Full Press Release Details
Medical Receives Quality Certification to Support Future Regulatory Submissions and Commercialization
ISO 13485 certification is a validation of the Company's robust quality system
Mass., August 13, 2024 - Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Endovascular
Robotic Surgical System, today announces it has received ISO 13485:2016 certification for its quality management system. Receiving ISO
13485 certification indicates that a company has developed and implemented robust policies and procedures for the development and manufacture
of regulated medical products.
ISO 13485 standard was designed for the medical industry and requires a specific approach to risk assessment and the management of each
process necessary for the development and realization of regulated medical products. Companies that comply with these quality requirements
must prove that they consistently review and validate their product development and manufacturing processes, manage their operations
with effective procedures, and maintain records for product traceability.
am extremely proud of the efforts by the entire Microbot team," said Noa Ofer, PhD, Sr. Director of Quality Assurance and Regulatory
Affairs. "An ISO 13485 audit is a very extensive process, and our certification is a testament that we are building the right capabilities
and infrastructure as we progress toward commercialization."
with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements under the new Medical Device
Regulation (EU MDR) and is required to obtain CE mark approval for sales in the European Union. In addition, in view of the recent revision
published by the FDA regarding the QMSR (quality system management regulation) and its incorporation by reference of the ISO 13485 standard,
this certificate helps streamline Microbot's transition into this revised FDA regulation.
Medical Inc. (NASDAQ: MBOT) is a clinical- stage 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
Investigational LIBERTY Endovascular 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 Endovascular Robotic Surgical System's remote operation
has the potential to be the first system to democratize endovascular interventional procedures.
information about Microbot Medical is available at http://www.microbotmedical.com.
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 the LIBERTY
Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY Endovascular Robotic Surgical
System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether
the Company's pivotal study in humans is successful, 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, disruptions resulting from new
and ongoing hostilities between Israel and the Palestinians and other neighboring countries, 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.