http://www.asx.com.au/asxpdf/20140204/pdf/42mjgywfbbptlg.pdf
Calzada Limited
ABN 96 083 866 862
2/320 Lorimer Street, Port Melbourne VIC 3207
Tel: +61 3 8681 4050 Fax: +61 3 8681 4099
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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