Item 1A. Risk Factors
Item 1A.
Risk Factors.
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
statements. If any of the following risks actually occurs, our business, financial condition or results of operations could be harmed.
In that case, you may lose all or part of your investment. In addition to other information in this registration statement and in other
filings we make with the Securities and Exchange Commission, the following risk factors should be carefully considered in evaluating our
business as they may have a significant impact on our business, operating results and financial condition. If any of the following risks
actually occurs, our business, financial condition, results of operations and future prospects could be materially and adversely affected.
Because of the following factors, as well as other variables affecting our operating results, past financial performance should not be
considered as a reliable indicator of future performance and investors should not use historical trends to anticipate results or trends
in future periods.
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
in nature. 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:
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.
·
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.
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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
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.
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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.
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Risk Associated With Legal and Regulatory Matters
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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.
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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.
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South Africa Specific Risk that South African authorities may disallow or delay a transfer of funds from South Africa to the United States
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South Africa Specific Risk of Being Grey listed by the FATF- Financial Action Task Force
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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
leverage and debt service obligations could adversely affect the business.
As of February 28, 2023, 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. During the
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%.
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.
From time to time the Group utilized trade
finance to assist with funding of orders for raw materials with longer lead and shipping times the interest spent on trade finance for
the year ended February 28, 2023 for the consolidated Medinotec Group of Companies was $48,230 and $13,209 for the year ended February
28, 2022. Trade Finance carries a charge of prime plus 1% therefore 11.75% at February 28, 2023 a 1% movement would equate to $4,104 for
the year ending February 28, 2023. 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.
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As of February 28, 2023, 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. A 1% movement in the interest rates constitutes a value of $16,612.
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
or in cash. Therefore, the impact on cashflow would be zero.
If we elect to settle the loan in cash: Cash
reserves available in February 2023 in the Consolidated Medinotec Group of Companies were $2,827,457 and the loan account outstanding
at the same time was $1,863,066. Therefore, if settled today it would constitute 66% 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.
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 and therefore complies with the arm’s length definitions in ASC
850-10-50-6.
We may also incur additional indebtedness in the future.
This could have adverse consequences, including the following:
•
making it more difficult for us to satisfy our financial obligations;
•
increasing vulnerability to adverse economic, regulatory and industry conditions;
•
placing us at a disadvantage to our competitors that are less leveraged;
•
limiting the ability to compete and flexibility in planning for, or reacting to, changes in the business and the industry in which we operate;
•
limiting the ability to borrow additional funds for working capital, capital expenditures, acquisitions and general corporate or other purposes; and
•
exposing us to greater interest rate risk since the interest rate on floating rate borrowings is variable.
Our debt service obligations require us to use a portion
of the operating cash flow to pay interest and principal on indebtedness instead of for other corporate purposes, including funding the
future expansion of the business, acquisitions, and ongoing capital expenditures, which could impede growth. If operating cash flow and
capital resources are insufficient to service debt obligations, we may be forced to sell assets, seek additional equity or debt financing
or to restructure our debt, which could harm long-term business prospects.
Our failure to comply with the terms of 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. If this occurs,
we may lose all of our assets and go out of business.
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The Medinotec Group of Companies may need additional
financing – any limitation on our ability to obtain such additional financing could have a material adverse effect on the business,
financial condition, and results of operations.
Our expansion plans may require additional capital
and we may need capital to operate our business in response to circumstances caused by the risks in conducting business in this industry.
The raising of additional capital could result in dilution to stockholders. In addition, there is no assurance that we will be able to
obtain additional capital if we need it, or that if available, it will be available to us on favorable or reasonable terms. Any limitation
on our ability to obtain additional capital as and when needed could have a material adverse effect on the business, financial condition
and results of operations.
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
or practices or existing taxation rules or practices may cause adverse or unexpected revenue fluctuations and affect the reported results
of operations within The Medinotec Group of companies.
A change in accounting standards or practices or a
change in existing taxation rules or practices can have a significant effect on our reported results and may even affect our reporting
of transactions completed before the change is effective. This also applies to new standards, practices and rules.
Changes to existing rules or the questioning of current
practices may adversely affect our reported financial results or the way we conduct our business. The fact that we operate in multiple
territories and have 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
as Covid-19. 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
on travel. 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.
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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.
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Healthcare industry cost-containment measures
could result in reduced sales of the Medinotec Group of Companies medical devices and medical device components.
Most of our customers and the healthcare providers
to whom our customers supply medical devices, rely on third-party payers, including government programs 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
are used.
The continuing efforts of governmental authorities,
insurance companies and other payers of healthcare costs to contain or reduce these costs could lead to patients being unable to obtain
approval for payment from these third-party payers.
If third-party payer payment approval cannot be obtained
by patients, sales of finished medical devices that include our components may decline significantly and our customers may reduce or eliminate
purchases of these components.
The cost-containment measures that healthcare providers
are instituting, both in the US and outside of the US could harm our ability to operate profitably.
The continuing development of many of our products
and offerings depends on our maintaining strong relationships with healthcare professionals, and these professionals are external to the
Medinotec Group of Companies.
If we fail to maintain our working relationships with
healthcare professionals, many of our products may not be launched and marketed in line with the needs and expectations of the professionals
who use and support our products, which could cause a decline in earnings and profitability.
The research, development, marketing and sale of many
of our new products depends on our maintaining working relationships with healthcare professionals, relying on them to provide considerable
knowledge and experience regarding the development, marketing and sale of products. Physicians assist us as researchers, product consultants,
inventors and public speakers.
Any failure to maintain these relationships and expand
our network to include new professionals in the territories we enter will have a negative impact on our financial success. In addition,
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
Medinotec Group of Companies may not come to market or fail to commercialize.
We will, at any time, have several innovative products
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.
The Medinotec Group of Companies operate in
a highly competitive industry and may be unable to compete effectively.
We compete in medical markets throughout the world,
which are characterized by rapid changes resulting from technological advances and scientific discoveries. In the product lines in which
we compete, we face competition ranging from large companies with multiple business lines to small, specialized manufacturers that offer
a limited selection of niche products. Development by other companies of new or improved products, processes, technologies, or the introduction
of reprocessed products or generic versions when our proprietary products lose their patent protection may make existing or planned products
less competitive.
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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
quality and safety, breadth of product lines, product support services, customer support, cost-effectiveness and price, reimbursement
approval from healthcare insurance providers, and changes to the regulatory environment.
Competition may increase as additional companies enter
our markets or modify their existing products to compete directly with ours. In addition, academic institutions, governmental agencies
and other public and private research organizations also may conduct research, seek patent protection and establish collaborative arrangements
for discovery, research, clinical development and marketing of similar products.
