Ir-Med Stock Price, News & Analysis

IR-MED Inc. (OTCQB: IRME) is a medical technology company developing noninvasive, artificial intelligence (AI)-driven spectrographic and infrared spectroscopy platforms for point-of-care decision support. According to the company’s disclosures, its technology is designed to gather harmless, non-invasive bio-information from patient skin, blood and tissue and analyze it with AI-based processes to assist healthcare professionals in assessing various medical conditions, with an initial focus on pressure injuries and diabetic foot ulcers.

Core technology and platform focus

IR-MED describes its core platform as a noninvasive spectrographic and infrared spectroscopy analysis technology. The system is being developed to detect, measure and monitor different molecules and biomarkers in blood, human tissue and body fluids without invasive procedures. The bioinformation collected is processed by AI algorithms to provide quantitative, real-time decision support at the point of care. The company states that this approach aims to augment traditional visual inspection and help reduce uncertainty in clinical decision-making.

Across multiple company communications, IR-MED emphasizes that its technology is intended to be skin-color agnostic, using infrared light and AI trained on diverse skin tones to assess tissue beneath the skin surface. The company holds patents protecting its innovations in noninvasive tissue analysis, noninvasive tissue assessment and the modeling and analysis of subcutaneous tissue.

PressureSafe™: pressure injury assessment device

PressureSafe™ is described as IR-MED’s first platform product and lead device. It is a handheld optical monitoring device and decision support tool designed for the early, non-invasive detection and assessment of pressure injuries (PIs), including suspected deep tissue injuries, affecting skin and underlying tissue. The device uses near-infrared or infrared spectroscopy combined with an AI-based algorithm to evaluate tissue status and detect biomarker changes beneath the skin surface before visible skin breakdown.

The company reports that PressureSafe is intended to provide real-time evaluation of skin and underlying tissue at the point of care, regardless of patient skin tone, by calibrating to each patient’s skin. IR-MED states that pressure injuries in the United States alone account for significant healthcare spending and tens of thousands of deaths annually, and that pressure injuries are among the most common patient harms and a major source of litigation. Within this context, the company positions PressureSafe as a tool that may support earlier detection and more equitable assessment of pressure injuries across diverse populations.

IR-MED has disclosed multiple usability and clinical studies for PressureSafe. In a usability study conducted at two hospitals owned by Clalit, described as Israel’s largest health maintenance organization and the second largest HMO in the world, PressureSafe detected Stage 1 and suspected deep tissue pressure injuries with reported sensitivity and specificity in the high eighty to low ninety percent range, and the incidence of pressure injuries during the study period was reported to have been reduced compared to prior levels. In a U.S. study at Methodist Healthcare in San Antonio, Texas, interim results presented by the company indicated high sensitivity in assessing tissue at risk for early-stage pressure injuries, including among patients with darker skin tones.

IR-MED states that PressureSafe is FDA-listed for the indication of pressure injuries. At the same time, the company notes that PressureSafe is undergoing usability studies at multiple medical centers and is not yet available for commercial use.

DiaSafe™: diabetic foot ulcer assessment

DiaSafe™ is described as IR-MED’s second product under development, based on the same noninvasive infrared spectroscopy and AI platform as PressureSafe. DiaSafe is being developed as a handheld decision support device for the assessment of diabetic foot ulcers (DFUs) and related risk. According to company announcements, DiaSafe is intended to provide safe, real-time optical readings of biomarkers in blood and tissue at the point of care to help evaluate DFU risk and the early presence of ulcers before visible skin breakdown.

The company notes that diabetic foot ulcers are a serious complication of diabetes, associated with a high risk of lower-extremity amputation and mortality, and that the global DFU treatment market is estimated in the multi-billion-dollar range. IR-MED reports that DiaSafe is being advanced with support from grants awarded by the Israel Innovation Authority (IIA) after peer review of the company’s technology platform. These grants are described as funding hardware and software development for DiaSafe and supporting first-in-human clinical trials. IR-MED has announced the launch of a first-in-human clinical trial of DiaSafe in a leading medical center in northern Israel, focused on noninvasive DFU risk assessment and early intervention.

Clinical validation and equity focus

Across its communications, IR-MED emphasizes a focus on addressing disparities in skin and tissue assessment, particularly for patients with darker skin tones. The company highlights that standard visual inspection can be less effective for early detection of pressure injuries in individuals with dark skin, and that its use of infrared spectroscopy and AI trained on diverse skin tones is intended to provide a more objective, quantitative assessment of tissue risk.

IR-MED has reported clinical and usability studies in both Israel and the United States. These include work at Clalit medical centers in Israel and at Methodist Healthcare in Texas, as well as presentations at professional conferences such as the National Pressure Injury Advisory Panel (NPIAP) meetings, HCA Healthcare & Galen College of Nursing Research Day, and the ANCC Magnet/ANE Research Symposium. The company states that its data-driven approach and these studies are intended to validate the performance of PressureSafe and support broader adoption by frontline caregivers.

Regulatory status and development stage

IR-MED discloses that PressureSafe has received U.S. Food and Drug Administration (FDA) listing confirmation for the indication of pressure injuries. At the same time, the company repeatedly notes that PressureSafe is undergoing usability studies at multiple medical centers and is not yet available for commercial use. DiaSafe is described as being in development, with ongoing hardware and software work and planned or initiated first-in-human clinical trials, supported by IIA grants.

In investor communications, IR-MED has described a broader platform strategy in which its noninvasive, AI-driven spectrographic technology could be applied to additional indications beyond pressure injuries and diabetic foot ulcers, though specific future indications are not detailed in the provided materials.

Corporate and capital markets context

IR-MED Inc. trades on the OTCQB market under the symbol IRME. The company has characterized itself as a developer of noninvasive, AI-driven spectrographic analysis technology addressing significant healthcare needs, and has communicated a strategic interest in expanding visibility among healthcare professionals, investors and media. In shareholder and investor updates, IR-MED has discussed efforts toward commercialization of PressureSafe, expansion of its product pipeline with DiaSafe, and a longer-term goal of potentially uplisting to a major U.S. stock exchange, subject to operational, clinical and financing milestones.

In a current report on Form 8-K, the company disclosed that it has experienced financial difficulties that prevented it from filing a Quarterly Report on Form 10-Q for a specified period by the required deadline. The same filing states that IR-MED is evaluating and pursuing alternatives to address its liquidity needs and intends to resume filing required periodic reports under the Securities Exchange Act of 1934 as soon as reasonably practicable, while noting that it cannot provide assurance regarding the timing or outcome of these efforts.

IR-MED has also reported entering into private placement transactions for common stock and warrants with investors, including participation by its chief executive officer, as part of its capital-raising activities. In a later Form 8-K, the company described amendments to employment agreements with senior executives, moving from fixed salaries to hourly compensation structures in light of its financial situation.

Intellectual property and technology protection

The company states that it holds patents protecting its technology and innovations in noninvasive tissue analysis, noninvasive tissue assessment and the modeling and analysis of subcutaneous tissue. These patents are described as covering aspects of its spectrographic and infrared spectroscopy-based platform and its application to pressure injury and related assessments.

Risk considerations

IR-MED’s public statements include cautionary language noting that many of its plans and expectations are forward-looking and subject to significant risks and uncertainties. The company cites factors such as the need for additional financing, the timing and outcome of development activities, usability and clinical studies, regulatory approvals, market acceptance of any future products, competition from other devices, and broader economic and geopolitical conditions. Investors reviewing IRME stock are therefore encouraged, by the company’s own filings, to consider these risks and to consult its most recent annual report and other SEC filings for detailed risk factor discussions.