Edwards completing their next gen Sapien trial first was never in doubt. They started enrolling the Sapien X4 pivotal trial more than a year ago and, while they did have an issue with the delivery device that forced them to pause the trial, they seem to have been enrolling again in the last few months.
Also, at TCT both Medtronic and Edwards presented ongoing 4 and 5 year data for their valves in low risk, typically younger, patients that showed the valves' durability. The big boys are always going to have more money to do more studies and thus generate more data in hopes of persuading doctors and patients to use their valves.
And it's important to remember that often the doctors singing the praises of the DurAVR also say nice things about competitors' valves, because those valves save lives too. This article on those long-term studies has quotes from Dr Leon, who is one of our advisors, and Dr Reardon, who is running our trial: https://www.fiercebiotech.com/medtech/tct-medtronic-edwards-longer-term-tavr-studies-continue-perform-par-open-heart-surgery
The important thing as an investment is whether the DurAVR can be expected to sell enough valves once commercialized, which I think will probably in the first half of 2028, to provide upside from the current market cap. I project that we'll have 35 million fully paid shares at most at approval, which means that sales of 1,200 valves are currently baked into the cap. That should be about 1% of TAVR sales in 2029. So if you think we'll capture more than 1% of sales in 2029 then AVR is likely a compelling investment but it's probably a long-term hold (barring buyout).
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Further Update on Edwards, page-7
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