Risk Factors Dashboard

Item 1A. Risk Factors” and elsewhere in this report, including:

• Our ability to obtain and maintain necessary regulatory approvals and clearances (including FDA 510(k) clearances for additional products and full compliance with the EU Medical Device Regulation);
• The success of our U.S. market entry and commercialization efforts, including sales growth of the Trachealator, Outflo, and future pipeline products;
• Risks associated with our significant customer and geographic concentration, particularly reliance on DISA Life Sciences in South Africa and related-party distribution arrangements;
• Foreign exchange rate volatility, currency controls, and economic or political instability in South Africa (including load-shedding, BEE requirements, and transfer pricing or exchange control regulations);
• Potential changes in U.S. trade policy, tariffs, or preferential market access for South African goods (including AGOA benefits);
• Manufacturing, supply chain, and quality risks, including dependence on third-party suppliers and our ability to scale production;
• Product development, clinical, and commercialization risks for our pipeline products;
• Intellectual property protection and third-party infringement claims;
• Dependence on key personnel and our ability to attract and retain qualified employees;
• Liquidity, capital requirements, and our ability to obtain additional financing on acceptable terms; and
• General economic, industry, and market conditions, including competitive pressures from larger medical device companies.

Because we are a smaller reporting company and our common stock is considered a “penny stock,” we are ineligible to rely on the safe harbor for forward-looking statements provided by Section 27A of the Securities Act and Section 21E of the Exchange Act to the full extent otherwise available to larger reporting companies. Forward-looking statements speak only as of the date they are made. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

You should carefully consider the risk factors described in Item 1A of this report, as well as the other information contained or incorporated by reference in this report, before making any investment decision regarding our securities. The occurrence of any of the events described as risk factors or other future events could have a material adverse effect on our business, results of operations, financial condition, and stock price. Investing in our securities involves a high degree of risk, and the occurrence of any of these factors could materially and adversely affect our business, financial condition, results of operations, or stock price.

As used in this Annual Report on Form 10-K, unless the context otherwise requires, the terms the “Company,” “Registrant,” “we,” “us,” “our,” “Medinotec,” “Medinotec Group of Companies” or “MDNC” refer to Medinotec, Inc., a Nevada corporation, and its wholly owned subsidiaries.

PART I

ITEM 1.

BUSINESS

Company Overview

Medinotec Inc. was registered on April 26, 2021, in the State of Nevada. With an effective date of April 26, 2022, we acquired DISA Medinotec Proprietary Limited, a South African corporation, from Minoan Medical Proprietary Limited ("Minoan"), a company incorporated in South Africa, and owner of all the capital stock of DISA Medinotec Proprietary Limited. We accomplished the acquisition pursuant to the terms and conditions of a Share Exchange Agreement under common control with Minoan whereby we acquired all the capital stock of DISA Medinotec Proprietary Limited in exchange for the issuance of stock at par value and the transfer of the outstanding loan account.

This purchase was concluded between Minoan and a local newly established investment vehicle of Medinotec Inc. called Medinotec Capital Proprietary Limited in South Africa after Medinotec Inc. registered the company as a shelf company by injecting $10,000 into it on December 18, 2021. Medinotec Capital Proprietary Limited serves as the acquisition vehicle for Medinotec Inc. on the continent of Africa.

Combined these companies now form the Medinotec Group of Companies.

We currently generate revenue from two principal sources: (1) internally designed and manufactured proprietary medical devices and (2) distribution of third-party medical products under exclusive or non-exclusive agreements in defined territories. Our proprietary products include the Trachealator (a non-occlusive airway dilation balloon), the Outflo Aortic Valve Dilation Balloon Catheter, and the Cape Cross family of PTCA balloon catheters. We also distribute a range of cardiology and renal dialysis products on behalf of multinational manufacturers, primarily in South Africa.

Our History

DISA Medinotec Proprietary Limited originated from DISA Vascular 2015, a South African medical device business focused on vascular technologies. DISA Medinotec has historically developed and manufactured medical devices, including products used in cardiology and airway-related procedures. The Company’s products are sold through distributor arrangements in South Africa and certain international markets.

Following the acquisition by Medinotec Inc. through Medinotec Capital Proprietary Limited, the Group continued operating its medical device manufacturing activities from Johannesburg, South Africa. The Johannesburg facility includes manufacturing, warehousing, quality, regulatory, and administrative functions.

The Company has appointed distributors and obtained distribution rights in certain territories, including South Africa, Namibia, Mauritius, the Middle East, Europe, South America, and portions of Asia. The Company has also taken steps to develop sales channels in the United States following FDA 510(k) clearance for Trachealator in November 2021 and Outflo in March 2025. The Company continues to evaluate additional regulatory filings and patent applications in selected territories, subject to commercial feasibility, regulatory requirements, and available resources.

Raw materials and components used in manufacturing are sourced from local and international suppliers. The Company maintains supplier evaluation procedures and quality processes intended to support compliance with applicable regulatory and product specifications.

Employees

As of February 28, 2026, the Medinotec Group of Companies had 48 employees and independent contractors supporting its operations. This consisted of 36 individual full time employees and 12 independent contractors. The 12 independent contractors include a mix of individual contractors and companies engaged to support the Group’s sales and commercialization activities.

Certain of the independent contractors that are companies, including U.S.-based companies, may in turn employ or engage individual sales representatives who participate in sales-related activities for the Group’s products. These individuals are employed or engaged by the relevant independent contractor company and are not employees or individual independent contractors of the Medinotec Group of Companies. Accordingly, where an independent contractor is a company, that company is counted as one independent contractor in the table below, and any individuals employed or engaged by that company are not included in the 48-person count.

The Group’s personnel support the following functions:

• Commercial and sales: pricing, customer engagement, product support, marketing coordination, logistics support, and distributor liaison.
• Marketing: product materials, trade show support, customer communications, and coordination of industry events.
• Warehouse and logistics: inbound and outbound shipments, inventory storage, product handling, and shipment coordination in accordance with applicable quality requirements.
• Technical and manufacturing support: maintenance of manufacturing equipment and technical support for production activities.
• Customer service: order support, customer communication, and coordination of product-related queries.
• Back-office and regulatory support: finance, administration, quality, regulatory affairs, and research and development.

The Company operates in a specialized industry and seeks to retain personnel with relevant technical, manufacturing, regulatory, commercial, and administrative experience. None of the Company’s employees are represented by a labor union. The Company has not experienced any work stoppages.

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 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.

Group Contractors

DISA Medinotec Proprietary Limited holds distribution arrangements with third-party medical device companies for cardiology and renal dialysis products. These arrangements form part of the Company’s third-party distribution business and supplement the Group’s internally manufactured product portfolio.

Certain third-party distribution relationships were introduced through Minoan Medical Proprietary Limited, which previously acted as distributor before DISA Medinotec assumed responsibility for the relevant distribution activities. The Company appointed DISA Life Sciences, a South African sub-distributor, to support sales and marketing activities in South Africa. DISA Life Sciences also distributes certain internally manufactured Medinotec products in South Africa.

The Company’s principal operating focus remains the development, manufacture, and commercialization of products for which it owns or controls intellectual property, together with the distribution of selected third-party products where management believes such arrangements are commercially appropriate.

The Trachealator received FDA 510(k) clearance in November 2021, permitting the Company to market the product in the United States. As the Company did not have an established U.S. sales infrastructure at that time, it entered into a relationship with Innovative Outcomes and provided a revolving credit facility of up to $750,000 to support the development of distribution infrastructure.

During the quarter ended November 30, 2023, the Company reassessed the relationship after determining that Innovative Outcomes’ focus on the wound care clinic market was no longer aligned with the Company’s intended focus on niche surgical units. The parties separated their respective distribution activities. The note receivable remained subject to its original terms and became payable during fiscal 2024. The Company recorded a full impairment allowance against the receivable as of November 30, 2023 because the receivable was no longer supported by anticipated Trachealator-related revenue streams. Any future recoveries will be recognized when received, as appropriate.

The Company relies on distributor relationships and customer relationships to sell its products, particularly in South Africa. Through its distribution arrangements, the Group has access to a network of sales representatives that service hospitals and healthcare providers in South Africa. The Company may seek to develop or access similar distribution capabilities in the United States; however, there can be no assurance that it will be able to do so on commercially acceptable terms or at all.

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.

DISA Life Sciences remains a significant customer and distribution partner in South Africa. The Company expects to continue selling products to DISA Life Sciences while it remains commercially viable to do so. Management’s strategy includes seeking to reduce customer and geographic concentration over time by expanding into additional markets. There can be no assurance that these efforts will be successful. Regulatory requirements, market acceptance, reimbursement, competition, pricing pressure, and other barriers to entry may limit or delay the Company’s ability to diversify revenue away from the South African market and from DISA Life Sciences.

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.

Seasonality

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.

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 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.

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DISA Life Sciences is a South African medical device distributor with an established sales and marketing presence in the South African market. DISA Medinotec entered into the relationship to access existing distribution capabilities rather than building a separate internal sales force for the South African market. DISA Life Sciences uses its own sales personnel and certain subcontractors to support sales within South Africa. Following the Company’s decision to manage exports internally, the DISA Life Sciences relationship primarily relates to sales and distribution within 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 related parties have been disclosed in detail.

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 entity’s role within the Company:

	Disa Medinotec (Pty) Ltd

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 countries such as Australia, Japan and China that have very strict regulatory approval processes.

The Company’s business strategy is focused on:

Our strategy includes investing in the entire value chain, ranging from the importation of raw materials, manufacturing capabilities and the marketing and selling of products, through to the distribution of our products to customers via our sales network.

A high-level overview of our strategy follows in this annual report on Form 10-K, which is followed by a discussion on how we implement this strategy.

Operating Capabilities

The Company’s operations include product development, manufacturing, quality management, regulatory affairs, sales support, and distribution management. Management believes the following operating capabilities are relevant to the Company’s business:

• experience in developing and manufacturing selected balloon catheter and airway dilation products;
• manufacturing operations in South Africa, including cleanroom production capabilities;
• quality management and regulatory processes applicable to medical device manufacturing;
• distributor relationships in South Africa and selected international markets;
• experience with product registration and regulatory submissions in selected jurisdictions; and
• internal technical, quality, regulatory, finance, and administrative support functions.

These capabilities are subject to the risks described in Item 1A, including risks relating to regulation, customer concentration, manufacturing, product quality, market acceptance, competition, and the Company’s ability to obtain additional funding if required.

The Three Pillars of our Strategy

The Company’s strategy is organized around three areas: (1) maintaining and expanding its proprietary product portfolio, (2) developing internal manufacturing, quality, and regulatory capabilities, and (3) evaluating acquisitions, distribution arrangements, or other strategic relationships where management believes they may support the Company’s business.

1.

Innovate and Grow our Product Range

DISA Medinotec Proprietary Limited develops and manufactures selected medical devices, including products used in cardiology and airway-related procedures. The Company has invested in product development, intellectual property protection, manufacturing processes, and regulatory submissions for certain products.

The Company currently has commercially available products and developmental products. Historically, a significant portion of revenue and gross profit has been generated in South Africa. Management’s strategy includes maintaining the existing South African business while seeking opportunities to commercialize selected products in additional markets, including the United States and certain other regulated markets, subject to regulatory clearance, distributor arrangements, market acceptance, pricing, reimbursement, and available resources.

The Company also evaluates changes to existing products and new product development opportunities where management believes these may be commercially viable and consistent with the Company’s technical and regulatory capabilities.

The products are generally targeted at more complex, specialized surgical cases and are specifically relevant in medical centers of excellence. During 2018, DISA Medinotec Proprietary Limited 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. 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 Company’s expansion efforts are focused on markets where the relevant procedures are performed and where the Company believes its products may be commercially viable. These efforts may include:

• identifying and appointing distributors;
• supporting product training and technical education where appropriate;
• obtaining or maintaining required regulatory approvals or registrations;
• supporting product adoption by healthcare providers; and
• evaluating whether clinical data, publications, or other product information may support market access.

There can be no assurance that these activities will result in increased sales, market acceptance, or reduced customer concentration.

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 and Outflo following the 510(k) substantially equivalence process for Class II medical devices. This has enabled us to start sales in the USA.

Demand for the Company’s products is affected by procedure volumes, healthcare infrastructure, hospital purchasing patterns, reimbursement, pricing pressure, regulatory requirements, and broader economic conditions in the markets in which the Company operates. The Company’s current revenue remains concentrated in South Africa, although management continues to evaluate opportunities in other markets where regulatory and commercial conditions support market entry.

The United States is an important target market for the Company because certain of its products have received, or may in the future seek, FDA 510(k) clearance. U.S. sales for fiscal 2026 were $611,860, representing 6% of total sales, compared to $678,105, representing 7% of total sales, in fiscal 2025. The Company’s ability to increase U.S. revenue will depend on factors including regulatory clearance, product adoption, distributor or sales arrangements, reimbursement, pricing, competition, and available capital.

Key Market Trends and Our Response to These

Medical device markets are affected by demand for less invasive procedures, hospital cost controls, reimbursement practices, product innovation, and competition. These factors may create opportunities for products used in minimally invasive procedures, but they may also increase pricing pressure and require ongoing investment in product development, regulatory compliance, quality systems, and commercial support.

The Company seeks to respond to these trends by maintaining its current product portfolio, evaluating product development opportunities, managing manufacturing costs, and supporting regulatory submissions in selected markets. The Company’s ability to benefit from these trends is subject to market acceptance, regulatory clearance, reimbursement, competition, and the risks described in Item 1A.

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.

In the current environment of managed care, economically motivated customers, consolidation among healthcare providers, increased competition, and declining reimbursement rates, we have been increasingly required to compete on the basis of price. In order to continue to compete effectively, we must continue to create or acquire advanced technology, incorporate this technology into proprietary product offerings, obtain regulatory approvals in a timely manner, maintain high-quality manufacturing processes, and successfully market these products. In order to continue to compete effectively, we must continue to create, invest in or acquire advanced technology, incorporate this technology into its proprietary products, obtain regulatory approvals in a timely manner, and manufacture and successfully market our products.

Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries in which the Medinotec Group does business, including the US.

These initiatives put increased emphasis on the delivery of more cost-effective medical devices and therapies. Government programs, including Medicare and Medicaid, private healthcare insurance and managed-care plans have attempted to control costs by limiting the amount of reimbursement they will pay for particular 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.

The Company may seek additional distributor relationships, strategic relationships, or financing arrangements to support its activities in North America and other selected markets. There can be no assurance that such arrangements will be available on acceptable terms or that they will result in increased revenue.

Our Competitor Landscape

The Medinotec Group of Companies operates in highly competitive medical device markets characterized by a number of large, multinational players as well as a number of small, regional or local distributors. Some of the major players include Johnson & Johnson, Boston Scientific, Cook Medical, Cordis, B. Braun, Teleflex, Medtronic, Merit Medical, Endotec, Conmed and Cadence.

Competition is based on price, consistency and quality of product, site location, distribution capability, customer service, reliability of supply, breadth of product offering and technical support. The principal competitive factors in these markets are product features, value-added solutions, reliability, clinical evidence, reimbursement coverage, and price.

We compete with many companies having significantly more capital resources, larger research laboratories and more extensive distribution systems. As a smaller company with limited market share, we are particularly vulnerable to these competitive pressures, especially as we seek to expand commercialization of our proprietary devices into the highly regulated and competitive United States market. As such, there are no assurances that we will be able to compete and gain market share.

2.

Build our Competencies

The Company has invested in its Johannesburg manufacturing facility, including cleanroom production capacity, laboratory space, packaging areas, sterilization capabilities, and equipment used in the development and manufacture of selected medical devices. The facility supports activities conducted under the Company’s ISO 13485 Quality Management System.

The Company’s manufacturing capabilities include processes relevant to balloon catheter and related device production, including balloon forming, bonding, coating, catheter lamination, packaging, and sterilization-related activities. These capabilities support the Company’s current products and certain product development activities.

At present, management does not intend to prioritize significant additional expansion of the production facility. The Company expects to focus available resources on maintaining current operations, supporting regulatory and quality requirements, product development, and commercial activities.

3.

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

The Company’s implementation plan is focused on the following operating priorities:

• maintaining manufacturing and quality processes for existing products;
• supporting regulatory compliance and product registrations in selected jurisdictions;
• managing distributor and customer relationships in South Africa and selected international markets;
• evaluating product development opportunities that align with the Company’s technical, regulatory, and financial resources;
• managing inventory levels to support expected demand while limiting excess or obsolete inventory;
• managing operating costs and working capital; and
• evaluating acquisitions, distribution arrangements, or other strategic transactions where management believes they may be commercially appropriate.

The Company’s ability to execute this plan depends on, among other factors, available capital, regulatory approvals, supplier performance, production capacity, customer demand, distributor performance, reimbursement, competition, and macroeconomic conditions.

Product Distribution

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.

As of February 28, 2026, the Company was represented in approximately 45 countries and had 31 appointed distributors globally. Product registrations were received in several additional jurisdictions during fiscal 2026, while registrations remained pending in certain other jurisdictions. All exports are managed directly from South Africa by the Company’s export manager.

We have had several training initiatives held in the US where FDA approval has been granted for both the Trachealator and Outflo following the 510(k) substantially equivalence process for Class II medical devices

The Company intends to continue evaluating distributor arrangements and regulatory requirements in additional markets, including Australia, Japan, and China. Entry into these markets would be subject to local regulatory approvals, commercial feasibility, distributor arrangements, and available resources.

Through the operating subsidiary DISA Medinotec Proprietary Limited, we ship our products to customers directly by freight or by air and through our network of in-house and courier partners. Recent market trends have resulted in more product volumes being transported by high-efficiency road freight.

The Company maintains distribution facilities in Johannesburg, South Africa and New York, United States of America. These facilities support access to road and air freight routes. The Company evaluates its distribution arrangements from time to time to manage delivery timing, inventory availability, freight costs, and customer requirements.

Product Manufacturing – Quality Assurance and Regulatory Requirements

Quality Management

The Company maintains documented procedures and a Quality Management System (“QMS”) intended to support compliance with ISO 13485, the European Union Medical Device Regulation 2017/745, U.S. FDA 21 CFR 820 regulations, and applicable South African regulatory requirements.

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 surveillance program, which enables product performance to be regularly assessed and to be reported to the regulatory authorities if any incident/malfunction occurs that results in severe injury to the patient or death.

Additionally, we maintain quality standards relevant to the storage and distribution of our products. These include technical/quality agreements with our suppliers. Since we import raw materials, all manufacturing of the products is performed in DISA Medinotec South Africa’s clean room facilities, and all instructions and quality manuals are written to convert a series of raw materials into finished goods against the applicable quality assurance standards and internal procedures. No manufacturing steps are outsourced at the moment.

Compliance to all procedures is monitored via an internal audit system and augmented by audits conducted annually by European and American Notified Bodies.

International Quality Regulations

Many of our 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. Most of our products carry the CE Mark. 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 to the legal requirements of the European Union. 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, 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.

The Company is in the process of addressing applicable requirements under the Medical Device Regulation (MDR) 2017/745. The Trachealator has been certified under this regulation, and technical files for certain remaining products are under review 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 in the EU. DEKRA's role includes conducting conformity assessments, issuing CE certifications, and performing post-market surveillance to ensure ongoing compliance.

The Company has obtained FDA 510(k) clearance for the Trachealator, and U.S. sales have commenced. FDA 510(k) clearance has also been obtained for Outflo, and the company is currently implementing marketing strategies in the United States with sales expected to commence in fiscal 2027. There can be no assurance as to the timing or outcome of any pending or future FDA submissions.

In addition, we are subject to numerous and increasingly stringent environmental laws and regulations concerning, among other things, the generation, handling, storage, transportation, treatment and disposal of toxic and hazardous substances, the discharge of pollutants into the air and water and the cleanup of contamination. We are required to maintain and comply with environmental permits and controls for some of our operations, and these permits are subject to modification, renewal, and revocation by the issuing authorities. Our environmental compliance may increase in the future because of changes in environmental laws and regulations or increased manufacturing activities at any of our facilities. We could incur significant 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 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.

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. Compliance costs decreased during fiscal 2026 compared to fiscal 2025, primarily due to lower audit fees following the change in the Company’s independent registered public accounting firm, as well as higher prior-year costs associated with seeking FDA approval for OutFlo, which was granted in March 2025.

Medical Device Regulation

Regulatory approvals and market acceptance are material to the Company’s business. The regulatory approval process for medical devices, including FDA clearance in the United States and CE/MDR certification in Europe, can be lengthy, costly, and uncertain. If the Company is unable to obtain or maintain required approvals, clearances, registrations, or certifications, or if approvals are delayed, the Company may be unable to commercialize certain products or may experience delays in commercialization. Even where regulatory clearance or certification is obtained, there can be no assurance that the relevant products will achieve market acceptance. See below and Item 1A. Risk Factors for further discussion of regulatory, compliance, and environmental risks in connection with our medical device products.

Regulation of Medical Devices in Europe

Medical devices placed on the market in the European Economic Area must comply with the Medical Device Regulation (MDR) (EU) 2017/745, which sets out the essential safety and performance requirements that all devices must meet. Under the MDR, manufacturers must undergo a conformity assessment process (typically involving an independent accredited Notified Body for higher-risk devices) to demonstrate compliance before the device can be CE-marked and legally sold throughout the EEA.

The Company maintains CE Mark certification for most of its products and is progressing toward full compliance with the MDR. The Trachealator has been certified under the MDR, and technical files for the remaining products are under review by the Notified Body.

Regulation of Medical Devices in South Africa

In South Africa, medical device manufacturing is regulated by the South African Health Products Regulatory Authority (“SAHPRA”), with guidelines published in the Government Gazette No. 40480 in 2016, which refer to licensing of medical devices establishments and the registration required to ensure an acceptable level of safety, quality, and performance. DISA Medinotec Proprietary Limited is registered with SAHPRA and possesses the above-described licenses and registrations for all our products.

Regulation of Medical Devices in Other Key Markets

Australia, Japan, and China have their own independent regulatory systems (Therapeutic Goods Administration – TGA; Pharmaceuticals and Medical Devices Agency – PMDA; National Medical Products Administration – NMPA respectively) and do not automatically accept CE marking or FDA clearance. Separate local registrations, testing, and compliance requirements apply in these jurisdictions.

The Company is also subject to numerous and increasingly stringent environmental, health and safety laws and regulations in the jurisdictions in which it operates.

Federal, State, and Foreign Fraud and Abuse and Physician Payment Transparency Laws.

In addition to FDA restrictions on the marketing and promotion of our medical devices, other federal, state and foreign laws may restrict our business practices particularly as we expand commercialization of our products into the United States and other markets where our devices may be reimbursable under government healthcare programs. These laws include, without limitation, anti-kickback, false claims laws, and physician payment transparency laws.

The federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting, or receiving any remuneration (in cash or in kind) to induce or reward the purchase, order, or recommendation of any item or service reimbursable, in whole or in part, under Medicare, Medicaid, or other federal healthcare programs. Violation of the Anti-Kickback Statute can also result in liability under the Civil Monetary Penalties Law (originally enacted as the Civil Monetary Penalty Act of 1981). Current penalties under the Civil Monetary Penalties Law can reach up to $100,000 per violation plus three times the amount of the remuneration, as well as exclusion from federal healthcare programs such as Medicare and Medicaid.

The federal False Claims Act prohibits knowingly presenting or causing to be presented a false or fraudulent claim for payment to the federal government, or knowingly making or using a false record or statement material to a false or fraudulent claim. Liability can arise even without specific intent to defraud. Private parties may bring “qui tam” lawsuits on behalf of the government and share in any recovery. Penalties include civil fines ranging from $14,308 to $28,619 per false claim, plus up to three times the damages sustained by the government, and potential exclusion from federal healthcare programs. The criminal False Claims Act imposes additional penalties for knowingly presenting a false claim to the government.

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) also created federal criminal statutes prohibiting schemes to defraud healthcare benefit programs (including private payers), embezzlement from such programs, and making false statements in connection with the delivery of or payment for healthcare services.

Many states have similar fraud and abuse laws that may be broader than their federal counterparts and apply regardless of the payor. In addition, many foreign jurisdictions in which we operate or plan to operate, including the European Union and South Africa, have analogous laws restricting improper payments and promotional activities involving healthcare professionals.

The Physician Payments Sunshine Act (now administered through the federal Open Payments program) requires manufacturers of drugs, biologics, and medical devices covered by Medicare, Medicaid, or CHIP to report annually to the Centers for Medicare & Medicaid Services certain payments or other transfers of value made to physicians, teaching hospitals, and other covered recipients. We are subject to these reporting requirements as we commercialize our devices in the United States. Failure to comply with these transparency and fraud and abuse laws could result in significant civil and criminal penalties, exclusion from government programs, and reputational harm.

Data Privacy and Security Laws.

In addition to other regulatory requirements, we are or may become subject to various federal, state, and foreign laws governing the collection, use, disclosure, and protection of personal information, including protected health information (“PHI”) and other sensitive data. These laws include the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), the European Union General Data Protection Regulation (“GDPR”), and the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act (“CCPA/CPRA”).

HIPAA establishes national standards for the privacy and security of PHI. It applies to covered entities (such as healthcare providers and plans) and their business associates (including contractors or agents that create, receive, maintain, or transmit PHI on behalf of a covered entity). HIPAA requires safeguards to protect the confidentiality, integrity, and availability of electronically transmitted or stored PHI, restricts the use and disclosure of PHI, and grants individuals certain rights regarding their health information (such as the right to access or amend records). In the event of a breach of unsecured PHI, HIPAA mandates notification to affected individuals without unreasonable delay and no later than 60 days after discovery. Breaches affecting 500 or more individuals must also be reported to the U.S. Department of Health and Human Services (HHS) and the media. Failure to comply with HIPAA’s privacy and security rules can result in civil monetary penalties of up to $71,000 per violation (adjusted for inflation), with an annual maximum of approximately $2.1 million for identical violations, as well as potential criminal penalties.

Many states have data privacy and breach notification laws that are broader than HIPAA or apply regardless of payor. For example, the CCPA/CPRA grants California residents rights to access, delete, and opt out of the sale of their personal information and creates a private right of action for certain data breaches. Although exceptions exist for PHI regulated by HIPAA, the CCPA/CPRA may still apply to certain personal data we process outside of covered healthcare activities.

In the European Economic Area, the GDPR and related national laws impose strict requirements on the processing of personal data, including special categories of data such as health information. As we expand operations and potentially process data of EEA individuals (including employees, customers, patients, or clinical trial participants), we must ensure compliance with GDPR principles such as lawful basis for processing, data minimization, security, and accountability. Violations of the GDPR can result in fines of up to 4% of global annual turnover or €20 million, whichever is greater.

We maintain policies, procedures, and technical safeguards designed to protect personal and health information; however, as we commercialize our devices in the United States and other regulated markets and handle increasing volumes of patient or clinical data, our exposure to these laws will grow.

Healthcare Reform.

The U.S. and certain foreign jurisdictions continue to consider or have enacted legislative and regulatory changes to the healthcare system that could affect our ability to sell our products profitably. Policymakers and payors remain focused on containing healthcare costs while seeking to improve quality and expand access. These efforts include ongoing cost-containment measures, value-based payment models, and reforms to reimbursement for medical devices.

In the United States, recent initiatives such as the One Big Beautiful Bill Act of 2025 and the new CMS/FDA RAPID coverage pathway (announced in April 2026) aim to accelerate Medicare reimbursement for certain breakthrough devices following FDA approval. While these developments could benefit our U.S. commercialization efforts for products such as the Trachealator and Outflo catheters, broader cost-containment pressures—including site-neutral payments, expanded use of ambulatory surgical centers, and ongoing scrutiny of device pricing—may limit coverage of or reduce reimbursement for procedures using our devices. Any such changes could reduce demand for our products or create additional pricing pressure.

