UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
☒
Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the quarterly period ended May 31, 2023
or
☐
Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
For
the transition period from ________ to __________
Commission
File Number: 333-265368
Medinotec,
Inc.
(Exact
name of registrant as specified in its charter)
Nevada
36-4990343
(State or other jurisdiction
of
incorporation or organization)
(IRS Employer
Identification No.)
Northlands
Deco Park | 10 New Market Street | Stand 299 Avant Garde Avenue
North
Riding | South Africa
| 2169
(Address
of principal executive offices)
+27
87 330 2301
(Registrant's
telephone number)
(Former
name, former address and former fiscal year, if changed since last report)
Securities registered
pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol
Name
of each exchange on which
registered
Common
MDNC
OTCQX
Indicate by
check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days Yes ☒ No ☐
Indicate by
check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate by check
mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☐ Large accelerated filer
☐ Accelerated filer
☒ Non-accelerated filer
☒ Smaller reporting company
☒ Emerging growth company
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by
check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
State the number
of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 11,733,750 common shares
as of July 14, 2023.
TABLE
OF CONTENTS
Page
PART
I – FINANCIAL INFORMATION
Item 1:
Condensed
Consolidated Financial Statements (unaudited for period ended May 31, 2023)
1
Item 2:
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3:
Quantitative and Qualitative Disclosures About Market Risk
26
Item 4:
Controls and Procedures
27
PART
II – OTHER INFORMATION
Item 1:
Legal Proceedings
29
Item 1A:
Risk Factors
29
Item 2:
Unregistered Sales of Equity Securities and Use of Proceeds
29
Item 3:
Defaults Upon Senior Securities
29
Item 4:
Mine Safety Disclosure
29
Item 5:
Other Information
29
Item 6:
Exhibits
29
i
PART
I - FINANCIAL INFORMATION
Item
1. Condensed Consolidated Financial Statements
Our condensed
consolidated financial statements included in this Form 10-Q are as follows:
Page
Number
2
Condensed Consolidated Balance Sheets as of May 31, 2023 and February 28, 2023;
3
Condensed Consolidated Statements of Operations and Comprehensive Income/(Loss) for the three months ended May 31, 2023 and May 31, 2022;
4
Condensed Consolidated Statements of Stockholders’ Equity for the three months ended May 31, 2023 and May 31, 2022;
5
Condensed Consolidated Statements of Cash Flows for the three months ended May 31, 2023 and May 31, 2022; and
6
Notes to the Condensed Consolidated Financial Statements.
1
Table of Contents
Medinotec
Incorporated
Condensed
Consolidated Financial Statements
Condensed Consolidated Balance Sheets (Unaudited)
(in US$)
May
31
2023
$
February
28
2023
$
Assets
Current
Assets
Cash
2,710,209
2,827,457
Accounts
receivable, net of allowances
241,170
21,074
Inventory
489,275
354,304
Other
current assets
186,173
166,643
Total
Current Assets
3,626,827
3,369,478
Loans
and notes receivable
605,277
605,130
Property,
plant and equipment, net of accumulated depreciation
360,724
406,873
Deferred
tax asset
103,159
108,951
Total
Assets
$ 4,695,987
$ 4,490,432
Liabilities
and Stockholders' Equity
Current
Liabilities
Accounts
payable and accrued liabilities
79,378
71,311
Due
to stockholders/directors
1,588
—
Total
Current Liabilities
80,966
71,311
Long
Term Liabilities
Related
party loans payable
1,992,075
1,863,066
Total
Liabilities
2,073,041
1,934,377
Commitments
and Contingencies
Stockholders’
Equity
Common
stock
11,734
11,734
Common
stock additional paid in capital
3,296,391
3,296,391
Retained
Earnings (Deficit)
( 814,349 )
( 836,637 )
Accumulated
comprehensive income
129,170
84,567
Total
Equity
2,622,946
2,556,055
Total
Liabilities and Stockholders’ Equity
$ 4,695,987
$ 4,490,432
The
accompanying notes are an integral part of these Condensed Consolidated financial statements.
2
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Medinotec
Incorporated
Condensed Consolidated Statements of Operations and Comprehensive
Income/(Loss)
Three
months ended (Unaudited)
May
31, 2023
$
May
31, 2022
$
Revenue
Goods
sold
$ 416,208
$ 196,472
Cost
of goods sold
( 98,498 )
( 86,022 )
Gross
profit
317,710
110,450
Operating
expenses
Depreciation
and amortization expense
( 12,444 )
( 23,028 )
General
and administrative expenses
( 216,115 )
( 88,638 )
Research
and development expenses
( 2,262 )
( 34,058 )
Selling
expenses
( 46,039 )
( 12,727 )
Total
operating expenses
( 276,860 )
( 158,451 )
Income/(loss) from operations
40,850
( 48,001 )
Non-operating
income and expenses
Interest
income
14,333
62
Other
revenue/(expense)
30,709
6,455
Interest
expense
( 65,573 )
( 42,420 )
Total
non-operating income and expenses
( 20,531 )
( 35,903 )
Income
(loss) before income taxes
20,319
( 83,904 )
Income
taxes
Deferred
income taxes
1,969
( 20,817 )
Net
income (loss)
22,288
( 63,087 )
Other
comprehensive income/(loss)
44,603
8,528
Total
comprehensive income/(loss)
$ 66,891
$ ( 54,559 )
Earnings
Per Share:
Basic
$ 0.00
( 0.00 )
The
accompanying notes are an integral part of these Condensed Consolidated financial statements.
3
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Medinotec
Incorporated
Condensed Consolidated Statements of Stockholders’ Equity
Common
Stock
Common
Stock Additional Paid in Capital
Shares
Amount
$
Amount
$
Accumulated
Comprehensive Income
$
Retained
Earnings (Deficit) $
Subtotal
$
Common
control reserve
$
Total
$
Balance,
Feb 28, 2022
10,000,000
10,000
—
( 3,917 )
( 123,999 )
( 110,082 )
( 359,903 )
( 469,985 )
Net
income (loss) for the period
—
—
—
—
( 63,087 )
( 63,087 )
—
( 63,087 )
Stock
issued
Stock
issued - pursuant to acquisitions @ $2 per share
1,733,750
1,734
3,465,766
—
—
3,467,500
—
3,467,500
Other
increase/decrease in stock
Raising
fees capitalized
—
—
( 169,375 )
—
—
( 169,375 )
—
( 169,375 )
Other
comprehensive income
Net
foreign currency translation adjustment
—
—
—
8,528
—
8,528
—
8,528
Balance,
May 31, 2022
11,733,750
11,734
3,296,391
12,445
( 187,086 )
3,133,484
( 359,903 )
2,773,581
Balance,
Feb 28, 2023
11,733,750
11,734
3,296,391
84,567
( 476,734 )
2,915,958
( 359,903 )
2,556,055
Net
income (loss) for the period
—
—
—
—
22,288
22,288
—
22,288
Other
comprehensive income
Net
foreign currency translation adjustment
—
—
—
44,603
—
44,603
—
44,603
Balance,
May 31, 2023
11,733,750
11,734
3,296,391
129,170
( 454,446 )
2,982,849
( 359,903 )
$ 2,622,946
The
accompanying notes are an integral part of these Condensed Consolidated financial statements.
4
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Medinotec
Incorporated
Condensed Consolidated Statements of Cash Flows
Three months ended (unaudited)
May 31, 2023
$
May 31, 2022
$
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) for the period
$ 22,288
$ ( 63,087 )
Depreciation
18,665
23,023
Interest (received) paid
51,240
42,358
Deferred income taxes and tax credits
( 1,969 )
( 20,817 )
(Increase) decrease in receivables
( 239,626 )
( 9,061 )
(Increase) decrease in inventories
( 134,971 )
( 64,842 )
Decrease in accounts payable and accrued expenses
$ 9,655
$ 24,219
TOTAL CASH FLOWS FROM OPERATING ACTIVITIES
$ ( 274,718 )
$ ( 68,207 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Payments to acquire property, plant, and equipment
—
( 20,093 )
NET CASH USED BY INVESTING ACTIVITIES
—
( 20,093 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from assuming long-term debt
63,436
63,436
Proceeds from
issuance of long-term debt
14,186
62
Proceeds from issuance of common stock
—
3,298,125
NET
CASH PRODUCED BY FINANCING ACTIVITIES
77,620
3,509,301
OTHER ACTIVITIES:
Effect of exchange rate on cash and cash equivalents
79,848
10,272
Net cash increase (decreases) in cash and cash equivalents
( 117,248 )
3,431,273
Cash and cash equivalents at beginning of the period
2,827,457
131,577
Cash and cash equivalents at end of period
$ 2,710,209
$ 3,562,850
Supplemental disclosure of cash flow information:
Cash paid for:
Interest
10,600
10,193
Income taxes
—
—
Cash received for:
Interest
1,225
62
Income taxes
—
—
The
accompanying notes are an integral part of these Condensed Consolidated financial statements.
