Anteris Technologies Global Corp.

ASX:AVR

Anteris Technologies Global Corp.

ASX:AVR
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$7.34 (0%)
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#31
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Forum Topics AVR AVR ASX Announcement

Pinned straw:
mikebrisy
Added 2 months ago

Interested in @PabloEskyBruh's take on today's announcement of a study by $AVR on performance of DurAVR in a particular patient segment. Note this is outside of the current all-comers, head-to-head PARADIGM pivotal registration trial.

TLDR: a further positive signal of superior performance compared to that typically seen for commercial devices on the specific metric of rate of PPM (defined below).

ASX Announcement

Analysis of the Study results and Relevance

The newly published 100-patient analysis of the DurAVR transcatheter heart valve provides important early insight into how the device performs in small aortic annuli, a subgroup known to be particularly challenging for today’s commercial valves. Small-annulus patients represent a minority of all people undergoing transcatheter aortic valve replacement, but they experience a disproportionately high rate of prosthesis–patient mismatch (PPM) because their anatomy limits how wide the valve can open.

In current commercial valves, moderate or severe PPM occurs in roughly 11–35% of such patients. In this pooled DurAVR analysis, however, the valve produced an average effective orifice area of 2.2 cm² (reflecting how well the valve opens) and a mean pressure gradient of 8 mmHg (indicating the resistance the heart must pump against), both pointing to excellent blood flow.

Most notably, 97% of patients were free from moderate or severe PPM, far lower than the mismatch rates historically seen with existing devices. This early signal is directly relevant to the company’s recently commenced PARADIGM pivotal trial, which will randomise more than 1,600 patients, including a large predefined subgroup of small-annulus patients, to determine whether DurAVR can consistently outperform standard valves such as Sapien and Evolut.

Limitations

That said, the scope of the current dataset is limited compared with PARADIGM’s broad, all-comers population. The 100-patient cohort is drawn from early-feasibility and prospective multicentre studies, not the controlled, head-to-head randomised setting of the pivotal trial. It represents only a fraction of the anatomical diversity, risk profiles, and comorbidities that PARADIGM will capture across its multinational enrolment. Follow-up in this dataset is only 30 days, whereas PARADIGM will evaluate long-term durability, structural valve performance, safety outcomes (such as death and stroke), and quality-of-life measures out to one year and beyond, with all imaging and hemodynamic data adjudicated by independent core laboratories. Thus, while the early low-PPM signal is encouraging (especially in a subgroup where current valves struggle)definitive conclusions will depend on the much larger and more rigorous PARADIGM trial.

Implications

I am still getting up to speed with this company, and the therapy area. However, I have recently conducted a "deep dive" that indicates that on all key metrics, DurAVR appears to be either superior or in some cases at least not inferior to existing commercial devices.

Today's announcement is not marked price sensitive. And that appears consistent with other clinical updates on studies not directly related to the clinical development program. However, I consider it significant, as it does provide another positive signal on a metric that is relevant to PARADIGM. With a 100 patient sample to have 97% free of moderate to severe PPM, is a good result considering the reported 11-35% incidience occurring in commercial products. Importantly, the larger data set adds to a much smaller, earlier study also indicating superior performance on the PPM risk.

I have recently initiated a tiny "research position" in RL (0.2%) in $AVR.

There's a long way for the PARADIGM trial to run, and we cannot know based on previous data, how the device will perform given the rigour of the trial, including independent assessment of outcomes. It is not the kind of clinical development risk I usually have in my portfolio (no current revenue; long time to commercialisation; high and uncertain levels of dilution ahead.) However, I will now hold a very small position, so that I can track development over time and keep it on my radar. In the success case, the value upside is very significant.

Disc: Held
PabloEskyBruh
Added 2 months ago

It is a good development @mikebrisy , as evidenced by the customary sell-off for good news for Anteris.

My understanding is that women are over-represented in the small aortic annuli category and the mean gradients tend to be higher. I think it is DurAVR’s low profile and potentially smaller diameter that give it its edge here. It is the same characteristic that makes it a promising valve-in-valve solution.

