Full Press Release Details
Alpha Tau Receives FDA Approval to Initiate
a Trial for Patients with Recurrent Glioblastoma
JERUSALEM, April 2, 2025 - Alpha Tau Medical
Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT , announced today
that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients
with recurrent glioblastoma (GBM) using the Alpha DaRT technology.
"This is very exciting news for patients
suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial,
we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are
not amenable to surgery," said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. "According to the National Brain Tumor
Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of
The clinical trial is expected to enroll up to
ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous
system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment following the Company's
promising results from pre-clinical studies.
"This IDE approval follows the FDA's
continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received
the FDA's Breakthrough Device Designation, followed by acceptance into the FDA's prestigious Total Product Life Cycle Advisory
Program to accelerate the Alpha DaRT treatment to market and to the GBM patients who may stand to benefit greatly," added Alpha
Tau Chief Executive Officer Uzi Sofer.
Alpha DaRT (Diffusing Alpha-emitters
Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224
impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy
alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims
to mainly affect the tumor, and to spare the healthy tissue around it.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau Medical Ltd. ("Alpha Tau",
or the "Company") is an Israeli oncology therapeutics company that focuses on research, development, and potential 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: (i) Alpha Tau's ability to receive regulatory
approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history;
(iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise
capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence
on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical
studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict
future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused
by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement
lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's
listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important
factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on
March 12, 2025, 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 its 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.
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