Microbot Medical Announces the Successful Completion of its Pivotal Human Clinical Trial; Accelerates Go-to-Market Strategy to Prepare for Commercial Launch of LIBERTY® during 2Q 2025
15 Octobre 2024 - 2:38PM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Endovascular Robotic Surgical System, today announced that
it has successfully completed enrollment and follow up for all
patients in its ACCESS-PVI human clinical trial. 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 Company also announced that it is
accelerating its go-to-market strategy. It expects to begin
building out the commercial infrastructure, including the hiring of
a seasoned healthcare executive to lead its sales efforts, upon the
FDA clearance, which is expected during 2Q 2025.
“We are very pleased with the performance of
LIBERTY® throughout the study,” commented Juan Diaz-Cartelle, MD,
Chief Medical Officer. “We want to thank all our investigators for
their enthusiastic commitment to the trial. We expect to share the
results of the clinical trial with the medical community and the
public at a conference in early 2025.”
“This is a monumental moment and a significant
achievement for Microbot Medical,” commented Harel Gadot, Chairman,
CEO and President. The conclusion of the trial and physician
feedback is an encouraging development, and our immediate task is
to prepare and finalize the FDA 510(k) submission package so we can
file it by the end of the year. Concurrently, we will deploy our
go-to-market strategy and begin to build out a commercial
infrastructure to ensure we are fully prepared to launch LIBERTY®
upon the FDA’s clearance, which we expect during 2Q 2025.
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 wants to thank
the patients, physicians and clinical sites for their participation
in the trial.
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,
whether the FDA will grant 510(k) clearance to commercially market
the LIBERTY® Endovascular Robotic Surgical System in the United
States, disruptions resulting from new and ongoing hostilities
between Israel and the Palestinians and other neighboring
countries, 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:
IR@microbotmedical.com
Microbot Medical (NASDAQ:MBOT)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Microbot Medical (NASDAQ:MBOT)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024