5
Table of Contents
Medinotec
Incorporated
Notes
to the Condensed Consolidated Entities Financial Statements
For
the period ended May 31, 2023
Description
of Business
Medinotec Inc. is a US-based company with a primary
investment in DISA Medinotec ("Medinotec"), a South African medical device manufacturing and distribution company, which in
managements opinion is a global leader in tracheal non-occlusive airway dilation technology and medical device design. “The Group”
(consists of Medinotec Incorporated in Nevada, Medinotec Capital Proprietary Limited and DISA Medinotec Proprietary Limited incorporated
in South Africa) has experience in establishing facilities for the manufacturing and design of niche medical devices and establishing
international distribution networks to commercialize these devices. Medinotec Inc. is seeking to expand sales and distribution operations
into the United States and other markets.
Currently, the South African government is deemed to
have aligned itself with Russia in the Ukraine Russian war, this leaves a possibility for sanctions and tariffs to be imposed in the
future. This has not yet been implemented. Further the impact of this military action and related sanctions on the world economy are
not determinable as of the date of these financial statements and the specific impact on the Company’s financial condition, results
of operations, and cash flows is also not determinable as of the date of these Condensed Consolidated financial statements.
The
Group’s Condensed Consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The Group received FDA 510(k) approval through
the substantially equivalence process for Class II medical devices for our main product being the Trachealator in November 2021. As the
research and development phase of this product has been completed, we expect to see an increase in sales being realized against expenditure
incurred, the build out of the United States of America market is evident from the profit of $ 22,288
for the period ended May 31,2023 versus the loss of $ 63,087
for the comparative period ending May 31,2022. A private placement was done in the wake of the successful research and development
(R&D) and subsequent regulatory approval in the prior financial year for $ 3,467,500
and therefore the Group has enough cash reserves and working capital to fund the roll out in the market of the United States of
America (USA) including new R&D activities and Marketing and Sales functions.
6
Table of Contents
Significant
Accounting Policies
a. Nature
of business/basis of preparation
The Condensed Consolidated financial statements
included herein have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”),
pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information or footnote disclosures
normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations
of the SEC for interim financial reporting. The Group’s management believes that the disclosures are adequate to make the information
presented not misleading. These Group’s financial statements should be read in conjunction with the consolidated financial statements
and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended February 28, 2023.
Emerging Growth Company (EGC) status
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart our
Business Startups Act of 2012, (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required
to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding
executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory
vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
b. Foreign
currency translation
Translation
of foreign subsidiary
The
accounts of the foreign subsidiaries are translated into U.S. dollars. Assets and liabilities are translated at year end exchange rates
and income and expense accounts are translated at average exchange rates in effect during the year. Translation adjustments resulting
from fluctuations in the exchange rates are recorded in accumulated other comprehensive income, a separate component of stockholders'
equity.
c. Accounts
Receivables
Allowance
based on a review and management evaluation
Accounts receivables are presented on the condensed consolidated balance
sheets, net of estimated uncollectible amounts. The carrying amounts of trade accounts receivable and unbilled accounts receivable represent
the maximum credit risk exposure of these assets. On a quarterly basis, in accordance with FASB ASC 326, Measurement of Credit Losses
on Financial Instruments ("ASC 326"), the Company evaluates the collectability of outstanding accounts receivable balances to
determine an allowance for doubtful accounts that reflects its best estimate of the lifetime expected credit losses. The allowance for
credit loss is based on an assessment of past events, current economic conditions, and forecasts of future events. Individual uncollectible
accounts are written off against the allowance when collection of the individual accounts appears doubtful.
The Group sells a significant amount
to DISA Vascular Distribution t/a DISA Life Sciences For the quarter ending May 31,2023 33 % (May 31, 2022:
64 % ) of the Group's total revenue is derived from this single customer in the distribution environment in South Africa.
No
allowance for doubtful accounts was recognized as of May 31, 2023 and February 28, 2023, respectively. Exports out of South Africa
is done on a pre-payment basis with exception of one customer who’s account was settled in full post quarter end, sales inside
South Africa is conducted through DISA Lifesciences who’s account was settled in full after the end of the quarter. All sales
in the United States was made for the first time during quarter one and fully collected post quarter within terms, therefore
management did not feel it is applicable to raise any doubtful debt provisions.
7
Table of Contents
d. Revenue
recognition
The Group generate their revenues from
the sale of high-quality medical devices which are self-manufactured through in-depth research and development. The products developed
are sold via a network of distributors in many parts of the world and through a direct sales force in South Africa.
Our clients are billed based on
a pricelist that are agreed upon in each customer contract, orders are shipped on a per order basis from our warehouse with Free-on-Board
Inco terms, therefore our client assumes the risk of the sale at point of invoice. The Group has two operating segments, Inside the USA
and Outside the USA, these sales are split by these territories and further segregated into the specific line of product sold into these
territories.
The Group has no contract assets
or liabilities representing accrued revenues that have not yet been billed to the customers due to certain contractual terms, because
of the fact that orders are placed, invoiced and shipped on a per order basis as and when our clients require additional inventory. All
revenue is recognized at a specific point and time.
Revenues are recognized when control
of the promised goods or services are transferred to a customer in an amount that reflects the consideration that the Group expects to
receive in exchange for those products. The Group apply the following five steps in order to determine the appropriate amount of revenue
to be recognized as it fulfills its obligations under each of its arrangements:
• identify
the contract with a customer,
• identify
the performance obligations in the contract,
• determine
the transaction price,
•
allocate the transaction price to performance obligations in the contract, and
•
recognize revenue as the performance obligation is satisfied.
Under ASC Topic 606, the Group estimate
the transaction price, including variable consideration, at the commencement of the contract and recognizes revenue at point of sale
when risks and rewards are transferred to the customer,There are no contract revenue agreements that would need to be recognized over
time and the point of risks and rewards being transferred is very clear.
Payment
Terms
Our
payment terms vary per segments; export sales made from within South Africa are subject to prepayment, where accounts are granted,
they generally have payment terms of 30 days from statement and sales made inside the USA are 45 to 60 days. The time between a
customer’s payment and the receipt of funds is not significant. Our contracts with customers do not result in significant
obligations associated with returns, refunds or warranties. Our payment terms are generally fixed and do not include variable
revenues.
e. Research
and development costs
All research and development expenses
are expensed as incurred and are included in operating expenses.
8
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f. Earnings
per share
Basic earnings per share
Basic earnings (loss) per share are
computed based on the weighted average number of ordinary shares outstanding during each year.
g. New Accounting Standards Adopted
In November 2019, the Financial
Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2019-11, Codification Improvements
to Topic 326, Financial Instruments-Credit Losses which amends ("ASU") No. 2016-13 Measurement of Credit Losses on Financial
Instruments ("ASU 2016-13") and modifies or replaces existing models for impairment of trade and other receivables, debt securities,
loans, beneficial interests held as assets, purchased-credit impaired financial assets and other instruments. The new standard requires
entities to measure expected losses over the life of the asset and recognize an allowance for estimated credit losses upon recognition
of the financial instrument. For the Group, this standard is effective December 15, 2022, with early adoption permitted. Entities are
required to apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first
reporting period in which the guidance is adopted. The impact of this was assessed on accounts receivable and loans receivable, and the
impact was not material for this reporting period.
Allowance for Credit Losses
– Accounts Receivable
The allowance for
credit losses required under ASC 326 is a valuation account that is deducted from the accounts receivables’ amortized cost basis
on the Group’s condensed consolidated balance sheets. Our accounts receivables are generated from the sales revenue. The Company
elected to estimate expected losses using an analytical model based on methods that utilize the accounts receivable aging schedule. This
analytical model incorporates historical loss activity, geographic location, customer-specific information, collection terms and customer
amounts. The Company evaluates the estimated allowance on an aggregate basis as each individual account receivable shares similar risk
characteristics. Upon adoption of ASC 326 using the modified retrospective transition method and as of May 31, 2023, the Company determined
that the allowance for credit losses, if any, is immaterial as of adoption date and the Company will continue to evaluate the accounts
receivable portfolio on an on-going basis.
