IR-MED’s PressureSafe™ Reduced Pressure Injuries by 50% During a Usability Study with Clalit, Israel’s Largest HMO

Rhea-AI Summary

IR-MED has published positive results from a usability study of its PressureSafe™ device, performed in collaboration with Clalit, Israel's largest HMO. The study, which included 924 scans on 154 body locations, demonstrated that PressureSafe™ could reduce pressure injuries by 50%. The device achieved 92% sensitivity and 88% specificity in detecting Stage 1 and suspected deep tissue injury pressure injuries. PressureSafe™, which uses AI-driven infra-red spectroscopy, has received FDA listing confirmation. The findings were also presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference.

Positive

• PressureSafe™ reduced pressure injuries by 50% during the study.
• Device achieved 92% sensitivity and 88% specificity.
• Received FDA listing confirmation for pressure injuries.
• Collaboration with Clalit, the largest HMO in Israel.
• Presented findings at NPIAP 2024 Annual Conference.
• Studied 924 scans on 154 body locations.

Negative

• Nurses did not see real-time results during scans, which may affect usability feedback.
• No financial data or market impact analysis provided.

Poster presentation available here: LINK

Rosh Pina, Israel, May 22, 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, which addresses significant healthcare needs, today published a poster presentation on its website titled “Near Infra-Red Spectroscopy scanner for early detection of stage 1 pressure injury and deep tissue injury – clinical study results”, which includes data that was presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference in San Antonio, Texas. The poster was also recently shared by Clalit Innovation, which described PressureSafe^™ as a “Breakthrough in pressure ulcer diagnosis…” and “Truly groundbreaking impact of an innovative tool!”.

PressureSafe^™ is a decision support device that has received U.S. Food and Drug Administration (FDA) listing confirmation for the indication of pressure injuries. 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.

IR-MED conducted a usability study in conjunction with two medical centers owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest HMO in Israel. A total of 924 scans were conducted on 154 body locations. Nurses conducting the scans did not see the PressureSafe^™’s results in real time as the results were coded to. PressureSafe^™ detected Stage 1 / suspected deep tissue injury (sDTI) pressure injuries with 92% sensitivity and 88% specificity. During the study period, the incidences of pressure injuries were reduced by 50% in comparison to the levels prior to the study.

“We believe that it is a truly remarkable result that the use of PressureSafe^™ reduced the incidences of pressure injuries significantly in the hospital setting. We are proud of this achievement, as we see the benefits of our innovation make an impact on the quality of life and health of people at risk of pressure injuries,” stated IR-MED’s Chief Technology Officer and Interim Chief Executive Officer, Ronnie Klein. “We are pleased that the people leading innovation at Clalit have recognized and praised these results. We are honored to work with global leaders that are advancing breakthroughs in healthcare.”

In the U.S. alone, 60,000 patients die every year as a direct result of pressure injuries. Patient care costs 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.

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.

IR-MED’s technology is being developed to allow readings of biomarkers in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes.

IR-MED holds patents protecting its technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.

Safe Harbor Statement / Forward-Looking Statements

Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For example, IR-Med is using forward-looking statements when it discusses the potential benefits from its PressureSafe product on the quality of life and health of people at risk of pressure injuries. Statements relating to the future performance of IR-Med are subject to many factors including, but not limited to, the sufficiency or working capital and our ability to raise the capital needed to fund our development efforts, completion of the development and design of PressureSafe device, results of clinical/useability studies and trials, timing of product development, FDA approval/clearance of products in development, customer acceptance of our products in the market, the introduction of competitive products, the impact of any product liability or other adverse litigation, commercialization and technological difficulties, and the other risks identified in our most recent annual report on Form 10-K/A filed on April 8, 2024 with the Securities and Exchange Commission. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.

Contact:
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

Attachment

• IR-Med, Inc.

FAQ

What is the effect of IR-MED's PressureSafe™ on pressure injuries?

IR-MED's PressureSafe™ reduced pressure injuries by 50% during a usability study.

How accurate is PressureSafe™ in detecting pressure injuries?

PressureSafe™ demonstrated 92% sensitivity and 88% specificity in detecting Stage 1 and suspected deep tissue injury pressure injuries.

Has PressureSafe™ received any regulatory approval?

Yes, PressureSafe™ has received FDA listing confirmation for the indication of pressure injuries.

Which organization collaborated with IR-MED on the PressureSafe™ study?

IR-MED collaborated with Clalit, the largest HMO in Israel, for the PressureSafe™ study.

Where were the results of the PressureSafe™ study presented?

The results were presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference.

How many scans were conducted in the PressureSafe™ usability study?

A total of 924 scans were conducted on 154 body locations during the usability study.