In the European Union, the Health Technology Assessment Regulation (effective since January 2025) requires Joint Clinical Assessments for high-risk medical devices, which may influence national reimbursement decisions. In South Africa, the phased implementation of National Health Insurance (NHI) continues, with Phase 2 (2026–2028) focused on centralized purchasing and reimbursement reforms that could affect our local distribution and pricing strategies.

We expect additional state, federal, and foreign healthcare reform measures to be adopted in the future. Any of these could limit the amounts that governments or private payors will reimburse for our products or the procedures in which they are used, potentially reducing demand or increasing pricing pressure.

Our Key Products

The Company’s key products include the Trachealator, the Outflo Aortic Valve Dilation Balloon Catheter, and the Cape Cross family of balloon catheters. Certain additional products remain in development or are subject to regulatory review. The discussion below summarizes the Company’s principal products and selected developmental products.

The Trachealator

The Trachealator is a non-occlusive airway dilation balloon intended for use in selected airway dilation procedures. Tracheal and bronchial stenosis can arise from a number of causes and may require one or more dilation procedures, depending on the patient and clinical circumstances.

The Trachealator received CE Mark approval in 2019 and FDA 510(k) clearance in November 2021. The product is sold in selected markets, including parts of Europe, the Middle East, South America, portions of Asia, South Africa, and the United States. In May 2021, the product received 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 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 and sales has since commenced in the USA.

FDA clearance and CE/MDR certification may support regulatory submissions or market access in certain jurisdictions, but medical device approval requirements differ by country. Some jurisdictions require additional local registrations, testing, certifications, or quality requirements before a product may be sold. The Company evaluates market entry requirements on a jurisdiction-by-jurisdiction basis.

For example, Australia (Therapeutic Goods Administration – TGA), Japan (Pharmaceuticals and Medical Devices Agency – PMDA), and China (National Medical Products Administration – NMPA) have their own independent regulatory systems and do not automatically accept CE marking or FDA clearance.

The Trachealator

The Trachealator

Outflo Aortic Valve Dilation Balloon Catheter

The Outflo Aortic Perfusion and Dilation Catheter is a non-occlusive perfusion balloon to allow the expansion of the aortic valve without impeding the cardiac output.

The product is intended for use in selected procedures involving post-dilation of an artificial valve in TAVI (Transcatheter Aortic Valve Implantation), where clinically appropriate.

FDA clearance was obtained on March 11, 2025. Outflo is currently marketed in South Africa, and marketing activities in the United States commenced during the fourth quarter of fiscal 2026.

Outflo Aortic Valve Dilation Balloon Catheter

The Cape Cross PTCA Catheter

The Company designed and developed the Cape Cross range of semi-compliant coronary PTCA catheters. The product has obtained CE Mark approval and is sold in South Africa and selected international markets.

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

Cape Cross Non-Compliant (“NC”) Catheter

The Cape Cross NC Catheter was developed as a non-compliant balloon catheter for post-dilation procedures. The product has obtained CE Mark approval and is sold in South Africa and selected international markets. After placement of a stent, a non-compliant balloon catheter may be used to assist with stent apposition, depending on the clinical circumstances.

The Cape Cross Non-Compliant (“NC”) Catheter

The Micro CTO Catheter (Developmental)

The Company has developed a micro CTO (Chronic Total Occlusion) balloon catheter range with diameters from 0.70 mm to 1.25 mm as a size range extension to the Cape Cross PTCA Catheter.

The product is intended for use in selected coronary cases involving chronic total occlusions, subject to applicable regulatory approvals or certifications. The technical file was submitted to the Company’s Notified Body at the end of July 2023 and remains under review.

The process of seeking FDA clearance for the Cape Cross PTCA catheter range through the 510(k) substantial equivalence process commenced in January 2024. There can be no assurance as to the timing or outcome of this process.

StaXstop Catheter (Developmental)

The StaXstop Catheter is an epistaxis catheter intended for use in the management of nasal bleeding. The product remains in the development pipeline and is currently subject to research and development, testing, pre-production prototyping, and related product validation activities. The Company expects that the product will require FDA 510(k) clearance before it may be marketed in the United States.

Septus Balloon (Developmental)

The Septus Balloon is a nasal fracture balloon intended for use in selected nasal procedures. The product remains in the development pipeline and is currently subject to research and development, testing, and pre-production prototyping activities. Further development, regulatory review, and commercialization assessments will be required before the product may be marketed in applicable jurisdictions.

Vaultseal Balloon (Developmental)

The Vaultseal Balloon is a balloon product intended for use in selected gynecological procedures. The product remains in the development pipeline and is currently subject to research and development, testing, and pre-production prototyping activities. The Company will continue to evaluate the product’s regulatory pathway, commercial feasibility, and timing of any potential market introduction.

Product Development Pipeline

The following distinct and finite developmental phases / stages are applicable to all our product pipeline, namely:

1)

R&D

2)

Pre-production prototyping

3)

Testing

4)

Production

5)

Clinical trials

6)

MDR/CE Mark accreditation

7)

Local marketing & selling

8)

International sales outside the US

9)

FDA 510 (k) approval

10)

Sales to the United States.

The products described have reached the following stages:

See Item 1A. Risk Factors for a discussion of risks associated with product development, clinical trials, and regulatory approvals.

Intellectual Property

The Medinotec Group of Companies currently holds various product registration certificates and operating licenses, which allow us to operate as an importer of raw materials for the manufacture of medical devices and an exporter and distributor of these products within the territories we service. We also hold various patents, trademarks, and other intangible proprietary rights that are considered material to the business and its ability to compete effectively with other companies.

The Medinotec Group pursues patent protection in selected jurisdictions where management believes such protection is appropriate for patentable subject matter in its products. The Company also reviews publicly available third-party patents and patent applications where relevant to its product development and commercialization activities. These activities are intended to support the Company’s intellectual property position and reduce the risk of infringing third-party rights, although there can be no assurance that these efforts will be effective.

Due to the Trachealator being fairly new, patent applications for the Trachealator have been filed in the following countries or regions: 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:

No patents have been licensed from third parties.

Trade Secrets

With respect to some of our products, Medinotec Group of Companies rely principally on trade secrets, rather than patents, to protect proprietary processes, methods, documentation, and other technologies, as well as certain other business information.

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

The Company sells to or through hospitals, clinics, third-party healthcare providers, distributors, governmental healthcare programs, and group purchasing organizations. A significant portion of the Company’s revenue is generated through distributor relationships, including DISA Life Sciences in South Africa.

Research and Development

All R&D is conducted within the Medinotec Group of Companies, which employs the necessary engineers, and technical and support personnel. The in-house technical expertise includes biomedical engineering and product design. The R&D team focuses primarily on developing new products and supporting existing products.

Condition of Physical Assets and Insurance

Parts of the Medinotec Group of Companies are capital intensive and require ongoing capital investment for the replacement, modernization and/or expansion of equipment and facilities. We therefore maintain insurance policies against property loss and business interruption and insure against other risks that are typical in the operation of the business, in amounts that we believe to be reasonable. Where costs are deemed to be commercially unviable, we self-insure. Such insurance, however, contains exclusions and limitations on coverage, particularly with respect to environmental liability and political risk. There can thus be no assurance that claims would be paid under such insurance policies in connection with a particular event.

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.

Third Party Coverage and Reimbursement

Healthcare providers that purchase medical devices generally rely on third-party payors, including private payors, such as indemnity insurers, employer group health insurance programs and managed care plans, to reimburse all or part of the cost of the products. As a result, demand for our products is and will continue to be dependent in part on the coverage and reimbursement policies of these payors.

Possible reductions in, or eliminations of, coverage or reimbursement by third-party payors, or denial of, or provision of uneconomical reimbursement for new products may affect our customers’ revenue and ability to purchase our products. 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.

Additional Information

The public may read and copy any materials the Company files with the SEC in the SEC’s Public Reference Section, Room 1580, 100 F Street N.E., Washington, D.C. 20549. The public may obtain information on the operation of the Public Reference Section by calling the SEC on 1-800-SEC-0330. Additionally, the SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, which can be found at http://www.sec.gov.

Item 1A.

Risk Factors.

You should carefully consider the risks described below, together with all of the other information included in this Annual Report on Form 10-K, before making an investment decision regarding our securities. The occurrence of any of the following risks, or additional risks and uncertainties not presently known to us or that we currently deem immaterial, could materially and adversely affect our business, financial condition, results of operations, cash flows and the trading price of our common stock. In such a case, you may lose all or part of your investment. In that case, you may lose all or part of your investment.

SUMMARY OF PRINCIPAL RISK FACTORS

The following is a summary of the principal risks that could materially and adversely affect our business, financial condition, results of operations and stock price. This summary does not include every risk we face; a more complete discussion of the risks set forth below appears later in this Item 1A under the corresponding headings. You should read the full “Risk Factors” section for a more detailed discussion of these and other material risks.

Liquidity, Capital Needs and Dilution Risk

We may require additional capital to fund U.S. commercialization, product development and potential acquisitions. There can be no assurance that such financing will be available on favorable terms, or at all. Any future equity offerings would dilute existing shareholders, and our failure to obtain necessary capital could delay or prevent execution of our growth strategy.

Customer and Geographic Concentration Risk

We derive a substantial majority of our revenue from a limited number of customers and geographic markets. In particular, sales to DISA Life Sciences in South Africa represented approximately 89% of our total revenue for the fiscal year ended February 28, 2026. Any loss or material reduction in business with DISA Life Sciences, or any disruption in the South African market, would have a material adverse effect on our revenue, profitability and cash flows.

Regulatory and Product Approval Risk

Our ability to commercialize current and future products in the United States and other major markets depends on obtaining and maintaining regulatory clearances and approvals, including FDA 510(k) clearance and compliance with the EU Medical Device Regulation (MDR). Delays in, or failure to obtain, these approvals, or any subsequent product modifications that require new clearances, could prevent or significantly delay product launches, harm our reputation and materially adversely affect our growth and financial results.

South Africa-Specific Operational and Political Risks

Our primary manufacturing operations are located in South Africa, exposing us to country-specific risks including frequent load-shedding and unstable power supply, political instability, Broad-Based Black Economic Empowerment (BEE) requirements that could limit growth or talent acquisition, stringent exchange controls that may restrict or delay repatriation of funds to the United States, and potential changes in South African tax, labor or regulatory policy. Any of these factors could disrupt manufacturing, increase costs or impair our ability to fund U.S. operations.

Geopolitical, Trade and Tariff Risks

We are subject to risks arising from U.S. tariffs on South African goods, potential revocation or modification of AGOA benefits, retaliatory trade measures, and broader geopolitical tensions (including conflicts involving Iran and global shipping disruptions). These developments could materially increase our costs, reduce competitiveness in the U.S. market, disrupt supply chains and adversely affect revenue and margins.

Dependence on Key Personnel and Founder Control

Our future success depends heavily on the continued service of our founder, CEO and director Dr. Gregory Vizirgianakis and our CFO Pieter van Niekerk. In addition, Dr. Vizirgianakis and his brother Stavros together control approximately 81% of our voting power. The loss of either key executive, or any actions by the controlling shareholders that are not aligned with minority shareholders, could materially harm our business, strategy execution and governance.

Market and Securities Risks

Our common stock trades on the OTCQX and is subject to “penny stock” rules, which may limit liquidity and make it more difficult for investors to sell shares. The market price of our stock may be highly volatile, and we may be unable to uplist to a national securities exchange or maintain such a listing if achieved. These factors could result in substantial losses for investors and limit our ability to raise capital in the future.

Product Development, Competition and Commercialization Risk

Our growth depends on successfully developing and commercializing new products and line extensions. Many of these products are in the development pipeline and may never reach market, may fail to obtain regulatory approval or may not achieve commercial acceptance. We also face intense competition from much larger, well-capitalized medical device companies, which could limit our market share and profitability.

Investing in our securities involves a high degree of risk. You should carefully review the full discussion of these and other risks in the “Risk Factors” section below before making an investment decision.

Risks Related to our Financial Position and Need for Capital

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

Our expansion plans, particularly the continued commercialization of our products in the United States (including the Trachealator and Outflo), pursuit of additional FDA 510(k) clearances, and scaling of manufacturing and regulatory compliance activities, may require additional capital. We may also need capital to operate our business in response to circumstances caused by the risks described in this report, including customer concentration, foreign exchange volatility, and South Africa-specific operational challenges.

The raising of additional capital could result in dilution to stockholders. In addition, there is no assurance that we will be able to obtain additional capital if we need it, or that if available, it will be available to us on favorable or reasonable terms. Any limitation on our ability to obtain additional capital as and when needed could have a material adverse effect on the business, financial condition and results of operations.

We may also incur additional indebtedness in the future. This could have adverse consequences, including the following:

Any potential future debt service obligations may require us to use a portion of the operating cash flow to pay interest and principal on indebtedness instead of for other corporate purposes, including funding the future expansion of the business, acquisitions, and ongoing capital expenditures, which could impede growth. If operating cash flow and capital resources are insufficient to service debt obligations, we may be forced to sell assets, seek additional equity or debt financing or to restructure our debt, which could harm long-term business prospects.

Our failure to comply with the terms of any potential future debt obligations could also result in an event of default which, if not cured or waived, could result in the acceleration of all its debt and impact our ability to operate as a going concern.

Management evaluated the Company’s ability to continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance of these financial statements.

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

A change in accounting standards or practices or a change in existing taxation rules or practices can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. This also applies to new standards, practices, and rules.

Changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business. The fact that we operate in multiple territories (including the United States and South Africa) heightens this risk in specific territories. The fact that we operate in multiple territories and have a worldwide footprint heightens this risk in specific territories.

