ClearPoint Neuro Announces FDA Clearance for SmartFrame OR™ Stereotactic System
January 16 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 SmartFrame OR™ Stereotactic System.
The SmartFrame OR Stereotactic System is composed of two main
components: the SmartFrame OR, and the ClearPointer™ Optical
Navigation Wand. The SmartFrame OR is intended to provide
stereotactic guidance for the placement and operation of
instruments or devices during planning and operation of
neurological procedures performed in conjunction with the use of a
compatible optical stereotaxic navigation system using preoperative
MR and/or CT imaging. These procedures include biopsies, catheter
placement and electrode introduction. The ClearPointer is intended
to be used in conjunction with the SmartFrame OR and a compatible
stereotactic optical navigation system for patient registration and
navigation. SmartFrame OR may be used with or without available
bone screw fiducials. The Company plans to commence limited market
release in the first half of 2024, with a planned full market
release in the second half of 2024.
“Expanding ClearPoint’s portfolio beyond the MRI into the
operating room is of key strategic significance to the Company in
2024 and beyond,” stated Joe Burnett, President and CEO at
ClearPoint Neuro. “More than 95% of all stereotactic
neuro-navigation procedures take place in the OR, supporting DBS,
Laser Ablation, Biopsy, sEEG, and more. This product is the first
in ClearPoint’s history that does not require the use of MRI during
the procedure, allowing us to access more hospitals, and to support
an order of magnitude more patients than our legacy portfolio.
Importantly, the SmartFrame OR is compatible with capital hardware
and software already present in many neurosurgical operating rooms
and should not require the approval by hospital capital committees
for surgeons to try this new product.”
“SmartFrame OR embodies over a decade of accumulated expertise
in MRI-guided navigation, now enhanced with the latest OR imaging
technology,” said Rob Rubio, Segment Leader for
Neuromodulation at ClearPoint Neuro. “It offers surgeons flexible
workflows, including iCT forward projection, enabling precise
image-based corrections to achieve submillimetric accuracy.”
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, 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.
A video accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/a2ebbab0-b838-4d64-b33f-d57fdb80a9a6
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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