Perth-based skin and burns treatment company Clinical Cell Culture Ltd today announced that Canada's health products regulatory body had approved its ReCell tissue harvesting device for commercial sales in Canada.
Perth-based skin and burns treatment company Clinical Cell Culture Ltd today announced that Canada's health products regulatory body had approved its ReCell tissue harvesting device for commercial sales in Canada.
The company suffered a blow earlier this year, when the American Food and Drug Administration refused to approve the treatment without further performance data.
ReCell is a stand-alone, rapid cell harvesting device that enables surgeons to treat skin defects using the patient's own cells that are collected during surgery. The product is already available for use in over 30 countries
Below is the edited announcement:
Clinical Cell Culture Ltd (C3, ASX: CCE) today announced that Health Canada Therapeutic Products Directorate has approved its ReCell tissue harvesting device for commercial sales in Canada.
ReCell is a unique medical device that assists plastic, cosmetic, dermatology and burn surgeons in repairing a wide range of skin defects. ReCell is intended for use in patients with injuries of up to 2% of the body surface or 320cm².
C3 Chief Executive Officer Bob Atwill said he was delighted that regulatory approval had been received in a key North American market.
"We have an excellent distributor in CanMedica Corp, training has already taken place and we expect commercial sales to commence in July", said Mr Atwill.
ReCell is now approved for sale in 33 countries worldwide, including Canada, Germany, Italy, United Kingdom, Australia and Japan.
ABOUT C3
Clinical Cell Culture (C3) is a publicly listed biomedical company that develops and distributes a number of tissue-engineered products for the treatment of wounds and other skin defects. Using proprietary tissueculture/collection technology, C3 is able to provide innovative treatment solutions derived from the patients own skin, to enhance healing rates, reduce scar formation and reintroduce pigmentation into the skin.
PRODUCT PORTFOLIO
- C3 products use autologous cells obtained from the patients themselves to lower the risks for cross contamination and rejection. Further, the rapid harvest and culture time has the potential to significantly improve the rate of healing which can favourably impact the aesthetic and functional outcome for the patient and reduce overall costs. C3 continues research into the development of newtissue engineered products and medical devices for burn and wound healing.
- CellSpray (www.cellspray.info) is a suspension containing cultured skin cells for use in the treatment of major burns and scars. Cells are harvested from a small skin sample (biopsy) and cultured in C3's laboratory over approximately 5 to 7 days. Traditional technologies take approximately 21 days to culture small sheets of skin.
- CellSpray XP (www.cellspray.info) 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
- ReCell (www.recell.info) is a stand-alone, rapid cell harvesting device that enables surgeons to treat skin defects using the patient's own cells that are collected during surgery. The surgeon can prepare a small quantity of cells within 30 minutes on site rather than having to send a biopsy to the laboratory. ReCell has been designed for use in a wide variety of plastic, reconstructive and cosmetic procedures.
Sales of all three products are now underway in several key markets, with distributors engaged to sell in additional markets as further approvals are confirmed.
C3's products have been used on more than 2,000 cases to date and have the potential to treat millions of patients worldwide.
P RODUCT D EVELOPMENT
C3 is currently working on a number of product development and enhancement projects. A reusable ReCell device is being developed which will give C3 access to price sensitive markets. An enhanced spray head is also being developed which will enhance IP protection. New versions of Trypsin are being tested and reviewed to further improve the performance of ReCell and provide C3 with additional IP protection.
ReCell APPROVED MARKETS
Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, New Zealand, Norway, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, TheNetherlands, United Kingdom
CellSpray APPROVED MARKETS
Austria, Denmark, Germany, The Netherlands, United Kingdom
CellSpray XP APPROVED MARKETS
Austria, Denmark, Germany, Italy, Switzerland, The Netherlands, United Kingdom
