Heartflow, Inc. Common Stock

AHA 2026: Heartflow Plaque Analysis Associated with 34% Fewer Major CVD Events and Half the Rate of Heart Attack at One Year in Prospective DECIDE Registry

Heartflow announced prospective one-year outcomes from the DECIDE registry showing its AI Plaque Analysis cut major cardiovascular events by 34% and myocardial infarction rate by half versus CCTA alone in more than 6,000 matched patients. The event reductions were linked to earlier therapy optimization: 50% of patients reached LDL-C goal (<70 mg/dL) by 90 days versus 35% with CCTA alone, with management changed in over 50% of patients. A second registry (GAMEFILM) found detectable coronary plaque in 85% of 200 retired NFL players, most of it soft plaque invisible to calcium scoring, and the registry is expanding to MLB and college sports. The data strengthen Heartflow's clinical evidence and adoption case ahead of commercial expansion, though near-term revenue impact depends on guideline, payer, and ordering-pattern follow-through.

•7d ago

TCT 2026: CT-guided PCI Matches IVUS Outcomes in Randomized P4 Trial; Heartflow PCI Navigator Changes PCI Plans in Approximately 70% of Patients

Heartflow announced late-breaking TCT 2026 data showing CT-guided PCI planning using its technology was non-inferior to IVUS on the P4 trial's one-year primary endpoint of target-vessel failure (4.1% vs. 4.6%) in 1,105 patients, with results simultaneously published in NEJM. CT guidance also delivered efficiency gains: 17-minute shorter median procedure time (46 vs. 63 minutes), roughly 12% lower contrast volume, and more than doubled use of advanced calcium modification. In the 203-patient NAVIGATE-PCI registry, Heartflow PCI Navigator drove changes to treatment plans in approximately 70% of cases versus angiography alone, most often stent length (41%) and lesion preparation technique (12%). The data support a commercial push of PCI Navigator as the only prospectively validated AI-based PCI planning tool, extending the Heartflow One platform deeper into interventional cardiology workflows.

•7d ago

Late Breaking Data from Independent Government-Funded Trial at ESC Shows Heartflow FFRCT Analysis Reduces Unnecessary Invasive Heart Procedures by Nearly Half

The independent, government-funded FUSION trial published in JACC showed HeartFlow's FFR(CT) Analysis reduced unnecessary invasive heart procedures by 44% compared to standard CT scans. One-year data from 528 patients demonstrated that while overall invasive catheterization rates dropped significantly in the HeartFlow group, necessary revascularization rates remained identical, proving safety and efficacy. The trial results validate the technology at a pivotal decision point immediately following anatomical stenosis identification, supporting broader clinical adoption.

•2mo ago

Heartflow Reports Second Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

Heartflow reported Q2 revenue of $64.1 million, up 48% year-over-year, driven by increased case volume for both its FFR(CT) and Plaque analysis products. The company significantly raised its full-year 2026 revenue guidance to $246 million to $250 million, representing 40% to 42% growth compared to the previous outlook of 29% to 32%. GAAP gross margin reached a record 83.0%, up from 75.5% in the prior year, while the net loss per share narrowed to ($0.18) from ($1.46) in the same period last year.

•2mo ago

New Data at SCCT 2026 Reinforce Heartflow Plaque Analysis as the Standard for AI-Powered Coronary Artery Disease Management

Heartflow launched Heartflow Plaque Staging, a new risk-stratification tool based on total plaque volume, integrated into every Heartflow Plaque Analysis case. The launch is supported by eight new datasets from clinical studies spanning over 36,000 patients, presented at the SCCT 2026 Annual Scientific Meeting. Key data shows that over 50% of symptomatic patients with zero coronary artery calcium harbor significant non-calcified plaque, which traditional scoring misses but Heartflow detects. The technology demonstrated high reproducibility (95% kappa score) and consistency across scanner transitions, reinforcing its position as the standard for AI-powered CAD management.

•4mo ago

Heartflow Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

Heartflow reported Q1 2026 revenue of $52.6 million, a 41% increase year-over-year, driven by strong growth in U.S. FFR(CT) volume. The company raised its full-year 2026 revenue guidance to $228 million-$232 million, up from the prior range of $218 million-$222 million, citing durable core business growth and ahead-of-schedule adoption of Heartflow Plaque Analysis. Non-GAAP gross margin expanded to 80.5%, while the company maintained a strong balance sheet with $254.9 million in cash and investments, despite a GAAP net loss of $27.4 million impacted by a $7.5 million facility impairment charge.

•5mo ago