Combat Medical HIVEC HEAT Trial Update

Combat Medical provided an update on its HIVEC HEAT FDA registration trial at The American Urological Association Annual Meeting. Professor Leyshon Griffiths, the Chief Investigator, outlined the study design and recruitment process for the phase 3, single-arm study being conducted across 25 sites in the United Kingdom, aiming to enroll 238 patients. The trial focuses on hyperthermic intravesical 80mg mitomycin C chemotherapy for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (NMIBC). The Combat bladder recirculation system (BRS) delivers chemotherapy at precisely controlled temperatures, showing promising results with up to 83% disease-free survival after one year and nearly 80% bladder preservation after two years. Edward Bruce-White, CEO of Combat Medical, emphasized the significance of this progress towards United States — Food and Drug Administration registration and the potential of BRS technology to improve bladder cancer treatment.