Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt
January 27 2021 - 7:30AM
Microbot Medical Inc. (Nasdaq: MBOT) announced the completion of
successful discussions with the U.S. Food and Drug
Administration (FDA) for its Self-Cleaning Shunt (SCS). After
review of the Company’s existing pre-clinical data, the FDA’s
feedback will allow the Company to apply for a limited clinical
investigation known as an Early Feasibility Study (EFS), which is
designed for novel technologies such as the SCS. Consequently, the
Company reiterates its timeline for the First-in-Human (FIH)
clinical trial under the EFS, expected to commence in the third
quarter of 2022.
“The FDA’s response is a significant milestone
for our SCS product, as it affirms the novelty of the technology
and our pathway as we advance to the next developmental, clinical
and regulatory phase,” commented Harel Gadot, Chief Executive
Officer, President, and Chairman. “Throughout the pre-submission
process with the FDA, we have sufficiently provided information
which we believe exhibits the strength of our data and provides us
with high level of confidence in the continued progression towards
the successful commercialization of our novel SCS.”
As anticipated, the FDA review focused on
product-specific, regulatory and scientific topics related to the
SCS, and included in the pre-submission were pre-clinical study
data conducted by leading U.S. academic institutions. The Company
expects to continue to work with the FDA towards finalizing the SCS
device design, and to incorporate their feedback prior to
submitting the Investigational Device Exemption (IDE) to seek
authorization to begin the EFS clinical trial. While there can be
no assurance that the FDA will approve the EFS study, the agency's
recent feedback indicates that the agency will be receptive to
allowing this FIH study to proceed based on existing data. After
completing the EFS, the Company would then seek FDA input on the
device design as finalized through the EFS process in a subsequent
IDE filing for approval of a clinical study proposal.
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).
About Microbot Medical
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 pertaining to the registered direct
offering, timing, the amount and anticipated use of proceeds and
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 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 and
the satisfaction of customary closing conditions, risks inherent in
the development and/or commercialization of potential products,
including LIBERTYTM and SCS, the outcome of its studies to evaluate
LIBERTY, SCS and other existing and future technologies,
uncertainty in the results of pre-clinical 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 Polyviou EVC Group mpolyviou@evcgroup.com
732-933-2754
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