ClearPoint Neuro Announces FDA Clearance for ClearPoint Navigation Software Version 3.0
ClearPoint Neuro (NASDAQ:CLPT) has received FDA 510(k) clearance for its ClearPoint Navigation Software Version 3.0, expanding its navigation capabilities from exclusively MRI-guided workflows to include intraoperative CT and Conebeam CT imaging in operating rooms. This enhancement allows precision-guided neurosurgery in facilities without intraoperative MRI capabilities.
The software, used with SmartFrame® XG stereotactic frame, provides precise guidance for neurosurgical procedures including biopsies, catheter and electrode insertion, and deep brain stimulation lead placement. Currently, over 95% of U.S. stereotactic procedures occur in operating rooms using CT imaging.
The company plans a market release in Q1 2025, followed by a full market release in the second half of 2025. This development aims to standardize cell and gene therapy delivery globally, supporting ClearPoint's 50+ global biopharma partners.
ClearPoint Neuro (NASDAQ:CLPT) ha ricevuto l'approvazione FDA 510(k) per il suo ClearPoint Navigation Software Versione 3.0, ampliando le sue capacità di navigazione da flussi di lavoro esclusivamente guidati da risonanza magnetica (MRI) a includere l'imaging intraoperatorio con CT e Conebeam CT nelle sale operatorie. Questo miglioramento consente interventi di neurochirurgia guidati da precisione in strutture senza capacità di MRI intraoperatoria.
Il software, utilizzato con il sistema stereotattico SmartFrame® XG, fornisce una guida precisa per procedure neurochirurgiche tra cui biopsie, inserimento di cateteri ed elettrodi e posizionamento di elettrodi per stimolazione cerebrale profonda. Attualmente, oltre il 95% delle procedure stereotattiche negli Stati Uniti si svolge in sale operatorie utilizzando imaging CT.
La società prevede un lancio sul mercato nel Q1 2025, seguito da un rilascio completo sul mercato nella seconda metà del 2025. Questo sviluppo mira a standardizzare la somministrazione di terapie cellulari e geniche a livello globale, supportando oltre 50 partner biopharma globali di ClearPoint.
ClearPoint Neuro (NASDAQ:CLPT) ha recibido la aprobación 510(k) de la FDA para su Software de Navegación ClearPoint Versión 3.0, ampliando sus capacidades de navegación de flujos de trabajo exclusivamente guiados por MRI a incluir imágenes intraoperatorias de CT y Conebeam CT en las salas de operaciones. Esta mejora permite una neurocirugía guiada con precisión en instalaciones sin capacidades de MRI intraoperatorias.
El software, que se utiliza con el marco estereotáctico SmartFrame® XG, proporciona orientación precisa para procedimientos neuroquirúrgicos como biopsias, inserción de catéteres y electrodos, y colocación de electrodos para estimulación cerebral profunda. Actualmente, más del 95% de los procedimientos estereotácticos en EE. UU. se realizan en salas de operaciones que utilizan imágenes de CT.
La empresa planea un lanzamiento al mercado en el primer trimestre de 2025, seguido de un lanzamiento completo en la segunda mitad de 2025. Este desarrollo tiene como objetivo estandarizar la entrega de terapias celulares y génicas a nivel global, apoyando a más de 50 socios biopharma globales de ClearPoint.
ClearPoint Neuro (NASDAQ:CLPT)는 ClearPoint Navigation Software Version 3.0에 대해 FDA 510(k) 승인을 받았으며, 이로 인해 MRI 유도 작업 흐름에서 수술실 내의 CT 및 Conebeam CT 이미지로 내비게이션 기능이 확장되었습니다. 이 개선을 통해 MRI 내시경 기능이 없는 시설에서도 정밀하게 유도된 신경외과 수술이 가능합니다.
SmartFrame® XG 스테레오타틱 프레임과 함께 사용되는 이 소프트웨어는 생검, 카테터 및 전극 삽입, 심부 뇌 자극 전극 위치 선정 등 신경외과 절차에 대한 정확한 가이드를 제공합니다. 현재 미국에서 시행되는 스테레오타틱 절차의 95% 이상이 CT 이미지를 사용하는 수술실에서 이루어지고 있습니다.
회사는 2025년 1분기에 시장 출시를 계획하고 있으며, 2025년 하반기에 풀 마켓 출시를 이어갈 예정입니다. 이번 발전은 전 세계적으로 세포 및 유전자 치료 제공의 표준화를 목표로 하며, ClearPoint의 50개 이상의 글로벌 바이오제약 파트너를 지원합니다.
ClearPoint Neuro (NASDAQ:CLPT) a reçu l'approbation FDA 510(k) pour son logiciel de navigation ClearPoint Version 3.0, élargissant ses capacités de navigation de flux de travail exclusivement guidés par IRM pour inclure l'imagerie intra-opératoire en CT et Conebeam CT dans les salles d'opération. Cet amélioration permet une neurochirurgie guidée avec précision dans des installations sans capacités d'IRM intra-opératoire.
Le logiciel, utilisé avec le cadre stéréotaxique SmartFrame® XG, offre une guidance précise pour les procédures neurochirurgicales, y compris les biopsies, l'insertion de cathéters et d'électrodes, ainsi que le placement d'électrodes de stimulation cérébrale profonde. Actuellement, plus de 95 % des procédures stéréotaxiques aux États-Unis se déroulent dans des salles d'opération utilisant l'imagerie CT.
