ClearPoint Neuro (NASDAQ: CLPT) is a commercial-stage medical device company, incorporated in Delaware in 1998, that develops and commercializes integrated systems for minimally invasive neurosurgical procedures. Revenue comes from three sources: product sales of neurosurgery navigation hardware and disposables, therapy system sales and placements, and biologics and drug delivery services including preclinical consulting and partnership arrangements with pharmaceutical and biotech companies. The company's product portfolio includes the ClearPoint navigation platform, the SmartFlow Neuro cannula, the SmartFrame OR Stereotactic System, the ClearPoint Prism Neuro Laser Therapy System (commercialized exclusively for neuro applications under a deal with Swedish partner CLS), and the IRRAflow Active Fluid Exchange System, added through the 2025 acquisition of IRRAS. A growing portion of revenue since 2021 comes from preclinical development services supporting biopharma partners in drug delivery to the brain. As of the 10-K filed March 17, 2026, the company operates a preclinical research facility, ClearPoint Advanced Laboratories (CAL), in San Diego, California.

Revenue model

Product sales of neurosurgery navigation disposables and capital equipment, placement of systems under a loaned-unit program (ClearPoint placement program), therapy system commercialization via the Prism laser, and fee-based preclinical consulting and development services sold to pharmaceutical and biotech partners pursuing brain drug delivery programs.

Products and services

ClearPoint navigation platform (FDA 510(k) cleared 2010, software version 3.0 cleared per FY2025 filing); SmartFlow Neuro cannula (CE marked May 2018); SmartFrame Array Neuro Navigation System (cleared January 2021); SmartFrame OR Stereotactic System (cleared January 2024); ClearPoint Prism Neuro Laser Therapy System (510(k) cleared September 2022, exclusive global neuro rights); IRRAflow Active Fluid Exchange System for intracranial fluid management (added via IRRAS acquisition, 2025); preclinical and clinical consulting services through ClearPoint Advanced Laboratories (CAL) in San Diego.

Customers and end markets

Hospital neurosurgery and neurocritical care units performing procedures including deep brain stimulation, brain tumor biopsy, laser ablation, and external ventricular drainage. Pharmaceutical and biotech companies developing biologics and gene therapies targeting brain disorders such as Parkinson's disease, AADC Deficiency, Friedreich's Ataxia, Angelman Syndrome, Huntington's disease, Alzheimer's disease, drug-resistant epilepsy, and glioblastoma. As of the FY2025 10-K, over ten pharmaceutical partners had received expedited FDA review designations.

Value-chain role

Vertically integrated medical device manufacturer: performs component processing, final assembly, packaging, and distribution in-house in FDA-registered, ISO 13485-certified, and MDSAP-certified facilities. Also provides upstream preclinical and clinical support services to biopharma customers, positioning the company as both a device supplier and a contract research services provider for brain drug delivery programs.

Geographic exposure

Primary operations and sales in the United States. CE marking held for the ClearPoint system (February 2011), SmartFlow Neuro cannula (May 2018), and ClearPoint software version 2.0 and Inflexion head fixation frame (June 2020), indicating European market authorization. Exclusive global commercialization rights for the Prism Neuro Laser Therapy System for neuro applications.

Source: SEC 10-K, filed 2026-03-17

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