ClearPoint Neuro Announces First EU MDR Certification Success and Approval to Ship Product to Europe
January 22 2024 - 4:05PM
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.
Contact:
Media Contact:
Jacqueline Keller, Vice President of Marketing
(949) 900-6833
info@clearpointneuro.com
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109
ir@clearpointneuro.com
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