Pinned straw:
Too Much Think + Maths = Make Brain Hurt
Trying to work out how many humans currently have a DuAVR is hard. It’s a bit like doing an escape room or scavenger hunt whilst simultaneously lodging your own tax return inclusive of applying post July 2027 CGT rules — and probably equally as pointless. The whole thing is almost certainly not good for you either.
I’ve just listened to a podcast published yesterday (but the interview appears to have been recorded last week), where CEO Wayne Paterson talks about the number being more than 200. He also said that just prior to the pivotal commencing that number was just north of 150.
The bulk of DurAVR implantation in between has been during the Paradigm trial. So approximately 50 patients, with the other 50 being randomised to standard of care. Which means that’s close to 10% of the 1200 patients done already and the US is only just getting started due to the CMS approval. Paterson went on to say that the study will be fully enrolled (read all patients implanted) by end of March 2027. Which means, the answer is…that by this time next year at least 750 people on this earth have a DurAVR in their heart.
The prospect of interim readouts has come up before in these discussions @mikebrisy, and it looks like we might now have an answer to that also:
Host: Is there an interim analysis on the pivotal study?
Paterson: No, it's such a quick study. Well, firstly, I think we've got so much data already that in a device, that doesn't change. It's not like the variability you get in the phase three or even a binary outcome.
When you've got this much data that we have on a device, you're within 1% of what the clinical trial is going to look like. And we've already been in clinical trials, including FDA studies, so controlled studies, of course. So interim analysis on a 12-month study is actually going to slow you down.
Interesting that he is thinking in terms of 12 months for what is a nearly 3 year pivotal trial — I think it shows that Paterson is saying the cat is out of the bag from the moment the last patient is off the table (and likely even before). I tend to agree. To industry insiders the skinny on this will be known long before the 12 month endpoints for each patient, and the share price re-rated accordingly.
@PabloEskyBruh interesting about the "no interim analysis" comment (I haven't listened to the podcast yet.).
At one level that makes sense, given that the Primary Endpoint is the composite outcome measure at 1 Year, and clearing that - I guess - is binary.
However, the Secondary Endpoints and Other Measures (including to test whether the product has superior haemodynamics, which seems likely based on lab data, and which will be an important proof point for commercial success) are measured at both 30-days and 1-year.
Once all patients are enrolled and fitted with devices, presumably it would be possible to give an interim analysis on the 30-day result. I don't understand why that would "slow you down", as the clock keeps ticking uninterrupted for all patients irrespective of any analysis. The only issue I can think of, is what good is data on secondary enpoints and other indicators, when you can't say anothing about the Primary Endpoint?
Sounds like I need to listen to the podcast, as I am interested!
It is positive that they are now enrolling in the US - that should speed things along. If Wayne is right, it means we get a full read out in March 2027 + 12 months + analysis time, so maybe mid-2028?
Disc: Held