SOLANA BEACH, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc.
(Nasdaq: CLPT) (the "Company"), a global device, cell, and gene therapy-enabling
company offering precise navigation to the brain and spine, today announced
receipt of European Medical Device Regulation (EU MDR) clearance for the manual
SmartTwist(®) MR Hand Drill and SmartTip(®) MR Drill Kit. Additionally, the
Company received updated certification from its Notified Body allowing for
shipment of products manufactured at its new Carlsbad, California facility to
Europe.
European Medical Device Regulation 2017/745 (EU MDR), the new medical device
regulation applicable in Europe, replaces the previous Medical Device Directive
93/42/EEC (MDD) regulation. With the introduction of EU MDR, the EU is placing
greater emphasis on safety measures, risk management, post-market surveillance,
and data collection of medical devices for companies who wish to obtain European
market access.
"EU MDR is much more rigorous than MDD, forcing many medical device companies in
our space who wish to enter or continue commercialization in Europe to closely
assess every product before committing the time and resources necessary to meet
its requirements," stated Megan Faulkenberry, Vice President of Quality at
ClearPoint Neuro. "Our team has risen to this challenge, especially given the
importance of the EU to our pharmaceutical partners."
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering
precise navigation to the brain and spine. The Company uniquely provides both
established clinical products as well as pre-clinical development services for
controlled drug and device delivery. The Company's flagship product, the
ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked.
ClearPoint Neuro is engaged with healthcare and research centers in North
America, Europe, Asia, and South America. The Company is also partnered with the
most innovative pharmaceutical/biotech companies, academic centers, and contract
research organizations, providing solutions for direct CNS delivery of
therapeutics in pre-clinical studies and clinical trials worldwide. To date,
thousands of procedures have been performed and supported by the Company's
field-based clinical specialist team, which offers support and services to our
customers and partners worldwide. For more information, please visit
www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the
federal securities laws, including the Company's expectation for the future
market of its products and services, regulatory and development plans, and other
performance and results. These forward-looking statements are based on
management's current expectations and are subject to the risks inherent in the
business, which may cause the Company's actual results to differ materially from
those expressed in or implied by forward-looking statements. Particular
uncertainties and risks include those relating to: global and political
instability, supply chain disruptions, labor shortages, and macroeconomic and
inflationary conditions; future revenue from sales of the Company's products and
services; the Company's ability to market, commercialize and achieve broader
market acceptance for new products and services offered by the Company; the
ability of our biologics and drug delivery partners to achieve commercial
success, including their use of the Company's products and services in their
delivery of therapies; the Company's expectations, projections and estimates
regarding expenses, future revenue, capital requirements, and the availability
of and the need for additional financing; the Company's ability to obtain
additional funding to support its research and development programs; the ability
of the Company to manage the growth of its business; the Company's ability to
attract and retain its key employees; and risks inherent in the research,
development, and regulatory approval of new products. More detailed information
on these and additional factors that could affect the Company's actual results
are described in the "Risk Factors" section of the Company's Annual Report on
Form 10-K for the year ended December 31, 2022, and the Company's Quarterly
Report on Form 10-Q for the three months ended September 30, 2023, both of which
have been filed with the Securities and Exchange Commission, and the Company's
Annual Report on Form 10-K for the year ended December 31, 2023, which the
Company intends to file with the Securities and Exchange Commission on or before
March 31, 2024. The Company does not assume any obligation to update these
forward-looking statements.
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