Ladies and gentlemen, and fellow shareholders, thank you for being here today, and welcome to the Anteris Annual Meeting of Stockholders. I'm John Seaberg, Chairman of the Board of Directors of the company, and I will be serving as Chair of the meeting today. Today's meeting is being held both in person at the InterContinental Brisbane and in a virtual meeting format via live webcast. Every effort has been made to ensure the meeting runs smoothly, but if you do experience technical difficulties, please contact the technical support number posted on the Virtual Stockholder Meeting login page. In addition, this meeting is being recorded, and the recording will be available on www.virtualshareholdermeeting.com for 90 days after the meeting. The format for the meeting today will consist of a presentation from Wayne Paterson, Vice Chairman and Chief Executive Officer, who will provide a business update followed by questions.
This presentation will be followed by the official business of the meeting. Joining us today in Brisbane are Wayne Paterson, Vice Chairman and Chief Executive Officer, Stephen Denaro, Director, and joining virtually are the other members of the Anteris Board of Directors, the other members of the Executive Management Team, and representatives of Broadridge Financial Solutions, who is hosting the virtual meeting and tabulating the votes. I would also like to introduce Stephen Board, Audit Partner from KPMG and the company's independent registered public accounting firm. Mr. Board has indicated that he does not wish to make a statement at this time, but will be available later to respond to any appropriate questions. In addition, Matthew McDonnell, the company's Chief Financial Officer, is in attendance and will be acting as Secretary for this meeting.
Before turning the meeting over to Wayne for his business update, I'd like to formally welcome several directors to our board and this general meeting. In addition to Wayne, Stephen Denaro, and myself, in March of last year, we promoted David St Denis to the role of President and Director. He is no stranger to our board, and he continues to function as Chief Operating Officer. Additionally, this June, we added Greg Moss and David Roberts to our board. You can read their bios on our website, and you'll note that they both have strong experience in NASDAQ healthcare companies as well as other complementary corporate skills. An annual meeting is, of course, a formal milestone, but it's something much more meaningful.
It is a reminder of what happens when a management team and an investor base choose to believe in a bold idea and decide to stand behind it with conviction, patience, and purpose. I often praise Wayne, David St Denis, and Chris Meduri, our Chief Medical Officer, for modeling the work ethic, the knowledge, and the passion required in this demanding space. They truly have created a corporate culture that has created a great product that is setting the standard for innovation in the TAVR space. This culture of saving lives and making money that energizes our employees can also be found in our investor base. With each of you invested, when each of you invested in Anteris, you invested in more than a company.
You invested in a mission, a mission grounded in compassion for the patient, innovation, and the unwavering belief that we can make a profound difference in the lives of patients around the world. Innovation in medical technology is not easy. It demands courage, it demands endurance, and it demands a willingness to hold firm to a vision long before the world fully recognizes its value. Yet this is exactly what you have done. You have stood with a team striving not just to improve a product, but to reshape what is possible in cardiac care. Today, let us take pride in the fact that we are part of something rare, an endeavor where scientific ambition meets human impact, an endeavor where the commitment of investors directly supports innovation that can and does transform real lives.
As we look ahead, let us carry with us a sense of confidence, not just in the company, but in the purpose that drives it. The journey may be demanding, but it is purposeful. The work may be complex, but it is important. The future, built on a foundation of vision and resilience, holds extraordinary potential. Let us continue forward together, focused, inspired, and united by the belief that progress worth making is progress worth standing behind. On behalf of the board, thank you for your trust, thank you for your belief, and thank you for being part of this remarkable journey. Now I'll turn it over to Wayne.
Thank you, John. Okay. Firstly, apologies to everybody out there for the delay. The InterContinental Brisbane has a problem with their internet, and hopefully you will be able to hear this presentation. If not, you'll be able to watch it after the event. For those online and for the packed house audience we have here today, you get to see it live. So lucky you. All righty. John gave a pretty good overview of where we are today. Many of you have gone through this journey for a lot of years. You understand the nature of the data and what we do. So today I'm really going to talk about a couple of things. But before I start, I wanted to share with you some insights from employees in the U.S. in Minneapolis.
Many of you on the Australian side of the register, of course, don't get to see the facility. Maybe think there's three blokes in a cowshed in Nowra who do this for, and that, you know, where does the money go? What I'm trying to show with this particular group of employees is the size of the facility, the size of the undertaking, and the things that we have to do as a company that are not negotiable when it comes to making medical products, obviously, that go into patients globally. Hopefully this will give you a good insight. If you could start the video.
And here I am in one of our tissue processing labs. Of course, we have these in Australia and the U.S., and Kevin is the actual global head of tissue processing. Kevin, tell me a little bit about what you do here.
Yeah. So right now, as you can see, we have a number of tissue processors. We're taking in raw pericardia that's coming from our harvested tissue in Australia, and they are cleaning this up so that it can be ready for and optimized for valve production. Obviously, you can see them removing aspects that then help bring in characteristics for the valve to be as optimal as possible.
Fantastic. And tell me a little bit about the ADAPT process in general. How is it different to the tissue that's available out there?
That's a great question. Yeah. So the tissue that we have for the ADAPT process, from this point on, we are able to impart certain aspects onto the tissue that help with patient outcomes. One of the main ones that we look at is the anti-calcific response that we get in our tissue that is really derived from some detoxification steps that we perform, as well as we have an acellularized tissue set that helps with immune response not occurring as readily in patients.
Great, and of course, the whole objective of doing this here is to increase our yield for clinical trial and production. How's that going?
Yeah, currently. So part of this effort here is we are trying to perform for a scale-up to pivotal studies and beyond. So we are doing quite a lot of just personnel, equipment, and space expansions, but we are also integrating in different processing and manufacturing aids to help with efficiency and help with quality output.
Great. Well, thank you very much for that information.
Yeah, thanks.
Now I'm coming up on part of our manufacturing facility here, and here's Brian, who is the head of tech ops or manufacturing. Good to see you, Brian.
Good to see you, Wayne.
Tell me a little bit about what you do here.
As the head of operations, my role is to make sure that we scale up manufacturing and ultimately deliver the highest quality product on time to our patients.
Of course, we've just had a recent facility expansion. Tell me a little bit about how that's impacted workflow?
Yeah, that's actually this room that you're looking at right here is our second clean room, which just by adding this alone has tripled our capacity.
Right. And of course, part of your job is to ensure that we have enough inventory to run the clinical trial. Of course, we're right in the middle of that at the moment, as well as get us ready for the next step, which is commercialization, to make sure we can supply product to our physicians out there. How are you tracking towards that objective?
We're actually ahead of our goals. We are going to exceed the expectations of the pivotal trial capacity.
That's fantastic. And of course, you were previously a head of global TAVR manufacturing for another company.
I was.
How are we tracking as Anteris with regards to other companies?
Actually, a big part of my team, a good portion of my team, has been part of larger organizations, TAVR organizations, and all of us, I can tell you, are very, very confident with where we are and where we're going to go.
Fantastic. Thank you so much.
You're very welcome.
We have one of our quality control labs, and of course, Eric, who is head of global quality. Eric, tell us a little bit about what you do here.
Sure. I run the quality organization for Anteris. We have a number of key responsibilities for the company, from partnering with the R&D organization during product development, and then really where we've spent a lot of time the last year to make sure that that product design goes into manufacturing and comes out as incredibly high-quality products. As part of that, where we are right now is our quality control lab, where we make sure that every single component that we buy goes into the manufacturing flawless and it comes out as an incredibly perfect device on the back end to give to a physician and a patient.
Yeah. And of course, some folks may not be familiar with what quality means when it comes to a healthcare product. Not only are we controlling the quality of what we do here, but also the quality of our third parties as well. How do you manage all of that?
Correct. It all starts with keeping in mind that it's all about putting the best product in the physician's hands to give the patients the best possible outcome they can have. To do that, we have to control our own operations internally as we scale into the paradigm pivotal trial, but we also do have to partner with a lot of other manufacturers and make sure that they fully understand our requirements and that they can meet them. And then when they ship us components, we confirm that every time before they go into manufacturing. So it really is internally, but also outside with our other partners.
Right, and of course, patient safety is non-negotiable for us.
Sure. Yeah. My philosophy is we will meet the global regulations in every single market that we operate, but that's just the starting point. At Anteris, we don't intend to be like every other medical device company out of there. We set the bar incredibly high for ourselves. So we will meet those requirements, but we add a lot of additional ones on top of it where they ensure that we will get the best product in the physician's hands and give the patients the best outcome.
Right. And of course, you are in charge of quality organizations in this industry globally in the past. How has that prepared you for a company like Anteris, who is now moving into that commercial place?
Sure. It's all about maturing the organization as we go along. It starts with hiring the right people. We have a great market here where we bring in a lot of talent locally, and then we bring them into the way we do things at Anteris and really educate them, get them operating the way we need to, and then it's maturing our systems as we go along. So it's a mix of maintaining what we've built today, but it is a great opportunity and a lot of fun doing the building as well.
Great. Thank you.
All right. Thank you.
This room has really been where all of our core and durable heart development has happened. Over the years, we've been testing initial prototypes on the pulse duplicator. That essentially is a machine that mimics the cardiac function of the hearts and allows us to assess the valves for their EOA and MPG. The durable design was chosen to mimic the native healthy aortic valve, and because of that, we've been able to optimize EOA and MPG in our design choices. Once hydrodynamic performance has been assessed, we then move the valve onto our accelerated wear testers. Our accelerated wear testers test at around about 10 Hertz. That's 10 times faster than your average heart rate. Those valves that run through the accelerated wear testers allow us to understand the durability.
That allows us to make sure these valves are not only going to improve flow in patients and restore their normal cardiac function, but also last for as long as a patient needs. So R&D has been preparing for the pivotal trial for years. We've done an extensive amount of rigorous testing to prove the hydrodynamic performance and durability of the valve. All of that work is required to make sure that this valve is truly safe and effective as it goes into our patients. And here we have the engineering lab for the delivery system, and Matty is the director of R&D. Hi, Matty.
Hey, Ray. How are you?
Doing well. Thank you. Why don't you tell us a little bit about what you do here in the lab?
