Tag: Heartflow

Heartflow Plaque Analysis to be Covered by UnitedHealthcare Plans Nationwide

Largest commercial insurer in the United States releases positive comprehensive coverage for AI-enabled Heartflow Plaque Analysis to support precise diagnosis and management of patientsMOUNTAIN VIEW, Calif., July 22, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced Heartflow Plaque Analysis will be covered by UnitedHealthcare across all lines of business, including Commercial, Medicare Advantage, and Community plans. UnitedHealthcare is the first insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines recently issued by radiology benefit manager EviCore. “UnitedHealthcare’s decision to cover Heartflow Plaque Analysis nationwide is a tremendous step in advancing patient access to our proven AI-driven plaque technology,” said John Farquhar, President and CEO of Heartflow. “We are pleased that this major commercial payer recognizes the innovation and value that Heartflow’s technology can provide to its members and healthcare providers in diagnosing and managing coronary artery disease. This decision will increase access for early detection and quantification of plaque using our precision Plaque Analysis tool, setting a new standard for cardiovascular care coverage.” The updated coverage will become effective October 1, 2025 for patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-70% stenosis) found on coronary computed tomography angiography (CCTA). Expanded access will allow for greater adoption of Heartflow Plaque Analysis for clinicians to incorporate into their diagnostic and patient management protocols, delivering more personalized treatment. Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled, noninvasive plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, in a prospective, global trial using blinded core lab adjudication.1 It is proven to change medical management in over half of patients beyond CCTA alone, helping physicians to improve outcomes.2 This coverage milestone follows the recent presentation of clinical outcomes from the DECIDE registry, which found management changes informed by Heartflow Plaque Analysis led to an average LDL cholesterol decrease of 18.7mg/dL.3 This clinically significant reduction is associated with an estimated 15% decrease in the risk of a cardiac event, highlighting the potential of Heartflow Plaque Analysis to improve patient outcomes by guiding more effective medical therapy and interventions.4 Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life. In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.5 Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide. About Heartflow, Inc. Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound. EHJ 2024.2 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.3 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.4 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-55 Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats.

Heartflow Unveils Landmark DECIDE Registry Data Demonstrating Impact of Heartflow Plaque Analysis on Coronary Artery Disease Medical Management

