SOLANA BEACH, California, April 13, 2023 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (NASDAQ: CLPT) (the “Company”), a global platform company that provides brain navigation and delivery, today announced the successful registration of its Neuro Navigation portfolio with the Brazilian regulatory body, Agência Nacional de Vigilância Sanitária (ANVISA) .
“I had the opportunity to see the ClearPoint Neuro Navigation System in action several times and was thrilled to learn that it was finally approved by the Brazilian regulatory agency,” said Raquel Rodrigues, MD, M.Sc, Pediatric Neurosurgeon and Neuro-oncologist in Brazil. “With a very intuitive interface and software, I personally believe that it is easy to manage its features, even for a neurosurgeon only trained in traditional neuro navigation methods. With ClearPoint we plan, for the first time in Latin America, to offer our patients unprecedented medical treatments, such as Convection Enhanced Delivery (CED) for brain cancer and neurodegenerative disorders with intra-procedural guidance by magnetic resonance imaging. Furthermore, with this system we hope to refine our DBS implants, deep brain biopsies and laser ablations. I am honored to lead the neurosurgical team that will perform the first neurosurgery with this splendid technology here in Brazil”.
“We are incredibly proud to have achieved ANVISA approval following an extensive review,” explained Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “Our first approval in Latin America is an important milestone that supports our 4th pillar of growth: international expansion”. Every global approval we gain helps us and our pharmaceutical partners deliver new therapies, both clinically and in clinical trials, to patients with some of the most devastating neurological diseases.”
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 accuracy. Applications of the company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and drug delivery, biology, and brain gene therapy. The ClearPoint® Neuro Navigation System is FDA cleared, CE marked, and installed in over 65 locations in North America, Europe, and South America. ClearPoint Neuro partners with more than 50 biological/pharmaceutical companies, academic centers, and contract research organizations, providing solutions for the direct delivery of CNS therapeutics in preclinical studies and clinical trials worldwide. To date, over 6,000 procedures have been performed and supported by the company’s team of clinical experts, who provide support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.
Forward-looking Statements
Statements in this press release regarding the Company’s plans, growth and strategies may be forward-looking statements within the context of federal securities laws. Statements regarding the Company’s future events, developments and future performance, the size of the total addressable markets or market opportunity for the Company’s products and services, as well as management’s expectations, beliefs, plans, estimates or projections relating to the future , are forward-looking statements within the meaning of these laws. Uncertainties and risks might cause the Company’s actual results to differ materially from those expressed or implied by forward-looking statements. Particular uncertainties and risks include those related to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenues from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, market and achieve broader market acceptance of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biological partners and drug distributors to achieve commercial success, including the use of our products and services in their delivery of therapies; and risks inherent in the research, development and regulatory approval of new products. More detailed information regarding these and additional factors that might 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, which was filed with Securities and Exchange Commission.
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Contato: Contato para os media – ClearPoint Neuro Jacqueline Keller, Vice-presidente de Marketing 949-900-6833 [email protected] Relações com Investidores – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke [email protected]
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