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Devices Oncology FDA

 News Release - October 8, 2021

Alpha Tau Receives FDA's Breakthrough Device Designation for the Treatment of Recurrent GBM

JERUSALEM, Oct. 8, 2021 -- (Healthcare Sales & Marketing Network) -- Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiforme (GBM). This is the second Breakthrough Device Designation that Alpha Tau has received from the FDA, following its announcement on June 8, 2021 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.

"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," said Alpha Tau CEO Uzi Sofer. "This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world."

About Breakthrough Device Designation

Breakthrough Device is a category designed by the FDA to expedite the review process and to facilitate the clinical trial development of devices that treat life-threatening conditions. 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.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors. The treatment is delivered by intratumoral insertion of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the source and disperse while emitting high-energy alpha particles that destroy the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT mainly affects the tumor, sparing the healthy tissue around it.

About Alpha Tau Medical, Ltd.

Founded in 2016, Alpha Tau Medical Ltd. is an Israeli medical device company that focuses on research, development, and commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; its limited operating history; its incurrence of significant losses to date; its need for additional funding and ability to raise capital when needed; its limited experience in medical device discovery and development; its dependence on the success and commercialization of the Alpha DaRT technology; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to enroll patients in its clinical trials; undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its Alpha DaRT technology; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's Registration Statement on Form F-4 dated August 19, 2021 and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.


Source: Alpha Tau Medical

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