HeartFlow Inc. (HTFL) reported second-quarter 2026 revenue exceeding $64 million, a 48% increase from a year earlier, and outlined accelerating adoption of its plaque analysis platform during a Sept. 9 presentation at the Wells Fargo 21st Annual Healthcare Conference.
The company, which has been publicly traded for roughly 18 months, saw gross margin reach approximately 82% in the quarter—about three percentage points above expectations, with roughly 75% of that beat driven by stronger-than-forecast revenue. Full-year guidance places the midpoint for plaque analysis revenue at around $30 million, an exponential increase from approximately $1.5 million in 2025. Full-year 2026 guidance implies roughly $1 million in incremental quarterly revenue in the second half of the year.
On a trailing twelve-month basis ending Q2 2026, revenue totaled $212 million with an 80% gross profit margin. Gross margin has expanded roughly 30 percentage points over five years, with a midterm target moving toward 85%. HeartFlow holds approximately $250 million in cash on its balance sheet, management said it expects the balance will fund operations through profitability by mid-2028. Shares surged 107% over the prior six months, pushing market capitalization to $4.15 billion.
Plaque analysis accounts grew from about 500 at the start of 2026 to more than 1,200, with the company projecting between 1,200 and 1,250 sites by year-end. Commercial insurance coverage for the product reached 78% of covered lives in Q2. Anthem, the largest uncovered commercial payer, accounts for an estimated 8% to 9% of covered lives; management expects coverage to reach the mid-80s once Anthem is added. Average selling prices for plaque analysis rose in the quarter as commercial penetration expanded beyond Medicare, with another step-up anticipated in early Q1 2027.
U.S. coronary CTA adoption remains low at about 11% of non-invasive coronary artery disease tests, though penetration reaches 40% to 45% in the most established accounts. Annual growth in coronary CTA usage runs approximately 20%.
The symptomatic market addresses an estimated $5 billion total addressable market, comprising about $3 billion for FFRCT and $2 billion for plaque analysis. An adjacent high-risk asymptomatic market adds another estimated $6 billion, bringing the combined TAM to $11 billion.
Chief Executive Officer John Farquhar said plaque analysis is expected to become a larger business than FFRCT within the symptomatic market, and orders of magnitude larger when the asymptomatic segment is included.
"To think about all the success we've had in this $5 billion TAM and we're still only less than 5% penetrated. Now we've got a $6 billion TAM sitting on our doorstep that we believe we can execute and monetize before 2030, I'm not sure has been appreciated yet," Farquhar said.
The company has built a proprietary database of over 200 million annotated CT images and cited more than 625 peer-reviewed publications. Plaque analysis is applicable for patients with visible plaque up to 60% stenosis, complementing FFRCT, which covers the 40% to 90% range. A Category I reimbursement code for plaque analysis took effect at the start of 2025.
The DECIDE registry, encompassing 23,000 prospective patients, is scheduled to release one-year outcome data—including LDL changes and major cardiovascular events—in November. A plaque analysis staging system launched in July 2026 draws on prospective follow-up data tracking those 23,000 patients for up to 16 years.
Several clinical trials are advancing: the REFINE CAC and REWRITE CAD studies begin enrollment in late 2026, a serial plaque study involving patients with prior stent placement undergoing PCSK9 inhibition starts in early 2027, and primary endpoints across these studies are expected between 2027 and 2028. A P4 study sponsored by HeartFlow, intended to support the PCI Navigator tool, is scheduled for presentation as a late-breaking trial at the TCT meetings.
Chief Medical Officer Campbell Rogers highlighted the value of the HeartFlow PCI Navigator tool, which provides interventional cardiologists with pre-procedure imaging data to anticipate procedural complexity and equipment needs.
