Medinotec Inc. is a Nevada-registered medical device company specializing in vascular and airway treatments, with manufacturing in South Africa and expanding international markets including the U.S.

# Company Summary: Medinotec Inc.

**Overview:**  
Medinotec Inc. is a medical device company registered in Nevada that develops, manufactures, and markets innovative healthcare products, primarily focused on vascular and airway treatments. The company has a strong foothold in South Africa and is expanding its international presence, including the United States.

**Key Operations & Business Activities:**  
- **Manufacturing & R&D:** Operates a manufacturing facility in Johannesburg, South Africa, producing high-quality medical devices such as balloons, catheters, and airway management devices. Owns patents and intellectual property for its products, including filings in the US, Europe, China, South Korea, South Africa, and Australia.
- **Product Portfolio:**  
  - **Trachealator:** A non-occlusive device for managing tracheal and bronchial stenosis, with FDA approval obtained via the 510(k) process in November 2021. It has been successfully used on thousands of patients and generated revenue in the US market starting in 2024.
  - **Cape Cross PTCA Catheters:** Coronary balloon catheters, CE marked, with ongoing FDA 510(k) application processes.
  - **Other Products:** Include non-compliant catheters, aortic valve dilation balloons, micro CTO balloons, and developmental tracheal stents.
- **Distribution & Markets:**  
  - **Global Presence:** Operates through 28 distributors across approximately 29 countries, with product registration in progress in 8 additional countries.
  - **U.S. Market:** Initiated sales in 2024, with revenue of $678,105 for FY2025.
  - **South Africa:** Long-standing distribution partner DISA Life Sciences handles significant local sales.
- **Employees & Customers:**  
  - **Employees:** 51 employees and independent contractors (as of February 28, 2025).
  - **Customers:** Primarily hospitals, clinics, healthcare providers, distributors, and government healthcare programs.
- **Revenue & Income:**  
  - **2025 Revenue:** $9,113,607 (a significant increase driven by new distribution agreements and U.S. product launch).  
  - **2025 Net Income:** $2,159,473, reversing a previous net loss of $404,688 in 2024.
  - **Revenue Breakdown:**  
    - **Outside U.S.:** $8,435,502  
    - **Within U.S.:** $678,105  
    - **Product Types:**  
      - Internally designed and manufactured sales: $863,337 (out of country) and $678,105 (U.S.)  
      - Distribution agreement sales: $7,572,165 (out of country).
- **Financial Position:**  
  - **Total Assets (2025):** $6,808,973  
  - **Current Assets:** $6,423,186  
  - **Working Capital:** $4,918,139  
  - **Liabilities:** $1,505,047 (current), $1,033,097 (long-term liabilities including loans and deferred tax).
  
**Strategic Focus:**  
- Expanding product offerings through innovation, patents, and strategic acquisitions.  
- Building expertise in R&D, manufacturing, distribution, and sales.  
- Entering and growing in international and first-world markets, notably the U.S. and Europe.  
- Maintaining high-quality manufacturing standards compliant with ISO 13485, EU MDR, and FDA regulations.

This summary captures Medinotec Inc.'s core business, product lines, operational scope, financials, and strategic intent based solely on provided information.

Medinotec Inc. is a Nevada-incorporated medical device company specializing in innovative vascular and cardiology products, focused on growing its presence in Africa and expanding into North America.

## Medinotec Inc. Overview

### Company Structure and Operations
- **Incorporation**: Medinotec Inc. was incorporated in Nevada on April 26, 2021.
- **Acquisition**: Acquired DISA Medinotec Proprietary Limited, a South African corporation, from Minoan Medical Proprietary Limited on April 26, 2022. This acquisition was an exchange of stock and transfer of a loan account.
- **Holding Company**: Medinotec Capital Proprietary Limited serves as the investment vehicle for Medinotec Inc. in Africa.
- **Group Composition**: The company operates as part of the Medinotec Group, which includes Medinotec Inc., Medinotec Capital, and DISA Medinotec Proprietary Limited.

### Products and Services
Medinotec specializes in manufacturing and distributing innovative medical devices primarily for:
- **Vascular Technologies**: Focus on devices for the treatment of coronary artery disease.
- **Interventional Cardiology and Respiratory Products**: Including:
  - **Trachealator**: A device for managing tracheal and bronchial stenosis. It has FDA approval and has sold 501 units in the U.S. since its launch.
  - **Balloon Catheters**: Such as the **Cape Cross PTCA Catheter** with European CE Mark and multiple variants developed for specialized needs.
  - **Developmental Products**: Ongoing R&D for new devices like the Aortic Valve Dilation Balloon Catheter and Micro CTO Catheter.
  
### Market Reach
- **Customer Base**: Over 100 sales representatives operate primarily in South Africa, with plans to expand into North America and other regions. The primary customers include hospitals, clinics, third-party healthcare providers, and governmental healthcare programs.
  
### Workforce
- **Employees**: As of February 29, 2024, Medinotec employs 54 individuals, including:
  - 35 full-time employees.
  - 3 part-time employees.
  - 16 independent contractors.

### Financial Performance
- **Revenue**: Generated approximately $553,967 in sales for the fiscal year ending February 29, 2024, marking a significant increase from $21,467 in the prior fiscal year.
- **Long-term Liabilities**: Approximately $1,809,655 as of February 29, 2024, primarily due to an unsecured loan from a related party and operational leasing.
- **Cash Reserves**: Approximately $2,808,910 at the close of February 2024.

### Business Strategy
- **Focus Areas**: Innovation in product offerings, strategic acquisitions, and market expansion.
- **Market Trends**: Actively pursuing growth in specialty surgical markets, particularly in regions with growing healthcare demands.

### Regulatory Compliance and Quality Assurance
- **Certifications**: Products are compliant with international standards, including CE marking in Europe and FDA clearances in the U.S.
- **Quality Management**: ISO 13485 certified, ensuring adherence to rigorous quality standards in manufacturing and distribution practices.

Overall, Medinotec Inc. is positioned for growth in the medical device industry, leveraging its innovation capabilities, expanding its geographic reach, and capitalizing on its extensive network of distribution and healthcare partnerships.

Medinotec Inc.

10-K / May 29, 2025

10-K / July 5, 2024

10-K / May 29, 2025

Company Summary: Medinotec Inc.