IR-MED Ltd. (OTCQB:IRME) Initiates Clinical Trial for DiaSafe™ DFU Risk Assessment Device

Rosh Pina, Israel — November 3, 2025 — Leads & Copy —IR-MED Ltd. (OTCQB: IRME) has launched its first clinical trial for DiaSafe™, an AI-driven device for non-invasive diabetic foot ulcer (DFU) risk assessment. The DFU treatment market is estimated at $10 billion globally.

DiaSafe™ aims to provide real-time tissue and blood biomarker readings to assess DFU risk before visible symptoms appear. DFUs affect up to 34% of diabetics, potentially impacting 183 million individuals. Of those, 20% may require amputation, and 10% could die within a year of diagnosis. Early intervention can reduce mortality.

Prof. Aviram Nissan, MD, is leading the trial at Ziv Medical Center. Dr. Yaniv Cohen, CSO of IR-MED, said DiaSafe™ could enable earlier interventions and reduce amputations.

PressureSafe™, IR-MED’s initial product, assesses pressure injuries. The company holds patents for non-invasive tissue assessment.

Kathy Cusumano, President of Hanover International, Inc., can be reached at Contact@ir-medical.com.

Source: IR-MED Ltd.

Source: IR-MED Ltd.

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