All other ASUs issued and not yet
effective for the three months ended May 31, 2023, and through the date of this report, were assessed and determined to be either not
applicable or are expected to have minimal impact on the Company’s financial position or results of operations.
h. Reporting segments
The Group has two main reportable segments that comprise
the structure used by the Group executive committee (Exco) to make key operating decisions and assess performance. The Group’s reportable
segments are operating segments that are differentiated by the activities that each undertakes and the products they manufacture and market
(referred to as business segments). Each business utilizes the same technology, manufacturing and marketing strategies, and differ by
geographical region only.
The Group evaluates the performance of its reportable segments
based on operating profit after re-measurement items. The Group accounts for inter-segment sales and transfers as if the sales and transfers
were entered into under the same terms and conditions as would have been entered into in a market-related transaction.
The financial information of the Group’s reportable
segments is reported to the Exco for the purpose of making decisions about allocating resources to the segment and assessing its performance.
Operating segments are reported
in a manner consistent with the internal reporting provided to the Exco who is responsible for allocating resources and assessing the
performance of the operating segments.
9
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Medinotec Inc's qualitative application
of the segmental accounting policy
The Exco is the Group’s chief
operating decision-maker. Management has determined the operating segments based on the information reviewed by the Exco for the purposes
of allocating resources and assessing performance.
The Exco considers the business
from a mainly a geographic perspective since products sold in all territories are the same. Geographically, management considers the performance
within the United States and Outside the United States. From a product sales perspective, management separately considers the activities
in these geographies on a segmental basis. The Group manufactures and sells medical devices in two divisions namely Sales inside the USA (Domestic) and Sales outside the USA (International).
Fair
Value Measurements
The
Group reports all financial assets and liabilities and nonfinancial assets and liabilities that are
recognized or disclosed at fair value in the Condensed Consolidated financial statements on a recurring basis. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative
guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The
hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1
measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three
levels of the fair value hierarchy are as follows:
Level
1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the Group has the ability
to access at the measurement date.
Level
2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices
for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the related assets or liabilities.
Level
3—Inputs are unobservable inputs for the asset or liability.
The
level in the fair value hierarchy within which a fair value measurement in its entirety falls is based on the lowest-level input that
is significant to the fair value measurement in its entirety.
At
May 31, 2023 and February 28, 2023, all of the Group’s cash and cash equivalents, trade accounts receivable
and trade accounts payable were short term in nature, and their carrying amounts approximate fair value. Our current and long-term
debt arrangements are classified as level 2 financial instruments.
10
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Property,
plant and equipment
Property,
plant and equipment consist of the following:
May 31
2023
$
Feb
28,
2023
$
Leasehold improvement
17,791
19,134
Computer equipment
142,017
152,731
Computer software
54,443
58,551
Office equipment
6,763
7,273
Furniture and fixtures
96,312
103,578
Motor vehicles
11,573
12,446
Small assets
13,154
14,146
Plant and machinery
1,026,722
1,104,182
Laboratory equipment
232,457
249,995
Total cost
1,601,232
1,722,036
Foreign currency adjustment
93,319
90,379
Total accumulated depreciation
( 1,333,827
)
( 1,405,542
)
Total
$
360,724
$
406,873
Depreciation expense totaled $ 18,665 for
the three months ending May 31, 2023 and $ 23,023 for
the three months ending May 31, 2022.
Additions
of $ 20,093 were made
to Plant and machinery for the three months ending May 31, 2022. There were no additions for the three months ending May 31, 2023. There
were no disposals in either of these periods.
The movement in property, plant
and equipment from February 28, 2023 to May 31, 2023 of $ 46,149 is due to foreign currency adjustments.
Other
current assets
May 31,
2023
$
February 28,
2023
$
Tax and statutory refunds
118,685
166,643
Prepayments
67,488
—
Total
$ 186,173
$ 166,643
Inventories
Inventory
consists of the following:
May
31
2023
$
February
28 2023
$
Finished Goods
122,968
59,004
Raw Material
321,407
288,030
Work in progress
70,087
34,356
Less
provisions for obsolescence
( 25,186 )
( 27,086 )
Total
$ 489,275
$ 354,304
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Loans
payable
Loans
from related parties
Loans payable consist of a $ 1,991,821
unsecured loan from the prior parent entity of DISA Medinotec Proprietary Limited incorporated in South Africa called Minoan Medical
Proprietary Limited. This loan originated to fund working capital and capex expansions of DISA Medinotec Proprietary Limited during the
developmental and startup phase. After the acquisition of DISA Medinotec Proprietary Limited Group assumed this liability. The Group
has a period of 3 years after any IPO date or a date at which the company starts trading on a recognizable exchange to repay the loan.
During these 3 years the loan will carry interest at the prevailing prime lending rate of the time.
The prevailing prime lending rate
on the quarter ending May 31, 2023 in South Africa is 11.75 % . The interest charged for the quarter was $ 55,806 and a 1% movement in the
interest rates constitutes a value of $4,980 on a quarterly basis . The interest rate chargeable is a guideline determined by the South
African Reserve Bank and gets utilized by financial institutions to determine the financial gain they may derive from a loan. The Prime
rate is therefore an arm’s length transaction and justifiable rate that can be applied to a loan within the borders of the Republic
of South Africa and therefore complies with the arm’s length definitions in ASC 850-10-50-6.
The loan can be settled in cash or
any other form of equivalent, it’s important to note that the South African Reserve Bank would need to approve any settlement made
by Medinotec Inc on behalf of its subsidiary DISA Medinotec Proprietary Limited.
Minoan Medical Proprietary Limited’s
ultimate beneficial owner is the CEO of the Group Dr. Gregory Vizirgianakis and is used to hold his medical investments and exports of
which DISA Medinotec Proprietary Limited was one of these investments before it got transferred into the Group. Pieter van Niekerk also
serves as a director on Minoan Medical Proprietary Limited.
Operational charges are charged to the
Minoan Medical loan account.
May 31
2023
$
February 28, 2023
$
Minoan Medical Proprietary Limited
1,991,821
1,862,793
Minoan Capital Proprietary Limited
254
273
Total loans payable
1,992,075
1,863,066
Minoan Medical Proprietary Limited:
This is an unsecured loan
entered into during the 2016 fiscal year which is repayable at the end of 3
years after any Initial Public Offering (IPO). This
note will become due in full on 31 March 2026. The loan carries interest at the prevailing prime lending rate of the time .
The prevailing prime lending rate on the quarter ending May 31, 2023 in South Africa is 11.75 % .
The interest charged for the quarter ending May 31, 2023 was $ 55,806 . Interest charged for the quarter ending May 31, 2022 was $ 35,243 at
the then prevailing interest rate of 8.25 % .
The Group has the option to settlement
in cash or equivalents, and any settlements of this loan account by Medinotec
Inc on behalf of its wholly owned subsidiary would require South African Reserve Bank Approval.
Minoan
Capital Proprietary Limited:
This
is an unsecured, interest free loan with no fixed terms of repayment.
Minoan
Medical and Minoan Capital are related parties of the Condensed Consolidated entities as the CEO Dr. Gregory Vizirgianakis has
common control.
12
Table of Contents
Accounts
payable and accrued expenses
Accounts
payable consist of the following:
May 31
2023
$
February 28,
2023
$
Trade accounts payable
44,800
53,615
Accrued payroll, payroll taxes and vacation
16,137
6,995
Royalties
payable
18,441
10,701
Other
payables
—
—
Total
$
79,378
$
71,311
Commitments
a. Leases
and deferred rent
The Group lease office and warehouse
spaces under noncancelable operating lease agreements, which expire through 2023, after which the lease will continue on a month-to-month
basis. The Group is required to pay property taxes, insurance, and normal maintenance costs for certain of these facilities and will
be required to pay any increases over the base year of these expenses on the remainder of the Consolidated entities facilities.
Certain of the Group’s operating leases contain
predetermined fixed escalations of minimum rentals during the lease term. For these leases, the Group recognize the related rental
expense on a straight- line basis over the life of the lease from the date the Group takes possession of the office and records the
difference between amounts charged to operations and amounts paid as deferred rent. As of May 31, 2023 $ 0 had
been accrued.
