Announcement • Aug 30

HeartFlow, Inc. Reports One-Year Results From Independent Government-Funded FUSION Clinical Trial Demonstrating Heartflow FFRCT Analysis Reduces Unnecessary Invasive Heart Procedures

Heartflow, Inc. reported late-breaking one-year results from an independent randomized clinical trial proving the Heartflow FFRCT Analysis safely and significantly reduced unnecessary invasive heart procedures by 44% (p < 0.001). Presented as Late-Breaking Science at the European Society of Cardiology Congress 2026, FUSION trial, funded by the Dutch National Health Care Institute, demonstrates that standard coronary computed tomography angiography (CCTA) alone drives overutilization of invasive catheterizations. By adding Heartflow FFRCT Analysis to standard CCTA scans, clinicians dramatically reduced diagnostic catheter lab procedures. The FUSION study has been published simultaneously in the Journal of the American College of Cardiology. CCTA is the primary first-line test recommended by both European and U.S. guidelines for evaluating patients with suspected coronary artery disease. Visual assessment of CCTAs is limited to assessing anatomy and whether plaque is present; it cannot determine lesion-specific physiology or whether a blockage significantly restricts blood flow to the heart. This diagnostic uncertainty frequently leads physicians to refer patients for invasive coronary angiography, a hospital procedure where a catheter is threaded through an artery to get into the heart to assess blocked or narrowed blood vessels. Heartflow FFRCT is the only AI platform prospectively validated against invasive gold standard. By applying advanced AI and computational fluid dynamics to standard CT scans with documented narrowings, Heartflow creates a personalized 3D model that quantifies blood flow within the coronary arteries. Enrolling 528 patients with stable chest pain across twelve hospitals in the Netherlands, FUSION is an independent randomized controlled trial funded through the Dutch government’s Zorginstituut Nederland ‘Potentially Promising Care’ program. The study evaluated Heartflow FFRCT Analysis across diverse scanner vendors in both academic and community hospital settings, with blinded, independent clinical event adjudication. Key 1-year findings include: A sustained 44% relative reduction in unnecessary invasive coronary angiography was demonstrated at one year in the Heartflow pathway compared to the CCTA-only group (22% [57/263] Heartflow vs. 39% [103/265] CCTA alone; p < 0.001), consistent with the 90-day primary endpoint results (18% [48/263] vs. 33% [87/265] CCTA alone; p < 0.001). Overall rates of invasive coronary angiography were significantly lower at one year in the Heartflow pathway compared to the CCTA-only group (43% [114/263] Heartflow vs. 61% [161/265] CCTA alone; p < 0.001). Rates of coronary revascularization remained identical across groups (20% [52/263] vs. 20% [53/265]; p = 0.948), proving that safely reducing diagnostic cath lab procedures did not prevent patients from receiving necessary intervention. There were no significant differences in safety endpoints between pathways, including major adverse cardiac events, invasive coronary angiography complications, or stroke. FUSION is the first randomized trial to test Heartflow FFRCT Analysis at a pivotal clinical junction: immediately following a CCTA scan that identifies anatomically obstructive stenosis, a decision point recently affirmed in the 2026 SCCT/SCAI expert consensus statement and endorsed by the ACC. As an independent, government-funded study with no industry involvement in trial design or analysis, FUSION delivers robust, unbiased evidence supporting the routine integration of Heartflow FFRCT Analysis into everyday clinical practice. The landmark findings build on more than 15 years of rigorous clinical research across major trials, further establishing Heartflow FFRCT as the leading and most extensively validated CT-FFR technology in cardiology. Heartflow’s technology is redefining precision diagnostic testing and management for coronary artery disease through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 750,000 patients worldwide. Key benefits include: Unmatched proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations. Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%. Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay. Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001.

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HeartFlow, Inc. Reports One-Year Results From Independent Government-Funded FUSION Clinical Trial Demonstrating Heartflow FFRCT Analysis Reduces Unnecessary Invasive Heart Procedures

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