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40 New Hospitals Join SynCardia's Certification Program to Implant Total Artificial Heart During Past Year


June 9, 2011 - Tucson, AZ

SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that during the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the world's only FDA, Health Canada and CE approved Total Artificial Heart.

SynCardia is currently certifying the company's first transplant centers in New York, Boston, Atlanta, Texas, Los Angeles and the Pacific Northwest, in addition to Great Britain, Lithuania and Israel.

"We are very excited to have renowned transplant centers adopt SynCardia's Total Artificial Heart technology, including Texas Children's Hospital, Brigham and Women's Hospital and Papworth Hospital," said Michael Garippa, CEO/President. "With the availability of the Freedom® portable driver, SynCardia's Total Artificial Heart is growing into the standard of care for patients dying from end-stage biventricular failure. We are working to bring the Total Artificial Heart to all major markets across the U.S. and the world."

Once currently enrolled hospitals complete the four-phase certification process, the number of U.S. SynCardia Certified Centers will double to 30, bringing the total number of centers worldwide to 70. In addition to the United States, there are currently SynCardia Certified Centers in Australia, Germany, France, Italy, Russia, Turkey, Austria and Canada.

The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. Weighing 13.5 pounds, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is intended to allow stable Total Artificial Heart patients to be discharged from the hospital to wait for a matching donor heart at home and in their communities.

CAUTION -- The Freedom® driver is an investigational device, limited by United States law to investigational use.

About the SynCardia Temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the Total is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. More than 900 implants account for more than 210 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular failure.

In March 2011, Fast Company magazine ranked SynCardia #20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients."

For additional information, please visit: http://www.syncardia.com or follow SynCardia on Twitter -- @SynCardia_News

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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Email Contact
Cell: (520) 955-0660

MarketWire

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