Detailed Narrative
Plaque Performance and Adoption
HeartFlow's Plaque offering demonstrated strong performance, with accelerating activations and utilization ahead of expectations. The company is on track to reach approximately 1,250 Plaque-activated accounts by year-end, a significant acceleration compared to FFRCT's historical adoption. Physician utilization trends are very strong, indicating broader application of Plaque analysis as clinical experience deepens. Market leadership is attributed to accuracy and reproducibility, validated in peer-reviewed studies and underscored by ACC's scientific statement on quantitative plaque analysis.
FFRCT Durability and Utilization
FFRCT performance also exceeded expectations in Q2, with durable utilization across existing accounts. The record cohort of 340 accounts added in 2025 continues to ramp as anticipated, and early utilization trends from the 2026 new account cohort are encouraging. FFRCT's differentiation lies in its accuracy, lesion-specific values, and prospective validation, which are reinforced by updated expert consensus guidelines from SCCT and ACC.
Innovation Pipeline Progress
HeartFlow continues to invest in R&D, launching Plaque Staging at SCCT in July. This tool translates personalized disease burden into four clinically distinct stages, validated in over 23,000 patients, and is expected to drive further Plaque adoption. PCI Navigator, launched earlier in the year, is gaining strong traction and is on track for a broader rollout in 2027, providing interventional cardiologists with enhanced pre-procedural planning capabilities and strengthening HeartFlow's position in new accounts.
Clinical Evidence Expansion
The company presented eight new data sets at SCCT's annual meeting, spanning over 36,000 patients, further validating the accuracy, reproducibility, and clinical utility of HeartFlow Plaque analysis. Key findings included minimal variability in repeat scans for Plaque analysis and its ability to reclassify half of patients with a calcium score of 0 into a higher risk category by identifying non-calcified plaque, offering a more precise assessment of disease burden.
Asymptomatic Market Expansion Strategy
HeartFlow is targeting the asymptomatic market, which represents a significant unmet need and an estimated $6 billion expansion to its U.S. TAM, bringing the total to approximately $11 billion. The strategy involves initiating three RCTs over the next three quarters, focusing on high-risk asymptomatic populations: patients with coronary artery calcium ($3B TAM), prior MI or PCI ($1B TAM), and prior plaque ($2B TAM). These trials aim to prove that Plaque analysis can improve outcomes by optimizing medical therapy and tracking disease progression, with the goal of accessing these TAMs with reimbursed technology before 2030.
Operating Leverage and AI Efficiencies
The company demonstrated significant operating leverage in Q2, with a 600 basis point improvement in operating expenses as a percentage of revenue. Non-GAAP operating loss was nearly halved year-over-year. AI efficiencies, volume leverage, and a higher mix of high-margin Plaque revenue are driving gross margin expansion. The autonomous processing initiative, aimed at reducing human touch in analysis, is progressing well and is on track for a broader rollout in 2027, underpinning the mid-term gross margin target of 85%.