IR-MED Ltd. Announces Launch of First-in-Human Clinical Trial of Its DiaSafe(TM) Device for Diabetic Foot Ulcer (DFU) Assessment
MWN-AI** Summary
IR-MED Ltd. has announced the launch of its first-in-human clinical trial for the DiaSafe™ device, aimed at improving the assessment and early intervention of diabetic foot ulcers (DFUs). This innovative technology is built on IR-MED's "Sensing the Invisible" platform, utilizing non-invasive infrared spectroscopy to provide real-time optical readings of tissue and blood biomarkers. With an estimated 537 million people worldwide living with diabetes, DFUs pose a significant risk, potentially affecting 19-34% of this population, leading to severe complications such as amputations and increased mortality.
The global market for DFU treatment is valued at approximately $10 billion, highlighting an urgent clinical need for effective intervention strategies. Early detection and management of DFUs can substantially reduce the risk of severe outcomes, making DiaSafe a critical tool for healthcare professionals. The clinical trial is headed by Prof. Aviram Nissan, MD, at Ziv Medical Center, whose collaboration with IR-MED underscores the importance of advancing innovative technologies for better patient outcomes.
Dr. Yaniv Cohen, Chief Scientific Officer of IR-MED, expressed optimism about DiaSafe's potential to enhance diabetic foot care by enabling clinicians to detect early signs of tissue damage. This non-invasive approach can significantly lower the rates of complications and improve health outcomes, particularly for high-risk and underserved populations. IR-MED's pioneering demeanor in AI-driven medical devices, highlighted by their previous product PressureSafe™, positions the company to make substantial impacts in the realm of diabetic care. As IR-MED progresses through this trial phase, stakeholders will closely monitor developments in its endeavor to address this pressing healthcare issue.
MWN-AI** Analysis
IR-MED Ltd. (OTCQB: IRME) has recently announced the initiation of its first-in-human clinical trial for the DiaSafe™ device, a non-invasive technology aimed at assessing diabetic foot ulcer (DFU) risk. This pivotal step arrives in light of the significant global DFU treatment market, currently valued at approximately $10 billion. Given the alarming statistics surrounding DFUs—impacting 19%-34% of the 537 million individuals living with diabetes—DiaSafe™ addresses an urgent, unmet clinical need for early intervention and preventive care.
From an investment perspective, this announcement should invigorate interest among potential and existing investors. The innovative capabilities of DiaSafe™ leverage IR-MED’s proprietary "Sensing the Invisible" technology, which allows for real-time evaluations of tissue and blood biomarkers at the point of care. This feature not only enhances clinical outcomes by enabling timely treatment but could translate into cost savings for healthcare systems grappling with high DFU-associated complications, including amputations.
While the upcoming clinical trial will serve as a litmus test for DiaSafe's efficacy and market viability, investors should closely monitor the progress and results of these trials, as successful outcomes could lead to expedited regulatory approval and commercialization—a key driver for the stock price. Furthermore, the collaboration with reputable institutions like Ziv Medical Center bolsters credibility and highlights the device's potential clinical impact.
Nevertheless, it is crucial to consider potential risks inherent in clinical trials, regulatory pathways, and market competition. Investors should adopt a cautious yet optimistic stance, focusing on the transformative potential of IR-MED’s offerings in addressing a pressing global health concern. As the clinical trial unfolds, IR-MED could emerge as a frontrunner in the burgeoning digital health landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- 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."
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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
https://www.transparencymarketresearch.com/diabetic-foot-ulcer-treatment-market.html.
International Diabetes Federation. Diabetes Facts and Figures.
Global DFU Epidemiology and Outcomes Reports.
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**
How does the DiaSafe™ technology developed by IR-Med Inc IRME improve the accuracy of DFU risk assessment compared to traditional methods used in clinical settings?
What specific biomarkers does DiaSafe™ measure in real-time, and how do these readings contribute to early intervention strategies for patients at risk of developing diabetic foot ulcers?
Can you elaborate on the anticipated timeline for the clinical trial's results, and what key performance indicators IR-Med Inc IRME will use to evaluate the effectiveness of DiaSafe™ in preventing amputations?
How does the launch of DiaSafe™ align with IR-Med Inc IRME’s broader vision for innovation in non-invasive medical technology, and what future products can we expect to see from the company?
**MWN-AI FAQ is based on asking OpenAI questions about IR-Med Inc (OTC: IRME).
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