Core Insights - Heartflow, Inc. announced significant findings from the FISH&CHIPS study, demonstrating that its FFRCT Analysis improves diagnostic decision-making and predicts cardiovascular events while providing substantial cost savings for healthcare systems [1][2][4] Group 1: Clinical Value - The FISH&CHIPS study, involving over 90,000 patients, is the largest FFRCT study to date, providing strong real-world evidence of the clinical benefits of Heartflow's technology [1][7] - Heartflow FFRCT Analysis predicts individual cardiovascular outcomes, including myocardial infarction (MI) and cardiovascular mortality, with lower FFRCT values correlating to higher risks of adverse events [3][5] - The technology enables clinicians to tailor care more precisely, improving patient outcomes and reducing costs [4][5] Group 2: Economic Impact - The introduction of Heartflow FFRCT Analysis into the NHS led to fewer avoidable tests and lower costs for both inpatient and outpatient care, resulting in significant savings for hospitals and patients [2][5] - The analysis indicated a per-patient cost saving of £1,042 GBP ($1,394 USD) over two years, suggesting potential annual savings of £25 million GBP ($33.45 million USD) for the health system [5] - Cost savings were observed from the first year and continued to persist in lifetime modeling, highlighting the economic viability of the technology [5] Group 3: Technological Advancements - Heartflow's platform integrates various analyses, including RoadMap™ Analysis and Plaque Analysis, enhancing the accuracy of CAD assessments [4][8] - The technology has been adopted by over 1,400 institutions globally, supported by extensive clinical validation and a large dataset of coronary imaging [8][9] - Heartflow's AI-driven solutions have been validated in over 100 studies, demonstrating high acceptance rates and reproducibility in clinical practice [8]

Core Insights - Heartflow, Inc. is a leader in AI technology for coronary artery disease and will participate in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The company’s technology is redefining precision cardiovascular care through clinically-proven AI and the largest coronary imaging dataset globally [3][4] Company Overview - Heartflow is transforming coronary artery disease management, enabling early detection, accurate diagnosis, and lifelong management [4] - The Heartflow One platform utilizes AI to create personalized 3D models from coronary CTA images, providing actionable insights into plaque characteristics and blood flow without invasive procedures [4] Technology and Research - Heartflow's proprietary data pipeline consists of over 110 million annotated CTA images, supporting advanced AI models that yield accurate insights across diverse patient populations [5] - The AI-driven solutions have been validated in over 100 studies involving more than 365,000 patients, demonstrating high reproducibility and accuracy with coronary CTA image acceptance rates exceeding 96% [5] Clinical Integration and Compliance - Heartflow ensures seamless clinical integration with upgraded workflows, delivering quality-reviewed analyses instantly upon order, facilitating prompt clinical decision-making [5] - The company adheres to leading international standards for quality systems, global security, and patient-data integrity, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001 [5]

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. will release its financial results for Q3 2025 on November 12, 2025, after market close, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET [1] Company Overview - Heartflow is a leader in AI technology for coronary artery disease (CAD), transforming CAD management through early detection, accurate diagnosis, and lifelong management [4] - The Heartflow One platform utilizes AI to convert coronary CTA images into personalized 3D heart models, providing actionable insights into plaque characteristics and their impact on blood flow without invasive procedures [4] - The company has a robust data pipeline with over 110 million annotated CTA images and has been validated through over 100 studies involving more than 365,000 patients, achieving a coronary CTA image acceptance rate exceeding 96% [3] Technology and Research - Heartflow's technology is supported by ACC/AHA guidelines and over 600 peer-reviewed publications, demonstrating its effectiveness in clinical practice [3] - The integrated workflow of Heartflow allows for instant analysis upon order, facilitating timely clinical decision-making [3] - The company adheres to stringent global security regulations, ensuring the integrity and security of patient data [3]