These companies and institutions compete with us in
recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. From time
to time we have lost, and may in the future lose, market share in connection with product problems, physician advisories, safety alerts
and publications about our products, which highlights the importance of product quality, product efficacy and quality systems to the business.
In the current environment of managed care, consolidation
among healthcare providers, increased competition, and declining reimbursement rates, we have been increasingly required to compete on
the basis of price. Further, our continued growth and success depend on our ability to develop, acquire and market new and differentiated
products, technologies and intellectual property. As a result, we also face competition for marketing, distribution, and collaborative
development agreements, establishing relationships with academic and research institutions and licenses to intellectual property.
In order to continue to compete effectively, we must
continue to create, invest in or acquire advanced technology, incorporate this technology into its proprietary products, obtain regulatory
approvals in a timely manner, and manufacture and successfully market our products. Given these factors, we cannot guarantee that we will
be able to compete effectively or continue its current level of success.
Reduction or interruption in supply or
other manufacturing difficulties may adversely affect operations and related product sales within the Medinotec Group of Companies.
The supply of products requires timely delivery and
exact planning due to most of our raw material either being manufactured by suppliers or imported. These suppliers/strategic partners
require a sufficient amount of quality components and materials and is highly exacting and complex, due in part to strict regulatory requirements.
We have generally been able to obtain adequate supplies
of such finished goods, raw materials, components, and services. However, for reasons of quality assurance, cost effectiveness, or availability,
certain components, raw materials, goods and services needed to fill our supply chain are obtained from various sole suppliers.
Although we work closely with our suppliers to ensure
continuity of supply while maintaining high quality and reliability, the supply of these goods, components, raw materials and services
may be interrupted or insufficient. In addition, due to the stringent regulations and requirements of regulatory agencies, regarding the
manufacture and import/export of our products, we may not be able to quickly establish additional or replacement sources. In addition,
a reduction or interruption in supply, and an inability to develop alternative sources for such supply, could adversely affect our ability
to supply products in a timely or cost-effective manner and could result in lost sales.
Other disruptions in the supply chain process or product
sales and fulfilment systems for any reason, including equipment malfunction, failure to follow specific protocols and procedures, supplier
facility shut-downs, defective raw materials, wars and conflict, natural disasters such as hurricanes, tornadoes or wildfires, property
damage from riots, and other environmental factors and the impact of epidemics or pandemics, such as Covid-19, and actions by businesses,
communities and governments in response, could lead to launch delays, product shortage, unanticipated costs, lost revenues and damage
to our reputation. 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
pandemic. 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.
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In addition, several key components are manufactured
or sterilized at a particular facility, with limited alternate facilities. If an event occurs that results in damage to or closure of
one or more of such facilities, such as the damage caused by natural disasters, power outages, civil unrest and other factors, we may
be unable to manufacture or sterilize the relevant products at the previous levels or at all. Because of the time required to approve
and license a manufacturing or sterilization facility, a third-party may not be available on a timely basis to replace production capacity
in the event manufacturing or sterilization capacity is lost.
In order to manage any supply chain risk, we have
identified key and crucial components in our manufacturing lines that we deem not to be readily available, and we have vetted 2-3 trusted
suppliers, which we believe mitigates the risk of becoming overly reliant on a specific supplier. Despite this precaution, there is no
assurances that we will be able to secure the materials needed if the event these sources are unable to fulfil orders. 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.
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; and
•
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.
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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. This may
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
be impaired.
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
adversely.
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
proper function, security and availability of our IT systems and data to operate the business, and a breach, cyber-attack or other disruption
to these systems or data could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation,
or competitive position.
We are increasingly dependent on sophisticated IT
systems to operate the business, including to process, transmit and store sensitive data, and many of our products and services include
integrated software and IT that collects data regarding patients or connects to its systems.
Like other multi-national corporations, we could experience,
and in the past have experienced, attempted or actual interference with the integrity of, and interruptions to, our IT systems, as well
as data breaches, such as cyber-attacks, malicious intrusions, breakdowns, interference with the integrity of our products and data or
other significant disruptions.
Furthermore, we rely on third-party vendors to supply
and/or support certain aspects of our IT systems. These third-party systems could also become vulnerable to cyber-attack, malicious intrusions,
breakdowns, interference, or other significant disruptions, and may contain defects in design or manufacture or other problems that could
result in system disruption or compromise the information security of our own systems.
In addition, we continue to grow in part through new
business acquisitions and, as a result, may face risks associated with defects and vulnerabilities in their systems, or difficulties or
other breakdowns or disruptions in connection with the integration of the acquisitions into its own IT systems.
Our worldwide operations mean that we are subject
to laws and regulations, including data protection and cybersecurity laws and regulations, in many jurisdictions. Any data security breaches,
cyber-attacks, malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation, any
of which could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation or competitive
position.
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In addition, our IT systems require an ongoing commitment
of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes
in information processing technology, evolving legal and regulatory standards, the increasing need to protect patient and customer information,
changes in the techniques used to obtain unauthorized access to data and information systems, and the IT needs associated with changing
products and services.
There can be no assurance that the process of consolidating,
protecting, upgrading, and expanding systems and capabilities, continuing to build security into the design of products, and developing
new systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues
will not arise in the future. 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
data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer a loss of product functionality.
We could lose existing customers, have difficulty attracting new customers, have difficulty preventing, detecting, and controlling fraud,
be exposed to the loss or misuse of confidential information, have disputes with customers, physicians, and other healthcare professionals,
suffer regulatory sanctions or penalties under federal laws, state laws, or the laws of other jurisdictions, experience increases in operating
expenses or an impairment in our ability to conduct operations, incur expenses or lose revenues as a result of a data privacy breach,
product failure, IT outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to
reputation.
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.
Foreign exchange risk refers to the losses that an
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.
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 can also affect investors, who trade in international markets, and businesses engaged in the import/export of products
or services to multiple countries.
Our business of import/exports of raw materials and
goods exposes us to foreign exchange risk by having account payables and receivables affected by currency exchange rates. This risk originates
when a contract between us and our suppliers specifies exact prices for goods or services, as well as delivery dates. If a currency’s
value fluctuates between when the contract is signed and the delivery date, it could cause a loss for one of the parties.
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.
There are three types of foreign exchange risk that
we are exposed to:
•
Transaction risk : This is the risk that we face when we are buying a product from a company located in another country. The price of the product will be denominated in the selling company's currency. If the selling company's currency were to appreciate versus the buying company's currency, then the company doing the buying will have to make a larger payment in its base currency to meet the contracted price.
•
Translation risk : A parent company owning a subsidiary in another country could face losses when the subsidiary's financial statements, which will be denominated in that country's currency, have to be translated back to the parent company's currency.
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•
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.
