Clearpoint Neuro Stock Price, News & Analysis

ClearPoint Neuro, Inc. (Nasdaq: CLPT) is a medical device company in the surgical and medical instrument manufacturing industry that focuses on device, cell, and gene therapy-enabling technologies offering precise navigation to the brain and spine. According to company disclosures, ClearPoint Neuro combines established clinical products with preclinical development services for controlled drug and device delivery to the central nervous system, supporting both routine neurosurgical procedures and advanced therapy development programs.

The company’s flagship product is the ClearPoint Neuro Navigation System, which has FDA clearance and is CE-marked. This system is used to perform minimally invasive surgical procedures in the brain under image guidance and is part of a broader ecosystem that includes software, hardware, disposables, and services. Polygon data and company descriptions state that ClearPoint Neuro develops and commercializes platforms for performing minimally invasive surgical procedures in the brain and heart under direct, intra-procedural MRI guidance, with its ClearPoint system in commercial use for brain procedures.

Business focus and growth pillars

ClearPoint Neuro describes its business around four existing growth markets or pillars: (1) pre-commercial biologics and drug delivery, (2) neurosurgery navigation, (3) laser therapy and access, and (4) intracranial fluid management. The company reports that these areas encompass both its neurosurgical technologies and its therapy delivery platforms. In biologics and drug delivery, ClearPoint Neuro provides disposable products and services related to customer-sponsored preclinical and clinical trials. In neurosurgery navigation and therapy, it generates revenue primarily from disposable products used in procedures that utilize the ClearPoint system.

ClearPoint Neuro also highlights its ClearPoint Advanced Laboratories (CAL), a pre-clinical contract research facility in the Torrey Pines, California biotech region, which supports preclinical studies for pharmaceutical sponsors. The company notes that this facility is intended to increase capacity for larger studies, enable higher value GLP studies including pivotal toxicology work, and expand the range of services offered to biopharma partners.

Product and technology ecosystem

Based on company descriptions and Polygon data, ClearPoint Neuro’s product ecosystem includes the ClearPoint system, ClearPoint Services, ClearPoint Disposables, ClearPoint Software, and ClearPoint Therapeutic Solutions. The company reports that thousands of procedures have been performed and supported by its field-based clinical specialist team, which provides on-site support and services to customers and partners worldwide.

Within laser therapy, ClearPoint Neuro offers the ClearPoint Prism Neuro Laser Therapy System (ClearPoint Prism). The company has announced that ClearPoint Prism received 510(k) clearance from the U.S. Food and Drug Administration to include 1.5T MRI guidance in addition to previously cleared 3T MRI guidance. ClearPoint Prism is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 1.5T and 3.0T MRI guidance in neurosurgery for a specified wavelength. ClearPoint Neuro has also reported promising results from a Phase I–II clinical study in glioblastoma and grade 4 astrocytoma using the ClearPoint Prism Neuro Laser Therapy System, highlighting a minimally invasive workflow and feasibility in neuro-oncology.

The company has announced development and demonstration of a prototype Robotic Neuro-Navigation System, designed to enable ClearPoint Neuro Navigation software to operate a KUKA LBR Med robotic arm. According to ClearPoint Neuro, this system is intended to support minimally invasive cranial procedures such as cell and gene therapy infusions, laser catheter placement, biopsy workflows, deep brain stimulation, and stereotactic EEG lead placements. The company states that this robotic system is being developed to provide both consistency and flexibility in surgical workflows across MRI-guided, intraoperative CT-guided, and robotic-assisted techniques, all driven by a single software planning module.

Global footprint and partnerships

ClearPoint Neuro reports that it is engaged with healthcare and research centers in North America, Europe, Asia, and South America. It states that it partners with pharmaceutical and biotechnology companies, academic centers, and contract research organizations to provide solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. The company notes that its products and services support more than 60 active biopharma partners, including programs that have been accepted for FDA expedited review.

The company has also emphasized its regulatory footprint. ClearPoint Neuro has announced expanded international clearances for key therapy delivery products in Canada, Hong Kong, and Taiwan, and reports a total of 34 countries worldwide with regulatory clearances for key therapy delivery products. It states that this regulatory history is intended to support biopharma partners’ clinical trial design and potential pathways toward global commercial scale.

Intracranial fluid management and IRRAS acquisition

ClearPoint Neuro has entered the intracranial fluid management and neurocritical care space through the acquisition of IRRAS Holdings, Inc., a medical technology company focused on treatments for intracerebral hemorrhage, chronic subdural hematoma, and other conditions requiring intracranial fluid management. An 8-K filing dated November 20, 2025, confirms completion of this acquisition pursuant to an Agreement and Plan of Merger and Reorganization.

The acquisition brings to ClearPoint Neuro the IRRAflow active fluid-exchange system, described as a differentiated technology designed to modernize the management of intracranial bleeding. Company disclosures state that IRRAflow is an FDA-cleared and CE-marked platform that integrates continuous irrigation, aspiration, and real-time intracranial pressure monitoring, and that it is intended for the delivery of physician-directed fluids with potential use in targeted intracranial drug delivery as reported in clinical literature. ClearPoint Neuro reports that the IRRAS transaction adds more than 50 active customers, an expanded commercial team of marketing, sales, and clinical specialists, and additional patent families, and that it is expected to expand the company’s presence into neurocritical care and complement its existing neurosurgical and drug delivery platforms.

Role in cell and gene therapy delivery

ClearPoint Neuro consistently describes itself as a neuro drug delivery partner for the biopharma community. The company states that it provides preclinical development services, co-labeled cannula-based routes-of-administration, quality control infusion modeling and monitoring, and field-based clinical specialist support. It emphasizes that its technology and services are used in cell and gene therapy clinical trials under FDA expedited review and that it works with neurosurgical teams and biopharma partners to identify and activate specialized treatment centers for future commercial deployment of neuro cell and gene therapies.

According to company commentary, ClearPoint Neuro’s strategy is to standardize and simplify surgical workflows for delivering novel therapies across multiple geographies, with the goal of reducing barriers to adoption and supporting consistent outcomes. The company highlights that its navigation and therapy delivery ecosystem is intended to serve as a common platform across MRI, intraoperative CT, and robotic navigation environments.

Market context and industry classification

ClearPoint Neuro operates within the surgical and medical instrument manufacturing industry in the broader manufacturing sector. Its activities span neurosurgical navigation systems, laser therapy technologies, intracranial fluid management systems, and specialized devices and services for central nervous system drug delivery. The company’s disclosures emphasize integration of hardware, software, disposables, and services to support neurosurgeons and biopharma partners in both clinical practice and research settings.

Exchange listing and geography

ClearPoint Neuro, Inc. trades on the Nasdaq under the ticker symbol CLPT. Company press releases identify the business as being based in Solana Beach, California. The company’s engagement with healthcare and research centers across multiple continents and its network of biopharma, academic, and CRO partners position it as an active participant in global neurosurgical and neuro-therapeutic development ecosystems, as described in its own communications.