0001464521-26-000042
SEC filingRevenue grew 40% to $176M as case volume surged 47%, but net loss widened to $117M from non-cash charges and higher opex.
Heartflow, Inc. is a provider of software and artificial intelligence designed to deliver a more accurate and clinically effective non-invasive solution for diagnosing and managing coronary artery disease (CAD). The company's Heartflow Platform leverages AI and advanced computational fluid dynamics to create a personalized 3D model of a patient's heart from a single coronary computed tomography angiography (CCTA) scan, providing actionable insights on blood flow, stenosis, plaque volume, and plaque composition.
Heartflow's product portfolio includes: Heartflow RoadMap Analysis (anatomic visualization tool, provided as an integrated feature), Heartflow FFR CT Analysis (flagship product, calculates fractional flow reserve values, representing 98% of total revenue as of Dec 31, 2025), Heartflow Plaque Analysis (AI-driven plaque quantification and characterization, launched for limited market education in second half of 2023), Heartflow PCI Navigator (expected launch in Q2 2026, pre-PCI planning tool), and Plaque Tracker (expected in 2027 for longitudinal plaque analysis).
Heartflow markets and sells its platform in the United States through a direct sales organization consisting of Territory Sales Managers (TSMs) focusing on new account acquisition and Territory Account Managers (TAMs) driving utilization at existing accounts. As of Dec 31, 2025, the company had an installed base of over 1,465 accounts in the U.S. Internationally, small direct teams operate in the United Kingdom, Japan, and other EU countries. The company generates revenue on a pay-per-click basis when physicians choose to review Heartflow FFR CT Analysis or Heartflow Plaque Analysis. Key reimbursement milestones include a Category I CPT code for Heartflow FFR CT Analysis (75580) effective Jan 1, 2024, and for Heartflow Plaque Analysis (75577) effective Jan 1, 2026, with coverage representing approximately 99% and 75% of covered lives in the U.S., respectively.
Primary competition consists of traditional non-invasive tests for CAD, including stress tests such as SPECT, stress echocardiography, and PET, with major imaging system providers like Siemens Healthineers, GE Healthcare, Philips, and Canon. Additionally, the company faces competition from AI-based platforms using CCTA, including Cleerly, Inc., Elucid Bioimaging Inc., and Keya Medical Technology Co., Ltd. Key competitive factors include accuracy, clinical data, speed, per-patient economics, ease of workflow integration, and physician education.
The company's growth strategies focus on: expanding adoption of the Heartflow Platform by new accounts through its TSM team; broadening awareness of the CCTA + Heartflow pathway to increase volumes at existing accounts; increasing adoption of Heartflow Plaque Analysis following new CPT code and expanded payer coverage; investing in additional clinical evidence (including three planned randomized trials in asymptomatic subpopulations); extending technology leadership through continued R&D in algorithm improvements, clinical utility, ease of use, and platform expansion; and pursuing adjacent and international market opportunities.
As of December 31, 2025, Heartflow employed 843 full-time employees globally. The company's human capital objectives include attracting and retaining top talent, investing in leadership development and technical training, and increasing diverse representation. Employees are not covered by a collective bargaining agreement, and the company believes it maintains good employee relations.
For the fiscal year ended December 31, 2025, Heartflow reported revenue of $176.0 million, a 40% increase from $125.8 million in 2024. Growth was driven by a 47% surge in revenue case volumes, partially offset by a reduction in average selling price due to a higher mix of lower-priced clinic/office-based accounts (32% of cases vs 28% in 2024) and increased utilization and volume rebates. Gross profit rose 43% to $135.2 million, with gross margin expanding from 75% to 77% as AI-driven production efficiency gains and volume leverage outpaced investment in hiring and training production staff. Operating expenses totaled $199.3 million, up 28% from $155.7 million, reflecting a 49% increase in R&D (to $64.9 million) from headcount growth and clinical trials, and a 20% increase in SG&A (to $134.3 million) from commercialization, public company costs, and professional fees. As a result, operating loss widened only 5% to $64.1 million. Net loss increased 21% to $116.8 million, primarily due to non-cash charges: a $43.9 million loss from remeasurement of common stock warrant liability and a $6.4 million loss on debt extinguishment, partially offset by a $7.3 million gain on derivative liability remeasurement. Interest expense decreased 48% to $9.6 million following debt repayment and conversion.
Heartflow operates as a single reportable segment, generating substantially all revenue from usage-driven fees from its Heartflow Platform, with Heartflow FFR CT Analysis contributing 98% of total revenue in 2025. Revenue case growth of 47% was the primary driver, with accounts expanding both in number and utilization. The product mix is shifting as Heartflow Plaque Analysis gains traction (limited market education began in H2 2023), but revenue contribution remains small. The clinic/office channel accounted for 32% of U.S. cases (up from 28% in 2024), reflecting a deliberate commercial push into lower-acuity settings, which exerts downward pressure on average selling prices but expands total addressable markets. No single customer exceeds 10% of revenue, limiting concentration risk. Future growth will depend on adoption of the broader CCTA+Heartflow pathway and the upcoming launches of Heartflow PCI Navigator (expected Q2 2026) and Plaque Tracker (2027).
