Microbot Medical Accelerates Patient Enrollment of its Pivotal Human Clinical Trial; Expects to Complete the Trial Earlier Than Anticipated as 80% of Patients Have Completed Follow up
30 Septiembre 2024 - 7:30AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Endovascular Robotic Surgical System, today announced that
it is currently experiencing an acceleration of patient enrollment
for ACCESS-PVI human clinical trial for LIBERTY®. As a result of
the increased rate of patient enrollment, 80% of the patients have
completed the follow up period, and the Company now anticipates
completing the trial ahead of its prior expectation. The Company
remains on track to file its 510(k) submission with the U.S. Food
and Drug Administration (FDA) by of the end of 2024.
“The trial is progressing well, and I am pleased
with the level of enthusiasm at all three clinical sites which has
resulted in the acceleration of patient enrollment. This gives us
additional confidence that we can complete the trial and submit for
FDA clearance by the end of 2024,” commented Harel Gadot, Chairman,
CEO and President.
“I applaud the entire team at Microbot Medical
and the physicians participating in the study as we near the finish
line. I believe their continued commitment will allow us to
maintain the positive momentum over the next several weeks and
allow us to achieve our near-term milestones, including the
completion of the study,” commented Juan Diaz-Cartelle, MD, Chief
Medical Officer of Microbot Medical.
ACCESS-PVI is a prospective, multi-center,
single-arm trial to evaluate the performance and safety of LIBERTY®
in human subjects undergoing Peripheral Vascular Interventions. The
trial will support the 510(k) submission to the FDA and subsequent
commercialization.
The Company also announced that is has
successfully completed all biocompatibility tests, as required by
its Investigational Device Exemption (IDE) application and received
full approval for the IDE study from the FDA. The Company had
previously disclosed that it had received approval from the FDA to
commence its clinical trial, and in parallel complete
biocompatibility testing. In parallel with the clinical trial, the
Company is performing additional customary bench testing, and these
final results will be included in the Company’s 510(k)
submission.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a
clinical- stage 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
IR@microbotmedical.com
Microbot Medical (NASDAQ:MBOT)
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