ClearPoint Neuro Inc

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The company provides both established clinical products and preclinical development services for controlled drug and device delivery. Its flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and CE marking, with regulatory approvals across 34 countries. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America, and partners with over 60 pharmaceutical and biotech companies, academic centers, and contract research organizations. The company operates across four product pillars: pre-commercial biologics and drug delivery (including preclinical CRO services), neurosurgery navigation and robotics, laser ablation therapy and access (Prism Laser Therapy System), and neurocritical care management (IRRAflow Active Fluid Exchange System, acquired via the IRRAS acquisition in November 2025). The company maintains an installed base of more than 175 active global centers, with approximately half of the top-ranked U.S. neurosurgery programs using its technology. ClearPoint is developing a robotic neuro-navigation platform, focused ultrasound drug delivery system, and Harmony software. The company operates its ClearPoint Advanced Laboratories (CAL) preclinical facility in Torrey Pines, California, offering GLP-capable services to biopharma partners developing central nervous system therapeutics. Updated Aug 3, 2026