PolyNovo (ASX:PNC) has received additional funding of US$10 million from the US Biomedical Advanced Research and Development Authority (BARDA) for the pivotal trial program of NovoSorb BTM.
The company said this increases the total funding commitment from BARDA to US$25 million. The contract is a cost-plus monthly reimbursement arrangement.
PolyNovo said it will continue to contribute to the trial through the provision of product, employee resources and infrastructure support.
The trial is gathering data on the effectiveness of NovoSorb BTM for treating full-thickness burns. The product is already indicated for full-thickness burns outside of the US and has the CE Mark for Europe, including an indication for use in full-thickness burns, other surgical wounds, and reconstruction procedures.
PolyNovo’s BARDA contract, funded by the US Department of Health and Human Services, commenced on 28 September 2015.
PolyNovo director of clinical operations, John Cockwill, said, “Our partnership with BARDA over the past decade has been extraordinary. Together, we have pioneered innovation in the medical device industry, pushing boundaries and saving many lives. It's been a journey of dedication, collaboration, and the relentless pursuit of excellence. Our shared vision has driven technological advancements but has also made for a profound impact on healthcare worldwide."
Chairman David Williams said, “BARDA and PolyNovo have a clear end game to bring our technology to as many patients as possible. It is an honour for us to know that our technology will play an important part in the US preparedness for mass disasters.”
CEO Swami Raote added, “BARDA has been partnering with us and the FDA on this program in the most collegial way. We appreciate their consistent engagement and guidance in helping us construct, navigate, and execute a complex, large-scale multi-centre trial to secure FDA approval for our life-saving and life-changing technology.”