PolyNovo (ASX:PNV) completed the recruitment for its pivotal clinical trial assessing the effectiveness of its treatment for traumatic wounds, with 120 patients enrolled, according to a Wednesday filing with the Australian bourse.
The randomized controlled trial aims to compare PolyNovo's NovoSorb BTM to the standard of care for third-degree, full-thickness burns.
The Australian medical technology company is now in talks with the US Food and Drug Administration on the timing of the premarket approval filing for an on-label indication supporting the use of NovoSorb BTM in full-thickness burns, the filing stated.
PolyNovo's shares were down over 4% in recent Wednesday trade.
Price (AUD): $2.31, Change: $-0.11, Percent Change: -4.36%
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