Sydney, Dec 23, 2005 AEST (ABN Newswire) - Clinical Cell Culture Ltd (ASX: CCE) Clinical Cell Culture (ASX: CCE) would like to clarify aspects of its application for approval to sell its ReCell tissue engineering device in Australia following media comments by the Therapeutic Goods Administration (TGA).
C3 has sought approval from the TGA to sell ReCell as a Class III Medical Device. The approval process is on-going, with substantial consultation and exchange of information between C3 and the TGA.
The TGA has stated to C3 that it will not approve the application for ReCell at this point and has indicated it requires some supplementary information from the Company in a number of areas. While C3 expects to receive the detail of the TGA's further information requirements in January 2006, the Company understands additional data/clarification of data will be sought in the areas of clinical data, product information labels, printed instructions for use and viral safety testing.
C3's application relates to the entire ReCell device and can be described as an application for 'Complete Device' approval. C3 remains very positive about the TGA approval process and will continue to work assiduously to reach a favourable outcome in the first half of 2006.
ReCell is already approved and available for sale in 26 countries, including Germany, France, United Kingdom, Italy and Japan.
Contact
Andrew Cannon or Troels Jordansen
Clinical Cell Culture
Tel: +44 (0)1223 341 150
Email: investor@clinicalcellculture.com
FOR GENERAL INFORMATION PLEASE CONTACT:
John McGlue
Porter Novelli
Tel: +61 (0) 8 9386 1233
Mob: +61 (0) 417 926 915
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