4 February 2014 Three Surgeons Receive TGA Approval to use NovoSorb TM
BTM in Surgical Wounds Calzada Limited’s (ASX:CZD) fully owned subsidiary PolyNovo Biomaterials (PolyNovo) is pleased to announce that three specialist plastic surgeons have been granted authorization to prescribe the NovoSorb TM polymer Biodegradable Temporising Matrix (BTM) wound implant in free flap donor sites (deep full thickness surgical wounds).
The BTM is implanted in patients with wounds of this nature and acts as a dermal scaffold allowing tissue regeneration and subsequent skin grafting.
The authorization from the Australian Government Therapeutic Goods Administration (TGA) follows a specific request from three surgeons at the Royal Adelaide Hospital (RAH) who had experience with the NovoSorb TM BTM in the successfully completed human clinical trial (refer ASX Announcement 10 October 2013). The authorization is given under the TGA’s early access scheme which allows Australian surgeons to apply to use the product prior to full marketing approval.
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