Ceribell, Inc.

CeriBell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, primarily in the acute care setting. The company has developed the Ceribell System, a point-of-care EEG platform that combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring. The system is designed to address the limitations of conventional EEG systems, which have led to significant delays in seizure diagnosis and suboptimal patient care. As of December 31, 2025, the Ceribell System has been adopted by more than 600 hospitals, ranging from top academic centers to small community hospitals ¹. The company's core business model revolves around two recurring revenue streams: the sale of disposable Wearables for single patient use and a monthly subscription fee for the use of Clarity, recorders, and the web-based portal ².

The Ceribell System integrates proprietary hardware, consisting of disposable, flexible headbands and headcaps (Wearables) and a pocket-sized, rechargeable battery-operated recorder, with AI-powered algorithms ³. The Wearables are designed for rapid application by non-specialized healthcare professionals within minutes after approximately one hour of training ⁴. The recorder captures and wirelessly transmits EEG signals and features a digital screen displaying raw EEG data and a proprietary seizure burden trend line produced by the Clarity AI-powered seizure detection algorithm ⁵. Clarity continuously monitors the patient's EEG signal, converting raw EEG data into a seizure burden metric that measures seizure activity in a rolling five-minute interval, and generates visual and audio alerts for suspected prolonged seizure activity ⁶. The web-based portal allows neurologists to remotely access EEG data in real time from any web-enabled device, offering simple sorting, filtering, annotation, and an extensive EEG reference library ⁷.

The company's revenue is segmented into product revenue and subscription revenue. For the fiscal year ended December 31, 2025, total revenue was $89.063 million ⁸, representing a 36% year-over-year growth from $65.444 million in fiscal year 2024 ⁹. Product revenue increased by $17.256 million, or 34%, to $67.335 million in fiscal year 2025 from $50.079 million in fiscal year 2024 ¹⁰. Subscription revenue grew by $6.363 million, or 41%, to $21.728 million in fiscal year 2025 from $15.365 million in fiscal year 2024 ¹¹.

Gross profit for fiscal year 2025 was $78.274 million ¹², an increase of 38% from $56.750 million in fiscal year 2024 ¹³. The overall gross margin for fiscal year 2025 was 88%, up from 87% in fiscal year 2024 ¹⁴. Product gross profit was $57.207 million with an 85% margin in fiscal year 2025, compared to $41.870 million and an 84% margin in fiscal year 2024 ¹⁵. Subscription gross profit was $21.067 million with a 97% margin in fiscal year 2025, consistent with the 97% margin in fiscal year 2024 on $14.880 million of gross profit ¹⁶. The net loss for fiscal year 2025 was $53.412 million ¹⁷, compared to a net loss of $40.455 million in fiscal year 2024 ¹⁸. Diluted EPS is not explicitly stated in the provided text.

Operating expenses increased significantly, with research and development expenses rising by $5.581 million, or 41%, to $19.143 million in fiscal year 2025 from $13.562 million in fiscal year 2024 ¹⁹. Sales and marketing expenses increased by $24.027 million, or 49%, to $73.082 million in fiscal year 2025 from $49.055 million in fiscal year 2024 ²⁰. General and administrative expenses increased by $10.609 million, or 31%, to $44.451 million in fiscal year 2025 from $33.842 million in fiscal year 2024 ²¹. The company reported $159.3 million in cash and cash equivalents and marketable securities as of December 31, 2025 ²². Total debt outstanding under the Venture Loan and Security Agreement (VLSA) was $20.0 million as of December 31, 2025 ²³. Net cash used in operating activities was $40.808 million in fiscal year 2025 ²⁴.

Significant operational developments during the period include the FDA granting 510(k) clearance for the company's proprietary delirium monitoring solution in December 2025, which is the first and only FDA-cleared delirium detection and monitoring device ²⁵. This clearance is expected to allow the Ceribell System to simultaneously support continuous monitoring of seizures, ESE, and delirium at the bedside ²⁶. In October 2025, Ceribell released the latest generation of Clarity with further enhancements to its seizure detection algorithm and user workflows ²⁷. The company also submitted an NTAP application to CMS for the new delirium indication in October 2025 ²⁸. In April 2025, the company received full FedRAMP High authorization from the U.S. government, enabling approximately 170 Veterans Administration hospitals to potentially purchase its products ²⁹. In July 2025, the company filed patent infringement complaints against Natus Medical Incorporated and related subsidiaries with the U.S. International Trade Commission and the U.S. District Court for the District of Delaware, alleging infringement on six patents related to the Ceribell EEG headband and electrode designs ³⁰.

Management believes that the expected cash generated from revenue transactions with customers and existing cash and cash equivalents and marketable securities will be sufficient to fund planned operating expenses and capital expenditure requirements for at least the next 12 months ³¹. However, this estimate is based on assumptions that may prove to be wrong, and the company could deplete its capital resources sooner than expected, potentially requiring additional capital through equity or debt financings ³².

