ClearPoint Neuro, Inc. (NASDAQ: CLPT)

ClearPoint Neuro, Inc. is a commercial-stage medical device company incorporated in 1998 as a Delaware corporation, focused on developing and commercializing integrated systems for minimally invasive neurosurgical procedures in the brain. The company’s primary activities involve creating technologies for magnetic resonance imaging-guided interventions, building an intellectual property portfolio, and expanding into neurosurgical device products for operating room settings and consulting services for pharmaceutical companies. Its business consists of two integrated components: medical devices for neurosurgical applications and partnerships in the biologics and drug delivery space.

ClearPoint Neuro generates revenue through the sale of medical devices and related disposable components, as well as through consulting and preclinical development services for pharmaceutical and biotechnology partners. The company sells reusable hardware at lower margins to secure hospital installations, while generating recurring revenue from high-margin disposable products such as cannulas, trajectory devices, and catheters. Its biologics and drug delivery business earns revenue from protocol consultation, preclinical study design and execution, in vivo biology services, clinical trial support, and regulatory consultation for partners developing gene and cell therapies for neurological conditions.

The company operates through the following segments: Medical Devices for Neurosurgical Application and Biologics and Drug Delivery.

• The Medical Devices for Neurosurgical Application segment includes the ClearPoint system, an integrated platform of hardware, disposable components, and software used to guide deep brain stimulation electrode placement, biopsy needles, laser catheters, and pharmaceutical infusions into the brain. This segment also encompasses the ClearPoint Prism Neuro Laser Therapy System for interstitial irradiation or thermal therapy of soft tissue under MRI guidance, the SmartFrame OR Stereotactic System for operating room procedures, the ClearPoint Navigation Software Version 3.0 for end-to-end operating room navigation, and the IRRA flow Active Fluid Exchange System acquired through the purchase of IRRAS Holdings, Inc., which provides continuous irrigation, drainage, and real-time intracranial pressure monitoring for neurocritical care and operating room settings.

• The Biologics and Drug Delivery segment focuses on partnerships with pharmaceutical companies to support research and development from preclinical stages through clinical trials and commercialization. Services include preclinical development such as protocol consultation and study design, in vivo biology testing in large and small research models to establish drug safety, clinical trial support, regulatory consultation, and translation from preclinical to clinical settings to enhance drug delivery accuracy. This segment leverages the SmartFlow Neuro cannula and ClearPoint navigation platform to enable direct injection of gene and cell therapies into the brain.

ClearPoint Neuro operates in a highly competitive medical device industry marked by rapid technological change and faces competition from larger firms with greater financial, manufacturing, marketing, and technical resources. In neurosurgical navigation and therapy applications, competitors include Medtronic, Boston Scientific, Abbott Laboratories, NeuroPace, Monteris Medical, Brainlab, Elekta, FHC Inc., Integra LifeSciences, Neurologica Corporation, and Zimmer Biomet Holdings’ ROSA® robot. In the neurocritical care market following the IRRAS acquisition, the company competes with traditional external ventricular drainage system manufacturers such as Medtronic plc, Spiegelberg GmbH & Co. KG, Sophysa, B. Braun, and Integra LifeSciences. ClearPoint Neuro differentiates itself through its MRI-guided precision, active fluid exchange capabilities in the IRRA flow system, and its integrated platform combining hardware, disposables, and software for both neurosurgical and drug delivery applications.

The company serves hospitals, neurosurgeons, neurologists, neuro-intensivists, critical care physicians, and hospital-based neurocritical care teams for its medical device products. For its biologics and drug delivery business, ClearPoint Neuro works with over 60 pharma/biotech, academic, and contract research organization partners, including PTC Therapeutics, Inc., which accounted for approximately 15% of the segment’s revenues in 2025. These partners use the company’s products and services to evaluate or deliver gene and cell therapies directly into the brain for neurological disorders.