Microbot Medical Announces Commencement of Pivotal Study for its Self-Cleaning Shunt
October 01 2018 - 7:00AM
Following the successful outcome of the initial study, Microbot
Medical Inc. (Nasdaq CM: MBOT), a medical device company
specializing in the design and development of transformational
micro-robotic medical technologies, announced the commencement of a
follow up pivotal study to evaluate the safety and efficacy of the
Company’s Self-Cleaning Shunt (SCS™). The Company’s innovative SCS
is designed to be a transformative device which prevents
obstruction in the cerebrospinal fluid (CSF) catheters implanted in
the ventricle of the brain of patients who suffer from
hydrocephalus or Normal Pressure Hydrocephalus (NPH).
The follow up study will be conducted by leading
hydrocephalus experts at Washington University in St. Louis, MO and
Wayne State University in Detroit, MI. The study will include
a larger sample size compared to the initial study and the primary
and secondary endpoints will seek to validate the safety and
efficacy of the SCS that will be activated in both in-vitro (lab)
and in-vivo (animal) models. The Company believes the follow
up study will continue to support the safety and efficacy of its
SCS product and plans to use the findings for its regulatory
submissions in the US, Europe and other jurisdictions.
“The positive outcome of the two earlier studies
for our SCS product provide us with increased confidence to proceed
with the pivotal study in order to validate our technology, moving
us one step closer to regulatory submissions,” commented Harel
Gadot, Chief Executive Officer, President and Chairman. “Our
objective is to conclude the follow up studies and publish the data
in mid-2019, which keeps us on track for the regulatory
submission.”
About Microbot Medical, Inc.
Microbot™, which was founded in 2010 and
commenced operations in 2011, became a NASDAQ listed company on
November 28, 2016. The Company specializes in transformational
micro-robotic medical technologies leveraging the natural and
artificial lumens within the human body. Microbot’s current
technological platforms platforms, ViRobTM, TipCATTM and
CardioSertTM, are comprised of three highly advanced technologies,
from which the Company is currently developing its first product
candidate: the Self Cleaning Shunt, or SCSTM, for the treatment of
hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and
focusing on the development of a Multi Generation Pipeline
Portfolio (MGPP) utilizing all technologies. Further information
about Microbot Medical is available at
http://www.microbotmedical.com.
The ViRobTM technology is a revolutionary
autonomous crawling micro-robot which can be controlled remotely or
within the body. Its miniature dimensions allow it to
navigate and crawl in different spaces within the human body,
including blood vessels, the digestive tract and the respiratory
system. Its unique structure gives it the ability to move in
tight spaces and curved passages as well as the ability to remain
within the human body for prolonged time. To learn more about
ViRobTM please visit
http://www.microbotmedical.com/technology/virob/.
TipCATTM is a transformational self-propelled,
flexible, and semi-disposable endoscope providing see & treat
capabilities within tubular lumens in the human body such as the
colon, blood vessels, and the urinary tract. Its locomotion
mechanism is perfectly suitable to navigate and crawl through
natural & artificial tubular lumens, applying the minimal
necessary pressure to achieve the adequate friction required for
gentle, fast, and safe advancement within the human body. To
learn more about TipCATTM, visit
http://www.microbotmedical.com/technology/tipcat/.
CardioSertTM technology is a unique combination
of a guidewire and microcatheter, technologies that are broadly
used for endoluminal surgery. The CardioSertTM technology features
unique steering and stiffness control capabilities, and it was
originally developed to support interventional cardiologists in
crossing the most complex lesions called chronic total occlusion
(CTO) during percutaneous coronary intervention (PCI) procedures
and has the potential to be used in other spaces and applications,
such as peripheral intervention, neurosurgery and urology.
CardioSertTM was part of a technological incubator supported by the
Israel Innovation Authorities (formerly known as the Office of the
Chief Scientist, or OCS), and its device has successfully completed
pre-clinical testing.
Safe Harbor
Statements pertaining 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. 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,
risks inherent in the development and/or commercialization of
potential products, the outcome of its studies to evaluate the SCS
and other existing and future technologies, uncertainty in the
results of pre-clinical and clinical trials or regulatory
approvals, need and ability to obtain future capital, and
maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the businesses of Microbot
Medical Inc. particularly those mentioned in the cautionary
statements found in Microbot Medical Inc.’s filings with the
Securities and Exchange Commission. Microbot Medical disclaims any
intent or obligation to update these forward-looking
statements.
Investor Contacts:
Michael PolyviouEVC Groupmpolyviou@evcgroup.com732-933-2754
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