Core Insights - IR-MED Ltd. has launched its first-in-human clinical trial for the DiaSafe™ device, aimed at diabetic foot ulcer (DFU) assessment, marking a significant advancement in the field of diabetic care [1][2]. Company Overview - IR-MED Ltd. specializes in developing AI-driven, non-invasive infrared spectrographic medical devices, with a focus on improving patient outcomes through innovative technology [1][8]. - The company’s first product, PressureSafe™, is designed to assess pressure injuries and is built on the same technology platform as DiaSafe™ [8]. Clinical Trial Details - The clinical trial will be led by Prof. Aviram Nissan, a respected figure in surgical clinical research, emphasizing the collaboration's goal to enhance patient outcomes by detecting early indicators of tissue damage in diabetic patients [3]. - The DiaSafe™ device aims to provide real-time optical readings of tissue and blood biomarkers, allowing for early intervention before visible skin breakdown occurs [6]. Market Potential - The global DFU treatment market is estimated to be approximately $10 billion, highlighting the urgent need for effective solutions in this area [5][6]. - DFUs affect 19%-34% of the 537 million people living with diabetes worldwide, translating to around 183 million individuals over their lifetime, with significant risks of complications such as amputations and mortality [6].

Core Insights - IR-MED Inc. is advancing towards commercial operations with significant milestones achieved in its product development and clinical trials [1][6][10] Financial Aspects - As of June 30, 2025, the company requires additional funding to support its operational and strategic actions [1] - The company is actively pursuing various financing avenues to secure the necessary funding [1] Product Development - PressureSafe™, an AI-powered device for assessing pressure injuries, is now FDA-listed, allowing for commercial entry into the U.S. market [6][18] - The device has shown 94% sensitivity in initial clinical trials, with a focus on improving outcomes for patients with darker skin tones [6][8] - DiaSafe™, another product aimed at diabetic foot ulcers, has received a $500K grant from the Israel Innovation Authority to support its clinical advancement [6] Clinical Trials - The first stage of the PressureSafe™ trial involved 786 scans across 163 anatomical sites, with 61% of participants having darker skin tones [6] - A second stage of the trial has been initiated, expected to take up to 6 months [6] Market Strategy - The company aims to secure pilot programs in various healthcare settings across the U.S. in the first half of 2026 as part of its go-to-market strategy [9] - Collaborations with respected medical care networks are being pursued to enhance growth and long-term value [10] Strategic Goals - Uplisting to a major stock exchange, such as NASDAQ or NYSE, remains a top strategic priority for the company [11] - The company plans to pursue uplisting after raising additional capital and achieving key product development milestones [12][13] Market Positioning - The current market valuation of IR-MED is viewed as misaligned with its actual stage and potential, prompting a strategic approach to investor relations [14] - The company emphasizes the importance of visibility and consistent market engagement to improve its positioning [14]