This is our delivery system testing lab. Here, a lot of the testing work that we do is related to all of the system-level testing. How does the product interact with our introducer sheath? How does the delivery system go into the anatomy over the track model and into the valve implant space? All of that test happens here. Our testing typically falls in like two major buckets. One is challenge case conditions because we want to be prepared for complex anatomies if they show up. At the same time, as engineers, we love breaking stuff. We will also test the product to its limits to understand what that failure mode looks like. That way, when we're designing, we are a few fold lower and we never have to hit it.
So that way, going into a clinical case, we have full confidence on the product that's going to perform and it's going to perform well testing.
Of course, to do that, you work very closely with doctors.
Yes.
Tell me a little bit about what that's like.
I think that is my favorite part of being a part of this Anteris community, and I don't think I've seen it elsewhere, is that close collaboration. We get to work very closely with our CMO, Dr. Meduri, and our physician advisory board. So what they do is they help us reduce that feedback loop because they're here with us testing in the lab at many conditions and letting us know what that gaps look like so that we can tweak the design, test it in a way that's more anatomically appropriate. They validate our models, and this gives us that opportunity to get that confidence in our testing. And we learn so much about their world firsthand. They learn about our engineering world. And many times, those are very different languages, and it allows for that collaboration and a better understanding to make a good, good quality, world-class product.
Right. And of course, it's never one and done.
Yes.
There's been a lot of years, a lot of your input and your colleagues into refining and iterating this device. Where do you think we are on that journey now?
We've had so many design loops and so much work done to optimize this product for good performance. I feel very confident that this product is going to do well. The team has done a tremendous job putting together every single detail of optimization to every single feature of the product, and whatever goes there into the clinic, I know it's going to do well.
Great. Well, thank you very much.
Thank you.
Now I'm entering the logistics and distribution center for the company. I've got Andrew and Brian here. Good to see you guys.
You too, Wayne. Good to see you, Wayne.
Andrew, you're head of this group. Tell me a little bit about what you guys do here.
Yeah, so we do a lot of our distribution and logistics out of this facility. So right now, what we're doing is getting ready to ship worldwide for our paradigm trial. All of our inventory is housed here in our main distribution center.
Great. And Brian, we've recently expanded the facility. Tell me how that's affected your workflow and what you do here?
When we came in here, we were in a small little warehouse, and we've expanded to almost three to four times the size of our warehouse now. The amount of product we're bringing in has doubled the amount, and just to get it out the door is double the amount of work too, so it's been amazing to have this facility to be able to do it.
Great, and what are you shipping right now?
Right now, we're working on current-present valves, Wayne. Those are intended to be for our next cases coming up in December.
Great. And you've got valves. What other components?
Valves, yep, delivery systems and sheets as well. So we've got the whole kit we're working on. The whole kit's going out, yep.
How do you think, guys, the next six months is going to look in terms of the volume going out of here?
Oh, the volume is going to be great. It's going to expand tremendously coming in the next six months, and we're ready for it too. We've expanded this building great. Our racking's in place. We're ready to go for the next phase.
Fantastic. Good stuff, guys. Thank you.
Yeah.
Thanks, Wayne. And here we have the testing room. Chris, good to see you. Matty, good to see you. Tell me what you guys are working on right now.
Yeah, so we're just testing and validating some of our products that are going out for our upcoming patients in the paradigm trial.
Fantastic. Tell me, Chris, what do you think is the most important thing that Anteris does?
Well, you know, Wayne, to be honest, what I love about the company I'm excited about is the fact that we are really making new technologies that are transforming the way we can treat patients. And we've been able to see that with these incredible results from our first 130 patients. And it really is rewarding to see the work we're doing here.
And tell me about your physician, doctor, colleagues, buddies, friends. What are they really saying about the product to you?
I think the excitement is the fact that there's a world of me-too products, and this is the first time that somebody's genuinely bringing something that has the ability to transform how we treat patients with aortic stenosis. We are actually making a valve that's shaped to work and perform like a healthy aortic valve, which hasn't been done before. And to have paradigm-changing practices, we have to have a paradigm-changing valve. And I'm really excited to see the way this valve performs in our trial.
Yeah. And we see that with the data too, right? We were just at London Valves, and we presented that 100-patient data. I got a lot of feedback. I don't know what you heard, particularly around the PPM number. Do you want to just explain what that PPM difference actually means clinically, what the number was?
Yeah.
And help people understand that.
Yeah, absolutely. So essentially, PPM is the fact that if your valve is the way it functions is too small for your body, it doesn't match you. It's patient prosthesis mismatch. There's a mismatch of the two. And I think what is concerning is having things that mismatch is not good in general. We know that in all of life. And even the best valves available right now still leave you 10, 12, 13% of patients having this problem. Traditional market-leading valves are a 30% plus problem. Our paradigm-changing results we saw in the trial was that we had a 3% rate of having patient prosthesis mismatch in 100 patients. And that's a powerful thing that really is getting physicians excited.
And that's what I was hearing from other physicians as well. What do you think that really means for patients over the long haul?
Yeah, I think what's exciting is, you know, in the early days of TAVR, patients really weren't living that long. So we didn't get to see the major impacts of some of these things. Now that we have patients living a long time, new studies are showing us that if you leave patients with this problem, they're more likely to have heart failure issues, their symptoms are going to be worse, and they're likely going to live shorter periods of time as well. So again, I know that we're kind of believing this, but it really is paradigm-changing if we can actually take people out of their pre-disease state and leave them in a truly healthy state after the durable interventions.
Yeah. And that was the target and the goal when we set out to do this. And you and me were in the room that day with a blank piece of paper. And I guess the final question is, why do you think that our PPM rate is an order of magnitude times 10 lower than some of the other valves out there?
That's the best first question because I think everybody looks at it and is almost skeptical for saying, "How could it be that good?" And I think it goes back to just understanding the fundamental difference of DurAVR. We did not make a traditional three-piece bioprosthetic valve like every single other valve is there. If you look at a healthy human, they don't have PPM. And who do we try to copy? The healthy human's valve. And I think that's the easy answer for why we don't have those PPM issues.
So more normal physiology and anatomy, we think matters clinically.
Absolutely. It only makes sense, right? We don't have all these problems when you're in a healthy state. When you get into the disease state, things in your life start changing.
Yeah. I'll let you get back to the work, Chris. Thank you.
Thanks, Wayne. Appreciate you.
Okay. Hopefully, that gives you an insight, some view to what is happening behind the company. Obviously, in global commercial healthcare, you don't get to wing it. You don't get to make it up. The things investors should look for now that we're past the really tricky part with the data and proving clinical superiority is what else can pull the rug out from under you from an investment thesis point of view, and it is quality, and it is manufacturing, and it is all of those things that if you don't do that part properly, the next big thing doesn't matter how great your data is because you're going to have a problem in the facility. Some of my favorite people you just saw on screen, they're all incredibly talented. They're all coming from major global companies where they've done this for a job.
Like I said, you can't make it up. And of course, you saw the folks in the warehouse and everywhere else. They're just great people to work with. So we are leading the field. I put this slide up here because in this room, in this country, you all know what that means. But often I get the question of, you know, how are you going to take on the competitors? How are you going to do this? How are you going to do that? Or in fact, you can't do those things. The simple fact is, and people may not be aware of it unless you've worked in this industry globally, the competitors are actually following us. And that's a fact on the podium.
We are leading the science and have done for several years now in that we are talking about stenosis in a very different way, and they are following us. So it's not, how do we take them on? It's more the other way around. I come from this, or I come from the pharmaceutical industry. It's a lot bigger than the med tech space. But what I would say as well is that the market-leading company out there is actually a small company, right? It's a pretty small company. This is a very compact market. It's not like a David and Goliath story. It's like a David and David story. If you want to just get context on that, that's not hubris. That's the way that it is. So I'll talk more about how we're leading the field. It is mandatory that I do the financials.
You can read that very quickly because this is, in fact, the 2024 AGM as we head into Christmas for 2025. These numbers, of course, don't have very much relevance at this point as they're almost two years old. But let's look at these ones, 2025. The key thing to keep in mind here is really, is the company delivering on all of the targets and milestones and goals that it's set for itself? And they're not small ones. And the simple fact is, yes. The FDA approval, it was one month, give or take, delayed to the quarter that we nominated to the market. We did actually have a government shutdown in the middle of that. That certainly didn't help. We had a cap raise that was a little bit truncated for the same reasons.
The SEC was shut as we were about to flip that cap raise into a bigger number, so it was a bridging round, and of course, we got the European approval, and the paradigm study did commence pretty largely in time with what we'd said. The cost structures, you can see as they should reflect the scale-up into the study and, frankly, the pathway to commercialization. You can see that change continues to grow for R&D and manufacturing, and that's what you want to see. That's where the money needs to go. These are the areas, like I said earlier, where if you don't invest in those properly, you're going to have an issue. The AU or the FX rates gave us marginal benefit, of course. We see this year on year.
The reality is we raise our money generally in USD, and most of our OpEx expenditures, of course, are in USD. So one thing that's changed is that our access to capital has increased with our data. Those of you who've been around long enough remember when this was a drug company. Even before I got here, it was certainly in that realm of being a penny dreadful in that it didn't have a lot of institutional support. The institutions that were probably around it at the time were the exploitative kind, the ones that don't have retail investors' best interests at heart, and you do terrible deals. All of that said, it's because you don't have a good investment thesis. At some point, you come out of the primordial ooze, and you end up with either legitimacy or not, and that's obviously the chasm you have to cross.
You have checkpoints to ensure that the investment thesis still exists. If it doesn't, things have to stop. Data access, sorry, access to capital improves significantly with data to the point where people don't need to talk to you about your data. A lot of our investments now really are coming from New York and their healthcare funds. Healthcare funds are very different to generalists. Healthcare funds in general understand the FDA process. They understand the competitors. They probably talk to the CEOs of the competitor companies as well. They do talk directly to some of the doctors. They're much more hooked up to the space than a lot of other folks. The discussions with these folks now are really around capital and timelines. They're certainly not about the legitimacy of the science or whether that science is potentially commercially interesting.
The big investors you see there are, of course, also either our physician-led healthcare specialized, SIO Capital. Michael Castor is an investor. He's been a great long-term supporter before TAVR when we only had ADAPT. When I first started, Michael came in on the basis of the ADAPT science. Perceptive is one of the blue-chip healthcare funds in New York. People always look at that and say, "How did you get these guys on your register?" That Perceptive, it's a healthcare fund, physician-led. L1 Capital, of course, is a fund here in Australia in Melbourne. The practice, they are generalists, but the practice we deal with is physician-led as well. And so you see those that know kind of know. And those data discussions become a lot more minimal than what they used to be, of course, when you're baking the cake and trying to prove the point.
