IR-MED’s PressureSafe Receives FDA Listing for the Indication of Decision Support Device for Pressure Injuries

• Marks major milestone prior to launch in U.S. market
• PressureSafe scanner and disposable pack both listed with FDA
• PressureSafe can support early detection of pressure injuries, potentially setting a new standard of care to address a healthcare challenge that costs $26.8 billion annually in the U.S. alone
  

Rosh Pina, Israel, April 05, 2024 (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, today announced its PressureSafe decision support device has received U.S. Food and Drug Administration (FDA) listing or the indication of pressure injuries. PressureSafe is classified as a Class I device and is exempt from 510(k) premarket submission.

PressureSafe uses infra-red spectroscopy combined with an AI-based algorithm for the early, non-invasive, and skin color agnostic detection of pressure injuries with real-time analysis at the point of care.

“This regulatory milestone is a major step towards the commercial launch in the U.S. and signifies our commitment to advancing patient care and safety through cutting-edge medical devices,” stated Ronnie Klein, IR-MED’s CTO and Interim CEO. “Following our successful usability studies for PressureSafe in Israel, we are expanding these studies into the U.S. and expect to commence with a major hospital network in 2024.”

PressureSafe achieved 92% efficacy in the early, non-invasive detection of pressure injuries, regardless of skin color, in a study conducted in Israel with the world’s second largest HMO, Clalit. Nearly 1,500 scans were performed on 154 body locations.

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.

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products.

About IR-MED

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.