Shares in biomedical company Clinical Cell Culture Ltd have surged over 7 per cent today after announcing the Therapeutic Goods Administration has completed its approval process of ReCell®.
Shares in biomedical company Clinical Cell Culture Ltd have surged over 7 per cent today after announcing the Therapeutic Goods Administration has completed its approval process of ReCell®.
Shares in biomedical company Clinical Cell Culture Ltd have surged over 7 per cent today after announcing the Therapeutic Goods Administration has completed its approval process of ReCell®, which has been placed on the Australian Register of Therapeutic Goods.
At market close, shares in C3 were up 1 cent to 14 cents.
The completion of the approval process follows the recommendation in April for approval by the TGA's Medical Device Evaluation Committee.
ReCell® is a medical device that assists plastic, cosmetic, dermatology and burn surgeons in repairing a wide range of skin defects and is intended for use in patients with injuries of up to 2 per cent of the body surface or 320cm2.
The company said the completion of the TGA approval process clears the way for first commercial sales of ReCell® in Australia in June through the company's recently appointed dedicated distributor.
ReCell® is now approved for sale in 33 countries worldwide, including Germany, Italy, United Kingdom, Argentina and Japan.
Last week, the company announced that it had appointed Bob Atwill as its new chief executive officer and a director of the company.
Mr Atwill has international experience in the pharmaceutical, medical device and medical services sectors. His experience includes commercialisation of innovative medical devices in international markets.
C3's chief financial officer Andrew Cannon, who was to become interim CEO as from June 1st pending the appointment of a permanent CEO, also joins the board.
In March, delays in securing regulatory approvals in the United States and Australia as well as slower than expected product sales prompted C3 to announce staff cuts and postponement of some R&D.
The move stemmed 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.