- Following the pre-specified interim safety report and overwhelming demand from clinicians to treat patients as quickly as possible, Alpha Tau to resume recruitment immediately for the remaining seven patients in the trial - 

- Marks the latest in a series of regulatory successes in this indication, following FDA's recognition of Alpha DaRT's potential through its Breakthrough Device Designation for recurrent glioblastoma (GBM) and Alpha Tau's selection for the FDA's prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) -

- With approximately 14,000 Americans newly diagnosed with glioblastoma each year and median survival after recurrence typically measured in months, Alpha DaRT® represents a potentially transformative new treatment option for patients with highly limited alternatives –

- Two additional leading U.S. academic cancer centers are now approved to participate in the REGAIN trial, expanding geographic access and clinical expertise for this important indication -

JERUSALEM, June 11, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ:DRTS, DRTSW))) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA's review of a pre-specified interim safety report of the first three patients treated in the trial. The Company intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial.

As previously announced on May 11, 2026, interim results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure.

This clearance to continue the trial is the latest in a series of successful regulatory submissions to the FDA over more than four years with respect to exploring the use of Alpha DaRT in treating recurrent GBM. In October 2021, the Company was awarded Breakthrough Device Designation by the FDA for Alpha DaRT in recurrent glioblastoma, and in October 2024, the Company was accepted into the FDA's prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, a highly selective program designed to expedite patient access to highly promising medical devices by providing coveted access to FDA expertise and guidance throughout the device development process.

In parallel with the FDA's clearance to advance enrollment, Alpha Tau has received FDA authorization for two additional leading U.S. academic cancer centers to join the REGAIN trial as participating sites. The addition of these centers increases the geographic reach of the REGAIN trial, with the aim to broaden access for patients across the United States, and to bring additional multidisciplinary neuro-oncology expertise to the program.