Sydney, April 26, 2006 AEST (ABN Newswire) - Clinical Cell Culture Ltd (ASX: CCE) today released its quarterly report, Appendix 4C, for the quarter ending 31 March 2006.
The key activities for the period included:
- Responding to the queries raised by the TGA relating to ReCell clearance in Australia. C3 announced earlier this month that TGA had recommended ReCell for approval.
- Meeting and discussions with the Food and Drugs Administration (FDA) relating to ReCell clearance in the United States. The FDA has now confirmed the preferred regulatory approval approach for ReCell and C3 has commenced preparations for the clinical trial.
- ReCell distributors appointed in Argentina, Canada, Philippines and Taiwan
- Training of surgeons and distributors in existing approved markets
As the Company stated in its recent announcements to the market, the Board of C3 has put a strong short and medium term focus on achieving sales penetration and driving sales revenue in its existing approved markets.
C3 products are approved for sale in major markets such as the UK, Germany, Italy and Japan where distributors are in place and sales of its 3 key products - ReCell, CellSpray and CellSpray XP - are already occurring.
The Company will continue to focus on building these existing, approved markets for its products as a priority to maximise cash returns.
For the current financial year, C3 is forecasting sales revenue of AUD1.1-1.4 million. ReCell is a unique medical device used by plastic, cosmetic, dermatology and burn surgeons in repairing a wide range of skin defects using the patient's own cells.
Application of the device takes about 30 minutes and is used on patients with injuries of up to 2% of the body surface, or 320cm2.
ReCell was recommended for approval by the TGA in early April and sales in Australia are expected to start in June 2006. The product is already approved and available for sale in 31 countries, including Germany, France, United Kingdom, Italy and Japan.
CellSpray is approved for sale in 5 European countries and CellSpray XP is approved for sale in 7 European countries and both products have been generating sales since October 2005.
CellSpray is a suspension containing cultured skin cells for use in the treatment of major burns and scars. Cells are harvested from a small biopsy and cultured in C3's laboratory for approximately 5 to 7 days and then reapplied to the wound. Traditional technologies take approximately 21 days to culture small sheets of skin.
CellSpray XP is a rapid version of CellSpray that is available within 48-hours of a biopsy being taken. CellSpray XP is generally applied to wounds that must be treated urgently. Moving forward into FY07, C3 is forecasting revenue in the range of AUD5-7 million, rising to AUD12-16 million in FY08. Sales of ReCell are expected to be the major contributor to group revenue in the near future, contributing approximately 80% of forecast revenue.
C3 Chief Financial Officer Andrew Cannon said that although sales and product take up was slower than expected, the Company's existing markets offered significant revenue opportunities.
"Sales in our existing markets have been slower than anticipated for a range of reasons, however we believe we are still very much on the right path and will benefit from placing heavy emphasis on generating sales in these key markets," said Mr Cannon.
"Overall, market feedback for our products remains encouraging and patients continue to be treated in the majority of Western European countries and in Japan."
"We are committed to restoring C3's reputation in the investor markets and by concentrating on sales in our existing markets we are confident we will be able to maximise returns for our shareholders."
Net cash outflows for the quarter amounted to AUD2.2 million leaving a cash balance at 31 March 2006 of AUD11.4m which is in line with expectations.
To Download the full Quarterly Report, go to this link.
http://www.clinicalcellculture.com/one/pdf/April%20-%20Quarterly%20Update.pdf
Contact
Andrew Cannon
Clinical Cell Culture
Tel: +44 (0)1223 341 150
Email: investor@clinicalcellculture.com
John McGlue
Porter Novelli
Tel: +61 (0) 8 9386 1233
Mob: +61 (0) 417 926 915
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