- Polynovo (PNV) has received US$15 million (nearly A$22 million) from the Biomedical Advanced Research and Development Authority (BARDA)
- The funding is to support its synthetic dressing, NovoSorb BTM, receiving U.S. Food and Drug Administrations (FDA) approval
- Last week, the FDA told the company it needs more information on the product
- Additionally, Polynovo will also make a modest co-funding contribution, which will be announced after it receives FDA approval
- Polynovo is down 1.71 per cent and is trading for $2.30 each
Polynovo (PNV) has received US$15 million (nearly A$22 million) from the U.S. Department of Health to support the NovoSorb BTM pivotal trial program.
Last week, the company received feedback from the U.S. Food and Drug Administration (FDA) on its pivotal trial protocol. The FDA asked for more information and a formalisation of the trial’s review points. Due to this, trial recruitment could be delayed.
NovoSorb BTM is a synthetic dressing that is used to treat severe burns and wounds, where there is a significant loss of flesh.
The pivotal trial will support future submissions leading to pre-market approvals.
The funding came from the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Polynovo will make a modest co-funding contribution to the trail, with the final budget to be announced after it received U.S. FDA approval.
The trial will gather extensive data on the effectiveness of Novosorb in treating burns. The product has already been approved outside of the U.S.
“We appreciate BARDA’s ongoing commitment to NovoSorb BTM in funding this trial,” Paul said.
“Their substantial non-dilutive funding for this and other programs better enables PolyNovo to bring our innovative, life-saving products to the U.S. and the rest of the world,” he added.
Polynovo is down 1.71 per cent and is trading for $2.30 each at 12:36 pm AEST.