7 sites for the EFS. Each site has a review board that must approve the trial before it can go forward at that site. Currently 2 sites have finished their review and have initiated the patient identification process. Full enrollment of the 15 patients is expected by late June. Then we'll get 30 day data with plans to present that data at the TCT conference in late October.
Anteris should receive $25,000 USD for each device used in the EFS. So not much in total but the pivotal trial will include many more patients and will generate up to $27.5 million USD in revenue depending on the number of patients enrolled.
The pivotal trial is expected to enroll from 500 to 1100 patients. Wayne thinks it can be enrolled in a year, which would mean that the trial will take 2 years (each patient will be followed for a year).
He thinks valve-in-valve can get FDA approval earlier, with revenue in 2024-25. I'm skeptical but he said more info should be forthcoming at the AGM.
AVR Price at posting:
$19.00 Sentiment: Hold Disclosure: Held
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