ClearPoint Neuro Announces FDA Clearance Expanding Compatibility of the ClearPoint Prism Neuro Laser Therapy System with 1.5T MRI Scanners
ClearPoint Neuro (NASDAQ:CLPT) has received FDA 510(k) clearance for its ClearPoint Prism Neuro Laser Therapy System to include 1.5T MRI guidance, expanding from the previously cleared 3T MRI guidance. This expansion is significant as 1.5T MRI systems represent approximately 60% of clinical use in the US and over 70% of the global installed MRI base.
The company's Functional Neurosurgery disposable products, including ClearPoint Prism laser applicators, demonstrated strong growth with 70% increase in Q1 and 33% in Q2 2025. The expanded compatibility positions ClearPoint Prism for immediate full market release on 1.5T systems, potentially accelerating the company's growth initiatives.
ClearPoint Neuro (NASDAQ:CLPT) ha ottenuto la clearance FDA 510(k) per il sistema ClearPoint Prism Neuro Laser Therapy, che ora supporta anche la guida con risonanza magnetica 1.5T, oltre alla precedente compatibilità con i sistemi a 3T. Questo aggiornamento è rilevante perché i sistemi 1.5T costituiscono circa il 60% dell'utilizzo clinico negli USA e oltre il 70% della base installata globale di RM.
I prodotti monouso per la neurochirurgia funzionale dell'azienda, inclusi gli applicatori laser ClearPoint Prism, hanno registrato una forte crescita: un aumento del 70% nel primo trimestre e del 33% nel secondo trimestre 2025. La nuova compatibilità su sistemi 1.5T consente il rilascio completo immediato sul mercato, potenzialmente accelerando le iniziative di crescita dell'azienda.
ClearPoint Neuro (NASDAQ:CLPT) ha obtenido la aprobación FDA 510(k) para su sistema ClearPoint Prism Neuro Laser Therapy para incluir la guía por resonancia magnética de 1.5T, ampliando la compatibilidad previamente autorizada con 3T. Esta ampliación es importante porque los sistemas 1.5T representan aproximadamente el 60% del uso clínico en EE. UU. y más del 70% de la base instalada mundial de resonancias.
Los productos desechables de cirugía neurológica funcional de la compañía, incluidos los aplicadores láser ClearPoint Prism, mostraron un fuerte crecimiento con un 70% de aumento en el primer trimestre y 33% en el segundo trimestre de 2025. La compatibilidad ampliada posiciona a ClearPoint Prism para un lanzamiento inmediato y completo en sistemas 1.5T, lo que podría acelerar las iniciativas de crecimiento de la compañía.
ClearPoint Neuro (NASDAQ:CLPT)가 ClearPoint Prism Neuro Laser Therapy System에 대해 1.5T MRI 가이드를 포함하도록 FDA 510(k) 승인을 받았습니다. 이전에는 3T MRI 가이드만 승인되어 있었습니다. 이번 확장은 미국 임상 사용의 약 60%를 차지하고 전 세계 설치된 MRI의 70% 이상을 차지하는 1.5T 시스템의 비중을 고려할 때 의미가 큽니다.
ClearPoint Prism 레이저 어플리케이터를 포함한 회사의 기능성 신경외과 일회용 제품은 1분기 70% 증가, 2025년 2분기 33% 증가로 강한 성장세를 보였습니다. 1.5T 시스템에 대한 확장된 호환성은 ClearPoint Prism이 즉시 전면 시장 출시될 수 있게 하여 회사의 성장 계획을 가속화할 가능성이 있습니다.
ClearPoint Neuro (NASDAQ:CLPT) a obtenu l'autorisation FDA 510(k) pour son système ClearPoint Prism Neuro Laser Therapy afin d'inclure la guidage par IRM 1,5T, en plus de la guidage précédemment approuvée pour 3T. Cette extension est importante car les systèmes 1,5T représentent environ 60% de l'utilisation clinique aux États-Unis et plus de 70% de la base installée mondiale d'IRM.
Les dispositifs jetables de neurochirurgie fonctionnelle de la société, y compris les applicateurs laser ClearPoint Prism, ont connu une forte croissance avec une augmentation de 70% au T1 et de 33% au T2 2025. La compatibilité étendue permet un déploiement complet immédiat sur les systèmes 1,5T, ce qui pourrait accélérer les initiatives de croissance de la société.
ClearPoint Neuro (NASDAQ:CLPT) hat die FDA-510(k)-Zulassung für sein ClearPoint Prism Neuro Laser Therapy System erhalten, die nun auch 1,5T-MRT-Führung einschließt und damit über die bisher zugelassene 3T-MRT-Führung hinausgeht. Diese Erweiterung ist bedeutend, da 1,5T-MRT-Systeme etwa 60% der klinischen Nutzung in den USA und über 70% des weltweit installierten MRT-Bestands ausmachen.
