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HeartFlow Announces FDA Clearance for HeartFlow Planner

September 12, 2019

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Sep 12, 2019--

HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review cases with colleagues, and ensure everyone has a clear picture of the initial treatment plan.

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“With the HeartFlow Planner, I am able to run multiple treatment scenarios in my office prior to the procedure which enables me to plan ahead about the resources I will need in the catheterization lab,” said Dr. Mark J. Goodwin, interventional cardiologist, Advocate Health Midwest Heart Specialists and system director, Cardiac Innovations & Structural Heart Center ®, Edward-Elmhurst Health. “HeartFlow Planner is an intuitive consulting tool I can use to discuss cases with the entire heart team to ensure the team is prepared and engaged.”

“The information provided by the HeartFlow technology is powerful and will not only help us efficiently diagnose coronary artery disease but help us better understand different treatment options,” said Dr. Victor Marinescu, cardiologist, Advocate Health Midwest Heart Specialists and member of the medical staff, Edward-Elmhurst Health. “The visual nature of the HeartFlow Planner also makes it a great tool to explain to patients what will happen during their procedure.”

The HeartFlow Planner is a pre-procedure planning tool that is based on an idealized model of the HeartFlow Analysis, a color-coded 3D model of a patient’s coronary arteries. Physicians can use this model to identify blockages and explore multiple treatment scenarios by virtually modifying the vessel. HeartFlow Planner will enable physicians to understand the impact of each modeled treatment strategy in real time.

“As part of the company’s commitment to improve the standard of care for patients with coronary artery disease, the FDA clearance of HeartFlow Planner represents a major milestone in ensuring more physicians have access to our innovative healthcare solution,” said Dana G. Mead, Jr., President and Chief Executive Officer, HeartFlow. “We look forward to introducing the HeartFlow Planner to the interventional cardiology community and continuing to change the way coronary artery disease is diagnosed and treated.”

HeartFlow will be showcasing the HeartFlow Planner at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place in San Francisco, September 25-29, Booth # 2343.

About the HeartFlow FFRct Analysis and HeartFlow Planner

Data from a patient’s non-invasive coronary computed tomography angiogram (CTA) are securely uploaded from the hospital’s system to HeartFlow’s software application running in the AWS cloud. HeartFlow leverages deep learning and highly trained analysts to create a personalized, digital 3D model of the patient’s coronary arteries. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. The HeartFlow Analysis is provided via a secure online interface to offer actionable information to enable clinicians to determine the optimal course of treatment. To date, clinicians around the world have used the HeartFlow Analysis for more than 40,000 patients to aid in the diagnosis of heart disease.

The HeartFlow Planner utilizes an idealized coronary anatomy model and physiology simulation created from the HeartFlow Analysis. Physicians are able to identify stenoses and virtually modify the vessel. For each treatment scenario, HeartFlow Planner will display the modified FFRct values in real time to enable physicians to understand the impact of the modeled treatment strategy. Common scenarios for using HeartFlow Planner include focal stenoses, serial stenoses, and borderline cases. HeartFlow Planner is only available on iOS platforms in the United States.

About HeartFlow, Inc.

HeartFlow, Inc. is a digital health company uniquely positioned at the intersection of advanced artificial intelligence and healthcare to transform how heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. The HeartFlow Planner is commercially available in the United States only. For more information, visit www.heartflow.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190912005216/en/

CONTACT: Jennie Kim

jekim@heartflow.com

415-793-7686

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: FDA MOBILE/WIRELESS TECHNOLOGY HEALTH MEDICAL DEVICES SOFTWARE HOSPITALS INTERNET DATA MANAGEMENT CARDIOLOGY

SOURCE: HeartFlow, Inc.

Copyright Business Wire 2019.

PUB: 09/12/2019 10:00 AM/DISC: 09/12/2019 10:01 AM

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