$29.17 +0.24 (+0.83%) As of 08/22/2025 04:00 PM Eastern
We have pioneered the use of software and AI to deliver a more accurate and clinically effective non-invasive solution for diagnosing and managing coronary artery disease (“CAD”), a leading cause of death worldwide. As of March 31, 2025, our Heartflow Platform has been used to assess CAD in more than 400,000 patients, including 132,000 in 2024 alone. We believe that we are the most widely adopted AI-powered test for CAD. Our novel 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”), a specialized type of scan that provides detailed images of the heart’s arteries. Our Heartflow Platform delivers actionable insights on blood flow, stenosis, plaque volume and plaque composition thereby overcoming the limitations of traditional non-invasive imaging tests which rely on indirect measures of coronary disease and lead to higher false negative and false positive rates, as demonstrated by our PRECISE trial. We believe the differentiated accuracy and clinical utility of our Heartflow Platform, along with its ability to enhance workflows, will continue to support our growth and advance the “CCTA + Heartflow” pathway as the definitive standard for the non-invasive diagnosis and management of CAD. Cardiovascular disease is the leading cause of death worldwide, with CAD being the most lethal form. CAD occurs when plaque—a buildup of cholesterol, fat, calcium and other substances—accumulates on the walls of the coronary arteries, restricting blood flow and increasing the risk of heart attack or stroke. This condition is responsible for half of all cardiovascular-related deaths globally. In the United States alone, the Centers for Disease Control (“CDC”) estimates that approximately 805,000 people suffer a heart attack each year. Despite significant advancements in therapeutic and interventional treatments, CAD remains a leading cause of death globally because healthcare systems generally lack scalable methods to efficiently detect, diagnose and quantify CAD at a personalized level. Based on our analyses using Clarivate’s ProcedureFinder data repository, we estimate that there were approximately 9.5 million non-invasive tests (“NITs”) in the United States in 2023 for patients experiencing stable or acute chest pain, which we refer to as symptomatic CAD patients. These NITs primarily include stress tests, such as single-photon emission computed tomography (“SPECT”), echocardiography and positron emission tomography (“PET”), which infer the presence of heart disease based on how well blood is supplied to the heart, and do not measure the actual disease itself. Accordingly, these tests have been shown to be unreliable and inconsistent. CCTA has emerged as a leading non-invasive imaging method for evaluating CAD, offering direct and detailed visualization of the coronary arteries. Unlike traditional stress-based NITs, CCTA enables physicians to identify the presence and extent of coronary blockage. As a result, CCTA has become the preferred first-line test for patients with suspected CAD, as evidenced by the AHA and ACC guidelines elevating CCTA to Class 1, Level A. However, while CCTA provides superior anatomical imaging, it does not independently quantify the severity of CAD, assess blood flow limitations, or characterize plaque composition—critical factors for determining the most appropriate, personalized course of treatment for a patient. Our Heartflow Platform builds upon the well established strengths of CCTA by going beyond its limitations and providing new quantified insights and compelling visualizations of data. By applying our advanced AI- powered technology to a single CCTA scan, we generate a precise, patient-specific analysis that quantifies blood flow, measures plaque burden, and characterizes plaque composition—at every point in the major coronary arteries. To date, we have developed three software products (with a fourth product expected to launch in 2026) under the Heartflow Platform that provide physicians with the critical insights needed to effectively diagnose and manage CAD: • Heartflow RoadMap Analysis offers a highly intuitive anatomic visualization of the coronary arteries, helping physicians quickly identify clinically relevant areas to focus their review. We provide Heartflow RoadMap Analysis to accounts as an integrated feature to enhance the efficiency of their CCTA program and it is not a stand-alone product. • Heartflow FFRCT Analysis calculates blood flow and pinpoints clinically significant CAD, which is CAD with a fractional flow reserve (“FFR”) value of 0.80 or below, at every point in the major coronary arteries. FFR measures the severity of blood flow restriction in the coronary arteries on a scale of 1.0 (no restriction) to 0.0 (complete blockage) by assessing pressure differences across a stenosis during induced stress, guiding decisions on whether a patient requires invasive revascularization. • Heartflow Plaque Analysis provides a comprehensive assessment of coronary plaque, enabling optimized medical treatment strategies. • Heartflow PCI Planner, which we expect to launch in 2026, will provide advanced visualization and clinical insights to optimize revascularization strategies, guide device selection, enhance procedural efficiency, and improve patient care. We plan to provide Heartflow PCI Planner to