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. This usually
involves forward contracts, options, and other exotic financial products that, if done properly, can protect us from unwanted foreign
exchange moves during periods of high volatility. We may also impose a strategy of not hedging due to the costs involved outweighing the
benefits. We then leave exposures unhedged until market conditions and costs justify proceeding with a hedging strategy into the future.
The long-term strategy is to make certain strategic
investments that will generate revenue in first-world, stable currencies to offset the impacts of cost of sales imports in developing
currencies.
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.
Accounts receivable concentration risk is the
level of revenue risk a portfolio holds as a result of relying on a small pool of customers. High customer concentration occurs when any
single customer accounts for 20% or more of revenue. 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”). These relationships provide the Group with more than 100 sales representatives in the South African
Market.
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. The Medinotec Inc. Group’s
expectation is to reduce reliance on the South African markets for customers and accounts as the Group endeavors to expand and enter into
international first world markets. However, there is no guarantee that our plan will result in a decrease in reliance on DISA Lifesciences
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
Year
ending February 28,
For
the period April 26, 2021 to February 28,
2023
2022
DISA Life Sciences
Sales
$ 335,786
$ 525,558
Minoan Medical
Sales
$ —
$ 465,695
% of sales made to related parties for the period*
34%
95%
* Percentages were calculated as a percentage
of related party sales against total sales.
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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. ASC
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
•
Greater focus on customer service and customer needs
•
Work with large customers similarly to partners
These relationships also pose the following risks
and downsides:
•
Loss can devastate revenue, profit and cash flow
•
Holds pricing and negotiating leverage, which can decrease revenue
•
Diverts disproportionate amount of resources away from smaller customers
•
Causes difficulty diversifying over time
•
Can decrease the value of a company
Due to the nature of the territories that we operate
in, it will be impossible to eliminate concentration risk. However, we do plan to diversify into a larger product basket and increase
our international footprint, either by growing operations into other territories or alternatively acquiring more business share in other
geographical territories.
The Medinotec Group of Companies insurance program
may not be adequate to cover future losses.
We have elected to combine a mix of self-insurance
and insured risks for most of the insurable risks across our company. We made this decision based on cost and availability factors in
the insurance marketplace.
We continue to maintain a directors and officers liability
insurance policy with third-party insurers that provides coverage for our directors and officers. This policy also covers product liability
claims to a limited extent. We also maintain a detailed stock throughput policy to ensure inventory is ensured against losses and fire
risk. All other assets fall into the category of self-insurance.
We continue to monitor the insurance marketplace to
evaluate the value of obtaining insurance coverage for other categories of losses in the future. Although we believe, based on historical
loss trends, that our self-insurance program accruals and existing insurance coverage will be adequate to cover future losses, historical
trends may not be indicative of future losses.
The absence of sufficient third-party insurance coverage
for other categories of losses increases our exposure to unanticipated claims and these losses could have a materially adverse impact
on the business, results of operations, financial condition and cash flows.
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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.
In order to develop new products and improve current
product offerings through our strategic partnerships with other principals, we focus our research and development programs largely on
the development of, or obtaining the exclusive distribution rights to, next-generation and technology offerings across multiple programs
and opportunities.
As a part of the regulatory process of obtaining marketing
clearance from the respective countries’ regulators for new products, we and our strategic partners conduct and participate in numerous
clinical trials with a variety of study designs, patient populations and trial endpoints. Unfavorable or inconsistent clinical data from
existing or future clinical trials conducted by us or partners related to us, by our competitors or by third parties, or the market’s
perception of this clinical data, may adversely impact our ability to obtain product approvals from the regulators, our position in, and
share of, the markets in which we participate and our business, financial condition, results of operations or future prospects.
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.
Our failure to maintain the effectiveness of our internal
controls in accordance with the requirements of best practices could have a material adverse effect on the business. It could lose investor
confidence in the accuracy and completeness of our financial reports, which could have an adverse effect on the price of the Common Stock.
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.
Risks Related to Management, Personnel and Control
Persons
The Medinotec Group of Companies depends on
our senior management personnel and may not be able to retain or replace these individuals or recruit additional personnel, which could
harm our business .
Our future success is substantially dependent on the
continued service of Dr. Gregory Vizirgianakis, our Founder, President, Chief Executive Officer and a member of our board of directors,
and Pieter van Niekerk, our Chief Financial Officer, Treasurer and a member of our board of directors. Dr. Vizirgianakis and Mr. van Niekerk
have extensive experience both with our company and in our industry and are familiar with our business, systems and processes. Their loss
would be catastrophic to our product offerings and ability to manage our business effectively, as we will likely not be able to find suitable
individuals to replace them on a timely basis or at all.
If the Medinotec Group of Companies are unable
to find, train and retain key personnel, including new showroom employees that reflect our brand image and embody our culture, we may
not be able to grow or sustain our operations.
We depend on several key management, executive, sales
and marketing, and technical personnel. The loss of the services of one or more key employees could delay the achievement of business
objectives. Our success will also depend on our ability to attract and retain additional highly-qualified executives, management, sales
and marketing and technical personnel to meet its growth goals. We further face intense competition for qualified personnel, many of whom
are often subject to competing employment offers, and we do not know whether we will be able to attract and retain such personnel.
Our success depends in a large part on the continued
service of the senior management team. In particular, the continued service of this group of individuals is critical to our vision, strategic
direction, culture, products and business plan. We do not maintain key-man insurance for any of the senior management team, and thus the
loss of any of our executives, even temporarily, or any other member of senior management, could harm the business.
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The Medinotec Group
of Companies’ largest shareholder, officer and director, Dr. Gregory Vizirgianakis, has substantial control over us and our policies
and will be able to influence corporate matters.
Dr. Gregory Vizirgianakis, our Founder, President,
Chief Executive Officer and a member of our board of directors, and his brother, Stavros Vizirgianakis, also a member of our board of
directors, together control our company with an 81% vote on all matters regarding shareholder approval by virtue of his ownership in our
common stock.
Gregory and Stavros Vizirgianakis have not agreed
to vote their shares together. If they decide to vote together on any matter, they are able to exercise significant influence over our
company, including the election of directors, the approval of significant corporate transactions, and any change of control of our company.
They could prevent transactions, which might be in the best interests of the other shareholders. Their interests may not necessarily be
in the best interests of the shareholders in general. The rest of our shareholders will be considered minority shareholders and these
will have little say in the direction of the Company as a result of their holdings.
The Medinotec Group of Companies’ officers
and directors are located outside of the U.S., so it will be difficult to effect service of process and enforcement of legal
judgments upon our officers and directors.
