elicon Group Limited 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.
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 from the originator, Clinical Cell Culture (C3). Helicon has already launched ReCell in Hong Kong and Macau.
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.
"It is our intention to launch ReCell in China immediately upon regulatory approval from the SFDA which is typically expected within 6 months from this acceptance of the dossier,” commented Peter Abrahamson, Helicon's CEO.
Helicon is listed on the Australian Securities Exchange. The Company's business is to identify and exploit niche market opportunities in the biomedical markets of North Asia, specifically China and to participate in the significant growth that has been projected for these markets over the next 25 years.