What changed in this filing

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Item 1. Business

2025-05-29 compared with 2024-07-05 · 322 added, 283 removed, 685 unchanged (47% of the section changed)

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of Companies.

Prior to the above, in 2015, DISA Vascular Distribution,

an innovative medical device company that specialized in vascular technology for the treatment of coronary artery disease, was established.

Prior to the above, in 2015, DISA Vascular 2015, an

innovative medical device company that specialized in vascular technology for the treatment of coronary artery disease, was established.

It was subsequently renamed DISA Medinotec Proprietary Limited.

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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.

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

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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.

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

The core values of care, learning, continuous

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mitigating risk.

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

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 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 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 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:

As of February 28, 2025, the Medinotec Group of

Companies employed 51 employees, which consists of full-time employees and independent contractors.

Within the Group of Companies the Commercial team representing the products currently consists of 6 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.

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.

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 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 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.

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

Customer Services team:

Services team:

This team is dedicated to creating an exceptional customer experience and making it easy to do business with us.

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 supported by various back-office

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

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.

functions are supported by various back-office functions including, but not limited to, R&D, Quality, Finance, Admin and Regulatory

Attracting the right talent is vital to the

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labor market in which we operate.

below table shows the

table below shows the

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

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Number of independent contractors

Medinotec Inc.

Medinotec Capital Proprietary Limited*

DISA Medinotec Proprietary Limited

Capital Proprietary Limited*

Medinotec Proprietary Limited

* 2 Executives employed by Medinotec Inc.

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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

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.

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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.

However, during the 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.

The note receivable will continue on the same terms and became payable

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

decision was made in prudence due to the fact that the receivable is no longer backed by any Trachealator revenue streams and does not

change that Innovative Outcomes will still be liable for payment of this in the future.

Should 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.

Group of Companies 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.

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

on a weekly basis in South Africa.

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

The Group has historical reliance on two related

parties for sales into South Africa:

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.

The Group has historical reliance on two companies

for sales into South Africa:

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

and for exports out of South Africa there was historical reliance on Minoan Medical (a related party).

These relationships provide the

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

Sales between the Medinotec Group and DISA

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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.

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

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 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.

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

Limited (a related party) and DISA Life Sciences.

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

that are developed are launched effectively.

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 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

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

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:

the below provides a brief overview of the Company structure as well as each individual entity’s 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.

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.

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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

to establish 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 is the operational company acquired by Medinotec

Capital in March of 2022.

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.

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 countries such as Australia, Japan and China that have

very strict regulatory approval processes.

Our objective is to become one of the significant

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building our competences;

through making strategic acquisitions.

making strategic acquisitions.

Our strategy includes investing in the entire value

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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.

high-level overview of our strategy follows in the 10-K ,

which is followed by a discussion on how we implement this

(Image depicting two healthcare professionals

in surgical attire are preparing to intubate a patient in a medical setting.

Shutterstock)

Our Strategic Differentiators

We attribute our success to the following key strengths:

Commitment to innovation:

We attri bute

our success to the following key strengths:

to innovation:

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

Experienced management team:

The members of the Company’s management team bring considerable experience to the dynamic environment in which we operate.

management team:

The members of the Company’s management team bring considerable experience to the dynamic environment

in which we operate.

Their expertise covers a range of disciplines, including industry-specific operating and technical knowledge.

The Company has assembled an agile, creative, and responsive team that can quickly adapt to changing market conditions.

Extensive geographic footprint :

We believe that the strategic location of our facilities and logistics capabilities contribute to our customer retention rates and our ability to reach broader market segments.

Low-cost operating structure:

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

Strong relationships with customers:

We have a long and enviable track record of timely delivery of products, which contributes to a reputation for dependability.

Our extensive network of technical resources and other expertise enables us to collaborate with customers to develop product offerings to improve their satisfaction.

Extensive knowledge of setting up distribution channels :

We have various exclusive distribution agreements in place with distributors to ensure these distributors include our products into an extensive product mix, which includes some of the most innovative and cutting-edge technologies available today.

