IR-Med is an early-stage medical device company developing handheld, non-invasive diagnostic tools that use infrared spectroscopy and AI to detect tissue damage beneath the skin before it becomes visible. The company has no commercial revenue to date. IR-Med's lead product, PressureSafe, shines infrared light on a patient's skin and uses AI to detect early-stage pressure injuries — wounds that develop under intact skin in bedridden or immobile patients — before they are visible to the naked eye. PressureSafe received FDA Class I listing in April 2024, with initial commercial sales targeted for the second half of 2025. IR-Med's second product, DiaSafe, adapts the same platform to detect early-stage diabetic foot ulcers before they progress to limb amputation. IR-Med targets hospitals, nursing homes, and home healthcare companies. The intended business model follows a "razor and blades" structure: the handheld device is leased at low cost, while recurring revenue comes from disposable probe tips required for each scan and a SaaS component for data analytics and EMR integration. Distribution is planned through local partners in the U.S., U.K., and Europe, though IR-Med's prior U.S. distribution agreement was terminated in late 2024 and the company currently lacks a committed commercial distribution partner. IR-Med operates with a very small team, outsources manufacturing, and is headquartered in Rosh Pina, Israel. The company is also exploring a longer-term strategy of licensing or partnering with larger medical device companies to access manufacturing scale and distribution.
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