SUNNYVALE, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that it will release financial results for the fourth quarter and full year of 2025 after the close of trading on Tuesday, February 24, 2026. Company management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on Febru ...

Core Insights - CeriBell has developed a neuromonitoring platform that simplifies EEG acquisition, allowing nurses to set up in minutes instead of waiting for specialized technicians [1] - The company focuses on seizure detection in acute care settings, with a significant market opportunity in the U.S. estimated at over $2 billion [2] - CeriBell projects a revenue of $87 million to $89 million for the current year, reflecting a 34% year-over-year growth with an 88% gross margin [2] - The total addressable market (TAM) for CeriBell is expected to grow from $2 billion to $3.5 billion by 2025, driven by expansion into pediatric and neonate populations and gaining FDA clearance for delirium detection [2] Company Overview - CeriBell's platform includes an AI-powered algorithm named Clarity, which detects various neurological disorders [1] - The company has made significant progress in expanding its market presence and product offerings [2] Market Opportunity - The focus on seizure detection in acute care settings highlights the prevalence of seizures and the need for efficient monitoring solutions [3]

Summary of Ceribell FY Conference Call Company Overview - **Company**: Ceribell (NasdaqGS:CBLL) - **Industry**: MedTech, specifically focused on neuromonitoring and seizure detection - **Market Opportunity**: The U.S. seizure detection market in acute care is estimated at over $2 billion, with a total addressable market (TAM) growing from $2 billion to $3.5 billion due to expansion into pediatric and neonate populations and FDA clearance for delirium detection [2][3] Key Points and Arguments Product and Technology - Ceribell has developed a neuromonitoring platform that simplifies EEG (electroencephalogram) acquisition, allowing nurses to set it up in minutes rather than waiting for specialized technicians [2] - The AI-powered algorithm, Clarity, detects various neurological disorders, focusing primarily on seizure detection in acute care settings [2] - 92% of seizures in the ICU are non-convulsive, making EEG essential for diagnosis [4] - Early detection and treatment of seizures can significantly improve patient outcomes, with 80% of patients responding to treatment within the first 30 minutes [5] Market Expansion and Growth - The TAM for seizure detection has expanded due to FDA clearances for pediatric and neonate populations, unlocking an additional $400 million opportunity [21] - Ceribell's penetration in the U.S. seizure acute care market is currently at 3%, with plans to increase account acquisition and utilization in existing accounts [18] - The company has expanded its sales force and gained access to 160 VA hospitals, which will drive growth in 2026 [19] Clinical Impact and Studies - The SAFER study showed that conventional EEG arrives at the bedside 19 hours later than Ceribell's solution, which can provide EEG within five minutes [16] - Patients using Ceribell spent 4.1 days less in the ICU, and the percentage of patients with severe disability at discharge was reduced from 76% to 58% [16] Future Growth Horizons - Ceribell plans to expand its offerings beyond seizure detection to include delirium and other neurological conditions, aiming to make EEG a new vital sign in critical care [27] - The company is preparing for the launch of its delirium detection product in late 2026 or early 2027, which is expected to further expand the TAM to $3.5 billion [34] Financial Performance - Ceribell reported $87 million to $89 million in revenue for 2025, representing a 34% year-over-year growth with an 88% gross margin [2] - The business model includes a recurring revenue stream from subscriptions (25%) and disposable headbands (75%) [17] - The company has maintained consistent quarterly revenue growth since its inception [18] Additional Important Insights - Continuous EEG monitoring is rare in current practice, leading to delays in treatment and poor patient outcomes [8] - The company emphasizes the importance of early EEG access to improve treatment efficacy and reduce the time patients spend in seizures [25] - Ceribell's algorithm is the first FDA-cleared solution for both preterm and pediatric populations, addressing a significant gap in the market [22] - The company is focused on building partnerships with hospitals to integrate its technology into patient care protocols [20] This summary encapsulates the key points discussed during the Ceribell FY Conference Call, highlighting the company's innovative approach to neuromonitoring, market expansion strategies, clinical impact, and financial performance.

