IR-Med, Inc. (: IRME)

IR-Med, Inc. develops point-of-care decision support devices based on patented infrared spectroscopy and artificial intelligence technology. The company focuses on creating handheld optical monitoring tools for early assessment of pressure injuries and diabetic foot ulcers. Its core platform analyzes subepidermal biomarkers to detect tissue changes before visible symptoms appear.

IR-Med, Inc. generates revenue through the sale of disposable probe tips and potential software-as-a-service offerings for data connectivity and analysis. The company plans to lease its handheld devices to healthcare providers while charging per use of disposables. Revenue is expected to come from hospitals nursing homes homecare companies and other healthcare settings seeking early injury detection tools.

The company operates through the following segments: PressureSafe™ and DiaSafe™.

• PressureSafe™ is a handheld decision support device designed for early assessment of pressure injuries affecting skin and underlying tissue. It uses harmless infrared light and AI algorithms to detect subepidermal changes regardless of skin tone. The device received FDA listing certification as a Class I device on April 9 2024. Initial commercial sales are planned for the second half of 2025 following completion of larger scale production.

• DiaSafe™ is a handheld optical monitoring device under development for early assessment of diabetic foot ulcers in lower limb skin and underlying tissue. It adapts the PressureSafe™ technology platform to detect biomarkers of diabetic foot ulcer formation before open wounds appear. The Israeli Innovation Authority has approved development funding for DiaSafe™ including a grant of approximately US$1 030 000 with royalty obligations.

IR-Med, Inc. operates in a competitive medical device market facing established players such as Bruin’s Biometrics Provizio SEM Scanner which uses electro-resistance measurement for moisture detection. The company’s competitive advantage lies in its proprietary infrared spectroscopy and AI-based multi-biomarker approach that works across all skin tones and detects early tissue changes invisible to visual inspection. Its technology is protected by patents including US Patent No. US 10 709 365 and US Patent No. US10 772 541 valid through August 2034.

IR-Med, Inc. serves hospitals nursing homes homecare companies and other healthcare providers focused on patient monitoring and injury prevention. Specific customer names are not disclosed in the filing but the company targets settings where pressure injuries and diabetic foot ulcers are prevalent including acute care long-term care and home healthcare environments.