Primary endpoints across three studies underscore the importance of accuracy, utility, and efficiency in coronary artery disease diagnostics and clinical decision making

MOUNTAIN VIEW, Calif. – July 28, 2023 — Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies. Study results were presented at the Society of Cardiovascular Computed Tomography (SCCT) Conference in Boston, MA.

HeartFlow is the first company to offer a suite of technologies to help clinicians non-invasively identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR_CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Together, this comprehensive solution offers valuable data not currently available with traditional non-invasive diagnostics tools, allowing clinicians to see the full picture of their patients’ coronary artery disease (CAD).

“Until now, clinicians have not had access to a complete view of a patient’s heart health with accurate data on coronary anatomy, physiology, and plaque. We are thrilled to now offer HeartFlow’s comprehensive solution, supported and validated by the findings of these studies,” said John Farquhar, Chief Executive Officer of HeartFlow. “Our company remains committed to empowering providers to make the best clinical decisions by strengthening precision CAD management solutions with the CCTA pathway.”

The REVEALPLAQUE Study is a large, global, prospective study with independent, blinded, core lab adjudication that demonstrated the accuracy of HeartFlow’s AI-based Plaque Analysis compared to intravascular ultrasound (IVUS) – the current gold standard. The HeartFlow Plaque Analysis demonstrated a 95% agreement with IVUS in quantification and characterization of total plaque volume.¹

The DECODE Study evaluated changes in treatment management decisions made by clinicians using Heartflow’s Plaque Analysis alongside CCTA in comparison to decisions made with CCTA alone. Clinicians using the HeartFlow Plaque Analysis alongside CCTA changed their management decisions for 66% of patients compared to using CCTA alone across various patient presentations and disease stages.² Furthermore, nearly 50% of patients with a calcium score of zero were reclassified following clinician review of the HeartFlow Plaque Analysis, highlighting the importance of quantifying total plaque beyond just calcium.

The SMART-CT Study measured the difference in CCTA read time using RoadMap Analysis³ compared to without RoadMap Analysis in Level 2 and Level 3 CT readers. With the use of the RoadMap Analysis, clinicians read cases 25% faster while maintaining diagnostic accuracy, allowing them to be more efficient.⁴ SMART-CT also demonstrated the RoadMap Analysis elevated consistency with reliable CAD diagnoses across all CT readers and amplified their confidence in CCTA reads by over 24%.
The results from these clinical studies, along with the launch of HeartFlow’s all-in-one portfolio (HeartFlow ONE), mark a significant milestone in HeartFlow’s mission to build a new standard of care for people at risk of heart disease. Clinicians can now see and gain a full understanding of anatomy, physiology, and plaque – allowing them to evaluate and provide earlier, timesaving, life-altering care that is truly individualized.

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About HeartFlow

HeartFlow is transforming precision coronary care with the only non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFR_CT, which is now supported by the ACC/AHA Chest Pain Guidelines, HeartFlow continues to advance the diagnosis and management of CAD. Our suite of non-invasive technologies helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR_CT Analysis), and characterize and quantify coronary atherosclerosis (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 200,000 patients. For more information, visit www.heartflow.com and connect on Twitter and LinkedIn.

Contact

Linly Ku
HeartFlow
media@heartflow.com

1. 1. REVEALPLAQUE Study, presented at SCCT 2023.

   2. DECODE Study, presented at SCCT 2023.

   3. AI Coronary Stenosis Quantification on Coronary CT Angiography versus Quantitative Coronary Angiography, presented at SCCT 2023.

   4. SMART-CT, presented at SCCT 2023.