16 Sep 2009 07:00
| For Immediate Release | September 16, 2009 |
AorTech Signs Licensing Agreement with SynCardia
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."
-Ends-
For further information please contact:
AorTech International plc
Frank Maguire, Chief Executive
Tel: + 1 801 201 4336
Evolution SecuritiesBobbie Hilliam / Chris Clarke
Tel: +44 20 7071 4300
AorTech International plc
Sarah Price, Investor Relations
Tel: + 1 801 550 4349
e-mail sprice@aortech.com
SynCardia Systems, Inc
Don Isaacs, VP Communications
Tel: + 1 520 955 0660
e-mail disaacs@syncardia.com
Notes to Editors:
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 go to: www.aortech.com
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 or follow SynCardia on Twitter - @SynCardia_News