IR-MED Inc. announced it has signed a Clinical Trial Agreement with the Methodist Healthcare System of San Antonio to conduct a useability study titled ?Safety and Efficacy of the PressureSafe Device for Early Detection of Pressure Injury in People with Various Skin Tones, Including Dark Skin Tones.? Methodist Healthcare is recognized as the most respected healthcare provider in its region. With a network of 85 hospitals, 9 of which are acute care facilities, Methodist Healthcare employs more than 11,000 people, including 2,700 physicians.

Approximately 50% of subjects recruited for the upcoming study will have dark skin tone, thus producing comparative data on PressureSafe?s accuracy as a decision support device in detecting early-stage pressure injuries in people of darker and lighter skin tones. While early stage pressure injuries can be more difficult to see on dark skin tones, the current standard of care for the detection of pressure injuries is visual skin inspection. Research shows that people with dark skin tones suffer from pressure injury at more than twice the rate of those with lighter skin tones, as characterized by higher pressure injury rates, higher risks of mortality from pressure injuries, and more severe pressure injuries.

According to a study published in September 2023 in Advances in Skin & Wound Care, among all racial and ethnic groups in the U.S., black patients had the highest prevalence of the most severe pressure injuries while white patients had the lowest. The peer-reviewed study goes on to state that due to increasing racial diversity in the U.S., including persons of mixed ethnic and racial backgrounds, there is an urgent need for improved techniques to identify and treat developing pressure injuries earlier. In the U.S. alone, 60,000 patients die every year as a direct result of pressure injuries.

Patient care cost per pressure injury ranges from $20,900 up to $151,700, for the 2.5 million patients per year who develop pressure injuries. Pressure injuries are one of the five most common harms experienced by patients and the second most common claim for lawsuits after wrongful death. IR-MED?s prior usability study for PressureSafe was conducted at two hospitals in Israel owned by Clalit, the world?s second largest health maintenance organization (HMO).

Interim results demonstrate PressureSafe detected pressure injuries with 96% sensitivity and 91% specificity. Final results are expected by the end of 2023.