IR-MED to Report New Clinical Efficacy Data for Detection of Pressure Injuries with its AI- Based PressureSafe™ Device at NPIAP 2024 Annual Conference on February 16

Final results to be reported from a study conducted at two medical centers owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest in Israel
PressureSafe, for the detection of pressure injuries, addresses a healthcare challenge that costs $26.8 billion and causes 60,000 deaths annually in the U.S. alone

Rosh Pina, Israel, Feb. 13, 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, announced today that final data from a study conducted at two medical centers, Beit Rivka Hospital, and Rabin Medical Center, both in Petah Tikva and owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest in Israel, will be presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference which will take place in San Antonio, Texas on February 16-17, 2024. The study’s Principal Investigator, Dr. Gal Maydan, of Beit Rivka Hospital Geriatric Rehabilitation Center, will present 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”.

The single arm, bi-center, open label, safety and efficacy study evaluated PressureSafe ^™, IR-MED’s decision support device, which uses infra-red spectroscopy combined with an AI-based algorithm to diagnose Stage 1 pressure injuries, compared to standard of care visual and tactile inspection.

IR-MED’s clinical and execute team will demonstrate PressureSafe at booth #102 at NPIAP 2024, which is attended by the world’s top thought leaders and practitioners in the prevention and treatment of pressure injuries.

“We are eager to share the results coming out of this collaborative study with Clalit, where real-world data was gathered at two hospitals, with hundreds of PressureSafe scans conducted on patients by hospital nurses and staff. We are grateful to the entire team at Clalit and to Dr. Gal Maydan for leading the study,” stated Tzur Di-Cori, IR-MED’s CEO. “PressureSafe’s non-invasive, skin color agnostic approach to detecting early-stage pressure injuries has the potential to significantly diminish the incidence pressure injuries and corresponding human suffering and medical costs.”

PressureSafe, an innovative non-invasive medical device that uses infrared optical spectroscopy and an AI-based algorithm, is designed to effectively detect early-stage pressure injuries for all skin tones. Pressure injuries cost the U.S. healthcare system $26.8 billion and lead to 60,000 deaths annually. PressureSafe was found to be over 90% accurate in detecting pressure injuries based on interim results from a multicenter study. Since Infra Read is agnostic to skin color the device shall effectively address equity in healthcare by using infrared light to detect biomarker changes below the skin’s surface.

About IR-MED

IR-MED Inc. is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professionals 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 accurate 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 that final data from its study conducted at two medical centers, Beit Rivka Hospital and Rabin Medical Center, will be presented at the NPIAP 2024; that PressureSafe’s non-invasive, skin color agnostic approach to detecting early-stage pressure injuries has the potential to significantly diminish the incidence pressure injuries and corresponding human suffering and medical costs. 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 filed on March 29, 2023 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