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Pinned straw:

Last edited 7 months ago

Anteris pushing boundaries…

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The above image is a screenshot from an Xray Fluroscopy video of a world first Valve-in-Valve replacement of both the Aortic valve and the Mitral valve of a patient using Anteris’ DurAVR. Hopefully there is an official Anteris press release this week about this.

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This is exceptional as DurAVR — as the name suggests — is designed only for Aortic Valve Replacement, but clearly has some versatility. Without the text I’ve pasted below I’d have no idea what I was looking at, but you can see the mesh frame in the top right is already expanded — that is the Aortic DurAVR from the month before. The one on the left is the Mitral DurAVR implantation during the balloon expansion. There appears to be no previous mesh frames/stents as the earlier valve replacements in this patient were surgical (as opposed to Transcatheter as in TAVR). In both cases the DurAVR is placed inside the surgically replaced valves, which themselves are inside the patient’s failed native valves. Dr Meduri is Anteris’ Chief Medical Officer.

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Click here for link, but extract (without video) from Dr Meduri’s LinkedIn post is below:

Christopher Meduri

Structural and Interventional Cardiologist at Karolinska University Hospital and Chief Medical Officer for Anteris Technologies

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First-in-Human Dual Valve-in-Valve Success with DurAVR™ THV

We are proud to share a groundbreaking case highlighting the versatility and performance of the DurAVR™ Transcatheter Heart Valve (THV) Anteris Technologies in both aortic and mitral valve-in-valve (ViV) procedures.

Patient Profile:

• A patient presented with a failed 25mm Sorin Crown aortic valve (True ID 21mm) exhibiting a mean gradient (MG) of 55 mmHg.

• Additionally, the patient had a degenerated 31mm SJM Biocor Epic mitral valve (True ID 27mm) with severe mitral stenosis (MG 18 mmHg) and moderate to severe mitral regurgitation.


Aortic ViV Procedure:

• The aortic valve was addressed first with a straightforward transfemoral approach

• Utilizing DurAVR™’s precise commissural alignment capabilities, the valve was successfully deployed with perfect alignment to the surgical valve.

• This resulted in a remarkable reduction of the MG to 5 mmHg at the 30-day echocardiographic follow-up.


Mitral ViV Procedure:

• One month later, a transseptal approach was employed for the mitral ViV.

• The deployment was straightforward, and post-procedure assessments revealed:

- Mean gradient of only 2 mmHg

- No residual mitral regurgitation

- Beautiful flow through the valve as seen on the TEE images in the surgeon's view, demonstrating the full opening of the biomimetic leaflet design.


Key Highlights of DurAVR™ THV:

• Exceptional Hemodynamics: Achieves low transvalvular gradients in both aortic and mitral positions.

• Versatile Deployment: Demonstrates effective performance in both transfemoral and transseptal approaches.

• Innovative Design: Features a single-piece, biomimetic ADAPT® tissue design that facilitates optimal leaflet coaptation and flow dynamics.


This case exemplifies the promising capabilities of DurAVR™ THV in addressing complex structural heart interventions. Much more coming in the upcoming PARADIGM Global trial! Incredible collaboaration across physicians and the Anteris team to successfully treat this patient! Vinayak Bapat Rishi Puri, M.D., Ph.D., F.R.A.C.P. Kari Feldt M.D. Won-Keun Kim Miho Fukui Marcus R. Burns Maia Zhividze Teona Zirakashvili Madhulika (Maddy) Srikanth Jason Quill Jamie Hughes, PT, MBA Angela McGonagle Udo van der Meulen Philip J. Olson Sophie Van Creij-Meewis Gary Mulkins, MBA, (RT)(CV) Justin Coe @courtneymcalister Salem Cherfi

Goldfish
Added 7 months ago

Yeah sure, it's another small piece of evidence that AVR have a quality product

The mitral valve is quite different anatomically than the aortic. Lower pressures, 2 leaflets (vs 3) and slightly larger. Not sure why in this particular case they decided to use a DurAVR rather than a product specifically designed to replace the mitral valve. I would have thought that using DurAVR to replace mitral valves will never be more than a small niche

Also, mitral valve replacements are an order of magnitude less common than AVRs

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PabloEskyBruh
Added 7 months ago

Yes @Goldfish, I should clarify the ‘World First’ is just for using the DurAVR product for both applications in the one patient. I didn’t mean to mislead. Edwards Sapiens 3 (or variations of it) are used for Mitral valve replacement. I know little about it but it seems like much smaller TAM and more surgical options (such as repair).

