Press Release:

The Freedom™ driver is designed to allow stable Total Artificial Heart patients to enjoy life at home and in their community while they wait for a matching donor heart.

TUCSON, Ariz. – June 24, 2009 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, today announced that it has raised $10.3 million in its Series D round of funding. Highway 12 Ventures led this round of financing.

“My partners and I believe that, with the release of the Freedom® driver, SynCardia can dramatically improve the quality of life for tens of thousands of people worldwide who are suffering from biventricular heart failure,” said Mark Solon, Managing Partner of Highway 12 Ventures, who has joined SynCardia’s board of directors.

Proceeds from the financing will support the launch of two new drivers for powering the Total Artificial Heart. In July, SynCardia anticipates that the Companion Driver System will receive the CE Mark for use in Europe. The Companion Driver is designed to support Artificial Heart patients from hospital implant until their condition stabilizes. Once stable, patients will be transferred to the 12-lb Freedom discharge driver, currently under development. 

The Companion Driver System is designed to support Artificial Heart patients from hospital implant until their condition stabilizes.

“For the first time in U.S. history, stable Total Artificial Heart patients will be able to enjoy life at home and in their community while they wait for a matching donor heart, thanks to the 12-lb Freedom discharge driver,” said Rodger Ford, President and CEO of SynCardia.

This summer, SynCardia plans to submit an application to the FDA to conduct an IDE clinical study of the Freedom driver in the U.S. and a Design Dossier to the Notified Body for the CE Mark in Europe.

This summer, SynCardia will submit a Pre-Market Approval supplement to the FDA for use of the Companion Driver in the U.S. In addition to the current 70cc Total Artificial Heart, the Companion Driver is also designed to power SynCardia's smaller 50cc Total Artificial Heart currently under 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