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JERUSALEM, June 8, 2021 / PRNewswire / – Alpha Tau Medical, the developer of the pioneering alpha radiation cancer therapy Alpha DaRT,MT is pleased to announce that it has received a breakthrough device designation for Alpha DaRT from the United States Food and Drug Administration (FDA). This designation applies to the treatment of squamous cell carcinoma of the skin and oral cavity without a standard of curative care.
“The FDA’s recognition of Alpha DaRT as a breakthrough device is a milestone for the company as we seek to bring our breakthrough technology to patients in need,” said Alpha Tau CEO. Uzi sofer. “This confirms our long-held hopes and expectations for this product and comes at the perfect time to accelerate our rapidly advancing clinical trials program in the United States.”
Alpha Tau Chief Physician Dr. Robert den added, “This achievement is the result of the dedication and hard work of the entire Alpha Tau team. While we are driven by our mission to help every possible patient, it is exciting and rewarding to see external recognition of our vision of clinical excellence. “
Breakthrough Device is a category designed by the FDA to speed up the review process and facilitate the development of clinical trials of devices that treat life-threatening conditions. The designation is awarded when preliminary clinical data for a device suggests that it may be more effective than the current standard of care on clinically significant endpoints of patient efficacy, safety, or quality of life. In addition, to accelerate access to new essential medical technologies, a Medicare coverage path called Medicare Coverage of Innovative Technologies is expected to provide breakthrough devices from the FDA with Medicare coverage for 4 years after the drug has been approved to market. FDA.
Alpha Tau has submitted data to the FDA supporting this designation, including a pilot clinical study of Alpha DaRT treatment for SCC of the skin, head and neck, in which nearly 80% of lesions showed a complete response and 100% demonstrated a complete response, with a moderate safety profile.
In preclinical studies using Alpha DaRT, a response was observed in all solid tumors tested, including pancreatic, lung, breast and prostate tumor cells. These and other cancers will be studied in the Alpha DaRT clinical trials program, which includes a skin cancer feasibility trial currently underway at Memorial Sloan Kettering Cancer Center in new York and other sites in the United States
About Alpha Tau Medical, Ltd.
Founded in 2016, Alpha Tau Medical Ltd, is an Israeli oncology therapy company focused on the research, development and commercialization of Alpha DaRT ™ technology for the treatment of solid tumors.
Alpha DaRT ™ (Diffusing Alpha-Emitters Radiation Therapy) is an innovative technology that enables the unique highly potent and conformal alpha irradiation of solid tumors. The treatment is administered by intratumoral insertion of Radium-224, which allows the release and diffusion of alpha emitting radioisotopes, releasing alpha particles that can destroy the tumor. Since alpha emitting atoms only diffuse a short distance, Alpha DaRT primarily affects the tumor and may spare the healthy tissue around it.
Contact:
Amnon Gat
Phone. : +1 833-455-3278
[email protected]
Media package: https://www.dropbox.com/sh/4wtkdggbyatxyly/AACobJHTz_OD2dNE3Z0cYKc1a?dl=0
SOURCE Alpha Tau Medical
