Market Overview

HeartFlow Analysis Enables Physicians to Confidently and Safely Differentiate Patients in Need of Invasive Treatment and Patients Who Can be Managed Medically for Coronary Artery Disease


Global Studies of Over 8,500 Patients Demonstrate Marked Improvement
in Outcomes When Physicians Utilize the HeartFlow Analysis in Diagnosis
and Treatment

Late-breaking data published and presented today confirm that the
non-invasive HeartFlow® FFRct Analysis enables physicians to
effectively differentiate patients in need of coronary stenting or
bypass surgery from those who can be managed with medications alone.

This press release features multimedia. View the full release here:

HeartFlow 3D Model (Graphic: Business Wire)

HeartFlow 3D Model (Graphic: Business Wire)

The ADVANCE Registry was published in the European Heart Journal
and the Aarhus University Hospital experience was published in
the Journal of the American College of Cardiology (JACC). Both
studies were presented during the late-breaking science session today at
the European Society of Cardiology (ESC) conference.

In these studies, the HeartFlow Analysis changed physician management of
patients and enabled physicians to determine more efficiently which
patients required invasive management and which did not. The HeartFlow
Analysis identified a set of patients at very low risk of adverse
outcomes when undergoing medical therapy, and a set whose risk was
reduced when undergoing invasive management.

The ADVANCE Registry included more than 5,000 patients in the U.S.,
Japan, Europe and Canada. The Aarhus University Hospital experience
included more than 3,600 patients in Denmark who were followed for an
average of two years.

"These studies confirm the role of the HeartFlow Analysis in identifying
disease that other tests may miss, and in providing reassurance to
patients and doctors that some blockages are not in need of invasive
management," said Campbell Rogers, MD, FACC, chief medical officer,

Identifying the Right Treatment for Each Patient

The HeartFlow Analysis provides FFRct values along the coronary
arteries, helping physicians to assess the impact of a blockage on blood
flow. A positive FFRct value ( ≤0.80) indicates that a coronary blockage
is impeding blood flow to the heart muscle. In both studies, patients
underwent a coronary computed tomography angiogram (CTA), and when
additional information was needed, a HeartFlow Analysis 3D digital model
was then used to help determine optimal management.

In the ADVANCE Registry, the added information contained in the
HeartFlow Analysis led physicians to reconsider and change management
plans for two-thirds of their patients. Some who were originally
scheduled to receive a coronary stent or bypass operation were safely
able to avoid the procedure and be treated with medications alone, while
others who would have received medications were redirected to stenting
or bypass surgery.

In the Aarhus University Hospital experience, physicians were able
confidently and safely to differentiate higher risk patients who
required additional testing, stenting or bypass surgery from patients
whose treatment required only medications.

In both studies, coronary narrowings associated with negative FFRct
values ( >0.80) were predominantly managed with medications alone and
were associated with excellent outcomes, similar to those outcomes in
patients who had no or minimal narrowings.

Enabling Treatment Decisions that Lead to Safer Outcomes

In both studies, the HeartFlow Analysis helped physicians identify
patients who could be treated safely without invasive testing or
treatment. In the ADVANCE Registry, among more than 1,500 patients with
a negative FFRct value, the vast majority received medical therapy
without invasive testing or treatment, and none experienced adverse

In contrast, when the HeartFlow Analysis showed a positive FFRct value,
it helped physicians identify patients who were at higher risk for
death, heart attack or emergency stenting or bypass, and who would
likely benefit from invasive management. In the Aarhus University
Hospital experience, patients with a positive FFRct value who received
medical therapy alone suffered heart attacks at a rate six times higher
than that seen among patients who received a stent or underwent bypass
surgery. In the ADVANCE study, patients with positive FFRct values were
at 20-fold higher risk compared to those with negative FFRct values.

"The HeartFlow Analysis is a tool that helps me more effectively develop
treatment plans with greater confidence for my CAD patients," said
Timothy Fairbairn, MBChB, FRCP, PhD, consultant cardiologist, Liverpool
Heart and Chest Hospital and first author of the ADVANCE registry paper.
"Being able to use a non-invasive cardiac test to clearly differentiate
which of my patients need invasive procedures or are most at-risk for
adverse events is instrumental in my ability to provide them with the
best care."

About the HeartFlow FFRct Analysis

Clinicians diagnosing someone with suspected coronary artery disease
(CAD) want to know as definitively as possible if the individual has a
significant blockage in their coronary arteries. They also want to know
the impact of that blockage on blood flow so they can best determine
which treatment pathway is appropriate (e.g., medical management,
stenting or coronary artery bypass grafting).

Data from a patient's non-invasive coronary CTA are securely uploaded
from the hospital's system to HeartFlow's software application running
in the AWS cloud. HeartFlow leverages deep learning 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 20,000 patients to aid in the diagnosis of heart disease.

The HeartFlow Analysis provides the highest diagnostic performance
compared to other commonly available testsand is able
to help physicians identify CAD often missed by other tests. The
technology also has demonstrated a reduction in unnecessary tests, such
as an invasive diagnostic coronary angiogram2, which
can be associated with bleeding, stroke, major blood vessel damage and
other serious complications. It also significantly reduces healthcare
costs for hospitals.3

About HeartFlow, Inc.

HeartFlow, Inc. is a medical technology company transforming the way
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. For more
information, visit

1 Driessen, et al. Presented at EuroPCR 2018. Nørgaard et al,
Euro Radiology 2015; 25(8):2282-90
2 Douglas et al.
PLATFORM Trial. Eur Heart J. 2015;36(47):3359-67
Douglas PS, DeBruyne B, Pontone G., Patel MR, et al. One-year outcomes
of FFRct-guided care in patients with suspected coronary disease: The
PLATFORM Study. J Am Coll Cardiol. 2016;68(5),435-45.

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