Microbot Medical Announces the Successful Completion of Its GLP Pivotal Pre-Clinical Study, a Critical Milestone for Its IDE submission to Commence Human Clinical Study
07 Dezembro 2023 - 10:00AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Endovascular Robotic Surgical System, today announces the
successful completion of its GLP pivotal pre-clinical study, done
under the guidelines of FDA-required levels of planning,
controlling, monitoring, and reporting, using a porcine model.
The study was conducted by three leading
interventional radiologists that utilized the LIBERTY Endovascular
Robotic Surgical System to perform a total of 96 robotic
navigations. Target vessels with surrounding tissue were examined
and evaluated microscopically after they were subjected to
procedures using a range of commercially available intravascular
catheterization devices controlled and manipulated via the LIBERTY
Endovascular Robotic Surgical System.
“I am very pleased with the positive outcomes of
the histopathology report and the completion of the GLP study,”
said Juan Diaz Cartelle, Chief Medical Officer. “This gives us
confidence to move forward to the next stage of human clinical
study.”
“Today’s announcement marks another important
milestone for the Company, as we continue our transition from
R&D and pre-clinical phase into the clinical, regulatory and
pre-commercial phase,” commented Harel Gadot, CEO. “We expect to
submit our IDE application to the FDA soon and commence our pivotal
human clinical study, completing our transition to a clinically
stage company.”
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® 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. 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, such as employees of Microbot and its vendors and
business partners being called to active military duty, 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
Microbot Medical (NASDAQ:MBOT)
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