What changed in this filing

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Item 1A. Risk Factors

2024-07-05 compared with 2023-05-30 · 480 added, 447 removed, 1019 unchanged (48% of the section changed)

1 unchanged sentence

You should carefully consider the risks described

below together with all of the other information included in this registration statement before making an investment decision with regard

to our securities.

The statements contained in or incorporated herein that are not historic facts are forward-looking statements that

are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking

below together with all of the other information included in this Annual Report before making an investment decision with regard to our

The statements contained in or incorporated herein that are not historic facts are forward-looking statements that are subject

to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking

If any of the following risks actually occurs, our business, financial condition or results of operations could be harmed.

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Such risks include, but are not limited to:

Related to our Financial Position and Need for Capital

The Medinotec Group of

Companies’ substantial leverage and debt service obligations could adversely affect the business.

The Medinotec Group of

Companies may need additional financing – any limitation on our ability to obtain such additional financing could have a material

adverse effect on the business, financial condition, and results of operations.

Future changes in financial

accounting standards or practices or existing taxation rules or practices may cause adverse or unexpected revenue fluctuations and

affect the reported results of operations within The Medinotec Group of companies.

Related to Our Business Operations

Consolidation in the healthcare

industry could have an adverse effect on revenues and results of operations of the Medinotec Group of Companies.

Healthcare industry cost-containment

measures could result in reduced sales of the Medinotec Group of Companies medical devices and medical device components.

The continuing development

of many of our products and offerings depends on our maintaining strong relationships with healthcare professionals, and these professionals

are external to the Medinotec Group of Companies.

Products in the development

pipeline of The Medinotec Group of Companies may not come to market or fail to commercialize.

The Medinotec Group of

Companies operate in a highly competitive industry and may be unable to compete effectively.

Reduction or interruption

in supply or other manufacturing difficulties may adversely affect operations and related product sales within the Medinotec Group

of Companies.

The Medinotec Group of

Companies rely on the proper function, security and availability of our IT systems and data to operate the business, and a breach,

cyber-attack or other disruption to these systems or data could materially and adversely affect the business, results of operations,

financial condition, cash flows, reputation, or competitive position.

The Medinotec Group of

Companies business model is concentrated around developing countries with higher growth rates, although this model also causes forex

risk exposure which may cause adverse or unexpected revenue fluctuations and affect the reported results of operations.

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.

The Medinotec Group of

Companies insurance program may not be adequate to cover future losses.

The Medinotec Group of

Companies future growth is dependent upon the development of new products and line extensions, which requires significant research

and development, clinical trials and regulatory approvals, all of which are very expensive and time-consuming and may not result

in a commercially viable product.

If the Medinotec Group

of Companies fails to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements

could be impaired, which could harm our operating results, our ability to operate and investors’ views of us.

We have limited experience

in marketing and sales and are in the early stages of building our sales channels in the life science market and internationally

We rely on a limited number

of subcontractors to manufacture, assemble, package and production test our products, and the failure of any of these third-party

subcontractors to deliver products or otherwise perform as requested could damage our relationships with our customers, decrease

our sales and limit our growth.

We distribute commodity

medical products on behalf of multinational manufacturers for a substantial portion of our sales, and our failure to maintain and

further develop these relationships could harm our business.

have identified material weaknesses in our internal control over financial reporting.

Failure to achieve and maintain effective

internal controls over financial reporting could adversely affect our ability to report our results of operations and financial

condition accurately and in a timely manner, which could have an adverse impact on our business.

Related to Management, Personnel and Control Persons

The Medinotec Group of

Companies depends on our senior management personnel and may not be able to retain or replace these individuals or recruit additional

personnel, which could harm our business.

If the Medinotec Group

of Companies are unable to find, train and retain key personnel, including new showroom employees that reflect our brand image and

embody our culture, we may not be able to grow or sustain our operations.

The Medinotec Group of

Companies’ largest shareholder, officer and director, Dr.

Gregory Vizirgianakis, has substantial control over us and our policies

and will be able to influence corporate matters.

The Medinotec Group of

Companies’ officers and directors are located outside of the U.S., so it will be difficult to effect service of process and

enforcement of legal judgments upon our officers and directors.

The Medinotec Group of

companies’ officers and directors have limited experience managing a public company.

Associated With Legal and Regulatory Matters

The Medinotec Group of

Companies are subject to extensive medical device regulation that may impede or hinder the approval process for our products and,

in some cases, may not ultimately result in approval or may result in the recall or seizure of previously approved products.

to obtain clearance or authorization for our medical devices, or other delays in the development of our medical devices, would

adversely affect our ability to grow our business.

Modifications

to our products may require new 510(k) clearances, de novo submissions, or pre-market approvals, or may require us to cease marketing

or recall the modified products until clearances are obtained.

to obtain clearance or authorization for our medical devices, or other delays in the development of our medical devices, would

adversely affect our ability to grow our business.

may be liable if the FDA or other U.S.

enforcement agencies determine we have engaged in the off-label promotion of our products

or have disseminated false or misleading labeling or promotional materials.

Healthcare policy changes

may have a material adverse effect on the Medinotec Group of Companies.

The Medinotec Group of

Companies is subject to environmental laws and regulations and the risk of environmental liabilities, violations, and litigation.

Claims made against the

Medinotec Group of Companies from time to time can result in litigation that could distract management from our business activities

and result in significant liability or damage to our brand.

Medinotec Group of Companies’ failure to comply with laws and regulations relating to reimbursement of healthcare goods

and services may subject it to penalties and adversely impact its reputation, business, results of operations, financial condition,

and cash flows.

Quality problems and product

liability claims could lead to recalls or safety alerts, reputational harm, adverse verdicts or costly settlements, and could have

a material adverse effect on the business, results of operations, financial condition and cash flows.

The Medinotec Group of

Companies may not be able to protect our intellectual property rights effectively.

Security breaches, loss

of data and other disruptions could also compromise sensitive information related to the business, preventing it from accessing critical

information or expose us to liability, which could adversely affect the business and reputation.

Changes in tax laws or

exposure to additional income tax liabilities could have a material impact on the Medinotec Group of Companies, the results of operations,

financial conditions and cash flows.

The failure to comply with

anti-corruption laws could materially affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.

Laws and regulations governing

international business operations could adversely impact the Medinotec Group of Companies.

As an Emerging Growth Company

under the Jobs Act, the Medinotec Group of Companies are permitted to rely on exemptions from certain disclosures requirements.

Associated with Political Instability and Regional Issues

South Africa Specific Risk

of stable power supply

South Africa Specific Risk

of Political instability may affect the Medinotec Group of Companies ability to operate effectively.

South Africa Specific Risk

that BEE requirements may restrict growth opportunities and limit the Medinotec Group of Companies’ ability to attract key

South Africa Specific Risk

that South African authorities may disallow or delay a transfer of funds from South Africa to the United States

South Africa Specific Risk

of Being Grey listed by the FATF- Financial Action Task Force

Relating to Our Securities

If the Medinotec Group

of Companies undertakes future offerings of our common stock, shareholders will experience dilution of their ownership percentage.

If a market for the Medinotec

Group of Companies' common stock does not develop, shareholders may be unable to sell their shares.

The Medinotec Group of

Companies’ common stock price may be volatile and could fluctuate widely in price which could result in substantial losses

for investors.

If securities analysts

do not initiate coverage or continue to cover the Common Stock or publish unfavorable research or reports about the business, this

may have a negative impact on the market price of the Common Stock of the Medinotec Group of Companies.

Because we are subject

to the “Penny Stock” rules and our shares are quoted on the over-the-counter bulletin board, the level of trading activity

in the Medinotec Group of Companies’ stock may be reduced.

If the Medinotec Group

of Companies issues shares of preferred stock with superior rights than the common stock, it could result in a decrease in the value

of our common stock and delay or prevent a change in control.

