Alpha Tau Submits First Module Of Pre-Market Approval Application To FDA For Use Of Alpha DaRT In Treating Recurrent Cutaneous Squamous Cell Carcinoma

- Initial module submission marks an important milestone in the pre-market approval process - 

- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted -

- Module submitted in parallel to execution of ReSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 -

JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ:DRTS, DRTSW))) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA's previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application.