Fortunately, also, as obviously our cost structures have to go up as we get to this point in the company's life cycle, this is a legitimate multi-billion dollar product. You can see that. You hear it. You know what the data is. There's no cutting corners on some of this stuff. But it's also beyond the realms of retail investors' ability to be able to fund that company when you get to these levels. And that matters because you can see the difference here in that the funding is really coming from institutions or new institutions, which you see in the red there. All of the new money coming in the last two, three, four rounds has also been healthcare funds from the states. They're not generalist funds. They're in our space. And they invest sometimes in Edwards and Medtronic and other companies as well.
So they know what they're doing there. And they talk to many people other than just me. Within our company, it's important to understand the mix. 66% of the company is up in the states now. A large part of that is a facility you just saw. We've got 8% in Europe. Why do we have people in Europe? Because the paradigm study is global. There are European sites that add patients. And you have people in the field who monitor the clinical trial. Without them, recruiting can go off in the wrong direction. So the recruitment, the numbers we commit to to the market are critically important. And you have people who are specialized in that job. And of course, 26% in Australia, we still have the Malaga facility, which is critical to our ongoing future where we get our ADAPT pericardium from.
And you see the breakdown between manufacturing, R&D, and PMO, which is the project management office. Critically important again to support where we are in our life cycle. There's a lot of folks now in the very technical jobs. Obviously, that has to be supported by an SG&A function. Company doesn't run itself. One of our dear shareholders once spoke to me about bookkeepers and other things. Obviously, you can't run a company that way. We are a global company. We interact with global companies. And that is the bare minimum structure to support what we have. Otherwise, it goes off a bridge. And of course, people in our company can work anywhere. And you saw the quality of those people. You have to operate like another company. And that's the expectation. You have to pay them competitively. You have to provide an environment that's also competitive for them.
or you don't have the people you need, and that stops us dead in our tracks. The split between male and female is 59%-41%. That's a good mix. Obviously, we all appreciate how important that is. The leadership split is 51%-49%. So almost line ball. It certainly wasn't that when we started. And as a small company with legacy employees, you don't necessarily have the luxury to manage these things. And as you have control of the headcount over time, of course, you can balance things properly. One thing I really love because my whole career has taken me all around the world for the last 20-something years, 30 years, and I've been very, very lucky to do that, is cultural diversity. And you can see that map there, largely reflected from the facility in Perth and in Minneapolis. The ethnic diversity we have is incredible.
It makes the place interesting. It makes it better. And it's something we really fully embrace and appreciate in our organization. And it's a good thing for shareholders. You move quicker when you have different ideas. Obviously, we had the privilege of getting to the Nasdaq and ringing the bell about this time last year, actually. For me, it was one and done. We ring the bell. We move on. It's a point in history we have to do to get to the next point. It certainly, though, is a big deal. And I really felt proud ringing the bell on behalf of shareholders. And that's a fact that we're able to see the company's name up on lights in Times Square. That's a proud moment.
You know, when we think about the origins of this company, where it came from, how it started, what it was, in fact, not a TAVR company. There was a very, very good feeling to see our brand and our logo up there in Times Square. Those of you who've been to Times Square, you'll know exactly where that is. And of course, we re-domiciled the company to the U.S., so it is a U.S. company. The reason we did that is twofold. One, access to capital obviously is a different kettle of fish, and you saw that. Two, we interact a lot with the other companies, the competitor companies, what's called the strategics. And all of them have indicated, all of them, that in the event of a deal, partnership, acquisition, whatever the case may be in the future, it needs to be U.S.-listed.
That's certainly a critically important thing. Also, liquidity. You know, it's an illiquid stock on the ASX, typically, as you all know. It's still a reasonably illiquid stock on the Nasdaq, but obviously, liquidity is far greater. Every retailer, every shareholder prior to this was definitely pushing at me to try and improve liquidity. It's a hard thing to do. That's probably one of the very few solutions. Liquidity is up 1,000%. That's good if you want to sell, right? Otherwise, not really that important. Now, share price. Let's address the elephant in the room because it's an interesting one, right? You see the data. You hear the doctors. You see the facility. You know that we're legitimately ready to roll. This company can stand on its own two feet, and the share price has been all over the place.
But it's important to use context and not just look at Anteris in isolation of the share price, regardless of its clinical progress or other companies in our space. It really matters because I don't get any of these questions from the U.S., from the institutions, because they have whole portfolios. Obviously, a lot of the moms and dads, the retailers who invest in us in Australia do have those concerns, and I fully, fully understand them. And I'm trying to alleviate that a little bit. You can see the changes all over the place. The critical ones that influence our share price, I believe, are when the tariffs were first announced in the U.S., the whole markets came down because there was some uncertainty. I am a supporter of some of these tariffs. I'll just say that for the record.
But the uncertainty it created did bring the market down. Now, the markets did recover, right? But the markets recovered through four or five tech stocks. And you know which they are: Nvidia, OpenAI. And they're very, very frothy. What didn't recover was MedTech stocks, particularly small caps. Now, here's some context for you. Believe it or not, no MedTechs had listed on the Nasdaq for three years when we listed. We were the second. There was one about two weeks before us. The one before us has revenue, and they are in profit. So I can't outline the reason as to why this happens. But as you can see there, they're down about 40% for the year. I'm not doing a victory lap on this, by the way.
I'm just giving context and hopefully peace of mind to some of the shareholders that this is an index-based issue right now. Obviously, it will recover if your company's decent. If it's not, it won't. So when you've got revenue and when you haven't got revenue, in fact, I would expect those two numbers to be reversed, right? We should be doing far worse than the company that does actually have revenue. All of that said, small cap MedTechs, non-revenue MedTechs are doing it tough as an index, and it's not our major shareholders that are trading us, right? It's the index traders. All of that said, there's no rhyme or reason. This is our performance last week. If you invested last Monday and sold on Friday, you're a happy camper, right?
Again, not doing a victory lap on that one, of course, but just to show the extreme nature of what's happening with the stock and the share market at the moment. I do believe our price closed at AUD 4.40 or something last night. The analysts are saying a lot. Now, the ASX very kindly asked me to remove a slide this morning that shows all of the content of what the analysts are saying, so I'll just give it to you straight. There are analysts, of course, in New York and Australia. They're not paid analysts, right? These people cover us. And I mean Barclays, TD Cowen. I mean legitimate TAVR analysts. The general range of coverage, they're all buys. Every one of them is a buy. I haven't seen a sell or a hold.
The average analyst consensus in the U.S. is about $15-$20 today, right? So it does start. Yeah, I know people say the markets get it right. Maybe very occasionally they just don't. We'll have to see on that one. But again, for shareholders here in Australia particularly, look at what the analysts say. Read that stuff. It's not made up. These are not generalist analysts. They're specialized TAVR analysts particularly. Look at the share price. Look at the markets. Look at the basket of goods that we trade in. And don't worry about the legitimacy. I thought that slide was out. Don't worry about the legitimacy of the data because you know it's good. Often when the share price is down, of course, particularly in the retail part of our business, people ask me what's wrong.
They judge the company's health with the share price or the product's health with the share price. And that's not the case. And I'll tell you why. I do not look good in an orange jumpsuit. If there is something wrong, I have to tell the markets. Otherwise, I'm misleading the markets. Therefore, you know if I'm not telling you something's wrong, then nothing is wrong. So stick with what you see out there. But we're really here to talk about this, right? One of these, the back of the room, you've all seen this before, but I want you to go back in time. Folks in the room who were there when it was just ADAPT, it's very, even for me, it's still very surreal. This was the idea I had in the room as to how we use ADAPT.
And then obviously brought people together who could do this for us. It's very surreal to view the components today as what they are, as a legitimate commercial product that goes on the shelf in a hospital anywhere in the world and goes into a patient. But let's talk about that with somebody who does this stuff for a living, which is Chris Meduri. You saw him a little bit on the opening video. Chris, can you hear me?
Yes. Hey, guys. How are you?
Good, good, good. How's the internet working for you up there?
I think it works pretty well up here. How about down there?
No, the InterContinental Hotel Brisbane has very bad internet.
I'm still out here.
So Chris, I've just been explaining to the folks a little bit about the financials of the company, but also showed a video which you were part of, as were others, about what we do in Minneapolis. But today, I really want to talk to you about where the product is today. I mean, everyone who follows our story, who's on our register, of course, has very much been kept up to date and is familiar with the clinical data. But look, you're in the room that day, right? The day I presented to your group of colleagues, people may not know that Chris was not the CMO. Chris was one of the key opinion leaders that I had asked to come to Minneapolis who did not know me at the time and represented a large volume of usage.
The guys that I had chosen, guys and girls that I had chosen to come down, were physicians like Chris practicing, treating a lot of patients. They were chosen for that reason. They were chosen for their profile. They were chosen for the amount of publications they'd put out, i.e., they were key opinion leaders. Chris was in that mix and later became our CMO. But all of that said, there was some skepticism even that day when I said, "Look, we've got tissue. We've got ADAPT." I presented that. If you needed a TAVR, what does that look like for you? Tell me a little bit, Chris. Why did you then continue to come to my meetings from that first day? What was it about ADAPT or the company that kept you coming back?
Well, besides the Vegemite you sent me after our first meeting, I think that what was, and yes, he did send me that after the first meeting. But no, I think really, Wayne, what was so interesting to me at that time was that, one, you came to us with a fascinating tissue background that I think many of us in our space at that time really had just been putting valves in and hadn't gotten to the point of, this is like an eight or nine years ago now, thinking about the longer-term implications. We were just really trying to get through procedures safely, and it felt there was just these fundamental trade-offs in our field. And the tissue was very interesting ADAPT and the incredible data that we know we all know well here, I think.
But I mean, to be honest, I think we were a bit skeptical of the idea that there is this team of people with the great tissue that wanted to try to do something intrinsically different than what our field has been doing. And I think in our space, different doesn't happen often. And people get very comfortable. They think things work well. And I walked away thinking, "Listen, this is an amazing tissue idea. Can they really do it?" But what really was taking me away that was fundamentally different than other companies was that there was a vision from the leadership, I think at that time, that we don't have to stop short. We don't have to just kind of do a little bit better. It is possible to fundamentally do something different.
