ClearPoint Neuro Announces Development and Demonstration of the Company's Proprietary Robotic Neuro-Navigation System
ClearPoint Neuro (NASDAQ:CLPT) has unveiled its proprietary Robotic Neuro-Navigation System, designed to operate the KUKA LBR Med Robotic Arm for minimally invasive cranial procedures. The system will support cell and gene therapy infusions, laser catheter placement, biopsy workflows, and deep brain stimulation.
The platform offers three deployment options: traditional MRI guidance, new ClearPoint 3.0 iCT guidance, and future robotic-assisted technique, all unified under ClearPoint's software planning module. The company will showcase a prototype at the 75th Annual Congress of Neurological Surgeons in Los Angeles (October 13-15, 2025).
The system, which has not yet received regulatory approval, aims to provide both consistency and flexibility for commercial launches of cell and gene therapies, particularly targeting BioPharma partners preparing for increased commercial case volumes.
ClearPoint Neuro (NASDAQ:CLPT) ha presentato il proprio sistema proprietario di Neuros Navigazione Robotica, progettato per azionare il braccio robotico KUKA LBR Med per procedure craniche minimamente invasive. Il sistema supporterà infusioni di terapie cellulari e geniche, posizionamento di cateteri laser, workflow di biopsia e stimolazione cerebrale profonda.
La piattaforma offre tre modalità di utilizzo: guida tradizionale MRI, nuova guida ClearPoint 3.0 iCT e futura tecnica assistita da robot, tutte unite dal modulo di pianificazione software di ClearPoint. L’azienda presenterà un prototipo al 75° Congresso Annuale dei Chirurghi Neurologici a Los Angeles (13-15 ottobre 2025).
Il sistema, che al momento non ha ottenuto l’approvazione regolatoria, punta a offrire coerenza e flessibilità per i lanci commerciali di terapie cellulari e geniche, in particolare rivolgendosi ai partner BioPharma che si preparano ad aumentare i volumi di casi commerciali.
ClearPoint Neuro (NASDAQ:CLPT) ha presentado su sistema propietario de Navegación Neuroquirúrgica Robótica, diseñado para operar el brazo robótico KUKA LBR Med en procedimientos craneales mínimamente invasivos. El sistema apoyará infusiones de terapias celulares y génicas, colocación de catéter láser, flujos de trabajo de biopsia y estimulación cerebral profunda.
La plataforma ofrece tres opciones de despliegue: guía tradicional por RM, nueva guía ClearPoint 3.0 iCT y una futura técnica asistida por robot, todas unificadas bajo el módulo de planificación de software de ClearPoint. La empresa mostrará un prototipo en el 75º Congreso Anual de Cirujanos Neurológicos en Los Ángeles (del 13 al 15 de octubre de 2025).
El sistema, que aún no ha recibido la aprobación regulatoria, busca proporcionar consistencia y flexibilidad para los lanzamientos comerciales de terapias celulares y génicas, orientándose especialmente a socios BioPharma que se están preparando para aumentar los volúmenes de casos comerciales.
ClearPoint Neuro (나스닥:CLPT)가 최소 침습적 두개 뇌 수술 절차를 위해 KUKA LBR Med 로봇 팔을 작동시키도록 설계된 독자적인 로봇 신경 내비게이션 시스템을 선보였습니다. 이 시스템은 세포 및 유전자 치료 주입, 레이저 카테터 배치, 생검 워크플로우, 심부 뇌 자극을 지원합니다.
플랫폼은 세 가지 배포 옵션을 제공합니다: 전통 MRI 가이드, 새로운 ClearPoint 3.0 iCT 가이드, 그리고 향후 로봇 보조 기법으로, 모두 ClearPoint의 소프트웨어 계획 모듈에 통합됩니다. 이 기업은 로스앤젤레스에서 열리는 제75회 신경외과학회 연차대회에서 프로토타입을 선보일 예정입니다(2025년 10월 13-15일).
규제 승인을 아직 받지 않은 이 시스템은 세포 및 유전자 치료의 상용 출시에 일관성과 유연성을 제공하는 것을 목표로 하며, 특히 상용 사례량 증가에 대비하는 BioPharma 파트너들을 대상으로 합니다.
ClearPoint Neuro (NASDAQ:CLPT) a dévoilé son système propriétaire de navigation neurorobotiques, conçu pour faire fonctionner le bras robotique KUKA LBR Med lors de procédures crâniennes mini-invasives. Le système prendra en charge les infusions de thérapies cellulaires et géniques, le placement de cathéters laser, les flux de travail de biopsie et la stimulation cérébrale profonde.
La plateforme offre trois options de déploiement : guidage IRM traditionnel, nouveau guidage ClearPoint 3.0 iCT et une technique future assistée par robot, toutes réunies sous le module de planification logicielle de ClearPoint. L’entreprise présentera un prototype lors du 75e Congrès annuel des chirurgiens neurologues à Los Angeles (du 13 au 15 octobre 2025).