accounts as an integrated feature to enhance procedural efficiency, not as a stand-alone product. We believe we are the first and most widely-adopted AI-powered test for CAD. With over a decade of commercial presence, we have established a competitively differentiated data set of approximately 110 million annotated images, which is primarily sourced from our commercial relationships with customers, driving training and refinement of our algorithms for over 10 years and the ability to train new AI models for future products. We believe our Heartflow Platform delivers the following key benefits: • More accurate non-invasive test for CAD, clinically validated to provide superior assessment of blood flow, plaque volume and plaque characterization compared to traditional non-invasive methods. • More informed assessments, personalized care, and better risk stratification, positively impacting physician decisions on which patients should receive an intervention, supporting more efficient intervention planning and driving more personalized medical management. • Superior economic efficiency and enhanced interventional treatment planning, accurately identifying more patients who need interventional treatment while reducing unnecessary invasive procedures—significantly improving the efficiency of the catheterization lab and therefore hospital economics. • Proprietary, secure bi-directional data communication with customers that feeds a growing database of approximately 110 million annotated CCTA images that we leverage to improve the Heartflow Platform’s accuracy, automation and clinical utility and seamlessly deliver new features and workflow efficiencies to our customers. • Improved workflow through our Heartflow RoadMap Analysis that, as demonstrated in our SMART- CT study, reduces CCTA interpretation times by approximately 25% and reduces variability between reviewing physicians by approximately 40%, leading to more consistent diagnoses and standardized patient care. • Better patient and provider experience, by leveraging a single CCTA for all of our products, patients complete their test in approximately 20 minutes with significantly lower radiation exposure compared to nuclear imaging tests such as SPECT and PET that take multiple hours and require radioactive tracers to be injected into the bloodstream. By providing a definitive diagnosis upfront, the Heartflow Platform eliminates the need for layered testing, streamlining the patient journey and reducing anxiety associated with uncertain or inconclusive results. We estimate our current market opportunity in the United States for our Heartflow FFRCT Analysis and Heartflow Plaque Analysis is approximately $5 billion. Based on our analyses using Clarivate’s ProcedureFinder data repository, we estimate that approximately 9.5 million unique stable chest pain patients receive NITs in the United States annually. In addition, based on our FORECAST randomized trial, we further estimate that 33% of patients have stenosis levels between 40% and 90%, which results in approximately 2.8 million patients eligible for our Heartflow FFRCT Analysis in the stable setting. Based on the Martin paper, where there were approximately 577,000 hospital discharges in the United States in 2020 due to a principal diagnosis of acute chest pain, and the Bhatt paper, where No ST Elevation (“NSTE”) related acute chest pain accounted for approximately 70% of acute chest pain, we further estimate that the annual incidence of patients who have acute chest pain with NSTE is approximately 0.4 million patients. Of these approximately 0.4 million patients, we estimate based on the Kofoed paper that approximately 70% have obstructive disease and are eligible for our Heartflow FFRCT Analysis, which results in approximately 0.3 million acute chest pain patients eligible for our Heartflow FFRCT Analysis. Therefore, we believe there is a market opportunity of approximately 3.1 million patients eligible for our Heartflow FFRCT Analysis, which, at a U.S. average sales price of $1,067, translates to an estimated market opportunity of approximately $3.3 billion in the United States. In addition, we believe our Heartflow Plaque Analysis is applicable to approximately 60% of those 9.5 million NIT patients annually and the majority of patients experiencing acute chest pain. Based on our PROMISE trial and the Hoffmann paper, we estimate that approximately 60% of CCTA patients have plaque and are eligible for plaque analysis, which translates to approximately 5.1 million patients eligible for our Heartflow Plaque Analysis in a stable setting. Based on our internal analysis and the findings in the Wang paper, where less than 5% of patients were expected to be contraindicated for CCTA, we also estimate that all of the approximately 0.4 million patients with acute chest pain with NSTE referred to above will be eligible for our Heartflow Plaque Analysis. Therefore, we believe there is a market opportunity of approximately 5.5 million patients eligible for our Heartflow Plaque Analysis, which, at an estimated U.S. sales price of $300, translates to an estimated market opportunity of approximately an incremental $1.7 billion in the United States. Beyond the commercialization of Heartflow FFRCT Analysis and Heartflow Plaque Analysis in symptomatic CAD, we see a significant market opportunity for our