The Medinotec Group of

Companies does not expect to pay dividends in the foreseeable future.

Any return on investment may be limited to the value of our

common stock.

Provisions in the Nevada

Revised Statutes and our Bylaws could make it very difficult for an investor to bring any legal actions against the Medinotec Group

of companies’ directors or officers for violations of their fiduciary duties or could require us to pay any amounts incurred

by our directors or officers in any such actions.

Risks Related to our Financial Position and Need

The Medinotec Group of Companies’ substantial leverage and debt service obligations could adversely affect the business.

The Medinotec Group of Companies may need additional financing – any limitation on our ability to obtain such additional financing could have a material adverse effect on the business, financial condition, and results of operations.

The Medinotec Group of Companies research and development efforts rely upon investments and investment collaborations, and we cannot guarantee that any previous or future investments or investment collaborations will be successful.

Future changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse or unexpected revenue fluctuations and affect the reported results of operations within The Medinotec Group of companies.

Risks Related to Our Business

Covid-19 has had, and is expected to continue to have, an adverse effect on the Medinotec Group of Companies, results of operations, financial condition and cash flows, the nature and extent of which are highly uncertain and unpredictable.

Consolidation in the healthcare industry could have an adverse effect on revenues and results of operations of the Medinotec Group of Companies.

Healthcare industry cost-containment measures could result in reduced sales of the Medinotec Group of Companies medical devices and medical device components.

The continuing development of many of our products and offerings depends on our maintaining strong relationships with healthcare professionals, and these professionals are external to the Medinotec Group of Companies.

Products in the development pipeline of The Medinotec Group of Companies may not come to market or fail to commercialize.

The Medinotec Group of Companies operate in a highly competitive industry and may be unable to compete effectively.

Failure of the Medinotec Group of Companies to integrate acquired businesses

into operations successfully, as well as liabilities or claims relating to such acquired businesses, could adversely affect the business

agreements and contracts entered into with partners and other third parties may not be successful.

Reduction or interruption in supply or other manufacturing difficulties may adversely affect operations and related product sales within the Medinotec Group of Companies.

If the Medinotec Group of Companies fails to manage any expansion or acquisition, the business could be impaired.

The Medinotec Group of Companies rely on the proper function, security and availability of our IT systems and data to operate the business, and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation, or competitive position.

The Medinotec Group of Companies business model is concentrated around developing countries with higher growth rates, although this model also causes forex risk exposure which may cause adverse or unexpected revenue fluctuations and affect the reported results of operations.

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.

The Medinotec Group of Companies insurance program may not be adequate to cover future losses.

The Medinotec Group of Companies future growth is dependent upon the development of new products and line extensions, which requires significant research and development, clinical trials and regulatory approvals, all of which are very expensive and time-consuming and may not result in a commercially viable product.

Risks Related to Management, Personnel and Control

The Medinotec Group of Companies depends on our senior management personnel and may not be able to retain or replace these individuals or recruit additional personnel, which could harm our business.

If the Medinotec Group of Companies are unable to find, train and retain key personnel, including new showroom employees that reflect our brand image and embody our culture, we may not be able to grow or sustain our operations.

The Medinotec Group of Companies’ largest shareholder, officer and director, Dr.

Gregory Vizirgianakis, has substantial control over us and our policies and will be able to influence corporate matters.

The Medinotec Group of Companies’ officers and directors are located outside of the U.S., so it will be difficult to effect service of process and enforcement of legal judgments upon our officers and directors.

The Medinotec Group of companies’ officers and directors have limited experience managing a public company.

Risk Associated With Legal and Regulatory Matters

The Medinotec Group of Companies are subject to extensive medical device regulation that may impede or hinder the approval process for our products and, in some cases, may not ultimately result in approval or may result in the recall or seizure of previously approved products.

Healthcare policy changes may have a material adverse effect on the Medinotec Group of Companies.

The Medinotec Group of Companies is subject to environmental laws and regulations and the risk of environmental liabilities, violations and litigation.

Claims made against the Medinotec Group of Companies from time to time can result in litigation that could distract management from our business activities and result in significant liability or damage to our brand.

The Medinotec Group of Companies’ failure to comply with laws and regulations relating to reimbursement of healthcare goods and services may subject it to penalties and adversely impact its reputation, business, results of operations, financial condition and cash flows.

The Medinotec Group of Companies may not be able to protect our intellectual property rights effectively.

Security breaches, loss of data and other disruptions could also compromise sensitive information related to the business, preventing it from accessing critical information or expose us to liability, which could adversely affect the business and reputation.

Changes in tax laws or exposure to additional income tax liabilities could have a material impact on the Medinotec Group of Companies, the results of operations, financial conditions and cash flows.

The failure to comply with anti-corruption laws could materially adversely affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.

Laws and regulations governing international business operations could adversely impact the Medinotec Group of Companies.

As an Emerging Growth Company under the Jobs Act, the Medinotec Group of Companies are permitted to rely on exemptions from certain disclosures requirements.

Risks Associated with Political Instability and

Regional Issues

South Africa Specific Risk of stable power supply

South Africa Specific Risk of Political instability may affect the Medinotec Group of Companies ability to operate effectively.

South Africa Specific Risk that BEE requirements may restrict growth opportunities and limit the Medinotec Group of Companies’ ability to attract key talent.

South Africa Specific Risk that potential damage to property caused by riots and protests may impact the Medinotec Group of Companies’ ability to operate.

South Africa Specific Risk that South African authorities may disallow or delay a transfer of funds from South Africa to the United States

South Africa Specific Risk of Being Grey listed by the FATF- Financial Action Task Force

Risks Relating to Our Securities

If the Medinotec Group of Companies undertakes future offerings of our common stock, shareholders will experience dilution of their ownership percentage.

If a market for the Medinotec Group of Companies' common stock does not develop, shareholders may be unable to sell their shares.

The Medinotec Group of Companies’ common stock price may be volatile and could fluctuate widely in price.

which could result in substantial losses for investors.

If securities analysts do not initiate coverage or continue to cover the Common Stock or publish unfavorable research or reports about the business, this may have a negative impact on the market price of the Common Stock of the Medinotec Group of Companies.

Because we will be subject to the “Penny Stock” rules once our shares are quoted on the over-the-counter bulletin board, the level of trading activity in the Medinotec Group of Companies’ stock may be reduced.

If the Medinotec Group of Companies issues shares of preferred stock with superior rights than the common stock registered in this prospectus, it could result in a decrease in the value of our common stock and delay or prevent a change in control of us.

The Medinotec Group of Companies does not expect to pay dividends in the foreseeable future.

Any return on investment may be limited to the value of our common stock.

Provisions in the Nevada Revised Statutes and our Bylaws could make it very difficult for an investor to bring any legal actions against the Medinotec Group of companies’ directors or officers for violations of their fiduciary duties or could require us to pay any amounts incurred by our directors or officers in any such actions.

Risks Related to Financial Condition

The Medinotec Group of Companies’ substantial

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As of February 29, 2024, the consolidated Medinotec

Group of Companies had approximately $71,311 of current debt obligations and $1,863,066 of long-term debt outstanding.

The long-term debt is an unsecured loan from

the related party Minoan Medical Proprietary Limited, which was the prior shareholder of DISA Medinotec Proprietary Limited.

Covid challenges interest on the loan was waived due to the loan being classified as an equity investment at that stage.

The Medinotec

Group of Companies has a period of 3 years post any Initial Public Offer ("IPO”) date 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 as of February 28, 2023,

in South Africa is 10.75%.

Group of Companies had approximately $827,454 of current liability obligations and $1,809,655 of long-term liabilities outstanding.

The long-term debt relates to the non-current

portion of the operating lease liability as well as an unsecured loan from the related party Minoan Medical, which was the prior shareholder

of DISA Medinotec Proprietary Limited.

