What changed in this filing

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Item 1. Business

2026-05-28 compared with 2025-05-29 · 569 added, 753 removed, 254 unchanged (84% of the section changed)

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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 Propriety 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 Propriety 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.

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

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Medinotec Capital Proprietary Limited serves

as the acquisition vehicle for Medinotec Inc on the continent of Africa.

as the acquisition vehicle for Medinotec Inc.

on the continent of Africa.

Combined these companies now form the Medinotec Group

of Companies.

Prior to the above, in 2015, DISA Vascular 2015, an

innovative medical device company that specialized in vascular technology for the treatment of coronary artery disease, was established.

It was subsequently renamed DISA Medinotec Proprietary Limited.

DISA Medinotec Proprietary Limited was situated in Cape Town, South Africa

and had been developing stents for the international market since 1998.

It has since produced high-quality medical devices through in-depth

research and development capabilities (“R&D”) and a total commitment to patient care.

Today, the products are sold via

a network of distributor partners both in South Africa and internationally.

A professional team consisting of our CEO and CFO

was recruited to implement and execute the strategy, and an infrastructure of a large manufacturing facility was established, substantially

increasing our manufacturing and warehousing capabilities.

Various distributors were appointed, and rights obtained

to grow sales internationally, especially in Namibia and Mauritius, as well as the Middle East, Europe, South America, and portions of

We have started establishing various networks to export and distribute our products in North America and other highly regulated

countries such as, Australia, Japan, and China.

The FDA approval that was granted for the Trachealator in November 2021 together with

the concluded private placement allowed for the roll out in the United States which started during the 2024 fiscal year.

we are finalizing multiple patent applications in several territories, which we believe will give us the ability not only to maintain

our intellectual property but also to market our products aggressively.

The manufacture of medical devices for the

treatment of vascular and airway diseases is now performed in our facility in Johannesburg, South Africa.

Raw materials and components

used in manufacture are sourced from a number of local and international suppliers to ensure continuity of supply while maintaining high

quality and reliability.

Procedures and processes are in place to ensure that these materials meet the regulatory requirements and comply

with specifications, and suppliers are regularly evaluated to monitor their quality performance.

The core values of care, learning, continuous

improvement, innovation, outstanding delivery, and relationship building are important to the success of our business.

The quality of

the manufactured products is achieved through careful selection of suppliers and the maintenance of good manufacturing practices, thereby

mitigating risk.

As of February 28, 2025, the Medinotec Group of

Companies employed 51 employees, which consists of full-time employees and independent contractors.

Within the Group of Companies the Commercial team representing the products currently consists of 6 individuals responsible

for all aspects of the sales process, including pricing, marketing, transportation and logistics, product development and general

customer service and training.

The team is organized by both region and end-market and comprises a group of experienced and dedicated team members

who understand the industry and who are experts in their various medical fields.

The team is led out of the Johannesburg head office

and is regionally positioned in the major medical markets across South Africa.

As the Company makes decisions to enter or expand

its presence in certain markets or regions, it expects to continue to add dedicated team members to support that growth.

company currently has seventeen dedicated sales members in the United States and this number is expected to increase as the sales

grow and regulatory and administrative hurdles are cleared to allow further revenue expansion.

This team coordinates all new and existing customer outreach efforts and identifies emerging market trends and new product

opportunities.

This includes producing exhibits for trade shows and exhibitions, manufacturing product overview materials, participating

in both regional and international industry meetings and other trade associations and managing advertising efforts in trade journals.

Transportation

Warehouse and Logistics team:

The team manages domestic and international shipments and product deliveries by directing

inbound and outbound ocean vessels and flights, supervising equipment maintenance, coordinating with freight carriers to ensure equipment

availability, ensuring compliance with shipping regulations and strategically planning for future growth.

This team also ensures

storage and shipping happens in accordance with the quality requirements of each product.

The team services and maintains all major equipment utilized in manufacturing.

Services team:

This team is dedicated to creating an exceptional customer experience and making it easy to do business with us.

It aims to accomplish this by consistently exceeding customer expectations, continually improving service performance, offering efficient

and timely responses to customer needs, being available to customers 24/7, and providing customers with personal points of contact.

functions are supported by various back-office functions including, but not limited to, R&D, Quality, Finance, Admin and Regulatory

Attracting the right talent is vital to the

success of the Medinotec Group of Companies, and the contribution they make to the business is highly valued.

Our focus on attracting

the most competent and suitable people to operate in a rewarding work environment is a priority, particularly in the highly competitive

labor market in which we operate.

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.

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.

Medinotec Capital Proprietary Limited, the Group continued operating its medical device manufacturing activities from Johannesburg, South

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

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.

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

The 12 independent contractors include a mix of individual

contractors and companies engaged to support the Group’s sales and commercialization activities.

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

Commercial and sales:

pricing, customer engagement,

product support, marketing coordination, logistics support, and distributor liaison.

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:

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:

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.

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.

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.

not experienced any work stoppages, and we consider our relations with our employees to be good.

We have not experienced

any work stoppages, and we consider our relations with our employees to be good.

Number of full-time employees

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Number of independent contractors

Capital Proprietary Limited*

Medinotec Proprietary Limited

* 2 Executives employed by Medinotec Inc.

