I agree that lack of awareness could be a big issue, especially...

I agree that lack of awareness could be a big issue, especially here in the US where nobody knows about AMEUF, the US version that is traded over the counter. A big part of this is because the stock is not DTC eligible, which means that the majority of brokerages don't offer trading in the stock so most investors aren't able to buy it. The DTC is the main clearinghouse for OTC traded stocks.

I talked to investor relations about this last December and they told me they were working on getting DTC eligibility but nothing has happened since then. I stopped checking on it because I figured the Nasdaq uplisting would happen soon, which would make the issue moot, but Wayne has said that they are going to wait on Nasdaq until market conditions better support the capital raise that a Nasdaq uplisting will require. I'll try to contact investor relations again this week and ask them about gaining DTC eligibility.

And then IMO there are a few other obvious reasons why the stock hasn't gained more momentum: general market conditions and an uncertain global economic future make investors more wary of companies that will need to raise large amounts of capital to fund operations.

Plus the delay in the EFS being announced makes it appear that timelines are being lengthened and that can be a buzz kill for clinical stage companies, especially ones that may be 3 years from approval. The latest Bioshares analyst report (available for download on Anteris' website) posits the pivotal trial starting early next year, which I think is probably overly optimistic, taking a year to enroll and then following patients for a year. That means 2 years to get data on the final patients, then time to prepare the data for the FDA and another 6 months to a year for the FDA to deliver its decision on approval. Then we can start impacting patients' lives on a large scale and selling DurAVR in volume but that's getting close to 2026.

That's why getting an FDA Breakthrough Device designation is crucial. It can speed up the process somewhat. Not the length of time the trials take but the time it takes for the FDA's administrative stuff to be done along the way. If we show significant advantages over currently available devices we have a good chance to get it, which I think we do. But we probably need to show that in FDA approved studies, which we haven't started yet.

The wildcard here is getting approval in other countries/regions in the interim. Being granted a CE Mark in Europe would allow us to sell DurAVR there and can probably happen in a shorter time frame and obviously there are other markets but the US is the largest and the FDA carries weight around the world so that's why the main focus is there/here.