Future
minimum lease payments under noncancelable operating leases as of May 31, 2023, are $ 0 as the lease will continue on a month-to-month
basis.
Rental
expense for operating leases for the quarter ended May 31, 2023 was $ 7,883 and $ 9,552 for the quarter ending May 31,2022.
b. Litigation
From time to time, the Group may
become involved in various legal proceedings in the ordinary course of its business and may be subject to third-party infringement claims.
In the normal course of business,
the Group may agree to indemnify third parties with whom they enter into contractual relationships, including customers, lessors, and
parties to other transactions with the Group, with respect to certain matters. The Group has agreed, under certain conditions, to hold
these third parties harmless against specified losses, such as those arising from a breach of representations or covenants, other third-party
claims that the Group’s products, when used for their intended purposes infringe the intellectual property rights of such other
third parties, or other claims made against certain parties. It is not possible to determine the maximum potential amount of liability
under these indemnification obligations due to the Group’s limited history of prior indemnification claims and the unique facts
and circumstances that are likely to be involved in each claim.
From time to time, the Group is subject
to various claims that arise in the ordinary course of business. Management believes that any liability of the Condensed Consolidated
entities that may arise out of or with respect to these matters will not materially adversely affect the financial position, results of
operations, or cash flows of the Group.
At reporting date there is no known
material litigation or claims against the Group.
13
Table of Contents
Stockholders’
equity
a. Authorized
and issued stock by period
Authorized:
As
of May 31, 2023, Medinotec Inc., the parent Company, had 188,266,250 shares of common stock authorized and available to issue for
purposes of satisfying conversion of preferred stock, the exercise of warrants, the exercise and future grant of common stock options,
and for purposes of any future business acquisitions and transactions.
As
of May 31, 2023, Medinotec Inc., the parent Company, had 20,000,000 shares of preferred stock authorized and available to issue.
Issued
and outstanding shares
May 31
2023
February
28, 2023
Common stock
$
11,734
$
11,734
Common stock additional paid in capital
$
3,296,391
$
3,296,391
Income
taxes
a. Provision
for income taxes
The
components of income tax expense are as follows:
May 31
2023
$
May 31, 2022
$
Tax from operations
Current
Deferred/future
Foreign
( 1,969 )
( 20,817
)
Total
$
( 1,969 )
$
( 20,817
)
The reconciliation of income tax expense (benefit) computed at the Federal
statutory tax rates to income tax expense (benefit) is as follows:
May
31
2023
$
May
31, 2022
$
Tax
at federal statutory rates
21 %
21 %
Deferred
taxes and timing differences
31 %
25 %
Effective
tax rate
10 %
46 %
No uncertain tax positions have been identified for the current or comparative
period.
b. Deferred
taxes/Future income tax assets and valuation allowance
Significant
components of the Group’s future tax assets are as follows:
May 31
2023
$
February 28,
2023
$
Leave pay provision
2,292
3,102
Tax
credits assessed by tax authorities
95,888
105,849
Provision
for Royalties
4,979
—
Total
103,159
108,951
Net deferred/future tax asset
$
103,159
$
108,951
Deferred tax assets refer to
assets that are attributable to differences between the Condensed Consolidated financial statement carrying amounts of existing
assets and liabilities and their respective tax bases. Deferred tax assets in essence represent future savings of taxes that would
otherwise be paid in cash. The realization of the deferred tax assets is dependent upon the generation of sufficient future taxable
income, including capital gains. If it is determined that the deferred tax assets cannot be realized, a valuation allowance must be
established, with a corresponding charge to net income. The current quarter, ending May 31, 2023 is the first quarter that the
Group has traded at a profit and therefore we can expect the tax losses to be realized over time as the profits build up.
14
Table of Contents
Related
party transactions
Related
Party Summary
Name
Relationship
with the Medinotec Group of Companies
Related
transactions with the Medinotec Group of Companies
Related
Directors with the Medinotec Group of Companies
Related
Owners with the Medinotec Group of Companies
Minoan
Medical Proprietary Limited
Medical
investment company controlled by Dr Gregory Vizirgianakis
Related
Party Loan and Sales
Dr
Gregory Vizirgianakis
Pieter
van Niekerk
Dr
Gregory Vizirgianakis is the ultimate beneficial owner
Minoan
Capital Proprietary Limited
Property
investment company controlled by Dr Gregory Vizirgianakis
Related
party loan
Rental
Expenses
Dr
Gregory Vizirgianakis is the ultimate beneficial owner
DISA
Vascular Distribution Proprietary Limited trading as DISA Lifesciences
Distributor
appointed by DISA Medinotec Proprietary Limited for Africa
Sales
Income
Pieter van
Niekerk – Serves as independent non-executive according to distribution agreement.
Pieter van
Niekerk resigned as a non-executive director on October 14, 2022 and therefore the related party relationship ceased to exist on
the same date.
n/a
external third party
Medinotec
Capital Proprietary Limited
The
African holding company of the Medinotec Group of Companies
Related
party loan payable to Minoan Capital
Dr
Gregory Vizirgianakis
Pieter
van Niekerk
Medinotec
Incorporated in Nevada is the 100% ultimate parent entity
DISA
Medinotec Proprietary Limited
The
African operating and manufacturing company
Related
party loan with Minoan medical
Operational
income and expenses with Minoan Medical
Dr
Gregory Vizirgianakis
Pieter
van Niekerk
Medinotec
Incorporated in Nevada is the 100% ultimate parent entity
Medinotec
Incorporated Nevada
Ultimate
parent of Medinotec Capital and DISA Medinotec
All
of the above for its related subsidiaries
Dr
Gregory Vizirgianakis
Pieter
van Niekerk
Joseph
P Dwyer
Stavros
Vizirgianakis
This
is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
Medinotec
Group of Companies
The
Consolidated group name of Medinotec Incorporated, Medinotec Capital Proprietary Limited and DISA Medinotec Proprietary
Limited
above
for its related subsidiaries
Dr
Gregory Vizirgianakis
Pieter
van Niekerk
Joseph
P Dwyer
Stavros
Vizirgianakis
This
is the entity owned by the shareholders and primarily controlled by Dr Gregory Vizirgianakis and his Brother Stavros Vizirgianakis
Pieter
van Niekerk
Chief
financial officer of the Medinotec Group of Companies
Transactions
relating to mutual entities disclosed above
Related
directorships disclosed above
Minority
Shareholder in Medinotec Inc
Gregory
Vizirgianakis
Chief
Executive officer of the Minoan Group of Companies
Brother
of Stavros Vizirgianakis
Transactions
relating to mutual entities disclosed above
Related
directorships disclosed above
Shareholder
in Medinotec Inc and Kingstyle investments.
Stavros
Vizirgianakis
Non-Executive
director of the Medinotec Group of companies
Brother
of Gregory Vizirgianakis
Transactions
relating to mutual entities disclosed above
No
Related other Directorships in Medinotec Group of Companies
n/a
Joseph
Dwyer
Non-Executive
director of the Medinotec Group of companies
Transactions
relating to mutual entities disclosed above
No Related
other Directorships in Medinotec Group of Companies
n/a
15
Table of Contents
a. Rent
DISA Medinotec Propriety Limited
leases commercial buildings from Minoan Capital Proprietary Limited (“Minoan Capital”). Minoan Capital is fully owned by the
Chief Executive Officer of the Medinotec Group of Companies, Dr. Gregory Vizirgianakis. Pieter van Niekerk, CFO of the Medinotec Group
of Companies, also serves as a director on Minoan Medical Proprietary Limited.
The lease agreement has expired
and the lease is currently continuing on a month-to-month basis.
Set forth below is a table
showing the Group’s rent paid and accounts payable for the quarters ended May 31, 2023 and 2022, with
Minoan Capital:
May
31
2023
$
May
31
2022
$
Rent expense
7,883
9,552
Accounts payable
—
3,823
Rent is comparable to rent charged for
similar properties in the same relative area. The Group does market research of a Minimum and a Maximum rental value within the area at
every renewal of the rental agreement to ensure this is market related, this exercise is undertaken together with a registered property
agent who has the appropriate knowledge of the area.
b. Loan Payable
Loans payable consist of a $ 1,991,821 unsecured loan from the prior
parent entity of DISA Medinotec Proprietary Limited incorporated in South Africa called Minoan Medical Proprietary Limited. This loan
originated to fund working capital and capex expansions of DISA Medinotec Proprietary Limited during the developmental and startup phase.
