Guest guest Posted January 6, 2004 Report Share Posted January 6, 2004 Corin Group PLC 01 December 2003 Corin Group PLC UPDATE ON US METAL-ON-METAL REGULATORY STATUS As reported in the interim statement dated 23 September 2003, Corin has been in discussions with the FDA concerning the appropriate approval route for its large diameter stemmed metal-on-metal hip in the US. The FDA has advised Corin that the Group will need to provide US-generated clinical data. Accordingly, Corin is now seeking FDA approval to run a full US-based clinical trial, which is expected to commence in the first quarter of 2004. The US clinical trial for Corin's metal-on-metal resurfacing device, Cormet, remains on schedule, with full approval expected to be granted in 2006. 1 December 2003 Enquiries: Corin Group PLC Ian Paling, Chief Executive Tel: 01285 659 866 Simon Hartley, Finance Director College Hill Tel: 020 7457 2020 Duffield/Clare Warren This information is provided by RNS The company news service from the London Stock Exchange Quote Link to comment Share on other sites More sharing options...
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