And so I think that vision of that and the commitment to it, because it didn't happen in a few months. It was years of getting to that point. I think that was something that really stuck with not just me, but all the physicians, because that's not something that we really have traditionally encountered. Because listen, we all operate and take care of patients. We're desperate to do things that can make our patients do better. And often, we're just incrementally making things better.
Yeah, thanks, Chris. And obviously, you guys enjoyed a four-hour ADAPT presentation from me that day. That's all I had, by the way. And a jar of Vegemite to follow up. So you did still come back. Credit to you. And I'll bet you never tried the Vegemite anyways. But you know.
I did. I did.
We didn't know if we're going to succeed, right? I mean, what's important here is we were building or writing a business plan eight years ago, writing a go-to-market plan and what I mean by that is having designed a product that is clinically better around an investment thesis with gating items, right? We didn't know if we'd succeed. If we could not, for example, create a valve that was going to be clinically better, there was no point launching and moving forward. There's no investment thesis and no point raising capital around that so the gating items for me were always there at the time. Maybe obviously weren't necessarily saying them out loud, but you kind of knew if we couldn't get over one hurdle, there's no point trying to go for the next because it's not a product that you or your colleagues would use.
So in that vein, tell me a little bit about the pivotal milestones that you think we achieved along the way that helped us to continue to support the investment thesis for this product globally?
Yeah, no, I think that's a great question. To me, probably a couple stand out. I think, and I think first of all, the only way to get to these milestones, and again, to your credit, it wasn't what I've traditionally seen with a lot of MedTech companies that it's an idea, a few talks with doctors, and bunker down in a room with a bunch of engineers and come back out a few years later hoping that it's what people needed in the field. It was really an integration of a team of incredible leaders and a team of really thoughtful, I think, experienced physicians and constantly having these feedback loops to get where we wanted to get, and reality is there were several years we weren't getting any of those places we wanted to get. But we were also hearing that too.
We didn't go try to take a product to market that wasn't what we wanted to get to. And so because of those things, I think to me, the biggest first catalyst was pivoting to a truly biomimetic design. And obviously, that wasn't easy. It's novel. No one else has done that before. It leverages the history of ADAPT's tissue and its shaping in the aortic space. And that was, I think, the first pivotal moment of something that fundamentally can change our field. And I think us as physicians, when we got to that point, as you got that immediate feedback, was like, "Wow, okay, this is really different." And of course, I think from there, we then started testing in animals. We were getting encouraging things in animals. But to be honest, I think sometimes it's a bit tricky to translate what you see in animals into humans.
I think to me, the fundamental biggest moment after that was us getting to our first cases. I mean, I think probably as investors, it's hard to appreciate the enthusiasm of doing our first cases. Of course, everybody's going to sound super excited and the world's going to change from those cases. But what we saw in those first five cases, we all kind of like, it was one of those surreal moments like, "Wow, we might have just been a part of something that really is differentiating for the history of our field." To me, that was a moment I'll never forget in my life because I didn't sleep for days leading up to it. I was just like, "Man, what is this going to show? What is this going to show?
Is it going to do everything we think it's going to do?" And just perseverating over it. And the energy after that moment was like, I remember us all flying home together across the Atlantic and just feeling as we were leaving Tbilisi and just feeling like, "Wow, this was a moment we will remember forever.
Yeah, thanks, Chris.
Of course, I mean, the only obviously now with all these clinical cases, there's a lot of other milestones, but those really stand out to me.
Yeah, thank you. And I will remember that aha moment. And you don't know whether you're going to make it or not at that point. You know you're not going to do damage. Of course, that's the first priority. Do no harm, but you don't know how good it's going to be until you actually get it there beyond the bench and the animals. And again, it comes back to the investment thesis. It comes back to the business plan we wrote that day in that room, which is if this is only as good as what's available, no one's going to use it, so there's no point going forward, which forced us into delivering a very new class of product. Many of us have done this for our whole careers, myself included. Bringing global products medically to the market is a good feeling on top of everything else.
That passion to achieve drives everything. The passion to be different. Tell me and tell the folks from a physician point of view, as an operator yourself, have done a billion Medtronic, a billion Edwards, even Boston Acurate. You are one of the highest users in the United States for that product. Let's talk about the procedural characteristics of DurAVR compared to the, let's start with the market leader. Let's start with the other balloon expandable. What are the differences you see from the operator point of view?
You mean the end result or the procedure itself?
Both, both.
So I'll take it twofold. Yeah, so from a procedure perspective, listen, again, I think it sounds like easy speak to say these things, but there's so many market, big companies, devices that, to be frank, are a total pain to use, and I've been the top two users in the United States for several times on these devices, and that is an accident because they're not listening to us when we're telling them how to make it. We're the users, and so again, this goes back to credit to the leadership of this group. We integrated physicians with the engineering team and met every week after we'd done collectively 40, 50 TAVRs and said, "What's good? What's bad?", and we took and we tweaked and we tuned and tweaked, tweaked, tweaked, tweaked until we get to what we needed, and it was many iterative cycles.
When I walk in the OR, the cath lab, it's easy. I mean, this is like, it wasn't by fluke. It was because we intentionally made it to get to that point. It is easier, if not easier, than any other device that exists out there. It is intuitive. The first time it hits your hands, you know what to do. It takes away a lot of variability we have with other devices. I think for a procedural perspective, it's everything we want it to be in one.
Yeah, perfect. And I think it's important because as we were developing that catheter, my remit was it had to be as easy or easier to use than the market leaders. So the learning curve was minimized because we know one of the barriers to adoption is whether you can put this thing into a patient. The valve is critically important, of course. How long does it take you to do a procedure now or any of the physicians we work with?
A DurAVR procedure?
Yep.
I mean, if people leave me alone, I can do it in 25 or 30 minutes.
25-30 minutes.
So people stay out of my way. So yeah, no, I mean, it's that easy. I mean, it's very straightforward. It's simple. And yeah, it is.
Yeah. So I want to just come back to the clinical aspect real quick. We talk about differentiation. Obviously, as a lay person, that can be difficult to understand how differentiated clinically this product is. And I think that fuels some of the questions that I get about how do we compete, how are we going to do those things. But for me, it comes down to a couple that I certainly want to address. It's the hemodynamics, mean gradients, of course. People, I think, pretty much understand that. That's the first part. The second part is laminar flow. And the third part now is certainly the PPM aspect of this that I want to dig into a little bit more. In terms of hemodynamics, a 22 or a small DurAVR versus a 22 SAPIEN, what do you see?
I mean, it's night and day different. I mean, this is, maybe I could step it back one step. I mean, tomorrow morning at 6:00 A.M., I have my heart valve team meeting. I'm going to go through 25 TAVR cases and pick and choose valves. And the thing is, at 6:00 A.M., I have to turn my brain on even more because I've got to make a conscious decision trade-offs in every one of those patients because currently today, there is a trade-off. Do I want a very easy-to-use valve that's short-framed but suboptimal hemodynamics? Or do I want a better hemodynamic valve, but it's a bit of a pain in the butt to put in and it's got other issues and called a tall frame and other things like that?
And so to me, the real difference is that you are getting the best hemodynamics with the very best of everything else from ease of implant and short frame. And that takes away your trade-offs, which is, again, what I spend my life talking about in every one of my RT meetings. So that mean gradient topic and such an easy-to-use valve is critically important. And like you said, in a mean gradient or small annulus of a SAPIEN versus DurAVR, I mean, we're talking about double gradients, perhaps. We're talking about literally 10x increases in PPM. These are really meaningful things that I understand as if I'm an investor or any other layperson, I'm just looking at slide decks from the CEO all the time. It's probably hard to translate that into what that means to people.
But if it's your mom or dad and you did them a procedure and you know it was a great result that's going to put them back into how they were before they had the disease, or it's going to leave them with some disease, you're going to feel very different. And it's hard to translate that from paper. And so to me, that's what this deals with. So that's the mean gradient issue. I think that's what our field has looked at today. What I'm really excited about, and I absolutely tell everybody and most people who are believing this now that five years from now, we're going to talk about that a bit and we're going to be talking about laminar flow and how it changes the left ventricle all day long because ultimately that's what people die from.
And so from my perspective, this goes back to the milestone changing thing in this company was pivoting to a biomimetic design, which we own all the IP on. We own that pathway. If you don't have a biomimetic design, you cannot restore laminar flow like other technologies fail to, but ours can. And I think this combined with the current value of low gradients PPM is clinically so, so meaningful. And I mean, the docs here, there, everywhere I talk to, they're genuinely excited and begging to get this in their patients because we all, I mean, listen, we're physicians. We make an oath to want to help people. And this is going to make a really, I think, big good difference for people.
Yeah. And thanks, Chris. You put that the right way. I don't think a lot of people fully grasped over the years, just based on the feedback I get from sometimes the investor base, that everything was deliberate with a gating go/no-go item. And it had to be differentiated. I'm not sure a lot of folks also understand outside the medical fraternity, of course, how incredibly different this product is compared to what's available. Mortality, ease of use, the mum test you just talked about, which product would you put in your mum if you had the choice tomorrow, right? Every doctor tells me, of course, it's DurAVR. And of course, the laminar flow thing is so critically important. But I want to close with this, Chris. I've been talking about leading the way.
Obviously, folks who don't know, who haven't worked in global commercial healthcare, don't necessarily understand how you get a product to market or how you can compete with some of the companies out there. They just imagine that it's something that's maybe not possible. In terms of leading the way, I was explaining earlier that in fact, Anteris is actually leading the science and has done for several years. It's not the larger company. So I want you to just give 30 seconds or less on why we're leading the way, how we're leading the way, and the fact that it is actually happening. It is actually us that is in the forefront of TAVR now.
Yeah. I mean, I'm going to admit that at the beginning, I was actually even a little skeptical on it because four or five years ago, yourself, David, people with a lot of biotech background were challenging me to think in a way that I hadn't thought before. Hey, you got to look at the disease process differently. And in order to do that, we had to look at different markers than what everybody does. I mean, honestly, it's kind of boring how our field looks at these things right now. We get pressure gradients, we check a few things, and we say good or bad. And the challenge was to identify novel ways to understand the disease process and how we can modify it. And a lot of the work, cardiac MRI, the CAT scan work, has been pioneering in the field.
