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."
About Alpha DaRT
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.
Investor Relations Contact
IR@alphatau.com
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SOURCE Alpha Tau Medical