IR-MED Ltd. Announces Launch of First-in-Human Clinical Trial of Its DiaSafe(TM) Device for Diabetic Foot Ulcer (DFU) Assessment

• DiaSafe™ technology for non-invasive DFU risk assessment and early intervention*
• The DFU treatment market is estimated to be approximately$10 billion globally¹

Rosh Pina, Israel--(Newsfile Corp. - November 3, 2025) - IR-MED Ltd. (OTCQB: IRME) (the "Company" or "IR-Med"), a pioneer in artificial intelligence ("AI")-driven, non-invasive infrared spectrographic medical device developer, today announced that it has initiated the first-in-human clinical trial of its DiaSafe™ device – built on the proven "sensing the invisible" platform – specifically targeting DFUs. This milestone marks a critical step toward transforming DFU assessment and prevention across diverse patient populations.

Key Highlights of the Trial Launch

• The DiaSafe device is designed to deliver real-time optical readings of tissue and blood biomarkers at the point of care, enabling clinicians and caregivers to assess DFU risk before visible skin breakdown occurs.

• DFUs represent one of the most serious complications of diabetes, affecting up to 19%-34% of the approximately 537 million people living with diabetes globally - equating to as many as 183 million individuals during their lifetime.²

• Among those who develop a DFU, up to 20% may require lower-extremity amputation and up to 10% may die within one year of their first ulcer diagnosis. Early assessment and intervention have been shown to reduce this mortality risk.³

• The DFU treatment market is estimated to be approximately $10 billion globally, underscoring the size and urgency of this unmet clinical need.¹

• DiaSafe leverages the Company's proprietary "Sensing the Invisible" core technology platform.

Clinical Trial Leadership and Collaboration
The trial will be led by Prof. Aviram Nissan, MD, Director of Surgery at Ziv Medical Center in Safed, Galilee, Israel – a seasoned surgical clinician and respected research leader. Prof. Nissan expressed his enthusiasm for the collaboration, stating, "This collaboration with IR-MED reflects our shared commitment to improving patient outcomes through innovation. The ability to detect early indicators of tissue damage in diabetic patients has the potential to significantly reduce the number of severe complications and amputations. We are pleased to collaborate in advancing this important technology for the benefit of patients everywhere."