I mean, we just had a paper published last year in Nature Cardiology, which we set the standard for, which is the biggest journal in the world in our space. We have the largest collection of cardiac MRI data in the world on any valve collectively, which blows my mind that these other companies haven't gotten there yet. I think it's two reasons. One is because they don't really want to know because they don't have anything that's going to be that exciting around that. But two, I think it's, again, a credit to a different way of thinking. To be honest, we wouldn't be here today if we didn't think through this whole process from day one differently. We'd just be a mom and pop thing. I wouldn't be hanging out with you guys if I thought it wasn't meaningfully different.
I don't know everybody else, but just particularly Wayne, but I think that the big thing is this is like we had to look at this differently and credit to the leaders who got us there, and I think that ultimately is why this journey doesn't stop today. This journey is going to be a celebration of really transforming the lives of countless people around the world with a debilitating disease process that is going to meaningfully change the trajectory of their lives.
Yeah. And thank you, Chris. And it's true. I mean, I come from an oncology background. As you know, I looked at this as a total disease management proposition, which we now do, which means looking at left ventricle, means looking at flow, means looking at the aorta. Prior to that, I think people were looking at a valve. It opens and closes. So a very acute view on the disease as opposed to total disease management. It's got us to where we are. Listen, man, appreciate you. Good to see you. I'll be back up there tomorrow.
All right.
All right. Thanks.
Thanks, everybody. Appreciate your support.
All right. Hopefully, some more insights there for everybody. Depending on your perspective, you've probably been involved with penny dreadfuls and even healthcare stocks that have gone belly up. Expertise, leadership, management, understanding of the state, it matters a lot. It definitely helps decide whether you're going to get there or not, obviously with capital. As Chris pointed out, the objective was never to be normal. What normal means is to create a company that creates employment but doesn't necessarily create an investment thesis. You all know that you get those snouts in the trough emails, which I despise. People who wrote those have never had the passion to achieve anything because they don't understand what drives you and what drives your career in these things.
But we definitely had a target that we knew we had to hit in order to make us clinically relevant, therefore a chance of being commercially viable. And those are the things we've hit. No one's ever done this before because it's really hard, right? You guys were smart enough to be invested along the way or had the vision to be invested along the way and had the patience to understand healthcare development is a long-term proposition, right? It's not a one-and-done. It's not a mining company. But if you're in the right vein, if you do things the right way, you'll do stuff that has never happened before. And that's exactly what this product is, as you just heard.
So real quick, I know all of you know the clinical data, and I thought it was important to have a decent chat with Chris Meduri to get the physician perspective. It matters, obviously, far more to hear from him than me on the same topics. You all understand, and maybe this is for some of the newer shareholders who will watch this online when it's posted, is that this is the first new class of valve. When you hear all of these clinical aspects coming from Chris, you're going to ask yourself why. These products were out there for 10 years. Yeah, there was a gaping clinical gap in the market that we recognized, which is the products were definitely not curative. And the reason they were not curative is that this is a disease that is fatal. You will die from it if you don't treat it.
There's no drug, so there's no pharmacotherapy to treat you. The only way they can treat you is to switch out a piece of your anatomy, to put it simply, and that piece is the aortic valve, which sits at the bottom of the aorta. The problem, every single valve out there belongs to a class called bioprosthetic, which does not look like the valve you were born with, right, so in its simplest form, that doesn't make sense to me, and it didn't make sense to me at the time, and there are reasons for that. I get it why they did it. They were solving for different problems. They weren't necessarily solving for a cure or solving for longevity. They were solving for patients whose chest couldn't be opened up to have a valve replacement because they were too sick, and so they put it on a catheter.
They didn't move the ball forward from that point, even as the regulators were approving these products in younger patients over the years. The dynamic of the patient population changed dramatically. The products didn't. If you're trying to work out where did I see the gap or where was the gap? Things that Chris just talked about, laminar flow, there's never been a manufactured valve. If you go to the far left, you'll see the 2D MRI there. You'll see normal on the left, and you'll see the DurAVR. We've seen this data before, but that hasn't been observed before in a valve. That is what happens when you have something that's anatomically and physiologically more normal going into your body, and you do live longer as a result. We're at the forefront of this. We are leading the field.
And the field, and I mean our competitor companies, are now starting to try and talk about this one major problem. They don't have it. We're on the biggest podiums in the world. Those of you outside of this space may not fully appreciate what these are. Clinical conferences, medical conferences are where doctors congregate at different places to talk about latest data. There can be up to 20,000, 30,000 delegates at these meetings from around the world, just so you get a feeling of scale. Also, who attends? Every executive from every company, every company in the space. So you'll have the CEOs of the major companies, of course, myself, and you have the financial analysts. The analysts also appear at these meetings because they report on this stuff, right? That's why those analysts matter. Really quickly, the 100-patient data was presented.
We put an announcement out on the exchange recently. It is a really big deal. I know you've seen a lot of data. It was simultaneously published in EuroIntervention, a very, very important journal, peer-reviewed, of course. That gives you some understanding. This stuff really, really matters, by the way, if you're trying to judge your investment and what it's going to look like moving forward. Are you attractive as an acquisition target? Can you also launch by yourself? And the answer is yes to both of those things. The pooled data, and this is an important point, totaled 100 patients at 30 days. 30 days is a significant marker for TAVR patients. It's the critical point that you measure outcomes, really, and you measure them acutely. Nothing changes really after 30 days. You can go for the next three years. It's going to look the same.
So that 30-day point is when you see the major variations between getting off the table and this point. So that's why it's 30 days. They all always use 30 days. 100 patients is a big number. I would also add this. The results that we saw, of course, are consistent with what we know from before. But the reason this gets published is because it's really important. The other thing I want to add, we were creating an investment thesis and a product to support that thesis. And if the product couldn't support it, there's no thesis. That makes sense. None of the folks that you see and talk to here needed the job. So sometimes is the inference. We also chose to do a lot of early feasibility patients. Typically, companies will do 20-30 and then go to the FDA and get their pivotal studies started.
We did 130, but there's an important reason and it's a bit like a stitch in time saves nine. There's an additional cost to doing those patients, of course, but again, we were looking at the investment thesis. I didn't want to get into a pivotal study on 30 patients and find out we had a problem. Game over. Company finished. Study stops, so it makes sense that we continue to push the envelope and what I mean by that, if you look at some of these anatomies, highly calcific, you don't have to be a doctor to know what you're looking at there. You see that white stuff. Bicuspids mean only two leaflets are working, not three and extreme LVOT calcium, which is around the left ventricle output part. These are patients that don't typically make studies, right?
In a clinical study, and I mean for every company, you're trying to isolate patients who don't have comorbidities, that don't have other problems, so you can really tell what your product is doing. You don't have these patients in studies. You exclude them for that reason. They can contaminate the data. We chose them on purpose because we wanted to test, as you heard Matty talk about, the most extreme cases to see whether this product is going to be used by physicians. It didn't matter whether we could prove a certain point that it worked. We had to prove that there was a reason doctors would use it over something else, meaning that they don't have data on these patients. 130 of those, and they're all like that, and you get results better than what's available. I can tell you the paradigm study, of course, has started.
We announced that. Of course, I get feedback on the patients we've already treated. They're better off than these patients, right? Because patients in a trial are excluded when they look like that, and here you see the technical success. These are the things Chris just talked about. This matters, right? The barrier to adoption is how this device works. If you can't use it properly as a doctor, the valve can be outstanding. It doesn't really matter. What you see here is just really, really nice expansion of that frame. There's no flaring of the frame. It opens up very, very well, and that's why you've got such high numbers there compared to others. Baseline characteristics don't need to get into those. I borrowed these off our good friend, Professor De Backer, who presented this data at London Valves recently, and hence the reference to their slides. Okay.
Mean gradients go down. That matters, so that's the 48.1 to 8.2. EOAs go up. That also matters, so they go in opposite directions. That is the opening area getting bigger. These are both back in the range of normal in small annuli patients, so these are outstanding numbers. They haven't changed. You guys all know that. Paravalvular leak, PVL, is a leak around the base of the valve, and back in the early days of TAVR, this was a significant thing because it creates regurg, which is something you don't want. PVL with our product here is still under the range of what's normal, and that's mild PVL, not moderate or severe, so clinically not relevant, and here is the PPM one that Chris talked about. 3% PPM versus 30% for the competitor. PPM is linked, of course, to mortality. It does kill you.
It's linked to increasing heart failure, which means left ventricle is getting bigger, and it's linked to worse outcomes and symptomology, so it's not just one thing with this product, right? There are many aspects that we understand and we study and, of course, we look at and we validate to give physicians a reason to use this product above what's available in the market, and these are the reasons you compete, so you can just see there, Professor De Backer did compare our product to a recent study. These are comparative numbers from the SMART study, which was a Medtronic study where they looked at Medtronic and Edwards, balloon expandable self-expander. You'll see the mean gradients. You'll see the EOAs and, again, particularly see the PPM. Now, the thing to focus on here is not SEV.
SEV is self-expanding, very difficult to use, and have about 30% market share for that reason. The product we're up against head-to-head is the BEV, balloon expandable valve, right? That's the market leader. That's the target clinically. And so you can see how those numbers compare. There's plenty of reasons there. Paradigm study, absolutely brilliant design. I have run over 20 studies in my career globally in different therapeutic areas. This one is a smaller number. Context matters. The big studies I've run can be 3,000, 4,000 patients. That's not what this is. Over 1,000 patients split down the middle because it's randomized. It's a head-to-head. So a few things that are really clever in this design. It's an all-comer study. So we're getting labels that other companies had to take multiple studies and many, many years to do. They did it study by study to get those labels.
We've got them all in one study. It's statistically powered, of course. So there's math that supports that. The FDA agrees with the math. So we get low, medium, high-risk patients out of this study. We also get our valve-in-valve cohort, which is an additional group of patients. This part is not head-to-head. This is a registry where we're just accumulating data. The reason it's not head-to-head is because there's no product available to treat this problem at the moment. So there's no way of doing other than collect data and submit it, of which we've already done for the prior patients. So hopefully you'll understand that not all teams are created equally, which, again, is a little bit of the feedback you get at times. These folks are global. They are the best at what they do.
