Just going through the format of today's meeting, it'll be as follows. Firstly, I'll present my chairman's address. This will be followed by a joint presentation and software demonstration by Matt and John, which will be pretty interesting. We'll then open the meeting and attend to the formal business of the meeting, including a poll on all resolutions. The meeting will be closed once the formal business is concluded. So there are a number of people attending virtually, and welcome. It has been another tough year for Artrya, but I can say with confidence that we have laid solid foundations for the growth ahead. Matt Regan, as the company's CEO, had much work to do when he joined in April last year.
His main priorities were to get things back on track with the FDA, including employing US-based competent and experienced experts with a proven track record when dealing with the FDA, and increase the capability of the product development team and commercialize the software. In relation to the first priority, a Q-Sub meeting was held with the FDA in June 2023, where the roadmap of work to be undertaken by Artrya was agreed. The right people to undertake this work were employed, and changes were made at senior levels within the company as well as with the product development team. At last year's annual general meeting, Drs. Girish Dwivedi and Abdul Ihdayhid demonstrated the software, which was close to having a product of commercial use. I'm pleased to say that with further development, we have a commercial product that clinicians can use, subject to having the necessary regulatory approvals.
We intend to do a presentation shortly of the current version of the software as a clinician would use it. In parallel with the further development of the product to FDA application status, Artrya has also concluded pre-FDA agreements with Northeast Georgia Health System, Tanner Health, and Cone Health in the U.S. The purpose behind these agreements is to generate income for these health systems as soon as possible post-FDA clearance. In total, these health systems conduct approximately 15,000-20,000 coronary computed tomography angiography CCTs, or in other words, CCTA scans per year. We are in advanced discussions with much larger U.S. health systems and will continue to work with them to execute contracts during the course of calendar 2025. One of the key benefits of the Artrya software is the real-time point of care approach.
Clinicians can treat the patient shortly after the CCTA scan is taken, retaining control over the reporting and their patient. This has become as important as U.S. hospital systems increasingly adopt a value-based care approach to patient care. Our competitors do not offer a cloud-based point of solution, point of care solution, sorry, which is a key differentiator for Artrya and a clear market advantage. John and Matt will cover this in more detail in the presentation and product demonstration shortly. Close to the home, we are generating small revenue from our first commercial client in Australia, the Cardiac Centre of New South Wales based in Wollongong. We are dealing with much larger Australia-wide radiology groups and are confident in the commercial arrangements with them in the coming months.
Having said that, I want to be clear that our primary focus is very much on the US market, where substantial reimbursement codes already exist for the use of AI-assisted CCTA scan interpretation for coronary artery disease detection. The US is a large market where approximately 4.4 million CCTA scans are conducted every year and growing at over 6% per annum. This growth will be further fueled by a recent decision by the Centers for Medicare & Medicaid Services (CMS) to more than double the Medicare reimbursement rate for CCTA scans, raising payments from $175 to $357 per scan. Upon FDA clearance of our current 510(k) application, Artrya will be well positioned to access this reimbursement. The payment rate for automated plaque analysis remains at $950 per scan, while fractional flow reserve reimbursement has increased from $997 to $1,017.
Artrya is targeting FDA approval for Salix Coronary Anatomy and Salix Coronary Flow by the end of calendar 2025, giving us access to a combined reimbursement of approximately $2,000 for both procedures. The American College of Cardiology and the Society of Cardiovascular Computed Tomography are recommending CCTA as a first-line test for patients with chest pain rather than other traditional modalities. The tailwinds for Artrya are clear and favorable. The staff are all aligned and incentivized around achieving FDA approval for the SCA, SCP, and SCF products during calendar 2025. It goes without saying that a growth company such as Artrya cannot deliver on the opportunities available if the company isn't well funded. To that end, we completed a successful AUD 5 million raise in early this month.
The Board decided that we needed to extend the runway before running cash too low and reduce the risk associated with the state of capital markets. The raising was minimised, and we brought on a number of new institutional shareholders as well as HealthLiant Ventures, the venture arm of U.S. hospital system, Tanner Health System, enhancing and widening our investor base. In closing, I'd like to thank our long-standing shareholders for your patience and offer a big welcome to our new shareholders who have joined us for what we consider to be an exciting journey ahead. I'd also like to pay a big thank you to my fellow Board members Bernie and Jacques, to Matt and JK, and the whole Artrya team who have worked tirelessly over the last 12 months to get us to this point and provide a great springboard for the year ahead.
