Update: US Regulatory Status
December 01 2003 - 4:30AM
UK Regulatory
RNS Number:6669S
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
Adrian Duffield/Clare Warren
This information is provided by RNS
The company news service from the London Stock Exchange
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