The plan is to submit the investigational device exemption in...

The plan is to submit the investigational device exemption in Q1, which requires completion of the animal and bench studies the FDA wanted so I'm assuming those are still ongoing. An investigational device exemption is required to allow a device to be used in a clinical trial and once submitted, the FDA has 30 days to approve it.

The pivotal trial design also has to be approved and factors into the IDE approval process and has been ongoing for quite some time, the press release in June mentioned that details about the trial's structure had been submitted. Not sure if being a novel design with the DurAVR being tested head to head against incumbents will lengthen the process but it's important to remember that unfortunately the FDA is swamped with work so back and forth can take an agonizingly long time from a company's perspective.

Once the IDE/study design is approved, it has to be approved by each hospital included in the study so that takes time. I think July would probably be a reasonably optimistic time to expect the first pivotal trial implant if everything with the FDA goes well. Maybe having half the trial consist of Medtronic and Edwards devices will speed things up but I'm sure that those implants will still have to go through strict trial protocol, otherwise Wayne could just use data from Edwards' and Medtronic's trials. With at least 30 sites by my guess and at least 1000 patients, this is a massive undertaking for a small company.