (Pty) Ltd is in South African Rand. Due to the emerging market nature
of this currency the spread volatility of the currency low and high can be material during a year. The conversion of the currency from
Rand to reporting currency US Dollar can cause significant up or downward trends that are recorded in reserves under the heading accumulated
comprehensive income.
The functional currency as well as the
reporting currency for Medinotec Inc is the US Dollar.
c. Cash and cash equivalents
i. Highly
liquid investments
The Medinotec Group of Companies considers
all highly liquid investments with a remaining maturity of three months or less at the time of purchase to be cash equivalents. These
cash equivalents consist primarily of term deposits and certificates of deposit. Investments with maturities from greater than three months
to one year are classified as short-term investments, while those with maturities in excess of one year are classified as long-term investments.
Cash equivalents and short-term investments are stated at cost which approximates market value.
d. Accounts Receivable
i. Allowance
based on a review and management evaluation
Accounts receivable are presented on the
consolidated balance sheets, net of estimated uncollectible amounts. The carrying amounts of trade accounts receivable represent the maximum
credit risk exposure of these assets.
In accordance with FASB ASC 326, Measurement
of Credit Losses on Financial Instruments ("ASC 326"), the Company evaluates the collectability of outstanding accounts receivable
balances to determine an allowance for credit losses that reflects its best estimate of the lifetime expected credit losses.
One major client constitutes 91 % of the
accounts receivable balance as at February 28, 2026, compared to 87 % on February 28, 2025.
An allowance for credit losses is calculated
taking into account all accounts older than 91+ days.
e. Property, plant and equipment
i. Depreciation
rates
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Property and equipment are stated at cost
less accumulated depreciation and amortization. Depreciation is provided for using the straight-line method over the estimated useful
lives as follows for the major classes of assets:
Plant and machinery
10 years
Laboratory equipment
5 years
Furniture and fixtures
6 years
Motor vehicles
5 years
Computer equipment
3 years
Office equipment
6 years
Computer software
2 years
Leasehold improvements
3 years
Small assets
1 year
f. Inventories
i. Valuation,
costing and obsolescence
Inventories are stated at the lower of
cost (weighted average) or net realizable value and consist of raw materials, work-in process and finished goods and include purchased
materials, machine time, direct labor and manufacturing overhead.
Management evaluates the need to record
adjustments to write down inventory to the lower of cost or net realizable value on a quarterly basis. The Company’s policy is to
assess the valuation of all inventories, including raw materials, work-in-process and finished goods and it writes down its inventory
for estimated obsolescence based upon the age of inventory and assumptions about future demand and usage.
g. Impairment of long-lived assets
The Company assesses long-lived assets
for impairment in accordance with the provisions of Financial Accounting Standards Board ASC 360, Property, Plant and Equipment. Long-lived
assets (asset group), such as property and equipment subject to amortization, are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of the asset may not be recoverable.
The carrying amount of a long-lived asset is not recoverable
if it exceeds the sum of the undiscounted future cash flows expected to result from the use and eventual disposition of the asset. The
amount of impairment loss, if any, is measured as the difference between the carrying value of the asset and its estimated fair value.
Fair value is determined through various
valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered
necessary.
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h.
Leases
We determine if an arrangement is a lease
at inception. We determine the classification of the lease, whether operating or financing, at the lease commencement date, which is the
date the leased assets are made available for use. We use the non-cancelable lease term when recognizing the right-of-use (“ROU”)
assets and lease liabilities, unless it is reasonably certain that a renewal or termination option will be exercised. We account for lease
components and non-lease components as a single lease component. Modifications are assessed to determine whether incremental differences
result in new contract terms and accounted for as a new lease or whether the additional right of use should be included in the original
lease and continue to be accounted for with the remaining ROU asset.
Operating lease ROU assets and liabilities
are recognized at the lease commencement date based on the present value of the lease payments over the lease term. Lease payments consist
of the fixed payments under the arrangement, less any lease incentives. Variable costs, such as common area maintenance costs and additional
payments for percentage rent, are not included in the measurement of the ROU assets and lease liabilities, but are expensed as incurred.
As the implicit rate of the leases is not determinable, we use an incremental borrowing rate based on the estimated rate of interest for
collateralized borrowing over a similar term of the lease payments in determining the present value of the lease payments. Lease expenses
are recognized on a straight-line basis over the lease term. We do not recognize ROU assets on lease arrangements with a term of 12 months
or less.
i. Allowance for credit losses
on loans receivable
The Company maintains an allowance for
credit losses on loans receivable in accordance with ASC 326, Financial Instruments—Credit Losses . This allowance reflects
management’s estimate of expected credit losses over the contractual life of the loans, considering historical loss experience,
current conditions, and reasonable and supportable forecasts. The estimate is developed using a combination of quantitative data and qualitative
factors, including borrower creditworthiness, loan-specific risk characteristics, macroeconomic trends, and other relevant information.
