Microbot Medical Shares Status Following Recent Geopolitical Events
April 15 2024 - 8:30AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY®
Endovascular Robotic Surgical System, today shared that despite the
unprecedented events in Israel yesterday, which are a continuation
to the situation in Israel since October 7th, 2023, the Company’s
activities both in Israel, USA and other parts of the globe
continue without interruption and it believes that current planned
timelines and milestones will be met.
From a regulatory perspective, the Company has been working with
the FDA on its recent IDE submission and believes that those
efforts will result in commencing its pivotal study in humans as
planned. In addition, as part of its efforts to gain regulatory
approval in Europe, the Company successfully completed an internal
audit in preparation for ISO 13485 certification audits, which are
expected this year, to ensure the Company continues to meet its
timeline toward CE approval.
From an operational perspective, the Company has established
sufficient inventory of the LIBERTY® Endovascular Robotic Surgical
System to support its pivotal study and other ongoing
activities.
In addition to focusing on gaining regulatory approval for the
current LIBERTY® Endovascular Robotic Surgical System in both the
USA and Europe, the Company already executed an initial phase
partnership with one clinical partner and is in advanced
discussions with additional clinical partners to develop the future
potential capabilities of the LIBERTY® Endovascular Robotic
Surgical System, such as remote operations, imaging integration and
AI capabilities.
With its pre-commercial activities, the Company is already in
discussions with multiple strategic partners, both in the USA and
globally, to allow the Company to evaluate the most efficient
commercialization channels once the product would be approved for
sale in the USA and globally.
“Overcoming multiple challenges over the past 4 years, starting
with COVID-19 and continuing with the war in Israel since October
7th which reached new heights yesterday, we have been successful in
establishing our infrastructure and meeting meaningful milestones
such as the successful completion of the GLP study and the IDE
submission to the FDA,” said Harel Gadot, CEO, President and
Chairman of Microbot Medical. “With the infrastructure we have both
in Israel and the USA, together with the milestones we already
achieved and believe that we will achieve over the next few months,
we are confident we can continue to execute against our regulatory
milestones and to position us to commercialize the LIBERTY® System
in both the USA and Europe as planned.”
About Microbot MedicalMicrobot Medical Inc.
(NASDAQ: MBOT) is a pre-clinical medical device company that
specializes in transformational micro-robotic technologies, with
the goals of improving clinical outcomes for patients and
increasing accessibility through the natural and artificial lumens
within the human body.
The LIBERTY® Endovascular Robotic Surgical System aims to
improve the way surgical robotics are being used in endovascular
procedures today, by eliminating the need for large, cumbersome,
and expensive capital equipment, while reducing radiation exposure
and physician strain. The Company believes the LIBERTY®
Endovascular Robotic Surgical System’s remote operation has the
potential to be the first system to democratize endovascular
interventional procedures.
Further information about Microbot Medical is available at
http://www.microbotmedical.com.
Safe Harbor
Statements to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for Microbot Medical Inc.
and its subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management, constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 and
the Federal securities laws. Any statements that are not historical
fact (including, but not limited to statements that contain words
such as “will,” “believes,” “plans,” “anticipates,” “expects” and
“estimates”) should also be considered to be forward-looking
statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, market conditions,
risks inherent in the development and/or commercialization of the
LIBERTY® Endovascular Robotic Surgical System, the outcome of its
studies to evaluate the LIBERTY® Endovascular Robotic Surgical
System, uncertainty in the results of pre-clinical and clinical
trials or regulatory pathways and regulatory approvals, including
whether the Company succeeds in obtaining FDA approval to commence
its pivotal study in humans, any failure or inability to recruit
physicians and clinicians to serve as primary investigators to
conduct regulatory studies which could adversely affect or delay
such studies, , disruptions resulting from new and ongoing
hostilities between Israel and the Palestinians and other
neighboring countries, any lingering uncertainty resulting from the
COVID-19 pandemic, need and ability to obtain future capital, and
maintenance of intellectual property rights. Additional information
on risks facing Microbot Medical can be found under the heading
“Risk Factors” in Microbot Medical’s periodic reports filed with
the Securities and Exchange Commission (SEC), which are available
on the SEC’s web site at www.sec.gov. Microbot Medical disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Investor Contact:
Michal Efraty+972-(0)52-3044404IR@microbotmedical.com
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