Medinotec Inc.

Medinotec Group

Overview

Medinotec Group develops, manufactures, and commercializes proprietary medical devices and distributes third-party medical products under exclusive or non-exclusive arrangements in defined territories. Proprietary products and programs include:

• Trachealator — non-occlusive airway dilation balloon. FDA 510(k) clearance obtained November 2021; CE Mark in 2019; U.S. sales commenced; market expansion ongoing.
• Outflo Aortic Valve Dilation Balloon Catheter — non-occlusive perfusion/dilation catheter. FDA 510(k) clearance obtained March 11, 2025; currently marketed in South Africa; U.S. marketing activities commenced in late fiscal 2026 with sales anticipated in fiscal 2027.
• Cape Cross family of PTCA balloon catheters (PTCA and NC variants) — CE Mark obtained; sold in South Africa and selected international markets; FDA 510(k) pathway ongoing for some variants.
• Pipeline and development programs include Micro CTO Catheter (FAA/Notified Body review), StaXstop Catheter (epistaxis), Septus Balloon (nasal fracture), Vaultseal Balloon (gynecological), and other projects.

Corporate structure

• Medinotec Inc. (Nevada, USA) — U.S. sales umbrella and director management.
• Medinotec Capital Proprietary Limited (South Africa) — holding company for African operations.
• DISA Medinotec Proprietary Limited (South Africa) — manufacturing, development, and primary South African sales/manufacturing entity.
• The group manages manufacturing, regulatory/compliance, distribution, and intercompany transfers through these entities.

Markets and footprint

• Represented in approximately 45 countries.
• Appointed distributors: 31 globally.
• Export activities managed from South Africa by the export manager.
• Distribution facilities in Johannesburg (South Africa) and New York (USA), with additional office/storage in Long Island, NY.

Revenue and customers (fiscal year ended Feb 28, 2026)

• Total revenue (estimated from disclosed U.S. share): approximately $10.2 million.
• U.S. sales: $611,860 (6% of total) in fiscal 2026; U.S. revenue in fiscal 2025: $678,105 (7% of total).
• A single customer, DISA Life Sciences, accounted for approximately 89% of total revenue in fiscal 2026.
• Strategy to diversify revenue by expanding into additional markets and distributors.

Employees

• Total personnel (as of February 28, 2026): 48 employees and independent contractors.
• By entity:
  • Medinotec Inc.: 3 full-time; 0 part-time; 12 independent contractors.
  • Medinotec Capital Proprietary Limited: 0 employees mentioned.
  • DISA Medinotec Proprietary Limited: 33 full-time; 0 part-time; 0 independent contractors.
• Overall group totals: 36 full-time employees and 12 independent contractors.

Capabilities and operations

• In-house product development and manufacturing at Johannesburg facility with ISO 13485 Quality Management System.
• Manufacturing capabilities: balloon forming, bonding, coating, catheter lamination, packaging, and sterilization-related activities.
• Quality and regulatory compliance programs include post-market surveillance and supplier quality agreements.
• Export operations and distribution management include direct shipping from South Africa and use of in-house courier/partners.

Intellectual property

• Patents held in the U.S., EU, China, Korea, Australia, South Africa, and other regions for Trachealator and related devices (patents listed with respective grant dates and validity in company records).
• Mix of patents and trade secrets; additional patent filings under consideration for other products.

Regulatory status

• Trachealator: FDA 510(k) clearance; CE Mark (DEKRA); MDR-related activities in progress.
• Outflo: FDA 510(k) clearance; MDR/CE activities in progress for European markets; U.S. marketing planned to ramp in fiscal 2027.
• Cape Cross family: CE Mark; FDA 510(k) pathway in progress for certain variants.
• Compliance framework aligned with FDA, EU MDR, and SAHPRA requirements; ongoing regulatory submissions for new products and market entries.

Business strategy

• Maintain and grow the proprietary product portfolio.
• Build internal manufacturing, quality, regulatory, and commercial capabilities.
• Consider bolt-on acquisitions, new distribution arrangements, and strategic partnerships to support the U.S. and other major markets.
• Diversify revenue sources beyond a heavy South African concentration and reduce customer and geographic concentration over time.

Financial and operational risks

• High revenue concentration: one customer (DISA Life Sciences) represented about 89% of revenue in 2026.
• U.S. market is a strategic growth focus; growth depends on regulatory clearances, distribution, reimbursement, and market acceptance.
• Ongoing efforts to expand international registrations and distributor networks (45 countries, 31 distributors as of 2/28/2026).
• No material litigation noted as of the report date; the company monitors regulatory risk, product liability, cybersecurity, and international trade/regulatory exposure.

Real estate and facilities

• Johannesburg manufacturing and operations facility: 8,783 square feet under lease.
• Office space in Melville, New York (short-term rental) and additional office/storage space in Long Island, NY.

Cybersecurity and data protection

• Cybersecurity risk management framework in place with a third-party consultant.
• Governance aligned with NIST CSF; quarterly board updates on material cybersecurity events.
• No dedicated cybersecurity insurance coverage reported.

Going concern

• Management concluded there is no substantial doubt about the company’s ability to continue as a going concern for at least 12 months from the stated financial statement date, based on current cash, projected operations, and available funding.