Alpha Tau Medical Ltd. and HekaBio K.K. announced that Japan's Pharmaceuticals and Medical Devices Agency 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. The head and neck cancer indication includes all solid tumor cancer types after prior radiation treatment, including squamous cell carcinoma, basal cell carcinoma, and melanoma.

According to the most recent registry of the Japan Society of Head & Neck Cancer, there are more than 10,000 new cases of head and neck cancers in Japan each year. Alpha Tau and HekaBio are in advanced discussions with a number of large biopharmaceutical companies regarding a potential long-term commercial partnership in Japan for this and future indications.