The allowance is adjusted through a provision for credit losses in the Company’s consolidated statements of operations, and loans
are charged off against the allowance when deemed uncollectible.
j. Employee benefit plans
The Company contributes 2.5 % of basic
salaries for eligible employees to a pension plan registered under the laws of South Africa. The Company also contributes a portion of
the medical aid contribution for eligible employees to an approved medical insurance scheme.
k. Income taxes
Income taxes are accounted for under
the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss
and tax credit carryforwards.
Deferred tax assets and liabilities
are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected
to be recovered or settled. The effect on deferred tax assets and liabilities
of a change in tax rates is recognized in income in the period that includes the enactment date.
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The Company recognizes the effect
of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured
at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period
in which the change in judgment occurs.
The Company records interest related
to unrecognized tax benefits in interest expense and penalties in general and administrative expenses.
l. Financial instruments
i.
Fair Value Measurements
Fair value accounting is applied for all
assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements
on a recurring basis (at least annually). Fair value is defined as the exchange price that would be received for an asset or an exit price
that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. The consolidated entities follow the established framework for measuring fair value
and expands disclosures about fair value measurements.
ii.
Concentrations of credit risk
Financial instruments that potentially
subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, trade accounts receivable and loans.
The Company invests its excess cash in low-risk, highly liquid money market funds and certificates of deposit with a major financial institution.
iii.
Exposed to currency variations in subsidiary
The primary operations and functional
currency of a subsidiary's business is in South African Rand. Due to the emerging market nature of this currency the spread volatility
of the currency low and high can be material during a year. The conversion of the currency from Rand to reporting currency US Dollar can
cause significant up or downward trends that are recorded in reserves under the heading accumulated comprehensive income. The effect on
the reserves for the year ended February 28, 2026 was $ 536,874 compared to ( $ 55,815 ) for the year ended February 28, 2025.
iv.
Interest rate risk
Market interest rate risk may result in
loss from fluctuations in the future cash flows or fair values of financial instruments. Interest rate risk is managed principally through
monitoring interest rate gaps and basis risk and by having pre-approved limits for repricing bands.
The interest rate risk relates solely
to the related party loan.
m. Comprehensive income/loss
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i.
Comprehensive income/loss
Comprehensive loss consists of net loss
and other gains and losses affecting stockholders’ equity that, under GAAP, are excluded from net loss. Our other comprehensive
loss represents foreign currency translation adjustment attributable to our operations. Refer to Consolidated Statements of Comprehensive
Loss.
Total foreign currency translation
gain for the year ended February 28, 2026 was $ 536,874 ,
compared to a loss of $ 55,815
for the year ended February 28, 2025.
n. Revenue recognition
Revenue represents the amount of consideration
expected to be received from customers in exchange for the transfer of products. Net sales exclude value added and other taxes we collect
from customers. Other costs to obtain and fulfill contracts are generally expensed as incurred due to the short-term nature of most of
our sales. Shipping and handling costs charged to customers are included in net revenue.
The Company generates
revenues through two distinct revenue sources:
1.
From the sale of high-quality medical devices which are self-manufactured through in-depth research and development; and
2.
Through the distribution of finished products on behalf of other principals around the world into pre-agreed territories which are usually exclusive territories granted by such principal.
The Company applies the following
five steps in order to determine the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its arrangements:
•
identify the contract with a customer,
•
identify the performance obligations in the contract,
•
determine the transaction price,
•
allocate the transaction price to performance obligations in the contract, and
•
recognize revenue as the performance obligation is satisfied.
Revenue from the sale of self-manufactured
products
These products are developed in-house.
The Company’s clients are billed
based on a price list that is agreed on in each customer’s contract. Orders are shipped on a per order basis from the Company’s
warehouse with Free-On-Board Inco terms.
Revenue relating to the self-manufactured
products are recognized when control of the promised goods or services is transferred to a customer at an amount that reflects the consideration
that the Company expects to receive in exchange for those products.
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Revenue from the distribution of products
The distribution products are sold via
a network, which consists of a mixture of sub-distributors and in some instances a direct sales force. The Company’s clients are
billed based on a pricelist that are agreed upon in each customer contract, orders are shipped on a per order basis from the Company’s
warehouse with Free-on-Board Inco terms. The Company’s sub-distributors order from the Company on the same basis as its customers
and have no preferential return rights on their inventory orders, therefore the client assumes the risk of the sale at point of invoice.
Revenues relating to the distribution
of products are recognized when control of the promised goods or services is transferred to a customer at an amount that reflects the
consideration that the Company expects to receive in exchange for those products. The transfer of control will typically be on the date
of shipment.
Goods delivered to a consignee pursuant
to a consignment arrangement are not considered sales, and do not qualify for revenue recognition. Once it is determined that substantial
risk of loss, rewards of ownership, as well as control of the assets have transferred to the consignee, revenue recognition would then
be appropriate, assuming all other criteria for revenue recognition have been satisfied.
For both revenue streams
The Company has two operating segments,
inside the United States and outside the United States. These sales are split by these territories and further segregated into the specific
revenue streams sold into these territories.
The Company has no contract assets or
liabilities representing accrued revenues that have not yet been billed to the customers due to certain contractual terms, because of
the fact that orders are placed, invoiced, and shipped on a per order basis as and when the clients require additional inventory. All
revenue is recognized at a specific point and time.
