Peer-Reviewed Scientific Journal Publishes U.S. Clinical Study Reporting Interim Results of 87.7% Accuracy for IR-MED’s PressureSafe™ Technology in Pressure-Injury Assessment
Summary by AI BETAClose X
ROSH PINNA, Israel, November 4th, 2026, FinanceWire
Peer-reviewed study published in the HCA Healthcare Journal of Medicine reports Phase 2 interim results of 90.0% sensitivity, 87.3% specificity and an AUC-ROC of 0.959 using a post hoc balanced classification threshold in assessing pressure injuries
Prospective pressure-injury study conducted at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak included 1,314 device scans across 219 anatomical sites, with approximately 54% of participants representing dark skin types
No device-related adverse events were identified during the pressure-injury study
Study demonstrated the investigational device’s usability and compatibility with routine pressure-injury assessment workflows in acute-care settings
IR-MED Ltd. (OTC: IRME) (the “Company” or “IR-MED”), a developer of infrared spectroscopy-based medical device technology, today announced the publication of peer-reviewed interim clinical results evaluating the Company’s Infra-Red Spectroscopy Scanner, or IRSS, the investigational device underlying its PressureSafe™ platform, for the assessment of pressure injuries in patients across a range of skin tones.
The original research article, titled “The Use of Infra-Red Spectroscopy to Assess Intact Skin of Various Skin Tones,” was published in the HCA Healthcare Journal of Medicine, Volume 7, Issue 5. The study evaluated the safety and performance of IR-MED’s non-invasive, machine-learning-enabled IRSS investigational device in distinguishing clinically healthy intact tissue from tissue classified by Certified Wound Ostomy Continence Nurses as a Stage 1 pressure injury or deep tissue injury.
PressureSafe™ is IR-MED’s proprietary platform based on the IRSS technology evaluated in the study.
- The interim Phase 2 analysis, which included nine participants and 65 anatomical sites, reported the following performance metrics using a post hoc balanced classification threshold:87.7% overall accuracy
- 90.0% sensitivity
- 87.3% specificity
- AUC-ROC of 0.959
- No device-related adverse events
The prospective, two-phase pilot device study was conducted at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak, two acute-care hospitals in San Antonio, Texas. Across both phases, 26 participants contributed 219 anatomical-site observations and 1,314 individual device scans. Approximately 54% of participants were classified as Fitzpatrick skin types IV–VI (dark skin tone). The interim Phase 2 analysis included nine participants, 65 anatomical sites and 390 individual device scans, including ten sites clinically classified as pressure injuries.
Addressing a Critical Clinical Challenge
Pressure injuries can begin beneath visually intact skin, making early tissue changes difficult to identify through conventional visual and tactile assessment alone. This challenge may be particularly significant in patients with darker skin tones, where melanin pigmentation can obscure visual indicators such as non-blanchable erythema and contribute to delayed or missed identification.
The investigational IRSS device underlying the PressureSafe™ platform uses diffuse-reflectance spectroscopy across visible and near-infrared wavelengths, together with a proprietary machine-learning classifier, to assess optical signals associated with tissue biomarkers and structural characteristics that may be associated with pressure injuries.
The handheld, battery-operated investigational device performs an individual scan in approximately 400 milliseconds and provides a real-time assessment intended to support clinical decision-making. The study also demonstrated the device’s usability and compatibility with routine clinical workflows in acute-care settings.
The technology underlying PressureSafe™ is designed to provide objective information that augments, rather than replaces, standard visual and tactile skin assessment by qualified healthcare professionals.
Study Design and Results
The study was conducted under protocol IRM-02-1123 and included two phases. Phase 1 supported IRSS device calibration and validation, clinical personnel training, safety evaluation and refinement of the machine-learning algorithm.
Phase 2, which remains ongoing, is evaluating the safety and diagnostic performance of the investigational device underlying PressureSafe™ against assessments performed by experienced Certified Wound Ostomy Continence Nurses.
During Phase 1, the IRSS demonstrated 81.2% accuracy, 90.5% sensitivity, 79.7% specificity and an AUC-ROC of 0.922.
Phase 1 data were subsequently used to refine the machine-learning model evaluated during Phase 2.
