IR-MED Inc. has announced promising clinical results for its PressureSafe device, demonstrating high accuracy in pressure injury assessment across diverse skin tones, while simultaneously expanding its technology platform to address diabetic foot ulcers.
The company's AI-driven spectrographic analysis technology has shown significant promise in clinical studies conducted in both Israel and the United States. According to CEO Ran Ziskind, PressureSafe addresses a $1.7 billion market opportunity in the U.S. and a $2.9 billion potential globally.
Clinical Study Results Demonstrate High Accuracy
Two key clinical studies have validated the effectiveness of PressureSafe's Infrared Spectroscopy Scanner (IRSS) technology. The first study, conducted at Clalit Medical Centers in Israel, assessed the device's ability to identify Stage 1 pressure injuries and suspected deep tissue injuries.
"Findings from 924 scans showed a sensitivity of 89% and specificity of 90%, with no device-related adverse events across 1,475 scans," reported investigators from Beit Rivka Hospital and Rabin Medical Center, both part of Clalit Health Services, the world's second-largest Health Maintenance Organization.
The study demonstrated that PressureSafe enhanced assessment of pressure injuries before skin breakage, reduced reliance on subjective visual assessment, and contributed to a measurable reduction in pressure injuries.
A second study focusing on diverse skin tones is currently underway at two Methodist hospitals in Texas. Preliminary data from 294 scans has shown a 90% sensitivity rate, validating PressureSafe's effectiveness across different populations—a critical advantage in addressing healthcare disparities in pressure injury assessment.
"The use of the IRSS to assess the underlying tissue with a multi-biomarker approach provides a reliable quantitative method to assist with clinical assessment by healthcare professionals," explained Ziskind.
Expanding Technology Platform to Diabetic Foot Ulcers
Building on the success of PressureSafe, IR-MED is leveraging its platform technology to develop DiaSafe, a decision-support device for diabetic foot ulcer (DFU) assessment. DFUs represent a significant healthcare challenge, being a leading cause of amputations and placing substantial financial burdens on healthcare systems.
DiaSafe aims to provide real-time, non-invasive optical readings of biomarkers to assess DFUs, enabling earlier and more effective intervention. The company has completed the first year of development with support from the Israel Innovation Authority (IIA), which provided 50% of the $1 million budget as grant funding.
IR-MED has applied for a second IIA grant to support continued development in 2025 and is in advanced discussions with a healthcare provider to launch the first-in-human clinical trial for DiaSafe.
Market Reception and Future Plans
The company recently demonstrated PressureSafe at the National Pressure Injury Advisory Panel (NPIAP) 2025 Conference, where it garnered significant interest from key opinion leaders, healthcare practitioners, scientists, and potential commercial partners.
"Attending NPIAP 2025 further reinforced our belief in IR-MED's unique value proposition—we have both a groundbreaking technology and a receptive market ready for it," said Ziskind. "Moving forward, we are accelerating our usability studies in the U.S., paving the way for commercial milestones."
As part of its growth strategy, IR-MED is actively working toward uplisting to the Nasdaq Stock Exchange, a move expected to enhance shareholder value and expand the company's reach among institutional investors.
Technology Platform and Market Impact
IR-MED's technology platform combines infrared spectroscopy with AI analysis to provide point-of-care decision support devices. The technology allows harmless and non-invasive gathering of bio-information from patient blood and tissue, which is then analyzed using the company's AI-based process.
Pressure injuries represent a significant healthcare burden in the U.S., accounting for $26.8 billion in healthcare spending and resulting in 60,000 deaths annually. PressureSafe is designed to contribute to the assessment of pressure injuries regardless of patient skin tone, potentially driving more equitable healthcare outcomes.
The device is currently undergoing usability studies at multiple medical centers and is not yet available for commercial use. IR-MED holds patents protecting its innovation in noninvasive tissue assessment.
"We are advancing our mission to transform non-invasive skin assessment and improve patient outcomes," concluded Ziskind, highlighting the company's commitment to addressing significant unmet needs in healthcare through innovative technology solutions.