The Medinotec Group of Companies has a period of 3 years post the Initial Public Offer ("IPO”)

date of 31 March 2023 to repay the loan, during these 3 years the loan will carry interest at the prevailing prime lending rate of the

The prevailing prime lending rate as of February 29, 2024, in South Africa is 11.75%.

The interest charged for the year ended

February 28, 2023 for the consolidated Medinotec Group of Companies was $178,584 and a 1% movement in the interest rates constitutes

a value of $16,612 on an annual basis.

February 29, 2024 for the consolidated Medinotec Group of Companies was $277,230 and a 1% movement in the interest rates constitutes a

value of $23,594 on an annual basis.

From time to time the Group utilized trade

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As of February 29, 2024, the related party

loan for the consolidated Medinotec Group of Companies had a balance of $1,863,066with an estimated interest charge of $178,584 per annum

at the prevailing prime interest rate of 10.75% at that date.

loan for the consolidated Medinotec Group of Companies had a balance of $1,769,957 with an interest charge of $236,873 per annum at the

prevailing prime interest rate of 11.75% at that date.

A 1% movement in the interest rates constitutes a value of $20,159.

The Medinotec Group of Companies has

the option to settle earlier, and settlement can be in cash or shares.

It is currently the intention of management to settle the loan

in equity at some point in the future, since the agreement allows the Medinotec Group Companies to settle the amounts either in equity

Therefore, the impact on cashflow would be zero.

the option to settle earlier, and settlement can be in cash or any form of equivalent.

It is currently the intention of management to

settle the loan in equity at some point in the future, since the agreement allows the Medinotec Group Companies to settle the amounts

either in equity or in cash.

If equity is used, the impact on cashflow would be zero.

If we elect to settle the loan in cash:

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Therefore, if settled today it would constitute 63% of available cash.

Since we are not cash generative

at the moment, we would not be able to settle the loan by using operational generated cashflows.

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 at arm’s length 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

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 at arm’s length and justifiable rate that can be applied to a loan within

the borders of the Republic of South Africa.

We may also incur additional indebtedness in the future.

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Our failure to comply with the terms of our indebtedness

could also result in an event of default which, if not cured or waived, could result in the acceleration of all of its debt.

could also result in an event of default which, if not cured or waived, could result in the acceleration of all its debt.

If this occurs,

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and results of operations.

The Medinotec Group of Companies research and

development efforts rely upon investments and investment collaborations, and we cannot guarantee that any previous or future investments

or investment collaborations will be successful.

Our mission is to provide a broad range of products

to restore patients to fuller, healthier lives, which requires a wide variety of technologies, products and capabilities.

The rapid pace

of technological development in the medical industry and the specialized expertise required in different areas of medicine make it difficult

for one company alone to develop a broad portfolio of technological solution.

In addition to internally generated growth through

our research and development efforts, historically we have relied on, and expect to continue to rely on, investments and investment collaborations

to provide us with access to new technologies both in areas served by our existing businesses as well as in new areas.

We expect to make future investments where we believe

that we can stimulate the development or acquisition of new technologies and products to further strategic objectives and strengthen our

existing businesses.

Investments and investment collaborations in and with medical technology companies are inherently risky, and we cannot

guarantee that any of our previous or future investments or investment collaborations will be successful or will not materially adversely

affect the business, results of operations, financial condition and cash flows.

Future changes in financial accounting standards

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The fact that we operate in multiple

territories and have worldwide footprint heightens this risk in specific territories.

territories and have a worldwide footprint heightens this risk in specific territories.

Risks Relating to Business Operations

Covid-19 has had, and is expected to continue

to have, an adverse effect on the Medinotec Group of Companies, results of operations, financial condition and cash flows, the nature

and extent of which are highly uncertain and unpredictable.

Our operations and interactions with healthcare systems,

providers and patients around the world expose us to risks associated with public health crises, including epidemics and pandemics such

In particular, the continuing global spread of Covid-19, including corresponding preventative and precautionary measures

that we and other businesses, communities and governments are taking to mitigate the spread of the disease, has led to unprecedented restrictions

on, disruptions in, and other related impacts on business and personal activities.

In addition to travel restrictions put in place in

early 2020, countries, states and governments may continue to close borders, impose prolonged quarantines or other restrictions and requirements

This will further limit the ability to conduct business in-person, requiring businesses to continue to use alternative methods

of communication.

It is also likely the pandemic will cause an economic slowdown of potentially extended duration, and even a global recession.

Together with the preventative and precautionary measures

being taken, as well as the corresponding need to adapt to new and different methods of communicating and conducting business, Covid-19

is having, and is likely to continue to have, an adverse impact on significant aspects of us, including on demand for and supply of products,

operations, supply chains and distribution systems.

Our strategic investment partners’ ability to research and develop and bring

to market new products and services, and our ability to generate cash flow, are being impacted.

Also, as hospital systems continue to prioritize treatment

of Covid-19 patients and otherwise comply with government guidelines, certain medical procedures have been suspended or postponed in many

of the markets where our products are marketed and sold, which has caused a decrease in the sales of these products.

It is not possible

to predict the timing of a broad resumption of deferrable medical procedures or to which extent individuals and hospital systems continue

to de-prioritize, delay or cancel these procedures.

It is also not possible to determine if unemployment or loss of insurance coverage

will adversely impact on people’s ability to pay for our products and services.

Both circumstances continue to negatively affect

the business, cash flows, financial condition and results of operations.

The pandemic is also placing strain on healthcare

systems and hospitals around the world, resulting in adverse financial impacts on those systems, which could result in reduced future

expenditure on capital equipment, including our products and services.

It could also disrupt product launches of our new products.

Furthermore, a significant number of our suppliers,

vendors, distributors and manufacturing facilities have been adversely affected by the Covid-19 pandemic.

This includes a negative impact

on the ability of their employees to get to their places of work and maintain the continuity of their on-site operations.

This could impair

our ability to move products through distribution channels to our end customers.

Any such delay or shortage in the supply of components

or materials may result in our inability to satisfy consumer demand for our products in a timely manner or at all, which in turn could

harm our reputation, future sales and profitability.

Covid-19 has impacted and may further impact the economy

and capital markets.

This includes the negative impact on access to capital markets (including the commercial paper market), foreign currency

exchange rates, and interest rates, each of which may adversely impact the business and its liquidity.

We could experience loss of sales

and profits due to delayed payments or insolvency of healthcare professionals, hospitals and other customers, suppliers and vendors facing

liquidity issues.

As a result, we may be compelled to take additional measures to preserve our cash flow.

In addition, Covid-19 could adversely impact our ability

to retain key employees and to ensure the continued service and availability of skilled personnel necessary to run our complex production

processes and operations.

This includes executive officers and other members of the management team.

It could also impact the ability

of third-party suppliers, manufacturers, distributors and vendors to retain their key employees.

To the extent that our management or other personnel

are impacted in significant numbers by Covid-19 and are not available to perform their job duties, we could experience delays in, or the

suspension of, manufacturing operations, research and product development activities, regulatory work streams, clinical development programs

and other important commercial functions.

While the impact of Covid-19 has had, and is expected to continue to have, an adverse effect

on the business, results of operations, financial condition and cash flows, the nature and extent of such impact remains uncertain and

highly unpredictable.

Consolidation in the healthcare industry could

have an adverse effect on revenues and results of operations of the Medinotec Group of Companies.

Many healthcare companies, including healthcare systems,

distributors, manufacturers, providers, and insurers, are consolidating or have formed strategic alliances.

As the healthcare industry

consolidates, competition to provide goods and services to industry participants will become more intense.

Further, this consolidation

creates larger enterprises with greater negotiating power, which they can use to negotiate price concessions.

If we must reduce our prices

because of industry consolidation, or if we lose customers as a result of consolidation, the business, financial condition, results of

operations and cash flows could be adversely affected.

