ClearPoint Neuro Announces Full Market Release of ClearPoint Navigation Software Version 3.0 – Delivering the First End-to-End ClearPoint Navigation Solution to the Operating Room
ClearPoint Neuro (NASDAQ:CLPT) has announced the full market release of ClearPoint Navigation Software Version 3.0, introducing an iCT image-guidance workflow option for traditional operating rooms. The new version builds on their decade of MRI-guided procedure experience, offering the same precision with enhanced accessibility and efficiency.
The software is compatible with standard iCT scanners in any operating room, with early adoption reported during market release. The platform will be showcased at the American Academy of Neurological Surgeons Annual Meeting in Boston (April 25-28, 2025).
Dr. Ellen Air from Henry Ford Health confirms the software achieves equivalent placement accuracy as MRI-guidance without requiring MRI infrastructure. The system supports various procedures including biopsies, catheter and electrode insertion, and deep brain stimulation lead placement.
ClearPoint Neuro (NASDAQ:CLPT) ha annunciato il rilascio completo sul mercato della Versione 3.0 del software ClearPoint Navigation, che introduce un'opzione di flusso di lavoro con guida per immagini iCT per le sale operatorie tradizionali. La nuova versione si basa su un decennio di esperienza nelle procedure guidate da risonanza magnetica, offrendo la stessa precisione con maggiore accessibilità ed efficienza.
Il software è compatibile con gli scanner iCT standard presenti in qualsiasi sala operatoria, con prime adozioni già registrate durante il lancio sul mercato. La piattaforma sarà presentata al Congresso Annuale dell'American Academy of Neurological Surgeons a Boston (25-28 aprile 2025).
La dottoressa Ellen Air della Henry Ford Health conferma che il software garantisce una precisione di posizionamento equivalente a quella guidata da MRI senza necessitare di infrastrutture MRI. Il sistema supporta diverse procedure, tra cui biopsie, inserimento di cateteri ed elettrodi, e il posizionamento di elettrodi per la stimolazione cerebrale profonda.
ClearPoint Neuro (NASDAQ:CLPT) ha anunciado el lanzamiento completo en el mercado de la Versión 3.0 del software ClearPoint Navigation, que introduce una opción de flujo de trabajo guiado por imágenes iCT para quirófanos tradicionales. La nueva versión se basa en una década de experiencia en procedimientos guiados por resonancia magnética, ofreciendo la misma precisión con mayor accesibilidad y eficiencia.
El software es compatible con escáneres iCT estándar en cualquier quirófano, con adopciones tempranas reportadas durante el lanzamiento. La plataforma se presentará en la Reunión Anual de la American Academy of Neurological Surgeons en Boston (25-28 de abril de 2025).
La Dra. Ellen Air de Henry Ford Health confirma que el software logra una precisión de colocación equivalente a la guiada por MRI sin requerir infraestructura MRI. El sistema soporta varios procedimientos, incluyendo biopsias, inserción de catéteres y electrodos, y colocación de electrodos para estimulación cerebral profunda.
ClearPoint Neuro (NASDAQ:CLPT)가 ClearPoint Navigation 소프트웨어 버전 3.0의 정식 시장 출시를 발표했으며, 기존 수술실에서 사용할 수 있는 iCT 영상 유도 워크플로우 옵션을 도입했습니다. 이번 버전은 10년간의 MRI 유도 시술 경험을 바탕으로 동일한 정밀도를 제공하면서 접근성과 효율성을 향상시켰습니다.
이 소프트웨어는 모든 수술실에 있는 표준 iCT 스캐너와 호환되며, 시장 출시 초기부터 조기 도입 사례가 보고되고 있습니다. 이 플랫폼은 2025년 4월 25일부터 28일까지 보스턴에서 열리는 미국 신경외과학회 연례회의에서 선보일 예정입니다.
Henry Ford Health의 Ellen Air 박사는 이 소프트웨어가 MRI 유도와 동등한 위치 정확도를 달성하면서 MRI 인프라가 필요 없다고 확인했습니다. 이 시스템은 생검, 카테터 및 전극 삽입, 심부 뇌 자극 전극 배치 등 다양한 시술을 지원합니다.
ClearPoint Neuro (NASDAQ:CLPT) a annoncé le lancement complet sur le marché de la version 3.0 du logiciel ClearPoint Navigation, introduisant une option de flux de travail guidé par imagerie iCT pour les blocs opératoires traditionnels. La nouvelle version s’appuie sur une décennie d’expérience en procédures guidées par IRM, offrant la même précision avec une accessibilité et une efficacité accrues.
Le logiciel est compatible avec les scanners iCT standards dans n’importe quelle salle d’opération, avec des premières utilisations rapportées dès le lancement. La plateforme sera présentée lors de la réunion annuelle de l’American Academy of Neurological Surgeons à Boston (du 25 au 28 avril 2025).
La Dre Ellen Air de Henry Ford Health confirme que le logiciel atteint une précision de positionnement équivalente à celle guidée par IRM sans nécessiter d’infrastructure IRM. Le système prend en charge diverses procédures, notamment les biopsies, l’insertion de cathéters et d’électrodes, ainsi que le placement d’électrodes pour la stimulation cérébrale profonde.
ClearPoint Neuro (NASDAQ:CLPT) hat die vollständige Markteinführung der ClearPoint Navigation Software Version 3.0 angekündigt, die eine iCT-Bildführung für herkömmliche Operationssäle einführt. Die neue Version baut auf einem Jahrzehnt Erfahrung mit MRI-geführten Verfahren auf und bietet dieselbe Präzision bei verbesserter Zugänglichkeit und Effizienz.
