IR-Med's PressureSafe Technology Advances Through Clinical Trials, Targeting $26.8B Pressure Injury Market
Key Insights
IR-Med's PressureSafe (search) device demonstrated high sensitivity in assessing pressure injuries (search) across all skin tones during clinical trials at HCA Methodist Metropolitan Hospital (search), with results presented at the world's largest nursing conference.
The AI-powered infrared spectroscopy (search) platform addresses a critical healthcare challenge, as pressure injuries (search) account for $26.8 billion in U.S. healthcare spending and result in 60,000 deaths annually.
The company has initiated the second stage of clinical trials and is preparing for additional usability studies at a major East Coast hospital, with pilot programs planned for the first half of 2026.
IR-Med Inc. (search) (OTCQB: IRME) has achieved significant clinical and regulatory milestones for its PressureSafe (search) technology, an AI-powered infrared spectroscopy (search) platform designed to assess pressure injuries (search) and diabetic ulcers (search). The medical technology company's progress comes as it targets a substantial market opportunity, with pressure injuries accounting for $26.8 billion in U.S. healthcare spending and resulting in 60,000 deaths annually.
Clinical Trial Results Show Promise Across Diverse Patient Populations
The company's clinical research, conducted at HCA Methodist Metropolitan Hospital (search) under the leadership of principal investigator Dr. Mary Lee Potter, PhD, MBA, RN, CWOCN, has demonstrated encouraging results. The study showed how near-infrared spectroscopy (search) combined with artificial intelligence trained on diverse skin tones provides high sensitivity in assessing pressure injuries (search), particularly among patients with darker skin tones.
"PressureSafe (search) 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," stated Dr. Potter. "These interim findings validate the device's clinical potential to improve equity and patient outcomes."
The clinical data was presented at the Magnet & Pathway 2025 Conference in Atlanta, Georgia, the world's largest professional nursing event. Dr. Potter's podium presentation, titled "Enhancing Skin Assessment: Infrared Spectroscopy (search) Across All Skin Tones," was selected by the Scientific Committee and received strong interest from attendees, with the conference describing it as "an interesting and much-needed product."
Expanding Clinical Program and Commercial Preparation
IR-Med has initiated the second stage of its clinical trial, which is anticipated to take up to six months to complete. Additionally, the company is in advanced stages of Institutional Review Board submission for an additional usability trial at a major East Coast hospital, following over 12 months of due diligence and preparation.
According to CEO Ran Ziskind, gaining entry into two of the most prominent hospital networks in the U.S. represents "not only a significant honor, but also a major commercial opportunity that strengthens our foothold in the largest healthcare market in the world."
The company is targeting several pilot programs in the first half of 2026 across various U.S. healthcare settings, which would serve as the cornerstone for its initial go-to-market strategy and help shape the product's adoption path.
Technology Platform and Market Positioning
PressureSafe (search) is a handheld device that uses infrared spectroscopy (search) technology to gather bio-information from patient skin and tissue non-invasively. The collected data is analyzed using the company's AI-based process to provide healthcare professionals with decision support in assessing various medical conditions, with particular focus on providing real-time evaluation of skin regardless of patient skin tone.
The technology platform holds patents protecting its innovation in non-invasive tissue assessment. IR-Med's broader platform technology serves as a basis for point-of-care decision support devices, with potential applications beyond pressure injury assessment.
Strategic Growth and Financing Plans
IR-Med is actively working toward uplisting to a major stock exchange such as NASDAQ or NYSE American, which the company considers a top strategic priority. The company has engaged with a leading investment bank to support near-term fundraising and the future uplisting process.
"We are seeing growing interest from highly respected medical care networks and players in the industry," said Ziskind. "Collaborations with such entities—should they materialize—could further support our growth and contribute to our long-term value."
The company believes that within the coming years, sales could become meaningful as it approaches the final stage toward commercialization. However, management acknowledges that current conditions in terms of operational readiness and financial positioning are not yet optimal for uplisting, planning to pursue this goal after additional capital raising and upon reaching key product development and clinical milestones.
Media and Investment Community Engagement
Beyond clinical progress, IR-Med has expanded its visibility within healthcare, investment, and media communities. The company presented at the 151st National Investment Banking Association Conference in Fort Lauderdale, Florida, where the executive team outlined progress toward commercialization to an audience of public company executives and investment professionals.
The technology was also featured on Israel's Channel 10 national economic program "The Next Big Thing," where Dr. Yaniv Cohen, Co-Founder and Chief Scientific Officer, demonstrated how the platform's AI and infrared technology enable clinicians to assess subdermal tissue health and support equitable wound care.
PressureSafe (search) is currently undergoing usability studies at multiple medical centers and is not yet available for commercial use.