Press Release:

TUCSON, Ariz. – Oct. 20, 2005 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, today recognizes the one year milestone of the FDA approval of its CardioWest™ temporary Total Artificial Heart (TAH-t). The CardioWest™ TAH-t is the only FDA approved device capable of providing full circulatory restoration in morbidly ill patients with irreversible bi-ventricular failure, ultimately bridging them to transplantation when a donor heart becomes available.

“This has been a tremendous year for SynCardia, as the CardioWest™ TAH-t continues to be implemented in transplant centers across the country, saving lives of critically ill patients with end-stage congestive heart failure. Several new centers, beyond the institutions that previously participated in the pivotal U.S. multi-center trial, have adopted this critical technology, including The Cleveland Clinic where four patients have been implanted with the device,” said Marvin J. Slepian MD, Founder and Chairman of the Board of SynCardia. “In addition, we continue to make progress in developing smaller, more portable driver technology which powers our device, enabling patients to be increasingly mobile with this system. In Europe, more than 14 patients have been discharged from transplant centers and are at home with our system and a smaller driver, and two patients have had the TAH-t implanted as a permanent cardiac replacement or ‘destination therapy.’”

Dr. Slepian adds, “We continue to make our CardioWest™ TAH-t available to major cardiac transplant centers in the U.S. and abroad and are excited to continue to move forward with the next phase of development.”

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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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660