Microbot Medical® Announces FDA Submission for the Commercialization of the LIBERTY® Endovascular Robotic System
10 Décembre 2024 - 2:00PM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
single use LIBERTY® Endovascular Robotic System, today announced
that it has submitted a 510(k) premarket notification to the U.S.
Food and Drug Administration (FDA) for LIBERTY®. LIBERTY® is the
world’s first single-use, fully disposable robotic system for
endovascular procedures. The 510(k) submission follows the
successful completion of its multi-center, single-arm, trial to
evaluate the performance and safety of LIBERTY® in human subjects
undergoing Peripheral Vascular Interventions.
The Company anticipates FDA marketing clearance
during the second quarter of 2025, with U.S. commercialization
activities expected to commence after the clearance.
“This is a pivotal milestone for our Company, as
the 510(k) submission reflects the commencement of our transition
to a commercially focused company,” commented Harel Gadot,
Chairman, CEO and President. “We are excited to transition our
focus towards preparing for our expected U.S. launch in the second
quarter of 2025 and targeting the more than 2 million peripheral
vascular procedures performed in the U.S. each year. We believe,
based on feedback from physicians and the medical community, that
LIBERTY® is positioned to redefine the peripheral endovascular
space with the introduction of the world’s first commercially
available single-use robotic system.”
As the world’s first single-use, fully
disposable endovascular robotic system, LIBERTY® eliminates the
need for large and expensive capital equipment and streamlines
customers’ access to robotics. With its remote control, LIBERTY® is
designed to significantly reduce radiation exposure to physicians
and staff, and improve ergonomics, which has the potential to
reduce the physical strain on healthcare providers. The Company
also believes that LIBERTY® has the potential to lower procedure
costs, increase procedure efficiency and improve the overall
quality of care.
About Microbot Medical®Microbot
Medical Inc. (NASDAQ: MBOT) is a pre-commercial stage medical
technology company with a vision to improve the quality of care for
millions of patients and providers globally. The Company has
developed the world’s first single-use, fully disposable
endovascular robotic system, which aims to eliminate traditional
barriers to accessing advanced robotic systems.
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, commercialization 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, the
Company’s need for and ability to obtain additional working capital
to continue its transition to a commercially focused company,
market conditions, risks inherent in the development and/or
commercialization of the LIBERTY® Endovascular Robotic Surgical
System, uncertainty in the results of regulatory pathways and
regulatory approvals, including 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, 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)
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