Delays in securing regulatory approvals in the United States and Australia as well as slower than expected product sales have prompted Clinical Cell Culture Ltd to announce staff cuts and postponement of some R&D.
Delays in securing regulatory approvals in the United States and Australia as well as slower than expected product sales have prompted Clinical Cell Culture Ltd to announce staff cuts and postponement of some R&D.
The move stems from a wide ranging review of the company's corporate and commercial strategies addressed a number of measures considered critical for C3's ongoing financial well being.
C3 chairman Dalton Gooding said the board had reviewed the medium term objectives of the company to ensure that its cash resources were focused on maximising revenues and returns for shareholders.
Key decisions from the review include the short and medium term focus on building sales in approved markets where C3 products are already approved for sale and the release of sales forecasts for financial years 2006-2008.
As part of the review process it also announced the postponement of its EpiGrow® chronic wound product research and development program, and a number of redundancies - which will see staff numbers reduced from 20 to 14.
C3 have been beset by a raft of unforeseen issues, which have resulted in slower than forecast progress for the company.
The company is facing ongoing delays in both Australia and the United States for regulatory approval for its ReCell skin defect treatment.
C3 chief executive Troels Jordansen said that the issues were to with wording of C3's proposal and also some technical issues.
"Regulators in Japan, the US, Europe and Australia all have different ideas on how products should be granted approval, so we need to tailor our presentation to suit," he said.
A response from the North American Food and Drugs Administration is expected in the third quarter of 2007, and a decision on Australian approval is expected by mid-2006.
The postponement of the EpiGrow® work and the staff cut backs were all precipitated by the company's tightening cash position.
Mr Gooding said the company was working to reduce its monthly 'cash-burn' from $1 million to $800,000 a month, and was also looking at a capital raising this year to boost its operating position.
The company is also considering measures to improve the time taken for the sales cycle of the ReCell technology to flow from the company to surgeon to patient.
It had initially budgeted on a period of not more than 4 months, but found in practice the average time-frame for the cycle had been six months, which impacted on sales numbers.
The company still believes strongly in its unique technology.
It said C3 products were more effective than other techniques, such as face peels or skin grafts, in treating skin problems, and that it had a window of opportunity of around four years before any direct competitors were likely to enter its market space.