After the acquisition of DISA Medinotec Proprietary Limited Group assumed this liability. The Group has a period of 3 years after any IPO date or a date at which the
company starts trading on a recognizable exchange to repay the loan. During these 3 years the loan will carry interest at the prevailing
prime lending rate of the time.
The prevailing prime lending rate
on the quarter ending May 31, 2023 in South Africa is 11.75 % . The interest charged for the quarter was $ 55,806 and a 1% movement in the
interest rates constitutes a value of $4,980 on a quarterly basis . The interest rate chargeable is a guideline determined by the South
African Reserve Bank and gets utilized by financial institutions to determine the financial gain they may derive from a loan. The Prime
rate is therefore an arm’s length transaction and justifiable rate that can be applied to a loan within the borders of the Republic
of South Africa and therefore complies with the arm’s length definitions in ASC 850-10-50-6.
The loan can be settled in cash or
any other form of equivalent, it’s important to note that the South African Reserve Bank would need to approve any settlement made
by Medinotec Inc on behalf of its subsidiary DISA Medinotec Proprietary Limited.
Minoan Medical Proprietary Limited’s
ultimate beneficial owner is the CEO of the Group Dr. Gregory Vizirgianakis and is used to hold his medical investments and exports of
which DISA Medinotec Proprietary Limited was one of these investments before it got transferred into the Group. Pieter van Niekerk also
serves as a director on Minoan Medical Proprietary Limited.
16
Table of Contents
Operational charges are charged to the
Minoan Medical loan account.
May 31
2023
$
February 28, 2023
$
Minoan Medical Proprietary Limited
1,991,821
1,862,793
Minoan
Capital Proprietary Limited
254
273
Total
$
1,992,075
$
1,863,066
c. Sales
to commonly controlled entities
The Group sells a significant amount to
DISA Vascular Distribution t/a DISA Life Sciences.
DISA Life Sciences is the main distributor
of the products of DISA Medinotec Proprietary Limited in South Africa which subject to a distribution agreement. The company is owned
by an independent third party but according to the distribution agreement DISA Life sciences needs to allow a Director of DISA Medinotec
Proprietary Limited registered in South Africa to become a board member in an Non – Executive role to oversee that good corporate
governance is maintained by the company and that the good name of DISA Medinotec Proprietary Limited is not brought into disrepute. Currently,
the Board position is held by Mr. Pieter van Niekerk, who is also the CFO of the Medinotec Group of Companies. Mr. van Niekerk has no
operational involvement and also no financial interest or benefit paid to him for assuming the role of independent non-executive of the
company.
Apart from this non-executive directorship
position there is no other related party ties to DISA Life Sciences. On October 14, 2022, Mr. Pieter van Niekerk resigned as a director
of DISA Life Sciences to focus on other commitments, on this same date the DISA Life Sciences ceased to be a related party to DISA Medinotec.
DISA Life Sciences is one of the
top 5 largest distributors of medical devices in the Republic of South Africa and therefore DISA Medinotec Proprietary Limited registered
in South Africa utilizes their sales footprint for cost efficiencies. All trading is considered to be at arm's length.
Minoan Medical Proprietary Limited’s
ultimate beneficial owner is the CEO of the Medinotec Group of Companies Dr. Gregory Vizirgianakis and is used to hold his medical investments
and exports of which DISA Medinotec Proprietary Limited was one of these investments before it got transferred into the Medinotec Group
of Companies. All sales made to Minoan Medical Proprietary Limited were utilized to build the export market for DISA Medinotec South Africa.
In the future these sales will be made directly to the export countries without utilizing Minoan Medical Proprietary Limited as an intermediate.
These sales were made on the same terms as the DISA Life Sciences distribution agreement. Pieter van Niekerk also serves as a director
on Minoan Medical Proprietary Limited.
The distribution agreement between
DISA Life Sciences and DISA Medinotec Proprietary Limited was entered into after a market feasibility study was conducted. Medical devices
are registered with a fixed maximum sales price, which is regulated within South Africa. It was determined that the profit split allowed
between the two companies would be based on this approved market price, where DISA Life Sciences would be allowed only to have 10% of
the total sales value and DISA Medinotec Proprietary Limited the remaining balance.
This profit split was determined by a benchmark
study that was completed by an external firm who compared the profit margins of a distribution/wholesale business. The allowed profit
margin was concluded as being within the appropriate benchmark and therefore arm’s length. The data base used to determine the market
related margin is the Worldwide Private Company Data Base from Thomson Reuters. Therefore, this agreement is deemed to be market related
and at arm’s length and compliant with. ASC 850-10-50-6 and ASC 850-10-50-5.
17
Table of Contents
Sales
between the entities are settled on a regular basis and there is no long outstanding Accounts receivable.
Set
forth below is a table showing the Group’s sales and accounts receivable for the quarter ended May 31, 2023 and year ended May
31, 2022 with DISA Life Sciences.
May
31
2023
$
May
31
2022
$
DISA
Life Sciences
Sales
—
125,523
Accounts
receivable
—
1,242
These
transactions occurred in the normal course of operations and are measured at the exchange amount, which is the amount of the consideration
established and agreed to by the related parties.
Loans
and notes receivable
May 31
2023
$
February 28, 2023
$
Innovative
outcomes
605,277
605,130
In furtherance of our efforts to expand
into the United States, on September 16, 2022, we entered into an unsecured revolving line of credit to lend Innovative Outcomes, Inc.
up to $ 750,000 , of which $ 585,000 has been drawn as of May 31,2023.
Innovative Outcomes is a company in Little
Rock, Arkansas, and we plan to enter into an arrangement with the company for the marketing and distribution of various products. The
funds from our line of credit will be used by Innovative Outcomes for setting up infrastructure for the products, including a headquarters
for sales representatives, an administrative hub and customer services to handle all back-office items, setting up a sales system and
marketing program, warehousing of inventory in a licensed warehouse, setting up distribution capabilities, marketing activities and training
activities.
•
Maximum
allowed according to Revolving Credit Agreement: $ 750,000
•
Amounts
advanced shall bear interest at a per annum rate equal to eight percent ( 8.0 % ), compounded monthly. In the event of a default, any
amounts advanced will bear interest at (12%) per annum .
•
Maturity:
September 30, 2024
•
Unsecured
•
Amount
drawn: $ 585,000
The entity considers the performance of the loan to
Innovative Outcomes against the development of the related infrastructure to support sales into the inside the USA Sales segment and then
determines the allowance for credit loan losses. Since the segment showed significant growth over the past quarter and the growth is expected
to continue in the USA sales territory management deems this loan made for the intention of building the USA market as being fully performing
at the moment. There has also not been any material breach in the contract for the quarter under review and therefore the loan is classified
as fully performing at the moment and no credit loss is provided against it. Management conducts this assessment once a quarter.
18
Table of Contents
Reporting Segments and Disaggregated Revenue
The
Group has two main reportable segments that comprise the structure used by the Group executive committee (Exco) who
are considered Chief Operating Decision Makers, to make key operating decisions and assess performance. The Group’s reportable segments
are operating segments that are differentiated by the activities that each undertakes and the products they manufacture and market (referred
to as business segments). Each business utilizes the same technology, manufacturing and marketing strategies, but differ by geographical
region only.
The
Exco is considered to be the Chief Operating Decision Makers and considers the business from a geographic perspective since products
sold in all territories are the same. Geographically, management considers the performance within the United States and Outside the United
States. From a product sales perspective, management separately considers the activities in these geographies on a segmental basis. The
Group manufactures and sells medical devices in two divisions namely Sales inside the United States of America (Domestic) And Sales outside
the USA (International).
Income statement measures applied
Q1 2024
Q1 2023
May
31, 2023
May 31, 2022
$
$
Revenue
Inside
United States of America
174,920
—
Outside
United States of America
241,288
196,472
Total
416,208
196,472
Medinotec Inc Group Consolidated Three months ended (unaudited)
Outside United States of America
May-23
May-22
Cape Cross NC Catheter
42,229
28,303
Cape Cross PTCA Catheter
45,283
70,285
Trachealator Catheter
145,037
81,903
Components
8,740
15,981
Sub Total
241,288
196,472
Inside United States of America
May-23
May-22
Trachealator Catheter
174,920
—
Total Group Sales
416,208
196,472
33 %
(2023:
64 % )
of the Group's total revenue is derived from a single customer in the distribution environment
in South Africa namely
DISA Vascular Distribution Proprietary Limited t/a DISA Life Sciences.