Many healthcare companies, including healthcare systems, distributors,

manufacturers, providers, and insurers, are consolidating or have formed strategic alliances.

As the healthcare industry consolidates,

competition to provide goods and services to industry participants will become more intense.

Further, this consolidation creates larger

enterprises with greater negotiating power, which they can use to negotiate price concessions.

If we must reduce our prices because of

industry consolidation, or if we lose customers as a result of consolidation, the business, financial condition, results of operations

and cash flows could be adversely affected.

Healthcare industry cost-containment measures

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to whom our customers supply medical devices, rely on third-party payers, including government programs and private health insurance plans,

to reimburse some or all of the cost of the procedures in which medical devices that incorporate components our manufacture or assemble

to reimburse some or all the cost of the procedures in which medical devices that incorporate components we manufacture or assemble are

The continuing efforts of governmental authorities,

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our network to include new professionals in the territories we enter will have a negative impact on our financial success.

as a result of the Covid-19 pandemic, our access to these professionals has been limited, and travel restrictions, shutdowns and similar

measures have impacted the ability to maintain these relationships, thereby affecting the ability to develop, market and sell new and

improved products.

Products in the development pipeline of The

2 unchanged sentences

in the R&D phase.

However, some of these projects may fail to come to market of reach commercialize for a number of reasons, which

could include competitors releasing a similar product at the same time, a lack of viability in terms of production costs or projected

sales, or low/no acceptance in the market, failures on safety and efficacy measures, among other factors.

However, some of these projects may fail to come to market for a number of reasons, which could include competitors

releasing a similar product at the same time, a lack of viability in terms of production costs or projected sales, or low/no acceptance

in the market, failures on safety and efficacy measures, among other factors.

The Medinotec Group of Companies operate in

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We believe our ability to compete depends upon many

factors both within and beyond our control, including:

product performance and reliability, product technology and innovation, product

factors both within and beyond our control, including product performance and reliability, product technology and innovation, product

quality and safety, breadth of product lines, product support services, customer support, cost-effectiveness and price, reimbursement

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These suppliers/strategic partners

require a sufficient amount of quality components and materials and is highly exacting and complex, due in part to strict regulatory requirements.

require a sufficient amount of quality components and materials and are highly exacting and complex, due in part to strict regulatory

requirements.

We have generally been able to obtain adequate supplies

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For example, in the past we have experienced an information technology (“IT”) systems interruption that

affected our customer ordering, distribution, and manufacturing processes, and is currently adversely impacted by the global Covid-19

Furthermore, any failure to identify and address manufacturing problems prior to the release of products to customers could

result in quality or safety issues.

affected our customer ordering, distribution, and manufacturing processes.

Furthermore, any failure to identify and address manufacturing

problems prior to the release of products to customers could result in quality or safety issues.

These disruptions are exacerbated by global economic

uncertainty and heightened geopolitical tensions, such as those in involved in the Russian war on Ukraine, between the United States and

China as well as Brexit, which can also have an impact on several factors influencing prices, exchange rates, and interest rates, all

of which can affect our business in turn.

uncertainty and heightened geopolitical tensions, such as the Russian war on Ukraine, between the United States and China as well as Brexit

and conflicts in the Middle East, which can also have an impact on several factors influencing prices, exchange rates, and interest rates,

all of which can affect our business in turn.

In addition, several key components are manufactured

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Despite this precaution, there is no

assurances that we will be able to secure the materials needed if the event these sources are unable to fulfil orders.

assurances that we will be able to secure the materials needed in the event these sources are unable to fulfil orders.

Any failure in

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are readily available from a variety of suppliers and therefore, the risk of sourcing them is minimal or non-existent.

Failure of the Medinotec Group of Companies

to integrate acquired businesses into operations successfully, as well as liabilities or claims relating to such acquired businesses,

could adversely affect the business, agreements and contracts entered into with partners and other third parties may not be successful.

As part of our strategy to develop and identify new

products and technologies, we have made significant investment in our in-house IP, and may make acquisitions in the future in an effort

to bolster both our IP and our product range.

Integration of the operations of acquired businesses will require significant efforts, which

result in additional expenses and involve significant amounts of management’s time that cannot then be dedicated to other projects.

Failure to manage and coordinate the growth of acquired

companies successfully could also have an adverse impact on the business.

Furthermore, acquired businesses may have liabilities, or be

subject to claims, litigation or investigations that were not anticipated , or which exceed estimates at the time of the acquisition.

In addition, we cannot be certain that the businesses

we acquire will become profitable or remain so.

Factors that will affect the success of any acquisitions made by us include:

the presence or absence of adequate internal controls and/or significant fraud in the financial systems of acquired companies;

the ability or inability to integrate IT systems of acquired companies in a secure and reliable manner;

liabilities, claims, litigation, investigations or other adverse developments relating to acquired businesses or the business practices of acquired companies, including investigations by governmental entities, potential US Foreign Corrupt Practices Act (“FCPA”) or product liability claims or other unanticipated liabilities;

any decrease in customer loyalty and product orders caused by dissatisfaction with the consolidated companies’ product lines and sales and marketing practices, including price increases;

the ability to retain key employees, and the ability to achieve synergies among acquired companies, such as increasing sales of the integrated company’s products, achieving cost savings, and effectively combining technologies to develop new products.

We could also experience negative effects on our business,

financial condition, results of operations and cash flows from acquisition-related charges, amortization of intangible assets and asset

impairment charges.

These effects, individually or in the aggregate, could cause a deterioration of its credit rating and result in increased

borrowing costs and interest expense.

We have in the past signed, and may pursue in the

future, agreements and contracts with third parties to assist our marketing, manufacturing, selling, and distribution efforts.

The performance

of these partners and third parties cannot be guaranteed, and as such we cannot assure that any agreements or contracts entered into in

the future will be successful.

If the Medinotec Group of Companies fails to

manage any expansion or acquisition, the business could be impaired.

We have a very ambitious acquisition strategy and

will rely on both organic growth and acquisitive growth to achieve our business goals.

We may, therefore, in the future acquire one or

more technologies, products or companies that complement the business.

We may not, however, be able to integrate these acquisitions effectively,

and any such acquisition could bring additional risks, exposures, and challenges to the business.

Due to the nature of our strategic investments division,

this may result in acquisitions or joint operations where we do not have full control of the operations or business strategies.

lead to conflicts or legal matters with joint partners and other shareholders.

In cases where we have control, conflicts may arise with

minority interests and these would need to be resolved in the legal jurisdiction in which they arise.

Litigation and arbitration around

these topics can be costly and time consuming and be highly disruptive to the business.

In addition, acquisitions may dilute our earnings

per share, disrupt our ongoing business, distract our management and employees, increase our expenses, subject us to liabilities, and

increase our risk of litigation, all of which could harm our business.

If we use cash to acquire technologies, products, or companies,

such use may divert resources otherwise available for other purposes.

If we use our common stock to acquire technologies, products, or

companies, our stockholders may experience substantial dilution.

If we fail to manage any expansions or acquisition, our business could

Our future success will depend, in part, upon our

ability to manage our expanded business, including challenges related to the management and monitoring of new operations and associated

increased costs and complexity.

If we are not able to continue the business combinations in an efficient and effective manner, the anticipated

benefits may not be realized fully, or at all, or may take longer to realize than expected, and the value of our common stock may be affected

An inability to realize the full extent of the anticipated

benefits of acquisitions, as well as any delays encountered in the integration process, could have an adverse effect upon our business,

financial condition, or results of operations.

The Medinotec Group of Companies rely on the

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will not arise in the future.

Further, a greater number of employees are working remotely in response to the Covid-19 pandemic and related

government actions, which could expose us to greater risks related to cybersecurity and its IT systems.