Core Insights - Ceribell Inc. (CBLL) has received FDA Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection and monitoring solution, which utilizes point-of-care electroencephalography (EEG) technology and an AI-based algorithm for improved stroke identification [1][7]. Company Developments - The Breakthrough Device Designation enhances Ceribell's regulatory momentum, allowing the company to expand its EEG platform into stroke care, thereby positioning it as a comprehensive brain-monitoring solution [2][4]. - The designation facilitates faster FDA interactions, prioritized reviews, and earlier commercialization, enabling Ceribell to broaden its market reach beyond seizures and delirium into high-acuity stroke care [5][9]. - Ceribell's current market capitalization stands at $790.1 million [6]. Market Context - LVO strokes are a severe form of ischemic stroke, contributing significantly to post-stroke disability and mortality, with nearly 800,000 strokes occurring annually in the U.S. [10]. - Up to 17% of all strokes happen in hospitalized patients, where timely detection and treatment are often delayed, leading to worse outcomes [10][11]. - The global stroke diagnostic and therapeutic market is projected to grow from $42.07 billion in 2025 to approximately $89.8 billion by 2035, with a compound annual growth rate (CAGR) of 7.88% from 2026 to 2035 [12].

Core Insights - Ceribell, Inc. has received Breakthrough Device Designation from the FDA for its Large Vessel Occlusion (LVO) stroke detection monitor, which utilizes AI algorithms to interpret EEG signals for early detection of LVO strokes in hospital settings [1][2][3] Group 1: Product Development and Innovation - The LVO stroke detection monitor is a first-in-class device that builds on Ceribell's existing hardware and aims to improve the diagnosis and management of serious neurological conditions [1][7] - This designation follows recent FDA clearances for Ceribell's Clarity® algorithm for detecting electrographic seizures in neonates and a proprietary delirium screening solution [2] Group 2: Market Need and Impact - Approximately 800,000 strokes occur annually in the U.S., with LVO strokes contributing to about 62% of post-stroke dependence and 96% of post-stroke mortalities, highlighting the critical need for timely detection [3] - In-hospital strokes, which account for up to 17% of all strokes, often experience significant delays in detection and treatment, leading to worse outcomes compared to community-onset strokes [3][4] Group 3: Clinical Significance - Timely detection of LVO strokes can significantly improve patient outcomes, with every minute saved correlating to a week of disability-free life [3] - The Breakthrough Device Designation underscores the potential of Ceribell's technology to provide accurate and timely detection, which is crucial for vulnerable patient populations [3][2]

Core Viewpoint - CeriBell, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on transforming the diagnosis and management of serious neurological conditions [1][2]. Group 1: Company Overview - CeriBell, Inc. is a medical technology company dedicated to improving the diagnosis and management of patients with serious neurological conditions [3]. - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3]. - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3]. - The system is FDA-cleared for detecting seizures and delirium in intensive care units and emergency rooms across the U.S. [3]. Group 2: Upcoming Event - Jane Chao, Ph.D., CEO and Co-founder of CeriBell, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 9:00 am PST / 12:00 pm EST [1][2]. - A live and archived webcast of the presentation will be available in the "Investor Relations" section of the Ceribell website [2].

Core Insights - CeriBell Inc. (CBLL) has received FDA 510(k) clearance for its delirium monitoring solution, establishing it as the only FDA-cleared option for continuous delirium tracking [1][9] - The technology utilizes electroencephalography (EEG) to continuously monitor brain activity, improving detection rates for delirium and potentially reducing treatment costs [2][10] - The FDA clearance allows CBLL to expand its presence in delirium care, aiming to make EEG a standard tool for brain monitoring in critically ill patients [3][7] Company Developments - The FDA-approved solution was tested on 225 critically ill adults, demonstrating real-world reliability and building on prior Breakthrough Device Designation [9][11] - CBLL's market capitalization currently stands at $748.59 million [8] - The company has applied for a New Technology Add-on Payment (NTAP) to support hospitals with reimbursement benefits [11] Market Performance - Following the announcement, CBLL shares have declined by 3.8%, with a year-to-date drop of 21.1%, contrasting with the industry's 1.1% growth and the S&P 500's 19.5% rise [6] - The FDA clearance is expected to provide a competitive advantage and support CBLL's long-term mission of establishing continuous AI-based EEG technology as a vital sign in detecting seizures and delirium [7]

