Microbot Medical Submits an IDE Application to Gain FDA Approval to Commence Its Pivotal Clinical Trial in the US
February 05 2024 - 7:30AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY®
Endovascular Robotic Surgical System, announced that it has filed
an Investigational Device Exemption (IDE) application with the US
Food and Drug Administration (FDA). The IDE application follows the
completion of multiple preclinical activities performed to provide
preliminary safety and effectiveness information, and its approval
by the FDA would allow the company to commence its pivotal human
clinical trial in the United States.
“This is an important milestone for the company, and it is
another step forward in our journey to achieve FDA clearance for
the LIBERTY® Endovascular Robotic Surgical System,” said Harel
Gadot, CEO, President and Chairman of Microbot
Medical.
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
potential products, including 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, disruptions resulting
from new and ongoing hostilities between Israel and the
Palestinians, 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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