Microbot Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024
October 24 2023 - 8:19AM
Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative
LIBERTY® Robotic Surgical System, today announces it has received
confirmation for the commencement of the process to support its
future CE Mark approval, and to ultimately allow the Company to
market the LIBERTY® Robotic Surgical System in Europe as well as
other regions who accept the CE Mark.
According to the confirmation, the Company will
commence audits for ISO 13485 certification to ensure its
compliance with the Quality Management System (QMS) requirements of
the EU Medical Devices Regulation (MDR 2017/745), during the first
half of 2024. The Company had previously taken the first step to
advance its European program by engaging with a leading Notified
Body, who recently confirmed dates for conducting the required
audits.
The audits for Microbot’s ISO 13485
certification will incorporate an off-site audit that includes a
review of the Company’s quality system and the LIBERTY® Robotic
Surgical System Technical File, followed by an on-site audit at the
Company’s facilities.
"We are confident that we have taken the right
measures to successfully complete these audits, which will serve as
the first step in our commercial approval process for Europe as
well as other regions across the globe which allow
commercialization under the CE Mark," said Noa Ofer, Sr. Director
QA/RA. “We intend that this process will be conducted in parallel
with our FDA approval efforts, to allow us to capture as many
markets across the globe as we prepare for future
commercialization.”
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
Microbot Medical (NASDAQ:MBOT)
Historical Stock Chart
From Sep 2024 to Oct 2024
Microbot Medical (NASDAQ:MBOT)
Historical Stock Chart
From Oct 2023 to Oct 2024