PolyNovo (ASX:PNV) said the clinical study report for its US pivotal randomized controlled trial of NovoSorb BTM has been finalized, with the premarket approval (PMA) submission now expected before the end of calendar 2026, according to a Friday Australian bourse filing.

NovoSorb, the company's polymer, is made to address unmet needs in wound care, as evidenced by its clinical adoption and patient outcomes, and the company is leveraging the technology platform to develop new products and markets, the filing said.

The company said it has proactively refined its PMA submission plan following updated Food and Drug Administration (FDA) guidance effective from February, including the sequencing of key manufacturing and validation activities, with certain activities originally planned post-submission to be included to strengthen the submission package.

The revised timing does not impact current sales or clinical use of NovoSorb products, the filing added.

The company's shares fell 4% in recent Friday trade.