Le système, qui n’a pas encore reçu d’approbation réglementaire, vise à offrir cohérence et flexibilité pour les lancements commerciaux de thérapies cellulaires et géniques, en particulier en s’adressant aux partenaires BioPharma qui se préparent à augmenter les volumes de cas commerciaux.
ClearPoint Neuro (NASDAQ:CLPT) hat sein firmeneigenes Roboter-Neuronavigation-System vorgestellt, das entwickelt wurde, um den KUKA LBR Med-Roboterarm für minimalinvasive craniale Verfahren zu betreiben. Das System unterstützt Zell- und Gentherapie-Infusionen, Laserkatheterschaltungen, Biopsie-Workflows und tiefe Hirnstimulation.
Die Plattform bietet drei Einsatzmöglichkeiten: traditionelle MRT-Guidance, neue ClearPoint 3.0 iCT-Guidance und künftige roboterassistierte Techniken, alle unter dem Software-Planungsmodul von ClearPoint vereint. Das Unternehmen wird einen Prototypen beim 75. Jahreskongress der Neurochirurgen in Los Angeles (13.–15. Oktober 2025) vorstellen.
Das System, das noch keine regulatorische Zulassung erhalten hat, zielt darauf ab, sowohl Konsistenz als auch Flexibilität für kommerzielle Markteinführungen von Zell- und Gentherapien zu bieten, insbesondere für BioPharma-Partner, die sich auf steigende Fallzahlen vorbereiten.
ClearPoint Neuro (ناسداك:CLPT) كشفت عن نظامها الحركي العصبي الروبوطي الملكي الخاص، المصمم لتشغيل الذراع الروبوتي KUKA LBR Med للإجراءات القحفية قليلة التوغل. سيدعم النظام حقن علاجات الخلايا والجينات، وضع قثاطير الليزر، سير عمل الخزعة، والتحفيز العميق للمخ.
تقدم المنصة ثلاث خيارات للنشر: التوجيه بالرنين المغناطيسي التقليدي، التوجيه الجديد ClearPoint 3.0 iCT، وتقنية مستقبلية مدعومة بالروبوت، جميعها موحدة تحت وحدة تخطيط البرمجيات لدى ClearPoint. ستعرض الشركة نموذجاً أولياً في المؤتمر السنوي 75 لجراحي الأعصاب في لوس أنجلوس (13-15 أكتوبر 2025).
النظام، الذي لم يحصل بعد على موافقة تنظيمية، يهدف إلى توفير الاتساق والمرونة لإطلاق العلاجات الخلوية والجينية بشكل تجاري، مع استهداف بشكل خاص شركاء BioPharma الذين يستعدون لزيادة أحجام الحالات التجارية.
ClearPoint Neuro（纳斯达克股票代码：CLPT）公布了其专有的机器人神经导航系统，设计用于驱动 KUKA LBR Med 机器人臂执行微创颅脑手术。该系统将支持细胞与基因治疗输注、激光导管放置、活检工作流与深度脑刺激。
该平台提供三种部署选项：传统的 MRI 引导、全新的 ClearPoint 3.0 iCT 引导，以及未来的机器人辅助技术，均整合在 ClearPoint 的软件规划模块下。公司将于洛杉矶举行的神经外科医生年度大会第75届（2025年10月13–15日）上展示一个原型。
该系统尚未获得监管批准，旨在为细胞与基因治疗的商业化推出提供一致性与灵活性，特别是面向为增加商业病案量而做准备的 BioPharma 合作伙伴。
- Partnership with FDA-cleared and CE-marked KUKA reduces development costs and accelerates market entry
- System provides unified software planning across three different surgical deployment options
- Strategic positioning to support upcoming commercial launches of cell and gene therapies
- Leverages existing ClearPoint software workflow and drug delivery features
- Product has not yet received regulatory approval
- Faces potential competition in the growing neuro-robotics market
- Development and commercialization timeline uncertainty
- Success depends on approval of partner therapies under FDA review
Insights
ClearPoint's new robotic system strategically positions them as a versatile navigation partner for emerging cell and gene therapies.
ClearPoint Neuro has unveiled its development of a proprietary Robotic Neuro-Navigation System that integrates with the KUKA LBR Med Robotic Arm. This strategic expansion represents a significant technological advancement in their product portfolio that addresses a crucial market challenge.
The system is designed to support all minimally invasive cranial surgical procedures, including cell and gene therapy infusions, laser catheter placement, biopsies, deep brain stimulation, and stereotactic EEG lead placements. What makes this approach particularly noteworthy is how it balances precision with flexibility.