technologies in at-risk individuals who show no symptoms, a segment comprised of approximately 200 million people globally, based on data from the U.S. Census Bureau, CDC, Eurostat, United Kingdom Office of National Statistics, the Yang paper and the MacDonald paper. To unlock this potential, we are continuing to evaluate new product opportunities and appropriate clinical evidence supporting eventual regulatory approval, payor coverage and commercialization. We believe the Heartflow Platform is the most extensively studied AI-enabled test for CAD. Our belief is grounded in our analysis, including that the Heartflow Platform and its accuracy, clinical utility and economic benefits have been evaluated in over 100 clinical studies and more than 130,000 patients, including our PRECISE and FORECAST trials, each a large randomized controlled trial, with results published in over 600 peer-reviewed clinical publications. Our studies, including the PRECISE, NXT and PACIFIC trials, have consistently demonstrated that the Heartflow Platform is more accurate than traditional non-invasive tests and highly concordant to invasive testing, reduces unnecessary invasive testing, and enables physicians to optimize treatment and ultimately provide more efficient care. We have developed a highly scalable, capital efficient commercial model that combines Territory Sales Managers (“TSMs”) who drive new account adoption with Territory Account Managers (“TAMs”) who focus on increasing utilization by educating referring physicians. Our commercial team does not cover cases or otherwise spend time in an operating room or lab setting, which enables them to focus solely on driving commercial adoption and educational activities. Our technology is simple and intuitive and does not require the purchase of any capital equipment. Our onboarding process seamlessly integrates the Heartflow Platform into the customer’s daily workflow. These unique attributes of our business model afford our commercial organization a differentiated level of efficiency and scalability. Current clinical guidelines strongly support the adoption of the Heartflow Platform. The CCTA + Heartflow FFRCT Analysis pathway is supported by the American Heart Association (“AHA”) and American College of Cardiology (“ACC”) guidelines, with CCTA identified as a Class 1, Level A test and Heartflow FFRCT Analysis identified as a Class 2a, Level B test for the diagnosis of CAD in certain patients with stable or acute chest pain and no known CAD. The AHA and ACC guidelines utilize Classes and Levels to indicate the strength of a recommendation and the quality of supporting evidence, respectively. Class 1 represents the strongest recommendation, followed by Class 2a, which represents a moderate recommendation. Similarly, Level A signifies the highest quality of evidence, while Level B indicates moderate quality. We believe current reimbursement policies support the adoption of the Heartflow Platform. Our Heartflow FFRCT Analysis is reimbursed under a dedicated Category I Current Procedural Terminology (“CPT”) code, effective as of January 1, 2024, and has established coverage policies representing approximately 99% of covered lives in the United States. A Category I CPT code was recently established for Heartflow Plaque Analysis. It will go into effect on January 1, 2026, and is covered by all seven Medicare administrative contractor (“MACs”). A Category I CPT code designates a procedure or service that uses device(s) with Food and Drug Administration (“FDA”) clearance or approval (when required), is performed by many physicians across the United States for its intended clinical use, aligns with current medical practice,and has documented efficacy in literature. The Category I CPT status for our Heartflow FFRCT Analysis and Heartflow Plaque Analysis validates their widespread use and distinguish them from emerging technologies that are assigned Category III CPT codes. We primarily generate revenue on a “pay-per-click” basis each time a physician chooses to review either our Heartflow FFRCT Analysis, Heartflow Plaque Analysis, or both. Heartflow FFRCT Analysis has served as our commercial foundation, representing 99% of our total revenue as of March 31, 2025. In the second half of 2023, we initiated limited market education efforts for Heartflow Plaque Analysis, our second commercial product. Our Heartflow RoadMap Analysis is generally provided as a workflow efficiency tool to drive customer retention and loyalty and is not a stand-alone product. We expect to launch our next product, Heartflow PCI Planner, in 2026 as an integrated feature to enhance procedural efficiency, not as a stand-alone product. We were incorporated under the laws of the State of Delaware in 2007. On March 1, 2021, we completed an internal reorganization in which a newly formed parent holding company was put in place. Our operations and business activities remained at HeartFlow, Inc., and the wholly-owned non-U.S. subsidiaries of HeartFlow, Inc. remained in place. On July 17, 2025, we consolidated HeartFlow Holding, Inc. into HeartFlow, Inc. In connection with this consolidation, we changed our name to Heartflow, Inc., whose name appears on the cover of this prospectus. Our principal executive offices are located in Mountain View, California.
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