Ann: Anteris Completes DurAVR THV EFS Enrolment, page-26

It'll take time because the trial design will need to be approved by the FDA, which shouldn't take long given that there won't likely be many changes from the EFS, but we'll need a lot more sites added beyond the 7 that participated in the EFS. Edwards is using 44 sites for its ongoing pivotal trial for their new Sapien version. That trial plans to enroll 915 patients and Wayne has said to expect maybe 900-1100 patients for our trial.

I'm sure Wayne and the team have been working diligently to bring 20-40 new sites into the fold for the pivotal but that still takes a lot of work. Once we have the trial design approved, each participating site will need to review the trial, complete their internal approval and sort all the legal issues to get patients identified and enrolled. A rough guess for how long that took for the EFS may be 7-8 months total, and 5-6 months from the first hospital's internal approval to the first EFS implantation given Wayne's comments in late March about where the first few hospitals were in the process and the first EFS implantation happening in early August.

Unfortunately with hospital key staff shortages and turnover, this has not been the best time to initiate trials but maybe that will improve a little next year as it's something the industry is trying to address.

So if we get approval for the pivotal early next year, the first implantations for the pivotal trial could start July-August next year but it will take time to get all of the 25-45 sites onboard and ready to go. Edwards's initial projection was 2 years to full enrollment from first implantation so that's probably a good benchmark depending on how many sites we have. That projection may be a little conservative but it's probably always smart to be conservative and then pleasantly surprised by things happening sooner.