Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial
June 03 2024 - 8:20AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Endovascular Robotic Surgical System, today announces that
it has received the U.S. Food and Drug Administration’s (“FDA”)
approval to proceed with its pivotal human clinical trial as part
of its Investigational Device Exemption (“IDE”) application for its
LIBERTY® Endovascular Robotic Surgical System.
The study will be conducted in the U.S., and the
Company has already signed a clinical trial service agreement with
a leading academic medical center. The Company is also in the
process of engaging additional leading centers to participate in
the trial.
In parallel to commencing the pivotal human
clinical trial, the Company is completing its biocompatibility
tests as required by its IDE application.
“The recent authorization by the FDA to commence
our pivotal clinical study, following submission of the results of
our extensive pre-clinical studies and tests, reinforces our
confidence in our innovative technology,” commented Harel Gadot,
CEO, President and Chairman. ”It is also a testament to our
commitment to meet meaningful milestones as we continue our path
towards potential regulatory clearance and subsequent
commercialization in the US and other regions across the
globe”.
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 Investigational 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’s pivotal study in humans is successful, 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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