ClearPoint Neuro Congratulates its Partner PTC Therapeutics on Completion of Biologics License Application Submission to FDA for Upstaza™ as a Treatment for AADC Deficiency
19 Mars 2024 - 1:07PM
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 congratulates its partner
PTC Therapeutics on completion of its BLA submission to the U.S.
Food and Drug Administration (FDA) for the approval of Upstaza™
(eladocagene exuparvovec), an investigational treatment for AADC
Deficiency. If approved, Upstaza™
would
become the first therapy to treat AADC Deficiency in the United
States.
“AADC Deficiency is a devastating rare pediatric movement
disorder that causes significant developmental delays and autonomic
symptoms starting from birth. Patients with AADC deficiency are at
a high risk of death in the first decade of life,” stated Jeremy
Stigall, Chief Business Officer at ClearPoint Neuro. “The Upstaza™
BLA is the first filing for FDA approval of a treatment that
addresses this devastating condition. Through our partnership with
PTC, we are demonstrating our commitment to drive progress for the
AADC Deficiency community.”
About aromatic L-amino acid decarboxylase (AADC)
deficiency
AADC deficiency is a fatal, rare genetic disorder that typically
causes severe disability and suffering from the first months of
life, affecting every aspect of life – physical, mental and
behavioral. The suffering of children with AADC deficiency may be
exacerbated by episodes of distressing seizure-like oculogyric
crises causing the eyes to roll up in the head, frequent vomiting,
behavioral problems, and difficulty sleeping.
The lives of affected children are severely impacted and
shortened. Ongoing physical, occupational and speech therapy, and
interventions, including surgery, also are often required to manage
potentially life-threatening complications such as infections,
severe feeding and breathing problems.
About the SmartFlow®
Cannula
With over 7,000 cannulas sold to date, SmartFlow is the only
co-labeled device to gain approval by a regulatory agency for
delivery of an approved gene therapy to the brain. The
industry-leading cannula is used by many of ClearPoint Neuro’s 50+
pharmaceutical, academic, and biotech partners to bypass the blood
brain barrier and deliver therapeutics to regions of interest using
Convection Enhanced Delivery (CED) under direct image guidance. The
SmartFlow Cannula has 510(k) clearance from the FDA for use in the
United States for the aspiration of cerebrospinal fluid or
injection of the chemotherapy drug Cytarabine into the ventricles.
It has also been CE marked to deliver approved fluids into the
brain and for aspiration of cerebrospinal fluid, and holds
regulatory clearance for clinical use in Israel and Brazil.
SmartFlow is utilized in approved clinical and preclinical studies
for various research and drug trials.
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 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, 2023, which has been filed with the Securities and Exchange
Commission. 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/d375ef5e-925f-4976-8bb2-63f3e90871a3
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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