Full Press Release Details
Medical Announces the Successful Completion of Its GLP Pivotal Pre-Clinical Study, a Critical Milestone for Its IDE submission to Commence
Human Clinical Study
final histopathology and lab report supplements previous positive Company findings.
The results of the study will support the Company's
IDE submission to the FDA to commence its human clinical study
Mass., December 7, 2023 - Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Endovascular
Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of
FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.
study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform
a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically after they were
subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via
the LIBERTY Endovascular Robotic Surgical System.
am very pleased with the positive outcomes of
the histopathology report and the completion of the GLP study," said Juan Diaz Cartelle, Chief Medical Officer. "This
gives us confidence to move forward to the next stage of human clinical study."
announcement marks another important milestone for the Company, as we continue our transition from R&D and pre-clinical phase into
the clinical, regulatory and pre-commercial phase" commented Harel Gadot, CEO. "We expect to submit our IDE application to
the FDA soon and commence our pivotal human clinical study, completing our transition to a clinically stage company."
Medical Inc. (NASDAQ: MBOT) is a pre-clinical 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
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 potential
products, including LIBERTY, the outcome of its studies to evaluate LIBERTY, whether the Company's core business focus program
and cost reduction plan are sufficient to enable the Company to continue to focus on its LIBERTY technology while it stabilizes its financial
condition and seeks additional working capital, 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, uncertainty in the results of pre-clinical and clinical
trials or regulatory pathways and regulatory approvals, disruptions resulting from new and ongoing hostilities between Israel and the
Palestinians, such as employees of Microbot and its vendors and business partners being called to active military duty, 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