Management expects to continue investing in R&D, including three randomized clinical trials in high-risk asymptomatic subpopulations beginning in H2 2026, which will increase operating expenses. Revenue growth is anticipated to continue, albeit with quarterly fluctuations from seasonality and account mix. Gross margin is expected to improve over the long term as AI further automates production, but near-term modulations will occur as the company hires and trains new staff. The IPO in August 2025 strengthened the balance sheet: cash and investments reached $280.2 million at year-end, with no outstanding debt. Management believes existing cash, together with future customer revenue, will fund operations for at least 12 months. Guidance on specific quantitative metrics was not provided; however, the company highlighted key strategic priorities: expanding account base, increasing utilization in existing accounts, commercializing new products, and driving AI efficiencies.
As of December 31, 2025, Heartflow reported $44.8M in cash and cash equivalents, $132.0M in short-term investments, and $103.4M in long-term investments, totaling $280.2M in liquidity. The company had no outstanding debt, following the full repayment of the $136.4M term loan in August 2025 and the conversion of $98.3M in convertible notes into common stock upon IPO. Shareholders' equity improved to $300.6M from a deficit of $859.5M a year earlier, primarily due to the IPO and conversion of preferred stock.
Heartflow had $5.2M in open purchase commitments for goods and services, expected to be fulfilled over the next four years. Additionally, the company has minimum royalty commitments of $50k annually under technology licensing agreements, totaling $0.3M through 2030 and beyond. The company also has operating lease obligations of $26.5M in undiscounted payments, with a present value of $22.1M.
No share buybacks or dividends were declared. Capital expenditures were $5.0M in 2025, representing 2.85% of revenue. The company completed its IPO in August 2025, raising net proceeds of $332.4M, which was used to repay debt and fund operations. There was no new debt issuance post-IPO.
Heartflow operates as a single reportable segment: non-invasive CAD detection solutions. Revenue for 2025 was $176.0M, up 39.9% from $125.8M in 2024. Geographic revenue breakdown: United States $162.7M (92.4%), Rest of World $13.3M (7.6%). The company's measure of segment profit is consolidated net loss, which was $116.8M in 2025.
Heartflow continues to incur significant net losses, with a $116.8 million loss in fiscal 2025 and an accumulated deficit of $1.1 billion. The company expects losses to persist as it invests heavily in R&D (37% of revenue) and commercialization. Revenue is almost entirely derived from a single product, Heartflow FFR CT Analysis (98% of total revenue), making the business highly vulnerable to any adverse changes in market adoption, reimbursement, or competition. The company's ability to achieve profitability is uncertain and depends on sustained revenue growth and cost control.
A major new risk is the DOJ investigation initiated in October 2025, which issued civil investigative demands under the Anti-Kickback Statute and False Claims Act, focusing on financial arrangements and sales practices. This could lead to significant penalties, exclusion from federal healthcare programs, and reputational damage. Additionally, the CMS proposed 2026 OPPS rule could reduce Medicare reimbursement for the APC covering Heartflow FFR CT Analysis by up to 15%, which would directly pressure revenue and adoption. Heartflow also faces ongoing regulatory risks related to FDA clearances for product modifications and new indications, as well as compliance with evolving AI regulations (e.g., Colorado AI Act) and data privacy laws (HIPAA, state laws).
Competition is intense from traditional non-invasive tests (SPECT, stress echo, PET) and emerging AI-based platforms (Cleerly, Elucid). Larger CT scanner manufacturers (Siemens, Philips, Canon) have the resources to develop competing integrated solutions or bundle products, potentially limiting Heartflow's market access. The commercialization of Heartflow Plaque Analysis is nascent, with minimal revenue so far, and its market acceptance is uncertain. Customer concentration is a concern: although no single customer accounts for more than 10% of revenue, decision-making is concentrated among a few large health systems, and loss of any could materially impact volumes and pricing.
Heartflow depends on AWS for cloud infrastructure; any prolonged outage could disrupt operations and damage customer trust. The company's AI models are critical but may contain bugs or produce errors, leading to misdiagnoses and liability. Cybersecurity risks are elevated given the handling of protected health information. The company's growth strategy requires scaling personnel and systems, but managing rapid expansion could strain resources and internal controls. International operations (8% of revenue) expose Heartflow to foreign regulatory, anti-corruption, and currency risks. Finally, intellectual property protection is uncertain, with patents potentially challenged or circumvented, and trade secrets at risk of exposure.
Overall, the risk factors paint a picture of a company facing severe financial strain, regulatory headwinds, and competitive threats, with the new DOJ investigation representing a particularly acute near-term concern.
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