Microbot Medical Reveals Successful Short Term Follow Up Outcomes from its Pivotal Pre-Clinical Study
31 Oktober 2023 - 1:25PM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Robotic Surgical System, today announces additional
updates regarding positive outcomes of its previously announced
pivotal pre-clinical study using the LIBERTY Robotic Surgical
System.
The pivotal study was conducted by three leading
interventional radiologists that utilized the LIBERTY Robotic
Surgical System to reach a total of 48 animal targets. In a series
of visual testing, preformed 72 hours following each procedure,
examination of the animals treated with the LIBERTY Robotic
Surgical System showed no visual evidence of vascular injury or any
other visual adverse event.
This new data follows the recently announced
successful initial outcomes from the pivotal pre-clinical study. 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 based on the initial outcomes, with 100% usability and
technical success. No acute adverse events or complications were
visually observed intra-operative.
The 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.
"We are excited to share additional positive
outcomes of our pivotal pre-clinical study. The absence of any
visual evidence of vascular injury in the follow-up examination
after 72 hours continues to reaffirm the safety and effectiveness
of our technology. This milestone, together with the advancement of
the verification and validation process, bring us one step closer
to the submission of the IDE and commencing our pivotal clinical
trial in humans," said Simon Sharon, Microbot’s GM & CTO.
About Microbot Medical
Microbot 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 the
human body.
The 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.Further information about Microbot Medical is available
at http://www.microbotmedical.com.
Safe Harbor
Statements 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 by law.
Investor Contact:
Michal Efraty+972-(0)52-3044404IR@microbotmedical.com
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