ClearPoint Neuro, Together with its Partner Clinical Laserthermia Systems, Announces FDA Submission to Expand the Labeling of ClearPoint Prism(R) to Include 1.5 T MRI
ClearPoint Neuro (NASDAQ:CLPT) and its partner Clinical Laserthermia Systems (CLS) have submitted a 510(k) application to the FDA to expand the labeling of ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance. The system, which has shown rapid adoption in functional and oncological neurosurgical LITT procedures, is currently only approved for use under 3.0 T MRI guidance.
The company expects to receive clearance in the second half of 2025, which would unlock access to over 50% of the neuro LITT market in the United States that is currently inaccessible. The ClearPoint Prism system is indicated for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy under MRI guidance in neurosurgery at a wavelength of 1064nm.
ClearPoint Neuro (NASDAQ:CLPT) e il suo partner Clinical Laserthermia Systems (CLS) hanno presentato una domanda 510(k) alla FDA per ampliare l'etichettatura del ClearPoint Prism Neuro Laser Therapy System includendo la guida con risonanza magnetica a 1,5 T. Il sistema, che ha mostrato una rapida adozione nelle procedure neurochirurgiche LITT funzionali e oncologiche, è attualmente approvato solo per l'uso con guida RM a 3,0 T.
L'azienda prevede di ottenere l'autorizzazione nella seconda metà del 2025, il che permetterebbe di accedere a oltre il 50% del mercato neuro LITT negli Stati Uniti attualmente non raggiungibile. Il sistema ClearPoint Prism è indicato per la necrosi o coagulazione del tessuto molle tramite irradiazione interstiziale o terapia termica sotto guida RM in neurochirurgia, con una lunghezza d'onda di 1064 nm.
ClearPoint Neuro (NASDAQ:CLPT) y su socio Clinical Laserthermia Systems (CLS) han presentado una solicitud 510(k) a la FDA para ampliar el etiquetado del Sistema de Terapia Láser Neuro ClearPoint Prism para incluir guía por resonancia magnética de 1,5 T. El sistema, que ha mostrado una rápida adopción en procedimientos neuroquirúrgicos LITT funcionales y oncológicos, actualmente solo está aprobado para uso bajo guía de resonancia magnética de 3,0 T.
La compañía espera recibir la aprobación en la segunda mitad de 2025, lo que permitiría acceder a más del 50% del mercado neuro LITT en Estados Unidos que actualmente está inaccesible. El sistema ClearPoint Prism está indicado para necrosar o coagular tejido blando mediante irradiación intersticial o terapia térmica bajo guía de resonancia magnética en neurocirugía, con una longitud de onda de 1064 nm.
ClearPoint Neuro (NASDAQ:CLPT)와 파트너인 Clinical Laserthermia Systems (CLS)는 ClearPoint Prism Neuro Laser Therapy System의 라벨 확장을 위해 1.5T MRI 가이드를 포함하는 510(k) 신청서를 FDA에 제출했습니다. 이 시스템은 기능성 및 종양 신경외과 LITT 시술에서 빠르게 채택되고 있으며, 현재는 3.0T MRI 가이드 하에서만 사용 승인을 받았습니다.
회사는 2025년 하반기에 승인 받을 것으로 예상하며, 이는 현재 접근할 수 없는 미국 내 신경 LITT 시장의 50% 이상에 접근할 수 있게 될 것입니다. ClearPoint Prism 시스템은 1064nm 파장에서 MRI 가이드 하에 신경외과에서 간질 조사 또는 열 치료를 통해 연조직을 괴사시키거나 응고시키는 데 적응증이 있습니다.
ClearPoint Neuro (NASDAQ:CLPT) et son partenaire Clinical Laserthermia Systems (CLS) ont soumis une demande 510(k) à la FDA pour étendre l'étiquetage du Système de Thérapie Laser Neuro ClearPoint Prism afin d'inclure la guidance par IRM à 1,5 T. Le système, qui a connu une adoption rapide dans les procédures neurochirurgicales LITT fonctionnelles et oncologiques, est actuellement approuvé uniquement pour une utilisation sous guidage IRM à 3,0 T.
L'entreprise prévoit d'obtenir l'autorisation dans la seconde moitié de 2025, ce qui permettrait d'accéder à plus de 50 % du marché neuro LITT aux États-Unis, actuellement inaccessible. Le système ClearPoint Prism est indiqué pour la nécrose ou la coagulation des tissus mous par irradiation interstitielle ou thérapie thermique sous guidage IRM en neurochirurgie, à une longueur d'onde de 1064 nm.
ClearPoint Neuro (NASDAQ:CLPT) und sein Partner Clinical Laserthermia Systems (CLS) haben bei der FDA eine 510(k)-Anmeldung eingereicht, um die Zulassung des ClearPoint Prism Neuro Laser Therapy System auf die Nutzung mit 1,5 T MRT-Erkennung zu erweitern. Das System, das schnell in funktionellen und onkologischen neurochirurgischen LITT-Verfahren angenommen wurde, ist derzeit nur für die Verwendung unter 3,0 T MRT zugelassen.
Das Unternehmen erwartet die Zulassung in der zweiten Hälfte des Jahres 2025, was den Zugang zu über 50 % des neurochirurgischen LITT-Marktes in den USA ermöglichen würde, der derzeit nicht zugänglich ist. Das ClearPoint Prism System ist zur Nekrotisierung oder Koagulation von Weichgewebe durch interstitielle Bestrahlung oder Wärmetherapie unter MRT-Führung in der Neurochirurgie bei einer Wellenlänge von 1064 nm indiziert.
- Expected FDA clearance would unlock access to over 50% of additional neuro LITT market in the US
- System has already achieved rapid adoption in functional and oncological neurosurgical procedures
- None.
SOLANA BEACH, CA / ACCESS Newswire / April 28, 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, announces that today its partner, Clinical Laserthermia Systems AB (publ) (CLS), completed the submission of its 510(k) application to the FDA, expanding the indication of the ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance.
ClearPoint Prism has already seen rapid adoption across functional and oncological neurosurgical LITT procedures. "We anticipate that we will achieve clearance for 1.5 T in the second half of this year, unlocking more than
"This submission is a result of great collaboration between our companies. At CLS, we're proud to support ClearPoint Neuro in expanding access to the neuro LITT Market and driving global adoption of ClearPoint Prism," said Dan J. Mogren, CEO of CLS.
ClearPoint Prism is currently indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0 T magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery for a wavelength of 1064nm.
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 regulatory review timelines and outcomes, 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, which has been filed with the Securities and Exchange Commission, and the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2025, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 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
SOURCE: ClearPoint Neuro, Inc.
View the original press release on ACCESS Newswire
FAQ
What is the expected timeline for FDA clearance of ClearPoint Prism's 1.5T MRI expansion?
How much additional market access will CLPT gain with the 1.5T MRI approval?
What are the current approved uses for ClearPoint Prism Neuro Laser Therapy System?
Which procedures has ClearPoint Prism shown adoption in?