Focus on safety and wellbeing:

geographic footprint :

We believe that the strategic location of our facilities and logistics capabilities contribute

to our customer retention rates and our ability to reach broader market segments.

operating structure:

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

relationships with customers:

We have a long and enviable track record of timely delivery of products, which contributes to a

reputation for dependability.

Our extensive network of technical resources and other expertise enables us to collaborate with customers

to develop product offerings to improve their satisfaction.

knowledge of setting up distribution channels :

We have various exclusive distribution agreements in place with distributors

to ensure these distributors include our products into an extensive product mix, which includes some of the most innovative and cutting-edge

technologies available today.

on safety and wellbeing:

We focus on the safety of our employees and our patients and maintain safe and responsible operations.

We are known in the communities in which we operate as a preferred employer and as a responsible corporate citizen.

The Three Pillars of our Strategy

Three Pillars of our Strategy

Innovate and Grow our Product Range

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recognized the need to become a significant player in manufacturing in reaction to the risk of price sensitivity.

DISA Medinotec Proprietary Limited currently

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

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

DISA Medinotec Proprietary Limited currently specializes

in niche products within the disciplines of cardiology and respir atory

interventions in which we are involved in medical device 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.

The surgery is performed by minimally invasive intravascular methods depending on the condition to be corrected.

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

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;

increasing the number of procedures conducted;

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, 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.

Interventional

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

The surgery is performed

by minimally invasive intravascular methods depending on the condition to be corrected.

Interventional Endolaryngeal

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

focus of our expansion is on markets with surgical centers of excellence, including the Middle East, Europe, and the US, with the aim

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

the number of procedures conducted;

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

addition, we appoin ted 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

the overall market for medical supplies and investment opportunities.

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 the

overall market for medical supplies and investment opportunities.

The US holds the largest market share in the region due to the superior

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Key Market Trends and Our Response to These

There is currently a massive drive for minimal

invasive procedures done at lower costs, which in turn decreases hospitalization and the cost of procedures and theatre time.

is the primary market for our devices, i.e., minimally invasive procedures, it is important for us to be at the cutting-edge of technological

developments at the correct price point to remain relevant.

It is also important to diversify product offerings to ensure that all the

products used during a procedure can be supplied by one service provider.

The price of these devices is also expected to fall given the

entry of many new players in the market.

There is currently a massive drive for minimal invasive

procedures done at lower costs, which in turn decreases hospitalization and the cost of procedures and operating room time.

this is the primary market for our devices, i.e., minimally invasive procedures, it is important for us to be at the cutting-edge of

technological developments at the correct price point to remain relevant.

It is also important to diversify product offerings to ensure

that all the products used during a procedure can be supplied by one service provider.

The price of these devices is also expected to

fall given the entry of many new players in the market.

Another market driver is the growing population

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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 industry.

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

In the current environment of managed care,

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for our products.

(Image depicting a team of surgeons performing

an operation.

Shutterstock)

The next logical step for us would be to secure

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Our Competitor Landscape

Medinotec Group of companies operates in

The 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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Build our Competencies

Our investment in R&D includes a state-of-the-art

production facility in Johannesburg, South Africa.

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

facility provide the capacity to perform sterilization on our products.

Our operations are governed by the ISO 13485 Quality Management

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 of the products incorporate high-performance medical balloons.

As a result, the latest balloon-forming manufacturing

equipment has been procured and commissioned in the new manufacturing facility to assist in increasing production capabilities of interventional

balloon catheter products.

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:

Focusing on processes, from sales management to customer relationships.

Creating new channels and brand availability.

Expanding growth strategy through strategic partners.

Identifying quick-return capital projects.

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

of the leading med-tech companies in the world.

Our investment in R&D has included the development

of a state-of-the-art production facility in Johannesburg, South Africa.

This facility, designed to significantly enhance capacity and

output within an ISO 7 cleanroom environment, also features expanded laboratory space, including a “dry” laboratory for microscopy,

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

and 3D printing.

Additionally, a workshop is equipped for turning, milling, grinding, and other processes required for custom machinery

and prototype development.

