Alpha Tau Medical Ltd. (NASDAQ: DRTS) treated the first patient in its U.S. pilot study for recurrent glioblastoma multiforme (GBM) at the Ohio State University Center in Columbus, Ohio, on December 9 2025. The procedure used the company’s Alpha DaRT® platform, a radium‑224–based intratumoral alpha‑particle therapy that delivers high‑dose radiation directly to the tumor while sparing surrounding brain tissue.
The treatment achieved more than 95 % coverage of the target tumor volume and was completed without any serious adverse events, confirming the safety and feasibility of the Alpha DaRT delivery system in a highly sensitive brain‑cancer setting. The pilot study will enroll up to ten U.S. patients who are not candidates for surgical resection and have previously received central‑nervous‑system radiation, with primary endpoints focused on safety and secondary endpoints on local tumor response and progression‑free survival.
Alpha Tau’s GBM program benefits from the device’s FDA Breakthrough Device Designation and its inclusion in the FDA Total Product Life Cycle Advisory Program, both of which are designed to accelerate development and review for high‑impact medical technologies. These regulatory designations signal strong confidence from the agency and provide a streamlined pathway for future clinical trials and potential market entry.
Strategically, the successful first treatment extends Alpha Tau’s Alpha DaRT platform beyond its established pancreatic‑cancer program into a new, high‑unmet‑need area. Glioblastoma is one of the most aggressive brain cancers, with an average survival of only eight months and recurrences typically occurring within six to nine months. By offering a localized, high‑dose alpha‑radiation therapy that minimizes collateral damage, Alpha Tau positions itself to address a critical therapeutic gap and potentially capture a sizable portion of the GBM market, which is currently dominated by systemic therapies with limited efficacy.
Financially, Alpha Tau reported a net loss of $30.5 million for the nine months ended September 30 2025, a rise from $22.3 million in the prior year, but the company maintained a healthy cash balance of $75.9 million. The strong cash position provides runway for continued investment in the GBM program and other ongoing trials, including pancreatic and prostate cancer studies.
CEO Uzi Sofer emphasized the clinical significance of the milestone, stating, “This is a historic day for Alpha Tau and for GBM patients worldwide. The first treatment of a brain cancer using Alpha DaRT demonstrates our platform’s potential to deliver potent, localized alpha‑radiation with a favorable safety profile in a disease that has few effective local therapies.”
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