Alpha Tau Medical Submits Pre-Market Approval Application for Alpha DaRT to FDA

Alpha Tau Medical announced the submission of the first module of its pre-market approval application to the U.S. Food and Drug Administration, 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 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, Alpha Tau said. Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program to accelerate market access for the potential treatment of recurrent GBM.