Ann: Final Patient enrolled in BARDA Feasibility Burn Trial, page-3

TIME IS UP NOW!


PolyNovo Limited
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VIC Australia 3207
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ASX Announcement
2 August 2018
Final patient enrolled in BARDA Feasibility Burn Trial
PolyNovo is pleased to announce that the last patient has been enrolled in the NovoSorb® Biodegradable Temporising Matrix (BTM) Full Thickness Burn feasibility clinical trial being conducted in the USA. In total, 15 patients across four study sites have been enrolled at: University of California Davis (Sacramento), University of Tennessee (Memphis), University of South Florida (Tampa) and Wake Forest University (Winston-Salem).
This is a significant milestone in the progression towards a full thickness burn regulatory claim via Pre-Market Approval (PMA) with the US FDA. This trial is funded by Biomedical Advanced Research and Development Authority (BARDA) and we will continue to follow these patients for 12 months post skin grafting (wound closure). The NovoSorb BTM has performed very well throughout the trial and we have learnt a great deal about the formal trial processes in the past three years.
The current US FDA 510(K) approval relates to sales of NovoSorb BTM for clinical indications outside of full thickness burns. Achieving a PMA for the NovoSorb BTM will allow for portion and sale for full thickness burns and opens the possibility for BARDA to acquire a stock pile of NovoSorb BTM for use in disaster management. It will also be the only synthetic dermal scaffold on the market with a PMA.
We will now commence, concurrent to monitoring the existing patients, the building of the protocol and dossiers required for the next phase, the Pivotal trial. This phase will require a new budget submission and contract award from BARDA. We expect to complete document submissions by the end of this financial year and commence recruitment into the Pivotal trial by the end of CY 2019.
CEO Paul Brennan said; “The conclusion of enrolment into the feasibility trial is a major achievement for our teams. We wish to thank the research teams at the hospitals themselves, our CRO PPD and the BARDA team for their collaborative efforts. These trials take a lot of resources and dedication on so many fronts and PolyNovo is proving itself capable of running these complex trials. Further, our surgical teams are experiencing good outcomes with the NovoSorb BTM and see it as a differentiated product offering in this critical clinical market.”.
Further information,
Paul Brennan David Williams Chief Executive Officer Chairman
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