Medinotec Capital Proprietary Limited are the same individuals.

Medinotec Inc.

Medinotec Capital Proprietary Limited*

DISA Medinotec Proprietary Limited

Group Contractors

DISA Medinotec Proprietary Limited successfully

secured multiple distribution contracts from renowned international medical device companies, collectively referred to as the Cardiology

distribution business.

These contracts were awarded following adjudication by independent international third-party medical device companies.

The introduction to these esteemed companies was facilitated by Minoan Medical Proprietary Limited, the previous distributor, before DISA

Medinotec assumed responsibility.

This transition underscores DISA Medinotec's strategic prowess in expanding its portfolio and underscores

the collaborative efforts within the medical device distribution sector.

These distribution products currently and in the future are expected

to add to the product group of the business and help to achieve increased revenues, which consists of more mature but also profitable

products that will complement our in house developed products.

The Company appointed DISA Life Sciences, a South African based sub-distributor,

which already distributes the in house manufactured brands of Medinotec within the market territory of South Africa.

This sub-distributor

will facilitate sales into the territory of South Africa while the principle focus of the business unit remains the development of products

for which it owns the IP, while the distributor will perform the sales and marketing functions in this territory.

The Trachealator product obtained FDA approval in

November 2021, which allowed the Company to sell this product into the United States.

Since the Company had no prior sales channels or

infrastructure in the United States, management found it prudent to plan a roll out of the product with a distributor that had an established

network and infrastructure.

For this business, the Company partnered with a company called Innovative Outcomes and entered into a revolving

credit facility to a maximum of $750,000.

Innovative Outcomes would use this facility to grow both their own distribution network and

infrastructure and also allow for the Company to utilize this network and infrastructure.

However, during the quarter ending November

30, 2023, there was a material change in strategic focus where the Company would require its products to be marketed to niche surgical

units, Innovative Outcomes would be servicing the wound care clinic market only which meant that the future growth of the combined network

and infrastructure would not be a strategic match between the two entities.

It was therefore decided to separate the network and infrastructure

developed and for each company to pursue its strategic focus.

The note receivable will continue on the same terms and became payable

during the 2024 financial year, but the Company decided to provide full impairment against this receivable on November 30, 2023.

decision was made in prudence due to the fact that the receivable is no longer backed by any Trachealator revenue streams and does not

change that Innovative Outcomes will still be liable for payment of this in the future.

Should payments be received this provision will

be reversed with the same amount of cashflow received.

Two of the most valuable assets the Medinotec

Group of Companies has are its long-term customer relationships and its strong distribution and marketing network.

Through its distribution

partnership, the Group has a network of over 100 sales representatives, who cover approximately 60% of all hospital operating room floors

on a weekly basis in South Africa.

The Group plans to replicate such a network in the US.

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.

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

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.

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.

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

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

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Group with more than 100 sales representatives in the South African Market.

Sales between the Medinotec Group and DISA

Life Sciences will continue into the future due to the vast distribution arm of DISA Life Sciences within South Africa.

expectation is to reduce reliance on the South African markets for customers and accounts as the Group endeavors to expand and enter into

international first world markets.

However, there is no guarantee that our plan will result in a decrease in reliance on DISA Life Sciences

for customers and accounts.

As with any expansion effort, there are barriers to entry and outside factors, such as regulatory approval,

competition, among others, that may prevent us from entering such markets.

As such, there is a risk that the concentration of customer

issue will remain an ongoing issue unless we are successful in overcoming barriers to entry, competing with those in our markets and achieving

regulatory approvals, none of which can be guaranteed.

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.

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.

Sales reflect the cyclical nature of the business,

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that are developed are launched effectively.

Life Sciences is, as per management’s best estimation, one of the top 5 medical device distributors in South Africa and has

a far reaching sales and marketing component to their business.

DISA Medinotec partnered with DISA Life Sciences to create a market

for the products in South Africa, due to the reach of this distributor, DISA Medinotec was able to reach its budgets and break even

scenarios on products much faster than it would have attempting to launch on their own.

DISA Life Sciences uses its own sales force

and certain sub-contractors to penetrate the South African market.

After we took exports in house, the DISA Life Sciences relationship

consists of supplying products in 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

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

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Medinotec Capital (Pty) Ltd

This company was established and incorporated by Medinotec Inc.

to establish an investment holding company on the continent of Africa.

The intention in the future will be that the same structure gets established for any continent on which Medinotec Group of Companies would like to expand into.

Consolidating all African investments under one holding company simplifies the transfer pricing policies inter group and would ensure a lower risk of breaching any transfer pricing regulations set by African regulators

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 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.

Our objective is to become one of the significant

industry players within the next five years.

We plan to achieve this by:

growing our product range;

building our competences;

making strategic acquisitions.

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.

The Company’s business strategy is focused on:

maintaining and expanding its existing product portfolio;

developing internal manufacturing, quality, regulatory, and commercial

capabilities;

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

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the distribution of our products to customers via our sales network.

high-level overview of our strategy follows in the 10-K ,

which is followed by a discussion on how we implement this

(Image depicting two healthcare professionals

in surgical attire are preparing to intubate a patient in a medical setting.

