Press Release

New 10-Year Data Demonstrate Superiority of the HeartFlow Analysis in Predicting Long-Term Outcomes in Patients with Coronary Artery Disease

REDWOOD CITY, Calif. – May 18, 2021 — HeartFlow, Inc., a leader in revolutionizing precision heartcare, today announced new data which indicate that the information provided by the HeartFlow FFRCT Analysis was a superior predictor of 10-year outcomes compared to the severity of a coronary stenosis shown on a coronary computed tomography angiogram (CTA). The 10-year results from the DISCOVER-FLOW trial were presented as a late-breaking trial during the virtual EuroPCR conference.

“When diagnosing and managing patients with coronary artery disease (CAD), physicians want to understand the impact of treatment. We want to be able to provide immediate symptom relief and have confidence that the treatment we are selecting, specifically the possible benefits of revascularization, will have a positive, long-lasting impact,” said Bon-Kwon Koo, MD, PhD, FACC, Professor of Internal Medicine, Seoul National University, and Director of the Cardiovascular Center and Chair of the Cardiology Division, Seoul National University Hospital. “The 10-year outcomes indicate that FFRCT is a more useful non-invasive test than coronary CT alone as the information provided helps physicians with long-term risk stratification and treatment selection for patients with coronary artery disease.”

The DISCOVER-FLOW trial was the first-in-human trial evaluating the HeartFlow Analysis and enrolled 103 patients from 4 international hospitals. All patients received a HeartFlow Analysis following a coronary CT scan.

“It’s rare to have the opportunity to follow patients for 10 years in clinical trials and we were pleased to confirm the long-term prognostic value of FFRCT through the DISCOVER-FLOW trial,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “These new data are a reflection of the company’s commitment to providing comprehensive clinical evidence on the diagnostic accuracy, safety, efficacy and utility of the HeartFlow Analysis to help clinicians engage patients in the decision-making process and confidently diagnose and optimize treatment for patients with coronary artery disease.”

ENDS

About the HeartFlow FFRCT Analysis

Starting with a standard coronary CTA, the HeartFlow Analysis leverages deep learning and highly trained analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and provides FFRCT values along the coronary arteries. This information helps physicians evaluate the impact a blockage may be having on blood flow and determine the optimal course of treatment for each patient. A positive FFRCT value (≤0.80) indicates that a coronary blockage may be impeding blood flow to the heart muscle to a degree which may warrant invasive management.

Data demonstrating the safety, efficacy and cost-effectiveness of the HeartFlow Analysis have been published in more than 425 peer-reviewed publications, including long-term data out to five years. The HeartFlow Analysis offers the highest diagnostic performance available from a non-invasive test.1 To date, clinicians around the world have used the HeartFlow Analysis for more than 75,000 patients to aid in the diagnosis of heart disease.

About HeartFlow, Inc.

HeartFlow, Inc. is a leader in revolutionizing precision heartcare, uniquely combining human ingenuity with advanced technology. Our non-invasive HeartFlow FFRCT Analysis leverages artificial intelligence to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRCT Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.

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  1. Driessen, R., et al. Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis. J Am Coll Cardiol. 2019;73(2),161-73.

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HeartFlow FFRCT 分析は、有資格の臨床医による臨床的に安定した症状のある冠状動脈疾患患者への使用を目的とした個別化された心臓検査です。 HeartFlow Analysis によって提供される情報は、資格のある臨床医が患者の病歴、症状、その他の診断検査、および臨床医の専門的判断と組み合わせて使用​​することを目的としています。

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The HeartFlow FFRCT Analysis is a personalized cardiac test indicated for use in clinically stable symptomatic patients with coronary artery disease by qualified clinicians. The information provided by the HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement.

For additional indication information about the HeartFlow Analysis, please visit www.heartflow.com/indications.

If you have additional questions, close out of this message to complete our form or call our support team: 877.478.3569.

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Campbell Rogers, M.D., F.A.C.C.

Executive Vice President and Chief Medical Officer

Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.

He received his A.B. from Harvard College and his M.D. from Harvard Medical School.