I am pleased to see your starter position too! May the endowment effect take hold and you can join me gollum-like in this dark corner of Strawman where we can post ad nauseam about our precious…

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JohnnyM
Added 2 months ago

It’s all good Pablo…

As I said in my first post about this company.. I don’t understand it.. but there is a 100% chance I need this technology in the future..

So I’m in the dark corner with you.. wake me up when we actually make some sales.. when the company shows some signs of financial discipline…

…… and tell the CEO to stop being such a greedy twat!

JM

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mikebrisy
Added 2 months ago

@PabloEskyBruh yes, its funny that.

Super strange that what is undoubtedly a positive signal for one of the PARADIGM endpoints should lead to a SP fall, given the prize in the success case. Let's see what NASDAQ does.

I guess it is a combination that: 1) it is not really on the ASX investor radar, 2) long time to trial end, and 3) multiple cap raisings ahead.


Musings for Gollum's Cave

While I am thinking about this, I was doing some quick calcs to better understand PARADIGM.

1,000 PARADIGM patients of approx. 200,000 TAVR procedures per year is 0.5% of available annual procedures are required for the trial.

$AVR have qualified 79 centres to date, and my BA estimates that there are around 1,000 - 1,500 sites globally that perform the procedure or, say, 6% at midpoint. Let's further assume that the qualfied sites are more specialist / CoE type sites, so that they do double the annual rate of procedures, i.e., that they get 12% of the annual 200,000 procedures, or 24,000 TAVRs p.a.

So PARADIGM needs 1,000 trial volunteers out of ballpark 24,000 annual patients at the centres (assuming patients don't "trave" to be part of the trial), or roughly 4% of the volume passing through the trial centres if it s going to get done in one year, or 2% if it going to get done in 2 years.

So, I guess a key determinant of timeframe is how good a job they can do "selling" the procedure to patients who need the procedure. And I started thinking, based on what I have found out about this, would I volunteer if I needed the procedure?

Maybe one challenge is that the existing, commercial devices have success rate data now for several years, whereas, there isn't the history for Dur AVR. From what I can find, around 130 procedures in total have been completed, with 0 device-related deaths, 1 explant, and 6 pacemaker interventions. So, I'm guessing the risk profile for a patient's informed consent looks reasonable, but the stats just have lower confidence around them due to the small population.

So, a key marker is going to be some kind of update on "enrolments to date", from which we can probably start to extrapolate timelines. Without knowing the timelines, it is just one more big uncertainty.

Which brings me back to today's result: a 3% PPM risk (alebit for a particular cohort) is a lot better than 11-35% risk. That kind of result could really help the enrolment rate to the trial, if the trial protocol allows potential patients to be offered the information!

One device to rule them all!

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PabloEskyBruh
Added 2 months ago

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Haha @mikebrisy, I think you are the GPU-enabled Gandalf that this discussion has been missing. I love that you’ve crunched those numbers. But, I also think you would be a unique patient in having done that level of research.

I think there are points in our lives where sometimes we just put our trust in the experts. I know, for me, that interventional cardiology (which I hope to never need) would be one such time. I also think there is a zeal to those surgeons that run these trials — and the patients are being treated by the surgeons, not the medtech companies. That’s where the trust is. I think as long as Anteris truly has picked the right centres and surgeons recruitment won’t be an issue.

Also, this is the States. I think you have already seen this video, but it’s worth re-posting here:

https://anteristech.com/news/PARADIGM-Trial-Launch-Video.html

Can doctors even talk about any product like this in Australia? Let alone an experimental one? I don’t think they can. I think insurance comes into it too. If your US health insurance company only offers TAVR by means of this trial you may have little choice. I’d say the patients would have to consent to the possibility of receiving either DurAVR or standard or care (Sapien or Evolut). Just FYI, this entire last paragraph are my best guesses — I haven’t done the research on it.

I definitely concur with all the cap raising portions of this straw but — to me this is the main hurdle for Anteris at the moment. It’s just an issue that doesn’t seem to ever go away.

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