IR-MED Reports 92% Efficacy for PressureSafe in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries - Seite 2

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. Maydan. “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.”

Tzur Di-Cori, IR-MED’s CEO, commented, “This robust and impressive data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the U.S. market with PressureSafe. We believe the 92% efficacy findings in real-world data settings at two world-class 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.”

Yaniv Cohen, PHD, IR-MED’s CSO, added, “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. 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.”