ClearPoint Neuro Announces EU MDR Certification for the SmartFlow Cannula
ClearPoint Neuro (NASDAQ:CLPT) has received European Medical Device Regulation (EU MDR) approval for its SmartFlow Neuro Cannula, well ahead of the 2027 deadline for Class III devices. The device, previously cleared under MDD 93/42/EEC, has now achieved extended shelf life of 48 months in the EU, doubled from the previous 24 months.
The SmartFlow Cannula has CE mark approval for delivering approved fluids into the brain during intracranial procedures and for Cytarabine injection or CSF removal from ventricles (14 gauge cannulas). Notably, it is included in PTC Therapeutics' Upstaza, the first approved gene therapy for direct brain infusion.
The company supports over 50 biopharma partners, with the approval reinforcing their ability to support clinical trials and commercialization globally. The certification was facilitated by the device's extensive clinical trial history, meeting EU MDR's enhanced requirements for safety measures, risk management, and post-market surveillance.
ClearPoint Neuro (NASDAQ:CLPT) ha ricevuto l'approvazione della Regolamentazione Europea sui Dispositivi Medici (EU MDR) per la sua SmartFlow Neuro Cannula, ben prima della scadenza del 2027 per i dispositivi di Classe III. Il dispositivo, precedentemente autorizzato secondo la MDD 93/42/EEC, ha ora ottenuto un'estensione della durata di conservazione di 48 mesi nell'UE, raddoppiata rispetto ai precedenti 24 mesi.
La SmartFlow Cannula ha l'approvazione del marchio CE per la somministrazione di fluidi approvati nel cervello durante le procedure intracraniche e per l'iniezione di Citarabina o la rimozione di liquido cerebrospinale dai ventricoli (cannule da 14 gauge). È particolarmente rilevante che sia inclusa nell'Upstaza di PTC Therapeutics, la prima terapia genica approvata per infusione diretta nel cervello.
L'azienda supporta oltre 50 partner biopharma, con l'approvazione che rafforza la loro capacità di supportare studi clinici e commercializzazione a livello globale. La certificazione è stata facilitata dalla lunga storia di trial clinici del dispositivo, che soddisfa i requisiti migliorati dell'EU MDR per misure di sicurezza, gestione del rischio e sorveglianza post-marketing.
ClearPoint Neuro (NASDAQ:CLPT) ha recibido la aprobación de la Regulación Europea de Dispositivos Médicos (EU MDR) para su SmartFlow Neuro Cannula, muy antes de la fecha límite de 2027 para dispositivos de Clase III. El dispositivo, previamente autorizado bajo la MDD 93/42/EEC, ahora ha logrado una vida útil extendida de 48 meses en la UE, el doble de los 24 meses anteriores.
La Cannula SmartFlow tiene la aprobación del marcado CE para la entrega de fluidos aprobados en el cerebro durante procedimientos intracraneales y para la inyección de Citarabina o la extracción de líquido cefalorraquídeo de los ventrículos (cánulas de 14 gauge). Es notable que esté incluida en Upstaza de PTC Therapeutics, la primera terapia génica aprobada para infusión directa en el cerebro.
La empresa apoya a más de 50 socios biopharma, con la aprobación que refuerza su capacidad para apoyar ensayos clínicos y comercialización a nivel global. La certificación fue facilitada por la extensa historia de ensayos clínicos del dispositivo, cumpliendo con los requisitos mejorados de la EU MDR para medidas de seguridad, gestión de riesgos y vigilancia post-comercialización.
ClearPoint Neuro (NASDAQ:CLPT)는 유럽 의료기기 규정(EU MDR)으로 SmartFlow Neuro Cannula에 대한 승인을 받았으며, 이는 2027년 클래스 III 장치의 기한보다 훨씬 앞선 것입니다. 이 장치는 이전에 MDD 93/42/EEC에 따라 승인되었으며, 이제 EU에서 48개월의 연장된 유통 기한을 달성하였으며, 이는 이전의 24개월에서 두 배로 증가한 것입니다.
SmartFlow Cannula는 뇌내 시술 중 승인된 액체를 주입하고, Citarabine 주사 또는 뇌실에서의 뇌척수액 제거를 위한 CE 마크 승인을 받았습니다 (14 게이지 캐뉼라). 특히, 이는 PTC Therapeutics의 Upstaza에 포함되어 있으며, 이는 뇌에 직접 주입하는 최초의 승인된 유전자 요법입니다.
회사는 50개 이상의 바이오제약 파트너를 지원하며, 이번 승인은 전 세계적으로 임상 시험 및 상업화를 지원할 수 있는 능력을 강화합니다. 이 인증은 안전 조치, 위험 관리 및 시판 후 감시에 대한 EU MDR의 강화된 요구 사항을 충족하는 장치의 광범위한 임상 시험 이력에 의해 촉진되었습니다.