Shutterstock)

Our Strategic Differentiators

We attri bute

our success to the following key strengths:

to innovation:

We are dedicated to continuing to develop patentable products and offerings through R&D.

management team:

The members of the Company’s management team bring considerable experience to the dynamic environment

in which we operate.

Their expertise covers a range of disciplines, including industry-specific operating and technical knowledge.

The Company has assembled an agile, creative, and responsive team that can quickly adapt to changing market conditions.

geographic footprint :

We believe that the strategic location of our facilities and logistics capabilities contribute

to our customer retention rates and our ability to reach broader market segments.

operating structure:

We focus on building and operating facilities with low operating costs to enable us to better manage market

relationships with customers:

We have a long and enviable track record of timely delivery of products, which contributes to a

reputation for dependability.

Our extensive network of technical resources and other expertise enables us to collaborate with customers

to develop product offerings to improve their satisfaction.

knowledge of setting up distribution channels :

We have various exclusive distribution agreements in place with distributors

to ensure these distributors include our products into an extensive product mix, which includes some of the most innovative and cutting-edge

technologies available today.

on safety and wellbeing:

We focus on the safety of our employees and our patients and maintain safe and responsible operations.

We are known in the communities in which we operate as a preferred employer and as a responsible corporate citizen.

Three Pillars of our Strategy

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;

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

(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.

Innovate and Grow our Product Range

DISA Medinotec Proprietary Limited established itself

as a highly successful company that has been investing heavily in creating its own IP, as well as the R&D and manufacturing techniques

involved in producing unique niche medical devices, thereby creating a value base that is ready to enter advanced high-value markets in

North America.

The approach, agility and excellent production

capabilities have allowed DISA Medinotec Proprietary Limited to capitalize on key medical trends, while an in-depth market knowledge and

understanding have enabled anticipation of market needs well in advance.

This, combined with accelerated product development, innovation,

and speed to market, with a focus on cost reduction, equipment upgrades and low-cost facilities, has proved to be a recipe for success.

We currently have three products that are commercially

available and a rich pipeline of developmental projects.

We currently derive most of our profits by selling these products in South Africa,

leaving ample room to grow the basket offering that sales personnel take to the market.

Our plan is also to constantly innovate and enhance

our product range to ensure our competitiveness.

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.

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.

The products are generally targeted at more complex,

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DISA Medinotec Proprietary Limited currently specializes

in niche products within the disciplines of cardiology and respir atory

interventions in which we are involved in medical device design, development, manufacture, all supported by a well-trained and educated

sales and distribution channel.

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.

focus of our expansion is on markets with surgical centers of excellence, including the Middle East, Europe, and the US, with the aim

the number of surgeons endorsing and using our products, not necessarily through sales, but through skills transfer;

the number of procedures conducted;

key opinion leader support and publications related to the use of our products during procedures.

addition, we appoin ted 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 following the 510(k) substantially

equivalence process for Class II medical devices.

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;

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.

The Medinotec Group’s growth plan is determined

by the surgical devices market, which is currently the main contributor to sales.

Moreover, healthcare in developing countries –

our primary target market – is undergoing rapid changes.

The growing population in these countries is likely to lead to increased

demand for healthcare, including medical devices.

The growing burden of diseases and innovative medical treatments currently, according

to management’s estimate, accounts for nearly two-thirds of the rise in spending.

North America is expected to continue dominating the

overall market for medical supplies and investment opportunities.

The US holds the largest market share in the region due to the superior

regulation of surgical devices and a growing awareness among the population of an alternative approach for procedures in the treatment

of injuries, and for chronic disease management.

Our sales in the United States for the fiscal year was $678,105, which represents 7%

of total sales.

This is up from $553,967 in the prior fiscal year, which represented 11% of total sales.

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.

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

There is currently a massive drive for minimal invasive

procedures done at lower costs, which in turn decreases hospitalization and the cost of procedures and operating room time.

this is the primary market for our devices, i.e., minimally invasive procedures, it is important for us to be at the cutting-edge of

technological developments at the correct price point to remain relevant.

It is also important to diversify product offerings to ensure

that all the products used during a procedure can be supplied by one service provider.

The price of these devices is also expected to

fall given the entry of many new players in the market.

Another market driver is the growing population

in developing countries for healthcare and procedures, which has increased significantly in recent years as previously mentioned.

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

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.

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.

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

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

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for our products.

(Image depicting a team of surgeons performing

an operation.

Shutterstock)

The next logical step for us would be to secure

investment opportunities and additional distributor relationships through the North American territory and to further deploy this for

growth in our distribution channels.

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 markets that are characterized by a number of large, multinational players as well as a number of small, regional or

local distributors.

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.

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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.

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

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more capital resources, larger research laboratories and more extensive distribution systems.

As such, there are no assurances that we

will be able to compete and gain market share.

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.

Build our Competencies

Our investment in R&D has included the development

of a state-of-the-art production facility in Johannesburg, South Africa.

This facility, designed to significantly enhance capacity and

output within an ISO 7 cleanroom environment, also features expanded laboratory space, including a “dry” laboratory for microscopy,

mechanical testing, prototyping, and experimentation, and a “wet” laboratory for pressure testing, weighing, liquid experimentation,

and 3D printing.