Our officers and directors are located outside of
the United States and reside in South Africa. As a result, it may be difficult to effect service of process within the
United States and enforce judgments of the US courts obtained against our executive officers and directors. Particularly, our shareholders
may not be able to:
•
Effect service of process in the U.S. on any of our officers and directors;
•
Enforce judgments obtained in U.S. courts against our officers and directors based upon the civil liability provisions of the U.S. federal securities laws;
•
Enforce, in a court outside of the U.S., judgments of U.S. courts based on the civil liability provisions of the U.S. federal securities laws; and
•
Bring an original action in a court in South Africa to enforce liabilities against any of our officers and directors based upon the U.S. federal securities laws.
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’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.
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Risk Associated With Legal and Regulatory Matters
The Medinotec Group of Companies are subject
to extensive medical device regulation that may impede or hinder the approval process for our products and, in some cases, may not ultimately
result in approval or may result in the recall or seizure of previously approved products.
The medical technology industry is regulated extensively
by governmental authorities, principally the FDA, and state regulatory agencies with oversight of various aspects of drug and device distribution,
sale, and use. The regulations are very complex, have become more stringent over time, and are subject to rapid change and varying interpretations.
Regulatory restrictions or changes could limit our ability to carry on or expand our operations or result in higher than anticipated costs
or lower than anticipated sales. The FDA and other federal and state governmental agencies regulate numerous elements of our business,
including:
•
product design and development;
•
pre-clinical and clinical testing and trials;
•
product safety;
•
establishment registration and product listing;
•
labeling and storage;
•
marketing, manufacturing, sales and distribution;
•
pre-market clearance or approval;
•
servicing and post-marketing surveillance, including reporting of deaths or serious injuries and malfunctions that, if they recurred, could lead to death or serious injury;
•
advertising and promotion;
•
post-market approval studies;
•
product import and export; and
•
recalls and field-safety corrective actions.
Before we can market or sell a new regulated product
or a significant modification to an existing product in the United States, we must obtain either clearance under Section 510(k) of the
FDCA, grant of a de novo classification request, or approval of a pre-market approval, or PMA, application from the FDA, unless an exemption
from pre-market review applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially
equivalent” to a legally marketed “predicate” device (in most cases Class II devices, with a few exceptions), with respect
to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. Class III devices approved
under the PMA process cannot serve as predicates. Clinical data are sometimes required to support substantial equivalence. In the de novo
process, the FDA must determine that general and special controls are sufficient to provide reasonable assurance of the safety and effectiveness
of a device, which is low to moderate risk and has no predicate (in other words, the applicant must justify the “down-classification”
to Class I or II for a new product type that would otherwise automatically be placed into Class III, but is lower risk). The PMA process
requires an applicant to demonstrate the safety and effectiveness of the device based on extensive data, including, but not limited to,
technical, preclinical, clinical trial, manufacturing and labeling data.
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The PMA process is typically required for devices that are deemed
to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices. Products that are approved through a PMA application
generally need FDA approval before they can be modified. Similarly, some modifications made to products cleared through a 510(k) may require
a new 510(k). The 510(k), de novo, and PMA processes can be expensive and lengthy and require the payment of significant fees, unless
an exemption applies. The FDA’s 510(k) clearance process usually takes from 3 to 12 months, but may take longer. The FDA’s
stated goal is to review de novo classification requests within 150 days, 50% of the time, but in reality the process for many applicants
generally takes even longer, up to a year or more. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance
process and generally takes from one to three years, or longer, from the time the application is submitted to the FDA until an approval
is obtained. The process of obtaining regulatory clearances, approvals, and emergency use authorization to market a medical device can
be costly and time-consuming, and we may not be able to obtain these clearances, approvals, or authorizations on a timely basis, or at
all for our proposed products.
If the FDA requires us to go through a lengthier,
more rigorous examination for marketing authorization of our medical devices or future modifications to our medical devices than we had
expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline or to not increase
in line with our forecasts. In addition, the FDA may determine that future products will require the more costly, lengthy and uncertain
PMA process. Although we do not market any devices under PMA, the FDA may demand that we obtain a PMA prior to marketing certain of our
future products. Further, even with respect to those future products where a PMA is not required, we cannot assure you that we will be
able to obtain the 510(k) clearances with respect to those products.
The FDA can delay, limit or deny clearance, approval,
or authorization of a device for many reasons, including:
•
we may not be able to demonstrate that our products are safe and effective for their intended users;
•
the data from our clinical trials may be insufficient to support clearance, approval, or authorization; and
•
the manufacturing process or facilities we use may not meet applicable requirements.
In addition, the FDA may change its clearance and
approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval
or clearance of our products under development. Any delay in, or failure to obtain or maintain, clearance or approval for our products
under development could prevent us from generating revenue from these products and adversely affect our business operations and financial
results. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or
other increased scrutiny on us, could dissuade some customers from using our products and adversely affect our reputation and the perceived
safety and efficacy of our product. Failure to comply with applicable regulations could jeopardize our ability to sell our products and
result in enforcement actions such as fines, civil penalties, injunctions, warning letters, recalls of products, delays in the introduction
of products into the market, refusal of the FDA or other regulators to grant future clearances or approvals, and the suspension or withdrawal
of existing clearances or approvals by the FDA or other regulators. Any of these sanctions could result in higher than anticipated costs
or lower than anticipated sales and negatively impact our reputation, business, financial condition and operating results. Furthermore,
any operations or product applications outside of the United States will subject us to various additional regulatory and legal requirements
under the applicable laws and regulations of the international markets we enter. These additional regulatory requirements may involve
significant costs and expenditures 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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Failure to obtain clearance or authorization
for our medical devices, or other delays in the development of our medical devices, would adversely affect our ability to grow our business.
Commercialization of our medical devices may require
an Emergency Use Authorization (EUA), FDA clearance of a 510(k) premarket notification submission, or authorization of a de novo submission.
The process for submitting and obtaining FDA clearance of a 510(k), authorization of a de novo submission, or EUA can be expensive and
lengthy. The FDA’s review process can take several months or longer, and we may not be able to obtain FDA clearance, de novo authorization,
or Emergency use Authorization for our medical devices on a timely basis, if at all. The FDA’s refusal of, or any significant delays
in receiving 510(k) clearance, de novo authorization, or Emergency use Authorization of our medical devices, would have an adverse effect
on our ability to expand our business.
FDA approval have been granted for the Trachealtor
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
the device can be marketed. Even if a clinical trial is completed, there can be no assurance that the data generated during a clinical
trial will meet the safety and effectiveness endpoints or otherwise produce results that will lead the FDA to grant marketing clearance,
approval, or authorization. In addition, any other delays in the development of our medical devices, for example, unforeseen issues during
product validation, would have an adverse effect on our ability to commercialize our medical devices.
