Full Press Release Details
Medical Accelerates Patient Enrollment of its Pivotal Human Clinical Trial; Expects to Complete the Trial Earlier Than Anticipated as
80% of Patients Have Completed Follow up
the Company on Track for FDA 510(k) Submission by end of 2024
All IDE required Tests and Receives Final IDE Approval from the FDA for the ACCESS-PVI Study
Mass., September 30, 2024 -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Endovascular
Robotic Surgical System, today announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human
clinical trial for LIBERTY . As a result of the increased rate of patient enrollment, 80% of the patients have completed
the follow up period, and the Company now anticipates completing the trial ahead of its prior expectation. The Company remains on track
to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024.
trial is progressing well, and I am pleased with the level of enthusiasm at all three clinical sites which has resulted in the acceleration
of patient enrollment. This gives us additional confidence that we can complete the trial and submit for FDA clearance by the end of
2024," commented Harel Gadot, Chairman, CEO and President.
applaud the entire team at Microbot Medical and the physicians participating in the study as we near the finish line. I believe their
continued commitment will allow us to maintain the positive momentum over the next several weeks and allow us to achieve our near-term
milestones, including the completion of the study," commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical.
is a prospective, multi-center, single-arm trial to evaluate the performance and safety of LIBERTY in human subjects
undergoing Peripheral Vascular Interventions. The trial will support the 510(k) submission to the FDA and subsequent commercialization.
Company also announced that is has successfully completed all biocompatibility tests, as required by its Investigational Device Exemption
(IDE) application and received full approval for the IDE study from the FDA. The Company had previously disclosed that it had received
approval from the FDA to commence its clinical trial, and in parallel complete biocompatibility testing. In parallel with the clinical
trial, the Company is performing additional customary bench testing, and these final results will be included in the Company's
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.