Additionally, a workshop is equipped for turning, milling, grinding, and other processes required for custom machinery

and prototype development.

The facility's large packaging area and dedicated

EtO sterilizer have enabled in-house sterilization, supporting operations governed by the ISO 13485 Quality Management System.

Our CE-Marked

products, with IP protection, have benefited from expertise in advanced medical manufacturing techniques, including balloon forming, heat

and adhesive bonding, device coating, catheter laminating, and more.

This has allowed for the commissioning of the latest balloon-forming

manufacturing equipment to increase production capabilities for interventional balloon catheter products.

While this investment has been an integral part of

our growth strategy, we are temporarily shifting focus away from further expansion of the production facility.

Instead, our strategic

focus will now center on the other two pillars of our strategy as these priorities are aligned with our vision to drive growth through

innovation and strategic alignment with key partners.

By concentrating on these focus areas, the Medinotec

Group of Companies aims to maximize impact, accelerate innovation, and leverage our low-cost base in South Africa to strengthen our position

as a leading med-tech company globally.

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

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

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.

Make Strategic Bolt-on Acquisitions

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Our Implementation Plan

Any business strategy requires a plan that

outlines a roadmap for implementation.

The Medinotec Group of Companies’ plan is to continue

to ensure quality manufacturing of our current products, ongoing investment into our own IP, and planned acquisitions to ensure the financial

stability of current operations, the longevity of our organization and a smooth integration process for new businesses we may acquire.

The key drivers in our plan that support the business strategy are as follows:

our presence and product offering in specialty product end-markets .

In the past, we have signed various exclusive

distribution agreements across multiple territories to enhance our product basket and reach.

R&D and business development teams work together to enhance existing product offering.

These teams also pursue opportunities

to acquire new product offerings through business acquisitions and distributorships that are expected to increase our presence and

market share in certain specialty product markets and/or allow us to enter new markets.

We manage a robust pipeline of new products

and business relationships in various stages of development and are also in various stages of expanding capabilities to improve product

offerings across our various platforms.

develop value-added capabilities to maximize margins.

We expect to continue investing in ways to increase the value we provide

to customers by growing our product offerings, improving our supply chain management, upgrading our IT, and enhancing our customer

service model.

We are also exploring other ways to expand our reach and our products to provide incremental value to our customers,

including new acquisitions to vertically integrate our supply chain and to obtain more of the gross profit share of the entire customer

product mix and keep operating costs low.

We continue to actively manage our product mix as we seek to maximize profit margins.

This requires us to use our proprietary expertise in balancing key variables, such as procurement and processing capacity, transportation

availability, customer requirements and pricing.

Additionally, we undertake continuous improvement efforts to increase the effectiveness

and efficiency of our production and distribution facilities.

position logistic capabilities and supply chain network to meet customers’ needs .

We continue to strategically position

our supply chain to deliver according to our customers’ needs.

We believe that our supply chain network and logistic capabilities

are a competitive advantage that enables us to provide superior service to customers.

strategic location of our distribution centers enables us to service major customers within 48 hours (this includes

certain deliveries to rural and outlying areas in South Africa, which have limited road access and infrastructure).

Additionally,

our in-house delivery capabilities allow for direct deliveries and last-minute route adjustments to support our customers.

expansion opportunities and other acquisitions.

We expect to continue leveraging our reputation, procurement, distribution capabilities

and infrastructure to increase our product offerings, as well as to explore other opportunities to expand our reserve base and sell

new products.

will pursue acquisitions of value-adding products and technologies.

We will prioritize acquisitions that will provide us with

opportunities to realize synergies, which include entering new geographic markets, acquiring attractive customer contracts, and improving

balance sheet strength and flexibility .

We intend to maintain financial strength and flexibility to enable us to better manage

the business through industry downturns and pursue acquisitions and new growth opportunities as they arise.

The business has good

cash-producing prospects and this, together with our entrepreneurial mindset, ensures that we can quickly pursue opportunities that

are time sensitive.

sufficient levels of inventory to meet the product delivery needs of customers .

We aim to carry sufficient inventory, and to

provide payment terms to customers in the normal course of business to meet the operational demands of our customers.

location of our distribution centers in relation to the US, Europe, and the Far East, we require our distributors to carry at minimum

three (3) months of inventory on fast moving items to avoid supply chain pressures.

and skills development:

Our continued investment into the healthcare landscape through training and academic development assists

in retaining and maintaining the necessary skills base within southern Africa.

Training and skills development in healthcare is an

intrinsic and necessary part of our growth strategy.

We use a state-of-the-art training facility at our Johannesburg head office,

which includes the latest cardiology simulators, to assist young surgeons and health professionals to develop their procedural skills.

We also have a full array of non-occlusive balloon dilation technology for training purposes and for hands-on product technical training.

The Company’s implementation plan is focused on the following operating

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;

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

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internationally, especially in Europe, North America, South America, Middle East, portions of Asia as well as Namibia and Mauritius.

We are currently represented in approximately

29 countries, with product registration in progress for an additional 8 countries.