L'entreprise prévoit un lancement sur le marché au premier trimestre 2025, suivi d'un lancement complet sur le marché dans la seconde moitié de 2025. Ce développement vise à standardiser la délivrance des thérapies cellulaires et géniques à l'échelle mondiale, en soutenant plus de 50 partenaires biopharma mondiaux de ClearPoint.
ClearPoint Neuro (NASDAQ:CLPT) hat die FDA 510(k)-Zulassung für seine ClearPoint-Navigationssoftware Version 3.0 erhalten, wodurch die Navigationsmöglichkeiten von ausschließlich MRT-geführten Arbeitsabläufen auf intraoperative CT- und Conebeam-CT-Bildgebung in Operationssälen erweitert werden. Diese Verbesserung ermöglicht eine präzisionsgeführte Neurochirurgie in Einrichtungen ohne intraoperative MRT-Funktionalitäten.
Die Software, die zusammen mit dem SmartFrame® XG stereotaktischen Rahmen verwendet wird, bietet präzise Anleitung für neurochirurgische Verfahren, einschließlich Biopsien, Katheter- und Elektrodeninsertion sowie die Platzierung von Elektroden für die tiefe Hirnstimulation. Derzeit finden über 95 % der stereotaktischen Verfahren in den USA in Operationssälen unter Verwendung von CT-Bildgebung statt.
Das Unternehmen plant einen Marktstart im ersten Quartal 2025, gefolgt von einer vollständigen Markteinführung in der zweiten Hälfte von 2025. Diese Entwicklung zielt darauf ab, die Bereitstellung von Zell- und Gentherapien weltweit zu standardisieren und unterstützt über 50 globale Biopharma-Partner von ClearPoint.
- FDA 510(k) clearance received for ClearPoint Navigation Software Version 3.0
- Expansion into CT-guided procedures, accessing 95% of U.S. stereotactic procedures market
- Enhanced market potential through compatibility with both MRI and CT imaging
- Potential for global standardization of cell and gene therapy delivery
- Phased rollout strategy may delay full revenue potential until H2 2025
Insights
The FDA clearance of ClearPoint's Navigation Software 3.0 marks a pivotal strategic expansion that could significantly reshape the company's market position. The new software's dual compatibility with both CT and MRI imaging represents a major competitive advantage in the
Three key factors make this development particularly significant for investors:
- The software's compatibility with CT imaging addresses 95% of the current stereotactic procedure market, dramatically expanding ClearPoint's addressable market from MRI-only procedures.
- The elimination of third-party navigation systems creates a compelling cost efficiency argument for hospitals, potentially accelerating adoption rates and improving margins.
- The standardized workflow across both CT and MRI procedures could make ClearPoint the preferred platform for the company's 50+ global biopharma partners conducting cell and gene therapy trials.
The planned Q1 2025 release, followed by full commercialization in H2 2025, suggests a methodical approach to market introduction. This timing aligns strategically with the anticipated surge in cell and gene therapy treatments, positioning ClearPoint to capture a larger share of this high-growth market segment.
The software's enhanced flexibility could drive faster hospital adoption rates, particularly among facilities without intraoperative MRI capabilities, which represent the majority of potential customers. This broader market access, combined with the simplified workflow and reduced dependence on third-party systems, creates a compelling value proposition that could accelerate revenue growth in both the hardware and recurring revenue segments.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 27, 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 it has received 510(k) clearance for its ClearPoint Navigation Software Version 3.0.
"As we prepare for the wave of new patients that will be treated with cell and gene therapies in the years ahead, it is crucial that ClearPoint helps healthcare providers be ready by providing simplified workflows, offering solutions to increase surgical capacity and expanding access to our hardware and software," commented Joe Burnett, President and CEO at ClearPoint Neuro. "The newest ClearPoint 3.0 platform is designed to do exactly that by offering one of the fastest and most accurate navigation systems available while enabling the flexibility to be used in both the MRI suite and the operating room. Today, more than nighty-five percent of all stereotactic procedures in the United States take place in the operating room using Computed Tomography (CT) as the imaging modality. Using CT, the ClearPoint Software now supports the entire operating room procedure, eliminating the need for additional third-party navigation systems. Hospitals can use ClearPoint in either or both settings, benefiting from a consistent workflow that streamlines procedures and builds proficiency. We believe that this single, flexible solution will benefit our 50+ global biopharma partners with the potential to standardize cell and gene therapy delivery around the world, starting here in the United States."
ClearPoint Navigation Software Version 3.0 introduces an intraoperative CT workflow that builds on over a decade of experience in enabling MRI-guided stereotactic procedures. While previous versions of ClearPoint software supported MRI-guided workflows exclusively, the latest release extends ClearPoint navigation capabilities to the operating room. With compatibility for intraoperative CT and Conebeam CT imaging, this enhancement broadens access to precision-guided neurosurgery for facilities without intraoperative MRI capabilities. The ClearPoint Navigation Software Version 3.0 when used in conjunction with the SmartFrame® XG stereotactic frame, is intended to provide precise stereotactic guidance when placing instruments or devices during neurosurgical procedures. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (asleep or awake) lead placement.
The Company plans to initiate a limited market release for ClearPoint Navigation Version 3.0 in Q1 2025, with a planned full market release in the second half of 2025.
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.
View the original press release on ACCESS Newswire
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