On February 3, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients (Press release, Alpha Tau Medical, FEB 3, 2025, View Source [SID1234649991]).

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The IDE supplement allows the Company to include an additional cohort for locally advanced pancreatic cancer patients, and to increase the number of each cohort to 15 patients, for a total of 30 patients across the two cohorts, at up to 10 U.S. clinical trial sites.

Alpha Tau CEO Uzi Sofer commented, "Following the incredible data that we released last week, analyzing disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT, we welcome the news of this IDE supplement as we continue to move forward, full steam ahead, in our efforts to explore a new treatment for patients with this deadly disease as quickly as possible."