[author: Steven Friedland]

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous tumors.  On October 8, 2021, Alpha Tau announced that it received FDA Breakthrough Device Designation for using Alpha DaRT to treat recurrent glioblastoma multiforme (GBM).  GBM is an aggressive, often incurable form of cancer responsible for malignant brain tumors.

According to the FDA, the goal of its Breakthrough Devices Program is to “provide patients and health care providers with timely access to [] medical devices by speeding up their development, assessment, and review.”

In a press release, Alpha Tau CEO Uzi Sofer stated:

“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.”

Alpha DaRT works by first inserting a “seed” into a cancerous tumor.  The seed then releases high-energy alpha particles that destroy the tumor while sparing the healthy tissue around it.

This is the second FDA Breakthrough Device Designation Alpha Tau has received.  In June 2021, Alpha Tau announced the FDA’s designation of Alpha DaRT for treating squamous cell carcinoma, a type of skin cancer.