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.

Site Readiness Continues for Specialized Treatment Centers Envisioned to Support a Growing Number of Cell and Gene Therapy Trial Patients and Later CommercializationSOLANA BEACH, CA / ACCESS Newswire / November 6, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell,

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.

Origin

ClearPoint Neuro (Nasdaq: CLPT) står enligt investeraren och Substack-skribenten Montrealer inför ett genombrott. Bolaget tillverkar medicintekniska produkter för behandling av neurologiska sjukdomar ...