Full-year 2026 revenue guidance raised to $262 million to $264 million.
Plaque Analysis reduced major cardiovascular events by 34% at one year.
Asymptomatic clinical trials expand total addressable market by $6 billion.
On its third-quarter 2026 earnings call, held on Nov. 12, 2026, HeartFlow (NASDAQ:HTFL) raised its full-year revenue outlook to between $262 million and $264 million. The company is accelerating commercial adoption of its artificial intelligence diagnostic platform across cardiovascular care pathways.
Expanding adoption and clinical trial milestones offer long-term investors a clear view of sustainable top-line growth. Three things management said on the call stand out.
Revenue grew 57% year over year in the third quarter of 2026, driven by higher utilization of FFRct, an artificial intelligence tool measuring coronary artery blockage, and Plaque Analysis, a software program analyzing arterial vessel walls. Expanding sales of high-margin software helped lift non-GAAP gross margin, an adjusted measure excluding non-cash compensation, to 83.8%.
In the third quarter, total revenue was $72.9 million, up 57% year-over-year, with U.S. revenue up 60%, our fastest U.S. growth in 11 quarters.
-- John Farquhar, President and Chief Executive Officer
A one-year study of 6,000 patients revealed that clinicians using Plaque Analysis reduced major cardiovascular disease (CVD) events by 34% compared to standard coronary computed tomography angiography, or CCTA, scans alone. Demonstrating improved patient outcomes encourages health systems to adopt the software across a broader portion of scan volumes.
The one-year findings demonstrate that HeartFlow Plaque Analysis provides clinicians with the objective outcomes data needed to optimize preventative care earlier and with greater precision, while significantly reducing major CVD events and heart attacks compared to CCTA alone.
-- John Farquhar, President and Chief Executive Officer
Management is initiating three clinical trials in late 2026 and early 2027 to evaluate high-risk patients without symptoms, aiming to unlock an additional $6 billion market. Winning regulatory and reimbursement coverage in this population would expand the company's total addressable market, or TAM, to $11 billion.
From a timing standpoint, we're going to expect to begin reporting out data by the end of 2028, and we'll enter these markets before the end of the decade.
-- John Farquhar, President and Chief Executive Officer
Operational leverage continues to strengthen as revenue growth outpaces expenses, narrowing operating losses significantly. The company holds $253 million in cash and short-term investments, which management expects will fund operations until achieving positive cash flow.
Structural advantages in proprietary imaging software, growing clinical trial evidence, and expanding health plan coverage protect its competitive position as management focuses on account activations and pricing discipline.
Finally, we remain committed to our midterm non-GAAP gross margin target of 85%. Given our continued financial performance, we have increased confidence in achieving cash flow profitability by mid-2028.
-- Vikram Verghese, Chief Financial Officer
New products like PCI Navigator, a software tool for planning catheter-based heart stent procedures, extend the platform into treatment planning. Clinical data supporting these tools helps embed the software into hospital workflows and drives long-term customer retention.
We believe these results further establish the CT-first pathway -- and HeartFlow as a platform -- as an emerging standard of care, while setting the stage for Navigator's broader rollout in 2027.
-- John Farquhar, President and Chief Executive Officer
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