If our IT systems, products or services or sensitive

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product failure, IT outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to

During the years ended February 29, 2024 and February

28, 2023, we did not, to our knowledge, experience any cybersecurity incidents or breaches that materially impacted or are reasonably

likely to materially impact our business, performance or results.

The Medinotec Group of Companies business model

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international financial transaction may incur due to currency fluctuations.

Also known as currency risk, FX risk and exchange-rate risk,

it describes the possibility that an investment’s value may decrease due to changes in the relative value of the involved currencies.

Also known as currency risk, forex risk and exchange-rate

risk, it describes the possibility that an investment’s value may decrease due to changes in the relative value of the involved

Investors may experience jurisdiction risk in the form of foreign exchange risk.

Foreign exchange risk arises when a company engages in

financial transactions denominated in a currency other than the currency where that company is based.

Any appreciation/depreciation of

the base currency or the depreciation/appreciation of the denominated currency will affect the cash flows emanating from that transaction.

Foreign exchange risk arises when a company

engages in financial transactions denominated in a currency other than the currency where that company is based.

Any appreciation/depreciation

of the base currency or the depreciation/appreciation of the denominated currency will affect the cash flows emanating from that transaction.

Foreign exchange risk can also affect investors who trade in international markets, and businesses engaged in the import/export of products

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Our business model is concentrated around developing

countries with higher growth rates causes greater exposure to forex risk which may cause adverse or unexpected revenue fluctuations and

affect the reported results of operations.

Usually the attractive growth rates of these developing countries offsets the long term forex

implications of their volatile currencies.

countries with higher growth rates which causes greater exposure to forex risk which may cause adverse or unexpected revenue fluctuations

and affect the reported results of operations.

Usually, the attractive growth rates of these developing countries offsets the long term

forex implications of their volatile currencies.

There are three types of foreign exchange risk that

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Translation risk:

A parent company owning a subsidiary in another country could face losses when the subsidiary's financial statements, which will be denominated in that country's currency, have to be translated back to the parent company's currency.

A parent company owning a subsidiary in another country could face losses when the subsidiary's financial statements, which will be denominated in that country's currency, is translated back to the parent company's currency.

Economic risk:

Also called forecast risk, this refers to when market value is continuously impacted by an unavoidable exposure to currency fluctuations for example during the Covid-19 pandemic.

Also called forecast risk, this refers to when market value is continuously impacted by an unavoidable exposure to currency fluctuations.

We continually assess our foreign exchange risks and

implements varying strategies based on the current economic conditions to implement hedging strategies to mitigate that risk.

implement varying strategies based on the current economic conditions to implement hedging strategies to mitigate that risk.

involves forward contracts, options, and other exotic financial products that, if done properly, can protect us from unwanted foreign

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Much like anything, there are benefits and risks associated with high customer concentration.

The Group has historical reliance on two related

parties for sales into South Africa:

there is reliance on the DISA Vascular Distribution Proprietary limited t/a DISA Life Sciences’s

(“DISA Lifesciences”) as a customer;

and for exports out of South Africa there was historical reliance on Minoan Medical Proprietary

Limited (“Minoan Medical”).

The Group has historical reliance on two parties

for sales into South Africa:

there is reliance on DISA Life Sciences as a customer;

and for exports out of South Africa there was historical

reliance on Minoan Medical Proprietary.

These relationships provide the Group with more than 100 sales representatives in the South African

The sales relationship with Minoan Medical

ceased to exist in FY 2022, when the Medinotec Group took the export functions in house.

Any sales in the future between the two entities,

if any, will be on an ad hoc basis when opportunities arise.

Disa Lifesciences is no longer considered a related party as of October 2022.

Sales between DISA Lifesciences and the Medinotec

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

Sales between DISA Life Sciences and the Medinotec

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

The Medinotec Inc.

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

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

international first world markets.

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

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 into such markets.

As such, and 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.

Set forth below is a

table showing material related party Company’s sales for the years ended February 28, 2023 and 2022 with DISA Life Sciences and

Minoan Medical:

The Consolidated Medinotec Group

ending February 28,

the period April 26, 2021 to February 28,

DISA Life Sciences

Minoan Medical

% of sales made to related parties for the period*

* Percentages were calculated as a percentage

of related party sales against total sales.

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.

Please refer to the related parties and entities section

for a more detailed discussion on each function and the relationships involved as well as any arm’s length disclosures.

850-10-50-6 and ASC 850-10-50-5.

These relationships have the upside of:

Developing long-term relationships with fewer large customers

Less contractual agreements and overhead per dollar

Less contractual agreements and overheads per dollar

Greater focus on customer service and customer needs

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In addition, if our efforts to comply with new or changed laws, regulations, and standards differ from the activities intended by regulatory

or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and the business

may be harmed.

or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and the

business may be harmed.

We have limited experience in marketing and

sales and are in the early stages of building our sales channels in the life science market and internationally .

We may not be able to market, sell or distribute our

current and future products effectively enough to support our planned growth.

Currently, we sell our products through a combination of

direct sales efforts and partnerships with distributors across all our key markets.

During 2022, our distributors accounted for a significant

portion of our total revenue.

We are in the process of broadening and diversifying our sales channels across all markets.

In the future,

if we fail to maintain good relationships with, or fail to successfully motivate any of our large distributors, our revenue may decline.

If we do not diversify our sales channels and effectively utilize our direct sales force, we will continue to be susceptible to risks

associated with having a large percentage of revenue concentrated with a limited number of distributors.

Competition for employees capable of selling expensive

medical devices within the pharmaceutical and biotechnology industries is intense.

We may not be able to attract and retain personnel

or be able to build an efficient and effective sales organization, which could negatively impact sales and market acceptance of our products

and limit our revenue growth and potential profitability.

In addition, the time and cost of establishing a specialized

sales, marketing and customer service force for a particular product or service may be difficult to justify considering the revenue projected

to be generated by such additional personnel and resources.

We also intend to add additional distribution partners in the life science

market, and if we are unable to do so successfully, it will adversely impact on our ability to increase the revenue from our product offerings.

We rely on distributors for the sale of our products

abroad and are entering into new agreements for the United States.

We intend to continue to grow our business internationally and in the

United States and to do so we must attract additional distributors and retain existing distributors to maximize the commercial opportunity

for our products.

We exert limited control over existing distributors under our agreements with them, and if their sales and marketing

efforts for our products in their particular region are not successful, our business would be materially and adversely affected.

qualifying, and engaging additional distribution partners with local industry experience and knowledge will be necessary in at least the

short to mid-term to effectively market and sell our platform in certain countries outside the United States.

We may not be successful

in finding, attracting, and retaining distribution partners, or we may not be able to enter into such arrangements on favorable terms.

Most of our distribution relationships are non-exclusive

and permit such distributors to distribute competing products.

As such, our distributors may not commit the necessary resources to market

our products to the level of our expectations or may choose to favor marketing the products of our competitors.

Some of our distribution

relationships are exclusive where the company is forced to rely on their efforts.

Our distribution partners may compete against our inside

sales force for sales opportunities.

If current or future distributors do not perform adequately, offer competitive products, compete

with our own sales staff, or we are unable to enter into effective arrangements with distributors in particular geographic areas, we may

not realize long-term international revenue growth.

We rely on a limited number of subcontractors

to manufacture, assemble, package and production test our products, and the failure of any of these third-party subcontractors to deliver

products or otherwise perform as requested could damage our relationships with our customers, decrease our sales and limit our growth.

While we design and market our products and conduct

test development in-house, we do not manufacture, assemble, package and production test the vast majority of components of our products,

and we must rely on third-party subcontractors to perform these services.

If these subcontractors do not provide us with high-quality

products, services and production and production test capacity in a timely manner, or if one or more of these subcontractors terminates

its relationship with us, we may be unable to obtain satisfactory replacements to fulfill customer orders on a timely basis, our relationships

with our customers could suffer, our sales could decrease, and our growth could be limited.