We currently have 28 appointed distributors to represent

our products globally.

All exports are managed directly out of South Africa by an export manager.

We have had several training initiatives held in the US where

FDA approval has been granted for the Trachealator following the 510(k) substantially equivalence process for Class II medical devices

We intend to complete our various networks and obtain

regulatory approvals to be able to export and distribute our product to countries such as Australia, Japan and China.

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

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

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market trends have resulted in more product volumes being transported by high-efficiency road freight.

Our distribution centers in Johannesburg, South Africa

and New York, United States of America are strategically located to provide access to road and air freight.

We also continually explore

ways of optimizing our network to ensure that the product remains close to the point of end use.

This approach allows us to provide excellent

customer service and positions us to take advantage of opportunistic sales.

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

Quality Management

The safety and quality of our medical devices is assured

through rigorous documented procedures and an accredited Quality Management System (“QMS”), which was established in accordance

with the requirements of ISO13485, the European Union Medical Device Regulation 2017/745, the US FDA 21 CFR 820 regulations, and the various

applicable acts and guidelines legislated by the South African regulatory authorities.

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

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International Quality Regulations

Many 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.

It is required for products manufactured anywhere in the world that are then marketed in the

European Union.

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

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been granted till the end of 2027 due to the European Notified Bodies being unable to handle the volume of the applications.

We are currently in the process of ensuring compliance

with the new and very demanding Medical Device Regulation (MDR) 2017/745 with the Trachealator already being certified under this regulation.

The Technical Files for the remaining products are currently being reviewed by DEKRA.

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.

DEKRA is a global testing, inspection, and certification

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to ensure ongoing compliance.

FDA certification via the 510(k) substantially equivalence

process for Class II medical devices for the Trachealator has been obtained and sales have started in the US during the past financial

For two cardiac catheters, we are in the process of obtaining the required FDA certification for our devices, thus enabling us to

market and sell our products in the US.

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

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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 body approvals and market acceptance play

a material role in the success of our business plan.

The approval process of the governing bodies for example FDA/CE is lengthy, time

consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our products it will have a material

impact on our business, we may encounter substantial delays in completing our clinical studies which in turn will require additional costs,

or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities.

If we are not able

to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed

in commercializing, our product candidates and our ability to generate revenue will be impaired even if our product candidates receive

marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in

the medical community necessary for commercial success.

Regulatory approvals are aligned with our operating segments, with U.S.

Drug Administration (FDA) requirements primarily applicable to our operations within the United States, while also relevant in certain

non-European international markets.

The Conformité Européenne (CE) marking, historically required for European market access,

is now being replaced by the European Union’s new regulatory framework under the Medical Device Regulation (EU MDR) and In Vitro

Diagnostic Regulation (IVDR), collectively referred to as the EU’s FDR (Future Device Regulation), which governs our activities

in Europe and certain other international jurisdictions

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.

Risk Factors for further discussion of regulatory, compliance, and environmental risks in connection with our medical device

Regulation of Medical Devices in Europe

Medical devices placed on the market in the European

Economic Area, or EEA must meet the relevant essential requirements laid down in Annex I of Directive 93/42/EEC concerning medical devices

("the Medical Devices Directive").

The most fundamental essential requirement is that a medical device must be designed and

manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users

In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured, and packaged

in a suitable manner.

The European Commission has adopted various standards applicable to medical devices.

These include standards governing

common requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical

There are also harmonized standards relating to design and manufacture.

While not mandatory, compliance with these standards

is viewed as the easiest way to satisfy the essential requirements as a practical matter.

Compliance with a standard developed to implement

an essential requirement also creates a rebuttable presumption that the device satisfies that essential requirement.

To demonstrate compliance with the essential requirements

laid down in Annex I to the Medical Devices Directive, medical device manufacturers must undergo a conformity assessment procedure, which

varies according to the type of medical device and its classification.

Conformity assessment procedures require an assessment of available

clinical evidence, literature data for the product, and post-market experience in respect of similar products already marketed.

for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-declare the conformity of its

products with the essential requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure

requires the intervention of a Notified Body.

Notified bodies are often separate entities and are authorized or licensed to perform such

assessments by government authorities.

The notified body would typically audit and examine a product’s technical dossiers and the

manufacturers’ quality system.

If satisfied that the relevant product conforms to the relevant essential requirements, the notified

body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer

may then apply the CE Mark to the device, which allows the device to be placed on the market throughout the EEA.

Once the product has

been placed on the market in the EEA, the manufacturer must comply with requirements for reporting incidents and field safety corrective

actions associated with the medical device.

In order to demonstrate safety and efficacy for their

medical devices, manufacturers must conduct clinical investigations in accordance with the requirements of Annex X to the Medical Devices

Directive ("MDD"), Annex 7 of the Active Implantable Medical Devices Directive ("AIMDD"), and applicable European

and International Organization for Standardization standards, as implemented or adopted in the EEA member states.

Clinical trials for

medical devices usually require the approval of an ethics review board and approval by or notification to the national regulatory authorities.

Both regulators and ethics committees also require the submission of serious adverse event reports during a study and may request a copy

of the final study report.

On April 5, 2017, the European Parliament passed the

Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the E.U.

