Microbot Medical Completes GLP Animal Study for the LIBERTY® Robotic System
October 13 2022 - 9:15AM
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 model.
During 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.
In 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.
“It 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.”
"Set-up 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.”
“We 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.
About Microbot Medical Inc.
Microbot 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).
Microbot 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 at
http://www.microbotmedical.com.
Safe Harbor
Statements 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.
Investor Contact:
Michael PolyviouEVC
Groupmpolyviou@evcgroup.com732-933-2754
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