In addition, the consolidation of foundry subcontractors,

as well as the increasing capital intensity and complexity associated with fabrication in smaller process geometries has limited the diversity

of our suppliers and increased our risk of a "single point of failure." The lack of diversity of suppliers could also drive

increased prices and adversely affect our results of operations, including our product gross margins.

We currently do not have long-term supply contracts

with any of our third-party subcontractors.

Therefore, they are not obligated to perform services or supply products to us for any specific

period, in any specific quantities or at any specific price, except as may be provided in a particular purchase order.

None of our third-party

subcontractors has provided contractual assurances to us that adequate capacity will be available to us to meet future demand for our

Our subcontractors may allocate capacity to the production of other companies' products while reducing deliveries to us on short

Other customers that are larger and better financed than we are or that have long- term agreements with these subcontractors may

cause these subcontractors to reallocate capacity to those customers, thereby decreasing the capacity available to us.

Other significant risks associated with relying on

these third-party subcontractors include:

control over product cost, delivery schedules and product quality;

price increases;

• inability to achieve sufficient production, increase production or test capacity and achieve acceptable

yields on a timely basis;

exposure to potential misappropriation of our intellectual property;

of materials used to manufacture products;

We distribute commodity medical products on

behalf of multinational manufacturers for a substantial portion of our sales, and our failure to maintain and further develop these relationships

could harm our business.

We act as a distributor on behalf of multinational

firms, and we depend on these third-party contracts for cardiac commodity product inventory to consumers.

Our distribution efforts for

these other products, some of which are competitive with our own commodity products such as our Cape Cross NC and Cape Cross products,

currently do and are expected to account for most of our net sales in the near future.

These relationships are mostly non-exclusive and

terminable upon a certain number of days’ notice.

The loss of, or business disruption at, one or more of these firms or a negative

change in our relationship with them, or a disruption to any one of our sales channels could have a material adverse effect on our business.

If we do not maintain our relationship with these product suppliers or develop relationships with other firms for inventory to sell, the

growth of our business may be adversely affected, and our business may be harmed.

If we are required to obtain additional or alternative

distribution agreements or arrangements in the future, we cannot be certain that we will be able to do so on satisfactory terms or in

a timely manner.

Our inability to enter into satisfactory distribution agreements may inhibit our ability to implement our business plan

or to establish markets necessary to expand the distribution of products successfully.

We may not be able to successfully implement our growth

strategy for our own branded products as a result of the distribution efforts we engage in of outside product offerings we distribute

We believe that our future success depends, in part,

on our ability to implement our growth strategy of leveraging our existing brand and products to drive increased sales.

Our ability to

implement this strategy depends, among other things, on our ability to:

distribution and other strategic arrangements with third-party retailers and other potential

distributors of our products successfully compete in the product categories in which we choose

• successfully

compete in the product categories in which we choose to operate;

new and appealing products and successfully innovate our existing products;

and maintain consumer interest in our brand;

our brand recognition and loyalty.

We may not be able to implement this growth strategy

successfully.

Our planned marketing expenditures may not result in increased total sales or generate sufficient levels of consumer interest

or brand awareness, and our high rates of sales and income growth may not be sustainable over time.

Our sales and results of operations

will be negatively affected if we fail to implement our growth strategy or if we invest resources in a growth strategy that ultimately

proves unsuccessful.

We have identified material weaknesses in our

internal control over financial reporting.

Failure to achieve and maintain effective internal controls over financial reporting could

adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner, which could

have an adverse impact on our business.

Since becoming a public company, ensuring that we

have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely

basis has been, and will continue to be, costly and a time-consuming effort.

In addition, the rapid changes in our operations and corporate

structure have created a need for additional resources within the accounting and finance functions in order to produce timely financial

information and to ensure the level of segregation of duties customary for a U.S.

public company.

Our management is responsible for establishing and

maintaining adequate internal control over financial reporting designed to provide reasonable assurance regarding the reliability of financial

reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles

in the United States (“GAAP”).

Our management is also required, on a quarterly basis, to evaluate the effectiveness of our

internal controls and to disclose any changes and material weaknesses identified.

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

in our annual or interim consolidated financial statements might not be prevented or detected on a timely basis, as occurred with our

interim consolidated financial statements in 2023, which were then restated and corrected in amended Quarterly Reports on Form 10-Q prior

to the filing of this Annual Report on Form 10-K.

As described in Item 9A of this Annual Report on Form 10-K, there were several material

weaknesses identified in our internal control over financial reporting.

We are working to remediate our material weaknesses

as soon as practicable.

Our remediation plan, which is continuing to be developed, can only be accomplished over time, and these initiatives

may not accomplish their intended effects.

Failure to maintain our internal control over financial reporting could adversely impact our

ability to report our financial position and results from operations on a timely and accurate basis or result in misstatements.

if our financial statements are not filed on a timely basis, we could be subject to regulatory actions, legal proceedings or investigations

by Nasdaq, the SEC or other regulatory authorities, which could result in a material adverse effect on our business and/or we may not

be able to maintain compliance with certain of our agreements.

Ineffective internal controls could also cause investors to lose confidence

in our financial reporting, which could have a negative effect on our stock price, business strategies and ability to raise capital.

Even after the remediation of our material weaknesses,

our management does not expect that our internal controls will ever prevent or detect all errors and all fraud.

A control system, no matter

how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be

No evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control

issues and instances of fraud, if any, within the business will have been detected.

Risks Related to Management, Personnel and Control

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have extensive experience both with our company and in our industry and are familiar with our business, systems, and processes.

would be catastrophic to our product offerings and ability to manage our business effectively, as we will likely not be able to find suitable

individuals to replace them on a timely basis or at all.

loss would be catastrophic to our product offerings and ability to manage our business effectively, as we will likely not be able to find

suitable individuals to replace them on a timely basis or at all.

If the Medinotec Group of Companies are unable

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are often subject to competing employment offers, and we do not know whether we will be able to attract and retain such personnel.

Our success depends in a large part on the continued

Our success depends in large part on the continued

service of the senior management team.

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direction, culture, products, and business plan.

We do not maintain key-man insurance for any of the senior management team, and thus the

loss of any of our executives, even temporarily, or any other member of senior management, could harm the business.

We do not maintain key-man insurance for any of the senior management team, and thus

the loss of any of our executives, even temporarily, or any other member of senior management, could harm the business.

The Medinotec Group

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Consequently, we may not be able to raise any funds or run our public company successfully.

Our executive’s officer’s and director’s lack of experience of managing a public company could cause you to lose some

or all of your investment.

Our executive officer’s and director’s lack of experience of managing a public company could cause you to lose some or all

of your investment.

Risk Associated with Legal and Regulatory Matters

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technical, preclinical, clinical trial, manufacturing, and labeling data.

The PMA process is typically required for devices that are deemed

to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices.

Products that are approved through a PMA application

generally need FDA approval before they can be modified.

Similarly, some modifications made to products cleared through a 510(k) may require

a new 510(k).

The 510(k), de novo, and PMA processes can be expensive and lengthy and require the payment of significant fees, unless

an exemption applies.

The FDA’s 510(k) clearance process usually takes from 3 to 12 months, but may take longer.

stated goal is to review de novo classification requests within 150 days, 50% of the time, but in reality the process for many applicants

generally takes even longer, up to a year or more.

The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance

process and generally takes from one to three years, or longer, from the time the application is submitted to the FDA until an approval

The process of obtaining regulatory clearances, approvals, and emergency use authorization to market a medical device can

be costly and time-consuming, and we may not be able to obtain these clearances, approvals, or authorizations on a timely basis, or at

all for our proposed products.

The PMA process is typically required for devices

that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices.

Products that are approved

through a PMA application generally need FDA approval before they can be modified.

