Articles from Alpha Tau Medical Ltd.

JERUSALEM, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced the achievement of Medical Device Single Audit Program (MDSAP) certification for the company’s manufacturing facility in Jerusalem, as part of the Company’s commitment to quality, safety, and regulatory compliance while accelerating the global expansion of alpha-radiation cancer therapy through the manufacturing of the Alpha DaRT.

JERUSALEM, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today 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.

- High disease control rate and strong interim safety results observed in pancreatic cancer patients across three trials exploring the use of Alpha DaRT® -

JERUSALEM, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that an abstract entitled “Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma,” submitted by principal investigators involved in the Company’s Israeli pancreatic cancer trial, has been accepted to the 2025 ASCO Gastrointestinal Cancers Symposium, to be held January 23 – 25, 2025 in San Francisco, CA. The poster will be presented during “Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract,” on January 24, 2025 at 11:30am – 1:00pm PT.

JERUSALEM, Dec. 17, 2024 (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®, announced today that following its Annual General Meeting of Company shareholders in Jerusalem, Ms. Maya Netser has been appointed to the Company’s Board of Directors (“Board”). Mr. Meir Jakobsohn is completing his term on the Board, having decided not to pursue re-election, but will continue to serve the Company in an advisory capacity.

JERUSALEM, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-emitters cancer therapy Alpha DaRT®, announced today that it has been accepted into the prestigious Total Product Life Cycle (TPLC) Advisory Program (“TAP”) Pilot of the U.S. Food and Drug Administration (“FDA”), to accelerate market access to the Alpha DaRT for patients with recurrent glioblastoma multiforme (“GBM”). This acceptance follows the Company’s previous receipt of Breakthrough Device Designation from the FDA for this indication, one of two such designations received for the Alpha DaRT, and a pre-requisite for application to the TAP program.

JERUSALEM, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel.

-Trial to focus on particularly vulnerable subset of patients, following strong clinician interest in use of the Alpha DaRT in this patient population -

The pooled analysis included data from 4 international clinical trials spanning an array of hard-to-treat indications including skin, head & neck, and oral cavity.

JERUSALEM, May 13, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that its first patient with liver cancer metastases has been treated in a feasibility and safety study of Alpha DaRT at the McGill University Health Center in Montreal, Canada.

- The overview presentation will review some of the Company’s recent achievements, including highly promising interim results from the Company’s pancreatic cancer safety and feasibility trial as well as robust long-term data analyzed across four clinical trials -

- Interim data read-out of the first five treated patients demonstrated successful delivery in all five cases, as well as no product-related Serious Adverse Events -

JERUSALEM, Nov. 20, 2023 (GLOBE NEWSWIRE) -- 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.

JERUSALEM, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that its U.S. subsidiary, Alpha Tau Medical Inc., has entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in Hudson, New Hampshire, with the intention of erecting the Company’s second U.S. manufacturing site, alongside its first site in nearby Lawrence, Massachusetts.

JERUSALEM, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that Stephen M. Hahn, M.D., former commissioner of the U.S. Food and Drug Administration (“FDA”), has joined its Scientific Advisory Board. A distinguished expert in the field of radiation oncology and translational/clinical research, and a renowned physician, Dr. Hahn brings a wealth of regulatory and scientific experience to the Company as it advances its Alpha DaRT technology towards FDA clearance.

JERUSALEM, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that a patient with advanced inoperable pancreatic cancer has been treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. The trial is designed for a broad range of solid tumor patients who do not qualify for participation in other existing trials or who do not have other treatment options according to the treating physician.

- 81 lesions treated across four feasibility trials of head and neck or skin cancers demonstrated 89% complete response rate.

-First patient treated in the feasibility and safety study of intratumoral diffusing alpha-emitters radiation therapy (Alpha DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva

JERUSALEM, May 11, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today the publication of the results of its US multicenter pilot trial in JAMA Network Open. The publication, titled “Feasibility and Safety of Diffusing Alpha-Emitter Radiation Therapy (DaRT) for Recurrent or Unresectable Skin Cancers”, can be accessed at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2804784, and was authored by clinicians from Memorial Sloan Kettering Cancer Center in New York, NY, University Cancer Centers in Houston, TX and West Cancer Center in Germantown, TN.

First patient treated in the feasibility and safety study of intratumoral diffusing alpha radiation emitters for the treatment of advanced inoperable pancreatic cancer.

-First two US patients with recurrent cutaneous squamous cell carcinoma have been treated at University Cancer Center in Houston, Texas

JERUSALEM, March 01, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that it has received authorization from Health Canada to proceed with a feasibility and safety study of Alpha DaRT in the treatment of liver metastases, subject to final approval by an institutional Research Ethics Board, which the Company expects to receive in the coming weeks. The study is planned to be conducted at the McGill University Health Center in Montreal, Canada.

JERUSALEM, Nov. 09, 2022 (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 the Company will present in person at the following investor conferences in November:

- Medicines and Healthcare products Regulatory Agency of the United Kingdom approves clinical trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge -