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WKN: A41F4V | ISIN: US42238D1072 | Ticker-Symbol:
NASDAQ
10.12.25 | 21:59
28,080 US-Dollar
+4,50 % +1,210
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HEARTFLOW INC Chart 1 Jahr
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GlobeNewswire (Europe)
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Heartflow, Inc.: Heartflow FFRCT Analysis Delivers Prognostic Power and Significant Cost Savings in New Analyses of Over 90,000 Patients with Coronary Artery Disease

Lesion-specific FFRCT predicts individual cardiovascular outcomes and delivers greater-than-modeled cost savings for real-world population in FISH&CHIPS analyses from England's National Health Service

MOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than 90,000 patients conducted by the National Health Service (NHS) in England, representing the largest fractional flow reserve (FFRCT) study ever conducted. The data, presented today at the European Society of Cardiology's European Association of Cardiovascular Imaging (EACVI) conference in Vienna, provide the strongest real-world evidence to date that Heartflow FFRCT Analysis derived from coronary computed tomography angiography (CTA) improves diagnostic decision-making, predicts future cardiovascular events, and delivers substantial, system-wide cost savings.

"These real-world data show that coronary CTA plus Heartflow FFRCT Analysis brings both clinical and economic value when utilized in a large health system," said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. "The introduction of Heartflow FFRCT Analysis into the NHS resulted in fewer avoidable tests, lower inpatient and outpatient costs, and substantial overall savings for both the hospitals and patients. It's a compelling example of how noninvasive AI-powered technology can reshape care pathways at scale."

Lesion-Specific Heartflow FFRCT Analysis Predicts Individual Cardiovascular Outcomes
In a nationwide analysis of 7,836 patients who underwent FFRCT in the FISH&CHIPS study, investigators evaluated the prognostic value of Heartflow FFRCT Analysis across individual outcomes, including myocardial infarction (MI), cardiovascular mortality, all-cause mortality, and revascularization. Key findings include:1

  • The lower the FFRCT values, the higher the risk of MI, revascularization, cardiovascular death, and all-cause death, independent of traditional cardiovascular risk factors.
  • Patients with the lowest FFRCT values faced a four-fold increased risk of heart attack and a three-fold increased risk of cardiovascular death.
  • Lesion-specific FFRCT (measured just beyond a specific stenosis) was the strongest predictor in the study of MI and revascularization, compared to distal vessel FFRCT (measured at the end of the artery).

Heartflow FFRCT Analysis Delivers Greater-Than-Expected Cost Savings
A separate analysis of FISH&CHIPS data evaluated the cost-effectiveness of incorporating Heartflow FFRCT Analysis into the diagnostic pathway for stable CAD. The findings showed that the national program:2

  • Reduced downstream cardiovascular testing, including invasive coronary angiography.
  • Increased appropriate revascularization and improved revascularization ratios.
  • Produced £1,042 GBP ($1,394 USD) in per-patient cost savings at two years, substantially exceeding the cost savings modeled by NHS and the National Institute for Health and Care Excellence (NICE) during initial assessment and adoption. This suggests a potential £25 million GBP ($33.45 million USD) cost savings per year for the health system.
  • Demonstrated cost savings beginning in the first year, with benefits persisting in lifetime modeling.

"These data provide compelling real-world evidence underscoring the clinical value of lesion-specific Heartflow FFRCT Analysis to provide precise, localized physiological assessments," said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. "We now see that lesion-specific FFRCT insights can also help predict which patients are most likely to experience future events, enabling clinicians to tailor care earlier with greater precision and reduce costs."

These analyses are the latest to demonstrate the prognostic power of the Heartflow One platform, the most accurate noninvasive AI-enabled CAD assessment technology, including RoadMap Analysis, FFRCT Analysis and Plaque Analysis. Insights from FISH&CHIPS add to a growing body of evidence demonstrating the clinical and economic value of the Heartflow One platform providing superior patient outcomes in patients with confirmed CAD.3,4 A retrospective analysisof symptomatic patients from a cohort of the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025 provided strong validation of total plaque volume-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death.5 Heartflow One provides an integrated workflow that empowers physicians to improve care by enabling a faster, more optimal diagnosis to avoid unnecessary tests.

About FISH&CHIPS
FISH&CHIPS, the largest FFRCT study conducted to date, is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a coronary CTA-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 coronary CTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care diagnostic chest pain pathway using coronary CTA alone. Two-year data were published in May 2025 in Nature Medicine, showing improved care efficiency with a reduction in unnecessary invasive and noninvasive cardiac tests using coronary CTA and Heartflow FFRCT versus coronary CTA alone. 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's Technology and Research
Heartflow's technology is redefining precision cardiovascular care through clinically-proven AI and the world's largest coronary imaging dataset. 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. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include:

  • Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow's data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.
  • Extensive clinical and real-world validation: Heartflow's AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. 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, ISO 13485, and ISO 27001.

About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world's leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow Oneplatform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow - all without invasive procedures. Discover how we're shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

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1 Bell et al. AHA 2025.
2 Fairbairn et al. EACVI 2025.
3 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024
4 Douglas PS, et al. The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023;8(10):904-914. doi:10.1001/jamacardio.2023.2595
5 Fairbairn et al. AHA 2025.


© 2025 GlobeNewswire (Europe)
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