BARDA feasibility trial closes enrollment with NovoSorb® BTM, the only synthetic dermal scaffold on the market with a PMA

PolyNovo is pleased to announce that the last patient has been enrolled in the NovoSorb® Biodegradable Temporizing 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 PreMarket 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.

BARDA trial opens way to acquiring stock pile of NovoSorb® BTM for use in disaster management

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 promotion 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 enrollment 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
Chief Executive Officer
Mobile, +61 427 662 317

David Williams
Chairman
Mobile +61 414 383 593