PresentationGood morning, everyone. I'm Robbie Marcus, the Med Tech Analyst at JPMorgan. Very happy to introduce our next company, CeriBell. We'll have Jane Chao, the CEO, come up for a presentation followed by some Q&A. Jane?Xingjuan ChaoCo-Founder, President, CEO & Director Thank you, Robbie. Good morning, everyone. I'm very excited to share with you the overview of CeriBell and our 2025 accomplishment and 2026 plan. So at the highest level, CeriBell has developed a platform for neuromonitoring. It has th ...

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.

Key Takeaways Ceribell received FDA Breakthrough Device Designation for its AI-based LVO stroke detection solution.CBLL is extending its point-of-care EEG platform beyond seizures and delirium into time-sensitive stroke care.The designation supports faster FDA interactions and earlier commercialization, boosting CBLL's visibility.CeriBell Inc. (CBLL) recently announced that the FDA has granted Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection and monitoring solution desig ...

SUNNYVALE, Calif., Jan. 05, 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 the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Large Vessel Occlusion (LVO) stroke detection monitor for patients in the hospital setting. This first-in-class LVO stroke detection monitor uses Ceribell’s existing ...

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].

Key Takeaways CeriBell gained FDA clearance for its continuous EEG-based delirium monitoring solution.The system delivers real-time EEG insights to cut clinical variability and aid earlier delirium detection.Tested on 225 adults, the algorithm builds on prior Breakthrough status and ties to a CMS NTAP bid.CeriBell Inc. (CBLL) recently announced that the FDA has given 510(k) clearance for its latest delirium monitoring solution, making it the one and only FDA-cleared solution for continuous tracking of delir ...

Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoringSUNNYVALE, Calif., Dec. 09, 2025 (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 the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprieta ...

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]

Core Insights - Ceribell, Inc. has received FDA 510(k) clearance for its Clarity algorithm, making it the first and only AI-powered EEG technology for detecting electrographic seizures in patients from pre-term neonates to adults [1][3] Group 1: Product and Technology - The Ceribell System combines proprietary algorithms with specialized hardware to enable real-time detection of non-convulsive seizures in neonatal patients, facilitating rapid diagnosis and treatment [3] - The FDA clearance was supported by EEG data from over 700 patients, representing the largest validation dataset for a neonatal seizure detection system [3] Group 2: Market Need and Impact - Early detection of seizures is critical in neonatal care, with approximately 9% of NICU patients diagnosed with seizures, while up to 90% may go undetected without EEG monitoring [2] - High-risk newborns who experience prolonged seizures have an 8-fold increased risk of poor outcomes, including mortality and long-term disability [2] - Recent guidelines recommend continuous EEG monitoring for neonates at high risk for seizures, highlighting the need for timely intervention [2] Group 3: Company Vision and Leadership - The CEO of Ceribell emphasized the importance of timely and accessible seizure detection for newborns, aiming to reduce delays and improve outcomes [4] - The Medical Director of Neonatal ECMO at Stanford Children's Hospital noted the lack of 24/7 EEG access in many NICUs, underscoring the need for faster, more accessible tools for evaluating brain activity [4] Group 4: Company Overview - Ceribell is focused on transforming the diagnosis and management of serious neurological conditions, with its system currently utilized in intensive care units and emergency rooms across the U.S. [7] - The company is headquartered in Sunnyvale, California, and aims to address unmet needs in acute care settings through its innovative EEG platform [7]