What changed in this filing

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Item 1. Business

2024-07-05 compared with 2023-05-30 · 393 added, 617 removed, 575 unchanged (64% of the section changed)

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Medinotec Inc.

was formed on April 26, 2021, in the

State of Nevada.

was registered on April 26, 2021, in

the State of Nevada.

With an effective date of April 26, 2022, we acquired DISA Medinotec Propriety Limited, a South African corporation,

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of stock at par value and the transfer of the outstanding loan account.

The consideration payable of $11 for the outstanding equity and

the Medinotec Group of Companies would take on the responsibility of the loan account payable to Minoan at that time of $1,583,661.

This Purchase was concluded between Minoan and a local

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

and within walking distance from Groote Schuur Hospital, had been developing stents for the international market since 1998.

produced high-quality medical devices through in-depth research and development capabilities (“R&D”) and a total commitment

to patient care.

Today the products are sold via a network of distributor partners both in South Africa and internationally.

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

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

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

Today the products are sold via

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

A professional team consisting of our CEO and CFO

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

We plan to establish various networks to export and distribute our products in North America and other FDA comparable countries

such as, Australia, Japan and China.

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

concluded private placement allows for the roll out in the United States to start during the 2023 fiscal year.

In addition, we are finalizing

multiple patent and trademark applications in several territories, which we believe will give us the ability not only to maintain our

intellectual property but also to market our products aggressively.

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

countries such as, Australia, Japan, and China.

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

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

During this period,

501 units were sold in the United States.

In addition, we are finalizing multiple patent applications in several territories, which we

believe will give us the ability not only to maintain our intellectual property but also to market our products aggressively.

The manufacture of medical devices for the

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

Raw materials and components used

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

and reliability.

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

and suppliers are regularly evaluated to monitor their quality performance.

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

Raw materials and components

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

quality and reliability.

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

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

The core values of care, learning, continuous

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

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

The quality of

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

guaranteeing the mitigation of risk.

mitigating risk.

As of February 29, 2024, the Medinotec Group of Companies

employed a total of 29 full-time employees.

employed 54 employees, which consists of full-time employees, part-time employees as well as independent contractors.

Commercial team :

Within the group of companies the Commercial team representing the products currently consists of 2 individuals responsible for all aspects of the sales process, including pricing, marketing, transportation and logistics, product development and general customer service and training.

The team is organized by both region and end-market and comprises a group of experienced and dedicated team members who understand the industry and who are experts in their various medical fields.

The team is led out of the Johannesburg head office and is regionally positioned in the major medical markets across South Africa.

As the Company makes decisions to enter or expand its presence in certain markets or regions, it expects to continue to add dedicated team members to support that growth, the company currently has two dedicated sales members in the United States and this number is expected to increase as the sales grow and regulatory and administrative hurdles are cleared to allow sales to happen.

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

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

The team is led out of the Johannesburg

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

As the Company makes decisions to enter

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

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

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

Marketing team:

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

This includes producing exhibits for trade shows and exhibitions, manufacturing product overview materials, participating in regional industry meetings and other trade associations and managing advertising efforts in trade journals.

This includes producing exhibits for trade shows and exhibitions, manufacturing product overview materials, participating in both regional and international industry meetings and other trade associations and managing advertising efforts in trade journals.

Transportation Warehouse and Logistics team:

The team manages domestic and international shipments and product deliveries by directing inbound and outbound ocean vessel and flights traffic, supervising equipment maintenance, coordinating with freight carriers to ensure equipment availability, ensuring compliance with shipping regulations and strategically planning for future growth.

The team manages domestic and international shipments and product deliveries by directing inbound and outbound ocean vessels and flights, supervising equipment maintenance, coordinating with freight carriers to ensure equipment availability, ensuring compliance with shipping regulations and strategically planning for future growth.

This team also ensures storage and shipping happens in accordance with the quality requirements of each product.

Technical team:

The team services and maintains all major equipment held in ours warehouses as well as products purchased by customers requiring regular servicing and general maintenance.

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

Customer Services team:

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It aims to accomplish this by consistently exceeding customer expectations, continually improving service performance, offering efficient and timely responses to customer needs, being available to customers 24/7, and providing customers with personal points of contact.

These functions are backed up by various back-office

functions including, but not limited to, Quality, Finance, Admin and Regulatory staff.

Attracting the right employees is vital to

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

Focus on attracting

These functions are supported by various back-office

functions including, but not limited to, R&D, Quality, Finance, Admin and Regulatory staff.

Attracting the right talent is vital to the

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

Our focus on attracting

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

labor market in which we operate.

The below table

approximate number of employees, the employment status as full or part time, and the employer within the Medinotec Group of Companies.

below table shows the

approximate number of employees and independent contractors, the employment status as full or part time, and the employer within the

Medinotec Group of Companies.

None of our employees are represented by a labor union with respect to their employment with us.

We have not experienced any work stoppages,

and we consider our relations with our employees to be good.

Number of Employees

Status of Employees

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

Number of full-time employees

Number of part-time employees

Number of independent contractors

Medinotec Inc.

Medinotec Capital Proprietary Limited*

Medinotec Proprietary Limited

* Executives employed in Medinotec Inc.

DISA Medinotec Proprietary Limited

* Executives employed by Medinotec Inc.

Medinotec Capital Proprietary Limited are the same individuals.

Group Contractors

Two of the most valuable assets the Group has

are its long-term customer relationships and its strong distribution and marketing network.

Through its distribution partnership, the

Group has a network of over 100 sales representatives, who cover approximately 60% of all hospital theatre floors on a weekly basis in

South Africa.

DISA Medinotec Proprietary Limited successfully

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

distribution business.

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

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

Medinotec assumed responsibility.

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

the collaborative efforts within the medical device distribution sector.

These distribution products currently and in the future are expected

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

products that will complement our in house developed products.

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

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

This sub-distributor

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

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

The Trachealator product obtained FDA approval

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

Since the Company had no prior sales channels

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

network and infrastructure.

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

credit facility to a maximum of $750,000.

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

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

However, during quarter ending November 30,

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

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

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

It was therefore decided to separate the network and infrastructure

developed and for each company to pursue its strategic focus.

The note receivable will continue on the same terms and become payable later

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

This decision

was made in prudence due to the fact that the receivable is not backed by any Trachealator revenue streams anymore and does not change

that Innovative Outcomes will still be liable for payment of this in the future Interest will accrue as normal until maturity date.

payments be received this provision will be reversed with the same amount of cashflow received.

