Full Press Release Details
Alpha Tau Announces Receipt of Radioactive License to Allow Production
in Main Manufacturing Floor at its Jerusalem Site, Amended Radioactive License with Increased Capacity at Lawrence, MA Site
JERUSALEM, June 16, 2022 /PRNewswire/ -- Alpha Tau Medical Ltd.
(Nasdaq: DRTS) ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy
Alpha DaRT , today announced that the Israeli Ministry of Environmental Protection has granted the Company an active radioactive
license for use and possession of Thorium-228 and Radium-224, radioactive materials which are utilized in the production of the Alpha
DaRT sources, in the main manufacturing floor of the Company's production facility in Jerusalem. This license will enable the Company
to shift production from a smaller, ancillary installation at the site, to the main manufacturing floor, thereby achieving a nearly 3x
increase in production capacity, to yield approximately 90,000 Alpha DaRT sources per year. As the Jerusalem site has been designed to
support production of up to 400,000 sources per year, the Company anticipates applying in the future for additional increases to the radioactive
license, in order to further expand its production capacity and fully utilize the Jerusalem facility.
In addition, the Company is also pleased to announce that the Radiation
Control Program of the Department of Public Health of the Commonwealth of Massachusetts has amended the license previously issued to Alpha
Tau's subsidiary, Alpha Tau Medical Inc., tripling the amount of Thorium-228 for use and possession at the Lawrence, MA site, from
10 milliCurie to 30 milliCurie.
"These are important milestones in the continued planned development
of our global manufacturing capabilities," said Uzi Sofer, CEO of Alpha Tau. "While our site in Lawrence, MA continues to serve
our global needs for the production of Thorium-228 generators, the receipt of a larger license will allow us to expand our production
capacity as intended and work toward local manufacturing of Alpha DaRT sources on the ground in the U.S. The increase of the Israeli production
capacity arrives at a perfect time, as we wrap up our first U.S. clinical trial and look towards our upcoming U.S. multi-center pivotal
trial, alongside a broader set of activities around the world."
Alpha Tau COO Amnon Gat added, "The continued expansion of our
manufacturing capacity is critical to ensure sufficient and timely supply of our Alpha DaRT treatment to patients worldwide. Moreover,
our ability to bring Alpha DaRT production into the U.S. will allow us to increase our redundancy across multiple plants and to support
a steady supply of Alpha DaRT treatments for our patients in our various clinical trials."
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 is an Israeli medical device 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; (xix) impacts from the COVID-19 pandemic;
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 28, 2022, 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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