IR-MED Ltd. Announces Launch of First-in-Human Clinical Trial of Its DiaSafe(TM) Device for Diabetic Foot Ulcer (DFU) Assessment

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].