Two of the most valuable assets the Medinotec

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

Through its distribution

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

a weekly basis in South Africa.

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

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parties for sales into South Africa:

there is reliance on DISA Lifesciences as a customer;

and for exports out of South Africa there was

historical reliance on Minoan Medical.

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

The sales relationship with Minoan Medical

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

Any sales in the future between the two entities,

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

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 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

there is reliance on DISA Life Sciences Proprietary Limited (“Disa Life Sciences”) as

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

These relationships provide the Group

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

Sales between the Medinotec Group and DISA

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

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

international first world markets.

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

for customers and accounts.

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

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

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

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

regulatory approvals, none of which can be guaranteed.

The Medinotec Group of Companies is in the

process of retaining additional independent consulting companies within the Medinotec Group of Companies of which DISA Lifesciences Proprietary

Limited and Minoan Medical Proprietary Limited both incorporated in South Africa are the largest.

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

The Medinotec Group of Companies operate in

countries where the market is dominated by certain players, and this creates a sales concentration risk which also causes an accounts

receivable concentration risk.

Sales reflect the cyclical nature of the business,

as the number of procedures incorporating our products does decrease in the summer holiday months of December and January within the South

African market, which is currently the predominant market in the Medinotec Group of Companies.

This cyclical nature has been enhanced

by the Covid-19 pandemic, which has resulted in an unprecedented decline in healthcare utilization, largely due to the postponement of

elective surgeries and patient aversion to exposure to the potential risk of infection in some healthcare settings.

as the number of procedures incorporating our products does decrease in the summer holiday months of December and January within the

South African market, which is currently the predominant market in the Medinotec Group of Companies.

Reliance on Other Parties

DISA Medinotec Proprietary Limited in the past focused

The Medinotec Group of Companies in the past focused

solely on product development and manufacturing and therefore outsourced its sales function to two parties namely Minoan Medical Proprietary

Limited and DISA Vascular Distribution Proprietary limited t/a DISA Lifesciences.

This was done to preserve funds for R&D and manufacturing

and to ensure the products that get developed are launched effectively.

Minoan Medical focused primarily on establishing an export market for the products manufactured by DISA Medinotec Proprietary Limited, this was however dampened by the covid travel restrictions and the lack of the ability to host training events and trade shows during the past few years.

DISA Medinotec made a conscious decision to take all export activities in house and appointed an international sales manager to build export country relationships.

This move was done to enhance the business offering and to align the business with the plans as described in this document.

DISA Vascular Distribution Proprietary limited t/a DISA Lifesciences is one of the top 5 medical device distributors in South Africa and has a far reaching sales and marketing component to their business, DISA Medinotec partnered with DISA Lifesciences to create a market for the products in South Africa, due to the reach of this distributor DISA Medinotec was able to reach its budgets and break even scenarios on products much faster than it would have attempting to launch on their own.

DISA LiveScience uses its own sales force and certain sub-contractors to penetrate the South African market.

After taking exports in house the DISA Lifesciences relationship is the main dependent to supply products into South Africa.

Management sees the risk associated with this relationship

as minimal since the entire business plan is drafted around export sales to the United States and Europe this relationship will become

less material over time.

Limited and DISA Life Sciences.

This was done to preserve funds for R&D and manufacturing and to ensure the products that get developed

are launched effectively.

DISA Life Sciences is, as per management’s best estimation, one of the top 5 medical device distributors in South Africa and has a far reaching sales and marketing component to their business, DISA Medinotec partnered with DISA Life Sciences to create a market for the products in South Africa, due to the reach of this distributor, DISA Medinotec was able to reach its budgets and break even scenarios on products much faster than it would have attempting to launch on their own.

DISA Life Sciences uses its own sales force and certain sub-contractors to penetrate the South African market.

After we took exports in house the DISA Life Sciences relationship consists of supplying products in South Africa.

Please refer to the related party footnotes

in the financial statements and as disclosed in the Section of this Prospectus, entitled, “Certain Relationships and Related Transactions”

where the nature and flow of transactions between each of these parties have been disclosed in detail.

in the financial statements and as disclosed in the Section of this Annual Report, entitled, “Certain Relationships and Related

Transactions, and Director Independence” where the nature and flow of transactions between each of these parties have been disclosed

Our Business Strategy

As we are currently operating in various markets,

the below provides a brief overview of the Company structure as well as each individual entities’ role within the Company:

Medinotec Inc

The company was incorporated in Nevada in April of 2021.

Currently this

company houses the directorship and management of the business and owns the subsidiary, Medinotec Capital Proprietary Limited, which in

turn wholly owns DISA Medinotec Proprietary Limited.

Medinotec Inc.

facilitates all sales into the United States.

Medinotec Capital (Pty) Ltd

This company was established and incorporated by Medinotec Inc.

an investment holding company on the continent of Africa.

The intention in the future will be that the same structure gets established

for any continent on which Medinotec Group of Companies would like to expand into.

Consolidating all African investments under one holding

company simplifies the transfer pricing policies inter group and would ensure a lower risk of breaching any transfer pricing regulations

set by African regulators

Disa Medinotec (Pty) Ltd

This is the operational company acquired by Medinotec Capital in March

This company manufactures and develops the products that are sold to Medinotec Inc.

It is a medical device manufacturing and

distribution company with distribution channels predominately in South Africa, but also in the Middle East, South America, Europe and

portions of Asia, with plans to enter the markets in North America and other FDA comparable countries such as Australia, Japan and China.

Our objective is to become one of the significant

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chain ranging from the importation of raw materials, manufacturing capabilities and the marketing and selling of products, through to

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

To date, organic growth that has been shown in the

strong track record and growth of the acquired DISA Medinotec Proprietary Limited, South Africa, in its multiple years of existence, which

has been supported by strong management teams and the development of intellectual property identified and then executed upon.

track record and strong growth paired with the successful private placement money raised by Medinotec Inc., positions the Medinotec Group

of Companies well to grow into new markets.

Regardless of whether we own 100% of the med-tech target or retain a smaller percentage ownership

via acquisitions, the model is supported by the strength and reach of the distribution channels we have created or partnered with over

the past years.

A high-level overview of our strategy follows on

page 4, which is followed by a discussion on how we implement this strategy.

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

high-level overview of our strategy follows on page 4 , which

is followed by a discussion on how we implement this strategy.

