Alpha Tau Medical, an Israeli medical technology company that developed breakthrough radiation cancer therapy, announced this month that it was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for the company’s Alpha DaRT solution. The designation applies to the treatment of Squamous Cell Carcinoma (SCC) of the skin and oral cavity without curative standard of care, the company indicated in a statement.
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 a device’s preliminary clinical data suggest it might be more effective than the current standard of care on clinically significant endpoints of efficacy, safety, or patient quality of life.
Alpha Tau Medical was founded in 2016 to focus on R&D and commercialization of its breakthrough cancer treatment, Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy). The technology, initially developed in 2003 by Professors Itzhak Kelson and Yona Keisari at Tel Aviv University (TAU), delivers high-precision alpha radiation that is released when radioactive substances decay inside the tumor, killing cancer cells while sparing the surrounding healthy tissue.
In late 2019, the company announced that the initial results of a preclinical trial have proved promising. The study of Alpha DaRT treatment of SCC of the skin, head and neck, in which almost 80 percent of the lesions showed a complete response, and 100 percent demonstrated a partial or complete response, alongside a mild safety profile, the company said.
Last year, it raised $26 million in a Series B round and said it was conducting clinical trials in multiple clinical oncology indications, including its first US trial at Memorial Sloan Kettering Cancer Center in New York, a pancreatic cancer trial at CHUM (Centre hospitalier de l’Université de Montréal) in Montreal, and trials at three academic institutions in Japan. The company had also indicated that it was establishing new global manufacturing facilities in Israel.
“The FDA’s recognition of the Alpha DaRT as a Breakthrough Device is a tremendous milestone for the company, as we seek to bring our revolutionary technology to patients in need,” said Alpha Tau CEO Uzi Sofer in the company statement. “This confirms our long-standing hopes and expectations for this product, and comes at the perfect time to accelerate our clinical trial program that is moving ahead rapidly now in the US.”
Alpha Tau Chief Medical Officer Dr. Robert Den added, “This achievement was the result of the dedication and hard work of the entire Alpha Tau team. While we are motivated by our mission to help every patient possible, it is exciting and gratifying to see external recognition of our vision of clinical excellence.”