Clearpoint Neuro (CLPT) Corporate presentation summary

Market opportunity and unmet needs

• Over 30 million people in the U.S. suffer from severe neurological disorders, costing nearly $800 billion annually, with less than 1% treated using minimally invasive neurosurgery.

• 2.1 million U.S. patients have disorders where a partner's therapy is under FDA expedited review, and 60+ pharma partners are engaged, with 10+ programs accepted for expedited review.

• The first gene therapy delivered directly to the brain was approved in 2024, using a device exclusively authorized for this purpose.

Strategic growth and product ecosystem

• A 4-phase strategy focuses on drug delivery, expanding the installed base, leveraging the current portfolio, and building a new $10B market with biopharma partners.

• The platform includes neuro navigation, predictive modeling, co-labeled delivery devices, infusion monitoring, and clinical support, with over $200m invested and 10,000+ procedures performed.

• The installed base exceeds 150 global centers, with 170+ employees and a presence in top neurosurgery programs.

Financial and operational highlights

• 2025 revenue reached $37.0m with a 61% gross margin, 130+ issued patents, and $45.9m in cash and equivalents.

• Facilities include headquarters, R&D, and manufacturing in California, with ISO 13485/MDSAP/EU MDR certified QMS and a strong audit history.

• Leadership team has deep experience in medical devices, biopharma, and clinical research.