Zacks Small Cap Research – IRME: IR-Med’s positive safety and efficacy data from recent PressureSafe study supports price target of $3.00. – Technologist

By Thomas Kerr, CFA

OTC:IRME

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New Clinical Efficacy Data for Detection of Pressure Injuries

On February 20, 2024, the IR-Med (OTC:IRME) announced highly favorable proof of efficacy data for PressureSafe, its decision support device which uses infra-red spectroscopy combined with an AI-based algorithm for the early, non-invasive, and skin color agnostic detection of pressure injuries.

Data from the study was collected at two medical centers owned by Clalit, the world’s second largest health maintenance organization and the largest in Israel, Beit Rivka Hospital and Rabin Medical Center. The results were presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference on February 16 and 17, 2024 in San Antonio, Texas. Dr. Gal Maydan of Beit Rivka Hospital Geriatric Rehabilitation Center, and Principal Investigator of the study, presented the data in a poster titled “Near Infra-Red Spectroscopy for early detection of stage 1 pressure injury and deep tissue injury – clinical study results”.

While the current standard of care for the detection of pressure injuries is visual and tactile clinical evaluation, physiological changes below the skin’s surface, including inflammation and interstitial fluids precede changes on the surface. The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to the current standard of care. PressureSafe detected biomarkers and changes in tissue structures under the skin’s surface as they relate to pressure injuries.

The 14-day efficacy portion of the single arm, bi-center study evaluated 38 patients at high risk of pressure injury development. A total of 924 scans were conducted on 154 body locations. Nurses conducting the scans were blinded to PressureSafe’s results, which were encrypted. PressureSafe detected Stage 1 / sDTI pressure injuries with 92% sensitivity and 88% specificity. Additional portions of the study evaluated safety, as well as device calibration and validation. Total data from 66 patients was obtained for safety analysis and no significant safety signals were identified in 1,493 scans. Based on this data, the study concluded that PressureSafe is a safe, efficient, and valuable method for early detection of pressure injuries.

Dr. Maydan stated, “This data demonstrates that PressureSafe, an IR-spectroscopy scanner combined with an AI- based algorithm, provides a very good option for detection of early stage pressure injuries – hence facilitating early treatment that is crucial for prevention of complications. This is especially important in diagnosis of people with darker skin colors, where visual and tactile inspection alone may miss early detection. Our medical staff, including nurses, found the device very easy to use. During the study period the incidence of pressure injuries was reduced by approximately 50% compared to the same period before the study. It is time to integrate advanced technology to augment standard human visual and tactile perception in order to minimize the harmful consequences of pressure injuries. PressureSafe is a device that I can see being used for exactly this purpose.”

Tzur Di-Cori, IR-MED’s CEO, also commented, “This robust and impressive data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the U.S. market with PressureSafe. We believe the 92% efficacy findings in real-world data settings at two world-class hospitals will be a big factor in driving adoption in the U.S. We thank Dr. Maydan and his entire team at Clalit for leading this study.”

The company plans to start a usability study for PressureSafe in the U.S. in collaboration with Methodist Healthcare of San Antonio in the coming months. This study aims to enroll approximately 50% of patients with darker skin tones in order produce comparative data for PressureSafe’s accuracy as a decision support device in people with lighter and darker skin tones. Published studies show black patients in the U.S. suffer disproportionally from pressure injuries, which are harder to detect visually in darker skin tones.

Other News

➢ On December 3, 2023, the company announced it has been granted a patent titled “System and method for noninvasive analysis of tissue” from the State of Israel Patent Office. This follows a similar patent granted in the U.S. and other patent applications pending in key markets including the European Union.

The patent addresses IR-MED’s platform technology, a method for noninvasive analysis of subcutaneous tissue. The method irradiates the surface of the tissue with infrared radiation (IR) in spectral bands that are strongly absorbed or scattered by tissue chromophores like water. The intensity of the radiation in each of the spectral bands emerging from the tissue is measured and then compared by an algorithm that produces data-driven support for the diagnostic assessment of subcutaneous tissue.

➢ On September 26, 2023, the company announced that it had 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.

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, which is expected to produce 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.

Valuation and Estimates

There are no changes to our revenue and earnings estimates at this time as we await the release of the company’s 4th quarter and full year 2023 results. We are maintaining our price target of $3.00 per share.

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