Core Insights - CeriBell, Inc. has received FDA 510(k) clearance for its proprietary delirium monitoring solution, marking it as the first and only FDA-cleared device for delirium screening and monitoring [1][3] - The Ceribell System is an AI-powered brain monitoring platform that aims to improve the diagnosis and management of critically ill patients at risk for seizures and delirium [1][6] Company Overview - CeriBell is a medical technology company focused on transforming the diagnosis and management of serious neurological conditions, specifically through its point-of-care electroencephalography (EEG) platform [9] - The company has developed a system that combines portable hardware with AI algorithms for rapid diagnosis and continuous monitoring of neurological conditions [9] Industry Context - Delirium affects approximately 31% of ICU patients and up to 80% of mechanically ventilated patients, leading to increased mortality and longer hospital stays [4] - The risk of post-ICU dementia is 60% higher in patients who experienced delirium compared to those who did not, highlighting the need for effective monitoring solutions [4] Technological Validation - The delirium algorithm was validated through rigorous studies involving 225 adults in critical care settings, demonstrating its reliability for continuous monitoring [3] - The FDA clearance follows the Breakthrough Device Designation received in 2022, indicating the technology's potential impact on patient care [3] Clinical Implications - Current methods for detecting delirium are labor-intensive and subject to human variability, while CeriBell's solution offers continuous monitoring that can improve detection rates and management [2][4] - Studies indicate a significant relationship between seizures and delirium, with the Ceribell System designed to monitor both conditions simultaneously, aiding clinical decision-making [5]

Summary of CeriBell FY Conference Call (December 03, 2025) Company Overview - CeriBell has developed a novel neuro monitoring platform that simplifies EEG acquisition, allowing non-specialized personnel to set it up quickly [3][4] - The platform includes a strong AI algorithm named Clarity, which focuses on seizure detection in acute care settings [3][4] Industry and Market Insights - The total addressable market (TAM) for seizure detection in the U.S. is estimated at over $2 billion [4] - CeriBell is currently active in over 600 accounts in the U.S., achieving $22.6 million in revenue for the last quarter, representing a 31% year-over-year growth [5] Clinical Unmet Needs - Seizures in ICU settings are often non-convulsive and can last for hours or days, leading to high mortality and morbidity rates [8][9] - Approximately 33% of neuro ICU patients experience seizures, with a significant portion being non-convulsive [9][10] - Early detection and treatment of seizures are critical, as treating within the first 30 minutes can lead to an 80% success rate [12] Product and Technology - CeriBell's system allows for rapid EEG setup and continuous monitoring, which is crucial for timely intervention [19][20] - The AI algorithm Clarity analyzes EEG data every ten seconds to detect seizures and provides real-time alerts [22][23] - The device is designed for ease of use, enabling nurses and residents to set it up in minutes [19] Clinical Evidence and Outcomes - CeriBell has published over 45 peer-reviewed journals demonstrating the effectiveness of its device [29] - The SAFR trial showed a reduction in ICU length of stay by 4.1 days and an 18% improvement in clinical outcomes [30][31] Business Model - Revenue is derived from a subscription model (25%) and sales of disposable headbands (75%) [32] - CeriBell has maintained consistent quarter-over-quarter growth since its inception, indicating a strong business model [34] Growth Strategy - The company aims to penetrate the U.S. market further, currently at only 3% penetration [35] - Future growth horizons include expanding EEG applications beyond seizure management and into other neurological conditions [36][39] - CeriBell has achieved FedRAMP high cybersecurity certification, allowing access to VA hospitals and expanding its market reach [40][41] Conclusion - CeriBell is positioned as a leader in the neuro monitoring space with a validated commercial model and significant growth potential across multiple indications [42]

Business Overview - Ceribell is an AI-powered point-of-care EEG platform targeting serious neurological conditions in the acute care setting[10] - The company estimates a U S annual addressable market of over $2 billion[13,64] - The company's 3Q 2025 revenue was $22 6 million, representing 31% year-over-year growth[13] - Ceribell has 615 active accounts as of 3Q 2025, with an 88% gross margin[13] Technology and Clinical Application - Ceribell's EEG system aims to provide suspicion to diagnosis in minutes, enabling earlier and more accurate treatment[39] - The system includes a headband EEG, portal, and recorder, combining portable hardware with AI-powered algorithms[43,44] - The Clarity algorithm provides seizure burden information to facilitate EEG reading for neurologists and offers real-time feedback on medication response[48,50] - Clinical data suggests that Ceribell can change clinical decisions in 20-53% of patients and reduce hospital or ICU length of stay by 0 4 to ~4 fewer days[56] Growth Strategy - Ceribell is pursuing growth by increasing adoption in new accounts, driving utilization within existing accounts, and expanding into new indications and markets[66] - The company has unlocked pediatric and neonate opportunities, opening an incremental ~$400 million market and ~280 children's hospitals[73]