September 16, 2009 AorTech Signs Licensing Agreement with Syncardia
September 16, 2009
AorTech International plc (AIM: AOR), the biomaterials and medical device development company, today announces an exclusive technology licensing and product supply agreement with SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart. This agreement licenses the use of AorTech’s Elast-Eon™ polymer heart valve (PHV) in the SynCardia Total Artificial Heart, as well as the company’s future family of pulsatile products.
As part of the larger program of preparing the PHV for both surgical and trans-catheter applications, the PHV has been tested extensively and has satisfied FDA pre-requisites for human use. The AorTech Polymer Heart Valve has been shown to have durability superior to that of biologic valves and comparable hemodynamic characteristics. In these studies, it has consistently demonstrated a remarkable freedom from calcification or thrombus formation. Due to its outstanding operating efficiency, the valve requires less pressure and therefore less power to open and close. Among other benefits, it is anticipated that the valve’s efficiency will result in longer times between battery changes and quieter operation, helping improve quality of life for Total Artificial Heart patients 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. Industry consensus is that the heart-assist device market could reach between $8 billion and $10 billion worldwide within the coming decade. SynCardia anticipates animal studies later this year, with FDA and CE Mark submissions in 2H 2010. “We are excited and pleased to be the only pulsatile mechanical circulatory support manufacturer with an exclusive agreement with AorTech,” said Michael Gaul, SynCardia Chief Operating Officer. “The Elast-Eon™ PHV combined with additional Total Artificial Heart improvements will provide long-term support for patients suffering from biventricular heart failure.” “This new license and supply agreement with SynCardia is a significant step for AorTech, inasmuch at it represents one of a number of developments in the commercialization of AorTech’s PHV technology and, more generally, in the expansion of our Elast-Eon based component business,” said Frank Maguire, AorTech Chief Executive Officer. “In July of this year, AorTech celebrated the 3rd anniversary of its polymers in long-term implant applications, and we continue to see expansion of the number of applications and volumes for our products.” 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, go to: www.syncardia.com
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