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
510(k) clearances, de novo submissions, or pre-market approvals, or may require us to cease marketing or recall the modified products
until clearances are obtained.
FDA approval have been granted for the Trachealtor
following the 510(k) substantially equivalence process for Class II medical devices. Any modification to a 510(k)-cleared device that
could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture,
requires a new 510(k) clearance or, possibly, a de novo or PMA. The FDA requires every manufacturer to make this determination in the
first instance, and provides some guidance on decision making, but the FDA may review any manufacturer’s decision at any time. The
FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. If the FDA disagrees with our determination
and requires us to submit new 510(k) notifications, de novo submissions or PMAs for modifications to our previously cleared or approved
products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall
the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.
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We may be liable if the FDA or other U.S. enforcement
agencies determine we have engaged in the off-label promotion of our products or have disseminated false or misleading labeling or promotional
materials.
Our promotional materials and training methods must
comply with FDA and other applicable laws and regulations, including laws and regulations prohibiting marketing claims that promote the
off-label use of our products or that make false or misleading statements. Healthcare providers may use our products off-label, as the
FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine. FDA also could conclude that
a performance claim is misleading if it determines that there are inadequate non-clinical and/or clinical data supporting the claim. If
the FDA determines that our promotional materials or training promote of an off-label use or make false or misleading claims, it could
request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance
of an untitled letter, a warning letter, injunction, seizure, civil fines and criminal penalties. It is also possible that other federal,
state or foreign enforcement authorities might take action if they determine that our promotional or training materials promote an unapproved
use or make false or misleading claims, which could result in significant fines or penalties. Although our policy is to refrain from statements
that could be considered off-label promotion of our products or false or misleading, the FDA or another regulatory agency could disagree.
Violations of the FDCA may also lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well
as state consumer protection laws, which may lead to costly penalties and may adversely impact our business. Recent court decisions have
impacted FDA’s enforcement activity regarding off-label promotion in light of First Amendment Considerations; however, there are
still significant risks in this area, in part due to the potential for False Claims Act exposure. In addition, the off-label use of our
products may increase the risk of product liability claims. Product liability claims are expensive to defend and could result in
substantial damage awards against us and harm our reputation.
Healthcare policy changes may have a material
adverse effect on the Medinotec Group of Companies.
In response to perceived increases in healthcare costs
in recent years, there have been and continue to be proposals by several governments, regulators and third-party payers globally, including
the US federal and state governments, to control these costs and, more generally, to reform healthcare systems.
Certain of these proposals could, among other things,
limit the prices we are able to charge for products or the amounts of reimbursement available for our products, and could also limit the
acceptance and availability of such products.
The adoption of some or all of these proposals could
have a material adverse effect on the business, results of operations, financial condition and cash flows. If we experience decreasing
prices for our goods and services and we are unable to reduce expenses, there may be a materially adverse effect on the business, results
of operations, financial condition and cash flows.
The Medinotec Group of Companies is subject
to environmental laws and regulations and the risk of environmental liabilities, violations, and litigation.
We are subject to numerous US and non-US environmental,
health and safety laws and regulations concerning, among other things, the health and safety of employees; the generation, storage, use
and transportation of hazardous materials; emissions or discharges of substances into the environment; investigation and remediation of
hazardous substances or materials at various sites; chemical constituents in medical products; and end-of-life disposal and take-back
programs for medical devices.
Our operations and those of certain third-party suppliers
involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes.
If we or our suppliers violate these environmental laws and regulations, facilities could be shut down and violators could be fined, criminally
charged or otherwise sanctioned.
Furthermore, environmental laws outside of the US
are becoming more stringent, resulting in increased costs and compliance burdens. Certain environmental laws also assess liability on
current or previous owners or operators of real property for the costs of investigation, removal or remediation of hazardous substances
or materials at their properties or at properties which they have disposed of hazardous substances. In addition to clean-up actions brought
by governmental authorities, private parties could bring personal injury or other claims due to the presence of, or exposure to, hazardous
substances. The ultimate cost of site clean-up and timing of future cash outflows is difficult to predict, given the uncertainties regarding
the extent of the required clean-up, the interpretation of applicable laws and regulations, and alternative clean-up methods.
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The costs of complying with current or future environmental
protection and health and safety laws and regulations, or liabilities arising from past or future releases of, or exposures to, hazardous
substances, may exceed our estimates, or have a material adverse effect on the business, results of operations, financial conditions and
cash flows.
Finally, in some jurisdictions around the world, culture
and practice encourages reuse of disposable products when the product is clearly labelled for single use. Such reuse may expose us to
liability in these jurisdictions.
Claims made against the Medinotec Group of Companies
from time to time can result in litigation that could distract management from our business activities and result in significant liability
or damage to our brand.
As a company with expanding operations, we increasingly
face the risk of litigation and other claims against us. We have no such claims at present. Litigation and other claims may arise in the
ordinary course of our business and include employee claims, commercial disputes, landlord-tenant disputes, intellectual property issues,
product-oriented allegations and slip and fall claims. These claims can raise complex factual and legal issues that are subject to risks
and uncertainties and could require significant management time. Litigation and other claims against us could result in unexpected expenses
and liabilities, which could materially adversely 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
to defend and divert management and operating personnel from other business issues. A successful claim or claims against us could result
in payment of significant monetary damages and/or injunctive relief.
The Medinotec Group of Companies’ failure
to comply with laws and regulations relating to reimbursement of healthcare goods and services may subject it to penalties and adversely
impact its reputation, business, results of operations, financial condition and cash flows.
Our devices, products and therapies are purchased
principally by hospitals or physicians that typically bill various third-party payers, such as governmental healthcare programs, private
insurance plans and managed care plans, for the healthcare services provided to their patients.
The ability of customers to obtain appropriate reimbursement
for products and services from third-party payers is critical because it affects which products customers purchase and the prices they
are willing to pay. As a result, our devices, products and therapies are subject to regulation regarding quality and cost for reimbursement
and regulation of health are goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and
healthcare fraud.
Many territories have similar laws that apply to reimbursement
by state and other funded programs as well as in some cases to all payers. In certain circumstances, insurance companies attempt to bring
a private cause of action against a manufacturer for causing false claims.
In addition, our strategic investments position the
company as a manufacturer of FDA-approved devices reimbursable by federal healthcare programs. We are thus subject to the Physician Payments
Sunshine Act, which requires us to annually report certain payments and other transfers of value our company makes to US-licensed physicians
or US teaching hospitals. Any failure to comply with these laws and regulations could subject us or our officers and employees to criminal
and civil financial penalties.
We are also subject to risks relating to changes in
government and private medical reimbursement programs and policies, and changes in legal regulatory requirements in the US and around
the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating
to coverage of / or reimbursement for our products by administrators of these systems, could have an impact on the acceptance of and demand
for our products and the prices that customers are willing to pay for them.