Risks Relating to Business Operations

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

Many healthcare companies, including healthcare systems, distributors, manufacturers, providers, and insurers, are consolidating or have formed strategic alliances. As the healthcare industry consolidates, competition to provide goods and services to industry participants will become more intense. Further, this consolidation creates larger enterprises with greater negotiating power, which they can use to negotiate price concessions or demand more favorable contract terms. Further, this consolidation creates larger enterprises with greater negotiating power, which they can use to negotiate price concessions.

As a smaller company with limited market share, we are particularly vulnerable to these dynamics. Our business is already subject to significant price pressure in both our proprietary product lines and our distribution business. Larger consolidated customers or distributors may demand deeper discounts, volume-based rebates, or exclusive arrangements that favor our much larger, better-capitalized competitors. If we are forced to reduce our prices or lose existing distributor relationships (including our significant relationship with DISA Life Sciences) as a result of industry consolidation, our revenues, gross margins, profitability, and cash flows could be materially and adversely affected.

We believe our low-cost manufacturing base in South Africa provides some competitive advantage, but there can be no assurance that this advantage will be sufficient to offset the pricing and contracting leverage held by larger consolidated entities.

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

Most of our customers and the healthcare providers to whom our customers supply medical devices, rely on third-party payers, including government programs (such as Medicare and Medicaid in the United States and public healthcare funding in South Africa) and private health insurance plans, to reimburse some or all the cost of the procedures in which medical devices that incorporate components we manufacture or assemble are used.

The continuing efforts of governmental authorities, insurance companies and other payers of healthcare costs to contain or reduce these costs, through mechanisms such as reduced reimbursement rates, bundled payments, competitive tender processes, prior-authorization requirements, and value-based purchasing, could lead to patients being unable to obtain approval for payment from these third-party payers or could cause hospitals and other providers to favor lower-cost alternatives.

If third-party payer payment approval cannot be obtained by patients, or if providers face increased pressure to reduce procedure costs, sales of finished medical devices that include our components (including our proprietary Trachealator, Outflo, and Cape Cross products) may decline significantly. Our customers, including distributors and hospitals, may reduce or eliminate purchases of our devices in favor of lower-priced competitors. These pressures are particularly acute in the U.S. market where we are expanding commercialization efforts and in South Africa where a large portion of our current revenue is generated. The cost-containment measures that healthcare providers are instituting, both in the United States and outside of the United States, could harm our ability to maintain pricing levels, achieve anticipated sales volumes, and operate profitably. The cost-containment measures that healthcare providers are instituting, both in the US and outside of the US could harm our ability to operate profitably.

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

If we fail to maintain our working relationships with healthcare professionals, many of our products may not be launched and marketed in line with the needs and expectations of the professionals who use and support our products, which could cause a decline in earnings and profitability.

The research, development, marketing and sale of many of our new products — including the Trachealator, Outflo, Cape Cross family, and our development pipeline (Micro CTO Catheter, StaXstop Catheter, Septus Balloon, and Vaultseal Balloon) — depends on our maintaining working relationships with healthcare professionals. Physicians, surgeons, and other key opinion leaders assist us as researchers, product consultants, clinical advisors, trainers, inventors, and public speakers. These relationships are critical for product feedback, clinical validation, surgeon training programs, endorsement, and adoption in both existing and new markets, particularly as we expand commercialization in the United States.

Any failure to maintain these relationships or to expand our network to include new professionals in the territories we enter (especially in highly regulated markets such as the United States), will have a negative impact on our ability to develop, obtain regulatory clearance for, launch, and achieve market acceptance of our products, which could materially and adversely affect our financial success.

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

We currently have several innovative products in various stages of the research and development pipeline, including the Micro CTO Catheter (Technical File submitted to our Notified Body in July 2023 and currently under review), as well as the StaXstop Catheter, Septus Balloon, and Vaultseal Balloon (in earlier developmental stages). However, some of these projects may fail to come to market for a number of reasons, including delays or failure to obtain necessary regulatory clearances (such as additional FDA 510(k) clearances or full compliance with the EU Medical Device Regulation), competitor products reaching the market first, lack of economic viability due to high production costs relative to projected sales, insufficient market acceptance by physicians and hospitals, or unfavorable results from safety, efficacy, or clinical evaluations.

Our growth strategy depends in significant part on successfully commercializing these and future pipeline products, particularly in the United States and other higher-value regulated markets, to diversify revenue and reduce our current heavy reliance on South African sales. Any failure to advance these products through regulatory approval, scale manufacturing, or achieve meaningful market adoption could materially delay or prevent revenue growth, limit our ability to compete effectively, and adversely affect our business, financial condition, and results of operations.

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

We compete in medical markets throughout the world, which are characterized by rapid changes resulting from technological advances and scientific discoveries. In the product lines in which we compete, we face competition ranging from large, multinational companies with multiple business lines and significantly greater financial, technical, marketing, and distribution resources (such as Johnson & Johnson, Boston Scientific, Medtronic, and others) to small, specialized manufacturers that offer niche products. Development by other companies of new or improved products, processes, technologies, or the introduction of lower cost alternatives, including reprocessed products or generic versions when our proprietary products lose their patent protection, may make existing or planned products less competitive. Development by other companies of new or improved products, processes, technologies, or the introduction of reprocessed products or generic versions when our proprietary products lose their patent protection may make existing or planned products less competitive. As a smaller company with limited market share, we are particularly vulnerable to these competitive pressures, especially as we seek to expand commercialization of our proprietary devices (including the Trachealator, Outflo, and Cape Cross family) into the highly regulated and competitive United States market.

We believe our ability to compete depends upon many factors both within and beyond our control, including product performance and reliability, product technology and innovation, product quality and safety, breadth of product lines, product support services, customer support, cost-effectiveness and price, reimbursement approval from healthcare insurance providers, and changes to the regulatory environment.

Competition may increase as additional companies enter our markets or modify their existing products to compete directly with ours. In addition, academic institutions, governmental agencies, and other public and private research organizations also may conduct research, seek patent protection, and establish collaborative arrangements for discovery, research, clinical development and marketing of similar products.

These companies and institutions compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. From time to time we have lost, and may in the future lose, market share in connection with product problems, physician advisories, safety alerts and publications about our products, which highlights the importance of product quality, product efficacy and quality systems to the business.

In the current environment of managed care, consolidation among healthcare providers, increased competition, and declining reimbursement rates, we have been increasingly required to compete on the basis of price. Further, our continued growth and success depend on our ability to develop, acquire and market new and differentiated products, technologies, and intellectual property. As a result, we also face competition for marketing, distribution, and collaborative development agreements, establishing relationships with academic and research institutions and licenses to intellectual property.

In order to continue to compete effectively, we must continue to create, invest in or acquire advanced technology, incorporate this technology into its proprietary products, obtain regulatory approvals in a timely manner, and manufacture and successfully market our products. Given these factors, we cannot guarantee that we will be able to compete effectively or continue its current level of success.

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

The supply of products requires timely delivery and exact planning due to most of our raw material either being manufactured by suppliers or imported. These suppliers/strategic partners require a sufficient amount of quality components and materials and are highly exacting and complex, due in part to strict regulatory requirements.

We have generally been able to obtain adequate supplies of such finished goods, raw materials, components, and services. However, for reasons of quality assurance, cost effectiveness, or availability, certain components, raw materials, goods, and services needed to fill our supply chain are obtained from various sole suppliers.

Although we work closely with our suppliers to ensure continuity of supply while maintaining high quality and reliability, the supply of these goods, components, raw materials, and services may be interrupted or insufficient. In addition, due to the stringent regulations and requirements of regulatory agencies, regarding the manufacture and import/export of our products, we may not be able to quickly establish additional or replacement sources. In addition, a reduction or interruption in supply, and an inability to develop alternative sources for such supply, could adversely affect our ability to supply products in a timely or cost-effective manner and could result in lost sales.

Other disruptions in the supply chain process or product sales and fulfilment systems for any reason, including equipment malfunction, failure to follow specific protocols and procedures, supplier facility shut-downs, defective raw materials, wars and conflict, natural disasters, power outages (including frequent load-shedding in South Africa), civil unrest, or other environmental factors, could lead to launch delays, product shortage, unanticipated costs, lost revenues and damage to our reputation. These risks are particularly relevant to us because our primary manufacturing facility is located in Johannesburg, South Africa, and we rely on both local and international suppliers for critical inputs. Furthermore, any failure to identify and address manufacturing problems prior to the release of products to customers could result in quality or safety issues.

These disruptions are exacerbated by global economic uncertainty and heightened geopolitical tensions, such as the Russian war on Ukraine, between the United States and China as well as Brexit and conflicts in the Middle East, which can also have an impact on several factors influencing prices, exchange rates, and interest rates, all of which can affect our business in turn.

In addition, several key components are manufactured or sterilized at a particular facility, with limited alternate facilities. If an event occurs that results in damage to or closure of one or more of such facilities, such as the damage caused by natural disasters, power outages, civil unrest, and other factors, we may be unable to manufacture or sterilize the relevant products at the previous levels or at all. Because of the time required to approve and license a manufacturing or sterilization facility, a third-party may not be available on a timely basis to replace production capacity in the event manufacturing or sterilization capacity is lost.

In order to manage any supply chain risk, we have identified key and crucial components in our manufacturing lines that we deem not to be readily available, and we have vetted 2-3 trusted suppliers, which we believe mitigates the risk of becoming overly reliant on a specific supplier. Despite this precaution, there is no assurances that we will be able to secure the materials needed in the event these sources are unable to fulfil orders. Any failure in the supply chain would result in a lack of inventory and an inability to sell products. For all other non-key materials, we find that these are readily available from a variety of suppliers and therefore, the risk of sourcing them is minimal or non-existent.

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

We are increasingly dependent on sophisticated IT systems to operate the business, including to process, transmit and store sensitive data, and many of our products and services include integrated software and IT that collects data regarding patients or connects to its systems.

Like other multi-national corporations, we could experience, and in the past have experienced, attempted or actual interference with the integrity of, and interruptions to, our IT systems, as well as data breaches, such as cyber-attacks, malicious intrusions, breakdowns, interference with the integrity of our products and data or other significant disruptions.

Furthermore, we rely on third-party vendors to supply and/or support certain aspects of our IT systems. These third-party systems could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant disruptions, and may contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security of our own systems.

In addition, we continue to grow in part through new business acquisitions and, as a result, may face risks associated with defects and vulnerabilities in their systems, or difficulties or other breakdowns or disruptions in connection with the integration of the acquisitions into its own IT systems.

Our worldwide operations mean that we are subject to laws and regulations, including data protection and cybersecurity laws and regulations, in many jurisdictions. Any data security breaches, cyber-attacks, malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation, any of which could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation or competitive position.

In addition, our IT systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving legal and regulatory standards, the increasing need to protect patient and customer information, changes in the techniques used to obtain unauthorized access to data and information systems, and the IT needs associated with changing products and services.

There can be no assurance that the process of consolidating, protecting, upgrading, and expanding systems and capabilities, continuing to build security into the design of products, and developing new systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues will not arise in the future.

If our IT systems, products or services or sensitive data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer a loss of product functionality. We could lose existing customers, have difficulty attracting new customers, have difficulty preventing, detecting, and controlling fraud, be exposed to the loss or misuse of confidential information, have disputes with customers, physicians, and other healthcare professionals, suffer regulatory sanctions or penalties under federal laws, state laws, or the laws of other jurisdictions, experience increases in operating expenses or an impairment in our ability to conduct operations, incur expenses or lose revenues as a result of a data privacy breach, product failure, IT outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to reputation.

During the years ended February 28, 2026, and February 28, 2025, we did not, to our knowledge, experience any cybersecurity incidents or breaches that materially impacted or are reasonably likely to materially impact our business, performance or results.

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

A significant portion of our manufacturing operations and supply chain is based in South Africa, where the functional currency is the South African Rand (ZAR). We import a substantial amount of raw materials and components, many of which are priced or paid in U.S. dollars or other foreign currencies, while a large part of our current revenue is generated in ZAR (primarily through our South African distribution activities). Our consolidated financial statements are reported in U.S. dollars. As a result, fluctuations in the ZAR relative to the U.S. dollar and other currencies directly affect our cost of goods sold, gross margins, and the translated value of our revenue and expenses.

Foreign exchange risk arises when a company engages in financial transactions denominated in a currency other than the currency where that company is based. Any appreciation/depreciation of the base currency or the depreciation/appreciation of the denominated currency will affect the cash flows emanating from that transaction.

Our business of import/exports of raw materials and goods exposes us to foreign exchange risk by having account payables and receivables affected by currency exchange rates. This risk originates when a contract between us and our suppliers specifies exact prices for goods or services, as well as delivery dates. If a currency’s value fluctuates between when the contract is signed and the delivery date, it could cause a loss for one of the parties.

Our business model is concentrated around developing countries with higher growth rates which causes greater exposure to forex risk which may cause adverse or unexpected revenue fluctuations and affect the reported results of operations. Usually, the attractive growth rates of these developing countries offset the long term forex implications of their volatile currencies.

There are three types of foreign exchange risk that we are exposed to:

We continually assess our foreign exchange risks and implement varying strategies based on the current economic conditions to implement hedging strategies to mitigate that risk. This usually involves forward contracts, options, and other exotic financial products that, if done properly, can protect us from unwanted foreign exchange moves during periods of high volatility. We may also impose a strategy of not hedging due to the costs involved outweighing the benefits. We then leave exposures unhedged until market conditions and costs justify proceeding with a hedging strategy into the future.

The long-term strategy is to make certain strategic investments that will generate revenue in first-world, stable currencies to offset the impacts of cost of sales imports in developing currencies. Material adverse movements in exchange rates could increase our costs, reduce gross margins, cause volatility in our reported financial results, and materially and adversely affect our business, financial condition, and results of operations.

