CeriBell (NASDAQ:CBLL) reported fourth-quarter and full-year 2025 results that management said reflected continued penetration of its core seizure market alongside a broadened product and regulatory foundation intended to expand the company’s addressable opportunity. The company also provided 2026 revenue guidance and discussed planned commercial steps for newly cleared indications, including neonatal and pediatric seizure detection and an FDA-cleared delirium monitoring algorithm.
Q4 and full-year 2025 results
Revenue for the fourth quarter of 2025 was $24.8 million, up 34% from $18.5 million in the year-ago quarter. For the full year, revenue was $89.1 million, representing 36% growth over 2024. Management attributed the quarterly increase primarily to higher adoption of the Ceribell System across both new and existing hospital accounts.
Gross margin was 87% in the fourth quarter, compared with 88% in the prior-year period. Full-year gross margin was 88%, up from 87% in 2024. CFO Scott Blumberg said the Q4 gross margin decline reflected a partial-quarter impact from transitioning to inventory acquired after increased tariffs on products originating in China.
Operating expenses rose as the company continued to invest in growth initiatives. Fourth-quarter operating expenses were $36.2 million, up 24% from $29.1 million a year earlier, including $3.3 million in non-cash stock-based compensation. Full-year operating expenses were $136.7 million, up 42% from $96.5 million in 2024, including $12.2 million in stock-based compensation. Management cited commercial organization investments, headcount growth, legal costs, and public company expenses.
Net loss in Q4 was $13.5 million, or $(0.36) per share, compared with a net loss of $12.6 million, or $(0.40) per share, in Q4 2024. Full-year net loss was $53.4 million, or $(1.46) per share, compared with a net loss of $40.5 million, or $(3.39) per share, in 2024. The company ended 2025 with $159.3 million in cash, cash equivalents, and marketable securities.
Account growth and commercial infrastructure
Ceribell finished 2025 with 647 active hospital accounts as of December 31, adding 32 net new accounts in Q4 and 118 during the year. Blumberg said the company achieved Q4 adds despite a strategy to avoid launches in the final weeks of the year, and noted that a small number of Q4 launches were tied to the company’s previously announced expansion within the U.S. Department of Veterans Affairs (VA) system. Ceribell said it expects additional VA account launches in coming quarters.
CEO Jane Chao highlighted a buildout of commercial coverage from 35 territories in the second half of 2024 to approximately 55 territories currently, and said the company is seeing “a very strong backlog” of interested accounts. Management said it expects the timing of these investments to begin accelerating account acquisition in 2026, with further acceleration anticipated in 2027.
Management also emphasized initiatives to drive deeper utilization within existing hospitals, describing a “playbook” that includes departmental expansion, protocol development, and physician training. The company said it is roughly 30% penetrated within its installed base, leaving room for “same-store” growth. In the Q&A, Ceribell also described a newer focus on health system-level selling—pursuing multi-hospital deals rather than single-site wins—based on successes by senior territory managers in 2025.
Regulatory milestones expand the opportunity
Chao said the company believes its total addressable market has increased from $2 billion to more than $3.5 billion, citing regulatory achievements and expansion into new indications. Key 2025 and early 2026 milestones discussed on the call included:
- FedRAMP High authorization, which management said unlocks access to all 170 hospitals within the VA system; Ceribell said the VA has committed to expanding following a pilot and that the first accounts launched in Q4 2025.
- FDA clearance for seizure detection products for neonate and pediatric patients, which Ceribell said expands the core seizure market opportunity by approximately $400 million.
- FDA 510(k) clearance (December 2025) for the company’s delirium algorithm, which management said makes Ceribell the first and only FDA-cleared delirium detection and continuous monitoring device.
- FDA breakthrough device designation (January 2026) for LVO stroke monitoring in the inpatient setting.
Neonatal/pediatric launch timing and revenue impact
Ceribell plans to move from a pilot to a full commercial launch of its neonatal and pediatric products in Q2 2026. However, Blumberg said the impact on 2026 revenue is expected to be “likely modest” due to launch timing and multi-month sales cycles that can include contracting, workflow design, and training—even within hospitals already using Ceribell for adult patients.
In the Q&A, Chao added that expanding within an existing hospital often requires purchasing additional recorders and a neonatal-dedicated version of the company’s software, and can involve additional committees. She also noted workflow and patient population discussions can take additional months, which management said helps explain why a Q2 launch could translate into more meaningful financial impact in Q4.
Blumberg said the neonatal product is expected to add incremental subscription cost for existing adult customers and could lift both product and subscription revenue via the current installed base, with some potential incremental accounts such as children’s hospitals.
Delirium pilot plans and reimbursement efforts
Management said it plans to initiate a delirium pilot in 2026 to identify target patient populations, optimize workflow, refine commercial messaging, and build clinical evidence, with an anticipated full commercial launch in Q4 2026 or Q1 2027. Chao said discussions with accounts are underway, but the company does not expect a commercial pilot to go live until Q2 as software integration work is completed.
Ceribell also said it submitted an NTAP application late last year for delirium; management said a preliminary CMS decision is expected in April 2026, and that if awarded, NTAP would become effective in October 2026. On pricing, management said it is too early to provide specifics and that pricing decisions are part of what the pilot is designed to inform.
Blumberg said Ceribell intends to largely leverage its existing commercial infrastructure across new indications, describing the platform as sharing the same call point and requiring primarily sales training and market development rather than a major salesforce expansion.
For 2026, Ceribell guided to total revenue of $111 million to $115 million, implying 25% to 29% growth over 2025. The company said its outlook includes VA expansion commitments already made, but not further VA expansion beyond that. Blumberg also said Ceribell expects to deliver gross margin in the mid-80% range in 2026, reflecting current tariff conditions and mitigation efforts including a manufacturing line in Vietnam and cost reduction initiatives, while noting the guidance does not include potential impacts from policy changes discussed on the call.
About CeriBell (NASDAQ:CBLL)
CeriBell Corp (NASDAQ: CBLL) is a healthcare technology company specializing in the design, manufacture and sale of automated newborn hearing screening devices. The company offers a suite of medical diagnostic tools based on otoacoustic emissions (OAE) and auditory brainstem response (ABR) technologies, enabling early detection of auditory impairments in infants. CeriBell’s solutions are used in hospitals, birthing centers and audiology clinics to support universal newborn hearing screening programs aimed at improving language development outcomes through prompt intervention.
The company’s product portfolio includes handheld and desktop screening units, proprietary software for data management, and accessories designed to streamline testing workflows.