A major growth area for CeriBell is the expansion into new indications beyond seizures. In December 2025, the FDA granted 510(k) clearance for the company's proprietary delirium monitoring solution, which is the first and only FDA-cleared delirium detection and monitoring device ³³. Delirium affects over three million patients in the U.S. annually, including around 30% of ICU patients, and up to 80% of those who are mechanically ventilated ³⁴. This new indication is expected to increase the value proposition among many patients in the current population who are at risk for delirium ³⁵. The company believes that with this expanded indication, its annual addressable market opportunity has increased to over $3.5 billion ³⁶. In October 2025, an NTAP application was submitted to CMS for this new delirium indication ³⁷.

Another significant growth vector is the development of a Large Vessel Occlusion (LVO) stroke detection and monitoring solution. In January 2026, the company announced FDA Breakthrough Device Designation for this solution, which is in development for adult patients in the hospital setting where a reliable neurological exam for LVO stroke is often challenging ³⁸. This potential first-in-class solution uses Ceribell’s existing hardware and an AI-based algorithm to interpret EEG signals for early detection of LVO stroke ³⁹. Nearly 800,000 strokes occur annually in the U.S., with up to 17% occurring in the hospital, and timely detection of LVO stroke can result in substantial health benefits ⁴⁰. The company expects to apply to the FDA for marketing authorization for this indication within the next three years, though this timeline is subject to change and commercialization timing is not yet intended ⁴¹. The company is also developing second-generation hardware with additional features to support potential future indications and aims to develop solutions for use beyond the acute care setting by identifying biomarkers for non-acute neurological and psychiatric conditions in the longer term ⁴².

Operationally, the company expects its research and development expenses to increase as it continues to improve and optimize its products, leverage its platform to expand indications, and develop products for use beyond the acute care setting ⁴³. Sales and marketing expenses are also expected to increase as the company expands its sales organization and market penetration in the United States, expands indications, and potentially establishes an international presence ⁴⁴. General and administrative expenses are anticipated to increase due to headcount growth and additional expenses associated with operating as a public company, including legal, accounting, regulatory, and intellectual property enforcement activities ⁴⁵. The company manages all aspects of manufacturing, supply chain, and distribution of Wearables and recorders from its Sunnyvale, California facility, with contract manufacturers in China and Vietnam assembling headbands ⁴⁶. The company believes its current manufacturing capacity is sufficient to meet current and expected near-term growth and maintains incremental supply of finished goods, subassembly, and individual components to mitigate potential supply disruptions ⁴⁷.

For capital allocation, the company intends to retain all available funds and any future earnings to fund the development and expansion of its business, and does not currently intend to pay any cash dividends on its capital stock in the foreseeable future ⁴⁸. The company's ability to pay cash dividends is limited by the terms of the VLSA ⁴⁹. The VLSA provides a term loan commitment of $50.0 million, of which $20.0 million was drawn at closing on February 6, 2024, and the remaining $30.0 million consists of three tranches of $10.0 million commitments ⁵⁰. The maturity date of the VLSA is March 1, 2029 ⁵¹.

