SAN FRANCISCO, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today reported financial results for the third quarter ended September 30, 2026.

Third Quarter 2026 Highlights

   -- Total revenue of $72.9 million, a 57% increase year-over-year 
 
   -- Gross margin of 83.6%, non-GAAP gross margin of 83.8% 
 
   -- Net operating loss of $13.8 million; non-GAAP net operating loss of $5.0 
      million 

2026 Annual Guidance

   -- Total revenue of $262 million to $264 million (approximately 49% to 50% 
      growth year-over-year), compared to previous guidance of $246 million to 
      $250 million (approximately 40% to 42% growth year-over-year) 
 
   -- Non-GAAP gross margin of approximately 82.5%, compared to previous 
      guidance of approximately 82% 

"Our third quarter was excellent, with revenue accelerating for the third consecutive quarter and U.S. revenue growing at its fastest pace in 11 quarters," said John Farquhar, President and CEO of Heartflow. "Our core FFR(CT) business remains durable, our installed base continues to expand rapidly, and activations of Heartflow Plaque Analysis are ramping ahead of plan, with utilization broadening across a wider share of applicable CCTAs. The CCTA market continues to grow rapidly and remains significantly underpenetrated. Strong performance across our diagnostic platform, along with disciplined execution of our commercial, innovation and clinical initiatives, gives us the confidence to raise our 2026 guidance once again. With continued momentum and a scaling business, we believe we are well positioned to extend our market leadership, and we have increased confidence in our path to profitability."

Third Quarter 2026 Financial Results

Total revenue was $72.9 million, a 57% increase year-over-year. U.S. revenue was $67.9 million, a 60% increase year-over-year. International and other revenue was $4.9 million, a 29% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFR(CT) revenue case volume and an increase in total U.S. Plaque revenue case volume.

Gross profit was $60.9 million, compared to $35.4 million in the prior year period. Non-GAAP gross profit was $61.1 million, compared to $35.5 million in the prior year period.

Gross margin was 83.6%, compared to 76.5% in the prior year period. Non-GAAP gross margin was 83.8%, compared to 76.8% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in total revenue case volume, an increase in total U.S. Plaque revenue case volume, and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel.

Total operating expenses were $74.8 million, or 103% of total revenue, compared to $50.5 million, or 109% of total revenue, in the prior year period. Non-GAAP total operating expenses were $66.1 million, or 91% of total revenue, compared to $46.7 million, or 101% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research.

Net operating loss was $13.8 million, compared to $15.1 million in the prior year period. Non-GAAP net operating loss was $5.0 million, compared to $11.1 million in the prior year period.

Net loss was $11.5 million, or ($0.13) net loss per share, compared to $50.9 million, or ($1.04) net loss per share, in the prior year period. Net loss in the prior year period included a $32.1 million noncash charge from the remeasurement of the fair value of the Company's warrant liability, a $4.8 million noncash benefit from the remeasurement of the fair value of the Company's derivative liability, and a $6.4 million loss on extinguishment of debt from the full prepayment of the Company's term loan in August 2025.

Non-GAAP net loss was $2.7 million, or ($0.03) non-GAAP net loss per share, compared to $13.2 million, or ($0.27) non-GAAP net loss per share, in the prior year period.

Adjusted EBITDA was ($3.6) million, compared to ($9.8) million in the prior year period.

Cash, cash equivalents and investments totaled $253.0 million as of September 30, 2026.

For additional information regarding non-GAAP financial measures, see "Use of non-GAAP Measures," "Heartflow GAAP to non-GAAP Reconciliations" and "Reconciliation of GAAP Net Loss to Adjusted EBITDA" below.

Webcast and Conference Call Details

Heartflow will host a conference call today, November 12, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the "Investor Relations" section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call.

About Heartflow's Technology and Research

Heartflow's technology is redefining precision diagnostic testing and management for coronary artery disease (CAD) through clinically proven AI and the world's largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 800,000 patients worldwide.(1) Key benefits include:

   -- Unmatched proprietary data pipeline: Built from the world's largest 
      database of more than 250 million annotated CTA images, Heartflow's data 
      foundation powers advanced AI models that deliver highly accurate, 
      reproducible diagnostic insights across diverse patient populations. 
 
   -- Extensive clinical and real-world validation: Heartflow's AI-driven 
      solutions have been validated through clinical evidence in over 200 
      studies assessing over 365,000 patients. Heartflow is the only AI 
      platform prospectively validated against invasive gold standards and 
      demonstrated through real-world evidence to improve patient 
      outcomes.2,3,4,5 Proven in real-world practice with reproducibility and 
      accuracy, Heartflow's coronary CTA image acceptance rates exceed 97%. 
 
   -- Seamless clinical integration via upgraded workflow: Heartflow delivers 
      final quality-reviewed analyses instantly upon order, enabling clinicians 
      to move from diagnosis to decision without delay. 
 
   -- Quality system, global security and patient-data integrity 
      compliance: Heartflow meets or exceeds leading international standards, 
      including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001. 

About Heartflow, Inc.

Heartflow is transforming coronary artery disease from the world's leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow -- all without invasive procedures. Discover how we're shaping the future of cardiovascular care at heartflow.com.

Use of Non-GAAP Measures

To supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the "Non-GAAP Measures") in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, loss on extinguishment of debt, certain litigation expenses and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, certain litigation expenses, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company's underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company's underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company's ongoing operations. Because of the variety of equity awards used by companies, the varying