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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 receipt of European Medical Device Regulation (EU MDR) approval for the SmartFlow Neuro Cannula.
The SmartFlow Cannula was previously cleared under the Medical Device Directive 93/42/EEC (MDD) and has now successfully achieved the more rigorous EU MDR certification well ahead of the 2027 deadline for Class III devices. In addition, the updated certification has extended the shelf life of the SmartFlow Cannula to 48 months in the European Union (EU), an increase from the prior shelf life of 24 months.
"Receiving EU MDR clearance for SmartFlow shows our commitment to the European market and to supporting our partners who are running clinical trials or commercializing their therapies in the region," stated Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. "We are also happy to announce the longer 48 month shelf life, which now matches our shelf life in the United States and Brazil, as this will help our customers with inventory management and improve sustainability by reducing waste. We are proud to have achieved this milestone so far in advance of the required timeframe."
"This approval is made possible by the significant global clinical trial history of the SmartFlow Cannula," said Jeremy Stigall, Chief Business Officer of ClearPoint Neuro. "Under EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access. The many years of trial experience with the SmartFlow Cannula contributed greatly to its successful review and approval. This approval will give our over 50 biopharma partners, some of whom are headquartered in the EU, the confidence that we can support clinical trials and eventual commercialization globally."
In the EU, SmartFlow has received CE mark for the delivery of approved fluids into the brain during intracranial procedures, as well as injection of Cytarabine or removal of CSF (14 gauge cannulas only) from the ventricles. PTC Therapeutics' Upstaza, the first marketed gene therapy approved for direct infusion into the brain, includes the use of SmartFlow for minimally invasive infusion of the gene therapy in the Summary of Product Characteristics.
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.