More than 50% of patients saw treatment changes following Heartflow Plaque Analysis – driving promising LDL cholesterol improvements and individualized careMONTREAL, July 17, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced new data for its AI-enabled Heartflow Plaque Analysis, including final primary endpoint data from the DECIDE Registry. Data from the DECIDE Registry showed Heartflow Plaque Analysis led to medical management change in over half of patients beyond coronary computed tomography angiography (CCTA) alone, regardless of traditional risk factors or CCTA findings. The DECIDE Registry is the largest prospective study of its kind, enrolling approximately 20,000 patients at over 30 sites across the United States. Data will be presented this week at the Society of Cardiovascular Computed Tomography (SCCT) 2025 Annual Scientific Meeting from a cohort of 972 patients across 15 sites by Sarah Rinehart, M.D., F.A.C.C., F.S.C.C.T., medical director of cardiovascular imaging, Charleston, WV, and co-lead principal investigator of the registry. DECIDE Registry investigator Cian McCarthy, MB, BCH, BAO, SM, is the first-place recipient of the 2025 SCCT Clinical Trials and Registries Award, which will be presented at the opening session of SCCT 2025 on Friday, July 18, followed by a presentation of the study results. For DECIDE Registry patients, management changes informed by Heartflow Plaque Analysis with Plaque Staging* led to an average LDL cholesterol decrease of 18.7mg/dL, which is associated with an estimated 15% decrease in risk of a cardiac event. Additionally, 30% of patients with a calcified plaque volume of zero had a change in management.1,2 These findings suggest Heartflow Plaque Analysis can deliver clinically meaningful impact by helping clinicians identify which patients require changes to their treatment plans. “These data confirm what we’re seeing in clinical practice — Heartflow Plaque Analysis provides individualized insights that go beyond what a traditional analysis of a patient’s risk factors or CCTA alone can show,” said Dr. Rinehart. “By quantifying plaque burden and characterizing higher-risk non-calcified plaque types, Heartflow’s technology empowers physicians to personalize care and intervene earlier, which can change the trajectory of a patient’s coronary health.” Traditional risk factors such as age, smoking, hypertension, and family history are useful for population-level CAD predictions but lack precision at the individual level. Similarly, while CCTA is effective in detecting calcified plaque, it often underreports non-calcified and low-attenuation plaque, which leaves many high-risk patients incorrectly classified. Heartflow Plaque Analysis addresses this critical gap by quantifying all plaque types and supporting informed decision-making for clinicians. As part of the DECIDE Registry, Heartflow’s recently introduced Plaque Staging* framework is being used prospectively to help translate these advanced insights into simplified, actionable treatment plans. The Heartflow Plaque Staging framework, which was developed by expert consensus and clinically validated using outcomes data from the FISH&CHIPS Study,3 stratifies patients into one of four risk-based stages — mild, moderate, severe, or extensive — based on AI-quantified plaque volume and composition.4 With data from over 2,800 patients, Heartflow Plaque Staging is the leading tool for risk stratification based on AI-quantitative coronary plaque assessment. The FISH&CHIPS Study data showed higher coronary plaque-based stages, measured by Heartflow Plaque Analysis, were associated with up to five times higher risk of cardiovascular event rates at 3.3 years. The data were presented at the British Society of Cardiovascular Imaging Annual Scientific Meeting in April 2025. “The results from the DECIDE Registry clearly show how Heartflow Plaque Analysis can meaningfully change CAD care, with more than half of patients seeing their treatment plans altered after Heartflow Plaque Analysis,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of Heartflow. “We expect that tools like Plaque Staging will enhance the impact Heartflow Plaque Analysis is already making by providing a clearer framework for personalized patient care.” *Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA. About the DECIDE RegistryThe DECIDE Registry is the largest prospective study of its kind, collecting real-world data from multiple sites investigating how Heartflow’s AI-enabled Plaque Analysis informs medical management plans compared to CCTA alone for patients with suspected CAD. Approximately 20,000 patients will be enrolled at over 30 sites across the United States. The primary endpoint for this registry highlights changes in medical management after Heartflow Plaque Analysis. Clinical outcomes and biomarkers are the secondary endpoints. Safety endpoints include MACE (major adverse cardiovascular events), such as myocardial infarction and urgent hospitalization leading to revascularization. About Heartflow, Inc. Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com 1 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.2 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-53 Fairbairn, et al. AI-Enabled CCTA Plaque Quantification and the Prediction of Cardiovascular Outcomes. Heart 2025.4 Rinehart, et al. Guiding Automated Implementation Strategies for Patients With Atherosclerotic Plaque on Coronary Computed Tomographic Angiography. JACC: Cardiovascular Imaging. 2025. https://doi.org/10.1016/j.jcmg.2025.03.019.

Heartflow Plaque Analysis Awarded First Coverage Recommendation by Radiology Benefits Manager