Our Strategic Differentiators

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

We have accelerated R&D efforts and made the route to market shorter.

Experienced management team:

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Low-cost operating structure:

We focus on building and operating facilities with low operating costs to enable it to better manage market downturns.

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

Strong relationships with customers:

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

We currently have four products that are commercially

We currently have three products that are commercially

available and a rich pipeline of developmental projects.

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specializes in niche products within the disciplines of cardiology and respiratory interventions in which we are involved in medical device

design, development and manufacture, all supported by a well-trained and educated sales and distribution channel.

The specialty areas

design, development, manufacture, all supported by a well-trained and educated sales and distribution channel.

The specialty areas include:

Interventional Cardiology, which involves surgery performed on the heart and vessels to correct life-threatening conditions.

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Interventional Endolaryngeal Endoscopy, which involves balloon dilation to treat suitable airway stenosis by ENT surgeons and anesthetists.

In the lead up to the listing,

during 2021 we embarked on a series of comprehensive market development activities, refocusing resources and efforts to increase awareness

the benefits of the Trachealator and other Medinotec products;

the indications for use of our products in territories that accept the European CE Mark;

the overall cost efficiency of our products.

The focus is on markets with surgical centers of excellence, including

the Middle East, Western Europe and the US, with the aim of:

The focus of our expansion is on markets with surgical centers of excellence,

including the Middle East, Europe, and the US, with the aim of:

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

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

In addition, we appointed and trained

various distributors in the Middle East, Western Europe, portions of Asia and South America, with several training initiatives also

held in the USA where FDA approval have been granted for the Trachealator following the 510(k) substantially equivalence process for

Class II medical devices.

We believe this positions the product to start sales in the USA.

In September last year we established the

first training center in the African region for our products, which is situated in Johannesburg, South Africa at the Oxygenics International

Medical Training Centre.

The region has been a major contributor to product placements and surgical cases.

The training center is expected

to drive increased utilization of our products worldwide by connecting our partners.

Given South Africa’s proximity as a centralized

hub it is easily reachable by most of our partners.

It is further expected to encourage greater adoption of our technology in other territories

and hospitals.

DISA Medinotec Proprietary Limited are pleased

to report that during the 2022 and 2021 fiscal years, surgeons performed over 3,000 procedures using our products, however the product

have not been marketed to its fullest potential over the previous years as a result of the impact of the Covid-19 pandemic on elective

surgeries and hospital operations.

Furthermore, a multitude of peer-reviewed clinical papers have been published providing further support

of the clinical utility of our products.

The Medinotec Group’s growth

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

The sector is expected to achieve

a compound annual growth rate (“CAGR”) of nearly 6.5% during the period 2017-2025.

Mordor Intelligence .)

Moreover, healthcare in developing countries – our primary target market – is undergoing rapid changes.

The growing population

in these countries is likely to lead to increased demand for healthcare, including medical devices.

The growing burden of diseases and

innovative medical treatments currently accounts for nearly two-thirds of the rise in spending.

In addition, we appointed and trained various distributors

in the Middle East, Europe, portions of Asia and South America, with several training initiatives also held in the USA where FDA approval

have been granted for the Trachealator following the 510(k) substantially equivalence process for Class II medical devices.

This has enabled

us to start sales in the USA.

The Medinotec Group’s growth plan is determined

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

The sector is expected to achieve a compound annual

growth rate (“CAGR”) of nearly 6.5% during the period 2017-2025.

Mordor Intelligence .) Moreover, healthcare

in developing countries – our primary target market – is undergoing rapid changes.

The growing population in these countries

is likely to lead to increased demand for healthcare, including medical devices.

The growing burden of diseases and innovative medical

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

North America is expected to continue dominating

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of injuries, and for chronic disease management.

Our sales in the United States for the fiscal year was $553,967 which represents 11%

of total sales.

This is up from $21,467 in the prior fiscal year, which represented 2% of total sales.

Key Market Trends and Our Response to These

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Major shifts in industry market share have

occurred in connection with product problems, physician advisories, safety alerts, results of clinical trials to support superiority claims,

and publications about products, reflecting the importance of product quality, product efficacy and quality systems in the medical device

occurred in connection with product problems, physician advisories, safety alerts, results of clinical trials to support superiority

claims, and publications about products, reflecting the importance of product quality, product efficacy and quality systems in the medical

device industry.

In the current environment of managed care,

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policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries

in which the Company does business, including the US.

in which the Medinotec Group does business, including the US.

These initiatives put increased emphasis on

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procedures or treatments, tying reimbursement to outcomes, shifting to population health management, and other mechanisms.

Hospitals, which purchase our technology,

are also seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases,

limiting the number of vendors that may participate in the purchasing program.

Hospitals are also aligning interests with physicians

through employment and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings

resulting from changes in practice patterns such as device standardization.

This has created an increased level of price sensitivity

among customers for our products.

Hospitals, which purchase our technology, are

also seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases, limiting

the number of vendors that may participate in the purchasing program.

Hospitals are also aligning interests with physicians through employment

and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings resulting from

changes in practice patterns such as device standardization.

This has created an increased level of price sensitivity among customers

for our products.

The next logical step for us would be to secure

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

growth in its distribution channels.

growth in our distribution channels.

Our Competitor Landscape

The Medinotec Group of companies operates in

Medinotec Group of companies operates in

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

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

As such, there are no assurances that we

will be able to compete and gain market share.

Build our Competencies

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production facility in Johannesburg, South Africa.

This facility allows for a significant increase in capacity and output, with a 400

m 2 ISO 7 cleanroom.

The facility also has increased laboratory space, including a “dry” laboratory for microscopy,

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

with liquids and 3D printing, as well as a workshop containing turning, milling, grinding and other equipment necessary for building custom

machinery and performing repairs or creating prototypes.

This facility allows for a significant increase in capacity and output, within an ISO

The facility also has increased laboratory space, including a “dry” laboratory for microscopy, mechanical testing,

prototyping and experimentation, and a “wet” laboratory for pressure testing, weighing, experimentation with liquids and 3D

printing, as well as a workshop containing turning, milling, grinding and other equipment necessary for building custom machinery and

performing repairs or creating prototypes.

A large packaging area and a dedicated EtO sterilizer

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Our products are also CE-Marked, with IP protection.

We have expertise in numerous innovative medical

manufacturing techniques, including balloon forming, several heat and adhesive bonding techniques, device coating, grinding, catheter

laminating and many others.