The Medinotec Group of Companies operate in countries where the market is dominated by certain players and this creates a sales concentration risk which also causes an accounts receivable concentration risk.

We have historically relied, and continue to rely heavily, on a limited number of customers and distributors for a substantial portion of our revenue. In particular, sales to DISA Life Sciences in South Africa represented approximately 89% of our total revenue for the fiscal year ended February 28, 2026. This high customer concentration also creates significant accounts receivable concentration risk.

The loss or material reduction in business with DISA Life Sciences, or any disruption in our South African distribution relationships, would have a material adverse effect on our revenue, gross profit, cash flows, and overall financial condition. Although we are actively working to diversify our customer base and geographic revenue mix through expanded U.S. commercialization and new international distributor relationships, there is no assurance that these efforts will succeed or reduce our concentration risk in the near term. Barriers to entry in new markets, regulatory delays, competitive pressures, and other factors may prevent or delay successful diversification.

As a result, our business, results of operations, and financial condition remain highly dependent on the continued success of our relationship with DISA Life Sciences and the stability of the South African market.

Please refer to the related parties and entities section for a more detailed discussion on each function and the relationships involved as well as any arm’s length disclosures.

These relationships have the upside of:

These relationships also pose the following risks and downsides:

Due to the nature of the territories that we operate in, it will be impossible to eliminate concentration risk. However, we do plan to diversify into a larger product basket and increase our international footprint, either by growing operations into other territories or alternatively acquiring more business share in other geographical territories.

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

We have elected to combine a mix of self-insurance and insured risks for most of the insurable risks across our company. We made this decision based on cost and availability factors in the insurance marketplace.

We continue to maintain a directors and officers liability insurance policy with third-party insurers that provides coverage for our directors and officers. This policy also covers product liability claims to a limited extent. We also maintain a detailed stock throughput policy to ensure inventory is ensured against losses and fire risk. All other assets fall into the category of self-insurance.

We continue to monitor the insurance marketplace to evaluate the value of obtaining insurance coverage for other categories of losses in the future. Although we believe, based on historical loss trends, that our self-insurance program accruals and existing insurance coverage will be adequate to cover future losses, historical trends may not be indicative of future losses.

Risks associated with insurance plans include:

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

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

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

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As our business inherently exposes us to claims, we may become subject to claims for which we are not adequately insured. Unanticipated payment of a large claim may have a material adverse effect on our business.

The absence of sufficient third-party insurance coverage for other categories of losses increases our exposure to unanticipated claims and these losses could have a materially adverse impact on the business, results of operations, financial condition, and cash flows.

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

In order to develop new products and improve current product offerings through our strategic partnerships with other principals, we focus our research and development programs largely on the development of, or obtaining the exclusive distribution rights to, next-generation and technology offerings across multiple programs and opportunities. Our current pipeline includes the Micro CTO Catheter (Technical File submitted to our Notified Body in July 2023 and currently under review), as well as the StaXstop Catheter, Septus Balloon, and Vaultseal Balloon (in earlier developmental stages).

As a part of the regulatory process of obtaining marketing clearance from the respective countries’ regulators for new products, we and our strategic partners conduct and participate in numerous clinical trials with a variety of study designs, patient populations and trial endpoints. Unfavorable or inconsistent clinical data from existing or future clinical trials conducted by us or partners related to us, by our competitors or by third parties, or the market’s perception of this clinical data, may adversely impact our ability to obtain product approvals from the regulators, our position in, and share of, the markets in which we participate and our business, financial condition, results of operations or future prospects.

Our growth strategy depends in significant part on successfully advancing these pipeline products through regulatory approval and achieving commercial acceptance, particularly in the United States and other higher-value regulated markets to diversify revenue and reduce our current heavy reliance on South African sales. Any delays, failures, or unfavorable outcomes in product development, clinical testing, or regulatory processes could materially delay or prevent revenue growth, limit our ability to diversify away from our current concentration in South Africa, and adversely affect our business, financial condition, and results of operations.

If the Medinotec Group of Companies fails to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate and investors’ views of us.

If we fail to maintain effective internal control over financial reporting, our ability to report our financial condition and results of operations accurately and on a timely basis could be adversely affected.

Although management concluded that our internal control over financial reporting was effective as of February 28, 2026, internal controls can provide only reasonable assurance and may not prevent or detect all misstatements. During fiscal 2026, we implemented remediation measures to address previously identified material weaknesses. There can be no assurance that these measures will continue to operate effectively or that additional material weaknesses or other control deficiencies will not be identified in the future. Any failure to maintain effective internal control over financial reporting could adversely affect our ability to report our financial condition and results of operations accurately and on a timely basis, which could negatively affect investor confidence in our reported financial information and adversely affect our business and the market price of our common stock.

We have limited experience in marketing and sales and are in the early stages of building our sales channels in the life science market and internationally.

We may not be able to market, sell or distribute our current and future products effectively enough to support our planned growth. Currently, we sell our products through a combination of direct sales efforts and partnerships with distributors across all our key markets. During the fiscal year ended February 28, 2026, our distributors (including DISA Life Sciences, which accounted for approximately 89% of our total revenue) represented the substantial majority of our sales. We are in the process of broadening and diversifying our sales channels across all markets, particularly as we expand commercialization of the Trachealator and Outflo in the United States. We are in the process of broadening and diversifying our sales channels across all markets.

In the future, if we fail to maintain good relationships with, or fail to successfully motivate any of our large distributors, our revenue may decline. If we do not diversify our sales channels and effectively utilize our direct sales force, we will continue to be susceptible to risks associated with having a large percentage of revenue concentrated with a limited number of distributors.

Competition for employees capable of selling expensive medical devices within the pharmaceutical and biotechnology industries is intense. We may not be able to attract and retain personnel or be able to build an efficient and effective sales organization, which could negatively impact sales and market acceptance of our products and limit our revenue growth and potential profitability.

In addition, the time and cost of establishing a specialized sales, marketing and customer service force for a particular product or service may be difficult to justify considering the revenue projected to be generated by such additional personnel and resources. We also intend to add additional distribution partners in the life science market, and if we are unable to do so successfully, it will adversely impact on our ability to increase the revenue from our product offerings.

We rely on distributors for the sale of our products abroad and are entering into new agreements for the United States. We intend to continue to grow our business internationally and in the United States and to do so we must attract additional distributors and retain existing distributors to maximize the commercial opportunity for our products. We exert limited control over existing distributors under our agreements with them, and if their sales and marketing efforts for our products in their particular region are not successful, our business would be materially and adversely affected. Locating, qualifying, and engaging additional distribution partners with local industry experience and knowledge will be necessary in at least the short to mid-term to effectively market and sell our platform in certain countries outside the United States. We may not be successful in finding, attracting, and retaining distribution partners, or we may not be able to enter into such arrangements on favorable terms.

Most of our distribution relationships are non-exclusive and permit such distributors to distribute competing products. As such, our distributors may not commit the necessary resources to market our products to the level of our expectations or may choose to favor marketing the products of our competitors. Some of our distribution relationships are exclusive where the company is forced to rely on their efforts. Our distribution partners may compete against our inside sales force for sales opportunities. If current or future distributors do not perform adequately, offer competitive products, compete with our own sales staff, or we are unable to enter into effective arrangements with distributors in particular geographic areas, we may not realize long-term international revenue growth.

We rely on a limited number of subcontractors to manufacture, assemble, package and production test our products, and the failure of any of these third-party subcontractors to deliver products or otherwise perform as requested could damage our relationships with our customers, decrease our sales and limit our growth.

While we design and market our products and conduct test development in-house, we do not manufacture, assemble, package and production test the vast majority of components of our products, and we must rely on third-party subcontractors to perform these services. If these subcontractors do not provide us with high-quality products, services and production and production test capacity in a timely manner, or if one or more of these subcontractors terminates its relationship with us, we may be unable to obtain satisfactory replacements to fulfill customer orders on a timely basis, our relationships with our customers could suffer, our sales could decrease, and our growth could be limited.

In addition, the consolidation of foundry subcontractors, as well as the increasing capital intensity and complexity associated with fabrication in smaller process geometries has limited the diversity of our suppliers and increased our risk of a "single point of failure." The lack of diversity of suppliers could also drive increased prices and adversely affect our results of operations, including our product gross margins.

We currently do not have long-term supply contracts with any of our third-party subcontractors. Therefore, they are not obligated to perform services or supply products to us for any specific period, in any specific quantities or at any specific price, except as may be provided in a particular purchase order. None of our third-party subcontractors has provided contractual assurances to us that adequate capacity will be available to us to meet future demand for our products. Our subcontractors may allocate capacity to the production of other companies' products while reducing deliveries to us on short notice. Other customers that are larger and better financed than we are or that have long- term agreements with these subcontractors may cause these subcontractors to reallocate capacity to those customers, thereby decreasing the capacity available to us.

Other significant risks associated with relying on these third-party subcontractors include:

We distribute commodity medical products on behalf of multinational manufacturers for a substantial portion of our sales, and our failure to maintain and further develop these relationships could harm our business.

We act as a distributor on behalf of multinational firms, and we depend on these third-party contracts for cardiac commodity product inventory to consumers. Our distribution efforts for these other products, some of which are competitive with our own commodity products such as our Cape Cross NC and Cape Cross products, currently do and are expected to account for most of our net sales in the near future. These relationships are mostly non-exclusive and terminable upon a certain number of days’ notice. In particular, our relationship with DISA Life Sciences in South Africa represented a very significant portion of our total revenue for the fiscal year ended February 28, 2026. The loss of, or business disruption at, one or more of these firms or a negative change in our relationship with them, or a disruption to any one of our sales channels could have a material adverse effect on our business. If we do not maintain our relationship with these product suppliers or develop relationships with other firms for inventory to sell, the growth of our business may be adversely affected, and our business may be harmed. If we are required to obtain additional or alternative distribution agreements or arrangements in the future, we cannot be certain that we will be able to do so on satisfactory terms or in a timely manner. Our inability to enter into satisfactory distribution agreements may inhibit our ability to implement our business plan or to establish markets necessary to expand the distribution of products successfully.

We may not be able to successfully implement our growth strategy for our own branded products as a result of the distribution efforts we engage in of outside product offerings we distribute for.

We believe that our future success depends, in part, on our ability to implement our growth strategy of leveraging our existing brand and products to drive increased sales. Our ability to implement this strategy depends, among other things, on our ability to:

We may not be able to implement this growth strategy successfully. Our planned marketing expenditures may not result in increased total sales or generate sufficient levels of consumer interest or brand awareness, and our high rates of sales and income growth may not be sustainable over time. Our sales and results of operations will be negatively affected if we fail to implement our growth strategy or if we invest resources in a growth strategy that ultimately proves unsuccessful.

Risks Related to Management, Personnel and Control Persons

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

Our future success is substantially dependent on the continued service of Dr. Gregory Vizirgianakis, our Founder, President, Chief Executive Officer and a member of our board of directors, and Pieter van Niekerk, our Chief Financial Officer, Treasurer and a member of our board of directors. Dr. Vizirgianakis and Mr. van Niekerk have extensive experience both with our company and in our industry and are familiar with our business, systems, and processes. Their loss would be catastrophic to our product offerings and ability to manage our business effectively, as we will likely not be able to find suitable individuals to replace them on a timely basis or at all.

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

We depend on several key management, executive, sales and marketing, and technical personnel. The loss of the services of one or more key employees could delay the achievement of business objectives. Our success will also depend on our ability to attract and retain additional highly qualified executives, management, sales and marketing and technical personnel to meet its growth goals. We further face intense competition for qualified personnel, many of whom are often subject to competing employment offers, and we do not know whether we will be able to attract and retain such personnel.

Our success depends in large part on the continued service of the senior management team. In particular, the continued service of this group of individuals is critical to our vision, strategic direction, culture, products, and business plan. We do not maintain key-man insurance for any of the senior management team, and thus the loss of any of our executives, even temporarily, or any other member of senior management, could harm the business.

The Medinotec Group of Companies’ largest shareholder, officer and director, Dr. Gregory Vizirgianakis, has substantial control over us and our policies and will be able to influence corporate matters.

Dr. Gregory Vizirgianakis, our Founder, President, Chief Executive Officer and a member of our board of directors, and his brother, Stavros Vizirgianakis, also a member of our board of directors, together control our company with an 81% vote on all matters regarding shareholder approval by virtue of his ownership in our common stock.

Gregory and Stavros Vizirgianakis have not agreed to vote their shares together. If they decide to vote together on any matter, they are able to exercise significant influence over our company, including the election of directors, the approval of significant corporate transactions, and any change of control of our company. They could prevent transactions, which might be in the best interests of the other shareholders. Their interests may not necessarily be in the best interests of the shareholders in general. The rest of our shareholders will be considered minority shareholders and these will have little say in the direction of the Company as a result of their holdings.

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

Our officers and directors are located outside of the United States and reside in South Africa. As a result, it may be difficult to effect service of process within the United States and enforce judgments of the US courts obtained against our executive officers and directors. Particularly, our shareholders may not be able to:

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

Our officers and directors have limited experience managing a public company. Consequently, we may not be able to raise any funds or run our public company successfully. Our executive officer’s and director’s lack of experience of managing a public company could cause you to lose some or all of your investment.

Risk Associated with Legal and Regulatory Matters

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

The medical technology industry is regulated extensively by governmental authorities, principally the FDA, and state regulatory agencies with oversight of various aspects of drug and device distribution, sale, and use. The regulations are very complex, have become more stringent over time, and are subject to rapid change and varying interpretations. Regulatory restrictions or changes could limit our ability to carry on or expand our operations or result in higher than anticipated costs or lower than anticipated sales. The FDA and other federal and state governmental agencies regulate numerous elements of our business, including:

Before we can market or sell a new regulated product or a significant modification to an existing product in the United States, we must obtain either clearance under Section 510(k) of the FDCA, grant of a de novo classification request, or approval of a pre-market approval, or PMA, application from the FDA, unless an exemption from pre-market review applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a legally marketed “predicate” device (in most cases Class II devices, with a few exceptions), with respect to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. Class III devices approved under the PMA process cannot serve as predicates. Clinical data are sometimes required to support substantial equivalence. In the de novo process, the FDA must determine that general and special controls are sufficient to provide reasonable assurance of the safety and effectiveness of a device, which is low to moderate risk and has no predicate (in other words, the applicant must justify the “down-classification” to Class I or II for a new product type that would otherwise automatically be placed into Class III, but is lower risk). The PMA process requires an applicant to demonstrate the safety and effectiveness of the device based on extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing, and labeling data.

