- ASX 200-lister PolyNovo (PNV) is celebrating after the U.S. Food and Drug Administration (FDA) greenlit a milestone approval
- The major regulatory body gave PolyNovo a pivotal trial investigation device exemption (IDE), meaning its surgical product is approved for clinical studies
- Currently, PNV is working on its NovoSorb Biodegradable Temporising Matrix (BTM), a tool which helps surgeons treat and heal traumatic wounds
- Now it’s received the FDA greenlight, the healthcare stock can focus on patient recruitment as soon as it receives approvals from some key hospital boards
- The company forecasts onboarding for a clinical trial can begin in early 2021 and finish towards the end of 2023
- PNV’s upcoming trial is supported by a US$15 million (around A$20.75 million) cash injection from a U.S. government agency
- Following today’s announcement, PolyNovo shares jumped 5.36 per cent, trading for $2.95
ASX 200-lister PolyNovo (PNV) is celebrating today after the U.S. Food and Drug Administration (FDA) greenlit a milestone approval.
The major regulatory body gave PolyNovo a pivotal trial investigation device exemption (IDE), meaning its surgical product is approved for clinical studies.
Currently, PNV is working on its NovoSorb Biodegradable Temporising Matrix (BTM), a tool which helps surgeons treat traumatic wounds.
Essentially, the martix works by closing a wound and supporting the body as it creates new tissue and heals. It’s entirely synthetic, meaning it’s far more effective at keeping bacteria at bay during the all-important healing stage.
Now it’s received the FDA greenlight, the healthcare stock can focus on patient recruitment. In fact, all that stands in the way is approval from a handful of hospital independent review boards (IRBs).
All up, PNV wants to onboard 150 patients across 20 sites, all of which the company is advancing contracts with. As it dots the i’s and crosses the t’s at these locations, PolyNovo says it will release further details in due course.
As a result, the company forecasts recruitment can begin in early 2021 and finish towards the end of 2023. The upcoming clinical trial is supported by a US$15 million (around A$20.75 million) cash injection from the U.S.’ Biomedical Advanced Research and Development Authority (BARDA).
PolyNovo Managing Director Paul Brennan spoke to today’s approval, calling it a significant milestone for the business.
“We are excited to begin this trial as it will build significant clinical data and further demonstrate the ability of NovoSorb BTM to enhance clinical outcomes and improve patients lives,” he stated.
“We greatly appreciate the ongoing support of BARDA with financial support and significant contribution of skill and expertise of their team,” Paul continued.
Following today’s announcement, PolyNovo shares jumped 5.36 per cent, trading for $2.95 at 12:21 pm AEDT.