Jerusalem, November 20, 2023 — Alpha Tau Medical Ltd. (“Alpha Tau”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, and HekaBio K.K. (“HekaBio”) a Japan-based healthcare investment, development and commercialization platform which is partnered with Alpha Tau, announced today 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.

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