IR-MED to Conduct Usability Study with Methodist Healthcare of San Antonio for its PressureSafe Device Which is Slated for U.S. Launch in H1 2024

• Study to address the substantial challenge of healthcare inequality in the early detection of pressure injuries in people of dark skin tones
• PressureSafe, a skin-color agnostic decision support device, uses AI and infrared light to see beneath skin’s surface to detect biomarkers of pressure injury
• Interim results from a usability study in Israel indicate PressureSafe identified early-stage pressure injuries with 96% accuracy
  

Rosh Pina, Israel, Sept. 26, 2023 (GLOBE NEWSWIRE) -- IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, announced today 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.