Under ASC Topic 606, the Company estimates
the transaction price, including variable consideration, at the commencement of the contract and recognizes revenue at point of sale when
risks and rewards are transferred to the customer. There are no contract revenue agreements that would need to be recognized over time
and the point of risks and rewards being transferred is very clear.
Payment Terms
Our payment terms vary per segments; export
sales made from within South Africa are subject to prepayment, where accounts are granted. They generally have payment terms of 30 days
from statement and sales made inside the United States are 45 to 60 days. Terms can be extended by the Company when it deems the business
case and credit worthiness of the customer is strong enough. The time between a customer’s payment and the receipt of funds is not
significant. The Company’s contracts with customers do not result in significant obligations associated with returns, refunds, or
warranties. Payment terms are generally fixed and do not include variable revenues.
The Company sells a significant amount
to DISA Life Sciences. For the year ending February 28, 2026, 89 % of the Company's total revenue is derived from this single customer
in the distribution environment in South Africa compared to 88 % for the year ending February 28, 2025.
o. Segment Reporting
This table indicates the sales per revenue
stream as a breakdown of the total revenue balance:
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Medinotec Group of Companies Consolidated Years Ended
Feb 28, 2026
$
Feb 28, 2025
$
Outside of United States of America
Internally Designed/Manufactured Sales
975,969
863,337
Distribution Agreement Sales
8,141,634
7,572,165
Sales Generated inside the United States of America
Internally Designed/Manufactured Sales
611,860
678,105
9,729,463
9,113,607
Chief Operating Decision Maker (CODM)
The Company’s CODM is the Chief
Executive Officer, who is responsible for strategic decision-making and resource allocation. The CEO, with support from the executive
leadership team, regularly reviews financial and operational results segmented by geographic region. These reports form the basis for
internal decision-making and operational management.
The Company has determined that it operates
in two reportable geographic segments: Inside the United States and Outside the United States. These segments reflect the manner in which
the CODM assesses financial performance and allocates resources.
Basis of Segmentation
Operating segments are determined based
on the internal reports regularly reviewed by the CODM. Geographic segmentation reflects the Company's internal management structure and
reporting lines, as operations within the United States and internationally are subject to distinct market, regulatory, and customer dynamics.
Performance Measures Reviewed by CODM
The CODM evaluates segment performance
primarily using income/loss from operations, which includes revenues, cost of goods sold, and major operating expenses. This measure is
reviewed regularly and is considered the most relevant indicator of segment profitability and operating efficiency. Segment results are
prepared on a basis consistent with the Company’s consolidated financial statements, with no adjustments for intersegment transactions.
Granular Segment Expense Reporting
To support effective decision-making,
the CODM reviews segment-level performance at a more detailed level than presented in the consolidated financial statements. Specifically,
the CODM receives and evaluates reports that disaggregate significant expenses such as:
•
Selling Expenses
•
Depreciation
•
General and Administrative Expenses
•
Research and Development Expenses
This level of detail enables the CODM
to evaluate cost drivers and profitability more effectively across geographic segments.
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The following table sets forth financial
information by reportable segment for the years ending February 28, 2026 and February 28, 2025:
1.
Income/(Loss) from operations
Inside the United States
Outside the United States
Total
2026
2025
2026
2025
2026
2025
Revenue
611,860
678,105
9,117,603
8,435,502
9,729,463
9,113,607
Cost of goods sold
( 155,214 )
( 87,826 )
( 4,446,136 )
( 4,207,292 )
( 4,601,350 )
( 4,295,118 )
Gross profit
456,646
590,279
4,671,467
4,228,210
5,128,113
4,818,489
Selling expenses
( 96,906 )
( 65,646 )
( 1,388,735 )
( 47,548 )
( 1,485,641 )
( 113,194 )
Depreciation expense
—
—
( 80,873 )
( 73,846 )
( 80,873 )
( 73,846 )
General and administrative expenses
( 865,855 )
( 725,834 )
( 1,451,374 )
( 622,983 )
( 2,317,229 )
( 1,348,817 )
Research and development expenses
( 54,495 )
( 50,000 )
( 95,363 )
( 41,133 )
( 149,858 )
( 91,133 )
Income/(loss) from operations
( 560,610 )
( 251,201 )
1,655,122
3,442,700
1,094,512
3,191,499
Other income/(expenditure)
—
—
—
—
( 300,010 )
( 1,032,026 )
Net income/(loss)
—
—
—
—
794,502
2,159,473
Other income/(expenditure) includes items not considered by the CODM at
segment level, and consist of items such as interest income, interest expense, current income taxes and deferred income taxes.
2.
