Company Overview - IR-MED, INC.

Business Focus:
IR-MED, Inc. is a development-stage medical device company specializing in point-of-care decision support devices based on proprietary infrared spectroscopy and artificial intelligence (AI) technologies. The company develops non-invasive, handheld diagnostic devices aimed at early detection and monitoring of medical conditions related to skin and tissue health.

Core Technologies:

• Infrared Spectroscopy & AI Platform: Utilizes harmless, multi-biomarker optical analysis through reflected and scattered infrared light from tissue layers. AI algorithms process data to assist healthcare providers in diagnosis and assessment.

Main Products Under Development:

1. PressureSafe™:

   • Handheld optical device designed for early assessment of pressure injuries (pressure ulcers).
   • Can differentiate between deep tissue PIs and superficial stage 1 PIs.
   • Received FDA listing certification in April 2024, classified as a Class I device (exempt from 510(k) submission).
   • Commercial units are in development with planned sales starting in the second half of 2025.
   • Studies show high efficacy (92%-96%) in detecting pressure injuries, with ongoing efforts to address skin tone disparities.

2. DiaSafe™:

   • Handheld device aimed at early detection and assessment of diabetic foot ulcers (DFU).
   • Supports prediction of ulcer development before it becomes an open wound.
   • Developed in collaboration with Israeli authorities; a grant from the Israeli Innovation Authority (IIA) supports its development, with a project cost of approximately US$ 1 million.
   • Planning to initiate clinical trials in Israel for validation.

Additional Future Indications/Devices:

• Otoscope (Nobiotics): To determine bacterial versus viral ear infections in children using AI-driven optical analysis.

Market & Population Data:

• Pressure Injury (PI) Market:

  • Affected populations are aging, obese, and with increasing chronic conditions like diabetes and cardiovascular diseases.
  • PIs are costly ($26.8 billion in U.S. healthcare costs annually), cause over 45% of HAC-related deaths, and result in 60,000 deaths annually.
  • The incidence is rising by about 10% annually, especially in hospitals, nursing homes, and home-care settings.
  • Estimated to impact a significant portion of long-term care, nursing home, and hospital patients.

• Diabetic Foot Ulcers (DFUs):

  • Affect about 18.6 million in the U.S. and 1.6 million annually worldwide.
  • Up to 15% of diabetic patients develop DFUs; many lead to amputations.
  • Treatment costs are high, with average DFU treatment costing thousands to over $70,000 for severe cases.

Employees & Operations:

• As of April 4, 2025:
  • Total employees: 3 full-time employees
  • 1 part-time employee and 1 service provider in product research and development.
• Facilities:
  • Shared office space (~130 sq. meters) in Rosh Pina, Israel.
  • Rent liabilities of approximately $82,000 recorded through December 2024.

Revenue and Income:

• No revenue has been generated to date from product sales.
• Losses:
  • 2024: $1,899,000
  • 2023: $4,909,000
• Accumulated deficit as of December 31, 2024: $16,738,000.
• The company operates at a significant loss with ongoing R&D expenses primarily related to development of PressureSafe™, DiaSafe™, and future devices.

Funding & Financial Position:

• Funded through private placements, equity sales, grants, and loans.
• Recent financing includes:
  • $3.6 million (2022)
  • $1 million (2023)
  • Multiple private placements totaling over $1.5 million in 2024.
  • A large investment agreement for up to $15 million over 24 months entered in March 2025.
  • New unsecured convertible notes totaling $31,200 issued in March 2025.
• As of December 31, 2024:
  • Cash resources: $129,000
  • Liabilities: $545,000 (including $388,000 of current liabilities).
• The company states a substantial doubt about ongoing operations ("going concern") due to limited cash and operating losses.

Business Strategy:

• Focus on expanding product pipeline across different indications (pressure injuries, diabetic foot ulcers, ear infections).
• Establish distribution channels and form strategic partnerships with healthcare providers in the U.S., U.K., and Europe.
• Plan to generate revenue mainly from disposables and software-as-a-service (SaaS) models, with devices likely leased.

Current Market & Customers:

• No specific customer count available; efforts are ongoing to develop commercial partnerships and sales channels.
• The company emphasizes regulatory approval and clinical validation as key steps before commercial launch.

Summary:
IR-MED, Inc. develops AI-powered, infrared spectroscopy-based point-of-care devices targeting early diagnosis of pressure injuries and diabetic foot ulcers. It currently has no revenue, operates at a loss, and relies heavily on private funding, grants, and strategic partnerships to continue development toward commercialization. The company has completed some validation studies and received FDA listing certification for PressureSafe™, with commercialization expected in late 2025.