Clearpoint Neuro Inc
NASDAQ:CLPT
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Clearpoint Neuro Inc
Clearpoint Neuro, Inc. engages in the development and commercialization of platforms for performing minimally invasive surgical procedures in the brain and heart. The company is headquartered in Solana Beach, California and currently employs 80 full-time employees. The company went IPO on 2019-07-03. The Company’s product platforms include SmartFlow Cannula and ClearPoint Navigation System Software. The SmartFlow Cannula is being utilized in approved combination product clinical and preclinical studies by pharmaceutical companies and academic research customers for various research and clinical trials in connection with delivery of therapeutic agents. The ClearPoint Navigation System Software is a software for surgical planning, navigation to target, and device delivery. The Company’s software and MRI-compatible workstation coordinate with the scanner to effectively utilize intraprocedural MR images. This provides real-time navigational instruction for the neurosurgeon to reach the desired anatomical target with a high degree of precision.
Clearpoint Neuro, Inc. engages in the development and commercialization of platforms for performing minimally invasive surgical procedures in the brain and heart. The company is headquartered in Solana Beach, California and currently employs 80 full-time employees. The company went IPO on 2019-07-03. The Company’s product platforms include SmartFlow Cannula and ClearPoint Navigation System Software. The SmartFlow Cannula is being utilized in approved combination product clinical and preclinical studies by pharmaceutical companies and academic research customers for various research and clinical trials in connection with delivery of therapeutic agents. The ClearPoint Navigation System Software is a software for surgical planning, navigation to target, and device delivery. The Company’s software and MRI-compatible workstation coordinate with the scanner to effectively utilize intraprocedural MR images. This provides real-time navigational instruction for the neurosurgeon to reach the desired anatomical target with a high degree of precision.
Merger Announcement: ClearPoint Neuro announced an agreement to acquire IRRAS, aiming to expand its product portfolio and commercial reach in neurosurgery and neurocritical care.
Q3 Revenue Growth: Revenue for Q3 2025 was $8.9 million, up 9% from the prior year but with slower growth due to the company's CRO facility transition.
Gross Margin Expansion: Gross margin improved to 63% from 60% a year ago, driven by product mix and higher-margin service revenue.
Guidance Narrowed: 2025 revenue forecast narrowed to $36–38 million (within previous guidance); combined company revenue for 2026 guided to $54–60 million.
Operational Funding: Secured access to $20 million in additional funding to support the IRRAS acquisition and post-merger integration.
Strategic Shift: Company outlined a two-pronged growth strategy, targeting both existing $1 billion+ markets and building a new $10 billion+ market in neuro drug delivery.
CRO Facility Impact: Temporary slowdown in biologics and drug delivery growth attributed to prioritization of moving and certifying the new CRO facility, with expectation of double-digit growth resuming in Q4 and beyond.
