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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