DRTS · Alpha Tau Medical Ltd.

Alpha Tau's completion of patient enrollment in the ReSTART trial marks a critical milestone as the company's first U.S. pivotal study, positioning it closer to potential FDA pre-market approval for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma, the second most common skin cancer with rising incidence and unmet needs for patients exhausted by surgery and conventional options. The prospective, multicenter, single-arm study enrolled 88 patients who failed first-line therapy and lack curative alternatives, with co-primary endpoints of objective response rate and six-month duration of response, alongside secondary measures like progression-free survival and overall survival at one year. This builds directly on foundational clinical evidence from skin cancer studies in Israel, Italy, France, and a U.S. pilot, where hundreds of tumors showed promising efficacy and safety. The FDA's Breakthrough Device Designation accelerates review, complemented by the January 2026 submission of the first modular PMA module. CEO Uzi Sofer highlighted this as a 'watershed moment' foundational to Alpha Tau's strategy since skin cancer was Alpha DaRT's initial application, while Chief Medical Officer Robert B. Den and VP Clinical Affairs Liron Dimnik praised the rigorous 88-patient evaluation and operational execution across U.S., Israel, and Canada sites. Transitioning to follow-up and data maturation now sets the stage for endpoint assessments supporting commercialization in this underserved population.