Total Assets
Inside the United States
Outside the United States
Total
2026
2025
2026
2025
2026
2025
Total assets
2,058,119
2,181,184
4,754,769
4,627,789
6,812,888
6,808,973
A major component of total assets is "Cash"
of $ 2,757,024 for the year ending February 28, 2026 and $ 2,769,686 for the year ending February 28, 2025. A significant portion of this
is maintained inside the United States in USD of $ 1,816,626 for the year ending February 28, 2026 and $ 2,019,628 for the year ending February
28, 2025.
p. Cost of goods sold
Cost of goods sold consists primarily
of raw material purchases, manufacturing costs and employee benefits paid to operational personnel associated with the production of our
medical devices.
q. General and administrative expenses
General and administrative expenses consist
mostly of personnel costs, consulting fees as well as audit fees.
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r. Research and development
All research and development expenses
are expensed as incurred and are included in operating expenses. Our research and development efforts are limited in scope and primarily
focused on enhancing existing production processes. We undertake R&D projects only when a working prototype and proof of concept exist,
and after assessing economic viability. Projects that cannot be efficiently integrated into our current manufacturing infrastructure are
not pursued.
s. Interest expense
Interest expense is primarily attributable
to an unsecured loan from Minoan Medical that accrued interest at the prevailing South African prime lending rate. The loan was fully
settled by August 31, 2025, after which no additional interest expense was recognized. At the settlement date, the South African prime
lending rate was 10.50 % . Management believes the terms of the loan were market-related.
t. Earnings per share
Basic Earnings
Per Share (EPS)
Basic earnings per share are computed
based on the weighted average number of common shares outstanding during the reporting period. This calculation provides a straightforward
measure of the Company’s earnings attributable to each share.
Diluted Earnings Per Share (EPS)
The diluted earnings per share is computed
by giving effect to all potentially dilutive securities outstanding for the period, by applying the treasury stock method. For periods
in which we report net losses, diluted net loss per share is the same as basic net loss per share because potentially dilutive common
shares are not assumed to have been issued if their effect is anti-dilutive. There were no potentially dilutive securities outstanding
or issuable during the fiscal year ended February 28, 2026; accordingly, no additional shares have been included in the diluted earnings
per share calculation.
Treasury Stock Method
For options and warrants, the Company
employs the treasury stock method to calculate the dilutive effect. Under this method, it is assumed that the proceeds from the exercise
of options and warrants would be used to repurchase common shares at the average market price during the period. The number of shares
repurchased is then subtracted from the total number of shares that would be issued upon exercise, resulting in the net increase in shares
outstanding. This method effectively illustrates the potential dilution impact of these securities on earnings per share.
u. Principles of consolidation
i. Consolidated
- all intercompany transactions eliminated
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The consolidated financial statements
include the accounts of Medinotec Inc., Medinotec Capital Proprietary Limited and the financial statements of DISA Medinotec Proprietary
Limited, known as “the Company”. All intercompany transactions have been eliminated.
v. Use of estimates
The preparation of consolidated financial
statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results
could differ from those estimates and may have an impact on future periods. As detailed in the Critical Accounting Estimates section above,
the key accounting estimates are as follows:
•
Allowance for credit losses on loans receivables
•
Inventory: Valuation, costing and obsolescence
•
Deferred tax assets
Management continually evaluates these
estimates and assumptions based on historical experience and various other factors, including current market conditions. Changes in these
estimates may have a material effect on the Company’s financial position and results of operations.
w. Recently issued accounting standards
In November 2024, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting
Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses . The
guidance requires additional disclosures intended to improve transparency regarding the nature of expenses included in certain income
statement captions. For public business entities, the guidance is effective for annual reporting periods beginning after December 15,
2026, and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company
is currently evaluating the effect that adoption of this guidance will have on its consolidated financial statement disclosures.
In November 2023, the FASB issued ASU
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which enhances reportable segment disclosure
requirements, primarily through expanded disclosures regarding significant segment expenses. The Company adopted this guidance during
the year ended February 28, 2026. Adoption did not have a material effect on the Company’s consolidated financial statements, but
did affect certain segment disclosures.
In December 2023, the FASB issued ASU
2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances the transparency and usefulness of income
tax disclosures, primarily through expanded rate reconciliation and income taxes paid disclosure requirements. For public business entities,
the guidance is effective for annual periods beginning after December 15, 2024. For entities other than public business entities, the
guidance is effective for annual periods beginning after December 15, 2025. The Company is an emerging growth company and has elected
to use the extended transition period for complying with new or revised accounting standards. Accordingly, the Company expects to adopt
ASU 2023-09 for the fiscal year beginning March 1, 2026. The Company is currently evaluating the impact of the guidance, but does not
expect adoption to have a material effect on its consolidated financial statements. The guidance is expected to affect the presentation
and content of the Company’s income tax disclosures.
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3. Fair
Value Measurements
The Consolidated entities report all financial
assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements
on a recurring basis. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use
of unobservable inputs. The authoritative guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements).
The three levels of the fair value hierarchy are as follows:
Level 1—Inputs are quoted prices
(unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Inputs are observable, unadjusted
quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities
in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the related assets or liabilities.
Level 3—Inputs are unobservable
inputs for the asset or liability.
The level in the fair value hierarchy
within which a fair value measurement in its entirety falls is based on the lowest-level input that is significant to the fair value measurement
in its entirety.