ClearPoint's strategy offers BioPharma partners a unified platform with three deployment options: traditional MRI-guided technique, the new ClearPoint 3.0 iCT guided technique, and the forthcoming robotic-assisted technique. All three utilize the same ClearPoint software workflow, providing consistency in planning while offering flexibility in execution.
This approach solves a critical dilemma faced by BioPharma companies developing cell and gene therapies. These companies value MRI guidance for regulatory submissions, but recognize that limited flexibility can restrict adoption. Conversely, too much flexibility compromises quality and consistency. ClearPoint's three-pronged approach maintains standardized planning with execution options tailored to different clinical settings.
By partnering with KUKA to leverage their FDA-cleared and CE-marked robotic arm rather than developing hardware from scratch, ClearPoint has accelerated their market entry while reducing development costs. This timing appears strategic as BioPharma partners prepare treatment centers for anticipated commercial volume increases.
The system is still in development and has not yet been submitted for regulatory approval, with commercialization timeline aligned with expected approvals of multiple neuro cell and gene therapies currently under FDA expedited review.
New Product Category Will Enable Added Flexibility to Support Commercial Launches of Cell and Gene Therapy
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 1, 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 formally announced the development and demonstration of the Company's proprietary Robotic Neuro-Navigation System. This new product category will enable the ClearPoint Neuro Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures including cell and gene therapy infusions, laser catheter placement, biopsy workflows and deep brain stimulation and stereotactic EEG lead placements. The Company will demonstrate a prototype of this robotic system at the 75th Annual Congress of Neurological Surgeons (CNS) in Los Angeles October 13th-15th.
"Everything we do at ClearPoint Neuro is viewed through the lens of 'how does this help us extend our lead in neuro drug delivery and help our partners prepare for the commercialization of these new cell and gene therapies," commented Jeremy Stigall, CBO and GM of the Biologics and Drug Delivery Business at ClearPoint. "Many of our BioPharma partners have the same dilemma that ClearPoint is helping to solve. On one side, they see the clear value of MRI guidance for drug delivery clinical trials and regulatory submissions, yet the requirements for MRI guidance can be viewed as narrow in flexibility and surgeon choice and can, therefore, limit adoption. On the other side, BioPharma understands that providing too much flexibility with the surgical technique can lead to less-than-optimal results because the ability to train on the crucial surgical technique in a consistent and organized manner can be lost with that flexibility. Just like a lean manufacturing line, you cannot increase quality and reduce procedure time and cost without consistency and repetition. BioPharma needs a single navigation partner that can provide that sweet spot of offering BOTH consistency and flexibility."
"The addition of the ClearPoint Neuro Robotic Neuro-Navigation System to our portfolio is designed to do exactly that - to provide consistency and flexibility to the commercial launches of various cell and gene therapies," continued Stigall. "First, for consistency, there will be one ClearPoint software planning module which is already used today. This software will be the first step for the surgical team to plan every patient's drug infusion plan, often days before the surgery itself. Second, the surgical team will then decide through which hardware mechanism to execute that surgical plan across three different ClearPoint options: the traditional MRI guided technique, the new ClearPoint 3.0 iCT guided technique in the operating room, and the future ClearPoint Robotic assisted technique also using iCT. Each of these options benefit from the same ClearPoint software workflow, and many advanced drug delivery features. We believe this strategy is unique, and that ClearPoint is best suited to take on this responsibility with our drug delivery portfolio, including co-labeled cannula-based routes-of-administration, pre-clinical CRO testing and live specialist procedural support."
"We have reached a point in medicine that if you close your eyes and imagine the future of neurosurgery, there is no way that robotics are not a significant part of that future," commented Joe Burnett, President and CEO of ClearPoint Neuro. "We have been very thoughtful and deliberate in our approach to enter the neuro robotics market. In years past, a company would have to develop a complete robotic system from scratch and bear the entire development risk and significant costs along the way. Today, by working with KUKA, we can leverage their decades of experience which has produced an FDA cleared and CE marked robotic arm and combine that with the decades of experience we have at ClearPoint, creating a state-of-the-art neuro navigation software to drive the robot in the same 3D space. This dramatically decreases the development cost and accelerates our speed to market. The timing is crucial as we are helping our BioPharma partners to identify regional treatment centers and to add surgical capacity in preparation of more significant commercial case volume in the next couple of years."
The ClearPoint Neuro Robotic Neuro-Navigation System has not yet been submitted to any regulatory body. The Company will continue product development with the goal of commercialization in concert with the approval of multiple neuro cell and gene therapies which are currently under FDA expedited review.
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 product development plans, and the expectation for commercial objectives, potential benefits, and timing of a product that remains in the initial stage of development. 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, including the ability to obtain and maintain regulatory clearances; manufacturing scale-up; supply chain and quality system readiness; intellectual property protection and freedom to operate; market acceptance and competitive dynamics. 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:
Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
SOURCE: ClearPoint Neuro, Inc.
View the original press release on ACCESS Newswire
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