Medical Devices Directive and the Active Implantable

Medical Devices Directive.

Unlike directives, which must be implemented into the national laws of the EEA member States, the regulations

would be directly applicable, i.e., without the need for adoption of EEA member State laws implementing them, in all EEA member States

and are intended to eliminate current differences in the regulation of medical devices among EEA member States.

The Medical Devices Regulation,

among other things, is intended to establish a uniform, transparent, predictable, and sustainable regulatory framework across the EEA

for medical devices and ensure a high level of safety and health while supporting innovation.

The Medical Device Regulation became applicable

The new regulations:

strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance, and safety of devices placed on the market;

improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

set up a central database to provide patients, healthcare professionals, and the public with comprehensive information on products available in the E.U.;

strengthen the rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

In the European Union, member states are responsible

for enforcing the EU’s medical device rules and for ensuring that only compliant medical devices are placed on the market or put

into service in their jurisdictions.

They have the power to suspend the marketing and use, or demand the recall, of unsafe or non-compliant

They also have the power to bring enforcement action against companies or individuals for breaches of the device rules.

Non-compliance

may also result in Notified Bodies revoking any certificate of conformity that they have issued for a device or the manufacturer’s

quality system.

We are subject to regulations and product registration

requirements in many foreign countries in which we may sell our products, including in the areas of:

design, development, and manufacturing;

product standards;

product safety;

product safety reporting;

marketing, sales, and distribution;

packaging and storage requirements;

labeling requirements;

content and language of instructions for use;

clinical trials;

record keeping procedures;

advertising and promotion;

recalls and field corrective actions;

post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury;

import and export restrictions;

tariff regulations, duties, and tax requirements;

registration for reimbursement;

necessity of testing performed in country by distributors for licensees.

The time required to obtain clearance required by

foreign countries may be longer or shorter than that required for FDA clearance, and requirements for licensing a product in a foreign

country may differ significantly from FDA requirements.

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

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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 marketing and promotion

of drugs and devices, other federal and state laws may restrict our business practices if our products will be reimbursable under federal

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

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.

These laws include, without limitation, foreign, federal, and state anti-kickback and false claims laws, as well

as transparency laws regarding payments or other items of value provided to healthcare providers.

The federal Anti-Kickback Statute prohibits, among

other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate),

directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for purchasing, leasing, ordering or arranging

for or recommending the purchase, lease or order of any good, facility, item or service reimbursable, in whole or in part, under Medicare,

Medicaid or other federal healthcare programs.

Violation of the AKS also triggers liability under

the Civil Monetary Penalties Law (CMPL).

The CMPL carries penalties of up to $50,000 per kickback, in addition to three times the

amount of the remuneration.

Similarly, violations can result in exclusion from participation in government healthcare programs, including

Medicare and Medicaid.

Liability under the federal Anti-Kickback Statute may also arise because of the intentions or actions of the parties

with whom we do business.

The federal civil False Claims Act prohibits, among

other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval

to the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or

fraudulent claim to the federal government.

A claim includes “any request or demand” for money or property presented

The federal civil False Claims Act also applies to false submissions that cause the government to be paid less

than the amount to which it is entitled, such as a rebate.

Intent to deceive is not required to establish liability under the federal

civil False Claims Act.

In addition, private parties may initiate “qui

tam” whistleblower lawsuits against any person or entity under the federal civil False Claims Act in the name of the government

and share in the proceeds of the lawsuit.

Penalties for federal civil False Claim Act violations include fines for each false claim, plus

up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion

from the federally funded healthcare program.

The criminal False Claims Act prohibits the making or presenting of a claim to the government

knowing such claim to be false, fictitious or fraudulent and, unlike the federal civil False Claims Act, requires proof of intent to submit

a false claim.

When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines

and penalties ranging from $13,946 to $27,894 for each false claim, plus treble damages, and exclude the entity from participation in

Medicare, Medicaid, and other federal healthcare programs.

The Civil Monetary Penalty Act of 1981 imposes penalties

against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal

healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent,

or offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence

the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier.

The criminal False Claims Act imposes additional penalties for knowingly presenting a false claim to the government.

The Health Insurance Portability and Accountability

Act of 1996 ("HIPAA") also created additional federal criminal statutes that prohibit among other actions, knowingly and willfully

executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly

and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare

offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious

or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Similar to the federal

Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order

to have committed a violation.

Many foreign countries have similar laws relating

to healthcare fraud and abuse.

Foreign laws and regulations may vary greatly from country to country.

For example, the advertising and

promotion of our products is subject to E.U.

directives concerning misleading and comparative advertising and unfair commercial practices,

as well as other EEA Member State legislation governing the advertising and promotion of medical devices.

These laws may limit or restrict

the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare

professionals.

Also, many U.S.

states have similar fraud and abuse statutes or regulations that may be broader in scope and may apply

regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

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

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 the future, we may also be subject to various federal,

state, and foreign laws that protect personal information including certain patient health information, such as the E.U.