They come from companies where they've done it before because you need that level of experience. You don't mess around and screw things up with the FDA because you don't know what you're doing. The team collectively has 163 studies between them. That matters because people worry about this. They ask me, "How are you going to recruit? How do you really get to the numbers?" There's a whole machine behind how you run a study to make sure it stays on time. It's not a random event. And that experience level matters right through executive. Obviously, I'm in that group as well. But right through the team who are running the trial, there's a lot of experience. What else do we need? Well, we heard about quality control, right?
You now know that that is not about picking a batch number of every second widget and having a look at whether it conforms. It's important stuff because if you fail here, the company's gone. Manufacturing to a level that is required by the FDA is critically important as well, and of course, we have third-party suppliers that make some of the plastics and catheters. We obviously don't mold those internally. Also matters, right? Because you've got to manage those guys. They all know how to do this, so if you look at the team, you'll see just through that list, I won't read it off, but these folks weren't working at McDonald's last week, right, and it does matter when I get emails about how you're going to do this, how you're going to do that, then you can see very clearly how we're going to do it.
You saw manufacturing. You saw Brian. You saw QC. You saw Eric. They are from the two biggest TAVR companies out there. Our regulatory affairs head, that's the person who deals with the FDA on all these submissions. She comes from one of the biggest out there. The clinical field team, these are the guys that monitor the study to make sure it stays on time. They're all TAVR. They're all coming from TAVR jobs. Why do they come to Anteris when they could be at Edwards and Medtronic? Think about that, right? It's not like we have to go beg them. We're overloaded with folks wanting to work with us because the science is understood everywhere in this space. And some of these folks follow the money. Medical affairs, again, critical job in this space. She's from a TAVR background, head of marketing, one of the biggest med techs.
That's this fellow here, also formerly an Air Force captain, and our team has dozens and dozens of global product launches behind them, right? Again, if you're sitting in maybe Sydney or Brisbane or Melbourne, it's hard to imagine how do you launch a drug or a product globally worth billions and billions of dollars. It's not just myself. Of course, I've done 36 of those, but there are other folks in the team who have all done this, right? And Debbie in the room has also been part of those things. We probably have the biggest number of launches and dollar value than anyone in all of the med tech space at the big companies, right? Just to give you context because everyone's coming from a big company background, so what's next?
What I really like is that you all have gone through this part now, and that's been challenging, and it requires patience, and we're at this part now, right, so we are getting there, obviously. You all know the history from 2018, pivot from a pharma company into a med tech company. None of this stuff is easy, but I'm not going to belabor it. We all understand it. It's not been done before, right? Creating a multi-billion-dollar product, well, we're here. All of that, and what's the really hard part? It's developing the product. It's getting a product that can be clinically better. That's really hard. There's no guarantee just because you want it to happen that you're going to make a product that's clinically better than what's available, but that's the only thing that drives the rest, so that is where all the risk is.
It's on this side. On this side, far less risk. An FDA study in our space is not like a phase three drug study. And I want to make that very, very clear. Drug studies and device studies are incredibly different from a risk point of view. We know of cases down here on the ASX where companies have failed in a phase three very recently, and it's game over. And I've had a couple of those in my career at big drug companies. And you just shelve that product. It is a binary outcome, and $1 billion gone down the drain. Merck can do that. Roche can do that. Small companies can't. And that's why it's binary. MedTech is not that.
You do 130 patients beforehand when you get here and make sure you're not going to end up in that boat so that you know, as Chris always says, within one or two% what our numbers will look like coming out of this trial because all of that work's been done, and in fact, it's been done in, of course, very difficult-to-treat patients. You all know the market. You've seen this before. It's $10 billion by 2028. Believe it or not, that is just 15% or 20% of patients being treated, which is to say the two companies that have been out there for a decade haven't done a stunning job, right, at penetration of the patient population. They should be looking more like 50, right, so there is a big untapped market, still big enough, $10 billion.
On the back of that, you see the dark blue bars, which is the valve-in-valve. That's a new phenomenon because patients have only just been treated at a younger point since 2019. So they hit the three, four, five-year curve, and that's why that's going up. Those valves are starting to fail. Many of you are familiar with the valve-in-valve data that we presented. It's very, very good. So just some numbers for context, right? Edwards is a pretty small company, right? Medtronic is much bigger. Medtronic's more of the scale of a drug company. People often say to you, "How do you go against these guys?" I know them well. I interact with their leadership team, and I talk to them a lot personally. Of course, all the physicians are working across all these companies. They have to use this product.
So just numbers for context. I'll let you guys do the math. They have a lot of shares on issue. We don't, right? Capital is important. Obviously, we have to capitalize the company. But it's important to keep this number in mind, right? And it's important to keep that number in mind. What is the share price, right? How much room have you got to move? Obviously, I've got models that support the number of shares we have to issue. I don't like calling it dilution. That's a very mining company-focused commentary. When you're funding this kind of development with that kind of upside, you've got to use more context than that. Most of their revenue, or a great percentage of their revenue, probably 75%-80% of their income comes from their TAVR product, right? So let's take 80% of that share price is TAVR.
80% of the shares on issue is TAVR, and start to translate that back across here. We obviously aren't going to have 580 million shares on issue by the time we become profitable. Just for context, math matters, and the math is your friend here, so hopefully you've seen that we are leading the field, right? I think you understand it's not hubris. It's not a throwaway line. It's not some CEO fantasy. It is built on the basis of how we approach this product, the investment thesis, and the experiences of bringing products to market where clinical data obviously matters. I'm going to throw to questions, and as always, I'll thank the anonymous person who I outed last time but remains anonymous this time, who puts together the questions from our retail community. I've left them unfiltered. There's a couple of things I want to address.
So we'll go through these pretty quickly. You're at the end of the show, so thank you. Other than the regulatory statutory points, do you have our valves have demonstrated success in elderly patients, valve-in-valve, blah, blah, blah? Will the FDA take this body of evidence, including European data, into account? The answer is yes, they do. You don't get to do the pivotal study without submitting this data, right? They don't just let you come in one day and say, "You know, we've got no patients, but we're going to do this." So all of that data is reviewed, safety, efficacy, and so on. What they don't do is count towards a total patient count, which I think is what this question is. And they can't because they're done under very different conditions. A protocol is a protocol is a protocol.
Once you hit a clinical trial, any clinical trial, but your final ones, all those patients and doctors are selected under strict protocol that you have to follow. Patients from other studies fall outside of that because those protocols might have been different. Does the FDA apply different standards, timelines? I left this here. No. It's a bit of a silly question. One, we are a U.S. company. But two, their job is to make sure you're safe. Their job is to make sure the product you put in patients doesn't kill them. And that's all they care about. They certainly don't have any biases around companies. Often, I don't even think they know where a company might be domiciled when you present the product. And I've done a lot of these from the drug industry throughout my career, in fact, over 20. So I have worked with them.
And one of those companies was Roche. It's actually one of the biggest drug companies, but Swiss. They don't care. Why are there no Australian sites? That's a good question. We're actually negotiating a couple right now. I hope that we can include those into the trial. We're just going through the motions right now. I desperately, badly want Australian patients in this study because of the origins of the company. And I think we will get there. So I think there will be some. Expected timing of institutional review boards is IRBs. Obviously, someone who gave that question has knowledge of these things. It's staggered. So once you get the FDA, the IRBs don't meet until you get FDA, and then it's staggered. So we're not anticipating to get our first U.S. patients. Of course, the study hasn't started until early in the new year.
But they're all going through that process, okay? So it's a staggered process. Come the end of the quarter, we should have everybody rolling in the States. Realistic timelines on enrollment. So yes, I can. We look at timelines mathematically. We look at number of hospitals, number of patients they need to do per week across a month and over a year. And that's just simply how we calculate it. Done that for every trial I've ever run. The critical limit to that is making sure you measure it every week so you know when you're over and under so you can pick up the pace where you need to. SAPIEN X4 Alliance trial is not a good benchmark because they stopped that trial for a year because they had a problem with the delivery system, believe it or not. So that's not the right benchmark.
If I recruited that slowly, I'd be in trouble. The right benchmark would be SMART, which is a study we talked about a little earlier. The SMART study had about 1,000 patients. So roughly the same number of TAVR patients took 12 months, all right? The physicians tell me a different number, and it's shorter than the timeline I'm putting out there, and that experience of working with physicians in many studies tells you just to extend it a little bit. But as you heard from Chris, there's huge enthusiasm to enroll this study, right? That's not, again, made up. Doctors want this in their patients because it's better for them. Valve-in-valve coming through earlier, don't know. There's a possibility. It's just uncharted territory. There's no path for valve-in-valve right now because there's no indication. We have stunning data.
We certainly are pushing on this, but we'll have to wait and see. Has DurAVR been used in the mitral position? Yes, it has. We have one patient. We call him Double D. They were doing his aortic valve, and they discovered that his mitral valve was leaking. He had regurg. So we brought him back a month later. I mean, these are sick patients. And we put another DurAVR in his mitral, which is not something we usually do. So the guy's got, hence, Double D, two DurAVRs, one in the aortic position, one in the mitral position. It's not a market we're pursuing. That's not somewhere you want to go. That's a whole different study. And right now, we need to focus on getting the big ticket items done, which is the paradigm study in aortic stenosis.
Maybe not in the future, but unless everyone's going to start throwing $50 million checks at us, we won't be able to cover all of these things. But there's enough out there with what we're doing at the moment. How much capital does management estimate we require to push? So end of recruitment, as we've told the markets, is 2026 Q4, about $120 million-$125 million, right? We know exactly what the budget is because we obviously calculate it backwards from number of sites running a trial. Not cheap, obviously. And then you saw the facility and all the things we have behind it. Do we receive reimbursement? Yes. We get $25,000 per device in the United States. We do not get the same in Europe. We have to pay for our device. But what's important to note, if you've been around drug trials, this is very different.
The competitor product and the procedure costs are both covered in Europe and the U.S., right? We obviously don't have those costs. That's why the cost of this trial is actually fairly small compared to what I'm used to. It's because in a drug study, you're covering procedure, and you're buying the competitor drugs to go into your study. And if you think about 4,000-5,000 patients, it's a lot. We don't have that here. So in Europe, we have to give the device, but everything else is covered. In US, everything is covered plus our device. Recent capital raises. How will management avoid further dilution? Well, we can't. We don't make money, right? I don't know what else to say to that one. If capital doesn't come in and you've got to have capital to fund your company, then that's a fact of life.
