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Alpha Tau Medical, an Israeli medical technology company that has developed breakthrough radiation therapy for cancer, announced this month that it has achieved breakthrough device designation from the U.S. Food and Drug Administration (FDA) for the Alpha DaRT solution from the society. The designation applies to the treatment of squamous cell carcinoma (SCC) of the skin and oral cavity without a standard of curative care, the company indicated in a report.
The FDA’s breakthrough device designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. 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.
Alpha Tau Medical was founded in 2016 to focus on the R&D and commercialization of its breakthrough cancer treatment, Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy). The technology, originally developed in 2003 by Professors Itzhak Kelson and Yona Keisari of Tel Aviv University (TAU), delivers high-precision alpha radiation that is released when radioactive substances decay inside the tumor, killing cancer cells while sparing surrounding healthy tissue.
At the end of 2019, the company announced that the first results of a preclinical trial were showing promise. The Alpha DaRT treatment study of SCC of the skin, head and neck, in which nearly 80 percent of the lesions showed a complete response and 100 percent demonstrated a partial or complete response, as well as a moderate safety profile, the company said.
Last year, she raised $ 26 million in a Series B funding round and said she is conducting clinical trials in several clinical oncology indications, including her first U.S. trial at Memorial Sloan Kettering Cancer. Center in New York, a trial on pancreatic cancer at the CHUM (Center hospitalier de l’Université de Montréal) in Montreal, and trials in three academic institutions in Japan. The company also said it was setting up new global manufacturing facilities in Israel.
“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 Uzi Sofer, CEO of Alpha Tau , in the company press release. “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 Medical Officer 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 all possible patients, it is exciting and rewarding to see external recognition of our vision of clinical excellence.
