ClearPoint Neuro Announces Expanded International Clearances for Key Therapy Delivery Product; Now Totaling 34 Countries Worldwide
ClearPoint Neuro (NASDAQ:CLPT) announced expanded regulatory clearances for its therapy delivery products in Canada, Hong Kong, and Taiwan, bringing total cleared countries to 34. The company said these clearances are intended to simplify regional clinical trial design and support BioPharma partners' paths toward global commercialization. ClearPoint noted it works with 60+ BioPharma sponsors and will demonstrate US-cleared products at the CNS Annual Congress, Oct 13–15, 2025. The release also highlights the SmartFlow Neuro Cannula 510(k) FDA clearance for CSF aspiration, intraventricular Cytarabine injection, and delivery of gene therapy KEBILIDI to brain parenchyma.
ClearPoint Neuro (NASDAQ:CLPT) ha annunciato l'espansione delle autorizzazioni regolamentari per i suoi prodotti di erogazione della terapia in Canada, Hong Kong e Taiwan, portando il numero totale di paesi autorizzati a 34. L'azienda ha dichiarato che queste autorizzazioni mirano a semplificare la progettazione di studi clinici regionali e a supportare i percorsi di commercializzazione globale dei partner BioPharma. ClearPoint ha osservato di lavorare con più di 60 sponsor BioPharma e mostrerà i prodotti autorizzati negli Stati Uniti al CNS Annual Congress, 13–15 ottobre 2025. Il comunicato evidenzia anche l'autorizzazione 510(k) FDA del SmartFlow Neuro Cannula per l'aspirazione di CSF, l'iniezione intraventricolare di Cytarabina e la consegna della terapia genica KEBILIDI nel parenchima cerebrale.
ClearPoint Neuro (NASDAQ:CLPT) anunció la ampliación de las autorizaciones regulatorias para sus productos de suministro de terapia en Canadá, Hong Kong y Taiwán, llevando el total de países autorizados a 34. La compañía dijo que estas autorizaciones están destinadas a simplificar el diseño de ensayos clínicos regionales y apoyar las rutas de comercialización global de los socios BioPharma. ClearPoint señaló que trabaja con más de 60 patrocinadores BioPharma y mostrará productos ya autorizados en EE. UU. en el Congreso Anual CNS, del 13 al 15 de octubre de 2025. El comunicado también destaca la aprobación 510(k) FDA del SmartFlow Neuro Cannula para aspiración de LCR, inyección intraventricular de Cytarabina y la entrega de la terapia génica KEBILIDI al parénquima cerebral.
ClearPoint Neuro (NASDAQ:CLPT)은 치료 전달 제품에 대한 규제 승인을 캐나다, 홍콩, 대만에서 확대했다고 발표했으며, 승인된 총 국가 수를 34로 늘렸습니다. 회사는 이러한 승인이 지역별 임상 시험 설계를 단순화하고 BioPharma 파트너의 글로벌 상용화 경로를 지원하기 위한 것이라고 밝혔습니다. ClearPoint는 60개 이상의 BioPharma 스폰서와 협력하고 있으며 미국 승인 제품을 CNS 연례 학회, 2025년 10월 13–15일에 시연할 예정이라고 말했습니다. 또한 발표에는 CSF 흡인, 뇌실내 Cytarabine 주사, 뇌 실질에 유전자 치료제 KEBILIDI 전달을 위한 SmartFlow Neuro Cannula의 510(k) FDA 승인이 강조되어 있습니다.
ClearPoint Neuro (NASDAQ:CLPT) a annoncé l'élargissement des autorisations réglementaires pour ses produits de délivrance de thérapie au Canada, à Hong Kong et à Taiwan, portant le total des pays autorisés à 34. L'entreprise a déclaré que ces autorisations visent à faciliter la conception des essais cliniques régionaux et à soutenir les voies de commercialisation mondiale des partenaires BioPharma. ClearPoint a indiqué travailler avec plus de 60 sponsors BioPharma et présentera ses produits approuvés aux États-Unis lors du Congrès annuel CNS, du 13 au 15 octobre 2025. Le communiqué met également en avant l'autorisation 510(k) FDA du SmartFlow Neuro Cannula pour l'aspiration du LCR, l'injection intraventriculaire de Cytarabine et la délivrance de la thérapie génique KEBILIDI au parenchyme cérébral.
ClearPoint Neuro (NASDAQ:CLPT) kündigte erweiterte behördliche Zulassungen für seine Therapielieferprodukte in Kanada, Hongkong und Taiwan an und erhöhte die insgesamt genehmigten Länder auf 34. Das Unternehmen sagte, diese Zulassungen sollen das regionale Design klinischer Studien vereinfachen und die Wege der BioPharma-Partner zur globalen Vermarktung unterstützen. ClearPoint erwähnte, dass man mit mehr als 60 BioPharma-Sponsoren zusammenarbeitet und US-zugelassene Produkte auf dem CNS Annual Congress, 13.–15. Oktober 2025 demonstrieren wird. Die Mitteilung hebt auch die SmartFlow Neuro Cannula-510(k) FDA-Zulassung für CSF-Aspiration, intraventrikuläre Cytarabine-Injektion und die Abgabe der Gentherapie KEBILIDI in das Gehirnparenchym hervor.
