AorTech Polymer Heart Valve Licensing Agreement

SynCardia Systems, Inc. manufacturer of the SynCardia temporary CardioWest Total Artificial Heart, announced an exclusive technology licensing agreement with AorTech International plc. 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,” says Michael Gaul, SynCardia COO. “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,” says Frank Maguire, AorTech CEO. “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.

A current story about SynCardia and their products can be read at http://onlinetmd.com/article.cfm?id=2294

About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge-to-transplant for patients dying from end-stage, biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
For additional information, please visit: www.syncardia.com

About AorTech International plc
AorTech develops and manufactures biostable, implantable polymers, including Elast-Eon, the world’s leading long-term implantable copolymer. With hundreds of thousands of successful long-term human implants, Elast-Eon is currently used in cardiology, orthopaedic, urological and gastroenterological applications, including pacing leads, cardiac cannulae and stents. Devices manufactured from Elast-Eon have multiple US FDA PMA approvals, CE Marks and Japanese Ministry of Health approval.

Elast-Eon’s biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. It can be processed using conventional thermoplastic extrusion and molding techniques. AorTech provides a range of materials in a variety of application-specific formulations for use in medical devices and components.

For additional information please visit: www.aortech.com