Depreciation and amortization
May 31
2023
$
May 31
2022
$
Inside United States of America
—
—
Outside United States of America
18,665
23,028
Subsequent events
Subsequent to the quarter ended May 31,
2023 the group obtained The Depository Trust and Clearing Corporation (DTCC) approval.
DISA Medinotec Proprietary Limited also
entered into a new lease agreement with the landlord, the terms of this lease are the same as the lease that expired and valid for a period
of 3 years.
Except for the above-mentioned events,
there were no subsequent events for the quarter ending May 31, 2023.
19
Table of Contents
Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking
Statements
Certain
statements, other than purely historical information, including estimates, projections, statements relating to our business plans,
objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are
identified by the words “believes,” “project,” “expects,” “anticipates,”
“estimates,” “intends,” “strategy,” “plan,” “may,” “will,”
“would,” “will be,” “will continue,” “will likely result,” and similar
expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking
statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of
complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions
that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements.
Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which
could have a material adverse effect on our operations and future prospects on a Consolidated basis include, but are not
limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition,
and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking
statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise
publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further
information concerning our business, including additional factors that could materially affect our financial results, is included
herein and in our other filings with the SEC.
Business Overview
Medinotec
Inc. established Medinotec Capital Proprietary Limited in South Africa as a wholly owned subsidiary, which in turn acquired DISA Medinotec
Proprietary Limited, after successfully proving that a private placement of a minimum of $3 Million was feasible.
Medinotec
Capital Proprietary Limited acquired DISA Medinotec Proprietary Limited (therefore establishing the Medinotec Group of Companies), a
South African based medical device manufacturing and distribution company.
In
2018, DISA Medinotec Proprietary Limited developed its most innovative product to date – the Trachealator. This award-winning (Medical
Design Excellence Awards – Gold Winner 2021) balloon catheter was developed to address an as-yet unmet supply need in the specialty
of advanced airway management, more specifically tracheal dilation. That makes this innovative product in our opinion a world first in
its ability to dilate a patient’s airway while maintaining ventilation to the patient without obstructing his/her airway.
This
life-saving device has quite literally changed the way that tracheal and, to a degree, bronchial stenosis, is managed in extremely ill
patients. This is especially true in a post Covid-19 world where tracheal stenosis due to extended tracheal intubation is becoming an
ever more frequent pathology encountered by surgeons, who, thanks to The Medinotec Group of Companies, they now have a safe and effective
tool at their disposal.
The
Medinotec Group of Companies is currently in management’s opinion considered a global leader in tracheal non-occlusive airway dilation
technology. This belief of management was formed on the fact that there are a number of airway dilation balloons that are offered for
the management of tracheal stenosis, but to our knowledge all of them are occlusive in nature. The fact that the Trachealator is a non-occlusive
airway solution, allowing for continuous ventilation during dilation, results in management believing that we could be regarded as a
global leader in this technology.
20
Table of Contents
Other
products manufactured by The Medinotec Group of Companies include:
•
The “Cape Cross
PTCA Catheter” The Medinotec Group of Companies also designed and developed a range of semi-compliant coronary PTCA balloon
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 balloons in the market. A PTCA balloon catheter (also known as a Plain Old Balloon Angioplasty [“POBA”]
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.
•
Cape “ Cross Non-Compliant
(“NC”) ” Catheter 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 placed. The NC catheter balloon
part is then inflated inside the stent. This is done to “seat” the stent inside the artery wall. 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 “Lamprey”
Suction Dissector, a surgical tool used in the fields of neurosurgery, ear, nose and throat (“ENT”) surgery and general
surgery to combine the processes of suctioning blood out of the surgeon’s field of view while allowing him/her to dissect sensitive
structures without having to change instruments.
•
The Aortic Perfusion and
Dilation Catheter, a non-occlusive perfusion balloon to allow the expansion of the aortic valve (“BAV” or Balloon Aortic
Valvuloplasty) without impeding the cardiac output, which is currently in the mid stages of research and development and could potentially
be used to post-dilate the artificial valve in Transcatheter Aortic Valve Implantation (“TAVI”), a rapidly growing market,
without the need for pacing.
•
A highly specific, niche
Chronic Total Occlusion (“CTO”) Catheter of 1mm in diameter. This micro balloon catheter addresses an extremely specific
market need for difficult coronary cases and will cement our position as one of the leading specialized coronary balloon catheter
manufacturers in the world.
•
A new self-expanding, temporary,
silicone Tracheal Stent to be used in conjunction with the Trachealator in the treatment of tracheal stenosis. The complimentary
nature of this product will build on our current expertise in the field of advanced airway management.
The
following distinct and finite developmental phases / stages are applicable to all our product pipeline, namely:
1)
R&D
2)
Pre-production prototyping
3)
Testing
4)
Production
5)
Clinical trials
6)
MDR/CE Mark accreditation
7)
Local marketing &
selling
8)
International sales outside
the US
9)
FDA 510 (k) approval
10)
Sales to
the United States.
21
Table of Contents
The
products described have reached the following stages:
Trachealator:
The only
outstanding phase is the commencement of material sales into the United States. All the necessary preparations have been made (e.g.,
renting offices, hiring sales and admin staff) and it is therefore envisaged that sales will begin once all paperwork and compliance
matters are addressed. While unlocking the United States of America as a commercial market for the product various Compliance documents
and customer registration were completed, these customers are performing their own in-house clinical overviews of the product. The
first order for $10,000 was placed during December, 2023 which means commercialization in the United States of America has started.
Cape Cross PTCA Catheter:
FDA 510(k)
approval still needs to be obtained.
Cape Cross NC Catheter:
FDA 510(k)
approval still needs to be obtained.
Lamprey Suction Dissector:
R&D, Testing, Pre-Production
Prototyping, Production, Clinical Trials, and CE Marking have all been completed. Commercialization of this product have been paused
in order to prioritize other products with better commercial prospects.
Aortic Perfusion & Dilatation Catheter:
R&D,
Testing, Pre-Production Prototyping, Testing, Production, Clinical Trials, Application for MDR CE Mark Accreditation has been submitted.
Micro CTO Catheter:
R&D, Testing, Pre-Production
Prototyping
Tracheal Stent:
R&D
Medinotec
Inc. was formed in Nevada and is at the moment a holding company, but it is expected to facilitate the sales of all products in the United
States directly in the near future. Therefore, over time, as we implement our business plan and realize commercial operations in the
United States, we believe Medinotec Inc. will become the primary operating company within the Medinotec Group of Companies and the South
African DISA Medinotec Proprietary Limited will be the manufacturing platform for the operations in the United States and other countries.
Results
of Operations for the Three Months ended May 31, 2023 and 2022
The Condensed Consolidated Medinotec Group of
Companies’ revenue for the quarter ended May 31, 2023 was $416,208 compared to $196,472 for the prior year ending May 31,
2022. US sales grew by $174,920 in the first quarter of 2023 demonstrating initial success the Groups initiatives to expand its
sales territory into the United States.
Revenue
The Condensed Consolidated Medinotec Group of
Companies’ revenue for the quarter ended May 31, 2023 was $416,208 compared to $196,472 in revenue in the comparative quarter
for the prior year.
The
revenue was up in comparison to the prior year with $219,736 for the quarter. The reason for the higher sales growth was due to demand
in the South African region and replenishing of inventory levels by hospitals as well as increased interest and demand in the products
of the Medinotec Group of Companies internationally especially in the United States of America. The growth presented includes the following
negative and positive economic and internal issues:
• DISA
Medinotec trades out of South Africa and its functional currency is the South African Rand, The Rand weakened from an average conversion
rate of 1$: 14.9 (Q1: 2022) to 1$: 18.6 (Q1: 2023) against the US Dollar. This translated to a decrease of 25% due to dollar strength
when the Rand was converted for reporting purposes, which means a decrease of approx. $60,172 for the quarter in sales when converted
to dollars from Rands. The Rand was very volatile against the US Dollar especially during the trailing twelve months.
• During
the quarter ending May 31, 2023, the group produced its first sales as it is in the process of entering the sales market of the United
States of America sales for this period was $174,920 compared to zero for the quarter ending May 31, 2022. This is in line with the Groups
strategy to grow expenses in hard currencies namely Dollar and Euro and to maintain expenses in the weaker Rand based currency.
