PolyNovo Limited (ASX:PNV)
has been granted regulatory approval by the US FDA.
The US Food and Drug Administration has provided regulatory approval for PolyNovo’s Biodegradable Temporising Matrix (BTM) for use in reconstructive and surgical wounds.
The 510(k) approval allows PolyNovo to sell the BTM in the US.
CEO Paul Brennan labelled the approval a ‘significant milestone’ which sets the company up as a commercial enterprise with access to the largest reimbursed dermal matrix market in the world.
PolyNovo recorded a net loss of $1.4 million at 30 June 2015.