ClearPoint Neuro Congratulates Partner PTC Therapeutics on Receiving European Commission Marketing Clearance for Upstaza™



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SOLANA BEACH, Calif., July 21 10, 2022 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy platform company enabling brain navigation and delivery, congratulates its partner PTC Therapeutics on obtaining the marketing authorization for Upstaza™ (eladocagene exuparvovec) by the European Commission. Upstaza is the first disease-modifying therapy approved for aromatic L-amino acid decarboxylase deficiency (AADC), a rare and life-threatening disease affecting children, and is the first commercially available gene therapy approved for direct infusion into the brain. The use of ClearPoint Neuro’s patented SmartFlow® neurological cannula for minimally invasive infusion of gene therapy is included in Upstaza’s SmPC (summary of product characteristics). The marketing authorization, approved for patients 18 months and older, applies to the 27 member states of the European Union, plus Iceland, Norway and Liechtenstein.

“The approval of Upstaza by the European Commission will have an immense impact on patients, their families and the global gene therapy research community. Upstaza is the world’s first approved gene therapy to be delivered by direct infusion into the brain using ClearPoint’s SmartFlow cannula during a minimally invasive neurosurgical procedure,” commented Joe Burnett, President and CEO. from ClearPoint Neuro. “We believe the precedent set by this regulatory approval paves the way for our 45 current and future pharmaceutical, academic and biotechnology partners. We are incredibly proud of our partnership with PTC and look forward to seeing our team continue to support patients and providers face-to-face during these procedures at neurosurgery centers around the world.

About Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency

AADC deficiency is a rare and fatal genetic disease that usually causes severe disability and suffering from the first months of life, affecting all aspects of life – physical, mental and behavioral. The suffering of children with AADC deficiency can be exacerbated by: episodes of distressing oculogyric crises such as convulsions causing rolling eyes in the head, frequent vomiting, behavioral problems and sleep disturbances.

The lives of affected children are severely affected and shortened. Ongoing physical therapy, occupational therapy, and speech therapy, as well as interventions including surgery, are also often needed to manage life-threatening complications such as infections, serious eating and breathing problems.

About SmartFlow® CannulaWith over 5,000 cannulas sold to date, SmartFlow is the only co-branded device to gain regulatory approval for delivery of approved gene therapy to the brain. The industry-leading cannula is used by many of ClearPoint Neuro’s 45 pharmaceutical, academic and biotechnology partners to bypass the blood-brain barrier and deliver therapeutics to regions of interest using the convection enhanced delivery (CED) under direct image guidance. The SmartFlow cannula has received 510(k) clearance from the FDA for use in the United States for aspiration of cerebrospinal fluid or injection of the chemotherapy drug Cytarabine into the ventricles. It has also been CE marked for delivering approved fluids to the brain and for cerebrospinal fluid aspiration. SmartFlow is used in approved clinical and preclinical studies for various research and drug trials.

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore the quality of life for patients and their families by enabling therapies for the most complex neurological disorders with pinpoint precision. Applications of the company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuroaspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System is FDA cleared, CE marked, and installed at more than 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 45 biologic/pharmaceutical companies and academic centers, providing solutions for the direct delivery of therapeutics to the CNS in preclinical studies and clinical trials worldwide. To date, more than 5,000 cases have been treated and supported by the company’s team of field clinical specialists, who provide support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com

Forward-looking statements

The following statements regarding the Company’s plans, growth and strategies may include forward-looking statements within the context of federal securities laws. Statements regarding future events, developments and future performance of the Company, as well as management’s expectations, beliefs, plans, estimates or projections regarding the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company’s actual results to differ materially from those expressed or implied by the forward-looking statements. Particular risks and uncertainties include those related to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenues from sales of the Company’s ClearPoint Neuro navigation system products; the Company’s ability to market, market and achieve broader market acceptance for the Company’s ClearPoint Neuro navigation system products; and the risks inherent in the research and development of new products. More detailed information about these and other factors that could affect the Company’s actual results is described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended 31 December 2021, and in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, both of which have been filed with the Securities and Exchange Commission.

Contact:

Jacqueline Keller, Vice President, Marketing
1 (888) 287-9109
[email protected]

Caroline Corner, Investor Relations
[email protected]

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Source: ClearPoint Neuro, Inc.

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