Core Insights - CeriBell, Inc. reported a strong financial performance for Q1 2025, with total revenue reaching $20.5 million, a 42% increase from $14.4 million in Q1 2024, driven by new account adoption and expansion within existing accounts [4][11] - The company is optimistic about continued growth in 2025, focusing on physician education and product development, including the introduction of a pediatric Clarity algorithm [3][8] Financial Performance - Total revenue for Q1 2025 was $20.5 million, up 42% from $14.4 million in Q1 2024, with product revenue at $15.6 million (41% increase) and subscription revenue at $4.9 million (45% increase) [4][15] - Gross profit for Q1 2025 was $18.0 million, with a gross margin of 88%, compared to $12.3 million and 86% in Q1 2024 [5][11] - Operating expenses increased by 55% to $32.2 million in Q1 2025, primarily due to investments in the commercial organization and increased headcount [6][11] - The net loss for Q1 2025 was $12.8 million, or $0.36 per share, compared to a net loss of $8.5 million, or $1.56 per share, in Q1 2024 [7][11] Future Outlook - CeriBell raised its revenue guidance for the full year 2025 to a range of $83 million to $87 million, indicating a growth of approximately 27% to 33% over the previous year [8] - The company ended Q1 2025 with 558 total active accounts and received FDA clearance for the expansion of its Clarity algorithm, marking a significant milestone [11][11] Company Overview - CeriBell is a medical technology company focused on transforming the diagnosis and management of serious neurological conditions through its innovative EEG platform [13]

SUNNYVALE, Calif., April 30, 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 Jane Chao, Ph.D., CEO and Co-founder, will present at the upcoming Bank of America Securities 2025 Health Care Conference. The presentation will take place on Wednesday, May 14, 2025, at 10:55 a.m. Pacific Standard Time / 1:55 p.m. Eastern Standard Time. Event ...

Ceribell is one of only 51 companies in the U.S. to achieve FedRAMP High authorization Ceribell's breakthrough technology can now be deployed in federal healthcare facilities, including U.S. Department of Veterans Affairs hospitals, helping clinicians deliver faster diagnosis and treatment for patients at risk of non-convulsive seizures SUNNYVALE, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company transforming the diagnosis and management of p ...

SUNNYVALE, Calif., April 24, 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 it will release financial results for the first quarter of 2025 after the close of trading on Thursday, May 8, 2025. Company management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on May 8, 2025. Investors i ...

Ceribell, Inc. (CBLL) recently announced that it has received FDA clearance for the Clarity algorithm for use in pediatric patients. This breakthrough expands the utility of Ceribell’s rapid electroencephalography (“EEG”) system, enabling faster seizure detection and treatment in critically ill children.With this clearance, Ceribell strengthens its position in the neurodiagnostic space by addressing a critical gap in pediatric care. The Clarity algorithm is designed to support timely clinical decisions, imp ...

References Forward-Looking Statements SUNNYVALE, Calif., April 15, 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 next generation Ceribell Clarity™ algorithm for the detection of electrographic seizures in patients ages 1 and older. This makes Ceribell the ...

