AOR.L Regulatory News (AOR)

25 Nov 2005 07:00

Aortech International PLC25 November 2005 For Immediate Release 25 November 2005 AorTech International plc FDA Approval AorTech announces today it has received notification from one of its licenseesof the first FDA approval of a long-term implantable, life sustaining deviceutilizing its polymer technology, Elast-Eon(TM). This FDA approval follows thegranting of a CE Mark in Europe for the same family of devices earlier thisyear. The particular device market for this product is large and characterized byrobust growth. AorTech will receive a $150,000 milestone payment as aconsequence of this achievement and royalty revenues are anticipated to commencewith first human use in Q1 2006. In anticipation of these developments, AorTech entered into an agreement withthe licensee for the client-funded scale up of its manufacturing operationslocated in Melbourne, Australia. These activities are currently underway and areanticipated 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 onthe part of AorTech and its licensee partner. The approval is significant in thesense that it validates the application of Elast-Eon in a high-demand, long-termimplant with a well respected licensee. I believe this approval will serve toaccelerate the numerous other application programs AorTech has underway in avariety of medical device markets." For further information please contact: AorTech International plc 020 7466 5000Frank Maguire, Chief Executive Buchanan Communications 020 7466 5000Ben Willey, Lisa Baderoon, Rebecca Skye Dietrich This information is provided by RNS The company news service from the London Stock Exchange