Regulatory Trials Commence

Aortech International PLC 1 October 2001 AORTECH INTERNATIONAL PLC New Trileaflet Heart Valve Commencement of Regulatory Trials AorTech International plc, the Scottish-based manufacturer of cardio-vascular devices, announces the commencement of the regulatory testing phase of its new synthetic trileaflet heart valve prior to the commencement of clinical trials in patients in the latter part of 2002. The new trileaflet heart valve, made from Elast-EonTM a novel synthetic material, aims to surmount the current clinical problems of mechanical valves and bioprosthetic (tissue) valves which, in the case of mechanical valves, require daily anticoagulant treatment for patients and, in the case of bioprosthetic valves, have a limited lifespan. The development and testing work to date has demonstrated excellent results in terms of the valve's performance. The formal regulatory testing will be carried out in the European Union and in the United States to comply with the requirements of both the European Regulatory Bodies and the FDA in the USA. Eddie McDaid, Chief Executive of AorTech, commented: 'The excellent results of our development work to date on both the material and the design of the valve has enabled us to reach the stage of regulatory testing which is required prior to starting clinical trials in patients in the latter part of next year. 'This development is indeed a milestone for AorTech and the heart valve industry in that the new synthetic trileaflet heart valve will represent the major innovation in replacement of diseased and damaged heart valves over the last 25 years. This milestone could not have been reached without the substantial work and efforts of our development teams, both in the United Kingdom and in Australia and I take this opportunity of acknowledging their outstanding contribution in bringing the development of this new heart valve to this stage.' For further details go to AorTech's website at: www.aortech.com 1 October 2001 ENQUIRIES: Aortech International plc Tel: 01698 746 699 Eddie McDaid, Chief Executive College Hill Tel: 020 7457 2020 Michael Padley Nicholas Nelson
UK 100

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