Heartflow unveiled late-breaking data at AHA 2025 showing AI-driven Heartflow Plaque Analysis with TPV-based staging that predicts long-term coronary risk in nearly 8,000 symptomatic patients.

The FISH&CHIPS study evaluates Heartflow Plaque Analysis and Heartflow Plaque Staging for coronary risk stratification, with retrospective analysis representing the largest validation to date of TPV-based staging.

The press release notes compliance with major standards (HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, ISO 27001) and highlights integration of the platform into clinical workflows.

TPV staging provides independent prognostic information, remaining significant after adjusting for stenosis, FFRCT, and traditional risk factors.

Lead investigator Dr. Timothy Fairbairn notes TPV-based staging can help predict risk beyond traditional factors and guide personalized treatment to prevent events.

Heartflow Plaque Analysis is FDA-cleared, while Heartflow Plaque Staging remains investigational and not FDA-reviewed for safety or effectiveness.

The release emphasizes Heartflow’s AI-driven plaque insights, its clinical validation across many studies and patients, and its aim to integrate into diagnostic pathways for CAD management.

Findings build on DECIDE Registry results shown at SCCT 2025, where Heartflow Plaque Staging guided management changes and was associated with an average LDL-C reduction of 18.7 mg/dL at 90 days and an estimated 15% reduction in cardiac event risk.

Higher TPV stages independently correlate with higher rates of cardiovascular death and myocardial infarction, with the highest stage showing a fivefold increase in major adverse cardiovascular events over a median 3.3-year follow-up (HR 5.10, p<0.0001).

The analysis, drawn from ~8,000 symptomatic patients, stands as the most extensive validation to date of Heartflow Plaque Staging using total plaque volume.

Media and investor contacts are provided, along with supporting references to related publications and past studies.

Public contact information for media and investors is listed, with references and figures supporting the significance of the findings.