Protection Regulation (“GDPR”) and the California Consumer Privacy Act (“CCPA”), and restrict the use and disclosure

of patient health information, such as HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”),

HIPAA established uniform standards governing the

conduct of certain electronic healthcare transactions and requires certain entities, called covered entities, to comply with standards

that include the privacy and security of Protected Health Information (“PHI”).

HIPAA also requires business associates, such

as independent contractors or agents of covered entities that have access to PHI in connection with providing a service to or on behalf

of a covered entity, of covered entities to enter into business associate agreements with the covered entity and to safeguard the covered

entity’s PHI against improper use and disclosure.

The HIPAA privacy regulations cover the use and disclosure

of PHI by covered entities as well as business associates, which are defined to include subcontractors that create, receive, maintain,

or transmit PHI on behalf of a business associate.

They also set forth certain rights that an individual has with respect to his or her

PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions

on the use or disclosure of PHI.

The security regulations establish requirements for safeguarding the confidentiality, integrity, and

availability of PHI that is electronically transmitted or electronically stored.

HITECH, among other things, established certain

health information security breach notification requirements.

A covered entity must notify any individual whose PHI is breached according

to the specifications set forth in the breach notification rule.

The HIPAA privacy and security regulations establish a uniform federal

“floor” and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to

the privacy or security of, and access to, their records containing PHI or insofar as such state laws apply to personal information that

is broader in scope than PHI as defined under HIPAA.

HIPAA requires the notification of patients, and other

compliance actions, in the event of a breach of unsecured PHI.

If notification to patients of a breach is required, such notification

must be provided without unreasonable delay and in no event later than 60 calendar days after discovery of the breach.

In addition, if

the PHI of 500 or more individuals is improperly used or disclosed, we would be required to report the improper use or disclosure to HHS

which would post the violation on its website, and to the media.

Failure to comply with the HIPAA privacy and security standards can result

in civil monetary penalties up to $68,928 per violation, not to exceed $2.07 million per calendar year for non-compliance of an identical

HIPAA authorizes state attorneys general to file suit

on behalf of their residents for violations.

Courts are able to award damages, costs and attorneys’ fees related to violations of

HIPAA in such cases.

While HIPAA does not create a private right of action allowing individuals to file suit against us in civil court

for violations of HIPAA, its standards have been used as the basis for duty of care cases in state civil suits such as those for negligence

or recklessness in the misuse or breach of PHI.

In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits

of HIPAA covered entities, and their business associates for compliance with the HIPAA privacy and security standards.

It also tasks HHS

with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage

of the civil monetary penalty paid by the violator.

In addition, California enacted the CCPA, effective

January 1, 2020, which, among other things, creates new data privacy obligations for covered companies and provides new privacy rights

to California residents, including the right to opt out of certain disclosures of their information.

The CCPA also creates a private right

of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

the law includes limited exceptions, including for “protected health information” maintained by a covered entity or business

associate, it may regulate or impact our processing of personal information depending on the context.

In the EEA, we may become subject to laws which restrict

our collection, control, processing, and other use of personal data (i.e.

data relating to an identifiable living individual) including

the GDPR (and any national laws implementing the GDPR).

As part of our operations, we process personal data belonging to data subjects

in the EEA, including employees, contractors, suppliers, distributors, service providers, customers, patients, or clinical trial participants.

For patients or clinical trial participants, we process special categories of personal data like health and medical information.

to ensure compliance with the GDPR (and any applicable national laws implementing the GDPR) in each applicable EEA jurisdiction.

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).

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.

exceptions exist for PHI regulated by HIPAA, the CCPA/CPRA may still apply to certain personal data we process outside of covered healthcare

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.

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.

Healthcare Reform.

and some foreign jurisdictions are considering

or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability

to sell our products profitably.

Among policy makers and payors in the U.S.

and elsewhere, there is significant interest in promoting

changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.

future legislative proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for

the procedures associated with the use of our products.

The cost containment measures that payors and providers are instituting and the

effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our products.

We expect additional state and federal healthcare

reform measures to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare

products and services, which could result in reduced demand for our products or additional pricing pressure.

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

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

Medinotec’s innovative surgical and healthcare

products are market leaders and meet high quality standards.

These are as follows with the Trachealator being one of our most sought-after

and innovative offerings.

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 has changed the way that tracheal,

and, to a degree, bronchial stenosis is managed in extremely ill patients.

While there are multiple causes of tracheal stenosis, it is

estimated that thousands of cases are reported every year.

Multiple, safe, serial dilations of the trachea are often curative and the

Trachealator is currently in our opinion as management the only device that is non-occlusive and which allows the procedure to be done

with the patient fully awake and un-sedated.

The Trachealator received its CE Mark in 2019 and is currently sold in various markets across Europe, Middle East, South America and portions

of Asia and has been used successfully on thousands of patients.

The FDA approval through the 510(k) substantially equivalence process

for Class II medical devices was obtained in November 2021.

In May of 2021 in recognition of the technology advancement in the device,

it was awarded a Gold Medal in the Medical Design Excellence Awards.

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

The Trachealator received the CE Mark of approval

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products in its market – a 510(k) accreditation that was obtained in November 2021 for the Trachealator and sales has since commenced

From prior experience, an FDA certificate and CE Mark

are widely accepted by other countries in the world as a valid accreditation for entry into their markets;

however, the medical device

approval process differs for each country and territory in the world and each may have additional requirements over and above CE mark

and FDA accreditation, or may even require their own quality standards.

