Full Press Release Details
Medical Announces FDA Submission for the Commercialization of the LIBERTY Endovascular Robotic System
510(k) Submission Follows the Successful Completion of the Pivotal Human Clinical Trial
510(k) Clearance Anticipated During the Second Quarter of 2025
Preparing to Commence Commercialization Following FDA 510(k) Clearance
Mass., December 10, 2024 - 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.
Company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence
after the clearance.
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
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.
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.
information about Microbot Medical is available at http://www.microbotmedical.com.
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.
Contact: IR@microbotmedical.com