Many of products incorporate high-performance medical balloons.

We have expertise in numerous innovative medical manufacturing

techniques, including balloon forming, several heat and adhesive bonding techniques, device coating, grinding, catheter laminating and

Many of the products incorporate high-performance medical balloons.

As a result, the latest balloon-forming manufacturing

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balloon catheter products.

The Medinotec Group of Companies will further invest

in strategic capital projects to introduce innovative technologies, efficiency improvements and capacity expansion in key growth categories.

The Medinotec Group of Companies plans to further

invest in strategic capital projects to introduce innovative technologies, efficiency improvements and capacity expansion in key growth

This will be implemented through:

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Identifying quick-return capital projects.

As explained in this prospectus, by leveraging off our low-cost base in

South Africa we aim to become one of the leading med-tech companies in the world.

By leveraging off our low-cost base in South Africa we aim to become one

of the leading med-tech companies in the world.

Make Strategic Bolt-on Acquisitions

The acquisitive growth strategy of the Medinotec Group

of Companies focuses largely centers around capacity or capability-enhancing businesses or as an entry into new or high-growth product

We will also focus on acquiring complementary IP and businesses.

This will be implemented through:

proactively identifying strategic bolt-on acquisitions to fill gaps in our existing product categories and manufacturing lines;

building strategic alliances with international customers or suppliers.

Our Implementation Plan

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outlines a roadmap for implementation.

The Medinotec Group of Companies plan outlines how we will continue to ensure quality manufacturing

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

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

The key drivers in our plan that

support the business strategy are as follows:

The Medinotec Group of Companies plan is to continue to ensure quality manufacturing of our current

products, ongoing investment into our own IP, and planned acquisitions to ensure the financial stability of current operations, the longevity

of our organization and a smooth integration process for new businesses we may acquire.

The key drivers in our plan that support the business

strategy are as follows:

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

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We manage a robust pipeline of new products and business relationships in various stages of development and are also in various stages of expanding capabilities to improve product offerings across our various platforms.

F urther develop value-added capabilities to maximize margins .

Further develop value-added capabilities to maximize margins.

We expect to continue investing in ways to increase the value we provide to customers by growing our product offerings, improving our supply chain management, upgrading our IT, and enhancing our customer service model.

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Additionally, we undertake continuous improvement efforts to increase the effectiveness and efficiency of our production and distribution facilities.

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

We continue to strategically position our supply chain in order to deliver according to our customers’ needs.

We believe that our supply chain network and logistics capabilities are a competitive advantage that enables us to provide superior service to customers.

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

We continue to strategically position our supply chain to deliver according to our customers’ needs.

We believe that our supply chain network and logistic capabilities are a competitive advantage that enables us to provide superior service to customers.

The strategic location of our distribution centers enables us to service major customers within 48 hours (this includes certain deliveries to rural and outlying areas in South Africa, which have limited road access and infrastructure).

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We expect to continue leveraging our reputation, procurement, distribution capabilities and infrastructure to increase our product offerings, as well as to explore other opportunities to expand our reserve base and sell new products.

We have completed several projects where we have signed exclusive distribution agreements and agreements, which became operational in 2016 These exclusive agreements have also unlocked the opportunity to bring to market great technological advancements in the medical intervention field in southern Africa.

We will pursue acquisitions of value-adding products and technologies.

We will prioritize acquisitions that will provide us with opportunities to realize synergies, which include entering new geographic markets, acquiring attractive customer contracts, and improving operations.

balance sheet strength and flexibility .

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

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

The business has good

cash-producing prospects and this, together with our entrepreneurial mindset, ensures that we are able to quickly pursue

opportunities that are time sensitive.

Maintain balance sheet strength and flexibility .

We intend to maintain financial strength and flexibility to enable us to better manage the business through industry downturns and pursue acquisitions and new growth opportunities as they arise.

The business has good cash-producing prospects and this, together with our entrepreneurial mindset, ensures that we can quickly pursue opportunities that are time sensitive.

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

We aim to carry sufficient inventory, and also to provide payment terms to customers in the normal course of business to meet the operational demands of our customers.

We aim to carry sufficient inventory, and to provide payment terms to customers in the normal course of business to meet the operational demands of our customers.

Due to the location of our distribution centers in relation to the US, Europe, and the Far East, we require our distributors to carry at minimum three (3) months of inventory on fast moving items to avoid supply chain pressures.

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Product Distribution

Various distributors were appointed, and rights obtained

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

Medinotec Group of Companies currently has an extensive

distribution network in South Africa and is in negotiations to establish distribution networks in Europe, if successful these networks

will be established and fully operational by the end of the 2023 financial year.

Until now all exports have been managed directly out

of South Africa by the South African based sales team.

We have appointed various distributors to grow sales

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

We are currently represented in approximately 31 countries,

with product registration in progress for an additional 15 countries.

We currently have 25 appointed distributors to represent our products

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

We have had several training initiatives held in the

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

We believe this positions the product to start sales in the US.

We intent to complete our various networks and obtain

During the past financial year 501 units of the Trachealator have been sold in the USA.

We intend to complete our various networks and obtain

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

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

During 2022, we shipped 3,000 orders to sites and

Generally, our distribution centers are strategically located to provide access to road and air freight.

We also continually

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

This approach allows us to provide

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

In furtherance of our efforts to expand into the United

States, on September 16, 2022, we entered into an unsecured revolving line of credit to lend Innovative Outcomes, Inc.

up to $750,000.

We have lent $585,000 so far under the line.

Innovative Outcomes is a US distributor in Little

Rock, Arkansas, and we plan to enter into an arrangement with the company for the marketing and distribution of our products for a fee

and to cover expenses.

The funds from our line of credit will be used by Innovative Outcomes for setting up infrastructure for our products,

including a headquarters for sales representatives, an administrative hub and customer services to handle all back - office items,

setting up a sales system and marketing program, warehousing of inventory in a licensed warehouse, setting up distribution capabilities,

marketing activities and training activities.

Our distribution centers in Johannesburg, South Africa

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

We also continually explore

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

This approach allows us to provide excellent

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

Product Manufacturing – Quality Assurance and Regulatory

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

Our QMS is implemented through Medinotec Group of

Companies’ policies, procedures and work instructions followed and utilized by all departments.

Our QMS is implemented through the Medinotec Group

of Companies’ policies, procedures and work instructions followed and utilized by all departments.

