According to the recent analyst reports, enrollment/recruiting will take a year and then the study will follow patients for a year. The recent Bioshares report available on Anteris' website gives the same timeline, so the timeframes may be coming from Anteris themselves but that's speculation.
Using your timeline combined with the analyst reports, if recruiting starts in Oct 2023 and takes a year, the last patient would be enrolled in October 2024 and the final implantation done in Jan 2025. Patients have to be followed for a year after the procedure, which means the final data on the last patient would be gathered in Jan 2026. Then the submission for approval would be made to the FDA and the FDA would have 180 days to decide, possibly a good bit shorter if we have a Breakthrough Device designation. So that still puts us well into 2026 for an FDA approval.
Here's a link to the Premarket Approval process below. We can do a modular submission, meaning that we submit sections as we complete them, which is a good idea for manufacturing and other associated items, but the 180 day review clock still only starts ticking once the final submission is made because it needs data on the final patient finishing the study. There is a Product Development Protocol but I don't think that applies here.
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