EVEREST Data Demonstrates Acute Reduction of Mitral Regurgitation Without Procedural Mortality in Patients Treated With the MitraClip(R) Therapy

MENLO PARK, California -

- Durability Observed in Both Functional and Degenerative MR Patient Populations

Data published today in the Journal of the American College of Cardiology (JACC) indicates that percutaneous valve repair with the MitraClip(R) therapy can reduce acute mitral regurgitation (MR) with sustained freedom from death, surgery or recurrent MR in a substantial proportion of functional and degenerative MR patients.

The published data is from the initial cohort of 107 registry patients treated in the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) trial, sponsored by Evalve, Inc.

Seventy-four percent of patients achieved MR reduction to 2+ or less after receiving the MitraClip(R) device. In 64 percent of these, MR reduction to 1+ was achieved. Additionally, there were no cases of clip embolization or procedural mortality. Kaplan-Meier freedom from surgery was 88.5 percent, 83.2 percent and 76.3 percent at 1, 2 and 3 years, respectively. Whereas prior to the MitraClip(R) procedure 100 percent of patients were indicated for surgery.

The MitraClip(R) system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of MR. The MitraClip(R) system is currently in late stage clinical trials in the United States and is available commercially in Europe.

MR is the most common type of heart valve insufficiency in Europe and the United States, and affects millions of people worldwide. Significant MR affects more than eight million people in the U.S. and Europe the majority of which have functional MR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the U.S.; however only 20 percent 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.

“We have seen procedural success in the majority of patients treated with the MitraClip(R) system,” said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston North Shore Hospital, co-principal investigator of the EVEREST trial and lead author of the JACC manuscript. “The results we’ve seen expand the range of options available to patients affected by MR, especially for people who are not good candidates for surgery or who want to avoid the risks of a surgical procedure.”

The study population included 107 registry patients with moderate-to-severe (grade 3+) or severe (grade 4+) MR who were candidates for mitral valve surgery. Of these patients, 79 percent had degenerative MR and 21 percent had functional MR. Among patients with functional MR, 74 percent had a history of coronary artery disease and 43 percent had prior bypass surgery.

At baseline, patients either presented with symptoms or when without symptoms, they had compromised left ventricular (LV) function, as defined by an ejection fraction less than 60 percent or a systolic ventricular size greater than 40 mm.

Transthoracic echocardiography was performed at baseline, pre-discharge, and at one, six, twelve months, and yearly thereafter up to five years. The data was analyzed by an independent echocardiographic core laboratory at the University of California, San Francisco under the direction of Elyse Foster, M.D.

“These data, along with experience in the REALISM continued access study in the U.S. and the commercial experience in Europe, continue to build a strong body of evidence in support of establishing the MitraClip(R) therapy as a viable option for select patients with functional or degenerative MR,” said Ferolyn Powell, president and chief executive officer of Evalve. “We have seen excellent safety and notable procedural success with the therapy and are encouraged by both the level and durability of MR reduction achieved by the MitraClip procedure. We believe the MitraClip(R) therapy has the potential to provide both a meaningful clinical benefit to patients and a substantial health economic benefit to healthcare systems worldwide.”

About the MitraClip(R) Procedure

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 in the US, which allows EVEREST investigators and their patients continued access to the MitraClip(R) therapy during the PMA phase. The MitraClip(R) system is commercially distributed in Europe.

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

Source: Evalve, Inc.

Amy Hytowitz of Edelman, +1-323-202-1028, amy.hytowitz at edelman.com, for Evalve, Inc.