Since the business plan is drafted mainly around the USA and European

markets the CE marking and planned future FDA submissions, entry into other markets will only be investigated if the expected launch of

our product candidates does not commercialize in the United States and Europe and each entry will be assessed on its own merits and requirements.

For example, Australia, Japan and China have

their own quality accreditation systems (TGF, JIS & CFDA respectively) and do not accept CE marking and/or an FDA certificate.

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

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.

FDA clearance was obtained on March 11, 2025.

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 Medinotec Group of Companies also designed

and developed a range of semi-compliant coronary PTCA catheters known as the Cape Cross, which attained a CE Mark and are marketed around

the world and in South Africa, becoming a widely used interventional balloon in the market.

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 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”)

On the back of the Cape Cross, the Cape Cross

NC Catheter was developed for post dilation purposes.

The product has become a mainstay of our cardiology range.

It is CE Marked and widely

used in South Africa.

After a stent is placed in an artery, it is followed up by moving a NC catheter to the site where the stent was

The NC catheter balloon part is then inflated inside the stent.

This is done to “seat” the stent inside the artery

In other words, if the stent was not optimally placed, the NC Catheter can be used to make the stent fit “snugly” against

the artery wall to avoid dislodgement and movement of the stent after placement.

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.

The Cape Cross Non-Compliant (“NC”)

Aortic Valve Dilation Balloon Catheter

The Aortic Perfusion and Dilation Catheter is a non-occlusive

perfusion balloon to allow the expansion of the aortic valve without impeding the cardiac output.

This catheter could be used to post dilate the

artificial valve in TAVI (Transcatheter Aortic Valve Implantation) without the need for pacing.

A clinical study was conducted in 2022, as part of

the development of the Technical File documentation which is currently undergoing examination by our Notified Body (DEKRA).

Submission for FDA certification via the 510(k)

substantially equivalence process was made on May 31, 2024.

FDA clearance was obtained on March 11, 2025, after the financial year end.

The Micro CTO Catheter (Developmental)

We have developed a highly specific niche CTO

(Chronic Total Occlusion) catheter balloon range with diameters of 0.70 to 1.25 mm, as a size range extension to the current Cape Cross

Rx PTCA Catheter.

These micro-balloon catheters address an extremely

specific market need for difficult coronary cases and will further cement our position as one of the premier specialized coronary balloon

catheter manufacturers.

The Technical File was submitted to our Notified Body at the end of July 2023, and is currently undergoing examination.

The process of obtaining FDA certification for the

full range of Cape Cross PTCA catheters via the 510(k) substantial equivalence process commenced in January 2024.

The Tracheal Stent (Developmental)

We are currently in the initial stages of development

of a new self-expanding, temporary, silicone tracheal stent to be used in conjunction with the Trachealator in the treatment of tracheal

The complimentary nature of this product will further

build on our know-how in the field of advanced airway management, and we look forward to its further design and testing over the upcoming

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.

Development Pipeline

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Trachealator:

The Company is pleased to report that, since sales commenced, it has supplied

940 Trachealators, both in private and academic hospitals throughout the United States of America.

FDA clearance and CE certification was obtained.

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:

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CE certification under the MDR is in progress.

Valve Dilation Balloon Catheter (OutFlo) :

FDA clearance was obtained on March 11, 2025, after the financial year end.

Micro CTO Catheter :

R&D, Testing, Pre-Production Prototyping, Clinical Trials MDR/CE Mark accreditation application was submitted in July 2023.

Tracheal Stent:

Epistaxis Catheter:

R&D, Testing, Pre-Production Prototyping, Testing, Production, Clinical Trials – FDA 510(k) exempted (Class I product)

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.

Risk Factors for a discussion of risks

associated with product development, clinical trials, and regulatory approvals.

Intellectual Property

Medinotec Group of Companies currently holds various

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

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with other companies.

Medinotec Group of Companies pursues a policy of obtaining

patent protection in the US, China, Europe, Middle East, and Australia for patentable subject matter in our products and attempt to review

third-party patents and patent applications to the extent publicly available to develop an effective patent strategy.

This assists in

avoiding the infringement of third-party patents, helps identify licensing opportunities and monitors the patent claims of others.

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

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

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European Union:

Intention to grant:

EP 3768363 / November 11, 2024.

This patent is valid until December 12, 2038.

Community Registered Patent No.

18903920.9 / has been granted with effect from March 5, 2025.

The patent is valid until March

South Africa:

1 unchanged sentence

This patent is valid until July 27, 2040.

Acceptance to be advertised, 2018406682, November 14, 2024.

This patent is valid until December 12, 2038.

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.

6 unchanged sentences

process with an uncertain outcome that would place confidential information in the public domain.

The Medinotec Group of Companies also relies on trade

secrets, expertise, continuing technological innovations, and licensing opportunities to develop, maintain and strengthen our competitive

We strive to protect our trade secrets indefinitely through the use of confidentiality agreements and other security measures,

understanding that these efforts may prove to be ineffective.

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

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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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business