Alpha Tau receives FDA nod for brain tumor device

Alpha DaRT has received FDA breakthrough designation for the treatment of patients with recurrent glioblastoma multiform (GBM).


Israeli alpha-radiation cancer therapy developer Alpha Tau Medical has announced that it has that it has received Breakthrough Device Designation for Alpha DaRT from the US Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiform (GBM). This is the second Breakthrough Device Designation that Alpha Tau has received from the FDA, following its announcement in June of the receipt of the designation for the treatment of skin cancer without curative standard of cure.

GBM is an aggressive malignant brain tumor, with an average 5-year survival rate of less than 10%, and is the most common malignant tumor of the brain or central nervous system. According to the designation, Alpha DaRT is proposed 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 centers 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.”

In July Alpha Tau agreed a SPAC merger with Healthcare Capital Corp. (Nasdaq: HCCC), which will see it listed on Wall Street before the end of the year at a company valuation of nearly $1 billion. Healthcare Capital Corp. has raised $275 million and a further $92 million is being raised in PIPE funding to support the merger.

Published by Globes, Israel business news – – on October 11, 2021