Die Software ist mit Standard-iCT-Scannern in jedem Operationssaal kompatibel, mit ersten Anwendern bereits während der Markteinführung. Die Plattform wird auf der Jahrestagung der American Academy of Neurological Surgeons in Boston (25.-28. April 2025) vorgestellt.
Dr. Ellen Air von Henry Ford Health bestätigt, dass die Software eine vergleichbare Platzierungsgenauigkeit wie die MRI-geführte Methode erreicht, ohne eine MRI-Infrastruktur zu benötigen. Das System unterstützt verschiedene Verfahren, darunter Biopsien, Katheter- und Elektrodeneinführungen sowie die Platzierung von Elektroden für die tiefe Hirnstimulation.
- Expands market accessibility by enabling procedures in traditional operating rooms without MRI infrastructure
- Demonstrated successful early adoption during market release
- Maintains same precision and accuracy as MRI-guided procedures
- Compatible with standard iCT scanners, reducing infrastructure requirements
- None.
Insights
ClearPoint's Software 3.0 expands neurosurgical navigation to standard ORs with iCT capability while maintaining MRI-level precision.
The ClearPoint Navigation Software Version 3.0 represents a significant technological advancement in neurosurgical navigation. The key breakthrough is the addition of intraoperative CT (iCT) capability to their existing MRI-guided workflow, effectively eliminating the dependency on specialized MRI infrastructure. This solves a critical accessibility problem in neurosurgery.
The clinical validation from neurosurgeons is particularly compelling. Dr. Ellen Air explicitly confirms the system "achieves the same accurate placement as with MRI-guidance, without requiring the MRI infrastructure," validating that precision hasn't been compromised. Meanwhile, Dr. Khanna's statement about potentially making it his "default navigation" for VIM DBS lead placements indicates strong physician confidence in the technology.
The system continues to support critical neurosurgical applications including biopsies, catheter insertions, and Deep Brain Stimulation procedures - both awake and asleep. By maintaining the precision of MRI-guided navigation while expanding compatibility to standard operating rooms with conventional iCT scanners, ClearPoint has effectively addressed one of the primary limitations of their previous technology - dependence on MRI availability.
The software's enhancement for existing MRI-guidance and Prism Laser Therapy users demonstrates ClearPoint's commitment to supporting their full technological ecosystem rather than simply shifting focus to new capabilities.
ClearPoint's Software 3.0 expands addressable market to standard operating rooms, showing early adoption success and positive physician feedback.
The full market release of ClearPoint Navigation Software 3.0 strategically broadens ClearPoint Neuro's market reach. By expanding beyond MRI-dependent environments to include iCT-guided workflows in traditional operating rooms, the company has removed a significant adoption barrier.
The article explicitly notes "rapid adoption among participating hospital sites" during the market release phase - a promising early indicator. The compatibility with "standard iCT scanners in any operating room" means hospitals without specialized MRI suites can now access ClearPoint's precision navigation technology.
From a product strategy perspective, this represents an intelligent evolution rather than revolution. The company leverages their "decade of experience with MRI-guided procedures" while expanding technological applicability to new clinical settings. Dr. Air's testimonial directly confirms the market expansion benefit, noting it "allows our team to offer the ClearPoint option at more points of care."
The software update simultaneously supports existing customers with "new features and enhancements" for MRI-guidance and Prism Laser Therapy users, balancing new market development with installed base satisfaction. While the article provides no specific financial projections, the technology expansion into standard operating rooms objectively increases ClearPoint's addressable market while maintaining the precision that differentiates their platform.
The platform will be showcased at the American Academy of Neurological Surgeons Annual Meeting in Boston on April 25-28, 2025.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / April 24, 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 the full market release of the ClearPoint Navigation Software Version 3.0 - which introduces an iCT image-guidance workflow option performed in the traditional operating room.
"The new iCT-guided neuro navigation workflow builds on our team's decade of experience with MRI-guided procedures and is designed to deliver the same workflow and precision with greater accessibility and efficiency," said Elizabeth Vasconcellos, Segment Leader of Systems and Software at ClearPoint Neuro. "Throughout the limited market release, we have seen rapid adoption among participating hospital sites, driven by the software's compatibility with standard iCT scanners in any operating room. We believe this will continue to build on the momentum established with SmartFrame OR by leveraging our purpose-built image-guidance software and enabling broader access to ClearPoint's technology when MRI access is limited. This major release also services our MRI-guidance and Prism Laser Therapy users by delivering new features and enhancements specifically to support their needs."
"My initial experience with ClearPoint Navigation Software Version 3.0 using iCT-guidance has demonstrated that it achieves the same accurate placement as with MRI-guidance, without requiring the MRI infrastructure," shares Dr. Ellen Air, Chair of Neurosurgery at Henry Ford Health. "The option to perform DBS placements in either an iMRI or iCT environment allows our team to offer the ClearPoint option at more points of care."
"The ClearPoint Navigation Software Version 3.0 supports procedural accuracy and efficiency," stated Dr. Arjun Khanna, Functional & Stereotactic Neurosurgeon in San Diego, CA. "If the performance of 3.0 continues as I've seen so far, I would love to make this my default navigation for all VIM DBS lead placements in my practice."
The new ClearPoint Navigation Software Version 3.0 supports the ClearPoint Neuro Navigation System. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) (asleep or awake) lead placement.
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 CNS 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, 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
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