Tag: Heartflow

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

HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

MOUNTAIN VIEW, Calif., June 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product. Five Medicare Administrative Contractors (MACs), CGS, NGS, Noridian, Palmetto GBA, and WPS, released draft Local Coverage Determinations (LCD) for Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). These draft LCDs recognize the importance of quantifying coronary artery plaque, which underscores the pivotal role HeartFlow technology plays in diagnosing and managing treatment for patients in need of cardiovascular care. HeartFlow’s accurate and actionable Plaque Analysis aligns with the Centers for Medicare & Medicaid Services (CMS) commitment to supporting technologies that enhance diagnostic accuracy and patient care: HeartFlow Plaque Analysis is the only FDA cleared plaque analysis with a reported 95% agreement prospectively compared to the gold standard, IVUS.¹Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.² Plaque Analysis is a major function of the HeartFlow portfolio, which offers the only comprehensive, AI-driven, precision coronary care solution based on the guideline-directed cardiac CT pathway, backed by robust clinical evidence and guidelines. HeartFlow FFRCT has an established reimbursement pathway which is covered for 99% of people in the US with health insurance. Leveraging our expertise and proven success creating new AI reimbursement categories as done with HeartFlow FFRCT, similar coverage and adoption for Plaque Analysis is anticipated, ensuring it becomes an integral part of coronary care. “We are excited about this milestone, as it highlights the critical importance of accurately quantifying plaque in cardiovascular disease management,” said John Farquhar, chief executive officer at HeartFlow. “This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all.” The release of these draft LCDs mark the first step in integrating accurate plaque measurement into standard clinical practice. Next steps toward coverage include a period for input from clinicians and other stakeholders before policy is finalized and released. “We are confident that Plaque Analysis will not only meet but exceed the rigorous standards of Medicare,” added Cara Santillo, Senior Vice President of Market Access and Reimbursement at HeartFlow. “This nod of support from the MACs underscores the importance of access and equity in cardiovascular care by ensuring that all patients, regardless of background, receive the critical insights needed for treatment for cardiovascular disease.” 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 Contact Linly Ku Digital Marketing Manager media@heartflow.com Investor Contact Nick Laudico VP of Business Development and Investor Relations 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 Rinehart et al. JSCAI 2024. https://doi.org/10.1016/j.jscai.2024.101296

HeartFlow’s Plaque Analysis Leading The Way: 95% Accuracy vs Invasive Imaging In Newly Published REVEALPLAQUE Study

MOUNTAIN VIEW, Calif., May 15, 2024 (GLOBE NEWSWIRE) — HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that the data from its REVEALPLAQUE study, highlighting the accuracy of its Plaque Analysis, was published in the European Heart Journal Cardiovascular Imaging.