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Item 1A. Risk Factors

2025-05-29 compared with 2024-07-05 · 302 added, 266 removed, 1233 unchanged (32% of the section changed)

15 unchanged sentences

SUMMARY OF RISK FACTORS

Our business is subject to numerous risks and uncertainties,

including those highlighted in the section titled “Risk Factors”, that represent challenges that we face in connection with

the successful implementation of our strategy.

Any investment in the business at its current stage can be deemed to be extremely speculative

The occurrence of one or more of the events or circumstances described in the section titled “Risk Factors,”

alone or in combination with other events or circumstances, may have an adverse effect on our business, cash flows, financial condition,

and results of operations.

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.

The following is a condensed summary of the principal

risks associated with our business.

These risks represent the key challenges and uncertainties we face, and they are described in greater

detail in the “Risk Factors” section of this report.

Investing in our securities involves a high degree of risk, and the occurrence

of any of these factors could materially and adversely affect our business, financial condition, results of operations, or stock price.

Financial Risks:

We carry substantial debt,

may need additional financing, and face exposure to interest rate changes, accounting rule shifts, and tax regulation updates, all of

which could impact financial flexibility and results.

Operational Challenges:

Our success depends

on product development, supply chain continuity, and competitive positioning.

Industry consolidation, pricing pressures, IT disruptions,

and foreign exchange volatility pose risks to our operations and profitability.

Customer and Market Exposure:

We rely heavily

on a limited number of customers, including DISA Life Sciences, which increases the risk of revenue concentration.

Inadequate insurance

coverage and internal control weaknesses may further exacerbate operational vulnerabilities.

Management and Governance:

Our business depends

on a small number of key personnel, many of whom are located outside the U.S.

Concentrated voting power among founders and limited public-company

experience heighten governance and compliance risks.

Regulatory and Legal:

Delays in obtaining regulatory

approvals, potential product liability, compliance with marketing and reimbursement rules, IP protection, and evolving environmental and

data privacy laws all pose significant risks.

Violations could lead to penalties or legal action.

Geopolitical and Regional Risks:

and economic instability in South Africa—such as load-shedding, exchange controls, and FATF grey-listing—may impair operations.

Broader geopolitical tensions and trade disputes also affect supply chains and market access.

Geopolitical and trade risks due to

tariffs and trade wars.

Market and Securities Risks:

Our shares trade

on the OTCQX market and are considered penny stocks, which may limit liquidity.

Future equity issuances could dilute existing shareholders,

and share prices may fluctuate significantly due to external factors

Details of the above risks are as follows:

Risks 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.

Risks 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.

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.

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.

Failure to obtain clearance or authorization for our

medical devices, or other delays in the development of our medical devices, would adversely affect our ability to grow our business.

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.

Failure to obtain clearance or authorization for our

medical devices, or other delays in the development of our medical devices, would adversely affect our ability to grow our business.

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

agencies determine we have engaged in the off-label promotion of our products or have disseminated false or misleading labeling or promotional

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.

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.

Because we are a “Smaller Reporting Company,” we may take advantage of certain scaled disclosures available to us, resulting in holders of our securities receiving less company information than they would receive from a public company that is not a Smaller Reporting Company.

Risks Associated with Political Instability

and Regional Issues

Geopolitical and trade risks due to tariffs and trade

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 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

Medinotec faces heightened geopolitical and trade risks due to South African international relations, as potential revocation of AGOA benefits, increased tariffs, and stricter import regulations on South African goods could significantly impact the cost, compliance, and competitiveness of its U.S.-bound medical exports.

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 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

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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

portion of the operating lease liability, deferred tax liabilities 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 time.

The prevailing prime lending rate as of February 28, 2025, in South Africa is 11.00%.

The interest charged for the year ended

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.

February 28, 2025, for the consolidated Medinotec Group of Companies was $176,416 and a 1% movement in the interest rates constitutes

a value of $16,038 on an annual basis.

From time to time the Group utilized trade

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the year ended February 28, 2025 for the consolidated Medinotec Group of Companies was $28,126 and $35,317 for the year ended February

Trade Finance carries a charge of prime plus 1% therefore 12.75% at February 29, 2024 a 1% movement would equate to $2,770 for

the year ending February 29, 2024.

