Elast-Eon Implant Development

Aortech International PLC 29 October 2004 For Immediate Release 29 October 2004 AorTech International plc ('AorTech' or 'the Company') AorTech to proceed with development of Elast-Eon Breast Implant AorTech International plc the biomaterials Intellectual Property and Material Manufacturing Company announces progress in the exploitation of its Elast-Eon biomaterial. The Company has recently met with representatives of the U.S. Food and Drug Administration ('FDA') to present its analysis of Elast-Eon for the specific application to breast implant devices in accordance with the January 2004 FDA Guidance Documents. As a consequence of this meeting with the FDA, AorTech has decided to move ahead with its device development programme for both saline filled and Elast-Eon filled devices. Over the past year, AorTech has been conducting material level testing and has been developing a strategy for the use of its polymer technology in a breast implant application. This program has used the FDA Guidance as a template for its work. Recently the company filed new intellectual property for a very soft class of its novel biostable polymer in this application to replace silicone gel. First generation prototype devices have been produced As a result of the recent FDA meeting, the company will commence full device and manufacturing process development of both saline and Elast-Eon filled devices in parallel with the material qualification work which is currently underway. These efforts will be designed to satisfy the FDA's requirements for the commencement of a clinical trial. The company believes that the use of its Elast-Eon polymer technology has the potential to significantly improve the safety profile of breast implant devices, in particular with respect to rupture and leakage. Additionally, the material is more compatible with imaging technology used in tumour screening. The company's new Elast-Eon filler technology provides the option to produce devices that are softer and consequently more natural than the current range of 'high consistency' silicone filled devices. The company strategy is to move ahead with internal product development and to identify a Partner to fund and manage the clinical trial phase and ultimately the sales and marketing functions for these products. Although this program is at an early stage, if the Company meets the FDA criteria, Elast-Eon will give AorTech access to the $600-million dollar global breast implant market. Commenting on these developments, Frank Maguire, AorTech's Chief Executive said: 'The Directors of AorTech are pleased with the outcome of this meeting, but are aware there is still a long way to go for this application. Thus, the focus of the management firmly remains with increasing Shareholder value as we exploit the target applications for our biomaterial technology.' For further information please contact: AorTech International plc Frank Maguire, Chief Executive 07766 543 649 00 1 801 201 4336 Laurie Rostron, Non-Executive Chairman 07767 782 824 Buchanan Communications 020 7466 5000 Ben Willey, Lisa Baderoon, Rebecca Skye Dietrich Visit AorTech's website at: www.aortech.com This information is provided by RNS The company news service from the London Stock Exchange
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