At February 28, 2026 and February 28,
2025, all of the Company’s cash and cash equivalents, trade accounts receivable and trade accounts payable were short term in nature,
and their carrying amounts approximate fair value. Our current and long-term debt arrangements are classified as level 2 financial instruments.
4. Property, plant and equipment
a. Accounts by year end
Property, plant and equipment consist
of the following:
Feb
28,
2026
$
Feb
28,
2025
$
Computer software
1,133
1,133
Motor vehicles
11,889
11,889
Plant and machinery
1,145,734
1,144,371
Furniture and fittings
99,098
99,098
Computer equipment
146,437
146,437
Laboratory equipment
239,834
239,834
Total cost
1,644,125
1,642,762
Effect of foreign currency translation
120,874
38,373
Total accumulated depreciation
( 1,433,653 )
( 1,332,649 )
Total
331,346
348,486
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Depreciation of property, plant and
equipment totaled approximately $ 80,873 for the period ending February 28, 2026 compared to $ 73,846 for the period ending February 28,
2025.
The Company has not acquired any property
and equipment under capital leases.
Depreciation Allocation to Cost of Goods
Sold:
A portion of the depreciation expense related
to Property, Plant, and Equipment has been allocated to the Cost of Goods Sold. This practice is in accordance with the company's accounting
policy, which recognizes a portion of the depreciation expense as part of the cost of producing goods.
The allocation of depreciation to Cost
of Goods Sold is based on the estimation of the assets' usage in the production process. This method is employed to better match the cost
of assets with the revenue generated during the period.
Depreciation of $ 20,131 was allocated to
Cost of Goods Sold for the year ending February 28, 2026, compared to $ 21,888 for the year ending February 28, 2025.
5. Accounts
receivable, net of allowances
a. Accounts receivable by period
Accounts receivable consist of the following:
2026
$
2025
$
Trade accounts receivable
2,451,911
2,682,361
Allowance for expected credit losses
( 99,437 )
( 69,921 )
Total
2,352,474
2,612,440
6. Inventories
a. Accounts by period
Inventory consists of the following:
Inventory consists of the following:
Feb 28, 2026
$
Feb 28, 2025
$
Raw materials
282,316
261,899
Work in progress
26,836
306
Finished goods
978,578
731,788
Less provisions for obsolescence
( 51,357 )
( 10,494 )
Goods in transit
—
4,842
Total
1,236,373
988,341
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7. Other
current assets
a. Other current assets by period
Other current assets consist of the following:
2026
$
2025
$
Prepayments
50,390
48,405
Deposits paid
3,148
2,681
Other receivables
20,396
1,633
Total
73,934
52,719
8. Loans Payable
a. Loans from related parties
2026
$
2025
$
Minoan Medical Proprietary Limited
Opening balance
940,001
1,769,688
Interest accrued
58,731
141,748
Received/Issued
620,202
1,664,939
Repayments
( 1,661,932 )
( 2,701,966 )
Foreign exchange difference
43,185
65,592
Closing balance
187
940,001
Minoan Capital Proprietary Limited
Opening balance
276
269
Foreign exchange difference
38
7
Closing balance
314
276
Total debt
501
940,277
Minoan Medical Proprietary Limited:
Loans payable include an unsecured loan
of $ 187 from Minoan Medical, the prior parent entity of DISA Medinotec in South Africa. This loan was initially obtained to support the
working capital and capital expenditure expansions of DISA Medinotec during its developmental and startup phases. Following the acquisition
of DISA Medinotec on March 2, 2022, the Company assumed this liability.
Under the terms of the loan agreement,
the loan was repayable within three years following the occurrence of an initial public offering, defined in the agreement as the point
at which the business had achieved sufficient growth to list on a national exchange. During this period, the loan accrued interest at
the prevailing South African prime lending rate. At August 31, 2025, the South African prime lending rate was 10.50 % . Management believes
the terms of the loan were market-related.
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On August 31, 2025, DISA Medinotec, Minoan
Medical and DISA Life Sciences entered into a tripartite set-off and settlement agreement in terms of which DISA Life Sciences undertook
to settle the loan payable on behalf of DISA Medinotec. In accordance with that agreement, DISA Medinotec’s trade receivable balance
with DISA Life Sciences was reduced by a corresponding amount.
During the fiscal year ended February 28,
2026, substantially all amounts previously reflected in loans payable were extinguished through the set-off arrangement described above
and related settlements. As of February 28, 2026, loans payable to Minoan Medical were not material.
Minoan Medical’s ultimate beneficial
owner is Dr. Gregory Vizirgianakis, Chief Executive Officer of the Medinotec Group of Companies. Prior to the transfer of DISA Medinotec
into the Medinotec group structure, Minoan Medical held Dr. Vizirgianakis’ medical investments and export interests, of which DISA
Medinotec was one.
Minoan Capital Proprietary Limited:
This is an unsecured, interest free loan
with no fixed terms of repayment.
Minoan Medical and Minoan Capital are related
parties of the Group as the CEO Dr Gregory Vizirgianakis has common control.
