Perth, Oct 29, 2007 AEST (ABN Newswire) - HELICON GROUP LIMITED (ASX: HCG) announced today that the Chinese regulatory authority, the State Food and Drug Administration (SFDA) has formally accepted Helicon's dossier seeking marketing approval for the China market for ReCell(R).
The SFDA's acceptance of the dossier does not confer regulatory approval of the product, however it is an important formal step on the path to the granting of marketing approval.
Helicon licensed exclusive rights for China, Hong Kong and Macau for this innovative single use autologous skin harvesting device branded ReCell(R) from the originator, Clinical Cell Culture (C3). Helicon has already launched ReCell(R) in Hong Kong and Macau.
ReCell(R) has been shown to be useful in treating small wounds, encouraging scar free healing and re-pigmentation of the skin.
The product was secured for its potential in the dynamic and rapidly growing cosmetic surgery market in China and Hong Kong. The key target market includes plastic reconstruction surgeons, dermatologists, burn surgeons and cosmetic specialists in the Level III and II hospitals as well as larger private hospitals and clinics in the larger metropolitan centers of China.
The product is approved and marketed in most major European markets. It also has approval from the Ministry of Health in Japan, the Therapeutic Goods Administration in Australia and various other markets in South East Asia.
"In formally accepting the ReCell(R) dossier, Helicon, together with its regulatory partner, ChinaGate have demonstrated their capability to meet the stringent and complex requirements of the Chinese regulatory authorities to evaluate a medical device of this kind" commented Peter Abrahamson, Helicon's CEO.
"It is our intention to launch ReCell(R) in China immediately upon regulatory approval from the SFDA which is typically expected within 6 months from this acceptance of the dossier." he added.
About Clinical Cell Culture
Clinical Cell Culture (C3, ASX: CCE) is a publicly listed biomedical company that develops and distributes tissue-engineered products for the treatment of wounds and other skin defects. Using proprietary tissue-culture/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.
Contact
Peter Abrahamson
Helicon Group Limited
Tel: +61 411 336 330 (Australia)
Tel: +86 1366 147 9600 (China)
Email: peter@helicongroup.com.au
Website: www.helicongroup.com.au
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