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) will release first-quarter 2026 financial results on Wednesday, May 13, 2026, after the market close. A live broadcast and conference call will begin at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Listeners can join via webcast or telephone; a replay will be available through June 12, 2026, and an online archive will be posted on the company's investor website.
ClearPoint Neuro (NASDAQ:CLPT) announced FDA 510(k) clearance of the Velocity Alpha MR High Speed Surgical Drill and reported the system's first clinical use on April 22, 2026 in a four-trajectory procedure. The drill integrates with ClearPoint's SmartFrame navigation and is manufactured by adeor medical AG.
The device is designed for multi-trajectory, MR and OR workflows, aims to streamline procedures, and is expected to be compatible with ClearPoint's robotic navigation platform now in development.
ClearPoint Neuro (NASDAQ:CLPT) received a Medical Device License from Health Canada on April 20, 2026 for its Neuro Navigation System, covering both MRI-guidance and new iCT-guidance workflows in Canada.
This clearance, which follows the SmartFlow Neuro Cannula delivery clearance in October 2025, allows biopharma partners to run Canadian clinical trial and commercial sites using ClearPoint's integrated navigation and therapy-delivery platform and supports the company's strategy to enable 20,000 cell and gene therapy procedures annually.
ClearPoint Neuro (Nasdaq:CLPT) reported record 2025 results with $37.0M revenue, 18% growth, and Q4 revenue of $10.4M (34% growth). The company completed the November 2025 acquisition of IRRAS, secured $20.0M additional financing access, achieved EU MDR certification, and ended 2025 with $45.9M cash.
Management projects 2026 revenue of $52.0–$56.0M and highlighted product, commercial, and cell/gene therapy expansion initiatives.
ClearPoint Neuro (NASDAQ: CLPT) will release its fourth quarter and full year 2025 financial results on March 17, 2026 after market close. A live broadcast and teleconference for investors and analysts is scheduled for 4:30 p.m. ET / 1:30 p.m. PT.
A replay will be available through April 16, 2026, and an online archive will be posted on the company's investor website.
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.