AorTech licenses heart valve to SynCardia for use in artificial
23 September 2009
AorTech International plc (AIM: AOR), a biomaterials and medical
device development company, has announced an exclusive technology
licensing and product supply agreement with SynCardia Systems, Inc.,
manufacturer of the SynCardia temporary CardioWest Total Artificial
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.”
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