MOUNTAIN VIEW, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in artificial intelligence (AI) technology for coronary artery disease (CAD), today reported financial results for the three months ended September 30, 2025. Third Quarter 2025 Highlights Total revenue of $46.3 million, a 41% increase year-over-yearGross margin of 76.5%, non-GAAP gross margin of 76.8%Net operating loss of $15.1 million, non-GAAP net operating loss of $11.1 million Recent Operating ...

Core Insights - The FISH&CHIPS study confirms total plaque volume (TPV) as a significant independent predictor of long-term cardiovascular events, enhancing the understanding of coronary artery disease (CAD) management through AI technology [1][2][7] Company Overview - Heartflow, Inc. is a leader in AI technology for CAD, with its Heartflow Plaque Analysis and Plaque Staging framework being the most clinically validated for actionable CAD care [1][4] - The company has been adopted by over 1,400 institutions globally and has supported nearly 500,000 patients, backed by ACC/AHA guidelines and over 600 peer-reviewed publications [4][9] Study Findings - The retrospective analysis involved nearly 8,000 symptomatic patients, marking the largest validation of the Heartflow Plaque Staging framework based on TPV measurement [2] - Key findings indicate that patients in the highest TPV stage have over a 5x greater risk of major cardiovascular events compared to those in the lowest stage, with a hazard ratio of 5.10 [7] - The study suggests that accurate plaque measurement can help cardiologists personalize treatment, potentially preventing future heart attacks or deaths [2][3] Clinical Impact - Changes in medical management guided by Heartflow Plaque Staging resulted in an average reduction of LDL cholesterol by 18.7 mg/dL at 90 days, indicating a 15% decrease in the risk of cardiac events [2] - Heartflow's AI-driven solutions have been validated through over 100 studies involving more than 365,000 patients, demonstrating high accuracy and reproducibility in clinical practice [8]

Core Insights - Heartflow, Inc. has presented new data from the FISH&CHIPS Study at the AHA Scientific Sessions 2025, reinforcing the effectiveness of its AI-powered Heartflow Plaque Analysis and Plaque Staging framework for coronary artery disease (CAD) [1][2] Group 1: Study Findings - The retrospective analysis involved nearly 8,000 symptomatic patients, marking the largest validation of the Heartflow Plaque Staging framework based on total plaque volume (TPV) measurement [2] - The study indicates that TPV-based staging is a strong predictor of future heart attacks or cardiovascular death, allowing for personalized treatment to prevent adverse outcomes [2][4] - Patients in the highest TPV stage faced over a 5x greater risk of major cardiovascular events compared to those in the lowest stage, with a hazard ratio of 5.10 [4] Group 2: Clinical Impact - The DECIDE Registry data showed that Heartflow Plaque Analysis with Plaque Staging led to changes in medical management for over 50% of patients, resulting in an average LDL cholesterol reduction of 18.7 mg/dL at 90 days [2] - Management changes guided by Heartflow Plaque Staging are expected to result in a 15% decrease in the risk of cardiac events [2] Group 3: Technology and Adoption - Heartflow's technology is redefining precision cardiovascular care through clinically-proven AI and a large coronary imaging dataset, adopted by over 1,400 institutions globally [3][5] - The company has validated its AI-driven solutions through over 100 studies involving more than 365,000 patients, achieving a coronary CTA image acceptance rate exceeding 96% [5] Group 4: Regulatory and Compliance - Heartflow's quality system meets or exceeds international standards, including HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001, ensuring patient data integrity and security [6]

Core Insights - Heartflow, Inc. is set to present new data on the clinical and economic value of its AI-powered Heartflow Plaque Analysis at the AHA Scientific Sessions 2025, emphasizing its role in predicting long-term cardiovascular outcomes [1][2]. Company Developments - Heartflow will showcase seven abstracts at the AHA Scientific Sessions, reinforcing the scientific foundation for its Plaque Analysis as a significant advancement in cardiovascular risk prediction and personalized treatment [3]. - The company continues to invest in clinical research to validate its Plaque Analysis technology, which aids cardiologists in personalizing treatment plans using non-invasive methods [4]. Research Highlights - Key presentations at the AHA will include studies on coronary CT angiography as a predictor of death and myocardial infarction, improvements in cardiovascular risk assessment, and the cost-effectiveness of AI-enabled coronary plaque analysis [5][8]. - The FISH&CHIPS study, which will be presented by Dr. Timothy Fairbairn, focuses on plaque volume burden and its implications for cardiovascular risk [2][6]. Technology and Impact - Heartflow's technology utilizes AI to convert coronary CTA images into personalized 3D heart models, providing actionable insights into plaque characteristics and their impact on blood flow [14]. - The company has been adopted by over 1,400 institutions globally and has supported the management of nearly 500,000 patients, demonstrating its significant impact on cardiovascular care [13][14].

Core Insights - Heartflow, Inc. has received FDA 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm, which is now available for use [1][2] - Cigna will cover Heartflow Plaque Analysis across all its lines of business starting in October 2025, following similar coverage by UnitedHealthcare [1][4] Technology Advancements - The Heartflow Plaque Analysis is the only FDA-cleared AI-powered plaque quantification tool, showing a 95% agreement with the gold standard, IVUS [2] - The new algorithm demonstrates a 21% improvement in plaque detection compared to the first-generation algorithm, enhancing clinician confidence in diagnosing CAD [2][3] - The updated platform features advanced 3D color-coded visualization of plaque type, volume, and distribution, providing clinicians with critical insights for care decisions [1][3][13] Clinical Impact - The enhanced nomogram is based on data from approximately 273,000 patients, which is nine times larger than any current plaque quantification study [3] - Heartflow Plaque Analysis has led to medical management changes in over 50% of patients beyond coronary CTA alone, with an expected event reduction of around 15% [5] Industry Position - Heartflow is recognized as a leader in coronary plaque analysis, with a commitment to transforming the management of coronary artery disease [5][6] - The company has supported nearly 500,000 patients worldwide, leveraging clinical rigor and a vast dataset of coronary CTA images [6]

Core Insights - UnitedHealthcare has announced comprehensive coverage for Heartflow Plaque Analysis, marking a significant advancement in patient access to AI-driven technology for diagnosing and managing coronary artery disease (CAD) [1][2] - The coverage will be effective from October 1, 2025, specifically for patients with acute or stable chest pain and mild-to-moderate coronary artery narrowing [2] - Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled, noninvasive plaque quantification tool, demonstrating a 95% agreement with the gold standard, IVUS [3] Coverage Details - The updated coverage includes all lines of business for UnitedHealthcare, such as Commercial, Medicare Advantage, and Community plans [1] - This decision aligns with guidelines from radiology benefit manager EviCore, enhancing the standard for cardiovascular care coverage [1][2] Clinical Impact - Management changes informed by Heartflow Plaque Analysis resulted in an average LDL cholesterol decrease of 18.7 mg/dL, which is associated with a 15% reduction in the risk of cardiac events [4] - The technology has been shown to change medical management in over half of patients beyond CCTA alone, improving clinical outcomes [3] Company Vision - Heartflow aims to transform CAD from a leading cause of death into a manageable condition, with CAD responsible for one heart attack every 40 seconds in the U.S. [5] - The company has been adopted by over 1,400 institutions globally, indicating a strong commercial presence and commitment to making advanced solutions widely available [5][6]