Full Press Release Details
Medical Announces Successful Initial Outcomes from Its Pivotal Pre-Clinical Study with the LIBERTY Robotic
| - | A total of 48 animal targets were reached with 100% usability and technical success and no visual acute intra-operative adverse events or complications | |
| - | This pivotal study, together with the verification and validation studies, is expected to serve as the basis for the IDE submission to the FDA |
Mass., October 17, 2023 - Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY
Robotic Surgical System, today announces the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal
pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a
total of 48 animal targets. A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets.
All 6 LIBERTY Systems performed flawlessly, with 100% usability and technical success. No acute adverse events or complications
were visually observed intra-operative.
company expects to receive the comprehensive final report later this quarter. Subject
to the final report, and the completion of the verification and validation (V&V) process, the Company plans on submitting
the Investigational Device Exemption (IDE) application to the FDA, in order to commence its pivotal clinical trial in humans.
are extremely pleased with the LIBERTY system performance during the pivotal pre-clinical study, both from the usability and
technical outcomes as well as the lack of visual acute intraoperative complications. The system operated without any issues
in all cases, achieving our initial objectives for the study," said Simon Sharon, CTO & GM. "We are continuing to take all necessary steps towards submitting our IDE application to the FDA
and commencing our pivotal clinical trial."
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 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 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