Microbot Medical Engages CRO to Support its Upcoming U.S. Pivotal Clinical Trial
27 Settembre 2023 - 2:30PM
Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY®
Robotic Surgical System, the first single-use endovascular robotic
system, announced today its partnership with a Contract Research
Organization (CRO) in the U.S. This is an additional step in the
preparations to the commencement of the Company's planned upcoming
clinical trial.
The CRO will provide an array of comprehensive
research management services, leveraging their expertise and
resources to bolster Microbot's clinical trial initiatives. The CRO
will also furnish guidance throughout the clinical trial process,
along with essential functional support and resources, to ensure a
seamless execution of the Company's U.S. pivotal clinical
trial.
This engagement is expected to support Microbot
as it seeks to navigate the regulatory landscape and achieve
necessary compliances with the Food and Drug Administration (FDA).
The Company's upcoming U.S. pivotal clinical trial has been
designed to evaluate the safety and efficacy of the LIBERTY®
Robotic Surgical System in endovascular procedures.
“Our new CRO partner has distinguished
themselves with an exceptional track record of excellence in the
very niche sector of cardiovascular and peripheral vascular device
trials and has paved the way for successful FDA approvals in the
past,” commented Jason Lewen, Director of Clinical Affairs at
Microbot Medical. “Their clinical team is comprised of individuals
with an extensive background in the clinical domain, many of whom
are former hospital employees with vast amounts of clinical trial
functional experiences. We believe that they will be able to
effectively expand our clinical trial capabilities with expert
guidance and functional support while maintaining the highest
standards of quality and regulatory compliance. We view this
significant development as an important milestone in our clinical
trial roadmap for FDA market approval and beyond.”
About Microbot Medical
Microbot 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® 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® 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
LIBERTY, the outcome of its studies to evaluate LIBERTY, whether
the Company’s core business focus program and cost reduction plan
are sufficient to enable the Company to continue to focus on its
LIBERTY technology while it stabilizes its financial condition and
seeks additional working capital, 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, uncertainty in the results of pre-clinical and
clinical trials or regulatory pathways and regulatory approvals,
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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