PolyNovo Limited Announces US FDA Approves Pivotal Trial IDE
November 12, 2020 at 06:31 pm EST
PolyNovo announced that, the US FDA has approved the pivotal trial investigation device exemption (IDE). This approval allows PolyNovo to begin patient recruitment once the various hospital Independent Review Boards (IRB) grant approval. The company will utilise 20 sites and recruit 150 patients. PolyNovo has prequalified the sites and are in advanced contracting with these sites. Further details of the sites and study details will be released in due course.