Similarly, some modifications made to products cleared

through a 510(k) may require a new 510(k).

The 510(k), de novo, and PMA processes can be expensive and lengthy and require the payment

of significant fees, unless an exemption applies.

The FDA’s 510(k) clearance process usually takes from 3 to 12 months, but may

The FDA’s stated goal is to review de novo classification requests within 150 days, 50% of the time, but in reality

the process for many applicants generally takes even longer, up to a year or more.

The process of obtaining a PMA is much more costly

and uncertain than the 510(k) clearance process and generally takes from one to three years, or longer, from the time the application

is submitted to the FDA until an approval is obtained.

The process of obtaining regulatory clearances, approvals, and emergency use authorization

to market a medical device can be costly and time-consuming, and we may not be able to obtain these clearances, approvals, or authorizations

on a timely basis, or at all for our proposed products.

If the FDA requires us to go through a lengthier,

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Regulatory enforcement or inquiries, or

other increased scrutiny on us, could dissuade some customers from using our products and adversely affect our reputation and the perceived

other increased scrutiny of us, could dissuade some customers from using our products and adversely affect our reputation and the perceived

safety and efficacy of our product.

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These additional regulatory requirements may involve

significant costs and expenditures and, if we are not able to comply with any such requirements, our international expansion and business

significant costs and expenditure and, if we are not able to comply with any such requirements, our international expansion and business

could be significantly harmed.

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product validation, would have an adverse effect on our ability to commercialize our medical devices.

FDA’s policy with respect to Emergency

Use Authorizations is evolving and may limit the ability for medical products, including our medical devices, to be eligible for commercialization

under an Emergency Use Authorization.

We intend to submit an application with the FDA for

Emergency Use Authorization (EUA) for our medical devices.

The FDA has the authority to grant an Emergency Use Authorization to allow

unapproved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions

when there are no adequate, approved and available alternatives.

If we are granted an Emergency Use Authorization for our medical devices

for the diagnosis of COVID-19, we would be able to commercialize our medical devices for the diagnosis of COVID-19 prior to FDA clearance

or authorization of a 510(k) or de novo submission, respectively.

However, the FDA does not have review deadlines with respect to such

submissions and, therefore, the timing of any approval of an EUA submission is uncertain.

We cannot guarantee that the FDA will review

our data in a timely manner, or that the FDA will accept the data when reviewed.

The FDA may decide that our data are insufficient for

an EUA and require additional pre-clinical, clinical or other studies and refuse to approve our application.

In addition, the FDA may

revoke an Emergency Use Authorization where it is determined that the underlying health emergency no longer exists or warrants such authorization,

and we cannot predict how long, if ever, an Emergency Use Authorization would remain in place.

Further, the FDA’s policy with respect

to EUAs related to COVID-19 is continuously evolving and may in the future limit the ability for medical products, including our medical

devices, to be eligible for an EUA.

If we are unsuccessful in obtaining an EUA for our medical devices in a timely manner or at all, or

if any granted EUA is revoked after a short period of time, it could have a material adverse effect on our future business, financial

condition, operating results and cash flows.

Modifications to our products may require new

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until clearances are obtained.

FDA approval have been granted for the Trachealtor

FDA approval has been granted for the Trachealator

following the 510(k) substantially equivalence process for Class II medical devices.

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protection and health and safety laws and regulations, or liabilities arising from past or future releases of, or exposures to, hazardous

substances, may exceed our estimates, or have a material adverse effect on the business, results of operations, financial conditions and

substances, may exceed our estimates, or have a material adverse effect on the business, results of operations, financial conditions,

and cash flows.

Finally, in some jurisdictions around the world, culture

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Litigation and other claims against us could result in unexpected expenses

and liabilities, which could materially adversely affect our operations and our reputation.

and liabilities, which could materially affect our operations and our reputation.

In addition, the medical device industry is characterized

by extensive litigation and, from time to time, we are the subject of various claims.

Regardless of outcome, such claims are expensive

Regardless of the outcome, such claims are expensive

to defend and divert management and operating personnel from other business issues.

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As a result, our devices, products, and therapies are subject to regulation regarding quality and cost for reimbursement

and regulation of health are goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and

healthcare fraud.

and regulation of health goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare

Many territories have similar laws that apply to reimbursement

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acceptance and demand for all products within that brand and could harm our reputation and ability to market products in the future.

Further, we may be exposed to additional potential

product liability risks related to products designed, manufactured and/or marketed in response to the Covid-19 pandemic, and unpredictable

or accelerated changes in demand for certain of our products in connection with Covid-19 and its related impacts could impact development

and production of products and services and could increase the risk of regulatory enforcement actions, product defects or related claims,

as well as adversely impact our customer relationships and reputation.

Should we fall short of these standards and our products

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could decline.

Our success also depends on the ability to manufacture to exact specification for precision engineered components, sub-assemblies

Our success also depends on the ability to manufacture to exact specifications for precision engineered components, sub-assemblies

and finished devices from multiple materials.

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We pursue a policy of obtaining patent protection

in both the US and overseas for patentable subject matter of our proprietary devices and also attempt to review third-party patents and

patent applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents,

identify licensing opportunities and monitor the patent claims of others.

in both the US and overseas for patentable subject matter of our proprietary devices and attempt to review third-party patents and patent

applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify

licensing opportunities and monitor the patent claims of others.

We also operate in an industry that is susceptible

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we take measures to protect sensitive information from unauthorized access or disclosure, our IT and infrastructure may be vulnerable

to attacks by hackers, viruses, breaches or interruptions due to employee error or malfeasance, terrorist attacks, hurricanes, fire, flood,

other natural disasters, power loss, computer systems failure, data network failure, internet failure, or lapses in compliance with privacy

and security mandates.

Any such virus, breach or interruption could compromise our networks and the information stored there could be

accessed by unauthorized parties, publicly disclosed, lost or stolen.

Any such access, disclosure or other loss of information could result

in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement actions

and regulatory penalties.

to attacks by hackers, viruses, breaches, or interruptions due to employee error or malfeasance, terrorist attacks, hurricanes, fire,

flood, other natural disasters, power loss, computer systems failure, data network failure, internet failure, or lapses in compliance

with privacy and security mandates.

Any such virus, breach or interruption could compromise our networks and the information stored there

could be accessed by unauthorized parties, publicly disclosed, lost or stolen.

Any such access, disclosure or other loss of information

could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement

actions and regulatory penalties.

Unauthorized access, loss or dissemination could also

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We are subject to income taxes, as well as non-income-based

taxes, in South Africa, the UAE, and other jurisdictions in which we operate, as well as jurisdictions such as the United States, in which

we intend to have operations.

The tax laws in these could change on a prospective or retroactive basis, and any such changes could adversely

affect us and our effective tax rate.

taxes, in South Africa, and other jurisdictions in which we operate, as well as jurisdictions such as the United States, in which we intend

to have operations.

The tax laws in these could change on a prospective or retroactive basis, and any such changes could adversely affect

us and our effective tax rate.

Taxation regulation in territories around the world

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various jurisdictions in which we operate.

We regularly assess the likely outcomes of these audits in order to determine the appropriateness

of our tax provisions.

We regularly assess the likely outcomes of these audits to determine the appropriateness of

our tax provisions.

However, there can be no assurance that we will accurately predict the outcomes of these audits, which could have

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The failure to comply with anti-corruption laws

could materially adversely affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.

could materially affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.

FCPA and similar anticorruption laws in other jurisdictions

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in non-convertible debt during the preceding three year period.

Until such time, however, we cannot predict if investors

Until such a time, however, we cannot predict if investors

will find our common stock less attractive because we may rely on these exemptions.

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In addition, South Africa is also a very solar capable country due to

the weather being warm with desert like conditions.

Therefore, we are looking into solar power as a means to run our production facilities

more efficiently in the longer run.

