IR-MED Ltd. (OTC: IRME), an Israel-based developer of infrared spectroscopy medical device technology, has announced the publication of peer-reviewed Phase 2 interim clinical results for its investigational Infra-Red Spectroscopy Scanner (IRSS), the technology underpinning its PressureSafe™ platform. The results, published in the HCA Healthcare Journal of Medicine (Volume 7, Issue 5), reported 90.0% sensitivity, 87.3% specificity, and an AUC-ROC of 0.959 using a post hoc balanced classification threshold. The study was conducted across two acute-care hospitals in San Antonio, Texas, with no device-related adverse events identified, representing a notable clinical milestone for the company and its investors.

Key Points

  • IR-MED Ltd. (OTC: IRME), referenced on Investegate under ticker FNEWS via FinanceWire (FNW)
  • Phase 2 interim results for the IRSS device published in a peer-reviewed journal, reporting 90.0% sensitivity, 87.3% specificity, and AUC-ROC of 0.959
  • Study conducted at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak; Phase 2 completion expected by March 2027
  • Investors should watch for continued Phase 2 enrolment data and any regulatory pathway updates as the clinical dataset expands

IRSS Device Achieves 90.0% Sensitivity Across 219 Anatomical Sites in San Antonio Hospitals

The prospective two-phase pilot study was conducted under protocol IRM-02-1123 at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak, both acute-care facilities in San Antonio, Texas. Across both phases, 26 participants contributed 219 anatomical-site observations and 1,314 individual device scans. The Phase 2 interim analysis specifically included nine participants, 65 anatomical sites, and 390 individual device scans, of which ten sites were clinically classified as pressure injuries. Approximately 54% of participants were classified as Fitzpatrick skin types IV–VI, representing darker skin tones, addressing a recognised challenge in conventional pressure-injury assessment where melanin pigmentation can obscure visual indicators.

Phase 2 Performance Improves on Phase 1 Metrics, with AUC-ROC Rising to 0.959

The Phase 2 interim analysis demonstrated 87.7% overall accuracy, representing a 6.5 percentage-point improvement over the 81.2% accuracy recorded in Phase 1. Specificity improved by 7.6 percentage points to 87.3%, while the AUC-ROC increased from 0.922 to 0.959, indicating stronger discrimination between healthy tissue and pressure-injured tissue. The announcement states that Phase 1 data were used to refine the machine-learning model subsequently evaluated in Phase 2. No device-related safety events were identified during either phase, including no adverse tissue reactions, participant discomfort, or infection-transmission concerns across all scans conducted.

PressureSafe™ Handheld Device Delivers Real-Time Scans in Approximately 400 Milliseconds

IR-MED's investigational IRSS device uses diffuse-reflectance spectroscopy across visible and near-infrared wavelengths, combined with a proprietary machine-learning classifier, to assess optical signals associated with tissue biomarkers. The handheld, battery-operated device performs a single scan in approximately 400 milliseconds and provides real-time output intended to support clinical decision-making. The study also confirmed the device's compatibility with routine acute-care workflows. The company holds patents protecting its non-invasive tissue assessment innovations, and the PressureSafe™ platform is designed to augment, rather than replace, standard clinical assessment by qualified healthcare professionals.

Phase 2 Enrolment Ongoing with Completion Expected by March 2027

Phase 2 enrolment and data collection remain ongoing, with completion currently expected by March 2027, according to the announcement. Continued enrolment is intended to expand the clinical dataset, improve the precision of performance estimates, and further evaluate IRSS performance across different skin-tone groups and anatomical locations. Investors may be watching for updates on the regulatory pathway, as the company has not yet disclosed any specific regulatory submissions or commercialisation timeline. IR-MED is headquartered in Rosh Pinna, Israel, and is listed on the OTC market under the ticker IRME.