The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices. Products that are approved through a PMA application generally need FDA approval before they can be modified. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k). The 510(k), de novo, and PMA processes can be expensive and lengthy and require the payment of significant fees, unless an exemption applies. The FDA’s 510(k) clearance process usually takes from 3 to 12 months, but may take longer. The FDA’s stated goal is to review de novo classification requests within 150 days, 50% of the time, but in reality the process for many applicants generally takes even longer, up to a year or more. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or longer, from the time the application is submitted to the FDA until an approval is obtained. The process of obtaining regulatory clearances, approvals, and emergency use authorization to market a medical device can be costly and time-consuming, and we may not be able to obtain these clearances, approvals, or authorizations on a timely basis, or at all for our proposed products.

If the FDA requires us to go through a lengthier, more rigorous examination for marketing authorization of our medical devices or future modifications to our medical devices than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline or to not increase in line with our forecasts. In addition, the FDA may determine that future products will require the more costly, lengthy, and uncertain PMA process. Although we do not market any devices under PMA, the FDA may demand that we obtain a PMA prior to marketing certain of our future products. Further, even with respect to those future products where a PMA is not required, we cannot assure you that we will be able to obtain the 510(k) clearances with respect to those products.

The FDA can delay, limit, or deny clearance, approval, or authorization of a device for many reasons, including:

In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our products under development. Any delay in, or failure to obtain or maintain, clearance or approval for our products under development could prevent us from generating revenue from these products and adversely affect our business operations and financial results. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny of us, could dissuade some customers from using our products and adversely affect our reputation and the perceived safety and efficacy of our product. Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as fines, civil penalties, injunctions, warning letters, recalls of products, delays in the introduction of products into the market, refusal of the FDA or other regulators to grant future clearances or approvals, and the suspension or withdrawal of existing clearances or approvals by the FDA or other regulators. Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and negatively impact our reputation, business, financial condition and operating results. Furthermore, any operations or product applications outside of the United States will subject us to various additional regulatory and legal requirements under the applicable laws and regulations of the international markets we enter. These additional regulatory requirements may involve significant costs and expenditure and, if we are not able to comply with any such requirements, our international expansion and business could be significantly harmed.

Failure to obtain clearance or authorization for our medical devices, or other delays in the development of our medical devices, would adversely affect our ability to grow our business.

Commercialization of our medical devices may require an Emergency Use Authorization (EUA), FDA clearance of a 510(k) premarket notification submission, or authorization of a de novo submission. The process for submitting and obtaining FDA clearance of a 510(k), authorization of a de novo submission, or EUA can be expensive and lengthy. The FDA’s review process can take several months or longer, and we may not be able to obtain FDA clearance, de novo authorization, or Emergency use Authorization for our medical devices on a timely basis, if at all. The FDA’s refusal of, or any significant delays in receiving 510(k) clearance, de novo authorization, or Emergency use Authorization of our medical devices, would have an adverse effect on our ability to expand our business.

FDA approval has been granted for the Trachealator following the 510(k) substantially equivalence process for Class II medical devices. We have no such FDA clearance with respect to the Cape Cross PTCA Catheter family, the Cape Cross NC Catheter, or the Micro CTO Catheter (for which the Technical File was submitted in July 2023 and is currently under review). We have not performed any clinical testing of our medical devices, which will likely be required before the device can be marketed. Even if a clinical trial is completed, there can be no assurance that the data generated during a clinical trial will meet the safety and effectiveness endpoints or otherwise produce results that will lead the FDA to grant marketing clearance, approval, or authorization. In addition, any other delays in the development of our medical devices, for example, unforeseen issues during product validation, would have an adverse effect on our ability to commercialize our medical devices.

Our growth strategy depends in significant part on successfully obtaining additional FDA clearances for our pipeline products and launching them in the United States and other regulated markets. Any failure or material delay in obtaining these clearances could prevent or significantly delay revenue growth, limit our ability to diversify away from our current concentration in South Africa, and materially and adversely affect our business, financial condition, and results of operations. Failure to achieve and maintain effective internal controls over financial reporting could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner, which could have an adverse impact on our business.

Modifications to our products may require new 510(k) clearances, de novo submissions, or pre-market approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.

FDA 510(k) clearance has been granted for the Trachealator (November 2021) and the Outflo Aortic Valve Dilation Balloon Catheter (March 2025). Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, requires a new 510(k) clearance or, possibly, a de novo or PMA. The FDA requires every manufacturer to make this determination in the first instance, and provides some guidance on decision making, but the FDA may review any manufacturer’s decision at any time. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. If the FDA disagrees with our determination and requires us to submit new 510(k) notifications, de novo submissions or PMAs for modifications to our previously cleared or approved products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.

As we continue to expand commercialization of our products in the United States and make iterative improvements to existing devices or develop line extensions, the need for new regulatory submissions could arise frequently. Any requirement to suspend marketing or initiate a recall while awaiting clearance could result in lost sales, damage to customer relationships, and harm to our reputation, all of which could materially and adversely affect our business, financial condition, and results of operations.

We may be liable if the FDA or other U.S. enforcement agencies determine we have engaged in the off-label promotion of our products or have disseminated false or misleading labeling or promotional materials.

Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including laws and regulations prohibiting marketing claims that promote the off-label use of our products or that make false or misleading statements. Healthcare providers may use our products off-label, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine. FDA also could conclude that a performance claim is misleading if it determines that there are inadequate non-clinical and/or clinical data supporting the claim. If the FDA determines that our promotional materials or training promote of an off-label use or make false or misleading claims, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fines, and criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they determine that our promotional or training materials promote an unapproved use or make false or misleading claims, which could result in significant fines or penalties. Although our policy is to refrain from statements that could be considered off-label promotion of our products or false or misleading, the FDA or another regulatory agency could disagree. Violations of the FDCA may also lead to investigations alleging violations of federal and state health care

fraud and abuse laws, as well as state consumer protection laws, which may lead to costly penalties and may adversely impact our business. Recent court decisions have impacted FDA’s enforcement activity regarding off-label promotion in light of First Amendment Considerations; however, there are still significant risks in this area, in part due to the potential for False Claims Act exposure. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could result in substantial damage awards against us and harm our reputation.

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

In response to perceived increases in healthcare costs in recent years, there have been and continue to be proposals by several governments, regulators, and third-party payers globally, including the US federal and state governments, to control these costs and, more generally, to reform healthcare systems.

Certain of these proposals could, among other things, limit the prices we are able to charge for products or the amounts of reimbursement available for our products, and could also limit the acceptance and availability of such products. These pressures are particularly relevant to us as we expand commercialization of our proprietary devices (including the Trachealator and Outflo) into the United States, where reimbursement policies, competitive bidding, value-based purchasing, and prior-authorization requirements by Medicare, Medicaid, and private payers can significantly influence hospital and physician purchasing decisions. Similar cost-containment measures in South Africa and other markets where we generate revenue could also reduce demand or force price concessions.

The adoption of some or all of these proposals could have a material adverse effect on the business, results of operations, financial condition and cash flows. If we experience decreasing prices for our goods and services and we are unable to reduce expenses, there may be a materially adverse effect on the business, results of operations, financial condition and cash flows.

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

We are subject to numerous US and non-US environmental, health and safety laws and regulations concerning, among other things, the health and safety of employees; the generation, storage, use and transportation of hazardous materials; emissions or discharges of substances into the environment; investigation and remediation of hazardous substances or materials at various sites; chemical constituents in medical products; and end-of-life disposal and take-back programs for medical devices.

Our operations and those of certain third-party suppliers involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes. If we or our suppliers violate these environmental laws and regulations, facilities could be shut down and violators could be fined, criminally charged, or otherwise sanctioned.

Furthermore, environmental laws outside of the US are becoming more stringent, resulting in increased costs and compliance burdens. Certain environmental laws also assess liability on current or previous owners or operators of real property for the costs of investigation, removal or remediation of hazardous substances or materials at their properties or at properties which they have disposed of hazardous substances. In addition to clean-up actions brought by governmental authorities, private parties could bring personal injury or other claims due to the presence of, or exposure to, hazardous substances. The ultimate cost of site clean-up and timing of future cash outflows is difficult to predict, given the uncertainties regarding the extent of the required clean-up, the interpretation of applicable laws and regulations, and alternative clean-up methods.

The costs of complying with current or future environmental protection and health and safety laws and regulations, or liabilities arising from past or future releases of, or exposures to, hazardous substances, may exceed our estimates, or have a material adverse effect on the business, results of operations, financial conditions, and cash flows.

Finally, in some jurisdictions around the world, culture and practice encourages reuse of disposable products when the product is clearly labelled for single use. Such reuse may expose us to liability in these jurisdictions.

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

As a company with expanding operations, we increasingly face the risk of litigation and other claims against us. We have no such claims at present. Litigation and other claims may arise in the ordinary course of our business and include employee claims, commercial disputes, landlord-tenant disputes, intellectual property issues, product-oriented allegations and slip and fall claims. These claims can raise complex factual and legal issues that are subject to risks and uncertainties and could require significant management time. Litigation and other claims against us could result in unexpected expenses and liabilities, which could materially affect our operations and our reputation.

In addition, the medical device industry is characterized by extensive litigation and, from time to time, we are the subject of various claims. Regardless of the outcome, such claims are expensive to defend and divert management and operating personnel from other business issues. A successful claim or claims against us could result in payment of significant monetary damages and/or injunctive relief.

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

Our devices, products and therapies are purchased principally by hospitals or physicians that typically bill various third-party payers, such as governmental healthcare programs, private insurance plans and managed care plans, for the healthcare services provided to their patients.

The ability of customers to obtain appropriate reimbursement for products and services from third-party payers is critical because it affects which products customers purchase and the prices they are willing to pay. As a result, our devices, products, and therapies are subject to regulation regarding quality and cost for reimbursement and regulation of health goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare fraud.

Many territories have similar laws that apply to reimbursement by state and other funded programs as well as in some cases to all payers. In certain circumstances, insurance companies attempt to bring a private cause of action against a manufacturer for causing false claims.

In addition, our strategic investments position the company as a manufacturer of FDA-approved devices reimbursable by federal healthcare programs. We are thus subject to the Physician Payments Sunshine Act, which requires us to annually report certain payments and other transfers of value our company makes to US-licensed physicians or US teaching hospitals. Any failure to comply with these laws and regulations could subject us or our officers and employees to criminal and civil financial penalties.

We are also subject to risks relating to changes in government and private medical reimbursement programs and policies, and changes in legal regulatory requirements in the US and around the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating to coverage of / or reimbursement for our products by administrators of these systems, could have an impact on the acceptance of and demand for our products and the prices that customers are willing to pay for them.

Quality problems and product liability claims could lead to recalls or safety alerts, reputational harm, adverse verdicts or costly settlements, and could have a material adverse effect on the business, results of operations, financial condition and cash flows.

Quality is extremely important to us and our customers due to the impact of our products on patients, and the serious and potentially costly consequences of product failure. We are thus exposed to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices.

In addition, many products are used in intensive care settings with seriously ill patients. Component failures, manufacturing nonconformance, design defects, off-label use, or inadequate disclosure of product-related risks or product related information with respect to our products, if they were to occur, could result in an unsafe condition or injury to, or death of, a patient.

This could lead to recall of, or issuance of a safety alert relating to, our products, and could result in product liability claims and lawsuits, including class actions, which could ultimately result, in certain cases, in the removal from the body of such products and claims regarding costs associated therewith. Due to the strong brand recognition of Medinotec name and our brands, a material adverse event involving one of our products could result in reduced market acceptance and demand for all products within that brand and could harm our reputation and ability to market products in the future.

Should we fall short of these standards and our products become subject to recalls or safety alerts, our reputation could be damaged, we could lose customers and revenue and results of operations could decline. Our success also depends on the ability to manufacture to exact specifications for precision engineered components, sub-assemblies and finished devices from multiple materials. If components fail to meet these standards or fail to adapt to evolving standards, our reputation, competitive advantage, and market share could be harmed.

In certain situations, we may undertake a voluntary recall of products or temporarily shut down production lines based on performance relative to our own internal safety and quality monitoring and testing data. Any of the foregoing problems, including future product liability claims or recalls, regardless of their ultimate outcome, could harm our reputation and have a material adverse effect on the business, results of operations, financial condition, and cash flows.

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

Patents, trademarks and other intangible proprietary rights are and will be essential to the business and our ability to compete effectively with other companies. During normal day-to-day trade, we also rely on trade secrets, know-how, continuing technological innovations, strategic alliances, and licensing opportunities to develop, maintain and strengthen our competitive position.

We pursue a policy of obtaining patent protection in both the US and overseas for patentable subject matter of our proprietary devices and attempt to review third-party patents and patent applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of others.

We also operate in an industry that is susceptible to significant intellectual property litigation. This litigation is expensive, complex, and lengthy and its outcome is difficult to predict. Future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and may significantly divert the attention of our technical and management personnel.

In addition, we may have to take legal action in the future to protect our patents, trade secrets, or know-how or to assert our intellectual property rights against claimed infringement by others. Any such legal action could be costly and time consuming and no assurances can be made that any lawsuit will be successful.