Trade finance is use specific and linked to inventory ordering therefore no forecast will be disclosed

for an expected change in annual utilization and the quarter and six-month sensitivity adjustments are disclosed on the current orders

financed by trade finance at the time.

Trade Finance carries a charge of prime plus 1% therefore 12.00%, at February 28, 2025.

A 1% movement in the interest rate would

equate to $2,344 for the year ending February 28, 2025.

Trade finance is use specific and linked to inventory ordering therefore no forecast

will be disclosed for an expected change in annual utilization and the quarter and six-month sensitivity adjustments are disclosed on

the current orders financed by trade finance at the time.

As of February 28, 2025, the related party

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Therefore, if settled today it would constitute 34% of available cash.

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.

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.

This could have adverse consequences, including the following:

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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 its debt.

If this occurs,

we may lose all of our assets and go out of business.

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

ability to operate as a going concern.

Management evaluated the Company’s ability to

continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available

funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance

of these financial statements.

The Medinotec Group of Companies may need additional

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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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Any failure in

the supply chain would result in lack of inventory and the inability to sell product.

For all other non-key materials, we find that these

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

the supply chain would result in a lack of inventory and an inability to sell products.

For all other non-key materials, we find that

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

The Medinotec Group of Companies rely on the

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and affect the reported results of operations.

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

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

forex implications of their volatile currencies.

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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

international first world markets.

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

for customers and accounts.

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

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

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

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

achieving regulatory approvals, none of which can be guaranteed.

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 Life Sciences for customers

and accounts.

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

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

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

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

approvals, none of which can be guaranteed.

Please refer to the related parties and entities section

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Holds pricing and negotiating leverage, which can decrease revenue

Diverts disproportionate amount of resources away from smaller customers

Diverts disproportionate amounts of resources away from smaller customers

Causes difficulty diversifying over time

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trends may not be indicative of future losses.

Risks associated with insurance plans include:

Insurance costs could increase significantly, or the availability of insurance may decrease, either of which could adversely impact our financial condition;

Deductible or retention amounts could increase, or our coverage could be reduced in the future and to the extent losses occur, there could be an adverse effect on our financial results depending on the nature of the loss and the level of insurance coverage we maintained;

Insurance may not be available to us at an economically reasonable cost, or our insurance may not adequately cover our liability in connection with claims brought against us;

As our business inherently exposes us to claims, we may become subject to claims for which we are not adequately insured.

Unanticipated payment of a large claim may have a material adverse effect on our business.

The absence of sufficient third-party insurance coverage

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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;

reduced control over product cost, delivery schedules and product quality;

potential price increases;

inability to achieve sufficient production, increase production or test capacity and achieve acceptable yields on a timely basis;

increased exposure to potential misappropriation of our intellectual property;

shortages of materials used to manufacture products;

capacity shortages.

We distribute commodity medical products on

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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.

enter distribution and other strategic arrangements with third-party retailers and other potential distributors of our products successfully compete in the product categories in which we choose to operate;

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

introduce new and appealing products and successfully innovate our existing products;

develop and maintain consumer interest in our brand;

increase our brand recognition and loyalty.

We may not be able to implement this growth strategy

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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.

by FINRA, 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

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

The Medinotec Group

of Companies’ largest shareholder, officer and director, Dr.

Gregory Vizirgianakis, has substantial control over us and our policies

and will be able to influence corporate matters.

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.

Gregory Vizirgianakis, our Founder, President,

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federal securities laws.

The Medinotec Group

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

Our officers and directors

have limited experience managing a public company.

The Medinotec Group of companies’ officers

and directors have limited experience managing a public company.

Our officers and directors have limited experience

managing a public company.

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

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

of your investment.

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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on our ability to expand our business.

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.

We have no such FDA approval with respect to the

reset of our medical devices and we have not performed any clinical testing of our medical devices, which will likely be required before

rest of our medical devices and we have not performed any clinical testing of our medical devices, which will likely be required before

the device can be marketed.

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and business and financial information.

