Full Press Release Details
Medical Announces the Successful Enrollment of 50% of the Patients in its Pivotal Human Clinical Trial for the LIBERTY
Endovascular Robotic Surgical System
of enrollment expected in Q4 with FDA submission for commercialization anticipated by the end of 2024
Mass., September 17, 2024 -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Endovascular
Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial,
enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY Endovascular
Robotic Surgical System. The Company expects to complete enrollment and follow up in the fourth quarter of 2024 and file its 510(k) submission
with the U.S. Food and Drug Administration (FDA) by the end of 2024.
is a prospective, multi-center, single-arm, clinical trial designed to evaluate the performance and safety of LIBERTY
in human subjects undergoing Peripheral Vascular Interventions. The trial is expected to support the future 510(k) submission to the
FDA and, when approved, subsequent commercialization.
have performed several procedures using LIBERTY during the trial and I am continuing to enroll patients," commented
Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology) at Brigham and Women's Hospital
in Boston. "I am pleased with the ease of use and quick set-up of the robot, requiring, in my experience, a very short learning
are excited by both the achievement of this milestone, and physician feedback. We remain on track to complete the trial and subsequent
submission of the 510(k) to the FDA before year end," commented Juan Diaz-Cartelle, MD, Chief Medical Officer.
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
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.
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, 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, any failure or inability to recruit physicians and clinicians to serve as
primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new
and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from
the COVID-19 pandemic, 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.