ClearPoint Neuro (NASDAQ:CLPT) a reçu l'approbation de la Réglementation Européenne sur les Dispositifs Médicaux (EU MDR) pour sa SmartFlow Neuro Cannula, bien avant la date limite de 2027 pour les dispositifs de Classe III. L'appareil, précédemment approuvé selon la MDD 93/42/EEC, a maintenant obtenu une durée de conservation prolongée de 48 mois dans l'UE, le double des 24 mois précédents.
La SmartFlow Cannula a l'approbation du marquage CE pour l'administration de fluides approuvés dans le cerveau lors de procédures intracrâniennes et pour l'injection de Citarabine ou le retrait de liquide céphalorachidien des ventricules (cannules de 14 gauge). Il est à noter qu'elle est incluse dans l'Upstaza de PTC Therapeutics, la première thérapie génique approuvée pour l'infusion directe dans le cerveau.
L'entreprise soutient plus de 50 partenaires biopharma, cette approbation renforçant sa capacité à soutenir les essais cliniques et la commercialisation à l'échelle mondiale. La certification a été facilitée par l'historique d'essais cliniques étendu de l'appareil, répondant aux exigences renforcées de l'EU MDR en matière de mesures de sécurité, de gestion des risques et de surveillance post-commercialisation.
ClearPoint Neuro (NASDAQ:CLPT) hat die Genehmigung der Europäischen Medizinprodukteverordnung (EU MDR) für seine SmartFlow Neuro Cannula erhalten, und zwar lange vor der Frist von 2027 für Klasse-III-Geräte. Das Gerät, das zuvor unter der MDD 93/42/EEC genehmigt wurde, hat nun eine verlängerte Haltbarkeit von 48 Monaten in der EU erreicht, doppelt so viel wie die vorherigen 24 Monate.
Die SmartFlow Cannula hat die CE-Kennzeichnung genehmigt, um genehmigte Flüssigkeiten während intrakranieller Eingriffe ins Gehirn zu bringen und für die Injektion von Cytarabin oder die Entfernung von Liquor aus den Ventrikeln (14-Gauge-Cannulas). Bemerkenswert ist, dass sie in Upstaza von PTC Therapeutics enthalten ist, der ersten genehmigten Gentherapie zur direkten Infusion ins Gehirn.
Das Unternehmen unterstützt über 50 Biopharma-Partner, wobei die Genehmigung ihre Fähigkeit stärkt, klinische Studien und die weltweite Kommerzialisierung zu unterstützen. Die Zertifizierung wurde durch die umfangreiche klinische Studiengeschichte des Geräts erleichtert, die die verbesserten Anforderungen der EU MDR an Sicherheitsmaßnahmen, Risikomanagement und Marktüberwachung erfüllt.
- Received EU MDR approval ahead of 2027 deadline
- Extended shelf life from 24 to 48 months in EU
- Included in first approved gene therapy (Upstaza) for direct brain infusion
- Supporting over 50 biopharma partnerships
- None.
Insights
The EU MDR certification for ClearPoint's SmartFlow Cannula represents a significant regulatory achievement with substantial market implications. Securing this certification well ahead of the 2027 deadline for Class III devices demonstrates strong regulatory compliance capabilities and provides a competitive advantage in the European medical device market.
The extended shelf life to 48 months harmonizes with existing approvals in the United States and Brazil, creating several strategic benefits:
- Reduced inventory carrying costs and improved working capital efficiency
- Enhanced supply chain flexibility for hospitals and research institutions
- Lower environmental impact through reduced medical waste
- Improved cost-effectiveness for clinical trial operations
The certification's timing is particularly strategic as it coincides with the expanding gene therapy market in Europe. The SmartFlow Cannula's inclusion in PTC Therapeutics' Upstaza's product specifications as the delivery device for the first approved direct-to-brain gene therapy establishes a important precedent. This positions ClearPoint advantageously in the growing field of CNS-targeted gene therapies.
The extensive clinical trial history supporting this approval strengthens ClearPoint's position with their 50+ biopharma partners. The EU MDR's emphasis on safety measures, risk management, and post-market surveillance makes this certification particularly valuable for partners developing novel therapeutic approaches. This approval effectively reduces regulatory risks for pharmaceutical companies considering SmartFlow for their clinical trials or commercial applications in Europe.
SOLANA BEACH, CA / ACCESS Newswire / February 12, 2025 / 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.
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, 2023, and the Company's Quarterly Report on Form 10-Q for the three months ended September 30, 2024, 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, 2024, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2025. The Company does not assume any obligation to update these forward-looking statements.
Contact Information
Danilo D'Alessandro
Chief Financial Officer
ir@clearpointneuro.com
(888) 287-9109 ext. 3
Media Contact
info@clearpointneuro.com
SOURCE: ClearPoint Neuro, Inc.
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