Heartflow, Inc. (NASDAQ: HTFL)

Heartflow, Inc. is a medical technology company that has pioneered the use of software and artificial intelligence to deliver a non-invasive solution for diagnosing and managing coronary artery disease. The company's core activities involve leveraging AI and computational fluid dynamics to create a personalized 3D model of a patient's heart from a single coronary computed tomography angiography scan. This platform provides actionable insights on blood flow, stenosis, plaque volume, and plaque composition to support clinical decision-making in cardiovascular care.

Heartflow, Inc. generates revenue primarily on a pay-per-click basis each time a physician reviews either the Heartflow FFR CT Analysis, Heartflow Plaque Analysis, or both products. The company's flagship product, Heartflow FFR CT Analysis, represented 99% of total revenue as of March 31, 2025. Revenue is derived from commercial relationships with healthcare providers who utilize the platform to enhance diagnostic accuracy and workflow efficiency in the assessment of coronary artery disease.

The company operates through the following segments:

• Heartflow FFR CT Analysis calculates blood flow and identifies clinically significant coronary artery disease at every point in the major coronary arteries using fractional flow reserve values. This product serves as the commercial foundation of the business and is reimbursed under a dedicated Category I CPT code effective January 1, 2024.

• Heartflow Plaque Analysis provides a comprehensive assessment of coronary plaque to enable optimized medical treatment strategies. This product quantifies plaque volume and composition down to the cubic millimeter and is supported by a Category I CPT code effective January 1, 2026.

• Heartflow RoadMap Analysis offers an intuitive anatomic visualization of the coronary arteries to help physicians identify clinically relevant areas for review. This product is provided as an integrated feature to enhance the efficiency of CCTA programs and is not a stand-alone product.

• Heartflow PCI Planner is expected to launch in 2026 and will provide advanced visualization and clinical insights to optimize revascularization strategies. This product will be provided as an integrated feature to enhance procedural efficiency and is not intended as a stand-alone product.

Heartflow, Inc. holds a leading position as the most widely adopted AI-powered test for coronary artery disease, with over 400,000 patients assessed using its platform as of March 31, 2025. The company benefits from a proprietary database of approximately 110 million annotated CCTA images sourced from commercial relationships, which fuels ongoing AI algorithm refinement. Its competitive advantages include strong reimbursement coverage with Category I CPT codes, extensive clinical validation across over 100 studies and 130,000 patients, and a scalable cloud-based model that integrates seamlessly into physician workflows without requiring capital equipment purchases.

Heartflow, Inc. serves hospitals, outpatient facilities, physician offices, and imaging centers in the United States and select international markets including the United Kingdom, European Union, Australia, Canada, and Japan. The company's installed base includes more than 1,100 accounts in the United States as of December 31, 2024, encompassing leading academic institutions, integrated delivery networks, and outpatient imaging centers.