Getting CMS reimbursement authorization is crucial because in the US people over the age of 65 have at least a large portion of their healthcare costs covered by Medicare, and obviously our trial patients will likely be over 65. I imagine that it will be a benefit not only in Anteris getting paid for devices used in trials but also guarantee that once we eventually go commercial there will be no issues with Medicare covering the cost of the DurAVRs.
Anteris still has a few things to clean up with their EFS submission as the application has been conditionally approved but we can begin enrollment as soon as we get the go ahead from the Institutional Review Boards of each of the 7 heart valve centers. The IRBs oversee studies done in their respective institutions. And the FDA's conditions could be something as simple as getting the patient consent form to the FDA's liking but don't have to be dealt with for the trial to start, they just have to be corrected in a timely manner. If anyone is interested, a range of conditions are listed on page 7 here:
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