The facility's large packaging area and dedicated

EtO sterilizer have enabled in-house sterilization, supporting operations governed by the ISO 13485 Quality Management System.

Our CE-Marked

products, with IP protection, have benefited from expertise in advanced medical manufacturing techniques, including balloon forming, heat

and adhesive bonding, device coating, catheter laminating, and more.

This has allowed for the commissioning of the latest balloon-forming

manufacturing equipment to increase production capabilities for interventional balloon catheter products.

While this investment has been an integral part of

our growth strategy, we are temporarily shifting focus away from further expansion of the production facility.

Instead, our strategic

focus will now center on the other two pillars of our strategy as these priorities are aligned with our vision to drive growth through

innovation and strategic alignment with key partners.

By concentrating on these focus areas, the Medinotec

Group of Companies aims to maximize impact, accelerate innovation, and leverage our low-cost base in South Africa to strengthen our position

as a leading med-tech company globally.

Make Strategic Bolt-on Acquisitions

While strategic bolt-on acquisitions remain a consideration

in our business plan, we currently have no active due diligence processes underway and no imminent acquisition transactions at this time.

Our Implementation Plan

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outlines a roadmap for implementation.

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 .

In the past, we have signed various exclusive distribution agreements across multiple territories to enhance our product basket and reach.

Our R&D and business development teams work together to enhance existing product offering.

These teams also pursue opportunities to acquire new product offerings through business acquisitions and distributorships that are expected to increase our presence and market share in certain specialty product markets and/or allow us to enter new markets.

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.

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.

We are also exploring other ways to expand our reach and our products to provide incremental value to our customers, including new acquisitions to vertically integrate its supply chain and to obtain more of the gross profit share of the entire customer experience.

Optimize product mix and keep operating costs low.

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:

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

In the past, we have signed various exclusive

distribution agreements across multiple territories to enhance our product basket and reach.

R&D and business development teams work together to enhance existing product offering.

These teams also pursue opportunities

to acquire new product offerings through business acquisitions and distributorships that are expected to increase our presence and

market share in certain specialty product markets and/or allow us to enter new markets.

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.

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.

We are also exploring other ways to expand our reach and our products to provide incremental value to our customers,

including new acquisitions to vertically integrate our supply chain and to obtain more of the gross profit share of the entire customer

product mix and keep operating costs low.

We continue to actively manage our product mix as we seek to maximize profit margins.

This requires us to use our proprietary expertise in balancing key variables, such as procurement and processing capacity, transportation availability, customer requirements and pricing.

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

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).

Additionally, our in-house delivery capabilities allow for direct deliveries and last-minute route adjustments to support our customers.

Evaluate expansion opportunities and other acquisitions.

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 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.

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 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.

Training and skills development:

Our continued investment into the healthcare landscape through training and academic development assists in retaining and maintaining the necessary skills base within southern Africa.

Training and skills development in healthcare is an intrinsic and necessary part of our growth strategy.

We use a state-of-the-art training facility at our Johannesburg head office, which includes the latest cardiology simulators, to assist young surgeons and health professionals to develop their procedural skills.

This requires us to use our proprietary expertise in balancing key variables, such as procurement and processing capacity, transportation

availability, customer requirements and pricing.

Additionally, we undertake continuous improvement efforts to increase the effectiveness

and efficiency of our production and distribution facilities.

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.

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).

Additionally,

our in-house delivery capabilities allow for direct deliveries and last-minute route adjustments to support our customers.

expansion opportunities and other acquisitions.

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.

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

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.

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

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.

and skills development:

Our continued investment into the healthcare landscape through training and academic development assists

in retaining and maintaining the necessary skills base within southern Africa.

Training and skills development in healthcare is an

intrinsic and necessary part of our growth strategy.

We use a state-of-the-art training facility at our Johannesburg head office,

which includes the latest cardiology simulators, to assist young surgeons and health professionals to develop their procedural skills.

We also have a full array of non-occlusive balloon dilation technology for training purposes and for hands-on product technical training.

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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

We are currently represented in approximately

29 countries, with product registration in progress for an additional 8 countries.

