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- IR-Med Inc. IR-Med Inc. (OTCQB: IRME) is a medical device company developing non-invasive, point-of-care decision support devices based on a patented infrared spectroscopy and artificial intelligence (AI) analysis technology platform that gathers bio-information from patient blood and tissue for real-time assessment of medical conditions. The company's core products include PressureSafe, a handheld scanner for early detection of pressure injuries (PIs) affecting skin and underlying tissue regardless of skin tone, utilizing electro-optic visual and infrared spectroscopy with AI algorithms to identify subepidermal biomarkers such as inflammation and tissue damage; and DiaSafe, a device under development for early assessment of diabetic foot ulcers (DFUs) in lower limbs through similar non-invasive optical monitoring of physiological changes before skin breakage. Additional pipeline candidates include Nobiotics, an otoscope for distinguishing bacterial from viral middle-ear infections to guide antibiotic use. IR-Med Inc. operates in the medical diagnostics and healthcare technology sectors, targeting hospitals, nursing homes, home-care providers, and high-risk patient populations such as the elderly, immobile individuals, and diabetics, with a focus on reducing PI-related costs exceeding $26.8 billion annually in the U.S. and addressing healthcare inequities in PI and DFU detection across skin tones. The company conducts its primary research, development, and headquarters operations from the ZHR Industrial Zone in Rosh Pina, Israel, where its wholly-owned subsidiary IR. Med Ltd., founded in 2013, manages day-to-day activities following a reverse acquisition in December 2020 by the Nevada-incorporated parent entity established in 2007. Recent developments include FDA listing certification for PressureSafe as a Class I exempt device on April 9, 2024, enabling commercial production and initial sales in the second half of 2025; receipt of an approximately $500,000 grant from the Israel Innovation Authority (IIA) on July 15, 2024, to advance DiaSafe development, culminating in completed milestones such as infrared light simulations by late 2025; commencement of a usability study for PressureSafe at Methodist Healthcare in San Antonio, Texas, on September 10, 2024, emphasizing efficacy across skin tones; and awards including the Netty Award for Best Up-and-Coming Health Tech Company in 2024 and Most Innovative Non-Invasive Diagnostics Technology Developer in Israel for 2023. The company holds patents such as U.S. Patent Nos. 10,709,365 and 10,772,541 protecting its noninvasive tissue analysis and continues clinical validation through studies demonstrating over 92% sensitivity and 88% specificity in PI detection.
IR-MED Ltd. Announces Launch of First-in-Human Clinical Trial of Its DiaSafe(TM) Device for Diabetic Foot Ulcer (DFU) Assessment
IR-MED's Key Clinical and Media Milestones
IR-MED Investor Update Letter - Sept-2025
IR-MED Reports Positive Interim Results from U.S. Clinical Study of PressureSafe(TM) for Pressure Injury Assessment Across Diverse Skin Tones
IR-MED Awarded $500,000 Grant from the Israel Innovation Authority to Advance AI-Powered DiaSafe(TM) Device for Diabetic Foot Ulcer Assessment
IR-MED CEO Issues Letter to Shareholders: Expanding Our Platform and Presenting New Clinical Data from Israel and the U.S.
Methodist Healthcare Adopts IR-MED's PressureSafe™ Device for Usability Study: Decision Support Device Aims to Reduce Substantial Healthcare Burden of Pressure Injuries
IR-MED Appoints Ran Ziskind, Tech Entrepreneur, Growth Manager, and Inventor as Chief Executive Officer
IR-MED Wins Prestigious Netty Award for Best Up-and-Coming Health Tech Company
IR-MED Receives $500,000 Grant from the Israel Innovation Authority to Develop its Platform Technology for the Early Detection of Diabetic Foot Ulcers
IR-MED's PressureSafe™ Reduced Pressure Injuries by 50% During a Usability Study with Clalit, Israel's Largest HMO
IR-MED's PressureSafe™ Receives FDA Listing for the Indication of Decision Support Device for Pressure Injuries
IR-MED Reports 92% Efficacy for PressureSafe™ in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries
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
IR-MED Granted Patent in Israel for its AI-Driven Platform Technology: Non-Invasive Analysis of Subcutaneous Tissue
IR-MED Appoints Healthcare Executive and Entrepreneur Tzur Di-Cori as Chief Executive Officer
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
IR-MED Appoints Richard Serbin, Esq. to its Advisory Board
IR-MED Chairman & Interim CEO Issues Letter to Shareholders
IR-MED's AI-Powered Infra-Red Spectrographic Decision Support System PressureSafe Device Demonstrates High Efficacy in Detecting Pressure Injuries with 96% Accuracy: Potential to Set a New Standard of Care