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Quality problems and product liability claims
could lead to recalls or safety alerts, reputational harm, adverse verdicts or costly settlements, and could have a material adverse effect
on the business, results of operations, financial condition and cash flows.
Quality is extremely important to us and our customers
due to the impact of our products on patients, and the serious and potentially costly consequences of product failure. We are thus exposed
to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices.
In addition, many products are used
in intensive care settings with seriously ill patients. Component failures, manufacturing nonconformance, design defects, off-label use,
or inadequate disclosure of product-related risks or product related information with respect to our products, if they were to occur,
could result in an unsafe condition or injury to, or death of, a patient.
This could lead to recall of, or issuance of a safety
alert relating to, our products, and could result in product liability claims and lawsuits, including class actions, which could ultimately
result, in certain cases, in the removal from the body of such products and claims regarding costs associated therewith. Due to the strong
brand recognition of Medinotec name and our brands, a material adverse event involving one of our products could result in reduced market
acceptance and demand for all products within that brand, and could harm our reputation and ability to market products in the future.
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
become subject to recalls or safety alerts, our reputation could be damaged, we could lose customers and revenue and results of operations
could decline. Our success also depends on the ability to manufacture to exact specification for precision engineered components, sub-assemblies
and finished devices from multiple materials. If components fail to meet these standards or fail to adapt to evolving standards, our reputation,
competitive advantage and market share could be harmed.
In certain situations, we may undertake a voluntary
recall of products or temporarily shut down production lines based on performance relative to our own internal safety and quality monitoring
and testing data. Any of the foregoing problems, including future product liability claims or recalls, regardless of their ultimate outcome,
could harm our reputation and have a material adverse effect on the business, results of operations, financial condition and cash flows.
The Medinotec Group of Companies may not be
able to protect our intellectual property rights effectively.
Patents, trademarks and other intangible proprietary
rights are and will be essential to the business and our ability to compete effectively with other companies. During normal day-to-day
trade, we also rely on trade secrets, know-how, continuing technological innovations, strategic alliances and licensing opportunities
to develop, maintain and strengthen our competitive position.
We pursue a policy of obtaining patent protection
in both the US and overseas for patentable subject matter of our proprietary devices and 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.
We also operate in an industry that is susceptible
to significant intellectual property litigation. This litigation is expensive, complex, and lengthy and its outcome is difficult to predict.
Future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and
may significantly divert the attention of our technical and management personnel.
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In addition, we may have to take legal action in the
future to protect our patents, trade secrets, or know-how or to assert our intellectual property rights against claimed infringement by
others. Any such legal action could be costly and time consuming and no assurances can be made that any lawsuit will be successful.
The invalidation of key patents or proprietary rights
that we own, or an unsuccessful outcome in lawsuits to protect intellectual property, could have a material adverse effect on the business,
financial condition, and results of operations. In the event that the right to market any of our products is successfully challenged,
or if we fail to obtain a required license or are unable to design around a patent, the business, financial condition, and results of
operations could be compromised.
Security breaches, loss of data and other disruptions
could also compromise sensitive information related to the business, preventing it from accessing critical information or expose us to
liability, which could adversely affect the business and reputation.
In the ordinary course of business, we collect and
store sensitive data, including patient health information, personally identifiable information about employees, intellectual property,
and proprietary business information. We manage and maintain applications and data utilizing on-site and off-site systems. These applications
and data encompass a wide variety of business-critical information including research and development information, commercial information
and business and financial information.
The secure processing, storage, maintenance and transmission
of this critical information is vital to operations and business strategy, and we devote resources to protecting such information. Although
we take measures to protect sensitive information from unauthorized access or disclosure, our IT and infrastructure may be vulnerable
to attacks by hackers, viruses, breaches or interruptions due to employee error or malfeasance, terrorist attacks, hurricanes, fire, flood,
other natural disasters, power loss, computer systems failure, data network failure, internet failure, or lapses in compliance with privacy
and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be
accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result
in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement actions
and regulatory penalties.
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.
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.
Taxation regulation in territories around the world
can also change very quickly, which may mean that all the implications for businesses may not have been fully thought through by the regulating
authorities before final guidelines and laws are issued. Furthermore, any changes made by tax authorities, together with other legislative
changes, to the mandatory sharing of company information (financial and operational) with tax authorities on both a local and global basis,
could lead to disagreements between jurisdictions with respect to the proper allocation of profits between such jurisdictions. We therefore
continuously monitor changes to tax regulation and double tax treaties between the territories in which we operate. We also maintain a
comprehensive transfer pricing policy to govern the flow of funds between various tax territories.
We are further subject to ongoing tax audits in the
various jurisdictions in which we operate. We regularly assess the likely outcomes of these audits in order to determine the appropriateness
of our tax provisions. However, there can be no assurance that we will accurately predict the outcomes of these audits, which could have
a material impact on the business, financial condition, results of operations, and cash flows.
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While we have recorded reserves for potential payments
to various tax authorities related to uncertain tax positions, the calculation of such tax liabilities involves the application of complex
tax regulations in many jurisdictions. Therefore, any dispute with a tax authority may result in payment that is significantly different
from our estimates. If the payment proves to be less than the recorded reserves, the reversal of the liabilities would generally result
in tax benefits being recognized in the period when we determine the liabilities to be no longer necessary. Conversely, if the payment
proves to be more than the reserves, we would incur additional charges, and these could have a materially adverse effect on the business,
financial condition, results of operations, and cash flows.
The failure to comply with anti-corruption laws
could materially adversely affect the Medinotec Group of Companies and result in civil and/or criminal sanctions.
FCPA and similar anticorruption laws in other jurisdictions
generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining
or retaining business. Because of the predominance of government-administered healthcare systems in many jurisdictions around the world,
many of our customer relationships are with governmental entities and are therefore potentially subject to such laws.
We also participate in public-private partnerships
and other commercial and policy arrangements with governments around the globe. Global enforcement of anti-corruption laws has increased
in recent years, including investigations and enforcement proceedings leading to assessment of significant fines and penalties against
companies and individuals.
Our international operations create a risk of unauthorized
payments or offers of payments by one of our employees, consultants, sales agents, or distributors. The business maintains policies and
programs to implement safeguards to educate employees and agents on these legal requirements, and to prevent and prohibit improper practices.
However, existing safeguards and any future improvements may not always be effective, and employees, consultants, sales agents or distributors
may engage in conduct for which we could be held responsible.
In addition, regulators could seek to hold us liable
for conduct committed by companies in which we invest or that we acquire. Any alleged or actual violations of these regulations may subject
us to government scrutiny, criminal or civil sanctions and other liabilities, including exclusion from government contracting, and could
disrupt the business, adversely affect our reputation and result in a material adverse effect on the business, results of operations,
financial condition and cash flows.