South Africa Specific Risk of Political

instability May Affect the Medinotec Group of Companies’ ability to operate effectively.

the weather being warm with sub-tropical like conditions.

Therefore, we are looking into solar power as a means to run our production

facilities more efficiently in the longer run.

South Africa Specific Risk of Political instability

May Affect the Medinotec Group of Companies’ ability to operate effectively.

Political instability in the countries in which we

operate, including South Africa, where recent episodes of violent civil unrest (riots) have further destabilized the country’s economy

operate, including South Africa, where episodes of violent civil unrest (riots) have further destabilized the country’s economy

and resulted in extensive damage to commercial property, and may cause increased uncertainty about our ability to exist in this environment.

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can affect our business in turn.

South Africa Specific Risk In South Africa,

BEE requirements may restrict growth opportunities and limit the Medinotec Group of Companies’ ability to attract key talent.

South Africa Specific Risk that Broad-based

Black Economic Empowerment (“BEE”) requirements may restrict growth opportunities and limit the Medinotec Group of Companies’

ability to attract key talent.

In South Africa, the correction of inequalities amongst

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and failure to attract, recruit and retain key candidates and suitably qualified personnel.

South Africa Specific Risk that potential damage

to property caused by riots and protests may impact the Medinotec Group of Companies ability to operate.

Businesses that have operations or own assets in South

Africa face risks from events such as civil commotion, public disorder, strikes, riots, loadshedding and terrorism.

Resultant damage to

property stemming from such events can potentially disrupt our operations and also have an impact on the health and safety of our employees.

South Africa Specific Risk that South African

authorities may disallow or delay a transfer of funds from South Africa to the United States

The Central Reserve Bank of South Africa

oversees the flow of currency in and out of the republic of South Africa and the South African Revenue services oversee all transfer pricing

The Medinotec Group of Companies has a transfer pricing bench marking in place for future planned transactions between its South

African subsidiaries and Medinotec Inc., its U.S.

parent company, and makes use of an external exchange control advisor to ensure any

cross-border transactions complies with the requirements of both the Reserve Bank and the South African Revenue services.

This is an approval

process for the flow of funds and therefore may cause timing delays to transfer funds cross border but does not mean that it is disallowed

We have successfully concluded a Private Placement during May of 2022 to the value of $ 3.3 million in the name of Medinotec

Inc., which raise provided enough cashflow to fund our expected American operations and therefore we do not foresee that in the near future

there will be intercompany or cross border dependence for operational activities.

The Central Reserve Bank of South Africa oversees

the flow of currency in and out of the republic of South Africa and the South African Revenue services oversee all transfer pricing issues.

The Medinotec Group of Companies has transfer pricing bench marking in place for future planned transactions between its South African

subsidiaries and Medinotec Inc., its U.S.

parent company, and makes use of an external exchange control advisor to ensure any cross-border

transactions complies with the requirements of both the Reserve Bank and the South African Revenue services.

This is an approval process

for the flow of funds and therefore may cause timing delays to transfer funds cross border but does not mean that it is disallowed entirely.

We have successfully concluded a Private Placement during May of 2022 to the value of $ 3.3 million in the name of Medinotec Inc., which

raise provided enough cashflow to fund our expected American operations and therefore we do not foresee that in the near future there

will be intercompany or cross border dependence for operational activities.

We believe that once Medinotec Inc.

establishes its

own sales network the company is expected to become self-sustaining.

If for some reason there is a time delay and the funding raised during

the private placement is not enough, to realize the business plan of the parent, the operating subsidiary in South Africa would be its

only source of cashflow to sustain the Medinotec Group of Companies.

Allowable cash flows and their expected

timelines are disclosed in the following table:

establishes its own sales

network the company is expected to become self-sustaining.

If for some reason there is a time delay and the funding raised during the

private placement is not enough, to realize the business plan of the parent, the operating subsidiary in South Africa would be its only

source of cashflow to sustain the Medinotec Group of Companies.

Allowable cash flows and their expected timelines

are disclosed in the following table:

Normal Time Delay Experienced

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It is important to note that the above-mentioned

table is the only three options to externalize funds out of South Africa, the time delays mentioned are based on prior experience and

table is the only three options to externalize funds out of South Africa.

The time delays mentioned are based on prior experience and

guidance from expert advisors.

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is important to note that this successful raise of money does not guarantee that we will obtain regulatory approval in the USA for product

candidates that falls outside the Trachealator product which already obtained FDA approval in November 2021.

candidates that fall outside the Trachealator product which already obtained FDA approval in November 2021.

In addition to this it also

does not guarantee successful commercializing of any products in the USA since all products are at a pre- commercialization phase in the

United States of America.

does not guarantee successful commercializing of any products in the United States of America.

South Africa Specific Risk of South Africa Being

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and positive progress, reducing the 67 Recommended Actions to 8 strategic deficiencies, where more progress is required.

South Africa did poorly in its 2021 mutual evaluation,

which was conducted in 2019 when many institutions (especially law-enforcement agencies) were at their weakest following state capture.

Whilst no country is fully compliant with all 40 FATF Recommendations and all 11 effective immediate outcomes, South Africa was deemed

to have too many weaknesses in its legal framework (being deemed to be inadequately compliant with 20 of FATF’s recommendations)

in all 11 effectiveness immediate outcomes.

South Africa was put under a one-year observation period in October 2021, giving the country

time to address 67 Recommended Actions.

South Africa made significant progress during the observation period, passing two major Amendment

Acts in 2022, and strengthening its institutions.

A January 2023 assessment of SA’s progress found that South Africa had made significant

and positive progress, reducing the 67 Recommended Actions to 8 strategic deficiencies, where more progress is required.

The most significant implication to a country that

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The second and related implication arises from consequential

action taken with regard to cross-border transactions, particularly possible action taken by foreign banks that provide correspondent

banking services.

action taken regarding cross-border transactions, particularly possible action taken by foreign banks that provide correspondent banking

It should be noted that FATF does not require enhanced due diligence measures to be applied, but rather that all jurisdictions

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already and applies high levels of due diligence and financial contol therefore the additional costs of compliance expected to be incurred

due to the Grey listing is in our opinion minimal, this assessment may however change based on Government’s response into the future.

due to the greylisting is in our opinion minimal, this assessment may however change based on Government’s response into the future.

This status may however make it harder for the business to raise capital in the future, Generally, it takes from one to three years for

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This may, in turn, result in a substantial decrease in the per-share value of your common stock.

If a market for our common

stock does not develop, stockholders may be unable to sell their shares

If a market for our common stock does not develop,

stockholders may be unable to sell their shares

Our common stock is quoted under the symbol “MDNC”

on the OTCQX operated by OTC Markets Group, Inc., an electronic inter-dealer quotation medium for equity securities.

We have just recently

been approved for trading, so we do not have an active trading market.

We were approved

for trading in March 2023, and we do not have an active trading market.

We can provide no assurances that an active trading market will

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cause the stock price or trading volume to decline.

Because we will be subject to the “Penny

Stock” rules once our shares are quoted on the over-the-counter bulletin board, the level of trading activity in the Medinotec Group

of Companies’ stock may be reduced.

Because we are subject to the “Penny Stock”

rules and our shares are quoted on the over-the-counter bulletin board, the level of trading activity in the Medinotec Group of Companies’

stock may be reduced.

The Securities and Exchange Commission has adopted

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If the Medinotec Group of Companies issues shares

of preferred stock with superior rights than the common stock, it could result in a decrease in the value of our common stock and delay

of preferred stock with superior rights to the common stock, it could result in a decrease in the value of our common stock and delay

or prevent a change in control of us.

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of operations and cash flows, and adversely affect prevailing market prices for our common stock.

UNRESOLVED STAFF COMMENTS

This information is not required for smaller reporting companies.

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 1A. Risk Factors