We also maintain an active post-market

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International Quality Regulations

Many products require CE marking before they can be

sold in the European Union.

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health

and environmental protection requirements.

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

European Union.

Most of our products carry the CE Mark, ensuring conformity

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The valid CE certificates for the devices concerned have been issued in compliance with

the Medical Device Directive 93/42/EEC and these devices could initially be placed on the market until May 2024, an extension was given

till beginning of 2028.

We are currently in the process of ensuring compliance with the new Medical Device Regulation 2017/745.

we are in the process of obtaining the required FDA certification for our devices, thus enabling us to market and sell our products in

, FDA certification via the 510(k) substantially equivalence process for Class II medical devices for the

Trachealator has been obtained in Nov 2021 and therefore marketing and sales of this product will start soon inside the US.

the Medical Device Directive 93/42/EEC and these devices could initially be placed on the market until May 2024, but an extension has

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

We are currently in the process of ensuring compliance

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

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

DEKRA is a global testing, inspection, and certification

organization.

In Europe, DEKRA is recognized as a Notified Body for medical devices, meaning it is authorized by the European Union to

assess whether medical devices comply with EU regulations and standards.

This involves evaluating the design, manufacturing process, and

quality management systems of medical devices to ensure they meet the required safety and performance criteria before they can be marketed

DEKRA's role includes conducting conformity assessments, issuing CE certifications, and performing post-market surveillance

to ensure ongoing compliance.

FDA certification via the 510(k) substantially equivalence

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

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

market and sell our products in the US.

In addition, we are subject to numerous and increasingly

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costs or liabilities because of any failure to comply with environmental laws, including fines, penalties, third-party claims, and the

costs of undertaking a clean-up on-site or at a site to which our wastes were transported.

In addition, we are planning to grow in part

by acquisition, and our diligence may not have identified environmental impacts from historical operations at sites we may acquire in

We have an extensive health and safety programmed this also stipulates how we handle waste materials and staff safety in the

cleanroom facility.

costs of undertaking a clean-up on-site or at a site to which any waste materials were transported.

In addition, we are planning to grow

in part by acquisition, and our diligence may not have identified environmental impacts from historical operations at sites we may acquire

in the future.

We have an extensive health and safety program.

This also stipulates how we handle waste materials and staff safety in

the cleanroom facility.

Our health and safety costs are included in our compliance costs.

The consolidated Medinotec Group of Companies for the Years Ended

For the period April 26, 2021 to

Proforma Medinotec Inc Group consolidated

The Medinotec Group of Companies for the Years Ended

February 29, 2024

February 29, 2023

Compliance cost

It should be noted that as we approach market and sales readiness with

our products our compliance costs are increasing to facilitate us to be able to sell products into new territories and to ensure legal

and statutory compliance in these markets.

The increases and fluctuations in annual and quarterly compliance costs from Feb 28, 2022 to

Feb 28, 2023 can be attributed to these new markets being prepared for sales activities.

our products our compliance costs are increased to facilitate the path to sell products into new territories and to ensure legal and statutory

compliance in these markets.

The fluctuations in annual and quarterly compliance costs can be attributed to these new markets being prepared

for sales activities.

Medical Device Regulation

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the medical community necessary for commercial success.

Regulation of Medical Devices in the United

FDA Premarket Clearance and Approval Requirements.

an exemption applies, each medical device commercially distributed in the U.S.

requires either FDA clearance of a 510(k) premarket notification

submission, granting of a de novo request, or premarket application (“PMA”) approval.

Under the Federal Food

Drug and Cosmetic Act, or FDCA, administered by the FDA, medical devices are classified into one of three classes, Class I, Class II,

or Class III, depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control

needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety

and effectiveness can be assured by adherence to the FDA’s general controls for medical devices, which include compliance with the

applicable portions of the Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse

medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Some Class I devices may require premarket

notification to the FDA.

Class II devices are moderate risk devices and are

subject to the FDA’s general controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness

of the device.

These special controls can include performance standards, post-market surveillance, patient registries, and FDA guidance

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices

are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute

The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known

as 510(k) clearance.

Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the

device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which

the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared to through the 510(k) or de

novo process.

Devices deemed by the FDA to pose the greatest risks,

such as life-sustaining, life-supporting or some implantable devices, or devices that have a new intended use, or use advanced technology

that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA.

device that is Class III by default (because it is a novel device that was not previously classified and has no predicate), the device

manufacturer may request that FDA reclassify the device into Class II or Class I via a de novo request.

510(k) Marketing Clearance.

510(k) clearance, a premarket notification submission must be submitted to the FDA demonstrating that the proposed device is “substantially

equivalent” to a predicate device.

A predicate device is a legally marketed device that is not subject to premarket approval, i.e.,

a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has

been reclassified from Class III to Class II or I (e.g., via the de novo classification process), or a device that was

previously cleared through the 510(k) process.

The FDA’s 510(k) review process usually takes from three to six months, but may take

The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

If the FDA agrees that the device is substantially equivalent to a predicate device, it will grant 510(k) clearance to market the device.

After a device receives 510(k) marketing clearance,

any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification

in its intended use, will require a new 510(k) marketing clearance or, depending on the modification, a de novo request

or PMA approval.

The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de

novo or a PMA in the first instance, but the FDA can review that decision and disagree with a manufacturer’s determination.

If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request

the recall of the modified device until FDA has cleared or approved a 510(k), de novo or PMA for the change.

these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

De Novo Process.

If a previously unclassified

new medical device does not qualify for the 510(k) pre-market notification process because no predicate device to which it is substantially

equivalent can be identified, the device is automatically classified into Class III.

The Food and Drug Administration Modernization Act

of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to

the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo

classification procedure.

This procedure allows a manufacturer whose novel device is automatically classified into Class III to request

down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather

than requiring the submission and approval of a PMA.

Prior to the enactment of the Food and Drug Administration Safety and Innovation

Act, or FDASIA, in July 2012, a medical device could only be eligible for de novo classification if the manufacturer first submitted a

510(k) pre-market notification and received a determination from the FDA that the device was not substantially equivalent.

FDASIA streamlined

the de novo classification pathway by permitting (under Section 513(f)(2) of the FDCA) manufacturers to request de novo classification

directly without first submitting a 510(k) pre-market notification to the FDA and receiving a not substantially equivalent determination.

FDASIA sets a review time for FDA of 120 days following receipt of the de novo application, but FDA does not always meet this timeline

and has publicly only committed to a review of 150 days for 50% of applications.

