Alpha Tau submits to Japanese PMDA for pre-market approval of Alpha DaRT

Alpha Tau Medical announced that Japan’s Pharmaceuticals and Medical Devices Agency, PMDA, has accepted Alpha Tau’s submission requesting shonin pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice in Japan. This submission is based upon Alpha DaRT’s clinical trial results in Japan which exceeded the target endpoints for safety and efficacy in patients with recurrent head and neck cancer. Uzi Sofer, CEO of Alpha Tau, noted, “We identified Japan as an important strategic market and initiated a local clinical trial early on in our clinical development, and we are excited that this trial has not only met but exceeded its endpoints. We are working on all necessary preparations ahead of potential approval and commercialization, while continually considering other indications for initiating clinical trial investigation in Japan based on the specific patient needs there.”