10. Accounts payable and accrued expenses
a. Accounts payable by period
Accounts payable consist of the following:
2026
$
2025
$
Trade accounts payable
1,003,965
1,198,953
Accrued payroll, payroll taxes and leave pay
45,566
9,656
Royalties payable
26,211
16,462
Tax liability
10,545
195,037
Other payables
—
56,879
Total
1,086,287
1,476,987
One major European Cardiac supplier constitutes 53 % ( 74 % in prior period)
of the total trade accounts payable.
11. Commitments
a. Leases and deferred rent
The Company accounts for leases under ASC
842, Leases . The Company leases office and warehouse spaces under a cancelable operating lease agreement with contractual terms
from August 1, 2023 to July 31, 2026 from a third-party entity that is considered a related party due to mutual directorship with a member
of the Company’s Board. The Company is required to pay property taxes, insurance, and normal maintenance costs for certain of these
facilities and will be required to pay any increases over the base year of these expenses on the remainder of the Company’s facilities.
Management believes the terms of the lease are consistent with market rates and were entered into at arm’s length.
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Operating lease right-of-use (ROU) assets
and corresponding lease liabilities are recognized on the consolidated balance sheet at the commencement date based on the present value
of future lease payments. The Company uses its incremental borrowing rate to discount lease payments, as the implicit rate is not readily
determinable. Lease expense is recognized on a straight-line basis over the lease term. Short-term leases (terms of 12 months or less)
are not capitalized and are expensed as incurred.
Lease payments for operating leases for
the period ended February 28, 2026 was $ 33,774 compared to $ 32,031 for the period ended February 28, 2025.
Lease cost associated with operating leases
is charged to general and administrative expenses in our consolidated financial statements. The exercise of lease renewal options is at
our sole discretion. No extension period has been included in the determination of the right of use asset or the lease liability, as we
concluded that it is not reasonably certain that we would exercise such option.
Maturities of our operating lease liability
as of February 28, 2026 was as follows:
Years ending February 26/27:
Amounts
FY 2027
15,346
Total undiscounted lease payments
15,346
Less: Imputed Interest
( 441 )
Present value of operating lease liabilities
14,905
Operating lease liabilities, current portion
14,905
Operating lease liabilities, net of current portion
—
The carrying amount of the operating right-of-use
asset as of February 28, 2026 was as follows:
Amounts
Opening balance at March 1, 2025
37,301
Depreciation for the year
( 28,348 )
Effect of foreign currency translation
3,927
Closing balance at February 28, 2026
12,880
From time to time, the Company may become
involved in various legal proceedings in the ordinary course of its business and may be subject to third-party infringement claims.
In the normal course of business, the consolidated
entities my agree to indemnify third parties with whom it enters into contractual relationships, including customers, lessors, and parties
to other transactions with the Consolidated entities, with respect to certain matters. The Consolidated entities has agreed, under certain
conditions, to hold these third parties harmless against specified losses, such as those arising from a breach of representations or covenants,
other third-party claims that the Group’s products when used for their intended purposes infringe the intellectual property rights
of such other third parties, or other claims made against certain parties. It is not possible to determine the maximum potential amount
of liability under these indemnification obligations due to the Consolidated entities limited history of prior indemnification claims
and the unique facts and circumstances that are likely to be involved in each claim.
From time to time, the Consolidated entities
are subject to various claims that arise in the ordinary course of business. Management believes that any liability of the consolidated
entities that may arise out of or with respect to these matters will not materially affect
the financial position, results of operations, or cash flows of the Consolidated entities.
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At the reporting date there is no known
material litigation or claims against the Group.
12. Stockholders' equity/(deficit)
a. Authorized and issued stock by period
Authorized:
As of February 28, 2026 the Company had
188,244,452 shares of common stock authorized and available to issue for purposes of satisfying conversion of preferred stock, the exercise
and future grant of common stock options, and for purposes of any future business acquisitions and transactions.
As of February 28, 2026, Medinotec Inc.,
the parent Company had 20,000,000 shares of preferred stock authorized and available to issue.
Shares outstanding as of February 28, 2025,
were 11,733,750 . During the second quarter of the fiscal year ended February 28, 2026, the Company issued 10,899 shares
of common stock to a retained physician in settlement of research services valued at $ 54,495 and 10,899 shares to
an independent non-executive director as compensation valued at $ 54,495 . The share issue resulted in 11,755,548 shares
outstanding as of February 28, 2026. The shares are restricted pursuant to restricted stock agreements and are subject to SEC Rule 144
transfer limitations. No cash consideration was exchanged, and the issuance of these shares had no impact on the Company’s cash
position. The fair value of the shares issued has been recognized under operating expenses in the Company’s statement of operations.
Issued and outstanding shares
12.
