Clinical Cell Culture Ltd today announced that the Therapeutic Goods Administration had recommended the approval of its ReCell ® tissue harvesting device in Australia.
The recommendation has been made by the TGA's Medical Device Evaluation Committee, which now allows the TGA to finalise its approval process and to issue an approval certificate within weeks, permitting the sale of ReCell ® in Australia.
ReCell ® is a unique medical device used by plastic, cosmetic, dermatology and burn surgeons in repairing a wide range of skin defects. Application of the device takes about 30 minutes and is used on patients with injuries of up to 2 per cent of the body surface, or 320cm².
The TGA approval recommendation clears the way for first commercial sales of ReCell ® in Australia.
C3 Chairman Dalton Gooding said the Company had worked very closely with the TGA to complete the approval process after the regulator's decision in December 2005 when TGA issued a notice of intention to reject approval and they requested additional information.
"As we said at the time, we were confident of approval once we had supplied the TGA with the further information requested. That has now happened," said Mr Gooding.
"We are in a similar position with the US Food and Drug Administration which has requested further clinical regulatory information from C3 before it can make a finalassessment."
"We remain confident ReCell ® will receive approval in the US by Q3 2007."
Over the past 3 years, ReCell ® has already been used by more than 40 surgeons in almost 300 patient cases under the TGA's Special Access Scheme.
This is a solid basis from which C3 will be able to expand usage by surgeons in the coming year now that product approval will be in place.
C3 Managing Director Troels Jordansen said TGA approval was a key milestone for the company given the technology was developed in Australia and the investor base of the company is predominantly resident in Australia.
"We are delighted that ReCell ® will soon be available in Australia and that both surgeons and patients will be able to benefit from the enhanced treatment of skin injuries," said Mr Jordansen.
