Welcome to our dedicated page for Clearpoint Neuro news (Ticker: CLPT), a resource for investors and traders seeking the latest updates and insights on Clearpoint Neuro stock.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) is a medical device company focused on device, cell, and gene therapy-enabling technologies for precise navigation to the brain and spine. This news page aggregates company-issued updates and market-moving announcements related to ClearPoint Neuro’s neurosurgical navigation systems, laser therapy platforms, intracranial fluid management technologies, and central nervous system drug delivery services.
Readers can follow earnings and financial updates, such as preliminary unaudited revenue results and quarterly reports furnished via Form 8-K, which outline trends in biologics and drug delivery revenue, neurosurgery navigation and therapy revenue, and capital equipment and software sales. News items also cover strategic transactions, including the completed acquisition of IRRAS Holdings, Inc., which adds the IRRAflow active fluid-exchange system and expands ClearPoint Neuro’s presence in neurocritical care and intracranial bleeding management.
ClearPoint Neuro’s news flow frequently highlights regulatory milestones like FDA 510(k) clearances, including expanded MRI compatibility for the ClearPoint Prism Neuro Laser Therapy System, and international regulatory approvals that extend product use to additional countries. The company also reports on clinical and scientific developments, such as Phase I–II study results in glioblastoma and grade 4 astrocytoma using ClearPoint Prism, as well as the development and demonstration of its proprietary Robotic Neuro-Navigation System.
Investors and observers can also track partnership and conference activity, including updates on more than 60 active biopharma partners, participation in global healthcare conferences, and progress at ClearPoint Advanced Laboratories. Bookmark this page to review historical and ongoing CLPT news related to neurosurgical devices, therapy delivery platforms, and the company’s role in enabling cell and gene therapy programs.
ClearPoint Neuro (NASDAQ:CLPT) announced EU MDR certification (CE mark) for ClearPoint Navigation Software Version 3.0.2, making the release available in Europe and unifying the US and EU navigation platforms.
Version 3.0.2 adds an intraoperative CT workflow and compatibility with intraoperative CT and cone-beam CT, extending navigation from MRI-only to operating room use when paired with the SmartFrame XG stereotactic frame. The company cited prior FDA clearance of ClearPoint 3.x 11 months earlier and said most US customers have adopted the software.
ClearPoint Neuro (Nasdaq:CLPT) reported preliminary unaudited Q4 2025 revenue of ~$10.4M, representing 20% comparable sales growth versus Q4 2024; IRRAflow product sales were only partially included after a recent acquisition. Full-year 2025 revenue was approximately $37M. Management expects 2026 total revenues of $54M–$60M, driven by organic growth and completion of IRRAflow integration. Segment trends in Q4 included functional neurosurgery disposables (+23%) and biologics/drug delivery (+26%). Results are preliminary and unaudited; audited financials and a Form 10-K will be filed in Q1 2026. Management will meet investors at the J.P. Morgan Healthcare Conference on January 12–13, 2026.
ClearPoint Neuro (Nasdaq:CLPT) completed its acquisition of IRRAS on November 20, 2025. Consideration included $5.0 million cash and 1,325,000 shares of ClearPoint common stock, plus a revenue share on certain IRRAS products for defined periods. IRRAS brings the IRRAflow active fluid-exchange system, more than 50 active customers, and an expanded commercial team. IRRAS results will be consolidated into ClearPoint's financials starting in Q4 2025. Management highlighted expected commercial scale and strategic fit with ClearPoint’s neuro drug-delivery platform.
ClearPoint Neuro (NASDAQ:CLPT) reported third quarter 2025 results on November 6, 2025, with Q3 revenue of $8.9M, a 9% increase year‑over‑year, and cash of $38.2M as of September 30, 2025.
Key operational updates include the new ClearPoint Advanced Laboratories (CAL) becoming operational, FDA 510(k) clearance for PRISM Laser compatibility with 1.5T MRI, a prototype Robotic Neuro‑Navigation System demo, regulatory clearances in 34 countries, activation of 5 new customers, and a signed agreement to acquire IRRAS Holdings.
The company achieved a 63% gross margin, reaffirmed full‑year 2025 revenue guidance of $36.0M–$38.0M, and expects combined 2026 pro forma revenue with IRRAS of $54.0M–$60.0M.
ClearPoint Neuro (Nasdaq:CLPT) announced an agreement to acquire IRRAS, maker of the FDA-cleared and CE-marked IRRAflow intracranial fluid management system. Consideration at closing: $5.0M cash plus 1,325,000 ClearPoint shares, plus a revenue‑share on certain IRRAS products. IRRAS brings >50 active customers, 10 patent families, an estimated $9.0M 2025 revenue run‑rate (83% growth in first 9 months of 2025), and ~40 commercial staff.
Management expects combined 2026 revenue of $54.0M–$60.0M. Closing is subject to IRRAS shareholder approval and customary conditions; deal expected in Q4 2025.
ClearPoint Neuro (Nasdaq:CLPT) will participate in multiple investor conferences in Q4 2025.
Management will present and be available for in-person investor meetings at: UBS Global Healthcare Conference in Palm Beach Gardens, FL on November 10, 2025; Stifel Healthcare Conference in New York, NY on November 13, 2025; and the Piper Sandler Healthcare Conference in New York, NY on December 3, 2025. Registered investors can request onsite meetings with ClearPoint Neuro management.
ClearPoint Neuro (NASDAQ:CLPT) reported encouraging Phase I-II results for the ClearPoint Prism Neuro Laser Therapy System from a 14‑patient study at Skåne University Hospital (NCT05296122) in Lund, Sweden, to be presented at the CNS Annual Meeting in Los Angeles Oct 13-15, 2025.
Key findings: improved survival versus matched open‑surgery controls, a median ablation time of 6.5 minutes, a safe and reproducible workflow, and no device‑related events reported.
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) 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) has appointed Dr. Paul Larson as Chief Medical Officer, effective January 2026. Dr. Larson, who has been a long-time advisor to the company, brings extensive expertise in neuro navigation and drug delivery, having performed or overseen more than 100 cell and gene therapy clinical procedures.
Dr. Larson will maintain his positions at the University of California San Francisco and Banner Hospital, University of Arizona, where he will continue participating in cell and gene therapy clinical trials. His appointment comes at a strategic time as ClearPoint Neuro and its partners prepare for the commercialization of new therapies targeting conditions like Huntington's Disease, Parkinson's Disease, epilepsy, dementias, tumors, and rare childhood genetic disorders.
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