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HeartFlow Planner is now FDA Cleared! Learn more about this exciting milestone here.

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HeartFlow Introduces Next Generation Platform

June 23, 2016

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REDWOOD CITY, Calif. - June 23, 2016 - HeartFlow, Inc., a personalized medical technology company seeking to transform the way cardiovascular disease is diagnosed and treated, announced today that it is launching its next generation of the HeartFlow® FFRct Analysis. The result of years of development, the next generation platform includes major advancements in the process and algorithms HeartFlow uses to calculate FFRct values.

These technology advancements resulted in the second FDA clearance for HeartFlow’s technology. The company will introduce the next generation platform to new and existing customers in the coming weeks. Major enhancements of the new platform include:

  • Advanced algorithms and streamlined case processing, which will provide the HeartFlow Analysis results to clinicians more quickly;
  • Cloud-based infrastructure utilizing Amazon Web Services (AWS), to ensure that delivery of the HeartFlow service is more secure, robust and scalable; and
  • Increased security measures to address the needs of healthcare institutions worldwide.

“This is a major milestone for HeartFlow and a crucial advancement as we see increasing adoption of the HeartFlow Analysis around the world,” said John H. Stevens, M.D., chairman and CEO of HeartFlow. “With this next generation platform, HeartFlow will be able to deliver results more quickly and securely to the growing number of physicians using the HeartFlow Analysis to aid in the diagnosis of coronary artery disease.”

The HeartFlow Analysis is the only non-invasive technology to provide insight into both the extent of coronary artery disease and the impact that disease has on blood flow to the heart, enabling clinicians to select an appropriate treatment. The technology, which first received de novo clearance from the FDA in 2014, is also available in Canada, Europe and Japan, and has been used to guide the treatment of thousands of patients globally.

“One of the benefits of HeartFlow’s cloud-based platform is that the technology utilizes the data we receive from our global community of clinicians,” said Charles A. Taylor, Ph.D., co-founder and chief technology officer of HeartFlow. “As the number of HeartFlow patients grows, the HeartFlow Analysis continues to improve as we apply deep learning technology to this vast set of data.”

Deep learning involves integrating multiple layers of nonlinear algorithms to help identify patterns and improve understanding of the information. By applying deep learning to large amounts of image data, HeartFlow has the potential to improve the performance with future software releases to help physicians better manage patients with coronary artery disease.

About HeartFlow, Inc.

HeartFlow, Inc. is a personalized medical technology company seeking to transform the way cardiovascular disease is diagnosed and treated. The company’s HeartFlow FFRct Analysis is the first available non-invasive solution that enables a physician to more accurately evaluate whether a patient has significant coronary artery disease (CAD) based on both anatomy and physiology. The solution, which produces a detailed summary of flow dynamics and model of the patient’s coronary arteries, is well positioned to become an integral part of the standard of care for patients who are at risk for CAD because of its potential to improve clinical outcomes, improve the patient experience and reduce the cost of care. The HeartFlow Analysis is available in the United States, Canada, Europe and Japan. For more information visit www.heartflow.com.

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