EviCore’s updated coverage guidelines support access to AI-enabled Plaque Analysis to help physicians precisely diagnose and manage patients with coronary artery diseaseMOUNTAIN VIEW, Calif., July 11, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced Heartflow Plaque Analysis will be included in updated cardiac imaging guidelines by radiology benefit manager EviCore, which provides coverage guidelines to leading commercial health insurers. The updated coverage guidelines become effective October 1, 2025 for patients with acute or stable chest pain and 1-70% stenosis found on coronary computed tomography angiography (CCTA). Commercial health insurers will then make individual decisions on guideline adoption and implementation timing. This milestone follows Medicare’s positive coverage of artificial intelligence-enabled coronary plaque analysis (AI-CPA). Once adopted, EviCore’s updated guidelines are expected to support the integration of Heartflow Plaque Analysis into clinical workflows and patient management, helping to standardize and streamline the assessment and personalized management of CAD with CCTA and Heartflow’s complete, non-invasive, precision coronary care platform. Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, in a prospective, global trial using blinded core lab adjudication.¹ It is proven to change medical management in over half of patients beyond CCTA alone, helping physicians to improve outcomes.² “Coronary artery disease is a silent killer, often characterized by plaque buildup that can lead to heart attacks and strokes,” said Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “EviCore’s updated guidelines recommending coverage of AI-enabled coronary plaque analysis technology lay the foundation for broader payor coverage and expanded patient access to this groundbreaking technology to quantify and characterize plaque buildup in the coronary arteries. Early detection and quantification of plaque using precise AI-driven tools enables us to offer personalized treatments sooner, with the opportunity to improve outcomes for our patients.” This coverage milestone comes as Heartflow prepares to highlight its latest Plaque Analysis clinical outcomes from the DECIDE registry and technology advancements at the upcoming Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting, taking place July 17-20, 2025, in Montreal. “EviCore’s inclusion of Heartflow Plaque Analysis in its guidelines marks a significant advancement in cardiovascular disease diagnosis and management,” said John Farquhar, President and CEO of Heartflow. “We applaud EviCore for acknowledging the crucial role and value of Heartflow’s AI-enabled plaque quantification technology in managing coronary artery disease. This decision will increase access for patients and help clinicians provide more targeted and effective management plans.” Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life. In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.³ Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide. About Heartflow, Inc. Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com ___________¹ Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound. EHJ 2024. ² Data on file.³ Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats.

Heartflow to Showcase Landmark DECIDE Data at SCCT 2025, Advancing AI-Driven Care for Coronary Artery Disease

