FDA Approval

Aortech International PLC 25 November 2005 For Immediate Release 25 November 2005 AorTech International plc FDA Approval AorTech announces today it has received notification from one of its licensees of the first FDA approval of a long-term implantable, life sustaining device utilizing its polymer technology, Elast-Eon(TM). This FDA approval follows the granting of a CE Mark in Europe for the same family of devices earlier this year. The particular device market for this product is large and characterized by robust growth. AorTech will receive a $150,000 milestone payment as a consequence of this achievement and royalty revenues are anticipated to commence with first human use in Q1 2006. In anticipation of these developments, AorTech entered into an agreement with the licensee for the client-funded scale up of its manufacturing operations located in Melbourne, Australia. These activities are currently underway and are anticipated to be completed in Q1 of 2006. AorTech CEO Frank Maguire, commented: 'This approval is the result of considerable effort over the past three years on the part of AorTech and its licensee partner. The approval is significant in the sense that it validates the application of Elast-Eon in a high-demand, long-term implant with a well respected licensee. I believe this approval will serve to accelerate the numerous other application programs AorTech has underway in a variety of medical device markets.' For further information please contact: AorTech International plc 020 7466 5000 Frank Maguire, Chief Executive Buchanan Communications 020 7466 5000 Ben Willey, Lisa Baderoon, Rebecca Skye Dietrich This information is provided by RNS The company news service from the London Stock Exchange
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