In the Phase 2 interim analysis, the balanced model demonstrated 87.7% accuracy, 90.0% sensitivity and 87.3% specificity. These results represented a 6.5 percentage-point improvement in accuracy and a 7.6 percentage-point improvement in specificity compared with Phase 1.
The AUC-ROC increased to 0.959, indicating strong discrimination between anatomical sites clinically classified as healthy tissue and those classified as pressure-injured tissue.
No device-related safety events were identified during either study phase, including participant discomfort, adverse tissue reactions, interference with patient-monitoring equipment or infection-transmission concerns.
“These peer-reviewed results represent an important clinical milestone for IR-MED and provide independent validation of the potential of the infrared spectroscopy and machine-learning technology underlying our PressureSafe™ platform,” said Dr. Yaniv Cohen, Co-Founder and Chief Scientific Officer of IR-MED.
“I would like to congratulate and thank Dr. Mary Lee Potter, the clinical research teams at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak, our co-authors, and everyone who contributed to the successful completion and publication of this important research. Their dedication and clinical expertise were instrumental in advancing this study.”
“The improvement observed in Phase 2 highlights the potential of our technology to learn from high-quality clinical data and enhance its diagnostic performance. Most importantly, the study supports our mission to provide healthcare professionals with an objective, rapid and non-invasive tool that may strengthen pressure-injury assessment across diverse patient populations and help address a persistent healthcare equity challenge.”
Dr. Mary Lee Potter, PhD, MBA, RN, CWOCN, the study’s principal investigator and lead author, commented:
“Early-stage pressure injuries and deep tissue injuries can be difficult to identify, particularly when tissue damage develops beneath intact skin or when visual signs are less apparent. The interim findings demonstrate promising agreement between the investigational infrared spectroscopy scanner underlying PressureSafe™ and assessments performed by experienced wound-care clinicians.”
“The study also supports the feasibility of using the device across a range of skin phototypes and its compatibility with routine acute-care clinical workflows. Continued enrollment will allow us to further evaluate performance across skin-tone groups and anatomical locations.”
Next Steps
Phase 2 enrollment and data collection remain ongoing, with completion currently expected by March 2027. Continued enrollment is intended to expand the clinical dataset, improve the precision of performance estimates and further evaluate the performance of the IRSS technology underlying PressureSafe™ across different skin-tone groups and anatomical sites.
The published study concluded that the interim results demonstrated promising anatomical-site agreement between the IRSS and the clinical classification of healthy versus pressure-injured intact tissue, with no device-related adverse events identified.
Full Article
Potter MLA, Sosa S, Polm C, et al. The Use of Infra-Red Spectroscopy to Assess Intact Skin of Various Skin Tones. HCA Healthcare Journal of Medicine. 2026;7(5), Article 19. DOI: 10.36518/2689-0216.2573.
The full peer-reviewed article is available through the HCA Healthcare Journal of Medicine:
About IR-MED Ltd.
IR-MED Ltd. 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 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™, the Company’s lead platform product, is based on the IRSS technology evaluated in the published study. It is a handheld device designed to support the assessment of pressure injuries affecting skin and underlying tissue, regardless of patient skin tone. IR-MED holds patents protecting its innovations in non-invasive tissue assessment.
For more information, visit: www.ir-medical.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.
Statements that are not statements of historical fact, including statements regarding the clinical performance, safety, continued development, regulatory pathway, commercialization and potential clinical benefits of IR-MED’s IRSS technology and PressureSafe™ platform; the expected timing and completion of Phase 2 enrollment and data collection; the collection of additional clinical data; future performance across different skin-tone groups and anatomical sites; improvements in machine-learning performance; and the potential adoption or commercial acceptance of the Company’s technology; the potential clinical utility of the technology; the ability to replicate or improve upon the interim clinical results in larger patient populations; the ability to demonstrate consistent performance across different skin-tone groups and anatomical sites; and the Company's ability to obtain any required regulatory authorizations; are forward-looking statements.
These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, the ability to complete the study within the anticipated timeline, regulatory requirements and delays, the need for additional studies or data, product development and manufacturing risks, competition, market acceptance, availability of financing and general economic conditions.
IR-MED undertakes no obligation to publicly update or revise any forward-looking statements, except as required by applicable law.
Website: www.ir-medical.com
Contact
Investor & Media ContactIR-MED Ltd.
contact@ir-medical.com
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