IR-MED Reports Positive Interim Results from U.S. Clinical Study of PressureSafe(TM) for Pressure Injury Assessment Across Diverse Skin Tones
June 23, 2025 8:30 AM EDT | Source: IR-MED, Inc.
- PressureSafe™, IR-MED's lead product, demonstrated 94% sensitivity in assessing tissue at risk for pressure injuries prior to visible skin breakdown
- Technology addresses longstanding disparities in skin assessment, particularly in patients with darker skin tones
- Results presented at HCA Healthcare & Galen College of Nursing Research Day; additional data to be featured at a podium session at the 2025 ANCC Magnet/ANE Research Symposium
Rosh Pina, Israel--(Newsfile Corp. - June 23, 2025) - As the U.S. commemorated Juneteenth, last week, IR-MED Inc. (OTCQB: IRME) ("IR-MED" or the "Company"), a developer of noninvasive artificial intelligence (AI)-powered spectrographic technology to address critical healthcare challenges, today announced positive interim results from its ongoing U.S. clinical study of PressureSafe™, a handheld infrared spectroscopy device for assessment of pressure injuries (PIs), including deep tissue injuries (DTIs) before visible skin breakdown - a breakthrough especially significant for patients with darker skin tones.
Preliminary findings from a study conducted at Methodist Healthcare in San Antonio, Texas, part of HCA Healthcare, encompass 786 scans across 163 anatomical sites, with 61% of participants representing Fitzpatrick skin types IV-VI (darker skin tones). The PressureSafe™ device demonstrated a sensitivity of 94% (Confidence Interval: 0.83-1.00) in assessing tissue status at high risk for Stage 1 pressure injuries and suspected deep tissue injuries (sDTI) before skin breakdown, with no safety concerns reported.
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Dr. Mary Lee Potter, PhD, MBA, RN, CWOCN, Principal Investigator and Wound Care Specialist at HCA Healthcare, commented, "PressureSafe represents a promising advancement in pressure injury prevention, offering clinicians a rapid, objective tool to assess tissue risk, especially in patients with dark skin tones. These interim findings validate the device's clinical potential to improve equity and patient outcomes."
In June 2025, the study findings were presented as a poster presentation at the HCA Healthcare & Galen College of Nursing Research Day. To further highlight the impact of this research, Dr. Potter has been invited to provide a podium presentation at the 2025 ANCC Magnet/ANE Research Symposium, the largest annual gathering of nursing professionals in the U.S., to be held on October 7th, 2025, in Atlanta, GA, where she will showcase PressureSafe's role in addressing disparities in pressure injury assessment.
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Dr. Yaniv Cohen, Chief Scientific Officer of IR-MED, added, "We are honored to witness our technology gain recognition both institutionally and nationally. With compelling interim data and forthcoming presentations at leading nursing conferences, we believe that PressureSafe™ is poised to establish itself as a clinically impactful and equitable solution in the assessment of pressure injuries before visible skin breakdown."
About IR-MED
IR-MED Inc. is developing a cutting-edge infrared spectroscopy and AI analysis platform technology as a basis for point-of-care decision support devices. The infrared spectroscopy technology allows harmless and non-invasive gathering of bio-information from patient skin and tissue. Bioinformation is then analyzed using the company's AI based process to provide healthcare professionals with decision support in the assessment of various medical conditions.
PressureSafe™, the company's first platform product, is a handheld device designed to revolutionize the assessment of pressure injuries (PI) affecting skin and underlying tissue. Pressure Injury in the US alone accounts for $26.8 billion in healthcare spending and results in 60,000 deaths annually. PressureSafe offers healthcare professionals a real-time evaluation of skin , regardless of patient skin tone. The potential assessment of pressure injuries using PressureSafe holds significant promise in addressing this widespread healthcare challenge and potentially reducing its burden worldwide.
IR-MED holds patents protecting its innovation in noninvasive tissue assessment.
PressureSafe is currently undergoing usability studies at multiple medical centers and is not yet available for commercial use.
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 PressureSafe's promising advancement in pressure injury prevention, especially in patients with dark skin tones; that the interim findings validate the device's clinical potential to improve equity and patient outcomes; Dr. Potter's expected presentation at the 2025 ANCC Magnet/ANE Research Symposium showcasing PressureSafe's role in addressing disparities in pressure injury assessment; and that PressureSafe™ is poised to establish itself as a clinically impactful and equitable solution in the assessment of pressure injuries before visible skin breakdown. 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, future revenues, uses of cash, capital requirements and the need for additional financing; the initiation, cost, timing, progress and results of our development activities, usability studies, preclinical studies and any clinical trials that it may be required to undertake; the timing of and the Company's ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that it may develop, and any related restrictions and/or limitations; the company's plans to research, develop and commercialize its current and future product candidates; the Company's ability to attract collaborators with development, regulatory and commercialization expertise; the company's ability to obtain and maintain intellectual property protection for its product candidates; 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; the success of competing devices that are or may become available; regulatory developments in the United States and other countries; the performance of its third-party suppliers and manufacturers and its ability to obtain alternative sources of raw materials; the impact of global inflationary pressures; its ability to obtain additional financing; use of the proceeds from its securities offerings; any restrictions on its ability to use its net operating loss carry-forwards; the impact of Israel's multi-front war on its results, including potential economic restrictions imposed on and political and military instability in Israel; its ability to attract and retain key personnel, and the other risks identified in our most recent annual report on Form 10-K filed on 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 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 we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.
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