Helicon Group Limited announced that earlier this month the Chinese State Food and Drug Administration (SFDA) granted approval for the skin regeneration concept and device, ReCell, for sale in China.
The approval process for the product has been complicated and intensive due in part to the pioneering nature and complexity of the ReCell kit. Importation issues with some components of the kit are being resolved with the SFDA.
The technology utilises a patient's own skin cells thereby achieving improved matching of the skin's texture and colour in the treatment area and eliminating the likelihood of tissue rejection.
Our CEO Peter Abrahamson said, "We are pleased that we have achieved this milestone in China's challenging regulatory environment and we are now exploring all avenues to resolve the importation issues including local sourcing to enable commercialisation to commence."
ReCell was developed by Professor Fiona Wood who successfully used the treatment approach on, amongst many others, victims of the 2002 Bali bombings.
The product is part of Avita Medical's (formerly Clinical Cell Culture) portfolio of tissue engineering medical devices and has proved highly effective in the treatment of burns, small wounds, encouraging scar free healing and re-pigmentation.
The target market for ReCell includes plastic reconstruction surgeons, dermatologists, burn specialists and cosmetic specialists in military and high end hospitals, as well as larger private hospitals in the major metropolitan centres of China.
The technology has huge sales potential in China where the cosmetics and plastics markets are growing exponentially, due to an emerging middle class with disposable income.
Estimates put the amount spent in this market annually in the order of US$2.4 billion and there are more than 3,000 cosmetic surgery units in major hospitals in China.
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.