ClearPoint Neuro (NASDAQ:CLPT) reported higher revenue for both the fourth quarter and full year 2025 and outlined a two-phase growth strategy that management said is designed to expand the company’s presence across multiple neurosurgical markets while positioning for longer-term opportunities in cell and gene therapy delivery to the brain.
Fourth quarter and full-year 2025 financial results
For full-year 2025, ClearPoint Neuro posted total revenue of $37.0 million, up from $31.4 million in 2024. The 2025 total included $1.2 million of revenue from the acquisition of IRRAS Holdings, Inc., which closed on November 20, 2025. Gross margin was 61% for the year, in line with 2024.
- Biologics and Drug Delivery: Revenue increased 10% to $19.0 million in 2025 from $17.3 million in 2024, which the company attributed primarily to increased product sales as pharmaceutical partners advanced development programs.
- Neurosurgery Navigation and Therapy: Revenue rose to $14.8 million in 2025, including $1.2 million of IRRAflow revenue. Management linked the growth to an expanded installed base and the full market release of the Prism laser system and the iCT solution.
- Capital equipment and software: Revenue was $3.1 million in 2025.
Fourth-quarter 2025 revenue was $10.4 million, compared with $7.8 million in the year-ago quarter. Biologics and Drug Delivery revenue grew 23% to $5.2 million, driven by higher disposable product demand as multiple partners progressed in trials, partially offset by a small decline in service revenue. Neurosurgery Navigation and Therapy revenue increased to $4.7 million from $2.9 million, which the company said reflected both customer base growth and the addition of the IRRAS product line. Capital equipment revenue was $0.5 million versus $0.6 million in the prior-year quarter. Gross margin for the quarter was 62%, up from 61% a year earlier.
Expenses, cash, and financing
Operating expenses increased in 2025, with management citing investments in development and commercial expansion as well as costs tied to the IRRAS acquisition. For the full year:
- R&D expense was $13.9 million versus $12.4 million in 2024, driven by higher product and software development costs, personnel costs (including share-based compensation), and additional costs from consolidation of IRRAS.
- Sales and marketing expense rose to $16.5 million from $14.5 million, reflecting higher personnel costs from increased clinical team headcount and IRRAS-related consolidation costs, partially offset by lower marketing and travel costs.
- General and administrative expense increased to $16.5 million from $12.0 million, primarily due to severance expense related to the IRRAS acquisition, higher professional service fees, higher personnel costs (including share-based compensation), increased IT and software costs, and other IRRAS-related costs.
Net interest expense was $1.2 million in 2025. Interest expense rose to $2.4 million from $0.45 million in 2024, which the CFO attributed to the issuance of notes payable in May and November 2025.
ClearPoint ended 2025 with $45.9 million in cash and cash equivalents, up from $20.1 million at the end of 2024. Management said the increase was driven by net proceeds of $51.4 million from notes payable and a stock offering, along with $1.1 million of cash acquired in the IRRAS acquisition, partially offset by $23.9 million used in operating activities and $1.9 million of cash paid for taxes related to net share settlement of equity awards.
Net cash used in operating activities was $23.9 million in 2025, an increase of $15.0 million from 2024. The CFO attributed the change to a higher net loss and a paydown of accounts payable and accrued expenses, including liabilities assumed from the IRRAS acquisition and acquisition-related expenses. He added that the company does not expect assumed-liability cash outflows “of a similar magnitude” in future periods, describing that paydown as non-recurring.
2026 guidance and FDA-related assumptions
CEO Joe Burnett said the company expects 2026 revenue of $52 million to $56 million. In the Q&A, Burnett elaborated that the outlook reflects two main considerations: recent FDA communications regarding rare diseases and integration priorities following the IRRAS acquisition.
On the rare-disease point, Burnett said the FDA has communicated to at least two of ClearPoint’s partners a preference for a more rigorous clinical trial strategy, noting the challenges of executing traditional Phase III studies in rare diseases. Based on that information, the company “effectively” removed revenue associated with the potential commercial launch of those particular products from its outlook. Burnett cited uniQure and REGENXBIO as examples where the company could revisit guidance if circumstances change, but said guidance is based on partners’ latest publicly presented information. He also said the majority of partners working in larger patient populations already planned to conduct Phase III sham studies, and the company does not believe the latest FDA posture changes timelines for those larger-population programs.
Regarding IRRAS, Burnett said the company is learning more as it meets customers and evaluates strategy, pointing to a “reset button” on European expansion, including distributor decisions. He said that adjustment may have reduced the European revenue contribution embedded in guidance, while noting the company may revisit guidance later in the year if developments are positive.
Strategy: four current pillars and a future “fifth”
Burnett described a growth strategy built around four current product pillars that represent essentially all of the company’s present revenue: (1) pre-commercial biologics and drug delivery products and services; (2) neurosurgery navigation and robotics; (3) laser therapy and access; and (4) neurocritical management. He said the company expects each of these segments to grow in the double digits in 2026, and noted that a future fifth pillar—commercial cell and gene therapy delivery—would be added as partners progress through global regulatory processes. Burnett emphasized that the 2026 revenue forecast does not include “meaningful” revenue from commercial drug delivery.
Operationally, Burnett highlighted progress at the ClearPoint Advanced Laboratories facility in Torrey Pines, California (“The CAL”), where the company performed its first pre-clinical study for a sponsor in Q4 2025 and began additional studies in early 2026, with a grand opening planned for the second half of 2026 and GLP capability expected to be added. He also cited more than 60 active biopharma partners, participation in more than 25 active clinical trials, and more than 10 partner programs accepted into some form of FDA expedited review.
Burnett also pointed to commercial and development activity across the portfolio, including the ClearPoint 3.0 software platform launch, CE marking for ClearPoint 3.0 under a new European notified body, initiation of the PMDA regulatory process in Japan with expectations to perform first cell therapy clinical trial cases in the second half of the year, and continued development of a robotic platform with usability showcases planned. In laser therapy, he noted 2025 FDA clearance for Prism to expand compatibility to 1.5 Tesla MRI scanners, initial 1.5 Tesla installations, and 2026 plans that include pursuing European approval for Prism, submitting Harmony 1.0 software, and publishing tumor clinical trial data enabled by Prism. On the access side, he cited FDA clearance received by drill partner adeor for the Velocity Alpha MR Conditional Power Drill, with a limited market release beginning and early prioritization toward drug delivery sites and cases.
For neurocritical management, Burnett said the IRRAflow assets provide entry into an existing market opportunity and add a flexible indwelling drug delivery option for the brain, with the IRRAflow catheter being made available as another tool biopharma partners can evaluate at The CAL facility. He also referenced a randomized clinical trial supported by IRRAS called the ARCH trial, with an expected data readout later in the year.
About ClearPoint Neuro (NASDAQ:CLPT)
ClearPoint Neuro, Inc is a medical technology company specializing in the development and commercialization of an MRI-guided therapy platform for minimally invasive neurosurgical procedures. Headquartered in Cambridge, Massachusetts, the company’s flagship ClearPoint® SmartFrame™ system enables surgeons to perform accurate and efficient intracranial interventions by providing real-time magnetic resonance imaging feedback. This technology is designed to improve patient safety and outcomes in treatments ranging from deep brain stimulation electrode placement to laser ablation of epileptic foci and brain tumors.
The ClearPoint System integrates hardware, software and imaging capabilities to guide instruments through the brain with submillimeter precision.
