Business
FDA Approval
FDA Approval.
About this update from Rua Life Sciences Plc
[{"type":"text","content":"\n Aortech International PLC\n25 November 2005\n\n\nFor Immediate Release 25 November 2005\n\n\n AorTech International plc\n\n FDA Approval\n\nAorTech announces today it has received notification from one of its licensees\nof the first FDA approval of a long-term implantable, life sustaining device\nutilizing its polymer technology, Elast-Eon(TM). This FDA approval follows the\ngranting of a CE Mark in Europe for the same family of devices earlier this\nyear.\n\nThe particular device market for this product is large and characterized by\nrobust growth. AorTech will receive a $150,000 milestone payment as a\nconsequence of this achievement and royalty revenues are anticipated to commence\nwith first human use in Q1 2006.\n\nIn anticipation of these developments, AorTech entered into an agreement with\nthe licensee for the client-funded scale up of its manufacturing operations\nlocated in Melbourne, Australia. These activities are currently underway and are\nanticipated to be completed in Q1 of 2006.\n\nAorTech CEO Frank Maguire, commented:\n\n'This approval is the result of considerable effort over the past three years on\nthe part of AorTech and its licensee partner. The approval is significant in the\nsense that it validates the application of Elast-Eon in a high-demand, long-term\nimplant with a well respected licensee. I believe this approval will serve to\naccelerate the numerous other application programs AorTech has underway in a\nvariety of medical device markets.'\n\n\nFor further information please contact:\n\n\nAorTech International plc 020 7466 5000\nFrank Maguire, Chief Executive\n\nBuchanan Communications 020 7466 5000\nBen Willey, Lisa Baderoon, Rebecca Skye Dietrich\n\n\n\n This information is provided by RNS\n The company news service from the London Stock Exchange \n ","length":2058,"tagName":"div"}]