If the manufacturer seeks reclassification into

Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of

the safety and effectiveness of the medical device.

The FDA may reject the reclassification petition if it identifies a legally marketed

predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls

would be inadequate to control the risks and special controls cannot be developed.

If the FDA agrees with the down-classification, the de

novo applicant will then receive authorization to market the device, and a classification regulation will be established for

the device type.

The device can then be used as a predicate device for future 510(k) submissions by the manufacturer or a competitor.

In December 2018 FDA issued proposed regulations to govern the de novo classification process, which if finalized would

further impact this path to market.

As an alternative to the de novo process,

a company could also file a reclassification petition, or FDA could initiate such a process, seeking to change the automatic Class III

designation of a novel post-amendment device under Section 513(f)(3) of the FDCA.

Premarket Approval Process.

devices require submission through the Premarket Approval (PMA) process before they can be marketed.

The PMA process is more

demanding than the 510(k) premarket notification process.

In a PMA, the manufacturer must demonstrate that the device is safe and effective,

and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials.

The PMA must also

contain, among other things, a full description of the device and its components, a full description of the methods, facilities and controls

used for manufacturing, and proposed labeling.

Following receipt of a PMA submission, the FDA determines whether the application is sufficiently

complete to permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its

review of a PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years.

panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as

to the approvability of the device.

The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will generally

conduct a preapproval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or

facilities to ensure compliance with the QSR.

The FDA will approve the new device for commercial

distribution if it determines that the data and information in the PMA application constitute valid scientific evidence and that there

is reasonable assurance that the device is safe and effective for its intended use(s).

The FDA may approve a PMA application with post-approval

conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion,

sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements

to conduct additional clinical studies post-approval.

The FDA may condition PMA approval on some form of post-market surveillance when

deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population

or for a longer period of use.

In such cases, the manufacturer might be required to follow certain patient groups for a number of years

and to make periodic reports to FDA on the clinical status of those patients.

Failure to comply with the conditions of approval can result

in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved device, such as changes

in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect

the safety or effectiveness of the device, require submission of a PMA supplement.

PMA supplements often require submission of the same

type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered

by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.

Certain other changes to an

approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation,

and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and

the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety

and effectiveness.

Emergency Use Authorization .

The Commissioner

of the FDA, under delegated authority from the Secretary of DHHS may, under certain circumstances, issue an Emergency Use Authorization

(“EUA”), that would permit the use of an unapproved medical device or unapproved use of an approved medical device.

an EUA may be issued, the Secretary must declare an emergency based on one of the following grounds:

a determination by the Secretary of the Department of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological or nuclear agent or agents;

a determination by the Secretary of DoD that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S.

military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents;

a determination by the Secretary of DHHS of a public health emergency that effects or has the significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.

In order to be the subject of an EUA, the FDA Commissioner

must conclude that, based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective

in diagnosing, treating, or preventing a disease attributable to the agents described above, that the product’s potential benefits

outweigh its potential risks and that there is no adequate, approved alternative to the product.

Clinical Trials.

Clinical trials are almost

always required to support de novo or a PMA and are sometimes required to support a 510(k) submission.

All clinical investigations

of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s Investigational

Device Exemption ("IDE") regulations which govern investigational device labeling, prohibit promotion of the investigational

device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit

an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

A significant risk device is

one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting

or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment

of human health, or otherwise presents a potential for serious risk to a subject.

An IDE application must be supported by appropriate

data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is

scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA notifies the manufacturer

that the investigation may not begin or is subject to a clinical hold.

If the FDA determines that there are deficiencies or other concerns

with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

In addition, clinical studies must be approved by,

and conducted under the oversight of, an Institutional Review Board ("IRB") for each clinical site.

The IRB is responsible for

the initial and continuing review of the IDE, and may pose additional requirements for the conduct of the trial.

If an IDE application

is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific

number of patients, as approved by the FDA.

If the device presents a non-significant risk to the patient, a sponsor may begin the clinical

trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated

IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping

requirements.

An IDE supplement must be submitted to, and approved by the FDA before a sponsor or investigator may make a change to the

investigational plan.

During a clinical trial, the sponsor is required to

comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing

them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping, and prohibitions on the promotion of

investigational devices or on making safety or effectiveness claims for them.

The clinical investigators in the clinical study are also

subject to FDA regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control

the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.

Additionally, after a trial

begins, we, the FDA, or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the

risks to study subjects outweigh the anticipated benefits.

Post-market Regulation.

After a device

is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply.

These include:

establishment registration and device listing with the FDA;

state licensure requirements for the manufacturing and distribution of medical devices;

QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing process;

labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced, provide adequate directions for use, and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;

clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to PMA devices;

medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

correction, removal, and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

complying with the new federal law and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;

the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device;

the federal Physician Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers;

the federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid.

A person or entity does not have to have actual knowledge of this statute or specific intent to violate it to have committed a violation;

the federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation to pay or transmit money to the federal government.

The government may assert that claim includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statute.

We may be subject to similar foreign laws that may

include applicable post-marketing requirements such as safety surveillance.

Our manufacturing processes, or those of any contract manufacturer

that we engage, are required to comply with the applicable portions of the QSR, which cover the methods and the facilities, controls for

the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation,

and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master file,

device history file, and complaint files.

The discovery of previously unknown problems with any of our products, including unanticipated

adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of

its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal

of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory compliance and enforcement

If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or

enforcement actions, which may result in any of the following sanctions:

warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties;

recalls, withdrawals, or administrative detention or seizure of our products;

operating restrictions or partial suspension or total shutdown of production (due to violations of the QSR or other applicable regulations) refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;

withdrawing 510(k) clearances or PMA approvals that have already been granted;

refusal to grant export or import approvals for our products;

criminal prosecution.

Regulation of Medical Devices in Europe

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

The Medical Device Regulation will become

applicable in May 2021.

The Medical Device Regulation became applicable

The new regulations:

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

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

In the European Union, member states are

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

market or put into service in their jurisdictions.

They have the power to suspend the marketing and use, or demand the recall, of

unsafe or non-compliant devices.

They also have the power to bring enforcement action against companies or individuals for breaches

of the device rules.

Non-compliance may also result in Notified Bodies revoking any certificate of conformity that they have issued

for a device or the manufacturer’s quality system.

the rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by

experts before they are placed on the market.

