- PolyNovo (PNV) enrols the first patient in the trial of its dermal application, NovoSorb BTM for the treatment of full thickness burns
- The dermal scaffold has been designed to regenerate skin when lost through extensive surgery or burn
- The US Biomedical Advanced Research and Development Authority is funding the trial, which will comprise up to 150 burn patients
- Data generated from the trial will support a premarket approval application for an on-label claim supporting the use of NovoSorb BTM in full thickness burns
- Shares closed up 1.57 per cent higher at $1.94
PolyNovo (PNV) has enrolled the first patient in the trial of its dermal application, NovoSorb BTM, for the treatment of full thickness burns.
NovoSorb is the company’s novel range of bio-resorbable polymers that can be produced in many formats including, film, fibre, foam and coatings.
PNV has developed NovoSorb Biodegradable Temporising Matrix (BTM) as a dermal scaffold specifically for the regeneration of the dermis when lost through extensive surgery or burn.
The trial is supported by $22 million from US Biomedical Advanced Research and Development Authority (BARDA) which is funded by the US Department of Health and Human Services.
In January this year, the US Food and Drug Administration gave the green light for the pivotal trial to commence, comprising up to 150 full thickness burn patients.
It’s being conducted in 20 US and five Canadian burn centres with up to 150 full thickness burn patients in a comparative study against the existing standard of care.
Now that recruitment has begun, PNV expects the trial to take around three years, depending on the recruitment rate.
Managing Director, Paul Brennan said recruiting the first patients was an “exciting milestone” for the company.
Once the trial has concluded, he said the data generated would support a premarket approval application with the US FDA for an on-label claim supporting the use of NovoSorb BTM in full thickness burns.
As the product has already been approved outside the US, Mr Brennan said approval would bring the company’s US market in line with global markets where the on-label claim was already established.
Shares closed 1.57 per cent higher at $1.94.