Microbot Medical Accomplishes the Next-Step in the Regulatory Process for the LIBERTY® Robotic System
October 18 2022 - 8:45AM
Microbot Medical Inc. (Nasdaq: MBOT), announced that it has
submitted the anticipated follow-up pre-submission package for the
LIBERTY® Robotic System to ensure the Company remains fully aligned
with the U.S. Food and Drug Administration (FDA) as it prepares for
its Investigational Device Exemption (IDE) submission and
first-in-human clinical trial with the system in 2023.
“We have had a positive experience with the FDA
to date, and we believe the continued dialogue and level of
engagement is very constructive and encouraging as we prepare for
our next regulatory steps in the USA for the LIBERTY Robotic
System,” commented Harel Gadot, Chairman, CEO and President. “This
planned submission is another critical step we needed to secure as
we make our first-in-human preparations, and we believe the outcome
of the continued dialogue will ensure that we are prepared for the
expected regulatory process moving forward.”
About Microbot Medical Inc.
Microbot Medical Inc. (NASDAQ: MBOT) is a
pre-clinical medical device company that specializes in
transformational micro-robotic technologies, focused primarily on
both natural and artificial lumens within the human body.
Microbot’s current proprietary technological platforms provide the
foundation for the development of a Multi Generation Pipeline
Portfolio (MGPP).
Microbot Medical was founded in 2010 by Harel
Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of
improving clinical outcomes for patients and increasing
accessibility through the use of micro-robotic technologies.
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
potential products, including LIBERTY, the outcome of its studies
to evaluate LIBERTY and other existing and future technologies, any
failure or inability to recruit physicians and clinicians to serve
as primary investigators to conduct the first-in-human clinical
trial of LIBERTY, which could adversely affect or delay such trial,
uncertainty in the results of pre-clinical studies and clinical
trials or regulatory pathways and regulatory approvals, 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.
Michael Polyviou EVC Group
mpolyviou@evcgroup.com 732-933-2754
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