Tag: Heartflow

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

HeartFlow Announces Favorable Coverage Determination for Plaque Analysis by Four Medicare Administrative Contractors

Coverage policy improves access to artificial intelligence-enabled plaque analysis providing insights to help physicians guide treatment decisions for patients with coronary artery disease Coverage policy improves access to artificial intelligence-enabled plaque analysis providing insights to help physicians guide treatment decisions for patients with coronary artery disease

SCCT 2024: HeartFlow to Present New Data on Coronary Artery Disease Management with Coronary Computed Tomography Angiography

MOUNTAIN VIEW, Calif., July 16, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced it will be presenting new findings on the use of coronary computed tomography angiography (coronary CTA) in coronary artery disease (CAD) management and insights on CTA reimbursement at the upcoming 19th Annual Scientific Meeting of SCCT. The annual meeting will take place on July 18-21, 2024 in Washington, D.C. Subset data from the PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) Trial will also be presented. The PRECISE clinical trial data, originally presented in late 2022, confirmed CTA + FFRCT increases diagnostic accuracy, reduces unnecessary testing and offers higher confidence in identifying patients needing treatment versus traditional testing (stress nuclear, stress echo, and invasive coronary angiography). The new subset data analyzes the association between body mass index, testing performance and clinical outcomes in patients with stable chest pain. New insights from the ADVANCE Registry, including analysis on the relationship between risk factors and quantified atherosclerotic burden and differences in plaque quantification in a Japanese patient population will be shared. Along with the significant work HeartFlow has undertaken to develop age and sex specific nomograms, these data will be a pivotal step to better stratify patients and impact treatment decisions going forward. “The critical role of CTA in the diagnosis and management of coronary artery disease continues to drive every decision we make, ensuring the right patients are getting the right care at the right time,” said Campbell Rogers, Chief Medical Officer of HeartFlow. “This year, we are excited to share the latest insights on the importance of quantifying coronary artery plaque, as well as changes in the reimbursement landscape. We are pleased to continue providing robust clinical evidence as to how our products can help health care providers manage their patient’s heart health.” Details of the presentations are as follows: Session: Poster Session 8 – CT in Non-Acute Chest PainTitle: “Association Between Body Mass Index, Testing Performance And Clinical Outcomes In Patients With Stable Chest Pain: Insights From The PRECISE Trial”Date: Friday, July 19, 2024Time: 9:30 – 10:15 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: The Relationship Of Risk Factors And Quantified Atherosclerotic Burden On Coronary Computed Tomographic Angiography – Lessons From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: Quantitative Differences Between Japanese And Non-Japanese Patients’ Coronary Computed Tomographic Angiography Derived Plaque – Insights From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Business Aspects of Cardiac CT – Part TwoTitle: “How clinicians can work with administrators to maximize cardiac CT reimbursement” Presenter: Cara SantilloDate: Thursday, July 18, 2024Time: 4:05 PM – 4:20 PM EDT Location: Liberty N-P Heartflow invites attendees to two sponsored events, including “Women in CT Happy Hour,” which will take place on July 18 from 6:00 PM – 7:00 PM EDT in the 2nd Floor Lobby, and “The Power of HeartFlow AI in the Management of CAD from Diagnosis to Treatment” symposium, which will take place on July 19 from 11:55 AM – 12:45 PM EDT in the Capitol/Congress Room. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media ContactLinly KuSr. Digital Marketing Managermedia@heartflow.com Investor ContactNick Laudico VP of Business Development and Investor Relationsnlaudico@heartflow.com