Perth, July 3, 2008 AEST (ABN Newswire) - HELICON GROUP LIMITED (ASX:HCG) today announced that the Chinese State Food and Drug Administration (SFDA) has granted approval for the skin regeneration concept and device, ReCell(R).
KEY POINTS
- Chinese State Food and Drug Administration approves skin regeneration concept and device: ReCell(R)
- Proven product effectiveness in treatment of burns and small wounds
- Significant market demand for the product in China
- Importation issues with some components of the device to be resolved with the SFDA
Following an exhaustive approval process, due in part to the pioneering nature and complexity of the kit, the SFDA has approved the product concept and ReCell(R) kit. Importation issues with some components of the kit, including the trypsin, 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.
"We are pleased that we have achieved this milestone in China's challenging regulatory environment" commented Helicon CEO Peter Abrahamson.
"We are now exploring all avenues to resolve the importation issues including local sourcing to enable commercialisation to commence " Mr Abrahamson added.
Recell(R) was developed by Professor Fiona Wood who used it to treat victims of the 2002 Bali bombings.
The product is part of Avita Medical's (formerly Clinical Cell Culture) portfolio of tissue-engineering medical devices.
Dr William Dolphin, recently appointed CEO of Avita Medical, said:
"China is a key market for the company's products. ReCell(R) addresses the growing demand for cosmetic surgery, scar revision, and burns treatment by China's burgeoning middle class."
"Helicon has done an excellent job to date of shepherding the ReCell(R) application through the highly complex SFDA approval and registration process and I am pleased that the company has passed the first major regulatory hurdle" Dr Dolphin concluded.
The product has proved highly effective in the treatment of burns, small wounds, encouraging scar free healing and re-pigmentation.
The target market for ReCell(R) includes plastic reconstruction surgeons, dermatologists, burn specialists and cosmetic specialists in high end and military hospitals, as well as in the larger private hospitals in major metropolitan centres of China.
The technology has significant 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. There are more than 3000 cosmetic surgery clinics in China's major hospitals.
About Avita Medical Limited
Avita Medical Limited (ASX: AVH) is an ASX listed medical device company formed through the merger of Clinical Cell Culture Ltd and Visiomed Group Ltd in February 2008.
Following the merger Avita Medical is now active in the regenerative medicine and respiratory sectors and has three products in the market:
ReCell(R) 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. ReCell(R) has been designed for use in a wide variety of plastic, reconstructive and cosmetic procedures.
Funhaler(R) is an incentive asthma spacer designed specifically for the paediatric market, incorporating auditory and visual incentives to encourage children to comply with their medication plan. The Funhaler(R) is patented, CE marked for the EU, FDA cleared for the US and TGA registered in Australia.
Breath-A-Tech is the leading spacer for adolescents and adults in Australia. The product is effective, compact, easy to use and competitively priced. The Breath-ATech hospital-grade spacer can also be autoclaved in the hospital or clinical setting.
Contact
Peter Abrahamson
Helicon Group Limited
Level 1, 173 Mounts Bay Road Perth WA 6000
Tel: +61 411 336 330 (Australia)
Tel: +86 1366 147 9600 (China)
Email: peter@helicongroup.com.au
Website: www.helicongroup.com.au
| ||
|