We currently have 28 appointed distributors to represent

our products globally.

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

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

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 devices

We intend to complete our various networks and obtain

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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.

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

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

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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

process for Class II medical devices for the Trachealator has been obtained and sales have 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

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The Medinotec Group of Companies for the Years Ended

February 28, 2025

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Compliance cost

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

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.

It should be noted that as we approach market and

sales readiness with 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.

Regulatory approvals are aligned with our operating segments, with U.S.

Drug Administration (FDA) requirements primarily applicable to our operations within the United States, while also relevant in certain

non-European international markets.

The Conformité Européenne (CE) marking, historically required for European market access,

is now being replaced by the European Union’s new regulatory framework under the Medical Device Regulation (EU MDR) and In Vitro

Diagnostic Regulation (IVDR), collectively referred to as the EU’s FDR (Future Device Regulation), which governs our activities

in Europe and certain other international jurisdictions

Regulation of Medical Devices in Europe

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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.;

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.

strengthen 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

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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 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.

and developed a range of semi-compliant coronary PTCA 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 balloon in the market.

A PTCA 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

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Aortic Valve Dilation Balloon Catheter

(Developmental)

The Aortic Perfusion and Dilation Catheter

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 (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 Aortic Perfusion and Dilation Catheter is a non-occlusive

perfusion balloon to allow the expansion of the aortic valve without impeding the cardiac output.

This catheter could 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).

Submission for FDA certification via the 510(k)

substantially equivalence process was made on May 31, 2024.

FDA clearance was obtained on March 11, 2025, after the financial year end.

The Micro CTO Catheter (Developmental)

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.

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 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 examination.

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.

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 in the treatment of tracheal

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

Development Pipeline

The following distinct and finite developmental

phases / stages are applicable to all our product pipeline, namely:

The following distinct and finite developmental phases / stages

are applicable to all our product pipeline, namely:

Pre-production prototyping

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Sales to the United States.

The products described have reached

the following stages:

The products described have reached the following stages:

Trachealator:

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

FDA listing and CE registration was obtained.

FDA clearance and CE certification was obtained.

Cape Cross PTCA Catheter:

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Final submission pending.

CE certification has been obtained.

CE certification under the MDD has been obtained, and is still valid under Regulation (EU) 2023/607.

CE certification under the MDR is in progress.

Cape Cross NC Catheter:

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Final submission pending.

CE certification has been obtained.

Lamprey Suction Dissector:

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.

CE certification under the MDD has been obtained, and is still valid under Regulation (EU) 2023/607.

CE certification under the MDR is in progress.

Valve Dilation Balloon Catheter (OutFlo) :

FDA clearance was obtained on March 11, 2025, after the financial year end.

Micro CTO Catheter :

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

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

USA, European Union, China, Australia, Korea and South Africa.

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:

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.

12,036,376, B2 has been granted on July 16, 2024.

This patent is valid until April 28, 2040.

201880086558.2 has been granted on March 31, 2023.

This patent is valid until December 12, 2038.

10-2635372 has been granted on February 5, 2024.

This patent is valid until September 4, 2040.

European Union:

Awaiting examination report :

Application No.

Awaiting examination Report :

Application No.

Intention to grant:

EP 3768363 / November 11, 2024.

This patent is valid until December 12, 2038.

South Africa:

Patent has been granted in June 2022 – Application :

Awaiting examination report – Application No.

2020/02618 has been granted on July 27, 2022.

This patent is valid until July 27, 2040.

Acceptance to be advertised, 2018406682, November 14, 2024.

This patent is valid until December 12, 2038.

No patents have been licensed from third parties.

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technologies, as well as certain other business information.

Although Medinotec Group of Companies seek patents

Although the Medinotec Group of Companies seek patents

from time to time as discussed above, patent protection for other industrial and specialty products requires a costly federal registration

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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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revenue and ability to purchase our products.

Any changes in the healthcare regulatory, payment or enforcement landscape relative to our

Any changes in the healthcare regulation, payment or enforcement landscape relative to our

customers’ healthcare services have the potential to significantly affect our operations and revenue.

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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