The company faces numerous material risks, including a limited operating history and rapid growth that may strain resources, leading to difficulties in evaluating future prospects and managing expansion effectively ⁵². It has a history of net losses, with a net loss of $53.412 million in fiscal year 2025, and expects to incur additional substantial losses in the foreseeable future ⁵³. The business is highly dependent on sales from the Ceribell System, and failure to achieve substantial market acceptance or diminished confidence in its products could be harmful ⁵⁴. The industry is highly competitive, with conventional EEG systems from Natus Medical Incorporated and Nihon Kohden Corporation posing primary competition, and competitive pressures could materially adversely affect the business ⁵⁵. Adapting manufacturing and production capacities to evolving demand is expensive and uncertain, potentially leading to an inability to predict customer trends or adjust inventory levels in a timely manner ⁵⁶. Reliance on international manufacturing and supply chain operations, particularly in China and Vietnam, exposes the company to foreign operational and trade risks, including changes in trade policies and tariffs, which could increase costs or disrupt supply ⁵⁷. The company's success depends on attracting and retaining senior management and other key personnel, especially those with hardware, software, and AI expertise, in a competitive market ⁵⁸. Failure to successfully develop new products, manage their introduction, or improve existing products could adversely affect the business ⁵⁹. The Ceribell System is complex to design and manufacture and can contain defects, leading to product liability claims, such as allegations of false alarms or missed seizure activity, or skin irritation from Wearables, which could result in substantial liabilities or sales limitations ⁶⁰. Alternative technologies or therapies for seizure, non-convulsive status epilepticus, delirium, or LVO stroke could significantly decrease demand for the company's products ⁶¹. Macroeconomic conditions, including high inflation, increased interest rates, and geopolitical instability, could adversely impact demand, raw material costs, and hospital spending ⁶². Shutdowns of the U.S. federal government could delay regulatory reviews, litigation, or program implementations ⁶³. Inadequate reimbursement for diagnostic tests using its products could diminish sales or profitability, especially after the New Technology Add-on Payment (NTAP) for Clarity expires after three years ⁶⁴. The company is subject to federal and state fraud and abuse laws, including the Anti-Kickback Statute and False Claims Act, and non-compliance could lead to substantial penalties, exclusion from government programs, and reputational harm ⁶⁵. Its employees, consultants, and commercial partners may engage in misconduct or improper activities, including non-compliance with regulatory standards ⁶⁶. Healthcare policy changes, such as the Inflation Reduction Act and the One Big Beautiful Bill Act, could limit coverage or lower reimbursement for products and services ⁶⁷. The company's products and operations are subject to extensive government regulation by the FDA and foreign authorities, and failure to comply with requirements, or delays in obtaining marketing authorizations, could harm the business ⁶⁸. Clinical testing is complex, lengthy, expensive, and has uncertain outcomes, with future trials potentially failing to replicate positive results observed to date, especially given the small sample sizes and company sponsorship of many studies ⁶⁹. Interim or preliminary clinical data may change upon full review, and regulatory agencies may disagree with interpretations ⁷⁰. Ongoing regulatory review and scrutiny, including compliance with the new Quality Management System Regulation (QMSR), could lead to enforcement actions or product recalls ⁷¹. Misuse or off-label use of products by healthcare professionals could result in patient injuries, product liability suits, reputational harm, or regulatory sanctions ⁷². Legislative or regulatory reforms, such as changes to medical device regulations or AI technology oversight, could make manufacturing, marketing, or distribution more difficult and costly ⁷³. Expansion into international markets will subject the company to additional costs and foreign regulatory risks, including varying reimbursement systems and potential difficulties in obtaining clearances ⁷⁴. The company relies on third-party manufacturers and suppliers, some of which are single-source, making it vulnerable to supply shortages, price fluctuations, and quality control issues ⁷⁵. Its use and development of AI and machine learning models, including the Clarity algorithm, present risks if models are incorrectly designed, trained on poor quality data, or used without sufficient oversight, potentially leading to reputational harm or liability ⁷⁶. The regulatory framework for AI technologies is rapidly evolving and uncertain, which could impose additional compliance costs or limit the company's ability to use AI ⁷⁷. Information technology system failures, cyber attacks, or deficiencies in cybersecurity practices could lead to business disruption, data loss, intellectual property compromise, and significant costs ⁷⁸. The company's success depends on its ability to obtain, maintain, enforce, and protect its intellectual property rights, including patents, trademarks, and trade secrets, and failure to do so could erode its competitive advantage ⁷⁹. It is currently involved in patent infringement litigation against Natus Medical Incorporated, which is costly and uncertain, and may face additional intellectual property litigation ⁸⁰. Claims challenging inventorship or ownership of intellectual property rights could lead to loss of valuable rights or personnel ⁸¹. Dependence on licensed intellectual property rights, such as the "brain stethoscope" EEG sonification technology from Stanford University, means termination or breach of license agreements could materially adversely affect the business ⁸². Failure to protect trade secrets could harm the value of products and competitive position ⁸³. Inadequate protection of trademarks and trade names could hinder brand recognition ⁸⁴. Use of third-party open source software components could restrict the ability to sell products or protect proprietary information if license terms are not complied with ⁸⁵. Manufacturing restrictions related to licensed intellectual property developed with U.S. government grants, under the Bayh-Dole Act, could limit manufacturing locations or lead to compulsory licensing ⁸⁶. The ability to use net operating loss carryforwards (NOLs) and other tax attributes may be limited by Internal Revenue Code Sections 382 and 383, potentially causing NOLs of approximately $165.6 million for federal and $157.6 million for state purposes to expire unused ⁸⁷. The effective tax rate may vary significantly due to changes in tax laws, regulations, or interpretations, such as the Inflation Reduction Act and the One Big Beautiful Bill Act ⁸⁸. The venture loan and security agreement contains restrictive covenants that limit operational flexibility, and a breach could lead to immediate repayment demands ⁸⁹. Cash deposits with financial institutions exceed insured limits, posing a risk of delayed or lost access to funds in case of institutional failure ⁹⁰.

Management's overall tone emphasizes the company's mission to establish the Ceribell System as the standard of care for EEG in the acute care setting and to help clinicians save patients' lives. They highlight the paradigm-shifting nature of their technology, its compelling benefits supported by a robust body of clinical and real-world evidence, and the large addressable market opportunity, which they believe has increased to over $3.5 billion with the expanded indication for delirium ⁹¹. Key strategic priorities include increasing adoption of the Ceribell System by new accounts, driving utilization within the existing customer base, continuing to drive awareness of seizures and delirium in the acute care setting, investing in further growing their base of clinical evidence, continuously improving and innovating the Ceribell System, and expanding into new indications and adjacent and international markets ⁹². Management explicitly states that they expect to apply to the FDA for marketing authorization for the LVO stroke detection and monitoring solution within the next three years ⁹³. They also note that the net proceeds from the IPO, together with expected cash generated from revenue and existing cash and cash equivalents, are believed to be sufficient to fund planned operating expenses and capital expenditure requirements for at least the next 12 months ⁹⁴.