Stockholders’ Equity - Issued and Outstanding Shares
2026
2025
Common shares
11,733,750
11,733,750
Stock issued
21,798
—
Total
11,755,548
11,733,750
Share capital:
2026
$
2025
$
Common shares
11,734
11,734
Stock issued
22
—
Total
11,756
11,734
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13. Income taxes
a. Provision for income taxes
The components of income tax expense are
as follows:
2026
2025
Current expense from income taxes:
Federal
—
17,666
State
—
1,525
Foreign
( 398,703
)
( 756,580
)
Total current expense from income taxes
( 398,703
)
( 737,389
)
Deferred benefit (expense) from income taxes
Federal
—
—
State
—
—
Foreign
124,018
( 127,276
)
Total deferred benefit (expense) from income taxes
124,018
( 127,276
)
Total
$
( 274,685
)
$
( 864,665
)
The following table sets forth a reconciliation
from the U.S statutory federal income tax rate to the effective income tax rate:
2026
2025
Federal
income tax rate
21 %
21 %
Permanent
differences
( 9 %)
( 4 %)
State
taxes
0 %
0 %
Valuation
allowance
5 %
5 %
Foreign
rate differential
9 %
7 %
Other
0 %
0 %
Effective
rate
26 %
29 %
b. Deferred taxes/Future income tax assets and valuation allowance
The following table sets forth the significant
components of deferred tax assets and liabilities:
2026
$
2025
$
Deferred tax assets
Leave pay provision
2,079
1,244
Provision for stock obsolescence
13,083
2,166
Provision for bad debt
22,189
17,504
Unrealized profit
inventory
24,147
24,503
Provision for royalties
7,077
4,445
Commission accrual
6,497
383
Impairment of note receivable
172,368
173,803
Foreign tax credits
487,591
264,820
Net operating loss - State
21,647
6,066
Advanced income
—
12,661
Lease liabilities
4,025
38,234
Total deferred tax assets
760,703
545,829
Less valuation allowance
( 708,368 )
( 462,576 )
Deferred tax assets, net
52,335
83,253
Deferred tax liabilities:
Right-of-use assets
( 3,478 )
( 37,302 )
Uninvoiced revenue GAAP adjustment
—
( 126,075 )
Total deferred tax liabilities
( 3,478 )
( 163,377 )
Deferred tax assets/(liabilities), net
48,857
( 80,124 )
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Deferred tax assets refer to assets that
are attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their
respective tax bases. Deferred tax assets in essence represent future savings of taxes that would otherwise be paid in cash. The realization
of the deferred tax assets is dependent upon the generation of sufficient future taxable income, including capital gains. If it is determined
that the deferred tax assets cannot be realized, a valuation allowance must be established, with a corresponding charge to net income.
It is management’s estimate that certain deferred tax assets will be utilized in full in the next 12 months.
c. Other
The geographic components of income before
income taxes consisted of the following for the years ended February 28, 2026 and February 28, 2025:
2026
2025
United States operations
( 484,832 )
( 248,501 )
International operations
1,554,019
3,272,639
Income before taxes
1,069,187
3,024,138
No U.S. federal tax has been provided on
the undistributed earnings of the foreign subsidiaries as of February 28, 2026 as the company intends to permanently reinvest the earnings.
As of February 28, 2025, the Company has no liabilities for uncertain tax positions. It is the Company’s policy to record interest
and penalties as a component of tax expense. The Company files income tax returns in the U.S. Federal jurisdiction, various U.S. state
jurisdictions and South Africa. With few exceptions, the fiscal years that remain subject to examination are February 28, 2025 through
February 28, 2026.
In October 2021, the Organisation for Economic
Co-operation and Development (OECD)/G20 Inclusive Framework released a two-pillar solution to address the tax challenges of the digital
economy. Pillar Two introduces a global minimum corporate tax regime that applies to multinational enterprises (MNEs) with annual consolidated
revenue of €750 million or more.
The Company operates manufacturing and
distribution activities in several jurisdictions, including the United States and South Africa. Although South Africa has announced its
intention to implement a Qualified Domestic Minimum Top-Up Tax (QDMTT) beginning in 2024 under Pillar Two, the Group’s consolidated
revenue for the past two fiscal years has not exceeded the
€750 million threshold. As such, the Group is not currently within the scope of the Pillar Two global minimum tax rules.
The Company continues to monitor developments
related to Pillar Two in the jurisdictions in which it operates, including the United States and South Africa. If future changes to revenue
thresholds or group composition bring the Company into scope, the potential tax impacts will be assessed in accordance with ASC 740, Income
Taxes .
Based on the current scope criteria and
the absence of substantively enacted legislation in the United States, no amounts have been recognized in the consolidated financial statements
related to Pillar Two. Any future obligations arising from the implementation of these rules, should the Group become subject to them,
will be accounted for as current-period tax expenses, consistent with the FASB staff guidance issued in 2023.