Laws and regulations governing international
business operations could adversely impact the Medinotec Group of Companies.
The US Department of the Treasury’s Office of
Foreign Assets Control (“OFAC”), and the Bureau of Industry and Security at the US Department of Commerce (“BIS”)
administer certain laws and regulations that restrict US persons and, in some instances, non-US persons, in conducting activities, transacting
business with or making investments in certain countries, governments, entities and individuals subject to US economic sanctions.
Our international operations subject us to these laws
and regulations, which are complex, restrict business dealings with certain countries, governments, entities, and individuals, and are
constantly changing. Further restrictions may be enacted, amended, enforced or interpreted in a manner that materially impacts our operations.
From time to time, certain subsidiaries have limited business dealings in countries subject to comprehensive sanctions.
Certain of our subsidiaries sell medical devices,
and may provide related services, to distributors and other purchasing bodies in such countries. These business dealings represent an
insignificant amount of our consolidated revenues and income but expose us to a heightened risk of violating applicable sanctions regulations.
Violations of these regulations are punishable by civil penalties, including fines, denial of export privileges, injunctions, asset seizures,
debarment from government contracts and revocations or restrictions of licenses, as well as criminal fines and imprisonment.
We have established policies and procedures designed
to assist with compliance with such laws and regulations. However, there can be no assurance that these will prevent us from violating
these regulations in every transaction in which we may engage. As such a violation could adversely affect our reputation, business, financial
condition, results of operations and cash flows.
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As an Emerging Growth Company under the Jobs
Act, the Medinotec Group of Companies are permitted to rely on exemptions from certain disclosures requirements.
We qualify as an "emerging growth company"
under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long
as we are an emerging growth company, we will not be required to:
•
have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
•
comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);
•
submit certain executive compensation matters to shareholder advisory votes, such as "say-on-pay" and "say-on-frequency;" and
•
disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive's compensation to median employee compensation.
In addition, Section 107 of the JOBS Act also provides
that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain
accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits
of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such
new or revised accounting standards.
We will remain an "emerging growth company"
for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed
$1 billion, (ii) the date that we become a "large accelerated filer" as defined in Rule 12b-2 under the Securities Exchange
Act of 1934, which would occur if the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the
last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion
in non-convertible debt during the preceding three year period.
Until such time, however, we cannot predict if investors
will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
Risks Associated with Political Instability and
Regional Issues
South Africa Specific Risk of Unstable Power
Supply
Electricity demand in South Africa is extremely high
and energy plants do not meet the demand. Therefore, there are frequent rolling black outs that are handled by a schedule of “load
shedding” during which the supply and demand of electricity is balanced out to prevent the entire power grid from collapsing. This
results in unstable energy sources and frequent production halts for our company. DISA Medinotec has a backup generator big enough to
sustain the entire production facility in case of a power outage. In addition, South Africa is also a very solar capable country due to
the weather being warm with desert like conditions. Therefore, we are looking into solar power as a means to run our production facilities
more efficiently in the longer run.
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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
and resulted in extensive damage to commercial property, and may cause increased uncertainty about our ability to exist in this environment.
This may adversely affect investor confidence as well as our business planning, operations and our market capitalization.
This risk extends to global economic uncertainty and
heightened geopolitical tensions, such as those in involved in the Russian war on Ukraine, between the United States and China as well
as Brexit, which can also have an impact on several factors influencing commodity prices, exchange rates, and interest rates, all of which
can affect our business in turn.
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.
In South Africa, the correction of inequalities amongst
the key demographic groups of the country as a result of Apartheid is regulated by the Broad-based Black Economic Empowerment Act 53 of
2003. This is a legislative framework for the promotion of BEE that seeks to advance economic transformation and enhance the economic
participation of Black people in the South African economy. Companies failing to meet the requirements of the Act and its associated codes
may be at risk of not being able to attract investment and may also face more limited opportunities for growth (both organic and acquisitive)
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
issues. 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
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:
Method
Description
Normal Time Delay Experienced
Management fees
Restricted to an amount that the business would need to prove that the services rendered by the Medinotec Group Internationally to the local company is at an arm’s length amount. If this cannot be proven authorities will disallow the charge and in certain instances levy fines and penalties
If these charges are proven to be at arm’s length, flow of funds can happen within a one-week time frame.
Loans
Restricted to arm’s length terms and would need to apply for formal approval to the authorities.
The application may be accepted or declined and would require 6-10 weeks before approval will be obtained.
Dividends
Dividends may be declared from time to time depending on the fact that the company declaring these dividends are liquid and solvent.
Since Medinotec Inc. is the registered owner
of the business in South Africa dividends may be declared at a Board meeting and these can be paid to the parent entity. A dividends withholdings
tax of 20% would apply and the funds may then exit the country.
The timeline to ensure compliance and transfer
the funds will be 2-3 weeks.
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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
guidance from expert advisors. The authorities do have the final decision-making powers on any transaction and therefore time delays may
become material and can have a material impact on the business and its ability to function especially when a dispute arises from interactions
with the regulators. Management fees and loans can easily be declined by authorities whereas dividends are less likely to be declined.
Our entire business plan is based on the successful
private placement that was concluded, and this funding is expected to facilitate two years of funding required before any funding would
be needed from the South African subsidiaries, therefore this leaves some time to obtain regulatory approvals in advance if the business
plan roll out in the United States is slower than expected. If the Central Reserve Bank declines or imposes any restrictions including
time delays for approvals for flow of funds it may have a material impact on the business operations of the Group and may delay its roll
out in the American Markets until a follow up capital raise or alternatively debt finance can be obtained on an international level. It
is important to note that this successful raise of money does not guarantee that we will obtain regulatory approval in the USA for product
candidates that falls 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.
South Africa Specific Risk of South Africa Being
Grey listed by the FATF- Financial Action Task Force
The FATF- Financial Action Task Force is a global
inter-governmental body, that promotes policies and sets international standards relating to the combating of money laundering, terrorist
financing, and the financing of the proliferation of weapons of mass destruction. There are currently 39 members of the FATF; 37 jurisdictions
including South Africa and 2 regional organisations (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. South Africa
is the only African member of FATF, but other African jurisdictions participate through FATF Regional Bodies like the Eastern and Southern
Africa Anti-Money Laundering Group (ESAAMLG) who are associate members of FATF.
The FATF grey list refers to the FATF’s practice
of publicly identifying countries with strategic Anti- Money Laundering and Countering the Financing of Terrorism (AML/CFT) deficiencies.
