Key Points: • Commercial negotiations are proceeding well. The Company is confident that an announcement will be made during November 2011 and sales of VitroGro® to treat chronic wounds are expected to start in the UK and Europe during the 2nd quarter of calendar 2012, as planned. • EU Approval for Sale: The EU human trial of VitroGro® has been completed and the final report is expected during October 2011. The EU regulatory consultant is confident that the results already achieved (ASX:TIS Strong New Clinical Trial Data, 14 July 2011) are sufficient for EU approval for sale. On track for start of sales during the 2nd quarter 2012. • Manufacturing: VitroGro® has been produced with the larger scale manufacturing system and final packaging of ready-to-sell VitroGro® is about to start. • FDA: Request for Designation result is expected by the end of October 2011. Expert regulatory consultants are confident of device classification. Recruitment for the FDA venous ulcer trial of VitroGro® is planned to start during December 2011.
TIS Price at posting:
43.5¢ Sentiment: LT Buy Disclosure: Held
