Clinical Data Support Early Detection Ability of IR-MED’s Pressure Injury Device

IR-MED Inc. is reporting highly favorable proof of efficacy data for PressureSafe, its decision support device which uses infra-red spectroscopy combined with an artificial intelligenceI-based algorithm, for early, non-invasive, and skin color agnostic detection of pressure injuries.
 
The study was conducted at two medical centers owned by Clalit, the world’s second-largest health maintenance organization (HMO) and the largest in Israel, Beit Rivka Hospital and Rabin Medical Center. While the current standard of care for detecting pressure injuries is visual and tactile clinical evaluation, physiological changes below the skin’s surface, including inflammation and interstitial fluids precede surface changes. The study’s objective was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1/suspected deep tissue injuries (sDTI) before skin breakage, compared to the standard of care. PressureSafe detected biomarkers and changes in tissue structures under the skin’s surface as they relate to pressure injuries.

 “In addition to this study in Israel, we look forward to starting a usability study for PressureSafe in the U.S. in collaboration with Methodist Healthcare of San Antonio in the coming months,” IR-MED Chief Scientific Officer Yaniv Cohen, Ph.D., said. “The Methodist study aims to enroll approximately 50% of patients with darker skin tones in order produce comparative data for PressureSafe’s accuracy as a decision support device in people with lighter and darker skin tones. This is a very important priority for IR-MED, as published studies show black patients in the U.S. suffer disproportionally from pressure injuries, which are harder to detect visually in darker skin tones.”
 
The 14-day efficacy portion of the single arm, bi-center study evaluated 38 patients at high risk of pressure injury development. A total of 924 scans were conducted on 154 body locations. Nurses conducting the scans were blinded to PressureSafe’s results, which were encrypted. PressureSafe detected Stage 1/ sDTI pressure injuries with 92% sensitivity and 88% specificity. Additional portions of the study evaluated safety, as well as device calibration and validation. Total data from 66 patients was obtained for safety analysis and no safety signals were identified in 1,493 scans. Based on these data, the study concluded that PressureSafe is a safe, efficient, and valuable method for early detection of pressure injuries.
 
“These data demonstrate that PressureSafe, an IR-spectroscopy scanner combined with an AI- based algorithm, provides a very good option for detection of early stage pressure injuries—hence facilitating early treatment that is crucial for prevention of complications. This is especially important in diagnosis of people with darker skin colors, where visual and tactile inspection alone may miss early detection,” stated Dr. Gal Maydan of Beit Rivka Hospital Geriatric Rehabilitation Center. “Our medical staff, including nurses, found the device very easy to use. During the study period the incidence of pressure injuries was reduced by approximately 50% compared to the same period before the study. It is time to integrate advanced technology to augment standard human visual and tactile perception in order to minimize the harmful consequences of pressure injuries. PressureSafe is a device that I can see being used for exactly this purpose.”
 
“This data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the U.S. market with PressureSafe,” IR-MED CEO Tzur Di-Cori said. “We believe the 92% efficacy findings in real-world data settings at two hospitals will be a big factor in driving adoption in the U.S. We thank Dr. Maydan and his entire team at Clalit for leading this study.” 
 
IR-MED’s PressureSafe technology advantages include: non-invasive, multi-biomarker analysis; scans for changes at tissue structure under the skin’s surface; effective for all skin tones; AI-based algorithm; real-time analysis at the point-of-care; personalized medical device; cloud based; and harmless infra-red light.
 
PressureSafe is a non-invasive medical device that uses infrared optical spectroscopy and AI to detect early-stage pressure injuries for all skin tones. Pressure injuries cost the U.S. healthcare system $26.8 billion and lead to 60,000 deaths annually. The skin-color agnostic device effectively addresses equity in healthcare by using infrared light to detect biomarker changes below the skin’s surface.
 
IR-MED Inc. is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, the first product under development, is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone as it calibrates personally to each patient’s skin. IR-MED’s technology is being developed to allow accurate readings of biomarkers in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes. The company holds patents protecting its technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.
 
PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.