The secure processing, storage, maintenance, and transmission

of this critical information is vital to operations and business strategy, and we devote resources to protecting such information.

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

The secure processing, storage, maintenance, and

transmission of this critical information is vital to operations and business strategy, and we devote resources to protecting such information.

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

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

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actions and regulatory penalties.

Unauthorized access, loss or dissemination could also

interrupt operations, including the ability to receive and ship orders from customers, bill our customers, provide customer support services,

conduct research and development activities, process and prepare company financial information, manage various general and administrative

aspects of our business and damage our reputation, any of which could adversely affect the business.

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.

C hanges in tax laws or

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

financial conditions and cash flows.

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

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as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Because we are a “Smaller Reporting Company,”

we may take advantage of certain scaled disclosures available to us, resulting in holders of our securities receiving less company information

than they would receive from a public company that is not a Smaller Reporting Company.

We are a “smaller reporting company” as

defined in the Exchange Act.

As a smaller reporting company, we may take advantage of certain of the scaled disclosures available to smaller

reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) our voting and non-voting common

stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or (ii) our annual

revenue is less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates

is less than $700 million measured on the last business day of our second fiscal quarter.

To the extent we take advantage of any reduced

disclosure obligations, it may make it harder for investors to analyze the Company’s results of operations and financial prospectus

in comparison with other public companies.

Risks Associated with Political Instability and

Regional Issues

Geopolitical and Trade Risks due to tariffs

and trade wars

Medinotec Inc.

operates in a challenging geopolitical

and trade environment that exposes the company to several risks that could adversely affect our financial performance and operations.

has recently impos ed

significant tariffs on imports from South Africa and other nations, with tariffs ranging up to 30% on a variety of goods, including

machinery, vehicles, and precious metals.

This has raised concerns regarding the future of the African Growth and Opportunity Act (AGOA),

which has previously provided preferential trade benefits, including duty-free access to the U.S.

market for South African goods.

these benefits be revoked, we could face increased export costs and reduced demand for our products in the U.S., which represents a significant

market for our business.

At the May 21, 2025

Oval Office meeting, U.S.

President Donald J.

Trump and South African President Cyril Ramaphosa met, but no changes to the imposed tariffs

were announced.

While the South African

government is exploring the possibility of negotiating a bilateral trade agreement with the U.S., the outcome and timeline of these discussions

are uncertain.

As a result, the tariffs and the potential loss of AGOA benefits could significantly disrupt our U.S.

market strategy

and increase the costs of our exports to the U.S.

The current global trade tensions, including the tariffs

imposed by the U.S., have led to a ripple effect in other markets, including Europe.

European governments may respond with retaliatory

tariffs or other trade measures, potentially increasing the cost of medical device products we distribute from European suppliers.

price increases could have an adverse impact on our business, as we may be unable to offset the rising costs without passing them onto

Since we are locked into agreements with our suppliers for the distribution of their products in South Africa, our ability

to mitigate these cost increases is limited.

South Africa is experiencing significant political

instability, with tensions rising within the ruling coalition government.

The potential collapse of the government of national unity and

the uncertainty surrounding fiscal policies, such as increases in VAT or other tax rates, could disrupt business operations.

In particular,

such instability may lead to regulatory changes, higher operating costs, or interruptions to our manufacturing activities in South Africa.

While Medinotec Inc.

cannot directly influence these

political developments, we are closely monitoring the situation and assessing potential risks to our operations.

We are also considering

contingency plans to manage any disruptions that could arise from governmental changes or civil unrest.

While we are not large enough to directly engage with

policymakers, we are actively monitoring developments related to trade tariffs and political instability in South Africa.

We will continue

to adapt our strategies based on emerging trends and adjust our risk management approach accordingly.

For our self-manufactured products, we are actively

exploring options to diversify our supply chain, which will help reduce exposure to any disruptions caused by tariff changes or political

However, for our agency business, where we distribute products for multinational medical device companies, we are reliant

on our suppliers and their pricing decisions, which limit our ability to mitigate the impact of potential tariff-induced cost increases.

Despite these efforts, the interconnected nature of

these risks means that their cumulative impact could be more significant than anticipated, potentially affecting our financial results

and operational stability.