What you look at is the modeling and the math around how much capital is required, how many shares are on issue. There is a plan. I know exactly how many shares on issue I want to be at when we're self-funding, fully diluted, and everyone is still doing all right, of course, out of the company. It's not random, and it's not a black hole that we just drive a bus off and don't know where we're going. At what point will Nasdaq investors, described previously as more sophisticated, re-rate the company to reflect this true value? I don't think Nasdaq investors are more sophisticated. I think our investors are just our investors. It doesn't matter where you come from. You're on the cap table. I would say all of the funds in the U.S. coming in, the Nasdaq are healthcare dedicated. There's no generalist funds.
They definitely have a different view on the stock. They don't panic around the price, right? They get excited by the data because that, for them, means there's obviously money somewhere in our future. So very, very different prospect. I would say also this. None of our investors are trading the stock. I can see who's running around trading, and it's not. It's index traders. The price, as much as it's painful, you kind of have to disconnect from everything else the company's doing and understand that it's not a reflection of the health of the company or the clinical data, which I think is what people conflate the two. What is the relative size European market? European market is about 40% of that $10 billion. So about 60 sits in the States. That's consistent for most healthcare products. Realistic timeline from pivotal trial to completion of the orchestra.
There's a 12-month follow-up, and then there is, of course, go to market. That 12 months at the end of the trial, the follow-up is critically important. You want that 12 months. No way you can finish a trial and launch because you've got to build inventory. You've got to do a lot of stuff that gets you ready. So that year becomes very, very important. How are we trying to bridge the gap? It's a good question. We are. We're looking for earlier approvals in certain markets. The EU regulators are definitely working with us on that, and it's definitely something that's a possibility. They have come out, already inspected our facility. We have passed that inspection. So there's a possibility. There's a few wild cards in there pretty much that could shorten up that timeline in certain markets.
Would the board consider a takeover offer if it was attractive and the company received any meaningful approaches for merger or acquisition? Well, one, we will never get an approach for merger, right? We're smaller than those guys. No one's merging. We have had offers for acquisition. That is factually true. And again, I do meet the leadership of these companies, including just two weeks ago with one of them in our space. The board will, of course, be obligated to consider any offer that is attractive. The problem is, right now, none of those have been attractive. So I've had no problem rejecting in the face of our friends in the other companies the size of those offers, which just were not in any way attractive to shareholders and, in fact, would have wiped out the smaller shareholders. And that's not something I'm about to do.
And I've told the bankers and the other companies that. How incentive executive incentive structure aligned with share value creation rather than repeated capital raising? News flash. I'm not incentivized for repeated capital raising. It's part of my job. I definitely don't get incentivized to them. Probably I would like to. There are two kinds of companies: revenue, non-revenue, right? And the incentive base for executives is very, very different. If you're running a revenue company, my prior jobs, you are incentivized for sales, P&L, operational aspects, the things you can control. And of course, you should be incentivized around those. If you're running a non-revenue company, then what is the target the board will set for you? Well, it's clinical development. It's passing those hurdles, bringing the product forward, and you know how difficult that is.
So I think on the side of things where we are incentivized, we've delivered that. Whether the share price keeps up with that or not is challenging to control, obviously. Also important that when you get to revenue, that flips back over, right? Then your job is, how many did you launch? How many did you sell? How profitable did you allow the company to be? So it's a tricky one. I think what's been achieved here is exceptional. I don't mean from my perspective, from all the team who have created this product. You know that it's never happened before for reasons. And so I think everything probably has a way of catching up in the end. But yeah, I think this one is, of course, I understand the shareholder perspective as well and don't need the shareholders to understand my perspective because they won't.
But I see where people are coming from. Retail shareholder engagement has declined. It's a funny thing, this one. The Nasdaq is a little bit stricter than the ASX in terms of what you can and can't put out there. They don't love you just putting announcements out for people to read over their cornflakes. The Nasdaq side of the coin, don't expect that because no company does it up there. They don't post stuff. Those guys will just pick up the phone and talk to me. The biggest funds out there will be talking to you. So they get their information. Not inside information. They just get information. And then, funnily enough, when you put out some communications, even webinars, you always hear, "Well, I've heard it all before," or, "That's a puff piece," or whatever. So you're kind of damned if you do, damned if you don't.
I personally love interaction with our shareholders, always have. On the retail side, I really, really enjoy it, and I've made friends with many of them over the years who are still with us, so I feel grateful for that, so I'll try to be mindful of putting things out when we can. I think recently we just put out more information from London Valves and so on, so I'll try and get better at that. What level of update frequency expect? Difficult. Obviously, a trial goes into a bit of a black hole, right? Because you don't get that patient data. You're not going to be updating that. What we will update is progress as we get to maybe the quarter point, the halfway point. I'm not sure yet.
But there will definitely be a lot of updates, as well as the ongoing clinical publications that come from the cohorts outside of the trial, the six-month follow-up, the 12-month. They all are very, very meaningful. So there's a bit coming in there, and there's probably a few wild cards that I didn't talk about before. Timelines be communicated realistically. Like I said, I will put this up unfiltered. Past optimism eroded trust. Can management keep to underpromising? No, I'm never going to commit to underpromising. And the reason for that is that we take a calculated view. We don't throw the ball in the air. If we miss a timeline, it's because something else happened, not because we made it up and got it wrong. That's how medical development works. That's how clinical trials work. We don't just pull a number out of the air.
Everything is modeled to a point. And if something goes X on that, so government shuts down, for example, something happens, there are things in there. The minute you start underpromising and over-delivering, you run the risk of not going as fast as you should. We are actually two to three years in front of where we should be. People may not understand that. Think about the capital savings of three years' worth of savings. And I've taken that from the development curves of the Edwards product, right? So I know exactly what that looks like from a cost point of view. So I think it's an important one to put up there. I think it's important to understand the minute you backpedal also in your company, you're going to slow down. If you start to put out timelines that are way too long, people aren't going to love that.
We run really hard at every timeline we set, and most of them we actually hit. But none of it is random. None of it's made up. None of it's hubris. All right. You made it to the end of the show. Apologies for the late start because the InterContinental Hotel in Brisbane has bad internet. I obviously have to make a bunch of thank yous, and we're going to hit the statutory votes and things that we have to do. And it would be remiss of me not to thank the board of directors. The total group there I've worked with, all of them for many years, and I've known some of them for many years, like Dave Roberts, who is over at LeMaitre. These new guys also, of course, coming from Nasdaq companies and coming from public companies and coming from long healthcare backgrounds.
Greg is from the pharma side, and David is from the medical device side. When I joined this board way back when with John, John and I joined on the same day, the board was full of old miners, and that's why we had the company we had. They don't know about global commercial healthcare. They can't, so how are they going to give good governance and direction to the folks that we had at the time? The management team, of course, I've got Matt in the room. Matt's team have done a phenomenal job. Obviously, when you go to the Nasdaq, you can imagine there's not two or three bits of paper, right? There is an absolute wall of documentation, legal stuff that has to go through, and it takes a million people a million days to get it done.
They did it with seven in about three months. So a lot of work there. David and I have worked together for many, many years over at Merck and now, of course, at Anteris here. He's got a long, long healthcare background, of course. You all know about Chris, who is back. He's still practicing once a week. He's doing patient loads in Memphis. He lives in Minneapolis, where I do, but he's flying down to Memphis to do his 25 TAVR hours or whatever next week. And it's really important that he keeps up with that. The physician advisor group has gotten so large now that I can't put all their pictures on one slide. So I just have to do the generic. Obviously, we're extremely not only grateful, but we're blessed to have the physicians at the level we do. These people save people's lives.
So on any given day, they're probably saving dozens and dozens of lives of the folks that we work with. You've invested in that. You've also invested in this team, right? And so you can be proud of the fact that these people work with us because, well, a bunch of reasons, but obviously one is the product is viable. I put visionary there because it's true. If you have stayed the distance, if you have gone in spite of the complaints and all the other things, if you've gotten to this point, and many of the existing shareholders actually have, then you had some vision, right? You either thought I was a good bullshitter or you believed that the product and the development process was actually working. And hopefully it was the latter because you can see the results there. It will pay off.
Making a healthcare product, developing a healthcare product is a challenging thing to do. And 90% of the time you will fail, right? Those products will fail. They will not come to market. So the fact that you get there as a small company on a shoestring, which I know there's views on our capital, but essentially it's a shoestring to get a job like this done, is testimony to people's belief and their desire to be invested in something that is not a widget. It's actually helping patients. This will be a global product, a global brand. It'll go on a lot of patients over the years, and you were part of it. And of course, patients who put their hand up to take an experimental product, inverted commas, right? Every time a patient comes into a study, they have to have what's called informed consent.
They have to sign a document that says, "I'll take the experimental product, not the actual product." That matters, right? They certainly take a risk. Now we talk to them about data, of course. Physicians have a lot of stuff there. We are leading the field. I started off with saying that we're leading the field. Hopefully you understand that we are, that the companies follow us. This is not a David and Goliath discussion, as I said earlier. It's a David and David discussion, except we're smarter. We've got the one up on the data, and we've got the folks behind us. And this one matters a lot. It tends to be that on the U.S. side, the big funds look firstly at management leadership. Can they do the job? On the ASX side, often it's assumed that anyone can run a company and that the product is good.
It'll sell itself. Not a fact. So hopefully when we looked at that opening video, we saw the team of people that we employ, that you understand that they're there. And there's a cost to that. There really is a cost, obviously, that the only way you get this done is with those kind of people who have done it before in a global perspective. And the only way you keep it running and make sure something doesn't break or fall over is because those people know what they're doing. So on that note, I will hand it back to John to read out the resolutions. But thank you very much to the people in the room, the people online, if you're still online, for your attention. Oh, yes. Sorry, before I do that, on the back of those questions, are there any other questions in the room? Joe Doyle.
Actually, I have a question.
Yep.
Why not just? It's not something I've.
Yeah, thanks, Wayne. I have a question. It's not something that I'd thought about asking before the video. I just wanted to, first of all, thank you for a fantastic presentation. The videos were very meaningful. Having invested for more than 10 years now, seeing the video of the team and getting an understanding of what's behind the company on the ground and what we've developed in the States is quite impressive. So thank you for sharing that. It really drives home the value of the investments that we've made. But hearing Chris was really special. I almost wanted to stop you and say, "Can I ask him a question?" Couldn't do it. Couldn't do it. But I wanted to ask you if you could sort of get into his mind a little bit, if that's possible.
