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

Rhea-AI Summary

IR-MED (OTCQB: IRME) on November 3, 2025 announced initiation of the first‑in‑human clinical trial of DiaSafe™, a non‑invasive, AI‑driven infrared spectrographic device for diabetic foot ulcer (DFU) assessment.

DiaSafe provides real‑time optical readings of tissue and blood biomarkers at point of care to identify DFU risk before visible skin breakdown. The trial is led by Prof. Aviram Nissan, MD at Ziv Medical Center. The company cited a global DFU treatment market of approximately $10 billion and prevalence estimates implying up to 183 million people may experience DFUs in their lifetime.

Positive

• First‑in‑human trial initiated on DiaSafe
• Device provides real‑time non‑invasive tissue biomarker readings
• Trial led by experienced clinician Prof. Aviram Nissan
• Addresses ~$10 billion DFU treatment market

Negative

• No clinical results yet from the initiated first‑in‑human trial
• Commercial impact and reimbursement timelines unspecified

• 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."

Company Commentary
"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."

IR-MED

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About IR-MED Ltd.
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™, 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™ 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.

Safe Harbor Statement / Forward-Looking Statements
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™ (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™ will complement the Company's existing FDA-listed PressureSafe™ 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 10-K filed April 4, 2025, 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.

Contact:
Hanover International, Inc.
Kathy Cusumano, President
Email: Contact@ir-medical.com

Footnotes

1. https://www.transparencymarketresearch.com/diabetic-foot-ulcer-treatment-market.html.

2. https://diabetesjournals.org/care/article/46/1/209/148198/Etiology-Epidemiology-and-Disparities-in-the.

3. https://pmc.ncbi.nlm.nih.gov/articles/PMC8973203/.

4. International Diabetes Federation. Diabetes Facts and Figures.

5. Global DFU Epidemiology and Outcomes Reports.

6. IR-MED internal data on PressureSafe™ platform.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/272978

FAQ

What did IR-MED (IRME) announce on November 3, 2025 about DiaSafe?

IR-MED announced initiation of a first‑in‑human clinical trial for the DiaSafe DFU assessment device.

What is DiaSafe and how does it assess DFU risk (IRME)?

DiaSafe is an AI‑driven infrared spectrographic device that gives real‑time optical tissue and blood biomarker readings at point of care.

Who is leading the DiaSafe clinical trial for IRME and where is it located?

The trial is led by Prof. Aviram Nissan, MD, Director of Surgery at Ziv Medical Center in Safed, Israel.

How large is the DFU market cited by IR-MED (IRME)?

IR-MED cited an estimated global DFU treatment market of approximately $10 billion.

What patient impact does IR-MED claim DiaSafe could deliver (IRME)?

The company says DiaSafe may enable earlier intervention to reduce amputations and improve outcomes by detecting risk before visible skin breakdown.