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This
table indicates the sales per product as a breakdown of the total revenue balance:
Medinotec Inc Group Consolidated Three months ended
(unaudited)
Outside United States of America
May-23
May-22
Cape Cross NC Catheter
42,229
28,303
Cape Cross PTCA Catheter
45,283
70,285
Trachealator Catheter
145,037
81,903
Components
8,740
15,981
Sub Total
241 288
196,472
Inside United States of America
May-23
May-22
Trachealator
174,920
—
Total Group Sales
416,208
196,472
Revenue
generated by affiliations to related parties were as follows:
Sales to Minoan Medical ceased during the quarter
ended May 31, 2023 because DISA Medinotec now employs its own international sales and marketing manager, which was outsourced in the past.
Minoan Medical primarily facilitated export business on behalf of DISA Medinotec.
The
profit percentage on these related party transactions was determined by a benchmark study that was completed by an external firm who
compared the profit margins of a distribution/wholesale business. The allowed profit margin was concluded as being within the appropriate
benchmark and therefore arm’s length. The data base used to determine the market related margin is the Worldwide Private Company
Data Base from Thomson Reuters. Therefore, this agreement is deemed to be market related and at arm’s length and compliant with.
ASC 850-10-50-6 and ASC 850-10-50-5.
Cost
of Goods
The Group recorded cost of goods of $98,498 for the
quarter ending May 31, 2023 up from $86,022 for the quarter ending May 31, 2022.
The
most material change in the increase of cost of goods is the function that it is directly relatable to sales and therefore the cost of
goods followed the same upward trend as sales.
The increase in the gross profit percentage from 56%
in the quarter ending May 31,2022 to 76% for the period ending May 31,2023 indicates a shift in production to include the sale of more
complex products into the product mix, therefore the production facility is approaching its fuller capacity and the allocations of labor
and machine time to product costing per unit manufactured is expected to be fairer in comparison to the amount of units manufactured and
therefore will decrease cost of goods as more efficiencies are achieved.
DISA
Medinotec trades out of South Africa and its functional currency is the South African Rand, The Rand weakened from an average conversion
rate of 1$: 14.9 (Q1: 2022) to 1$: 18.6 (Q1: 2023) against the US Dollar. This translated to a decrease of 25% due to dollar strength
when the Rand was converted for reporting purposes and a positive estimated foreign exchange conversion of the $24,624 for the three
months ending May 31, 2023.
The
Group also increased production to build inventory volumes, and did not do any projects or trail products that would have increased the
cost of sales in the quarter, Inventory grew by $134,971 in the first quarter ending May 31, 2023.
There were no obsolete stock charges for the period
ending May 31, 2023. A provision for obsolescence of $25,186 was raised for the period ending May 31, 2023.
No
related party transactions are recorded in cost of sales for both quarters in 2023 and 2022.
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Operating
Expenses
The Group’s operating expenses were $276,860
for the quarter ended May 31,2023, up from $158,451 for the quarter ended May 31, 2022.
The
Rand weakened from an average conversion rate of 1$: 14.9 (Q1: 2022) to 1$: 18.6 (Q1: 2023) against the US Dollar. Therefore, this will
cause an expense decrease/improvement of 25% on the operating expenses due to dollar strength within the conversion rate applied. This
is estimated at a value of $ 39,612.
After
taking into account the effects of the foreign currency exchange, the remaining changes are mainly attributable to the Sales and Marketing
expenses that, together with the Compliance cost, showed a step cost increase to support the higher sales figure. Due to the amount of
territories entered during the year, there was also an increase in general compliance costs to list products in these countries and to
provide initial training and marketing into these countries.
Limited R&D activities were conducted in
this quarter due to the focus on rolling out the Trachealator in the United States which consumed all production and testing
resources. R&D activities are estimated to resume in quarter two.
General and administrative expenses showed significant
growth due increases in payroll costs in the United States, indemnity insurance and payments made to service providers as part of obtaining
our quotation on the OTCQX markets. Costs relating to the quotation on the OTC markets that will not be non-recurring in the future is
estimated at $30,000 for this quarter and all other costs will be repeated in the future.
One
of the major components that affects the operating expenses is the costs of compliance for the business. These costs increased significantly
as we started to grow our product portfolio and is expected to rise as we enter new sales territories. Certain costs are once off in
nature and others will be recurring this will be determined after the markets have been entered and all regulatory requirements met.
Medinotec Inc Group
Consolidated Three months ended (unaudited)
May 31, 2023
May 31, 2022
Compliance cost
60,263
79,699
*Compliance costs are included in the General and
Admin expenses line item
Sales
and Marketing expenses was insignificant due to Covid restrictions stopping travel and conferences, this started to normalize in FY 2022
and is expected to grow significantly in the later end of FY 2023 since the company is in the process of expanding its sales footprint
in the United States of America, the dedicated sales force will continue to grow as new territories pass the compliance hurdles.
Medinotec Inc Group
Consolidated Three months ended (unaudited)
May 31, 2023
May 31, 2022
Sales and Marketing
46,039
12,727
Related
party expenses included in operating expenses include Minoan Capital Proprietary Limited for Rental expenses in the third quarter ending
was $7,883. The related party rental expenses in the same quarter preceding year ending May 31, 2022 amounted to $9,552.
The
rent charge is comparable to rent charged for similar properties in the same relative area. The company does market research of a Minimum
and a Maximum rental value within the area at every renewal of the rental agreement to ensure this is market related, this exercise is
undertaken together with a registered property agent who has the appropriate knowledge of the area. ASC 850-10-50-6.
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Net
Profit / Loss
The Consolidated Medinotec Group of Companies for
the quarter ending May 31,2023 showed total net profit of $22,288 up from a loss of $63,087 from the prior quarter ending May 31,2022.
The change is mainly attributable to the higher sales
in the Unites States of America, Currency fluctuations, general and Admin expenses and sales and marketing expenses which showed a step
cost increase to support the higher sales figure, which includes the compliance costs discussed in operating expenses above which is expected
to continue to rise as new planned roll territories become active.
Related party expenses included in operating expenses
include Minoan Capital Proprietary Limited for Rental expenses in the first quarter ending May 31, 2023 was $7,883. The related party
rental expenses in the same quarter preceding year ending May 31, 2022 amounted to $9,552.
The rent charge is comparable to rent charged for
similar properties in the same relative area. The company does market research of a Minimum and a Maximum rental value within the area
at every renewal of the rental agreement to ensure this is market related, this exercise is undertaken together with a registered property
agent who has the appropriate knowledge of the area.
Interest
charged on the loan account for the quarter ended in favor of related party Minoan Medical Proprietary Limited was $55,806 for the quarter
ended May 31, 2023, up from $35,243 in the same quarter ending May 31, 2022. This change is attributable to an increase in the prime lending
rate and additional draw downs on the loan. The
interest rate chargeable is a guideline determined by the South African Reserve Bank and gets utilized by financial institutions to determine
the financial gain they may derive from a loan. The Prime rate is therefore an arm’s length transaction and justifiable rate that
can be applied to a loan within the borders of the Republic of South Africa and therefore complies with the arm’s length definitions
in ASC 850-10-50-6.
Liquidity
and Capital Resources
The Group, as of May 31, 2023, had total current assets
of $3,626,827 and total assets in the amount of $4,695,987. Total current liabilities as of May 31, 2023 was $80,966. Consolidated we
had working capital of $3,545,861 as of May 31, 2023.
As of February 28, 2023 the Group had total current
assets of $3,369,478 and total assets in the amount of $ 4,490,432. Consolidated total current liabilities as of February 28, 2023 was
$71,311. We had working capital of $3,298,167 as of February 28, 2023.
This increase was mainly due to growth in working
capital to support future sales growth and the successful private placement during which $3,467,500 was raised.
Cash Flow movements
Investing activities was flat during the quarter ended
May 31, 2023 and consumed $20,093 for the prior quarter ending May 31, 2022. The investment into property, plant and equipment peaked
in the 2021 Fiscal period as the plant reached maximum potential production its current form. The new focus will be on sales and compliance
activities as described in the operating expenses section during the first quarter ending May 31, 2023.
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Operating activities used cash of $274,718 during
the quarter ended May 31, 2023 compared to $68,207 for the same quarter ended 2022. This is mainly due to an increase in investment for
accounts receivables and inventory combined of $374,597 in order to support the sales initiative in the USA. Since sales significantly
increased quarter over quarter the terms of customers paying the business also increased with approximately $239,626 in accounts receivables.
As the business continues to grow the terms of customers will continue to affect the growth in accounts receivables while sales grow.