It really resonated with me when he said he's still doing TAVRs at the moment that are non-DurAVR. He knows what DurAVR offers. He knows the benefits to clients. I couldn't even imagine what it would mean for him to have to make a compromise now. So he's going and doing 25 TAVRs, and he's got to decide, "Do I do self-expanding? Do I do balloon-expand?" Whatever it is, and make that compromise between DurAVR and these other products. How does he feel making those decisions and having those discussions with patients when he knows what could be available in the future?
Yeah. Look, Joe, and again, you and I have known each other a long time, so appreciate that 10-year investment from your side in patients' time and capital. Getting inside Meduri's head, as you said, is always a dangerous thing, but I've done it a few times. Look, the thing about Chris and other physicians, and we hear it a lot, is yes, there's a compromise, but no, there's not an alternative, right? This will help you understand a little bit about the clinical trial. There is a huge pent-up demand for the reasons you just said for the use of DurAVR. So recruiting the trial, people are waiting for that. Now, these are patients with a fatal disease. You can't wait and wait five years, right?
So today, if you're faced with patients, as Chris does, 25 patients next week, he will triage those into Evolut and SAPIEN patients, depending on a bunch of things. And they just have to do that because that's what they've been doing the whole way along. And there's no other alternative for those patients today. But it does cause frustration. We get requests from hospitals who want to be in our trial for that very reason that we can't even support because there's too many of them. So again, coming back to recruitment times. And so it's just a matter of, yeah, they all know. Particularly the guys like Cleveland Clinic have used a lot of DurAVR. Go back and then use other things. But there's nothing they can do about it. The Hippocratic Oath dictates they've got to do no harm, first and foremost.
And so I think they're meeting that criteria. But the minute this thing becomes available in commercial quantities for them, there is already a huge commitment from a lot of the big centers for those reasons you stated and people like Chris and his colleagues who are going to switch to DurAVR as quickly as they can.
Thanks, Wayne.
John Wayne, there are no questions online either.
Good. There's a John.
Hi. Thank you, Wayne. The meeting will now officially come to order. The time is now 7:14 P.M. in Minneapolis, Minnesota, and 11:14 A.M. in Brisbane, Australian Eastern Standard Time, on Thursday, December 4th, 2025. I now declare the polls open for voting on all matters to be presented today. The meeting is convened to consider matters specified in the proxy statement and notice of annual meeting of stockholders dated November 10th, 2025. Anteris is incorporated in Delaware in the United States, and today's agenda reflects these requirements of Delaware and U.S. law. The meeting today is being conducted pursuant to the company's annual meeting rules of procedure, which are posted on the annual meeting website. These procedures will be followed in accordance with the company's certificate of incorporation and bylaws.
The proxy statement and notice of annual meeting of stockholders provide explanatory information on the proposals to be put for the resolution to the meeting today. As I mentioned earlier, the polls are currently open for voting on all matters to be presented, as set out in the notice of annual meeting of stockholders. Only stockholders holding common stock on the record date may vote during this meeting, either in person or through the virtual meeting platform. For stockholders, each share of common stock is entitled to one vote. For CDI holders, in order to vote on the proposals at today's meeting, each holder as of the record date must have instructed CHESS Depositary nominees as the stockholder of record to vote the shares of common stock underlying their CDIs pursuant to instructions in the CDI voting instruction form.
If you are a CDI holder, a valid CDI voting instruction form or electronic vote pursuant to these instructions located in the CDI voting instruction form must have been provided to Computershare or completed as applicable no later than 5:00 P.M. U.S. Central Time on Sunday, November 30th, 2025, or 9:00 A.M. Australian Eastern Standard Time on Monday, December 1st, 2025, in order for your vote to count. After I describe each voting item to be voted on, we will close the polls. We will not accept ballots, proxies, revocations, or changes after the closing of the polls. If you have already submitted your vote by proxy or voted by telephone or internet and do not wish to change your vote, you do not need to vote now, and your shares will be voted as previously instructed.
If you are a stockholder and intend to vote or wish to change your vote, you may do so by voting in person or clicking on the voting button on the web portal and following the instructions there. As the chair of the meeting, any undirected proxies given to me in relation to any items of business will be voted in accordance with the unanimous recommendation by the board of directors in favor of all proposals as sought out in the notice of annual meeting of stockholders. Broadridge will tally the results of the ballot, and details of the voting results will be announced in accordance with SEC and ASX rules after the meeting. Will the secretary please report at this time with respect to the mailing of the notice of annual meeting of stockholders and the stockholders' list?
I have at this meeting a complete list of the holders of record of the company's Common Stock at the close of business on October 30, 2025, U.S. time, which was fixed as the record date for this meeting by the Board of Directors. The list shows that as of the record date, there were 38,409,506 shares of Common Stock outstanding and entitled to vote at this meeting. An affidavit has been delivered attesting to the fact that on or about November 10, 2025, the notice of annual meeting of stockholders, proxy statement, and accompanying proxy card were mailed to all stockholders of record as of the record date. Such affidavit will be filed with the minutes of this meeting.
I hereby appoint Heather Obi from The Carideo Group Inc. as our inspector of election for this meeting and any adjournment or postponement of this meeting. She has signed an oath to act, and this oath will be filed with the minutes of the meeting. I have been informed by Ms. Heather Obi from The Carideo Group Inc., the inspector of election for this meeting, that there are represented in virtual attendance or by proxy a majority of the shares of common stock issued and outstanding and entitled to vote at the meeting today. In accordance with the company's certificate of incorporation and bylaws, I'm advised that the necessary quorum is present here today, and this meeting is duly convened for purposes of transacting business. We will now proceed with a discussion of the proposals to be voted upon, followed by a period to address relevant questions. Proposal number one A.
Part A of the first proposal is to elect John Seaberg as a Class 1 director to serve until the 2028 annual meeting of stockholders and until his successor is duly elected and qualified or until the earlier of his death, resignation, disqualification, or removal. We will refer to this proposal as Proposal Number 1A from here on. The board of directors has unanimously recommended that the stockholders vote for the election of John Seaberg as a Class 1 director. I will ask that those eligible to vote please do so now. Proposal Number 1B. Part B of the first proposal is to elect Gregory Moss as a Class 1 director to serve until the 2028 annual meeting of stockholders and until his successor is duly elected and qualified or until the earlier of his death, resignation, disqualification, or removal.
We will refer to this proposal as Proposal Number 1B from here on. The board of directors has unanimously recommended that the shareholders vote for the election of Gregory Moss as a Class 1 director. I will ask that those eligible to vote, please do so now. Proposal Number 2. The second proposal is to ratify the appointment of KPMG as the company's independent registered public accounting firm for the 2025 fiscal year. We will refer to this proposal as Proposal Number 2 from here on. The board of directors has unanimously recommended that the stockholders vote for the ratification of KPMG as the company's independent registered public accounting firm for the 2025 fiscal year. I will ask that those eligible to vote, please do so now.
The third proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 1 million RSUs to Wayne Paterson in connection with the company's U.S. initial public offering on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 3 from here on. The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal Number 4. The fourth proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 83,333 RSUs to John Seaberg in connection with the IPO on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 4 from here on.
The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number five. The fifth proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 41,666 RSUs to Stephen Denaro in connection with the IPO on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number five from here on. The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number six.
The sixth proposal is to approve, for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 52,742 RSUs to Gregory Moss in connection with appointment to the board on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number six from here on. The Board of Directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number seven. The seventh proposal is to approve, for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 52,742 RSUs to David Roberts in connection with appointment to the board on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number seven from here on.
The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number 8. The eighth proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of 250,000 in grant date value of RSUs to John Seaberg in connection with the annual meeting for the 2025 fiscal year on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 8 from here on. The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number 9.
The ninth proposal is to approve, for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of $125,000 in grant date value of RSUs to Stephen Denaro in connection with the annual meeting for the 2025 fiscal year on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 9 from here on. The Board has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal Number 10.
The tenth proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of $61,644 in grant date value of RSUs to Gregory Moss in connection with the annual meeting for the 2025 fiscal year on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 10 from here on. The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal number 11.
The eleventh proposal is to approve for the purposes of ASX Listing Rule 10.14 and for all other purposes, the grant of $61,644 in grant date value of RSUs to David Roberts in connection with the annual meeting for the 2025 fiscal year on the terms and conditions set out in the proxy statement. We will refer to this proposal as Proposal Number 11 from here on. The board of directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote please do so now. Proposal number 12. The twelfth proposal is to approve for the purposes of ASX Listing Rule 6.23.4 and for all other purposes, adjustments to the exercise price of certain stock options previously granted under the company's employee incentive plan on the terms and conditions set out in the proxy statement.
We will refer to this proposal as Proposal Number 12 from here on. The Board of Directors has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now. Proposal Number 13. The thirteenth proposal is to approve for the purposes of ASX Listing Rule 6.23.4 and for all other purposes, amendments to the terms of stock options previously granted under the company's 2017 employee long-term incentive plan and 2020 employee incentive plan as set out in the proxy statement. We will refer to this proposal as Proposal Number 13 from here on. The Board has unanimously recommended that the stockholders vote for the approval of this proposal. I will ask that those eligible to vote, please do so now.
That was the final proposal for today's meeting, and we will now open up for questions on the order of business.
John, mine.
Hand over to you.
Sorry, John. There are no questions online. Did I lose him?
No, I'm here. That was all the time we allotted to questions. We have now come to the end of our formal order of business, and shortly I will close the poll and voting system. Please ensure, as eligible, you have cast your votes on all proposals. I will now pause to allow you time to finalize your votes. For those attending in person, please lodge your voting card in the ballot box, which will now be circulated. I hereby request that the final report of the inspector of election be filed with the minutes of this meeting when available. As a reminder, Broadridge will tally the final results of the poll, and details of the voting results will be announced in accordance with SEC and ASX rules after the meeting closes. Ladies and gentlemen, that concludes the formalities of today's meeting.
On behalf of the board of directors and management of Anteris, I would like to thank you for your attendance and participation, both in person and virtual, in our annual meeting of stockholders today. I now declare the annual meeting of stockholders of Anteris Technologies Global Corp closed. Thank you and have a great day.