Rosh Pina, Israel-based IR-MED designed PressureSafe to support the early detection of pressure injuries (PI) to skin and underlying tissue.
In the study, PressureSafe demonstrated high efficacy in noninvasively detecting the presence and absence of pressure injuries below the skin. Sensitivity came in at 96% while specificity registered at 91%, IR-MED said in a news release.
Overall, the study performed 370 PressureSafe scans on 25 patients across two medical centers in Israel. These patients presented Stage 1 pressure injuries or deep tissue injuries. The study observed no device-related safety issues across a total of 44 patients evaluated for safety.
Dr. Yaniv Cohen, IR-MED chief science officer, said the company plans to conduct additional studies in the U.S. The data shared today, though, confirms the accuracy of PressureSafe combined with benefits of automated cloud-based digital storage of scan results, Cohen noted. This contributes to data-driven decision-making while saving time for the provider.
Cohen also pointed out that PressureSafe detects biomarkers below the skin’s surface. This could make it more effective at sensing pressure injuries not yet visible to the human eye.
“We believe PressureSafe can become the new standard of care in the detection of pressure injuries, and we are very pleased to share this data as we plan to file for U.S. FDA approval and subsequent market launch following regulatory clearance,” said Oded Bashan, IR-MED executive chair and interim CEO. “We believe that the healthcare economics benefits PressureSafe offers combined with the improvement in patient outcomes is a powerful combination for rapid market adoption.”