The invalidation of key patents or proprietary rights that we own, or an unsuccessful outcome in lawsuits to protect intellectual property, could have a material adverse effect on the business, financial condition, and results of operations. In the event that the right to market any of our products is successfully challenged, or if we fail to obtain a required license or are unable to design around a patent, the business, financial condition, and results of operations could be compromised.

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

In the ordinary course of business, we collect and store sensitive data, including patient health information, personally identifiable information about employees, intellectual property, and proprietary business information. We manage and maintain applications and data utilizing on-site and off-site systems. These applications and data encompass a wide variety of business-critical information including research and development information, commercial information and business and financial information.

The secure processing, storage, maintenance, and transmission of this critical information is vital to operations and business strategy, and we devote resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our IT and infrastructure may be vulnerable to attacks by hackers, viruses, breaches, or interruptions due to employee error or malfeasance, terrorist attacks, hurricanes, fire, flood, other natural disasters, power loss, computer systems failure, data network failure, internet failure, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, government enforcement actions and regulatory penalties.

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

We are subject to income taxes, as well as non-income-based taxes, in South Africa, and other jurisdictions in which we operate, as well as jurisdictions such as the United States, in which we intend to have operations. The tax laws in these could change on a prospective or retroactive basis, and any such changes could adversely affect us and our effective tax rate.

Taxation regulation in territories around the world can also change very quickly, which may mean that all the implications for businesses may not have been fully thought through by the regulating authorities before final guidelines and laws are issued. Furthermore, any changes made by tax authorities, together with other legislative changes, to the mandatory sharing of company information (financial and operational) with tax authorities on both a local and global basis, could lead to disagreements between jurisdictions with respect to the proper allocation of profits between such jurisdictions. We therefore continuously monitor changes to tax regulation and double tax treaties between the territories in which we operate. We also maintain a comprehensive transfer pricing policy to govern the flow of funds between various tax territories.

We are further subject to ongoing tax audits in the various jurisdictions in which we operate. We regularly assess the likely outcomes of these audits to determine the appropriateness of our tax provisions. However, there can be no assurance that we will accurately predict the outcomes of these audits, which could have a material impact on the business, financial condition, results of operations, and cash flows.

While we have recorded reserves for potential payments to various tax authorities related to uncertain tax positions, the calculation of such tax liabilities involves the application of complex tax regulations in many jurisdictions. Therefore, any dispute with a tax authority may result in payment that is significantly different from our estimates. If the payment proves to be less than the recorded reserves, the reversal of the liabilities would generally result in tax benefits being recognized in the period when we determine the liabilities to be no longer necessary. Conversely, if the payment proves to be more than the reserves, we would incur additional charges, and these could have a materially adverse effect on the business, financial condition, results of operations, and cash flows.

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

FCPA and similar anticorruption laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business. Because of the predominance of government-administered healthcare systems in many jurisdictions around the world, many of our customer relationships are with governmental entities and are therefore potentially subject to such laws.

We also participate in public-private partnerships and other commercial and policy arrangements with governments around the globe. Global enforcement of anti-corruption laws has increased in recent years, including investigations and enforcement proceedings leading to assessment of significant fines and penalties against companies and individuals.

Our international operations create a risk of unauthorized payments or offers of payments by one of our employees, consultants, sales agents, or distributors. The business maintains policies and programs to implement safeguards to educate employees and agents on these legal requirements, and to prevent and prohibit improper practices. However, existing safeguards and any future improvements may not always be effective, and employees, consultants, sales agents, or distributors may engage in conduct for which we could be held responsible.

In addition, regulators could seek to hold us liable for conduct committed by companies in which we invest or that we acquire. Any alleged or actual violations of these regulations may subject us to government scrutiny, criminal or civil sanctions and other liabilities, including exclusion from government contracting, and could disrupt the business, adversely affect our reputation and result in a material adverse effect on the business, results of operations, financial condition, and cash flows.

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

The US Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), and the Bureau of Industry and Security at the US Department of Commerce (“BIS”) administer certain laws and regulations that restrict US persons and, in some instances, non-US persons, in conducting activities, transacting business with or making investments in certain countries, governments, entities and individuals subject to US economic sanctions.

Our international operations subject us to these laws and regulations, which are complex, restrict business dealings with certain countries, governments, entities, and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced, or interpreted in a manner that materially impacts our operations. From time to time, certain subsidiaries have limited business dealings in countries subject to comprehensive sanctions.

Certain of our subsidiaries sell medical devices, and may provide related services, to distributors and other purchasing bodies in such countries. These business dealings represent an insignificant amount of our consolidated revenues and income but expose us to a heightened risk of violating applicable sanctions regulations. Violations of these regulations are punishable by civil penalties, including fines, denial of export privileges, injunctions, asset seizures, debarment from government contracts and revocations or restrictions of licenses, as well as criminal fines and imprisonment.

We have established policies and procedures designed to assist with compliance with such laws and regulations. However, there can be no assurance that these will prevent us from violating these regulations in every transaction in which we may engage. As such a violation could adversely affect our reputation, business, financial condition, results of operations and cash flows.

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

We qualify as an "emerging growth company" under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

We will remain an "emerging growth company" for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed $1 billion, (ii) the date that we become a "large accelerated filer" as defined in Rule 12b-2 under the Securities Exchange Act of 1934, which would occur if the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.

Until such a time, however, we cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

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

We are a “smaller reporting company” as defined in the Exchange Act. As a smaller reporting company, we may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. To the extent we take advantage of any reduced disclosure obligations, it may make it harder for investors to analyze the Company’s results of operations and financial prospectus in comparison with other public companies.

Risks Associated with Political Instability and Regional Issues

Geopolitical and Trade Risks due to tariffs and trade wars

Medinotec Inc. operates in a challenging geopolitical and trade environment that exposes the company to several risks that could adversely affect our financial performance and operations.

The U.S. has recently imposed significant tariffs on imports from South Africa and other nations, with tariffs ranging up to 30% on a variety of goods, including machinery, vehicles, and precious metals. This has raised concerns regarding the future of the African Growth and Opportunity Act (AGOA), which has previously provided preferential trade benefits, including duty-free access to the U.S. market for South African goods. Because our primary manufacturing operations are located in South Africa and we export medical devices to the United States, any revocation or material reduction of AGOA benefits, or the continuation or increase of these tariffs, could significantly raise the cost of our U.S.-bound shipments, reduce our competitiveness in the U.S. market, compress profit margins, and materially adversely affect our revenue and financial results. The U.S. market is an important part of our growth strategy, particularly for our proprietary products such as the Trachealator and Outflo.

At the May 21, 2025 Oval Office meeting, U.S. President Donald J. Trump and South African President Cyril Ramaphosa met, but no changes to the imposed tariffs were announced.

While the South African government is exploring the possibility of negotiating a bilateral trade agreement with the U.S., the outcome and timeline of these discussions are uncertain. As a result, the tariffs and the potential loss of AGOA benefits could significantly disrupt our U.S. market strategy and increase the costs of our exports to the U.S.

The current global trade tensions, including the tariffs imposed by the U.S., have led to a ripple effect in other markets, including Europe. European governments may respond with retaliatory tariffs or other trade measures, potentially increasing the cost of medical device products we distribute from European suppliers. These price increases could have an adverse impact on our business, as we may be unable to offset the rising costs without passing them onto customers. Since we are locked into agreements with our suppliers for the distribution of their products in South Africa, our ability to mitigate these cost increases is limited.

South Africa is experiencing significant political instability, with tensions rising within the ruling coalition government. The potential collapse of the government of national unity and the uncertainty surrounding fiscal policies, such as increases in VAT or other tax rates, could disrupt business operations. In particular, such instability may lead to regulatory changes, higher operating costs, or interruptions to our manufacturing activities in South Africa.

While Medinotec Inc. cannot directly influence these political developments, we are closely monitoring the situation and assessing potential risks to our operations. We are also considering contingency plans to manage any disruptions that could arise from governmental changes or civil unrest.

While we are not large enough to directly engage with policymakers, we are actively monitoring developments related to trade tariffs and political instability in South Africa. We will continue to adapt our strategies based on emerging trends and adjust our risk management approach accordingly.

For our self-manufactured products, we are actively exploring options to diversify our supply chain, which will help reduce exposure to any disruptions caused by tariff changes or political instability. However, for our agency business, where we distribute products for multinational medical device companies, we are reliant on our suppliers and their pricing decisions, which limit our ability to mitigate the impact of potential tariff-induced cost increases.

Despite these efforts, the interconnected nature of these risks means that their cumulative impact could be more significant than anticipated, potentially affecting our financial results and operational stability.

South Africa Specific Risk of Unstable Power Supply

Electricity demand in South Africa is extremely high and energy plants do not meet the demand. Therefore, there are frequent rolling black outs that are handled by a schedule of “load shedding” during which the supply and demand of electricity is balanced out to prevent the entire power grid from collapsing. This results in unstable energy sources and frequent production halts for our company.

DISA Medinotec has a backup generator big enough to sustain the entire production facility in case of a power outage. In addition, South Africa is also a very solar capable country due to the weather being warm with sub-tropical like conditions. Therefore, we are looking into solar power as a means to run our production facilities more efficiently in the longer run.

However, load shedding remains unpredictable and can still disrupt manufacturing schedules, increase operating costs (including fuel for generators), delay product shipments, and impair our ability to meet customer demand — particularly as we expand sales in the United States. Any prolonged or severe power instability could materially and adversely affect our production capacity, supply chain reliability, revenue, and overall financial results.

South Africa Specific Risk of Political instability May Affect the Medinotec Group of Companies’ ability to operate effectively.

Political instability in the countries in which we operate, including South Africa, where episodes of violent civil unrest (riots) have further destabilized the country’s economy and resulted in extensive damage to commercial property, and may cause increased uncertainty about our ability to exist in this environment. This may adversely affect investor confidence as well as our business planning, operations and our market capitalization.

This risk extends to global economic uncertainty and heightened geopolitical tensions, such as those in involved in the Russian war on Ukraine, between the United States and China as well as Brexit, which can also have an impact on several factors influencing commodity prices, exchange rates, and interest rates, all of which can affect our business in turn.

Any significant political instability in South Africa could lead to interruptions in manufacturing, higher operating costs, delays in product shipments, or restrictions on the movement of goods and capital. These disruptions could materially and adversely affect our ability to meet customer demand (particularly in the United States), our revenue, profitability, and overall financial condition.

South Africa Specific Risk that Broad-based Black Economic Empowerment (“BEE”) requirements may restrict growth opportunities and limit the Medinotec Group of Companies’ ability to attract key talent.

In South Africa, the correction of historical inequalities is regulated by the Broad-based Black Economic Empowerment Act 53 of 2003 and its associated codes. This legislative framework promotes economic transformation and increased economic participation of Black people in the South African economy. Companies are evaluated on a scorecard that considers ownership, management control, skills development, enterprise and supplier development, and socio-economic development.

Failure to meet the requirements of the Act and its associated codes may limit our ability to qualify for certain government contracts, licenses, or incentives in South Africa. It may also restrict organic and acquisitive growth opportunities and make it more difficult to attract, recruit, and retain key candidates and suitably qualified personnel, particularly in technical, engineering, and management roles. Because our primary manufacturing operations and the majority of our workforce are located in South Africa, non-compliance or lower BEE ratings could materially limit our growth prospects, increase compliance costs, and adversely affect our ability to compete effectively in the local market. We continue to monitor and work toward compliance with BEE requirements; however, there can be no assurance that we will be able to meet evolving scorecard targets or that failure to do so will not have a material adverse effect on our business, financial condition, and results of operations in South Africa.

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

The Central Reserve Bank of South Africa oversees the flow of currency in and out of the republic of South Africa and the South African Revenue services oversee all transfer pricing issues. The Medinotec Group of Companies has transfer pricing bench marking in place for future planned transactions between its South African subsidiaries and Medinotec Inc., its U.S. parent company, and makes use of an external exchange control advisor to ensure any cross-border transactions complies with the requirements of both the Reserve Bank and the South African Revenue services.

This is an approval process for the flow of funds and therefore may cause timing delays to transfer funds cross border but does not mean that it is disallowed entirely. The Company completed a private placement in May 2022 for approximately $3.3 million, which provided funding for expected U.S. operations. If the Company’s U.S. business plan takes longer than expected, if operating costs exceed management’s expectations, or if additional funding is required, the Company may need to obtain additional debt or equity financing. There can be no assurance that such financing will be available on acceptable terms or at all. We believe that once Medinotec Inc. establishes its own sales network the company is expected to become self-sustaining. If for some reason there is a time delay and the funding raised during the private placement is not enough, to realize the business plan of the parent, the operating subsidiary in South Africa would be its only source of cashflow to sustain the Medinotec Group of Companies.

Allowable cash flows and their expected timelines are disclosed in the following table:

It is important to note that the above-mentioned table is the only three options to externalize funds out of South Africa. The time delays mentioned are based on prior experience and guidance from expert advisors. The authorities do have the final decision-making powers on any transaction and therefore time delays may become material and can have a material impact on the business and its ability to function especially when a dispute arises from interactions with the regulators. Management fees and loans can easily be declined by authorities whereas dividends are less likely to be declined.

Our entire business plan is based on the successful private placement that was concluded, and this funding is expected to facilitate two years of funding required before any funding would be needed from the South African subsidiaries, therefore this leaves some time to obtain regulatory approvals in advance if the business plan roll out in the United States is slower than expected. If the Central Reserve Bank declines or imposes any restrictions including time delays for approvals for flow of funds it may have a material impact on the business operations of the Group and may delay its roll out in the American Markets until a follow up capital raise or alternatively debt finance can be obtained on an international level. It is important to note that this successful raise of money does not guarantee that we will obtain regulatory approval in the USA for product candidates that fall outside the Trachealator product which already obtained FDA approval in November 2021. In addition to this it also does not guarantee successful commercializing of any products in the United States of America.

Newly imposed or increased U.S. tariffs, changes in trade policy, or reduced preferential market access for South African goods may materially impact our U.S. revenue, profit margins and competitiveness.

