Israeli medical company Alpha Tau Medical Ltd. announced today that it has completed enrollment of all 88 patients for its U.S. multicenter pivotal clinical trial (ReSTART) evaluating the novel radiotherapy Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). This marks a significant step forward for the therapy toward obtaining Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA).

The ReSTART trial is a prospective, multicenter, single-arm, open-label study. Enrolled patients are all biopsy-confirmed cases of recurrent cSCC for whom prior first-line standard treatments have failed and who are not candidates for surgery, conventional radiotherapy, or curative systemic therapy. The study's co-primary endpoints are set as Objective Response Rate (ORR) and Duration of Response (DOR) sustained for six months from the initial observation of response. With the completion of enrollment, the study has now formally transitioned into the follow-up and data collection phase.

Cutaneous squamous cell carcinoma is the second most common type of skin cancer globally. For recurrent cases not controlled by traditional surgery or conventional therapies, there is a significant unmet clinical need. The Alpha DaRT therapy is designed to provide localized treatment through a targeted intratumoral radiation mechanism. Currently, the therapy has received the "Breakthrough Device" designation from the U.S. FDA for the treatment of recurrent cSCC. Based on prior clinical data accumulated in Israel, Italy, France, and the U.S., Alpha Tau formally initiated a modular PMA application process in January 2026 and has submitted the first application module.

Alpha Tau CEO Uzi Sofer stated that completing patient enrollment for this U.S. pivotal trial is a core step in advancing the therapy toward commercialization. He emphasized that multi-year, multinational clinical evidence has preliminarily validated the efficacy of the intratumoral radiotherapy approach, laying the groundwork for subsequent expanded indications research and development.

The company's Chief Medical Officer, Robert B. Den, and Vice President of Clinical Affairs, Liron Dimnik, noted that the ReSTART study is the most rigorous clinical evaluation of the Alpha DaRT therapy conducted to date. The next step involves the research team leveraging the multicenter collaboration network to strictly control data quality and protocol compliance during the follow-up period, thereby continuing to advance the product's regulatory approval process.