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Rosh Pina, Israel–(Newsfile Corp. – November 3, 2025) – IR-MED Ltd.<\/b> (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\u2122 device\u00a0\u2013 built on the proven “sensing the invisible” platform\u00a0\u2013 specifically targeting DFUs. This milestone marks a critical step toward transforming DFU assessment and prevention across diverse patient populations.<\/p>\n
Key Highlights of the Trial Launch<\/b><\/p>\n 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.<\/p>\n<\/li>\n DFUs represent one of the most serious complications of diabetes, affecting up to\u202f19%-34% of the approximately\u202f537\u202fmillion people living with diabetes globally – equating to as many as\u202f183\u202fmillion individuals during their lifetime.2<\/sup><\/p>\n<\/li>\n Among those who develop a DFU, up to\u202f20% may require lower-extremity amputation and up to\u202f10% may die within one year of their first ulcer diagnosis. Early assessment and intervention have been shown to reduce this mortality risk.3<\/sup><\/p>\n<\/li>\n The DFU treatment market is estimated to be approximately\u202f$10\u202fbillion globally, underscoring the size and urgency of this unmet clinical need.1<\/sup><\/p>\n<\/li>\n DiaSafe leverages the Company’s proprietary “Sensing the Invisible” core technology platform.<\/p>\n<\/li>\n<\/ul>\n Clinical Trial Leadership and Collaboration<\/b> Company Commentary<\/b> IR-MED<\/p>\n To view an enhanced version of this graphic, please visit: About IR-MED Ltd.<\/b> Safe Harbor Statement\u202f\/\u202fForward-Looking Statements<\/b> Contact:<\/b> Footnotes<\/p>\n https:\/\/www.transparencymarketresearch.com\/diabetic-foot-ulcer-treatment-market.html<\/a>.<\/p>\n<\/li>\n https:\/\/diabetesjournals.org\/care\/article\/46\/1\/209\/148198\/Etiology-Epidemiology-and-Disparities-in-the<\/a>.<\/p>\n<\/li>\n\n
The trial will be led by Prof. Aviram Nissan, MD, Director of Surgery at Ziv Medical Center in Safed, Galilee, Israel\u00a0\u2013 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.”<\/p>\n
“We are excited to initiate the first in human trial of DiaSafe as a meaningful step toward addressing a critical gap in diabetic foot care,” said Dr. Yaniv Cohen Ph.D, Chief Scientific Officer of IR-MED. “By enabling non-invasive, rapid biomarker assessment at the point of care, we believe DiaSafe has the potential to help clinicians intervene earlier, reduce amputations and improve outcomes – especially among high risk and underserved populations. Our platform’s proven pedigree, via PressureSafe, gives us the confidence to now take this next leap.”<\/p>\n![\"Cannot](\"https:\/\/images.newsfilecorp.com\/files\/11614\/272978_aec8dd0d54d168e0_002full.jpg\")
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IR-MED Ltd. is developing a cutting-edge infrared spectroscopy and AI analysis platform to support point-of-care decision-support devices. The infrared spectroscopy technology allows harmless, non-invasive gathering of bio-information from patient blood and tissue. That data is then processed by the Company’s AI-based system to provide healthcare professionals with decision support in the assessment of various medical conditions. PressureSafe\u2122, IR-MED’s first product built on this platform, is a handheld device designed to revolutionize the assessment of pressure injuries (PIs) affecting skin and underlying tissue. PI in the U.S. alone accounts for significant healthcare spending and results in thousands of deaths annually. PressureSafe\u2122 offers healthcare professionals a real-time evaluation of skin and underlying tissue regardless of patient skin tone. IR-MED holds patents protecting its innovations in non-invasive tissue assessment.<\/p>\n
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For example, IR-MED is using forward-looking statements when it discusses the initiation and conduct of its first-in-human clinical trial, the potential benefits of DiaSafe\u2122 (such as reducing healthcare costs, preventing amputations and saving lives), the belief that DiaSafe has the potential to help clinicians intervene earlier, reduce amputations and improve outcomes – especially among high risk and underserved populations, the expectation that DiaSafe\u2122 will complement the Company’s existing FDA-listed PressureSafe\u2122 device as part of a broader platform of AI-powered, non-invasive diagnostic tools, and the size and growth of the addressable DFU market opportunity. Statements relating to the future performance of IR-MED are subject to many factors including, but not limited to, the accuracy of the Company’s estimates regarding expenses, revenues, uses of cash, capital requirements and the need for additional financing; the initiation, timing, cost, progress and results of development activities, clinical trials, regulatory approvals and commercialization; the Company’s ability to attract collaborators with development, regulatory and commercialization expertise; the Company’s ability to obtain and maintain intellectual property protection; the Company’s ability to successfully commercialize its product candidates; the size and growth of the markets for its product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; competition from existing and future devices; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers and the Company’s ability to obtain alternative sources of raw materials; and the other risks identified in its most recent Annual Report on Form\u202f10-K filed April\u202f4,\u202f2025, with the Securities and Exchange Commission. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and the Company does not undertake any obligation to update any such statements, whether as a result of new information, future events or otherwise.<\/p>\n\n
Hanover International, Inc.
Kathy\u202fCusumano, President
Email: Contact@ir-medical.com<\/a><\/p>\n<\/div>\n\n