DECIDE Registry receives top award as company plans to unveil the next generation plaque technology at SCCT Annual Scientific MeetingMOUNTAIN VIEW, Calif., June 30, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced it will present new data and technology for its AI-enabled Plaque Analysis at the upcoming Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting, including final primary endpoint data from the DECIDE Registry. Together, these data and advancements mark a bold step forward in how clinicians manage CAD with Heartflow’s AI-enabled plaque assessment. The SCCT Annual Scientific Meeting is taking place July 17-20, 2025 in Montreal. In the DECIDE Registry, Heartflow’s AI-enabled Plaque Analysis led to medical management change in over half of patients beyond coronary computed tomography angiography (CCTA) alone. Full insights on medical management and clinical outcomes will be presented at the SCCT meeting. DECIDE Registry investigator Cian McCarthy, MB, BCH, BAO, SM, is the first-place recipient of the 2025 SCCT Clinical Trials and Registries Award. The award recognizes clinical trials that use CCTA-based analyses to detect atherosclerotic burden in the diagnosis and treatment of CAD, as well as demonstrate a positive impact on patient outcomes. SCCT will present Dr. McCarthy with the award at the opening session of SCCT 2025 on Friday, July 18, followed by a presentation of the study results. The DECIDE Registry is the largest prospective study of its kind, collecting real-world data from multiple sites investigating how HeartFlow’s AI-enabled Plaque Analysis informs medical management plans compared to CCTA alone for patients with suspected CAD. Approximately 20,000 patients will be enrolled at over 30 sites across the United States. Heartflow will also showcase its next generation Plaque Analysis technology and a vastly expanded data set of age- and sex-specific nomograms for atherosclerotic plaque. Heartflow’s numerous presentations at SCCT, demonstration of new Plaque Analysis technology, and recognition of the DECIDE study by the SCCT scientific community all underscore Heartflow’s investment in clinical evidence and technology with continued unwavering commitment to being at the forefront of cardiovascular management. “As Heartflow marks 15 years of innovation and SCCT celebrates its 20th annual meeting, we’re proud to lead the way in transforming how CAD is diagnosed, treated and managed,” said Campbell Rogers, M.D., FACC, Chief Medical Officer of Heartflow. “This year, we’re especially excited to share our next generation AI-enabled Plaque Analysis technology and our award-winning clinical research. With the DECIDE Registry and enhanced technology, we’re equipping clinicians with deeper insights that lead to real-world impact, guiding more confident, personalized and precise treatment decisions for patients.” Heartflow’s data presentations at SCCT will include: DECIDE Registry Primary Endpoint: Guiding Implementation of Preventative Care Strategies for Patients with Atherosclerotic Plaque on Coronary Computed Tomographic Angiography: Primary Outcomes of the DECIDE (Artificial Intelligence-Derived Plaque Quantification: CTA and AI-CPA for Determining Effective CAD Management) Registry Presenter: Cian McCarthy, MB, BCH, BAO, SM  Session: Opening Session Date: Friday, July 18, 2025 Time: 8:00-9:35 a.m. EDT Location: 210 B/F DECIDE Registry Primary Endpoint: Guiding Preventive Care Strategies for Patients with Atherosclerotic Plaque on Coronary Computed Tomographic Angiography: Primary Outcomes of the DECIDE (Artificial Intelligence-Derived Plaque Quantification: CTA and AI-CPA for Determining Effective CAD Management) Registry Presenter: Sarah Rinehart, M.D., FACC Expanded Plaque Nomogram: CT-Derived Nomograms of Coronary Plaque Volume by Age and Sex Presenter: Georgios Tzimas, M.D. Cost Economics: Modeling Long-term Outcomes and Costs of Care Guided By AI-enabled CCTA Plaque Analysis as Compared to Standard of Care in Patients Undergoing CCTA for Stable Chest Pain Presenter: Suzanne J. Baron, M.D.  Session: Poster Session 18 Date: Saturday, July 19, 2025 Time: 10:50-11:25 a.m. EDT Location: Exhibit Hall Heartflow also invites meeting attendees to join its other programs, including an educational dinner, symposium, interactive workshop, reception, and more. See the full schedule at heartflow.com/SCCT. About Heartflow, Inc. Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com

New Analysis Published in Nature Medicine Demonstrates Advantages of Nationwide Coronary CTA Strategy with Heartflow FFRCT in Over 90,000 Patients with Coronary Artery Disease

