They looked into expedited US regulatory pathways (De Novo or PMA), however, the FDA or Orthocell's US advisers must have recommended the 510(k) was the most appropriate US regulatory pathway for Remplir. The reason they've conducted a comparator study in rats is because "the study provides information regarding mechanism of action that is not possible to collect in human clinical trials." - Quarterly Report – June 2023
I'd say that the comparator in the study is Integra NeuraWrap (not sure if it has been stated by Orthocell though) because that was what was used in the pilot study that Remplir showed superior results: "A pilot study compared the repair of severed nerves using Orthocell Remplir and Integra NeuraWrap. It clearly demonstrates how Remplir produces superior nerve repairs to the incumbent. Remplir was also easier for surgeons to work with." - Veritas Securities Ltd
If you haven't already, I'd recommend reading the 18 April 2023 | Veritas Securities Ltd | Analyst Report because there a lot of good information in there.
All the best with your DD
They looked into expedited US regulatory pathways (De Novo or...
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