In the European Union, member states are responsible

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

into service in their jurisdictions.

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

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

Non-compliance

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

quality system.

We are subject to regulations and product registration

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and registrations for all our products.

Federal, State, and Foreign Fraud and

Abuse and Physician Payment Transparency Laws.

Federal, State, and Foreign Fraud and Abuse

and Physician Payment Transparency Laws.

In addition to FDA restrictions on marketing and promotion

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Medicaid or other federal healthcare programs.

Violations of the federal Anti-Kickback Statute may

result in civil monetary penalties up to $100,000 for each violation, plus up to three times the remuneration involved.

Civil penalties

for such conduct can further be assessed under the federal False Claims Act.

Violations can also result in criminal penalties, including

criminal fines of up to $100,000 and imprisonment of up to 10 years.

Similarly, violations can result in exclusion from participation

in government healthcare programs, including Medicare and Medicaid.

Liability under the federal Anti-Kickback Statute may also arise because

of the intentions or actions of the parties with whom we do business.

Violation of the AKS also triggers liability under

the Civil Monetary Penalties Law (CMPL).

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

amount of the remuneration.

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

Medicare and Medicaid.

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

with whom we do business.

The federal civil False Claims Act prohibits, among

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

from the federally funded healthcare program The criminal False Claims Act prohibits the making or presenting of a claim to the government

from the federally funded healthcare program.

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

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

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

provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment.

HIPAA authorizes state attorneys general to file suit

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Our Key Products

innovative surgical and healthcare products are market leaders and meet high quality standards.

These are as follows with the Trachealator

being one of our most sought-after and innovative offerings.

Medinotec’s innovative surgical and healthcare

products are market leaders and meet high quality standards.

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

and innovative offerings.

The Trachealator

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While there are multiple causes of tracheal stenosis, it is

es timated that thousands of cases are reported every year.

Multiple, safe, serial dilations of the trachea

are often curative and the Trachealator is currently in our opinion as management the only device that is non-occlusive and which allows

the procedure to be done with the patient fully awake and un-sedated.

The Trachealator received its CE Mark in 2019 and is currently sold in 14 markets across Europe, Middle East, South America and portions

estimated that thousands of cases are reported every year.

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

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

with the patient fully awake and un-sedated.

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

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

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

The Trachealator received

the CE Mark of approval by a European notifying body (DEKRA).

CE Marking is a qualification mandatory for any product to be sold in countries

of the European Union.

The Trachealator received the CE Mark of approval

by a European notifying body (DEKRA).

CE Marking is a qualification mandatory for any product to be sold in countries of the European

The USA recognizes only an FDA approval to accept

products in its market – a 510(k) accreditation that was obtained in November 2021 for the Trachealator.

From prior experience,

an FDA certificate and CE Mark are widely accepted by other countries in the world as a valid accreditation for entry into their markets;

however, the medical device approval process differs for each country and territory in the world and each may have additional requirements

over and above CE mark and FDA accreditation, or may even require their own quality standards.

Since the business plan is drafted mainly

around the USA and European markets the CE marking and planned future FDA submissions, entry into other markets will only be investigated

if the expected launch of our p roduct candidates do not commercialize in the United States and Europe and each entry will be assessed

on its own merits and requirements.

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

From prior experience, an FDA certificate and CE Mark

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

however, the medical device

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

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

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

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

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

For example, Australia, Japan and China have

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The Cape Cross PTCA Catheter

Medinotec Group of Companies also designed

The Medinotec Group of Companies also designed

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

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

A PTCA balloon catheter (also

known as a Plain Old Balloon Angioplasty [“POBA”] catheter) is inserted either from the groin or the arm and threaded through

the blood vessels, through the aorta into the heart.

The cardiac surgeon and/or interventional cardiologist will move the catheter to

the blocked artery (plaque).

The balloon part of the catheter is inflated to open the blockage in the artery, after which the balloon

is deflated, and the entire catheter withdrawn and removed.

If this procedure is not effective enough to open the artery, a coronary stent

will be placed inside the diseased area of the artery.

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

A PTCA balloon catheter (also known as a

Plain Old Balloon Angioplasty [“POBA”] catheter) is inserted either from the groin or the arm and threaded through the blood

vessels, through the aorta into the heart.

The cardiac surgeon and/or interventional cardiologist will move the catheter to the blocked

artery (plaque).

The balloon part of the catheter is inflated to open the blockage in the artery, after which the balloon is deflated,

and the entire catheter withdrawn and removed.

If this procedure is not effective enough to open the artery, a coronary stent will be

placed inside the diseased area of the artery.

The Cape Cross PTCA Catheter.

Cape Cross Non-Compliant (“NC”)

On the back of the Cape Cross,

the Cape Cross NC Catheter was developed for post dilation purposes.

On the back of the Cape Cross, the Cape Cross

NC Catheter was developed for post dilation purposes.

The product has become a mainstay of our cardiology range.

CE Marked and widely used in South Africa.

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

where the stent was placed.

It is CE Marked and widely

used in South Africa.

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

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

This is done to “seat” the stent

inside the artery wall.

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

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

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

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

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

The Cape Cross Non-Compliant (“NC”)

The “Lamprey” Suction Dissector

The “Lamprey” Suction Dissector is a surgical

tool used in the fields of neurosurgery, ENT surgery and general surgery to combine the processes of suctioning blood out of the surgeon’s

field of view while dissecting sensitive structures simultaneously without having to change instruments.

It is both a precision and time

saving device, which has received the CE Mark.

The “Lamprey” works where the suction

is connected to the back of the device when used during surgical procedures.

During removal of extra tissue/tumors, etc.

it is used to

remove the blood from the site as well as any additional pieces of tissue/blood clots/debris etc.

Inside the mesh tip at the front end

of the device are “fingers” which facilitate the quick removal of debris through the handle to ensure that the canal remains

open and free flowing.

The device is currently undergoing more user-specific testing.

The “Lamprey” Suction Dissector.

Aortic Perfusion and Dilation Catheter

Aortic Valve Dilation Balloon Catheter

(Developmental)

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is a non-occlusive perfusion balloon to allow the expansion of the aortic valve without impeding the cardiac output.

It is currently in

the mid stages of research and development.

This catheter could potentially be used to post dilate the artificial valve in TAVI without

the need for pacing.

We anticipate the commencement of human during the 2023/2024 financial year.