Two-year data from England’s National Health Service show improved care efficiency with reduction in unnecessary invasive and noninvasive cardiac tests using CCTA and Heartflow FFRCT versus CCTA aloneMOUNTAIN VIEW, Calif., May 06, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced two-year data from FISH&CHIPS, a real-world, multicenter, retrospective study, conducted by the National Health Service (NHS) in England, were published in Nature Medicine. The study, which analyzed the impact of adding Heartflow fractional flow reserve (FFRCT) derived from coronary computed tomography angiography (CCTA) to a CCTA pathway for the evaluation of CAD, showed improved care efficiency and reduction in unnecessary tests with CCTA+FFRCT versus CCTA alone. “New findings from the FISH&CHIPS study demonstrate that a CCTA+FFRCT pathway at a national level can positively impact individual patient care, improving the suspected coronary artery disease patient’s journey,” said Dr. Timothy Fairbairn, principal investigator for the study, Liverpool Heart and Chest Hospital NHS Foundation Trust, and associate professor at the University of Liverpool, U.K. “FFRCT is a major AI-driven advancement in the management of cardiac disease that is helping to ensure that patients receive more precise, improved care, by reducing unnecessary invasive procedures and additional tests whilst identifying those who need intervention.” The overarching results of the more than 90,000-patient study, covering the breadth of NHS England, showcased the positive impact of a CCTA+FFRCT diagnostic pathway using Heartflow technology versus CCTA alone. Key outcomes outlined in the published data include: The CCTA+FFRCT cohort reduced the need for an invasive coronary angiography (ICA) procedure by 7% and led to a reduction in inappropriate ICA procedures that did not result in treatment by 16%.CCTA+FFRCT helped to identify more patients that would benefit from revascularization, with one additional appropriate percutaneous coronary intervention (PCI) identified for every two negative diagnostic catheterizations that were avoided.CCTA+FFRCT showed a 12% relative reduction in the need for a secondary non-invasive test after CCTA, for example requiring a repeat CCTA or nuclear stress test. “By implementing a nationwide CCTA-first strategy for assessing patients with potential cardiovascular disease, NHS has set the standard for both clinical efficacy and efficiency — an approach now reflected in clinical guidelines worldwide,” said Campbell Rogers, M.D., FACC, Heartflow’s chief medical officer. “The FISH&CHIPS data underscore how the addition of Heartflow’s FFRCT technology can improve upon the CCTA-first approach for many patients and optimize the use of both noninvasive testing and treatment.” Heartflow is the only company to offer a complete non-invasive, precision coronary care platform designed to manage CAD for life. With Heartflow One, a CCTA scan is transformed into a dynamic and personalized 3D model of the heart. Within the platform, Heartflow FFRCT provides lesion-specific physiology, enhancing CCTA’s diagnostic accuracy and helping determine whether there is benefit to revascularization. Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque in the coronary arteries to determine appropriate medical management. These advancements provide physicians with more precise, personalized insights into heart health, aiding in treatment planning and identifying individuals at high risk of major adverse cardiovascular events (MACE), such as heart attacks, which can occur in patients with or without symptoms of CAD. Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life by partnering with physicians and institutions to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally. About FISH&CHIPSFISH&CHIPS is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a CCTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a CCTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care CCTA diagnostic chest pain pathway. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com

Heartflow Closes $98 Million Convertible Notes Financing

Additional Capital to Support Broadening Adoption of a Leading Platform That Transforms Diagnosis and Management of Coronary Artery DiseaseMOUNTAIN VIEW, Calif., March 26, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced additional investments in the company of approximately $98 million through the sale and issuance of convertible notes by its parent company, Heartflow Holding, Inc., including a new investment by Fidelity Management & Research Company and additional investments from existing investors including Janus Henderson Investors, Bain Capital Life Sciences, Hayfin, US Venture Partners (USVP), HealthCor, Capricorn Investment Group and Martis Capital. Certain members of Heartflow management and the Board of Directors also participated in the financing. Proceeds from the convertible notes financing will support research and development efforts to further support Heartflow’s continued advancement of the coronary computed tomography angiography (CCTA)+Heartflow pathway as the definitive standard for the non-invasive diagnosis and management of CAD. The Heartflow Platform is widely adopted, driven by its improved accuracy over traditional non-invasive tests, superior economic efficiency relative to the traditional CAD diagnosis pathway and strength of supporting clinical evidence, published in over 600 peer-reviewed publications. The Heartflow Platform is also supported by a large and growing database of over 100 million annotated CCTA images, and the training of its algorithms over more than 10 years. Heartflow was recently named one of Fast Company’s Most Innovative Companies in Medical Devices for 2025 and won the Innovation in Cardiac Imaging award at the Global Cardiovascular Awards 2025. “Heartflow pioneered the use of AI-driven technology to diagnose and manage coronary artery disease, delivering accurate and efficient non-invasive solutions from a single CCTA scan. Our technology has been used to help manage more than 400,000 patients worldwide, and we believe we continue to lead the market in transforming coronary care,” said John Farquhar, president and CEO of Heartflow. “This investment enables us to strengthen our leadership and accelerate our vision to rewrite the story for people living with CAD.” In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.1 Heartflow is working to ensure that its technology not only helps clinicians identify and diagnose CAD earlier, but also transforms how they understand and manage the disease for life. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform – including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis – is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com Reference1. Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats. Accessed March 19, 2025.

