CLPTNasdaqSurgical & Medical Instruments & ApparatusUS GAAP · USD

ClearPoint Neuro, Inc.

ClearPoint Neuro, Inc. develops and commercializes image-guided neurosurgery platforms used for minimally invasive procedures in the brain. Its business combines capital equipment and disposable products for the ClearPoint system with consulting and service revenue tied to biologics and drug delivery programs that aim to deliver therapies directly to targeted brain tissue.

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Revenue37.0m USD
+17.8 %y/y
Operating profit (EBIT)-24.2m USD
−22.4 %y/y
EBIT margin-65.4%
−2.5 ppy/y
Net income-25.5m USD
−35.0 %y/y
Free cash flow-24.4m USD
−165.0 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-40-2002040m USD2020: 13 m USD2020: EBIT -6.2 m USD20202021: 16 m USD2021: EBIT -13 m USD20212022: 21 m USD2022: EBIT -16 m USD20222023: 24 m USD2023: EBIT -22 m USD20232024: 31 m USD2024: EBIT -20 m USD20242025: 37 m USD2025: EBIT -24 m USD202537-24
RevenueOperating profit (EBIT)

Business

Share of revenue
Neurosurgery navigation and therapy products55 %

Capital and disposable products used for image-guided brain procedures, including the ClearPoint platform and related navigation systems.

Biologics and drug delivery services40 %

Consulting, protocol design, and execution support for customers developing gene, cell, and other brain-delivery therapies.

Laser therapy and adjunct commercialization products5 %

Therapy-related offerings such as the Prism laser system and newer product launches that expand the platform's clinical use cases.

Products

Reported · share of revenue
40.1%31.7%19.8%FY2025100 %
  • Neurosurgery Navigation and Therapy Disposable Products40.1 %
  • Biologics and Drug Delivery Services and License Fees31.7 %
  • Biologics and Drug Delivery Disposable Products19.8 %
  • Capital Equipment and Software Systems and Software Products4.6 %
  • Capital Equipment and Software Services3.8 %

Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.

Customers

ClearPoint sells to hospitals and neurosurgeons for clinical procedures, while its biologics and drug delivery business serves pharmaceutical companies, biotech firms, academic institutions, and customer-sponsored CROs. These partners use ClearPoint-related products and services to support preclinical work, clinical trials, and eventual commercialization of therapies that must reach targeted brain tissue. The customer base is therefore split between clinical users buying devices and research/development customers buying expertise and workflow support.

Clinical neurosurgery users

Hospitals and surgeons buy ClearPoint navigation and therapy products for minimally invasive brain procedures.

Biologics and drug delivery partners

Pharma and biotech customers buy consulting and workflow support to develop therapies delivered into the brain.

Academic research institutions

Universities and research centers use the platform for preclinical and translational neuroscience work.

Contract research organizations

CROs use ClearPoint-related services to support customer-sponsored studies and trial execution.

Strategy

ClearPoint is focused on expanding its commercial neurosurgery platform while building a larger biologics and drug delivery business around gene and cell therapy programs. Management views the biologics segment as the largest growth opportunity, but it depends on customer trial progress, regulatory approvals, and continued partner relationships. The company is also broadening its product set with newer systems such as SmartFrame OR and Prism to deepen clinical use and recurring revenue.

Grow biologics and drug delivery partnershipsMedium term

This is management's largest stated growth opportunity and can create recurring service and product demand.

Expand ClearPoint platform commercializationShort term

Recurring product sales from the installed base help stabilize revenue and support operating leverage.

Broaden therapy applicationsMedium term

New indications and products increase the number of procedures and addressable customers.

Geography

The company is headquartered in the United States and received FDA clearances for its core products there, making the U.S. the anchor market for commercialization. It also has CE-marked products for Europe, which broadens the addressable market for its neurosurgery platform and supports international adoption. Geography matters because regulatory approvals, reimbursement, and clinical adoption differ by region, especially for novel brain-delivery therapies.

Risks

The business depends on clinical and regulatory success in highly uncertain brain-therapy programs, so delays or failures in FDA review can directly reduce future demand. ClearPoint also remains loss-making and has relied on external financing, which increases execution and funding risk as it scales commercialization. In addition, the company faces integration risk from the planned IRRAS merger and the typical adoption, reimbursement, and competition risks seen in medical devices.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Continued operating losses and financing dependence1Regulatory delay or failure for cell and gene therapies2Merger integration risk3Commercial adoption risk4
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Continued operating losses and financing dependenceImpact: HighLikelihood: High

    The company has not achieved profitability and has historically funded operations with equity and debt.

    Exposure: Enterprise-wide

  2. Regulatory delay or failure for cell and gene therapiesImpact: HighLikelihood: Medium

    A large part of growth depends on customers' therapies reaching approval and commercialization.

    Exposure: Biologics and drug delivery business

  3. Merger integration riskImpact: MediumLikelihood: Medium

    The planned IRRAS transaction may create integration costs, employee retention issues, and liability surprises.

    Exposure: Post-merger operations

  4. Commercial adoption riskImpact: MediumLikelihood: Low

    New neurosurgical products require surgeon training, workflow integration, and clinical acceptance.

    Exposure: ClearPoint platform

Accounting

Judgemental items
Revenue recognition by product vs service line

Different timing and contract terms can change quarterly revenue and gross margin mix.

Impact: Product sales are mostly ClearPoint-related; service revenue is tied to biologics programs.

Project-based and partner-driven timing

Clinical and consulting work depends on customer milestones, causing quarter-to-quarter variability.

Impact: Can make revenue and operating leverage difficult to forecast.

Merger-related valuation and liabilities

The IRRAS transaction may require fair value estimates for consideration and assumed obligations.

Impact: Could affect goodwill, intangible assets, and future impairment risk.

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Last updated: 24/09/2026

ClearPoint Neuro, Inc. (CLPT) Revenue, Earnings & Financials 2025 – Clarifo