Microbot Medical® Concludes 2024 by Achieving Key Milestones Culminating in FDA Submission for the Commercialization of LIBERTY®
30 Dezember 2024 - 2:30PM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Endovascular Robotic System, concludes 2024 with the
achievement of several key milestones, including the recent FDA
510(k) submission for FDA commercial approval of LIBERTY®, which
the company believes will position the Company for continued
success in 2025.
“As we entered 2024, the Company had three
primary goals in our quest to ensure we are ready for the
successful commercial launch of LIBERTY in 2025: 1) complete FDA
510(k) submission, 2) establish pre-commercial infrastructures, and
3) execute strategic initiatives to support future growth,”
commented Harel Gadot, Chairman and Chief Executive Officer.
“Thanks to the efforts of our team, coupled with a close
collaboration with our internal and external stakeholders, I am
very pleased with the progress we made throughout the year toward
achieving these goals. I have a high level of confidence we will be
positioned to meet our commercial objectives moving forward.”
The following are the key milestones the Company
has reported achieving during the past 12 months:
Complete FDA 510(k)
submission
- Received Investigational Drug Exemption (IDE) approval from the
FDA to initiate the ACCESS-PVI pivotal human clinical trial.
- Successfully completed the ACCESS-PVI pivotal human clinical
trial in three leading medical centers in the USA: Miami Baptist
(Miami, FL), Memorial Sloan Kettering (NYC, NY) and Brigham &
Women’s (Boston, MA).
- Successfully completed the substantial R&D testing required
for FDA’s 510(k) submission, including biocompatibility,
transportation validation, and usability testing, among
others.
- Submitted 510(k) file to FDA for the commercialization of the
LIBERTY® Endovascular Robotic System.
Establish pre-commercial
infrastructures
- Received ISO 13485 certification for our quality management
system to support commercialization.
- Initiated inventory build-up while improving operational
infrastructure.
- Submitted the ACCESS-PVI pivotal human clinical trial results
to conferences in anticipation of sharing them publicly by
leveraging these professional channels.
- Attended several endovascular medical conferences, including
the Society of Interventional Radiology (SIR) and Cardiovascular
and Interventional Radiological Society of Europe (CIRSE).
Execute strategic initiatives to support
future growth
- Completed Phase 1 and Phase 2 of the telesurgery collaboration
with Corewell Health, culminating in a simulated procedure between
two facilities located 5 miles apart.
- Entered into an agreement with Emory University to collaborate
on the development of autonomous robotics.
Based on these achievements, the Company
believes it has laid the necessary groundwork to support its
commercial objectives in 2025. The Company is anticipating the
launch of LIBERTY in Q2 2025 in the U.S. and continuing its efforts
to receive additional regulatory approval outside the U.S. to
support future growth.
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
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