ClearPoint Neuro Announces FDA Clearance of Prism Bone Anchor Accessory
April 29 2024 - 8:00AM
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 it has received
510(k) clearance for its Prism Bone Anchor Accessory. This
clearance marks the Company’s second new product introduction
within the first four months of 2024.
“Similar to the recent launch of our SmartFrame OR platform, the
introduction of the Prism Bone Anchor Accessory for use with the
ClearPoint Prism Neuro Laser Therapy System supports our continued
expansion beyond the MRI into the operating room. This is where
most laser applicators are placed today,” stated Chris Osswald,
PhD, Director, Global Segment Leader for Laser Therapy at
ClearPoint Neuro. “We are pleased to round out our laser portfolio
and look forward to working with hospitals in the United States
interested in the Prism System that may have challenges with MRI
access. We plan to begin our limited market release on schedule
here in the second quarter, with a full market release in the
second half of 2024.”
The Prism Bone Anchor Accessory is intended to be used with
commercially available stereotactic systems for intracranial and
neurosurgical procedures which require accurate positioning of
compatible small surgical instruments or accessories in the
cranium, brain or nervous systems. It is designed to provide
short-term fixation and positioning of compatible neurosurgical
instruments or accessories under image-guidance.
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, which
may include the Company’s expectations for the future performance,
market, and revenue of its products. 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, 2023, which has been filed with the Securities and Exchange
Commission, and the Company’s Quarterly Report on Form 10-Q for the
three months ended March 31, 2024, which the Company intends to
file with the Securities and Exchange Commission on or before May
15, 2024. The Company does not assume any obligation to update
these forward-looking statements.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/66f919ac-c17e-402e-a88e-1211e8044e7c
Contact:
Media Contact:
Jacqueline Keller, Vice President of Marketing
(888) 287-9109 ext. 4
info@clearpointneuro.com
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
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