Core Insights - Ceribell, Inc. has received FDA 510(k) clearance for its Ceribell Clarity™ algorithm, making it the first AI-powered point-of-care EEG system capable of detecting electrographic seizures in patients aged 1 and older [1][2][3] - The Clarity algorithm is designed to provide comprehensive seizure detection across the largest age range ever addressed by such technology, enhancing the capabilities of hospitals, particularly in emergency departments and ICUs [1][3] - The pediatric clearance was supported by EEG data from over 1,700 patients, marking it as the largest validation dataset for FDA clearance of a seizure detection system [1][3] Company Overview - Ceribell is a medical technology company focused on improving the diagnosis and management of serious neurological conditions through its innovative EEG platform [6] - The Ceribell System combines portable hardware with AI-powered algorithms to enable rapid diagnosis and continuous monitoring of neurological conditions, currently utilized in intensive care units and emergency rooms across the U.S. [6] Industry Impact - The FDA clearance is expected to significantly impact the lives of critically ill children, who are at high risk for preventable brain injury due to seizures [3] - Non-convulsive seizures, which can only be detected through EEG, require prompt identification and treatment to prevent brain injury, highlighting the importance of rapid EEG access [3]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $18.5 million, reflecting a 41% increase from $13.1 million in Q4 2023 [31] - Full-year revenue totaled $65.4 million, representing a 45% growth over 2023 [33] - Gross margin for Q4 2024 was 88%, compared to 85% in the prior year [34] - Net loss for Q4 2024 was $12.6 million, or a loss of $0.40 per share, compared to a loss of $8.3 million, or a loss of $1.53 per share in Q4 2023 [36] Business Line Data and Key Metrics Changes - Product revenue for Q4 2024 was $14.1 million, a 41% increase from $10.0 million in Q4 2023 [32] - Subscription revenue for Q4 2024 was $4.4 million, representing a 40% increase from $3.1 million in Q4 2023 [32] - Active accounts increased to 529 as of December 31, 2024, an increase of 25 during the quarter [16] Market Data and Key Metrics Changes - The company estimates there are 6,000 acute care facilities in the U.S. that could benefit from its offerings [17] - The current market for seizure detection and management in the acute care setting is valued at $2 billion in the U.S. [29] Company Strategy and Development Direction - The company plans to expand its account acquisition team to 55 territory managers by mid-2025 [20] - Focus on optimizing algorithm performance and user experience while expanding indications beyond seizure management [22] - The company aims to make EEG a new vital sign, targeting various neurological conditions [24][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven with the current cash on hand and the strength of the balance sheet [41] - The company anticipates full-year 2025 total revenue to be in the range of $81 million to $85 million, representing annual growth of 24% to 30% over 2024 [37] - Management highlighted the importance of maintaining a strong margin profile despite increased operating expenses due to public company status [34][41] Other Important Information - The company has made significant strides in commercial growth and R&D pipeline development, impacting tens of thousands of patients [7][9] - The company has received breakthrough device designation from the FDA for its delirium detection algorithm [25] Q&A Session Summary Question: Guidance for 2025 and underlying assumptions - Management indicated that guidance reflects continued investment in sales infrastructure, expecting growth to be consistent with 2024 [46] Question: Strength of new account adds in Q4 - Management noted that the strength of account adds was due to good planning and early launches [50] Question: Thoughts on gross margin and OpEx spend in 2025 - Management expects gross margins to normalize in the mid to high 80% range and anticipates a significant increase in R&D expenses [54][56] Question: Update on stroke detection algorithm - Management reported encouraging results from the stroke study and plans to expand enrollment speed for data collection [70] Question: Utilization of headbands per account - Management expects an upward trajectory in usage, although purchasing patterns may vary [90] Question: Update on VA facilities - Management expressed optimism regarding interest from VA hospitals and hopes to share tangible milestones in the next quarter [97]

CeriBell, Inc. (NASDAQ:CBLL) Q4 2024 Earnings Conference Call February 25, 2025 4:30 PM ET Company Participants Brian Johnston - Gilmartin Group Xingjuan Chao - President and Chief Executive Officer Scott Blumberg - Chief Financial Officer Conference Call Participants Stephanie Piazzola - Bank of America Robert Marcus - JPMorgan Chase & Co. Macauley Kilbane - William Blair & Company Joshua Jennings - TD Cowen William Plovanic - Canaccord Genuity Corp. Operator Operator Hello, and thank you for standing by. ...

CeriBell (CBLL) Q4 2024 Earnings Call February 25, 2025 04:30 PM ET Company Participants Brian Johnston - Investor RelationsXingjuan Chao - Co-Founder, President, CEO & DirectorScott Blumberg - Chief Financial OfficerStephanie Piazzola - VP - Equity ResearchMacauley Kilbane - Equity Research AssociateJoshua Jennings - Managing DirectorWilliam Plovanic - Managing Director - Equity Research Conference Call Participants Robert Marcus - Analyst Operator thank you for standing by. At this time, I would like to w ...