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 July 2011 Major Milestone for PolyNovo and NovoSorbTM: First Human Study PolyNovo Biomaterials Pty Ltd (PolyNovo), a wholly owned subsidiary of Calzada Ltd, is pleased to announce that Associate Professor John Greenwood AM, has been granted approval by the Human Research Ethics Committee of the Royal Adelaide Hospital to conduct its first human study utilising NovoSorbTM. This approval will enable the investigation of NovoSorbTM in the form of a Biodegradable Temporising Matrix (BTM) in surgically created full thickness wounds following free-flap donor site surgery. This model is ideal as it will allow investigators to test the safety and efficacy of BTM in a large surgically created wound without interference from other ailments usually experienced by patients with extensive burns such as shock, smoke inhalation, etc.
A/Professor Greenwood said “This approval is the milestone to which extensive and meticulous laboratory and animal research, using the NovoSorbTM material, have been leading. This study will assess, for the first time, the safety and efficacy of NovoSorbTM in humans. Our earlier work, in a porcine (pig) model, in which the BTM has markedly reduced wound contraction and resisted the development of infection, suggests that NovoSorbTM will reliably perform all the functions for which it has been designed”.
Laurent Fossaert, CEO of PolyNovo said “This is a major achievement for our team as it will represent the first human use for NovoSorbTM and will provide valuable data for future planned regulatory submissions. It also shows that our technology has the potential to be used in applications far beyond full thickness burns, significantly increasing the range of target markets for BTM”. The study is planned to start in Q4 2011, further information will be communicated to the market before commencing patient recruitment.
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