Press Release:

Michael Gaul, SynCardia Chief Operating Officer

TUCSON, Ariz. – Sept. 22, 2009 – On Sept. 22, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced an exclusive technology licensing agreement with AorTech International plc (AIM: AOR). This agreement licenses the use of AorTech’s Elast-Eon™ polymer heart valve (PHV) in the Total Artificial Heart, as well as SynCardia’s future family of pulsatile products.

“The Total Artificial Heart is the only device that eliminates biventricular heart failure by replacing both failing ventricles,” said Michael Gaul, SynCardia Chief Operating Officer. “The Elast-Eon PHV is designed to provide reliable support for patients who need the Total Artificial Heart as their Bridge To Life™.”  

“Our polymer heart valve has been tested extensively and has satisfied FDA pre-requisites for human use,” said Frank Maguire, AorTech Chief Executive Officer. “The valve has been shown to have durability superior to that of biologic valves and comparable hemodynamic characteristics. In these studies, it has consistently demonstrated freedom from calcification and thrombus formation.”

Due to its outstanding operating efficiency, the Elast-Eon valve requires less pressure and therefore less power to open and close. It is anticipated that the valve’s efficiency will lengthen discharge driver battery life and result in quieter operation of the Total Artificial Heart, helping improve patient quality of life while they wait for a matching donor heart.

The license structure includes $2.1 million in fees payable over an 18 month period, minimum valve purchases and volume related discounts.

SynCardia anticipates animal studies later this year, with FDA and CE Mark submissions in 2H 2010.

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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