The FATF maintains two such lists: I. jurisdictions under “increased monitoring” that are actively working with the FATF to
address strategic deficiencies in their regimes” and II. “high-risk jurisdictions subject to a call for action” that
are not actively engaging with the FATF to address these deficiencies.
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 country2 is fully3 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
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
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 with regard to 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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“The FATF does not call for the application
of enhanced due diligence measures to be applied to these jurisdictions. The FATF Standards do not envisage de-risking, or cutting-off
entire classes of customers, but call for the application of a risk-based approach. Therefore, the FATF encourages its members and all
jurisdictions to take into account the information presented below in their risk analysis.” However, despite the FATF requirement,
selected institutions are expected to undertake more enhanced monitoring, for their own business reasons, or as may be required by their
own laws (eg EU directives). Hence institutions based in a greylisted 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. 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
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
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 Grey listing 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
delays.
Despite the progress the South African Government
is making on addressing deficiencies, it is still unclear how long this designation will remain in place and what ramifications, if any,
the designation will have for the Company.
Risks Relating to Our Securities
If the Medinotec Group of Companies undertakes
future offerings of our common stock, shareholders will experience dilution of their ownership percentage.
Generally, existing shareholders will experience dilution
of their ownership percentage in the company if and when additional shares of common stock are offered and sold. In the future, we may
be required to seek additional equity funding in the form of private or public offerings of our common stock. In the event that we undertake
subsequent offerings of common stock, your ownership percentage, voting power as a common shareholder, and earnings per share, if any,
will be proportionately diluted. This may, in turn, result in a substantial decrease in the per-share value of your common stock.
If a market for our common
stock does not develop, stockholders may be unable to sell their shares
Our common stock is quoted under the symbol “MDNC”
on the OTCQX operated by OTC Markets Group, Inc., an electronic inter-dealer quotation medium for equity securities. We have just recently
been approved for trading, so we do not have an active trading market. We can provide no assurances that an active trading market will
ever occur, and you may have issues selling your securities in our company.
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The Medinotec Group of Companies’ common
stock price may be volatile and could fluctuate widely in price, which could result in substantial losses for investors.
The market price of our common stock is likely to
be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including:
•
new products and services by us or our competitors;
•
government regulation of our products and services;
•
intellectual property disputes;
•
additions or departures of key personnel;
•
sales of our common stock;
•
our ability to integrate operations, technology, products and services;
•
our ability to execute our business plan;
•
operating results below expectations;
•
loss of any strategic relationship;
•
industry developments;
•
economic and other external factors; and
•
period-to-period fluctuations in our financial results.
You should consider any one of these factors to be
material. Our stock price may fluctuate widely as a result of any of the above.
In addition, the securities markets have from time-to-time
experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market
fluctuations may also materially and adversely affect the market price of our common stock.
If securities analysts do not initiate coverage
or continue to cover the Common Stock or publish unfavorable research or reports about the business, this may have a negative impact on
the market price of the Common Stock of the Medinotec Group of Companies.
The trading market for the Common Stock will depend
on the research and reports that securities analysts publish about our business and us. We do not have any control over these analysts.
There is no guarantee that securities analysts will cover the Common Stock. If securities analysts do not cover the Common Stock, the
lack of research coverage may adversely affect our market price.
If we are covered by securities analysts, and the
stock is the subject of an unfavorable report, the stock price and trading volume would likely decline. If one or more of these analysts
ceases to cover our company or fails to publish regular reports on us, we could lose visibility in the financial markets, which could
cause the stock price or trading volume to decline.
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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.
The Securities and Exchange Commission has adopted
regulations which generally define "penny stock" to be any listed, trading equity security that has a market price less than
$5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. The penny stock rules require a broker-dealer,
prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides
information about penny stocks and the risks in the penny stock market. The broker-dealer must also provide the customer with current
bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly
account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules
generally require that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny
stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure
requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to
the penny stock rules which may increase the difficulty Purchasers may experience in attempting to liquidate such securities.
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 of us.
Our board of directors is authorized to issue up to
20,000,000 shares of preferred stock. Our board of directors has the power to establish the dividend rates, liquidation preferences, voting
rights, redemption and conversion terms and privileges with respect to any series of preferred stock. The issuance of any shares of preferred
stock having rights superior to those of the common stock may result in a decrease in the value or market price of the common stock. Holders
of preferred stock may have the right to receive dividends, certain preferences in liquidation and conversion rights. The issuance of
preferred stock could, under certain circumstances, have the effect of delaying, deferring or preventing a change in control of us without
further vote or action by the stockholders and may adversely affect the voting and other rights of the holders of common stock.
The Medinotec Group of Companies does not expect
to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.
We do not anticipate paying cash dividends on our
common stock in the foreseeable future. The payment of dividends on our common stock will depend on earnings, financial condition and
other business and economic factors affecting it at such time as the board of directors may consider relevant. If we do not pay dividends,
our common stock may be less valuable because a return on your investment will occur only if our stock price appreciates.
Provisions in the Nevada Revised Statutes and
our Bylaws could make it very difficult for an investor to bring any legal actions against the Medinotec Group of companies’ directors
or officers for violations of their fiduciary duties or could require us to pay any amounts incurred by our directors or officers in any
such actions.
Members of our board of directors and our officers
will have no liability for breaches of their fiduciary duty of care as a director or officer, except in limited circumstances, pursuant
to provisions in the Nevada Revised Statutes and our Bylaws as authorized by the Nevada Revised Statutes. Specifically, Section 78.138
of the Nevada Revised Statutes provides that a director or officer is not individually liable to the company or its shareholders or creditors
for any damages as a result of any act or failure to act in his or her capacity as a director or officer unless it is proven that (1)
the director’s or officer’s act or failure to act constituted a breach of his or her fiduciary duties as a director or officer
and (2) his or her breach of those duties involved intentional misconduct, fraud or a knowing violation of law.
This provision is intended to afford directors and
officers protection against and to limit their potential liability for monetary damages resulting from suits alleging a breach of the
duty of care by a director or officer. Accordingly, you may be unable to prevail in a legal action against our directors or officers even
if they have breached their fiduciary duty of care.
In addition, our Bylaws allow us to indemnify our
directors and officers from and against any and all costs, charges and expenses resulting from their acting in such capacities with us.
This means that if you were able to enforce an action against our directors or officers, in all likelihood, we would be required to pay
any expenses they incurred in defending the lawsuit and any judgment or settlement they otherwise would be required to pay. Accordingly,
our indemnification obligations could divert needed financial resources and may adversely affect our business, financial condition, results
of operations and cash flows, and adversely affect prevailing market prices for our common stock.
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ITEM 1B.
UNRESOLVED STAFF COMMENTS
This information is not required for smaller reporting companies.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.