South Africa Specific Risk of Unstable Power

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37 jurisdictions

including South Africa and 2 regional organisations (the Gulf Cooperation Council and the European Commission).

including South Africa and 2 regional organizations (the Gulf Cooperation Council and the European Commission).

There are a further 31

international and regional organisations which are Associate Members or Observers of the FATF and participate in its work.

international and regional organizations which are Associate Members or Observers of the FATF and participate in its work.

is the only African member of FATF, but other African jurisdictions participate through FATF Regional Bodies like the Eastern and Southern

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The most significant implication to a country that

is greylisted is the reputational damage to the country, as its effectiveness in combatting financial crimes like corruption and money-laundering

as well as terror financing are deemed to be below international standards.

The second and related implication arises from consequential

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

take account of it in their risk analysis.

is grey-listed is the reputational damage to the country, as its effectiveness in combatting financial crimes like corruption

and money-laundering as well as terror financing are deemed to be below international standards.

The second and related implication arises

from consequential action taken regarding cross-border transactions, particularly possible action taken by foreign banks that provide

correspondent banking services.

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

that all jurisdictions take account of it in their risk analysis.

The same FATF statement quoted above notes:

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own laws (eg EU directives).

Hence institutions based in a greylisted country that engages in cross-border trade and other activities

Hence institutions based in a grey-listed country that engages in cross-border trade and other activities

may be subject to higher levels of customer due diligence by financial institutions outside of that country.

In practice, this means being

more thorough processing and vetting clients and understanding the sources of their funds.

However, if a country has demonstrated that

it has taken strong and credible steps to prevent or get out of greylisting, the costs of greylisting will likely be reduced.

of South Africa, none of the items on the action plan relate directly to preventive measures in respect of the financial sector, reflecting

significant progress since the mutual evaluation in the application of a risk-based approach to the supervision of banks and insurers.

National Treasury, therefore, expects that if South Africa continues to make significant improvements in effectiveness and swiftly exits

greylisting, it will have a limited impact on financial stability and costs of doing business with South Africa, particularly if South

Africa moves speedily to get out of greylisting.

Companies in South Africa, responding to the greylisting

will require context-specific solutions depending on the broader impact of the greylisting on their plans around aspects such as strategic

In practice, this means

being more thorough processing and vetting clients and understanding the sources of their funds.

However, if a country has demonstrated

that it has taken strong and credible steps to prevent or get out of grey listing, the costs of grey listing will likely be reduced.

In the case of South Africa, none of the items on the action plan relate directly to preventive measures in respect of the financial

sector, reflecting significant progress since the mutual evaluation in the application of a risk-based approach to the supervision of

banks and insurers.

National Treasury, therefore, expects that if South Africa continues to make significant improvements in effectiveness

and swiftly exits grey listing, it will have a limited impact on financial stability and costs of doing business with South Africa, particularly

if South Africa moves speedily to get out of grey listing.

Companies in South Africa, responding to the grey-listing

will require context-specific solutions depending on the broader impact of the grey listing on their plans around aspects such as strategic

expansions, capital raising, and any general increased cost of doing business.

Medinotec trades in a highly regulated environment

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

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

countries to address the deficiencies and to be taken off the grey list, something that occurs after a final, on-site assessment when

both FATF and the relevant country believe that all elements of the action plan have been largely or fully addressed.

The South African

Government communicated that it plans to address the eight (8) areas of strategic deficiencies identified by the FATF, by no later than

the end of January 2025 and that government has an intention to exit the grey list as fast as possible.

There may however be unplanned

already and applies high levels of due diligence and financial control 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

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 countries to address the deficiencies and to be taken off the grey list, something that occurs after a final, on-site assessment

when both FATF and the relevant country believe that all elements of the action plan have been largely or fully addressed.

African Government communicated that it plans to address the eight (8) areas of strategic deficiencies identified by the FATF, by no

later than the end of January 2025 and that government has an intention to exit the grey list as fast as possible.

There may, however,

be unplanned delays.

Despite the progress the South African Government

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

Management evaluated the Company’s ability to

continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available

funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance

of these financial statements.

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