Research & Development
Alpha Tau Medical's Alpha DaRT granted US FDA Breakthrough Device Designation
11 October 2021 -

Alpha Tau Medical, an Israel-based company that develops alpha-radiation cancer therapy Alpha DaRT, announced on Friday that the United States Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Alpha DaRT intended for the treatment of patients with recurrent glioblastoma multiforme (GBM).

According to the designation, the product is intended for use in treating recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted.

Alpha Tau CEO Uzi Sofer, said, 'As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA's Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centres in the U.S. and across the world, and to bring new hope for GBM patients. I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things. This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.'



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