This particular patient seems like an unwell person. With two failed surgical valves already and no longer young or strong enough for open heart surgery they opted for DurAVR Valve-in-valve and then, one month later, there was perhaps not enough room (or perhaps the surgeon was impressed with unique aspects of DurAVR’s catheter delivery) they lead to them favouring DurAVR again.

I think it’s important because it showcases the versatility of DurAVR (especially in Valve-in-Valve replacements) and — as Wayne Paterson says — it’s a platform, not a single product.

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Goldfish
Added 7 months ago

Agree completely

What this definitely shows is that Cardiologists at Sweden's highest ranked teaching hospital have confidence in DurAVR. Even to the point where they are prefer it for a difficult mitral valve replacement. Without doubt this is a small piece of further evidence of the quality of the product. Big research centres like Karolinska tend to be very influential. This will give others confidence to try DurAVR.

Good product, bad financials.

What to do?

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PabloEskyBruh
Added 7 months ago

I know your question is slightly rhetorical @Goldfish, but I’ll give you my answer. What I’ve decided to do is come up with my best guess of what a successful DurAVR platform might be worth in 5 years time and work back from there.

I trust the market and I trust capitalism. In the same way that I trust science, I trust it without understanding all of it — or even anywhere close to half of it. I’ve learned bits and pieces about how Wall Street covers MedTech, and some of what the finance options are for companies at the stage Anteris is at. It’s nowhere near enough to be across it. But for me it’s been enough to give me confidence that Anteris will weather the quarterly financial storms, will weather the culture wars and any regulatory changes associated with it, and that any value in DurAVR will flow to me as a shareholder in accordance with the proportions that I own. Maybe that’s blind optimism, but maybe that’s also just how the system works.

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Goldfish
Added 7 months ago

Ok I understand where you're coming from

I agree that someone is probably going to make money out of this product. The concern is that it may not be current shareholders

Trying to understand what management has done. They IPOed on the NASDAQ 5 months ago. Raised enough capital to keep the company running for just one year. Presumably the thinking was that within that year they would get FDA approval and get the pivotal trial started. Then they would be able to raise more capital at a higher price. Obviously, given what has happened to the share price since then, it would have been better to raise more capital at US$6.

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PabloEskyBruh
Added 7 months ago

Yes. That’s right. There is the risk of dilution.

Maybe they wanted to raise more but couldn’t. Personally, I think the redomicilation was much more of a priority than the amount raised during that specific raise — it was about being in the position that all future funding happened in the United States and that M&A negotiations had the starting point of Anteris already being a Delaware company.

I’ve grown to trust the CEO, the executives, and the board over the last 3 to 5 years in particular. If you go back further than that — say during times of no news in the middle of ASX suspensions — there will be a post or two of mine about management that may have even earnt a cursory glance from @Strawman ’s lawyers. Since that time I’ve learned not to underestimate Paterson.

Things may take longer and go over budget but they have delivered consistently (in terms of direction and strategy) accordingly to plans and roadmaps laid out in the years before they happen. I’m confident that, for them, there is nothing occurring now that they don’t have reasonable contingencies for.

For me, the risk in trying to time an entry point now is smaller than the risk of missing out on the upside. If my holding in Strawman does dip below 20% again I can always put more in. For my IRL portfolio that would be harder to achieve because I’m already fully invested — but I would weather consecutive quarters of dilution and accept it as the cost of Anteris remaining a going concern for the duration of the pivotal trial.

One thing I have noticed about US medtech companies is that do seem to guard their equity capital quite jealously, much more than pretty much every ASX small cap. I think all options for bridging financial gaps will be on the table, and the board — as is their duty — will be acting to preserve the capital of their existing shareholders.

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PabloEskyBruh
Added 7 months ago

I’m honoured to be finally vigorously defending my investment thesis after many years of posting into the ether. It does kind of feel like I’m sitting here in a meeting wearing a T-shirt and a bad haircut whilst qualified people in suits make very good points (only in this case I have none of that comfort of actually knowing how this story turns out)…

Pablo E. Bruh: Watch, it will pay. I may have been early, but I’m not wrong.

Every sensible Strawman investor: It’s the same thing! …It’s the same thing Pablo.

https://youtu.be/pLLgNi5UmB0?si=2CPAA6527X5ABV20

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Goldfish
Added 7 months ago

Lol

I enjoyed that movie

And this has been an interesting discussion

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PabloEskyBruh
Added 7 months ago

Haha, it’s one of my favourites @Goldfish. It has been, thank you for your insights and interest.

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