Die Einwegprodukte des Unternehmens für die funktionelle Neurochirurgie, darunter die ClearPoint Prism Laser-Applikatoren, verzeichneten starkes Wachstum mit einem 70%igen Anstieg im ersten Quartal und 33% im zweiten Quartal 2025. Die erweiterte Kompatibilität ermöglicht die sofortige vollständige Markteinführung auf 1,5T-Systemen und könnte die Wachstumsinitiativen des Unternehmens beschleunigen.
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Insights
FDA clearance of ClearPoint Prism for 1.5T MRIs unlocks 60% of US market, significantly expanding revenue potential and clinical adoption.
ClearPoint Neuro has secured a crucial FDA clearance that expands compatibility of their Prism Neuro Laser Therapy System to include 1.5T MRI machines, in addition to previously approved 3T systems. This regulatory win is strategically significant as 1.5T MRIs represent
The timing couldn't be better for CLPT's growth trajectory. Their functional neurosurgery disposable products, which include the Prism laser applicators, have shown impressive momentum with
What makes this particularly valuable is the dual-impact nature of the approval. Beyond the immediate revenue potential from laser ablation procedures, ClearPoint's technology establishes the infrastructure and clinical expertise needed for the company's long-term strategy in cell and gene therapy delivery. Each laser procedure a surgical team performs today builds capabilities that position hospitals for future adoption of minimally-invasive cell and gene therapy techniques.
Most importantly, the company is executing a full market release immediately rather than a phased rollout, indicating confidence in the technology and suggesting minimal barriers to adoption at 1.5T facilities. For a company targeting Functional Neurosurgery growth, this expansion removes a significant bottleneck and should accelerate procedure volumes in the coming quarters.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 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 that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance.
This expanded labeling could significantly increase ClearPoint Prism's market opportunity within the United States, where 1.5T MRI systems account for approximately
"The expanded labeling for ClearPoint Prism is perfect timing for the Company as it delivers added fuel to our 2025 growth initiatives, which we call Fast Forward," commented Joe Burnett, President & CEO at ClearPoint Neuro. "This product will contribute meaningfully to these goals, both today and tomorrow. In the immediate term, we are excited to bring the benefits of ClearPoint Prism to hospitals that did not have the previously cleared MRI scanner available. As a reminder, our Functional Neurosurgery disposable products, including ClearPoint Prism laser applicators, grew
"The longer-term benefits are more subtle but equally important," continued Burnett. "As a company, we are still at the very early stages of our biggest value driver in commercial cell and gene therapy delivery. The expanded labeling helps us in this exciting and adjacent market in two ways. First, we gain scale because we will have another product in our commercial bag that will allow us to hire expert clinical specialists into cities that have greater volume, increasing hospital consistency and relationships, while at the same time reducing travel expenses. Second, we believe there is no procedure that surgeons can do clinically today that better mimics a drug delivery procedure than laser ablation. ClearPoint Prism cases cover many different trajectories, are minimally invasive through tiny burr holes, are performed under MRI guidance, and deliver a volume-driven therapy to the patient. Every ClearPoint Prism case a surgical team does today helps them to build a new capability for the exciting future of cell and gene therapy."
"We're dedicated to providing our customers an adaptable, forward-thinking system that is designed for a streamlined setup, consistent performance, and optimized surgical workflows," stated Chris Osswald, PhD, Director and Global Segment Leader for Laser Therapy. "With this clearance, we've maintained our high-performance specifications and are well-positioned to build upon our momentum. Since the full market release on 3T MRI last year, we are encouraged by the number of inquiries from sites without 3T access, reflecting strong market interest. We believe surgeons are eager to use ClearPoint Prism on 1.5T, enabling more patients to benefit from advanced laser therapy. Given the significant and positive early experience that we've had on 3T, we plan to enter full market release on 1.5T immediately."
ClearPoint Prism is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 1.5T and 3.0T magnetic resonance imaging (MRI) guidance in neurosurgery for a wavelength of 1064nm.
1 Moser E, Laistler E, Schmitt F and Kontaxis G (2017) Ultra-High Field NMR and MRI-The Role of Magnet Technology to Increase Sensitivity and Specificity. Front Phys. 5:33. doi: 10.3389/fphy.2017.00033.
2 IMV Medical Information Division. 2015 MR Market Outlook Report. IMVinfo, 2015.
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 preclinical 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 central nervous system delivery of therapeutics in preclinical 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: macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; 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 ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; 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 the Company's new products and the new products of its biologics and drug delivery partners. 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, 2024, and the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2025, both of which have been filed with the Securities and Exchange Commission. 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
SOURCE: ClearPoint Neuro, Inc.
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