Full Press Release Details
Alpha Tau Announces FDA
Approval of IDE Supplement to Expand Pilot Trial of Alpha DaRT to Thirty Patients with Pancreatic Cancer in Two Cohorts,
with Locally Advanced or Metastatic Disease
JERUSALEM, February 3rd,
2025 -- Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative
alpha-radiation cancer therapy Alpha DaRT , announced
today an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption
(IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha
DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical
trial to a broader group of pancreatic cancer patients.
The IDE supplement allows the Company to include an
additional cohort for locally advanced pancreatic cancer patients, and to increase the number of each cohort to 15 patients, for a total
of 30 patients across the two cohorts, at up to 10 U.S. clinical trial sites.
Alpha Tau CEO Uzi Sofer commented, "Following
the incredible data that we released last week, analyzing disease control and overall survival in pancreatic cancer patients treated with
Alpha DaRT, we welcome the news of this IDE supplement as we continue to move forward, full steam ahead, in our efforts to explore a new
treatment for patients with this deadly disease as quickly as possible."
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau 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.
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
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 7, 2024, 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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