PolyNovo Nears FDA Approval with Trial Completion

Polynovo Limited (AU:PNV) has released an update.

PolyNovo Limited has announced the completion of patient enrollment for their pivotal clinical trial, which compares the efficacy of NovoSorb BTM—a dermal regeneration scaffold—against standard burn care treatments. This major step, funded by BARDA and involving 120 patients from numerous centers, may lead to premarket approval by the FDA, aligning U.S. market regulations with those of other countries. The company and its officers expressed gratitude towards participants, investigators, and their long-standing partnership with BARDA.

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