MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up

ORLANDO, Florida - EVEREST High-Risk Registry Data Shows Improved Symptomatic Status and
Cardiac Function in Functional MR Patients Treated with the MitraClip(R)
System

Percutaneous mitral valve repair using the MitraClip(R) system in
symptomatic high-risk surgical patients with functional mitral regurgitation
(FMR) improves patient clinical status, and left ventricular function,
according to 12-month data from the high-risk registry arm of the EVEREST II
(Endovascular Valve Edge-to-Edge REpair STudy) study presented today at the
58th Annual Scientific Session of the American College of Cardiology (ACC) i2
Summit Scientific Sessions.

As the most common type of heart valve disease, MR affects more than four
million people in the United States, the majority of which have FMR. There
are 250,000 new diagnoses of significant MR each year; however only 20
percent, or approximately 50,000, of these patients undergo surgery each
year. Many higher risk surgical patients and non-surgical patients continue
to be affected by the chronic volume overload caused by MR, which requires
the heart to work harder, and may ultimately lead to heart failure.

The data were presented today by Ted Feldman, M.D., director of the
cardiac catheterization lab at Evanston North Shore Hospital and co-principal
investigator of the EVEREST trials.

“The high-risk registry data in the functional MR patients demonstrate
that these patients benefit substantially from the MitraClip(R) therapy,”
said Dr. Feldman. “By expanding the options available to these patients,
clinical practice will change for the better when this therapy is available
in the U.S.”

Patients considered at high-risk for surgery are those with increased
likelihood of mortality following surgery, usually because of advanced age
and co-morbidities, which limit their treatment options. Without MR
reduction, these symptomatic patients have a poor quality of life, are
frequently hospitalized for heart failure and have reduced survival.

The FMR high-risk registry cohort was composed of 46 symptomatic patients
with grade 3 or 4 MR and at least a 12 percent predicted risk of surgical
mortality. Mortality risk was determined by either the Society of Thoracic
Surgery Mortality Risk Model, or by a cardiac surgeon’s determination that
one or more specifically defined risk factors resulted in a predicted
mortality risk of at least 12 percent. The average age was 73 years and most
patients had several co-morbidities.

At 12 months, 73 percent of patients with matched data were in NYHA
functional class I or II, compared to only 9 percent at baseline. This
improvement in functional class was accompanied by improved LV function. The
rate of hospitalization for heart failure in the year after treatment with
the MitraClip(R) system was significantly (p=0.02) lower than the rate in the
year prior to treatment.

“This data from the high-risk registry provides important new information
for clinicians in both the US and Europe as they consider treatment with the
MitraClip(R) therapy for high risk patients with severe MR,” said Ferolyn
Powell, president and chief executive officer of Evalve. “This new data
illustrates the benefit the MitraClip(R) therapy provides to those patients
who are not good candidates for surgery. It also adds to the evidence
demonstrating the benefit of the MitraClip(R) therapy for patients with
Functional MR who currently often have limited surgical options. The observed
decrease in hospitalization for heart failure in this population could have
an important health-economic impact.”

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve’s MitraClip(R) device is performed
by physicians in the catheterization laboratory. The heart beats normally
during the procedure, and therefore does not require a heart-lung bypass
machine. In addition to improving blood flow through the heart, the procedure
may also relieve symptoms such as fatigue and shortness of breath that often
affect patients with significant MR. After treatment, patients generally
recover quickly. The MitraClip(R) device may improve quality of life and may
help MR patients avoid or delay surgery, having preserved surgical options
(valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc., headquartered in Menlo Park, Calif., has
developed a proprietary system which enables percutaneous repair of cardiac
valves. The company’s initial products are intended to reduce the risks,
trauma and costs associated with current open, arrested heart surgical
options. For more information about Evalve, Inc., and for an animated
explanation of the procedure using the MitraClip(R) device, visit
www.evalveinc.com. Evalve is the first portfolio company from the medical
device company incubator, The Foundry (www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in
the United States and Canada. Enrollment is ongoing in the REALISM study
which allows EVEREST investigators and their patients continued access to the
MitraClip(R) therapy. The MitraClip(R) system is available for commercial
distribution in the EU.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

Media Contact:
Lisa Waters
Edelman
+1-323-202-1051
Lisa.Waters@edelman.com

Source: Evalve, Inc.

Lisa Waters of Edelman, +1-323-202-1051, Lisa.Waters at edelman.com, for Evalve, Inc.