ClearPoint Neuro (NASDAQ:CLPT) أعلنت عن توسيع التراخيص التنظيمية لمنتجات توصيل العلاج في كندا وهونغ كونغ وتايوان، ليرتفع إجمالي الدول المصرح لها إلى 34. وقالت الشركة إن هذه التراخيص تهدف إلى تبسيط تصميم التجارب السريرية الإقليمية ودعم مسارات الاعتماد العالمية لشركاء BioPharma. وأشار ClearPoint إلى أنه يعمل مع أكثر من 60 راعٍ BioPharma وسسيعرض المنتجات المصادق عليها في الولايات المتحدة في المؤتمر السنوي ل-CNS، من 13 إلى 15 أكتوبر 2025. كما يبرز الإصدار اعتماد FDA للـ SmartFlow Neuro Cannula 510(k) لاستخراج CSF، وحقن Cytarabine داخل البطين، وتوصيل العلاج الجيني KEBILIDI إلى النسيج الدماغي.
ClearPoint Neuro (NASDAQ:CLPT)宣布在加拿大、香港和台湾扩大其治疗递送产品的监管批准，总批准国家数达到34个。公司表示这些批准旨在简化区域临床试验设计并支持生物制药伙伴走向全球商业化的路径。ClearPoint 指出其与60+ 生物制药赞助商合作，并将在CNS 年度大会，2025 年 10 月 13–15 日上展示美国已获批的产品。公告还强调了 SmartFlow Neuro Cannula 针对脑脊液引流、脑室内 Cytarabine 注射以及将基因治疗药物 KEBILIDI 送达脑实质的 510(k) FDA 专项批准。
- Regulatory clearances added in Canada, Hong Kong, Taiwan
- Total market clearances now 34 countries
- Engagement with 60+ BioPharma sponsors
- SmartFlow Neuro Cannula received FDA 510(k) clearance
- Not all ClearPoint products are cleared in every territory
Insights
Expanded clearances in Canada, Hong Kong and Taiwan bring ClearPoint to 34 countries, easing clinical delivery paths for partners.
The approvals establish a broader regulatory footprint for ClearPoint's therapy-delivery products and reinforce the company's role as a standardized surgical delivery option for cell and gene therapy programs. The press release cites clearance in three additional jurisdictions and a stated total of 34 countries, plus an existing 510(k) clearance for the SmartFlow Neuro Cannula for CSF aspiration, Cytarabine intraventricular injection, and delivery of the gene therapy KEBILIDI to brain parenchyma.
Dependencies and risks remain tied to external regulatory and partner outcomes explicitly described in the release, including regulatory timelines, partners' ability to obtain approvals, and commercialization execution. The company also lists macro, policy, and operational risks that could alter expected benefits; these are cited as material uncertainties in the forward-looking statement. Monitor the company's partner programs and any filings that confirm localized trial starts or regulatory dossiers built using these clearances.
Concrete near-term items to watch include the company's product demonstrations at the 75th Annual Congress of Neurological Surgeons on
The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 6, 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 several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan. This most recent batch of strategically selected geographical clearances establishes a total of 34 countries worldwide in which BioPharma partners will have a reliable and familiar delivery system for clinical use. Each clearance is intended to serve programs with regional clinical trial needs by simplifying trial design, and longer term should provide partners with expanded pathways for achieving global commercial scale.
"The importance of these international regulatory clearances is well established and continually discussed with each partner within our portfolio of 60+ BioPharma sponsors," commented Mary McNamara-Cullinane, VP of Regulatory Affairs at ClearPoint Neuro. "The extensive regulatory support we provide partners evolves with each new therapy development program. After we support the early pre-clinical work and INDs, these expanded international clearances can play a role in localized trials and simplify pathways to commercialization from one country to the next. We leverage our team's expertise to anticipate what each regulatory body will need to reduce complexity for our partners."
"Each clearance is expected to provide a decisive advantage for all sponsors trusting us to support their new therapy development as our products have extensive testing, credible history, and technical dossiers on-file across various geographies," added Megan Falkenberry, VP of Quality at ClearPoint Neuro. "We believe that this is essential for speeding up the cell and gene therapy clinical trial process, reducing technical risks, and reducing surgical risks. The ClearPoint Neuro team is incredibly motivated to do our part in ensuring more patients can be treated by these first-of-kind, breakthrough restorative gene and cell therapies being developed by our partners. By standardizing and simplifying every possible aspect of the surgical workflow, ClearPoint Neuro hopes to reduce barriers to adoption and allow partners' therapies improved chances to succeed."
The company plans to demonstrate US-cleared products at the 75th Annual Congress of Neurological Surgeons (CNS) in Los Angeles October 13th-15th.
The SmartFlow Neuro Cannula has received 510(k) clearance from the FDA for the aspiration of CSF, injection of the chemotherapy drug Cytarabine into the ventricles, or delivery of the gene therapy KEBILIDI to the brain parenchyma. This device is not intended for implant and is single patient use. Not all products are cleared in all territories.
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 expectations regarding regulatory timelines, pathways, and outcomes for therapeutic products delivered with the Company's cleared or approved products in various geographies, and the future commercial success and market acceptance of the Company's therapy delivery products. 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; delay impacts from the effects of government shutdowns or reduced agency operations; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; 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 regulatory approval and 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 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, regulatory approval and commercialization of the Company's new products and the new therapeutics of its BioPharma partners, 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
FAQ
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