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14. Transactions with related parties
Name
Relationship with the Medinotec Group of Companies
Related transactions with the Medinotec Group of Companies
Related Directors with the Medinotec Group of Companies
Related Owners with the Medinotec Group of Companies
Amount for the 2026 fiscal year
Minoan Medical Proprietary Limited
Medical investment company controlled by Dr Gregory Vizirgianakis
Related Party Loan
Dr Gregory Vizirgianakis
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Loan payable - $ 187
Management fee - $ 40,000
Account Payable - $ 40,000
Minoan Capital Proprietary Limited
Property investment company controlled by Dr Gregory Vizirgianakis
Related party loan
Rental Expenses
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Dr Gregory Vizirgianakis is the ultimate beneficial owner
Loan payable - $ 314
Lease liability - $ 14,905
Short-term rental expense - $23,712
Medinotec Capital Proprietary Limited
The African holding company of the Medinotec Group of Companies
Related party loan payable to Minoan Capital
Dr Gregory Vizirgianakis
Pieter van Niekerk
Medinotec Incorporated in Nevada is the 100% ultimate parent entity
n/a
DISA Medinotec Proprietary Limited
The African operating and manufacturing company
Related party loan with Minoan Medical
Operational income and expenses with Minoan Medical
Dr Gregory Vizirgianakis
Pieter van Niekerk
Medinotec Incorporated in Nevada is the 100% ultimate parent entity
n/a
Medinotec Incorporated Nevada
Ultimate parent of Medinotec Capital and DISA Medinotec
All of the above for its related subsidiaries
Dr Gregory Vizirgianakis
Pieter van Niekerk
Joseph P Dwyer
Stavros Vizirgianakis
Athanasios Spirakis
This is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
n/a
Medinotec Group of Companies
The Consolidated group name of Medinotec Incorporated, Medinotec Capital Proprietary Limited and DISA Medinotec Proprietary Limited
above for its related subsidiaries
Dr Gregory Vizirgianakis
Pieter van Niekerk
Joseph P Dwyer
Stavros Vizirgianakis
Athanasios Spirakis
This is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
n/a
Pieter van Niekerk
Chief financial officer of the Medinotec Group of Companies
Transactions relating to mutual entities disclosed above
Related directorships disclosed above
Minority Shareholder in Medinotec Inc
n/a
Gregory Vizirgianakis
Chief Executive officer of the Minoan Group of Companies
Brother of Stavros Vizirgianakis
Transactions relating to mutual entities disclosed above
Related directorships disclosed above
Shareholder in Medinotec Inc and Kingstyle investments.
n/a
Stavros Vizirgianakis
Non-Executive director of the Medinotec Group of companies
Brother of Gregory Vizirgianakis
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
Joseph Dwyer
Non-Executive director of the Medinotec Group of companies
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
Athanasios Spirakis
Independent director of the Medinotec Group of companies
Transactions relating to mutual entities disclosed above
No Related other Directorships in Medinotec Group of Companies
n/a
n/a
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a. Rent
DISA Medinotec Proprietary Limited leases
commercial buildings from Minoan Capital Proprietary Limited (“Minoan Capital”). Minoan Capital is owned 100% by the Chief
Executive Officer of the Medinotec Group of Companies, Dr. Gregory Vizirgianakis. We are currently also renting storage and office space
in the US on a 12-month lease agreement.
Set forth below is a table showing the
Consolidated entities' lease payments for the year ended February 28, 2026 and February 28, 2025 with Minoan Capital:
2026
$
2025
$
Lease payments
33,774
32,031
The Company incurs monthly rental charges
payable to Minoan Capital for the use of training centre facilities. As no long-term fixed rental agreement exists and the arrangement
is invoiced monthly, the Company does not account for the arrangement as a lease.
Set forth below is a table showing the
Consolidated entities' rental expenses relating to the training centre facilities for the year ended February 28, 2026 and February 28,
2025 with Minoan Capital:
2026
$
2025
$
Rental
expense
23,712
—
Rent is comparable to rent charged for
similar properties in the same relative area. The company does market research of a Minimum and a Maximum rental value within the area
at every renewal of the rental agreement to ensure this is market related, this exercise is undertaken together with a registered property
agent who has the appropriate knowledge of the area.
b. Loan
There is an unsecured loan from the prior
parent entity of DISA Medinotec Proprietary Limited incorporated in South Africa called Minoan Medical Proprietary Limited (a related
party). This loan originated to fund working capital and capex expansions of DISA Medinotec Proprietary Limited Incorporated during the
developmental and startup phase.
The Consolidated entities, particularly
Medinotec Inc. has the option to settle earlier in cash or any form of equivalent.
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There is also an unsecured, interest free
loan with no fixed terms of repayment from Minoan Capital.
Minoan Medical and Minoan Capital are related
parties of the Group as the CEO Dr Gregory Vizirgianakis has common control.
15. Reclassification of Financial
Statement Items
Certain prior-year amounts have been
reclassified to conform to the current-year presentation. These reclassifications relate to amounts previously included in general and
administrative expenses that are now presented as cost of goods sold, consistent with the nature of the underlying costs. The reclassifications
had no impact on the Company’s net income, cash flows, total assets, total liabilities, or stockholders’ equity.
The adjustment results in:
February 28, 2025
$
Original
item: General and administrative expenses
( 42,297 )
Reclassified
to: Cost of Goods Sold
42,297
16. Subsequent events
Management has evaluated subsequent events
through May 28, 2026, the date the consolidated financial statements were issued, and has determined that there were no subsequent events
requiring adjustment to or disclosure in the consolidated financial statements.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.