It is currently in the mid stages of research

and development.

This catheter could potentially be used to post dilate the artificial valve in TAVI (Transcatheter Aortic Valve Implantation)

without the need for pacing.

A clinical study was conducted in 2022, as

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

FDA certification via the 510(k) substantially

equivalence process is currently underway, with submission expected by the end of April 2024.

The Micro CTO Catheter (Developmental)

We have started developing a highly specific

niche CTO catheter balloon of 1mm diameter in diameter, which is expected to be launched during the 2023 financial year.

This micro-balloon

catheter addresses an extremely specific market need for difficult coronary cases and will further cement our position as one of the

premier specialized coronary balloon catheter manufacturers.

We have developed a highly specific niche

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

Cross Rx PTCA Balloon Catheter.

These micro-balloon catheters address an

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

balloon catheter manufacturers.

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

The process of obtaining FDA certification

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

submission date is July 2024.

The Tracheal Stent (Developmental)

We are currently in the initial

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

in the treatment of tracheal stenosis.

The complimentary nature of this product will further build on our know how in the field of advanced

airway management, and we look forward to its further design and testing over the upcoming months.

We are currently in the initial stages of

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

treatment of tracheal stenosis.

The complimentary nature of this product

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

over the upcoming months.

Development Pipeline

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Trachealator:

The only outstanding phase is the commencement of material sales into the

United States.

All the necessary preparations have been made (e.g., renting offices, hiring sales and admin staff) and it is therefore

envisaged that sales will begin once all paperwork and compliance matters are addressed.

While unlocking the United States of America

as a commercial market for the product various Compliance documents and customer registration were completed, these customers are performing

their own in-house clinical overviews of the product.

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

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

FDA listing and CE registration was obtained.

Cape Cross PTCA Catheter:

FDA 510(k) approval still needs to be obtained.

Application for FDA 510(k) clearance in progress with external consultants.

Final submission pending.

CE certification has been obtained.

Cape Cross NC Catheter:

FDA 510(k) approval still needs to be obtained.

Application for FDA 510(k) clearance in progress with external consultants.

Final submission pending.

CE certification has been obtained.

Lamprey Suction Dissector:

R&D, Testing, Pre-Production Prototyping, Production, Clinical Trials, and CE Marking have all been completed.

Commercialization of this product have been paused in order to prioritize other products with better commercial prospects.

Aortic Perfusion & Dilatation Catheter:

R&D, Testing, Pre-Production Prototyping, Testing, Production,

Clinical Trials, Application for MDR CE Mark Accreditation has been submitted.

The progress of this product's development has been temporarily suspended to prioritize the pursuit of products with greater economic viability.

Aortic Valve Dilation Balloon Catheter (Outflo) :

R&D, Testing, Pre-Production Prototyping, Testing, Production, Clinical Trials, Application for MDR CE Mark Accreditation has been submitted.

Application for FDA 510(k) clearance in progress with external consultants.

Final submission pending.

Micro CTO Catheter :

R&D, Testing, Pre-Production Prototyping, Clinical Trials commenced

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

Tracheal Stent:

Medinotec Inc.

in Nevada and is at the moment a holding company, but it is expected to facilitate the sales of all products in the United States directly

in the near future.

Therefore, over time, as we implement our business plan and realize commercial operations in the United States, we

believe Medinotec Inc.

will become the primary operating company within the Medinotec Group of Companies and the South African DISA Medinotec

Proprietary Limited will be the manufacturing platform for the operations in the United States and other countries.

Epistaxis Catheter:

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

Intellectual Property

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Medinotec Group of Companies pursues a policy of obtaining

patent protection in the US, China, Europe, Middle East, South America and Australia for patentable subject matter in our products and

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

This assists in avoiding the infringement of third-party patents, helps identify licensing opportunities and monitors the patent claims

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

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

This assists in

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

Due to the Trachealator being fairly new, patent applications

for the Trachealator have been filed in the following countries or regions:

USA, European Union, Canada, China, Australia, Brazil, Korea

and South Africa.

All other products are either not novel enough to file a patent or not yet developed far enough to start filling processes.

USA, European Union, Canada, China, Australia, Korea and South

All other products are either not novel enough to file a patent or not yet developed far enough to start filing processes.

The status of these applications is listed below:

Examination is expected by the end of 2022 – Application number:

The official notice of allowance has been issued by the United States Patents and Trademark Office – Attorney Docket number :

CU 74801-CH-BSE-DG

201880086558.2 has been granted on the 31st of March 2023.

10-2635372 has been granted on the 5th of February 2024.

European Union:

An examination report is expected by the end of the Second quarter of 2022 – Application Number:

Examination has been demanded and is expected by the October2022 – Application number:

Examination of formalities was conducted successfully in April 2022.

Substantive examination is now awaited – Application number 2018800865582

Direction to request examination is expected early 2023 – Application number:

Patent has been awarded in June 2022.

Application number:

Awaiting examination report :

Application No.

Awaiting examination Report :

Application No.

South Africa:

Patent has been granted in June 2022 – Application :

Awaiting examination report – Application No.

No patents have been licensed from third parties.

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

Medinotec Group of Companies also rely on trade secrets,

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

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

that these efforts may prove to be ineffective.

The Medinotec Group of Companies also relies on trade

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

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

understanding that these efforts may prove to be ineffective.

Research and Development

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Primary Customers

Medinotec Group of Companies primary customers include

hospitals, clinics, third-party healthcare providers, distributors, and other institutions, including governmental healthcare programs

and group purchasing organizations (“GPOs”).

We also benefit from strong and long-standing relationships with customers in

each of the industrial and specialty products end-markets we serve.

Medinotec Group of Companies primary customers

include hospitals, clinics, third-party healthcare providers, distributors, and other institutions, including governmental healthcare

programs and group purchasing organizations (“GPOs”).

We also benefit from strong and long-standing relationships with customers

in each of the industrial and specialty products end markets we serve.

Third Party Coverage and Reimbursement

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be dependent in part on the coverage and reimbursement policies of these payors.

The manner in which reimbursement is sought and obtained

varies based upon the type of payor involved and the setting in which the product is furnished and utilized.

Reimbursement from Medicare,

Medicaid and other third-party payors may be subject to periodic adjustments as a result of legislative, regulatory and policy changes,

as well as budgetary pressures.

Possible reductions in, or eliminations of, coverage

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

What changed 10-K

Item 1. Business