HeartFlow Company Profile

Background

HeartFlow, Inc., headquartered in Mountain View, California, is a pioneering medical technology company dedicated to transforming precision heart care. The company's mission is to revolutionize the diagnosis and treatment of coronary artery disease (CAD) by providing non-invasive, AI-driven solutions that enhance patient outcomes and streamline clinical workflows. HeartFlow's flagship product, the HeartFlow® FFRCT Analysis, exemplifies this commitment by offering clinicians a detailed, personalized assessment of coronary blood flow, thereby facilitating more accurate and efficient treatment decisions.

Key Strategic Focus

HeartFlow's strategic objectives center on:

• Advancing Non-Invasive Diagnostics: Developing and commercializing AI-enabled, non-invasive diagnostic tools that provide comprehensive insights into coronary anatomy and physiology.

• Expanding Product Portfolio: Introducing innovative products such as the RoadMap™ analysis for coronary anatomy and Plaque analysis for plaque characterization, thereby offering a holistic approach to CAD assessment.

• Enhancing Market Penetration: Increasing adoption of its technologies across global healthcare systems, with a focus on integrating into existing clinical workflows to improve patient care.

• Building Clinical Evidence: Conducting robust clinical studies to validate the efficacy and safety of its products, thereby strengthening their acceptance and utilization in the medical community.

Financials and Funding

HeartFlow has secured substantial funding to support its growth and innovation initiatives:

• Series F Funding (April 2023): Raised $215 million, led by Bain Capital Life Sciences, with participation from Janus Henderson Investors and existing investors including Baillie Gifford, Capricorn Investment Group, Hayfin Capital Management, HealthCor, Martis Capital, USVP, and Wellington Management. This funding aims to scale commercial operations, support clinical evidence generation, and advance the product portfolio.

• Series E Funding (February 2018): Secured $240 million to accelerate commercial expansion and technological innovation.

These investments underscore strong investor confidence in HeartFlow's vision and technological capabilities.

Pipeline Development

HeartFlow's product pipeline includes:

• HeartFlow® FFRCT Analysis: A non-invasive diagnostic tool that creates a personalized 3D model of the coronary arteries to assess the impact of blockages on blood flow.

• RoadMap™ Analysis: Provides detailed anatomical mapping of coronary arteries to aid in the visualization and assessment of stenosis.

• Plaque Analysis: Offers insights into plaque composition and volume, assisting clinicians in evaluating the risk of adverse cardiac events.

These products are designed to work synergistically, offering a comprehensive suite for CAD diagnosis and management.

Technological Platform and Innovation

HeartFlow distinguishes itself through its proprietary technologies and innovative methodologies:

• AI-Driven 3D Modeling: Utilizes advanced artificial intelligence to construct detailed, patient-specific 3D models of coronary arteries from standard coronary computed tomography angiography (CCTA) scans.

• Computational Fluid Dynamics: Applies sophisticated algorithms to simulate blood flow and assess the physiological impact of arterial blockages, providing functional information without invasive procedures.

• Integrated Diagnostic Suite: Combines anatomical, physiological, and plaque analyses to deliver a holistic view of coronary health, enhancing diagnostic accuracy and treatment planning.

These innovations have been validated in over 600 peer-reviewed publications, demonstrating their clinical efficacy and impact.

Leadership Team

HeartFlow's leadership comprises seasoned professionals with extensive experience in healthcare and technology:

• John Farquhar: President, Chief Executive Officer, and Board Member. Formerly Vice President and General Manager of the Aortic business at Medtronic, with a background in strategic oversight and operational excellence.

• Tim Fonte: Chief Technology Officer. Joined HeartFlow in 2010, leading product and technology development, with prior experience at Cameron Health and expertise in healthcare innovation.

• Stephanie Heller: Chief Human Resources Officer. Brings HR leadership experience from organizations like Edwards Lifesciences, Johnson & Johnson, and Allergan, focusing on talent development and organizational growth.

• Campbell Rogers, M.D., F.A.C.C.: Executive Vice President and Chief Medical Officer. Former Chief Scientific Officer at Cordis Corporation, with a background in cardiovascular research and clinical practice.

• Vikram Verghese: Chief Financial Officer. Experience in strategy, business development, and marketing at Verily Life Sciences and Medtronic, with a focus on financial management and growth strategies.

• Angela Ahmad: Chief Legal & Compliance Officer. Over 25 years of legal and compliance experience, including roles at Inari Medical, Inc., CoreLogic, and leading law firms.

• Shivanth Bhaskaran: Senior Vice President, Marketing, International Sales & Customer Success. Background in global commercial leadership and strategy at Medtronic, focusing on market expansion and customer engagement.

• Kathleen Carey: Senior Vice President, Operations. Expertise in process improvement and operational excellence, with leadership roles at Alto Pharmacy, Cardinal Health, and Medtronic.

• Nathan Chan: Senior Vice President, US Sales. Extensive experience in healthcare sales and clinical leadership, including roles at Medtronic.

• Cara Santillo: Senior Vice President, Market Access and Reimbursement. Over 15 years of experience in market access strategy, with prior roles at Elekta and Bayer Healthcare.

This team collectively drives HeartFlow's mission to innovate and lead in precision heart care.

Leadership Changes

In March 2022, John Farquhar was appointed CEO, succeeding John H. Stevens, M.D., who transitioned to Vice Chair of the Board of Directors.

Competitor Profile

Market Insights and Dynamics

The global cardiovascular devices market is projected to grow from $45 billion in 2022 to approximately $61 billion by 2027, reflecting a compound annual growth rate (CAGR) of 6.4%. This growth is driven by increasing prevalence of cardiovascular diseases.