Alpha Tau Medical Receives FDA Approval For Investigational Device Exemption Supplement To Expand Its U.S. REGAIN Study

Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement expanding its U.S. REGAIN (Recurrent Glioblastoma Alpha DaRT Intratumoral Therapy) trial. The Company also announced that an abstract has been accepted for presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), to be held November 12 - 15, 2026, in Philadelphia.

Under the approved supplement, REGAIN can now enroll up to 20 patients, up from the previously approved 10 patients, at the three U.S. academic cancer centers authorized to participate. Based on initial discussions, the Company believes that the expanded trial could generate additional data on the use of Alpha DaRT to treat recurrent glioblastoma, which may support market submission requirements for Alpha DaRT in patients with this disease.