Full Press Release Details
Medical Completes GLP Animal Study for the LIBERTY Robotic System
Mass., October 13, 2022 - Microbot Medical Inc. (Nasdaq: MBOT) announced a significant development milestone as it completed
the GLP animal study for the LIBERTY Robotic System, the first disposable robotic system being developed for endovascular
procedures. The study was performed by a team of seasoned Key Opinion Leaders (KOLs) in the endovascular space at a world-class MedTech
research laboratory with FDA-required levels of planning, controlling, monitoring, and reporting (GLP standards), using porcine
the GLP animal study, the physicians conducted pre-determined 63 navigations to the targeted sites using the investigational LIBERTY
Robotic System and performed an equal number of procedures manually. The performance endpoint of the LIBERTY Robotic System after robotic
navigation was successfully completed for 58 out of the 63 targets (92%), while 3 of the targets (4.8%) were not completed due to technical
issues and 2 (3.2%) were not completed due to fluoroscopy related issues (non-device related). Post navigation intra-operative
selective angiograms of the target vessels showed no definite evidence of acute vascular injury. Follow up angiograms of these vessels
in post-procedure day 3 showed normal vessel anatomy without signs of injury. Initial postmortem gross pathology examination of
some of the target organs showed preliminary findings, which will be further investigated in the pending histopathology analysis,
and potentially an additional pre-clinical study.
addition to the objective measurements, the performance and usability of the LIBERTY Robotic System were subjectively graded by each
of the physicians, with their assessments accounting for features such as ease of navigation to the target, learning curve, and system
stability. For the target sites reached, the physicians graded the LIBERTY Robotic system at the highest grade.
was a very satisfying experience," commented Dr. Sebastian Flacke, MD PhD, Professor of Radiology Tufts Medical School, Chief Interventional
Radiology, Vice Chair for Research, Lahey Hospital and Medical Center. "It gives you a very precise feeling on what you're
doing with a lot of control."
time is quick," added Dr. Dmitry J. Rabkin, MD, Ph.D., FSIR, Assistant Chief, Division of Angiography and Interventional
Radiology, Department of Radiology, Brigham and Women's Hospital, after his own experience with LIBERTY during the GLP study. "The
learning curve appears to be easy. The all-around experience was very good, delicate and precise."
are very proud and excited of how LIBERTY performed during the GLP animal study," commented Dr. Eyal Morag, Chief Medical Officer
of Microbot. "It was exciting to watch my very esteemed colleagues quickly adapt to performing the procedures robotically, and
their success in hitting the targets is a testament to just how accessible LIBERTY is."
The LIBERTY Robotic System is investigational and
has not been cleared by the U.S. Food and Drug Administration for any use, and accordingly it is not commercially available in the United
States or in any other market. The Company plans to further support this study with additional pre-clinical and clinical data.
Microbot Medical Inc.
Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies,
focused primarily on both natural and artificial lumens within the human body. Microbot's current proprietary technological platforms
provide the foundation for the development of a Multi Generation Pipeline Portfolio (MGPP).
Medical was founded in 2010 by Harel Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of improving clinical outcomes for
patients and increasing accessibility through the use of micro-robotic technologies. Further information about Microbot Medical is available
as 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 and other existing and future technologies, uncertainty
in the results of pre-clinical studies and clinical trials or regulatory pathways and regulatory approvals, 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.