Core Insights - Heartflow, Inc. has introduced the Heartflow PCI Navigator, an AI-driven tool designed to enhance percutaneous coronary interventions (PCI) planning by providing interventional cardiologists with a patient-specific 3D model that integrates anatomy, plaque composition, and lesion-specific physiology [1][4][11] - The PLAN CALCIUM study will be presented at the TCT 2025 conference, showcasing how AI-powered plaque analysis can influence decisions in managing highly calcified lesions during PCI [6][2] - The NAVIGATE-PCI registry will enroll approximately 2,500 patients across 30 sites to evaluate the impact of CT-guided PCI planning on physician confidence, procedural safety, and patient outcomes [8][9] Company Overview - Heartflow is a leader in AI technology for coronary artery disease (CAD), with a focus on transforming how clinicians manage care through innovative solutions [11] - The company has a robust data pipeline built from over 110 million annotated CTA images, supporting its AI-driven solutions that have been validated through over 100 studies involving more than 365,000 patients [10][11] - Heartflow's technology is backed by ACC/AHA guidelines and has been proven in real-world practice, achieving coronary CTA image acceptance rates exceeding 96% [10] Product Features - PCI Navigator integrates essential measurements, including IVUS-like and FFR-like visualizations, into a seamless web-based interface, streamlining the decision-making process in the cath lab [3][5] - The tool enhances planning by providing insights into lesion-specific physiology, stent landing zones, and optimal outcomes, thereby improving procedural efficiency and clinical confidence [7][5] Research and Development - The PLAN CALCIUM study demonstrated that AI-powered plaque analysis can significantly alter plans for calcium modification in over half of the lesions evaluated, indicating the potential for more precise coronary interventions [6][8] - The NAVIGATE-PCI registry aims to address unmet needs in PCI planning and is expected to lead to broader clinical use of PCI Navigator by 2026 [9][8]

Core Insights - Heartflow, Inc. has introduced the Heartflow PCI Navigator, an AI-driven tool designed to enhance percutaneous coronary interventions (PCI) planning by providing interventional cardiologists with a patient-specific 3D model that integrates anatomy, plaque composition, and lesion-specific physiology [1][16] - The PLAN CALCIUM study will present data at the TCT 2025 conference, demonstrating how AI-powered plaque analysis can influence decisions in managing highly calcified lesions during PCI [6][2] - The NAVIGATE-PCI registry will enroll approximately 2,500 patients across 30 sites to evaluate the impact of CT-guided PCI planning on physician confidence, procedural safety, and patient outcomes [8][9] Company Overview - Heartflow is a leader in AI technology for coronary artery disease (CAD), with a focus on transforming how clinicians manage care through innovative solutions backed by extensive clinical evidence [10][15] - The company has developed a proprietary data pipeline from over 110 million annotated CTA images, which supports its AI-driven solutions and has been validated in over 100 studies involving more than 365,000 patients [10] - Heartflow's technology is designed to provide actionable insights into plaque location, volume, and composition, facilitating early detection and accurate diagnosis of CAD [15] Product Features - The PCI Navigator integrates essential measurements, including IVUS-like and FFR-like visualizations, into a seamless web-based interface, streamlining the decision-making process in the cath lab [3][5] - The tool enhances planning by allowing interventional cardiologists to review and input data on anatomy, plaque, and lesion-specific physiology before procedures, addressing the information gap that often exists prior to PCI [4][5] - The technology aims to improve efficiency and clinical confidence for both patients and healthcare staff by consolidating necessary information into one intuitive view [5][4] Research and Development - The PLAN CALCIUM study highlights the potential of combining Heartflow Plaque Analysis with coronary CTA imaging and FFRCT analysis, showing that over half of the lesions had altered plans for calcium modification due to AI insights [6][7] - The NAVIGATE-PCI registry is set to begin in 2026, aiming to assess the broader clinical use of PCI Navigator and its impact on interventional practice and patient care [8][9]