Helicon Group Limited (ASX:HCG) is pleased to announce that earlier this month the Chinese State Food and Drug Administration (SFDA) granted approval for the skin regeneration concept and device, ReCell(R), 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(R) 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."