The United States has recently imposed increased tariff measures on certain imported goods, including goods from South Africa, and may further revise tariff rates, trade terms, or import restrictions in response to broader trade policy objectives or geopolitical developments. In July 2025, the White House announced updated reciprocal tariff rates applicable from August 1, 2025, including a 30% tariff rate for South Africa. These measures, together with any future revisions, exemptions, or enforcement actions, may materially affect the landed cost of our products in the United States.

As a company that exports goods from South Africa into the United States, tariffs or similar import measures may increase the cost of our U.S.-bound shipments, reduce our gross margins, and impair our competitiveness in the U.S. market. Such measures may also lead to delayed, reduced or cancelled purchase orders from distributors or customers, require price increases that reduce demand, or necessitate changes to our sourcing, manufacturing or distribution arrangements.

In addition, our U.S. market access may be adversely affected by changes in trade policy, including any reduction in preferential treatment for South African exports, changes in customs or import procedures, stricter compliance requirements, or increased scrutiny of South African-origin products. Any such developments could increase our costs, lengthen delivery times, reduce commercial flexibility and adversely affect our revenue and profitability.

We are actively assessing the potential impact of tariff and trade-policy developments on our operations and financial results and evaluating contingency strategies, including pricing adjustments, sourcing alternatives and geographic diversification of revenue. However, there can be no assurance that these measures will be successful or that tariffs, trade restrictions or related policy changes will not materially and adversely affect our business, financial condition and results of operations. However, there can be no assurance that we will accurately predict the outcomes of these audits, which could have a material impact on the business, financial condition, results of operations, and cash flows.

Geopolitical tensions, including conflict involving Iran and South Africa’s geopolitical positioning, may materially adversely affect our business, financial condition and results of operations.

Our business is exposed to geopolitical risk due to our corporate structure and operating footprint. While Medinotec Inc. The Medinotec Inc. is publicly quoted in the United States, our primary operating subsidiary is based in South Africa, an emerging market and member of BRICS. As a result, we are sensitive to geopolitical developments affecting both global markets and South Africa specifically.

Conflict involving Iran and related instability in the Middle East have contributed to volatility in global energy markets, shipping routes, freight pricing, insurance costs and financial markets. Disruptions affecting the Strait of Hormuz and surrounding trade corridors may increase fuel, transportation, logistics and input costs, while also contributing to inflationary pressures and currency volatility. Reuters has recently reported disruptions to shipping and surges in war-risk insurance and oil prices associated with the Iran conflict and Strait of Hormuz instability.

Our reliance on international distribution partners and cross-border supply chains exposes us to risks arising from trade disruptions, higher shipping costs, supply shortages, delays, sanctions-related compliance burdens and reduced market access. Escalation of conflict or broader regional instability could impair our ability to efficiently source, manufacture and supply products to our key markets, including the United States and other international jurisdictions.

South Africa’s geopolitical positioning and foreign policy stance may further increase our risk exposure. Divergence between South Africa’s international relationships and the policy positions of the United States or other major trading partners could result in heightened regulatory scrutiny, trade friction, investor caution, reduced access to capital, tariffs or other restrictions on market access. Recent South African market weakness linked to renewed U.S.-Iran tensions illustrates how these geopolitical developments may affect the rand and broader financial conditions.

Macroeconomic instability associated with these geopolitical dynamics, including fluctuations in the South African rand, may also impact our reported financial results, particularly where revenues and costs are denominated in different currencies. Sustained uncertainty may also reduce healthcare spending, delay procurement decisions or impair customer demand in certain markets.

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The duration, scope and outcome of these geopolitical developments remain highly uncertain. Any escalation or prolonged instability could have a material adverse effect on our supply chain, operating costs, revenue generation, access to capital and overall financial performance.

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

South Africa’s international relations and foreign policy positioning may affect its trade relationship with the United States and other key markets. Any deterioration in those relationships could result in reduced preferential market access, increased tariffs, enhanced customs scrutiny, stricter import requirements, sanctions-related restrictions or other barriers affecting South African exports.

Because our primary operating subsidiary manufactures in South Africa and exports products into the United States, our business is particularly exposed to such developments. Increases in tariffs or changes in import rules may raise the cost of our products in the United States, reduce our competitiveness, compress margins, delay shipments, increase compliance burdens, or reduce the willingness of U.S. distributors and customers to purchase our products.

These risks may be heightened by broader geopolitical tensions, diplomatic disagreements, trade negotiations, or changes in U.S. trade policy. Recent U.S. tariff actions applicable to South African goods illustrate the potential for these developments to materially affect our business.

If any of these events occur, our ability to grow U.S. revenue, maintain profit margins and expand our international operations could be materially adversely affected.

Risks Relating to Our Securities

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

Generally, existing shareholders will experience dilution of their ownership percentage in the company if and when additional shares of common stock are offered and sold. In the future, we may be required to seek additional equity funding in the form of private or public offerings of our common stock. In the event that we undertake subsequent offerings of common stock, your ownership percentage, voting power as a common shareholder, and earnings per share, if any, will be proportionately diluted. This may, in turn, result in a substantial decrease in the per-share value of your common stock.

If a market for our common stock does not develop, stockholders may be unable to sell their shares

Our common stock is quoted under the symbol “MDNC” on the OTCQX operated by OTC Markets Group, Inc., an electronic inter-dealer quotation medium for equity securities. We were approved for trading in March 2023, and we do not have an active trading market. We can provide no assurances that an active trading market will ever occur, and you may have issues selling your securities in our company.

The Medinotec Group of Companies’ common stock price may be volatile and could fluctuate widely in price, which could result in substantial losses for investors.

The market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including:

You should consider any one of these factors to be material. Our stock price may fluctuate widely as a result of any of the above.

In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

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

The trading market for the Common Stock will depend on the research and reports that securities analysts publish about our business and us. We do not have any control over these analysts. There is no guarantee that securities analysts will cover the Common Stock. If securities analysts do not cover the Common Stock, the lack of research coverage may adversely affect our market price.

If we are covered by securities analysts, and the stock is the subject of an unfavorable report, the stock price and trading volume would likely decline. If one or more of these analysts ceases to cover our company or fails to publish regular reports on us, we could lose visibility in the financial markets, which could cause the stock price or trading volume to decline.

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

The Securities and Exchange Commission has adopted regulations which generally define "penny stock" to be any listed, trading equity security that has a market price less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules generally require that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules which may increase the difficulty Purchasers may experience in attempting to liquidate such securities.

We may be unable to uplist our common stock to a national securities exchange, or maintain such a listing if achieved, which could adversely affect the liquidity and price of our common stock.

We intend to pursue an uplisting of our common stock to a national securities exchange, such as the Nasdaq Capital Market or NYSE American. However, there can be no assurance that we will satisfy the applicable initial listing requirements, including quantitative and qualitative standards relating to stockholders’ equity, market value of publicly held shares, public float, bid price, number of round lot holders, corporate governance and other criteria. Even if we satisfy those requirements initially, there can be no assurance that we will be able to maintain continued listing standards following any uplisting.

Failure to achieve or maintain an uplisting could reduce investor interest in our common stock, limit trading liquidity, restrict access to certain institutional investors, impair our ability to raise capital and negatively affect our stock price, valuation and strategic flexibility.

In addition, efforts to achieve an uplisting may require us to incur substantial additional costs, including accounting, auditing, legal, governance, investor-relations and compliance costs. We may also seek additional financing in connection with an uplisting or to support operations more generally. Any such financing could be dilutive to existing stockholders, involve unfavorable terms, or be unavailable when needed.

Actions taken in pursuit of an uplisting, including public or private financings, governance changes, structural transactions or other corporate actions, could also increase volatility in our stock price or otherwise adversely affect existing stockholders. There can be no assurance that any uplisting strategy will be successful or that the benefits of a listing on a national securities exchange will be realized.

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

Our board of directors is authorized to issue up to 20,000,000 shares of preferred stock. Our board of directors has the power to establish the dividend rates, liquidation preferences, voting rights, redemption and conversion terms and privileges with respect to any series of preferred stock. The issuance of any shares of preferred stock having rights superior to those of the common stock may result in a decrease in the value or market price of the common stock. Holders of preferred stock may have the right to receive dividends, certain preferences in liquidation and conversion rights. The issuance of preferred stock could, under certain circumstances, have the effect of delaying, deferring, or preventing a change in control of us without further vote or action by the stockholders and may adversely affect the voting and other rights of the holders of common stock.

The Medinotec Group of Companies does not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.

We do not anticipate paying cash dividends on our common stock in the foreseeable future. The payment of dividends on our common stock will depend on earnings, financial condition and other business and economic factors affecting it at such time as the board of directors may consider relevant. If we do not pay dividends, our common stock may be less valuable because a return on your investment will occur only if our stock price appreciates.

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

Members of our board of directors and our officers will have no liability for breaches of their fiduciary duty of care as a director or officer, except in limited circumstances, pursuant to provisions in the Nevada Revised Statutes and our Bylaws as authorized by the Nevada Revised Statutes. Specifically, Section 78.138 of the Nevada Revised Statutes provides that a director or officer is not individually liable to the company or its shareholders or creditors for any damages as a result of any act or failure to act in his or her capacity as a director or officer unless it is proven that (1) the director’s or officer’s act or failure to act constituted a breach of his or her fiduciary duties as a director or officer and (2) his or her breach of those duties involved intentional misconduct, fraud or a knowing violation of law.

This provision is intended to afford directors and officers protection against and to limit their potential liability for monetary damages resulting from suits alleging a breach of the duty of care by a director or officer. Accordingly, you may be unable to prevail in a legal action against our directors or officers even if they have breached their fiduciary duty of care.

In addition, our Bylaws allow us to indemnify our directors and officers from and against any and all costs, charges and expenses resulting from their acting in such capacities with us. This means that if you were able to enforce an action against our directors or officers, in all likelihood, we would be required to pay any expenses they incurred in defending the lawsuit and any judgment or settlement they otherwise would be required to pay. Accordingly, our indemnification obligations could divert needed financial resources and may adversely affect our business, financial condition, results of operations and cash flows, and adversely affect prevailing market prices for our common stock.

Management evaluated the Company’s ability to continue as a going concern in accordance with ASC 205-40 and concluded that, based on current cash, projected operations, and available funding, there is no substantial doubt about the Company’s ability to meet its obligations for at least 12 months from the issuance of these financial statements.

ITEM 1B.

UNRESOLVED STAFF COMMENTS

This information is not required for smaller reporting companies.

ITEM 1C.

CYBERSECURITY

Cybersecurity Risk Management and Strategy

We rely on our information technology to operate our business. As such, we have policies and processes designed to protect our information technology systems, some of which are managed by third parties, and resolve issues in a timely manner in the event of a cybersecurity threat or incident.

We have designed our business applications and hosting services to minimize the impact that cybersecurity incidents could have on our business and have identified back-up systems where appropriate. We seek to further mitigate cybersecurity risks through a combination of monitoring and detection activities, use of anti-malware applications, employee training, quality audits and communication and reporting structures, among other processes. We engage a third-party consultant to assist us with our cybersecurity risk management framework, including the monitoring and detection of cybersecurity threats and responding to any cybersecurity threats or incidents.

The Company maintains an ongoing partnership with a third-party cybersecurity service provider, which facilitates continuous communication through regular electronic updates and periodic onsite engagements. This collaboration ensures alignment in key areas of cybersecurity, including threat detection, vulnerability management, and incident response.

We have implemented internal communication protocols designed to promptly escalate any cybersecurity incidents to the appropriate personnel responsible for evaluating their significance and potential materiality. Upon identification of an incident, the matter is assessed in coordination with our cybersecurity service provider. Relevant information is then communicated to the Board of Directors, which is responsible for determining whether public disclosure is required under applicable securities laws. This process is intended to support timely and accurate reporting in accordance with the Company’s disclosure obligations.

We do not currently maintain dedicated cybersecurity insurance coverage.

Cybersecurity Governance

The Company’s cybersecurity program is supported by a third-party consultant team, which provides expertise in monitoring, threat detection, and risk mitigation. This team operates under the oversight of senior leadership, specifically the Chief Executive Officer and an Independent Director with relevant experience. Together, they are responsible for managing the relationship with the cybersecurity consultants and ensuring that cybersecurity risk management remains aligned with the Company’s overall strategic objectives and risk tolerance.

Our cybersecurity program is informed by industry-recognized best practices, including the National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF), which guides our efforts across key domains such as risk identification, protection, threat detection, incident response, and recovery. This framework helps ensure consistency and effectiveness in our cybersecurity approach and supports compliance with evolving regulatory expectations.

Cybersecurity oversight is also integrated into the Company’s broader corporate governance structure. Management provides updates to the Board of Directors at least quarterly, or more frequently as necessary in response to immediate threats or incidents. These updates cover any material cybersecurity events, as well as incidents of lesser impact that may indicate emerging risks or operational vulnerabilities. The Board, in exercising its oversight responsibilities, evaluates the potential impact of such incidents on the Company’s operations, financial condition, and disclosure obligations.

This governance framework is designed to ensure that the Company remains responsive to the dynamic cybersecurity landscape, maintains regulatory compliance, and protects the integrity of its information systems and data assets.

Our management team is responsible for assessing and managing our material risks from cybersecurity threats.

Risks from Cybersecurity threats

Although cybersecurity risks have not materially affected us, including our business strategy, results of operations or financial condition, to date, we face numerous and evolving cybersecurity threats in our business. For more information about the cybersecurity risks we face, see the risk factor entitled "The Medinotec Group of Companies rely on the proper function, security and availability of our IT systems and data to operate the business, and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect the business, results of operations, financial condition, cash flows, reputation, or competitive position." in Item 1A. Risk Factors.

During the years ended February 28, 2026 and February 28, 2025, we did not, to our knowledge, experience any cybersecurity incidents or breaches that materially impacted or are reasonably likely to materially impact our business, performance or results.