Heartflow Unveils Bold New Vision for Management of Coronary Artery Disease

New Brand Identity Reaffirms Commitment to Transforming the World’s Leading Cause of Death Into a Manageable Condition

We’ve entered a new era at Heartflow – reaffirming our commitment to transforming coronary artery disease into a manageable condition. Discover what it means to see CAD clearly and manage it for life.

MOUNTAIN VIEW, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the global leader in AI technology for coronary artery disease (CAD) management, today introduced its new brand identity reflecting its focus on delivering clarity, precision, and confidence in the prevention, diagnosis, and treatment of CAD. This updated identity represents a new era for Heartflow, reinforcing the company’s leadership in providing clinicians with decisive insights to manage CAD throughout patients’ lives. Heartflow has helped clinicians manage over 400,000 patients worldwide and is striving to make a difference for the millions of patients whose lives are impacted by CAD every year. “At Heartflow, we are working toward a new vision to transform coronary artery disease from the leading cause of death to a disease that can be managed for life,” said John Farquhar, president and CEO of Heartflow. “With our AI-driven technology, we’re doing more than diagnosing CAD – we’re equipping clinicians with the insights needed to develop personalized treatment plans to provide the best possible care to each patient. We’re excited about the future, where Heartflow is positioned to help physicians identify CAD earlier and guide patients toward a lifetime of better health.” Heartflow’s new branding will be rolled out across all company materials, product interfaces, social media channels, and the Heartflow.com website beginning today. Importantly, the new brand identity and materials reflect input collected from Heartflow customers and cardiovascular community stakeholders. A key element of Heartflow’s approach is close collaboration with clinical teams to improve patient experiences, create efficient care pathways, and reach more patients with personalized insights, ensuring the best possible outcomes. In the U.S., CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.1 Many of the estimated 18 million adults in the U.S. and 315 million people globally living with CAD either have no symptoms or symptoms that go unrecognized.2, 3 Heartflow is working to ensure that its technology not only helps clinicians see CAD earlier but also transforms how they understand and manage the disease. Coronary computed tomography angiography (CCTA) was a major advancement in CAD diagnostics, helping physicians estimate if a stenosis was significant and requiring intervention. Technologies like Heartflow fractional flow reserve computed tomography (FFRCT) provide lesion-specific physiology, which enhances CCTA’s diagnostic accuracy. Now Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque present in the arteries from a single CCTA scan. These advancements provide physicians with more precise, personalized insights into heart health, aiding in treatment planning and identifying individuals at high risk of major adverse cardiovascular events (MACE), such as heart attacks, which can occur in patients with and without symptoms of CAD. Heartflow is dedicated to defeating CAD by partnering with physicians to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make its cutting-edge solutions more widely available to an increasingly diverse patient population worldwide. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform – including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis – is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. References Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats. Accessed Feb. 18, 2025.Cleveland Clinic. Coronary Artery Disease. https://my.clevelandclinic.org/health/diseases/16898-coronary-artery-disease. Accessed Feb. 21, 2025.Stark, B, Johnson, C, Roth, G. Global Prevalence of Coronary Artery Disease: An Update From The Global Burden of Disease Study. JACC. 2024 Apr, 83 (13_Supplement) 2320. https://doi.org/10.1016/S0735-1097(24)04310-9 Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bcb78bab-c373-4d0e-98f6-de83872371f6

HeartFlow Announces New Category I CPT Code from the American Medical Association for AI-Enabled Plaque Analysis to Assess Risk for Coronary Artery Disease

New reimbursement code follows recent favorable Medicare coverage decision, expanding access to HeartFlow’s Plaque Analysis to help physicians provide personalized treatment plans New reimbursement code follows recent favorable Medicare coverage decision, expanding access to HeartFlow’s Plaque Analysis to help physicians provide personalized treatment plans