Full Press Release Details
Medical Receives FDA 510(k) Clearance for Its LIBERTY Endovascular Robotic System
Launch Readiness Plans Position Company for Commercialization during Q4 2025
Company's Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually
President & Chairman to Present Live Webcast at the H.C. Wainwright Annual Investor Conference on
9, 2025, at 9 AM ET.
Mass., September 08, 2025 - Microbot Medical Inc. (Nasdaq: MBOT), developer and
manufacturer of the innovative LIBERTY Endovascular Robotic System, today announced that the U.S. Food and Drug Administration
(FDA) has granted 510(k) clearance for the LIBERTY System, the first FDA cleared single-use, remotely operated robotic
system for peripheral endovascular procedures. The FDA clearance positions the Company to commercialize LIBERTY in the
U.S., with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital
equipment and a dedicated infrastructure.
FDA 510(k) clearance for LIBERTY marks
a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission
to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,"
commented Harel Gadot, Chairman, CEO & President. "With our commercial readiness strategy being developed and executed since
Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial
activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5
million annual U.S. peripheral vascular procedures, and pursue entry into global markets."
LIBERTY pivotal study showed 100% success in the robotic navigation to target, and zero device related adverse events.
The study also showed a 92% relative reduction in radiation exposure for physicians. Its remote design is expected to improve ergonomics,
which would aid in reducing the physical strain on healthcare providers. The Company believes that LIBERTY has the potential
to enhance procedure efficiency, lower procedure costs, and improve the overall quality of care. The Company plans to continue clinical
data collection for LIBERTY during the commercial launch.
Company will attend the H.C. Wainwright Annual Investor Conference held in NYC from September 8-10, 2025. Mr. Gadot will present live
on Tuesday, September 9th at 9:00am ET, and a live webcast may be accessed via the Events' section of the Company's
website at www.microbotmedical.com.
Investors should reach out to their H.C. Wainwright sales representatives or contact mpolyviou@evcgroup.com to schedule a one-on-one
meeting with Microbot Medical's management team.
Medical Inc. (NASDAQ: MBOT) is a breakthrough medical device company focused on transforming endovascular procedures through advanced
robotic technology. Microbot's LIBERTY Endovascular Robotic System is the first single-use, remotely operated robotic
solution designed for precision, efficiency and provider safety. Backed by a strong intellectual property portfolio and a commitment
to innovation, Microbot is driving the future of endovascular care.
more at www.microbotmedical.com and connect on LinkedIn and X.
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 "contemplates," "continues," "could," "forecasts," "intends,"
"may," "might," "possible," "potential," "predicts," "projects,"
"should," "would," "will," "believes," "plans," "anticipates,"
"expects," "estimates" and similar expressions) should also be considered to be forward-looking statements, but
the absence of these words does not mean that a statement is not forward-looking. 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 commercialization of the LIBERTY Endovascular
Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory
pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes
in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from
new and ongoing hostilities between Israel and the Palestinians, Iran 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.