Financing activities provided cash of $77,620 during
the quarter ended May 31, 2023 and $3,509,301 for the same quarter in the prior year. The increase in the prior year is mainly due to
the private placement being concluded during which $3,467,500 was raised and capital raising fees of $ 169,375 was incurred. The increase
of $77,620 in the current quarter is due to an additional draw down on the related party borrowing from Minoan Medical Proprietary Limited.
The loan account in favor of Minoan Medical Proprietary Limited increased by $129,028 during the quarter ended May 31, 2023. In the prior
year the loan account increased by $211,114 in the quarter ended May 31, 2022. The loan account is used to fund operational requirements.
$594,243 was invested into a revolving credit facility with a company called Innovative Outcomes Inc during the 2022 financial year. Innovative
outcomes will utilize this facility to build a sales and infrastructure for the Group in the USA. The maximum drawdown allowed for this
facility is $750,000 and this facility constitutes a material part of the Group’s planned major capital commitments that existed
May 31, 2023. Other capital commitments will be for the purchase of inventory due to the group deciding to pursue potential distribution
contracts with principles to ensure a better product basket and enhance future cash flows.
We further expect to grow distribution revenues in
the future which will add to the product basket and ensure more revenue streams with mature profitable products that will complement our
in house developed products. We have cash available on hand and believe that this cash will be sufficient to fund operations and meet
our obligations as they come due within one year from the date these Condensed Consolidated financial statements are issued. In the event
that we do not achieve the revenue anticipated in its current operating plan, management has the ability and commitment to reduce operating
expenses as necessary. Our long-term success is dependent upon our ability to successfully raise additional capital, market our existing
services, increase revenues, and, ultimately, to achieve profitable operations.
Our
Condensed Consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of
assets and the satisfaction of liabilities in the normal course of business. We received FDA 510(k) approval through the
substantially equivalence process for Class II medical devices for our main product being the Trachealator in November 2021. As the
research and development phase of this product has been completed, we expect to see an increase in sales being realized against
expenditure incurred, the build out of the United States of America market is evident from the profit of 22,288 for the period ended
May 31,2023 vs the loss of 63,087 for the comparative period ending May 31,2022. A private placement was done in the wake of the
successful research and development and subsequent regulatory approval.
Off
Balance Sheet Arrangements
As
of May 31, 2023, there were no off-balance sheet arrangements.
Critical
Accounting Policies
Our critical accounting policies are set forth in
Note 2 to the Condensed Consolidated financial statements.
We are classified as an emerging growth company for
our first five fiscal years after obtaining an IPO since our gross revenues does not exceed $1.07 billion, we have not issued over $1
billion in non-convertible debt over three years, and have not elected to become a large accelerated filer. We also qualify as a small
reporting company since our public float is below $250 Million and less than $100 million in revenue. If a company qualifies as a “smaller
reporting company,” as defined in Item 10(f)(1) of Regulation S-K, it may choose to prepare it’s disclosure relying on scaled
disclosure requirements for smaller reporting companies in Regulation S-K. With the current information available the company expects
to remain an Emerging Growth Company for at least five years
Recently Issued Accounting Pronouncements
The Company does not expect the adoption of recently
issued accounting pronouncements to have a significant impact on the Company’s Consolidated results of operation, financial position
or cash flow.
Item 3. Quantitative
and Qualitative Disclosures about Market Risk
Not applicable
26
Table of Contents
Item 4. Controls
and Procedures
Disclosure
Controls and Procedures
We
conducted an evaluation, with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934, as amended, or the Exchange Act, as of May 31, 2023, to ensure that information required to be disclosed by us in the reports
filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in
the Securities Exchange Commission’s rules and forms, including to ensure that information required to be disclosed by us in the
reports filed or submitted by us under the Exchange Act is accumulated and communicated to our management, including our principal executive
and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required
disclosure. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of May 31, 2023,
our disclosure controls and procedures were not effective at the reasonable assurance level due to the material weaknesses identified
and described below.
Our
principal executive officers do not expect that our disclosure controls or internal controls will prevent all error and all fraud. Although
our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives and our principal
executive officers have determined that our disclosure controls and procedures are effective at doing so, a control system, no matter
how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the system are met. Further,
the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered
relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally,
controls can be circumvented if there exists in an individual a desire to do so. There can be no assurance that any design will succeed
in achieving its stated goals under all potential future conditions.
Remediation
Plan to Address the Material Weaknesses in Internal Control over Financial Reporting
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there
is a reasonable possibility that a material misstatement of our annual or interim Condensed Consolidated financial statements will
not be prevented or detected on a timely basis. Management identified the following three material weaknesses that have caused
management to conclude that, as of May 31, 2023, our disclosure controls and procedures, and our internal control over financial
reporting, were not effective at the reasonable assurance level:
1.
We do not have
written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial
reporting is a requirement of Section 404 of the Sarbanes-Oxley Act as of the period ending May 31, 2023. Management evaluated the
impact of our failure to have written documentation of our internal controls and procedures on our assessment of our disclosure controls
and procedures and has concluded that the control deficiency that resulted represented a material weakness.
2.
We do not have sufficient
segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of
all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation
of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Management
evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and
has concluded that the control deficiency that resulted represented a material weakness.
3.
Effective controls over the control environment were not maintained. Specifically,
a formally adopted written code of business conduct and ethics that governs our employees, officers, and directors was not in place. Additionally,
management has not developed and effectively communicated to employees its accounting policies and procedures. This has resulted in inconsistent
practices. Since these entity level programs have a pervasive effect across the organization, management has determined that these circumstances
constitute a material weakness.
27
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Mitigating factors include:
• The board consists of 50% executive and 50% non-executive directors.
• There is an independent non-executive director on the board.
• The audit committee is chaired by an independent non-executive director
who has extensive experience and deemed to be a financial expert.
• Management is in the process of developing a control charter.
In addition to address these
material weaknesses, management performed additional analyses and other procedures to ensure that the Condensed Consolidated financial
statements included herein fairly present, in all material respects, our Consolidated financial position, results of operations and cash
flows for the periods presented. Accordingly, we believe that the Condensed Consolidated financial statements included in this report
fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.
We
intend to remedy our material weakness with regard to insufficient segregation of duties by hiring additional employees in order to segregate
duties in a manner that establishes effective internal controls once resources become available.
Changes
in Internal Control over Financial Reporting
No
change in our system of internal control over financial reporting occurred during the period covered by this report, the period ended
May 31, 2023, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
28
Table of Contents
PART
II – OTHER INFORMATION
Item 1. Legal
Proceedings
We are not a
party to any material pending legal proceeding. We are not aware of any pending legal proceeding to which any of our officers, directors,
or any beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.
Item
1A: Risk Factors
As
a “smaller reporting company”, we are not required to provide the information required by this Item.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
On
December 1, 2023, the SEC declared effective our Registration Statement on Form S-1 filed in connection with the offer and sale of 1,733,750
shares of our common stock at a purchase price of $5 per share. The SEC assigned that registration statement file no. 333-265368.
The
offering of the securities registered by that registration statement has commenced as of December 1, 2023 and is ongoing. There
has been no material change in the planned use of proceeds from the public offering as described in the Prospectus.
Item 3. Defaults
upon Senior Securities
None
Item 4. Mine
Safety Disclosure
Not applicable
Item 5. Other
Information
None
Item
6. Exhibits
Exhibit
Number
Description
of Exhibit
31.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
EX-101.INS**
XBRL
Instance Document
EX-101.SCH**
XBRL
Taxonomy Extension Schema Document
EX-101.CAL**
XBRL
Taxonomy Extension Calculation Linkbase
EX-101.DEF**
XBRL
Taxonomy Extension Definition Linkbase
EX-101.LAB**
XBRL
Taxonomy Extension Labels Linkbase
EX-101.PRE**
XBRL
Taxonomy Extension Presentation Linkbase
**
XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus
for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections.
29
Table of Contents
SIGNATURES
In accordance
with the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Medinotec, Inc.
Date: July 14, 2023
By:
/s/ Gregory
Vizirgianakis
Gregory Vizirgianakis
Title:
Chief Executive Officer and
Principal Executive Officer
Medinotec, Inc.
Date: July 14, 2023
By:
/s/ Peter
van Niekerk
Peter van Niekerk
Title:
Chief Financial Officer,
Principal Financial Officer and
Principal Accounting Officer
30
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.