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SynCardia Systems, Inc.

Press Release:

Forbes Names SynCardia One of "America's Most Promising Companies"

List Features 100 Privately-Held Companies with Compelling Business Models, Strong Management Teams, Investment Capital and Notable Customers

Total Artificial Heart patient Shawn Galloway, pictured with her husband Joey, was discharged from Texas Heart Institute carrying her Freedom® portable driver in the Shoulder Bag on Aug. 23, 2011. She received a donor heart transplant on Sept. 20, 2011. Total Artificial Heart patient Shawn Galloway, pictured with her husband Joey, was discharged from Texas Heart Institute carrying her Freedom® portable driver in the Shoulder Bag on Aug. 23, 2011. She received a donor heart transplant on Sept. 20, 2011. TUCSON, Ariz. – Dec. 8, 2011 – SynCardia Systems, Inc., the privately-held manufacturer of the world's only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has been selected by Forbes as one of "America's Most Promising Companies." The list features 100 privately held up-and-comers with compelling business models, strong management teams, notable customers, strategic partners and precious investment capital. Ranked No. 77, SynCardia was the only Arizona company to make the cut.

"In 2010, SynCardia doubled sales over 2009, and in 2011, we are on track to double sales again, representing a four-fold increase since 2009. We are profitable for the first time in the company's 10-year history," said Michael Garippa, CEO/President. "SynCardia is lean by design and many of our employees are cross-trained in multiple departments. Every Friday, we continue our six-year tradition of the entire company having lunch together and sharing project updates to ensure everyone is on the same page."

SynCardia designed, developed, and launched the Freedom® portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. Weighing 13.5 pounds, 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. To date, 34 patients have been enrolled in the study. Of these patients, 23 have been discharged from the hospital using the Freedom driver. The study requires that 30 patients be discharged. 

Worldwide, more than 65 patients have been supported by the Freedom portable driver. From Russia to Richmond, from Australia to Arizona, Total Artificial Heart patients have been discharged from the hospital without human hearts to wait for a matching donor heart at home and in their communities. There are currently SynCardia Certified Centers in 12 countries on 3 continents – North America, Europe and Australia.

Prior to the development of the Freedom driver, stable Total Artificial Heart patients in the U.S. were confined to the hospital for months, sometimes years while they waited for a matching donor heart because the only FDA-approved driver is hospital-based "Big Blue" which weighs 418 pounds. 

SynCardia has been honored with multiple awards in 2011, including being ranked #20 in Fast Company's annual list of the "World's 50 Most Innovative Companies," named "Arizona Bioscience Company of the Year" and selected as one of six finalists for the World Technology Award in Health and Medicine by the World Technology Network in association with TIME, Fortune, CNN, Science/AAAS and Technology Review.

To view the complete the list of America's Most Promising Companies, please visit www.forbes.com/ampc.

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

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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