Thank you, and I'll now hand you over to Matt and John for their presentation.
Yeah, good morning, and thank you, Bernie. Thank you for that. And thank you all for joining us for the annual general meeting this year. For those who don't know, my name is Matt Regan, and I'm the CEO at Artrya. As Bernie mentioned, my primary focus over the past year has been to refine our Salix product to meet the high performance standards expected of a commercial product in this medical sector. If I start with the presentation here on slide three, you'll see I've listed out some of the key achievements over the last 12 months. A key priority has been re-engaging with the FDA to prepare for our entry into the US market, all while carefully trying to manage our financial runway.
Our goal is to secure FDA clearance for our Salix Coronary Anatomy product, which we all anticipate to be cleared in the first quarter of calendar year 2025. We took a cautious yet strategic approach by scheduling a second Q-Sub meeting with the FDA in August this year to ensure we were on track. We submitted our 510(k) application at the end of September this year with a high level of confidence. On the commercial front, we secured strategic partnerships with three U.S. hospital groups. These partners serve three critical purposes: one, testing our software into hospital imaging workflow systems; two, further validating our software by clinicians; and three, streamlining the sales cycle to generate revenue as soon as possible once SCA has achieved FDA clearance. Close to the home, we successfully launched Salix in Australia and have begun generating revenue.
The feedback from clinicians has been positive, particularly regarding the benefits of plaque assessment and our unique point of care approach. Our collaboration with the Cardiac Centre of New South Wales has increased awareness and interest, and we are in active discussions with top-tier imaging groups across Australia. The rigorous process of preparing our 510(k) submission has also strengthened our ability to navigate further applications with greater assurance. Looking at our product roadmap on slide four, just wait for that to come through. On slide four, across the bottom of the slide, you'll see our SCA product, which is the subject of our current 510(k) application with the FDA. Our intention is to follow this 510(k) application for Salix Coronary Plaque, SCP, which is on the left-hand side there, in the first half of calendar year 2025, building on top of the other one.
And then that will be followed by our Salix Coronary Flow, our SCF product, that's our blood flow product, mid next year. The goal is to have both SCP and SCF approved by the end of calendar 2025. Slide five, please. This sets out the current approach to CCTA reporting and the approach that our main U.S. competitors take. The current system, which is the top line, is very manual, time-consuming, and generally does not report high-risk plaque because it's very time-consuming and difficult to see, difficult to see with the human eye. The middle line depicts our main competitors being HeartFlow, Cleerly, and Elucid. The CCTA scans get sent off-site to their premises where a manual workup of the images, a fixed report is generated and sent back to the clinician.
This process is time-consuming, expensive, and the clinician cannot amend the report if they disagree with the findings. It has to request a subsequent additional report at extra cost. The bottom line shows the Salix process, which is fully cloud-based with no human in the loop, and it is currently the only point of care approach which takes approximately 10 minutes to generate the report for the clinician. The clinician can review, amend where necessary, and approve the report and provide a treatment regimen for the patient in the same visit. Slide six sets out why we are focused on the U.S. market. There are 4.4 million scans per annum and growing at a rate of better than 6% per year.
The Centers for Medicare & Medicaid Services (CMS) has recently increased the reimbursement for CCTA to encourage clinicians to use this pathway, and we expect further CCTA growth because of this. Slide seven. This drills down into how Artrya fits into the reimbursement regime. Post our FDA clearance, Artrya will charge a monthly subscription for the use of our SCA product. When SCP is approved, we can charge a fee per scan where the reimbursement is established currently at $950 per scan. Approximately 70% of patients who have had a scan will require plaque analysis. About 50% of those patients who have had a plaque assessment will have potentially obstructive lesions and will be sent for non-invasive blood flow assessment. That's our SCF product. Once SCF is cleared by Artrya, by the FDA, Artrya can access a reimbursement of $1,017 per scan.
On slide eight, there are significant tailwinds and drives of growth in the U.S. market. The American College of Cardiology and the American Heart Association are recommending CCTA as the first line of evaluation for patients with chest pain, and as mentioned earlier, attractive reimbursement exists for AI-enabled CCTA. This is a tremendous advantage as many healthcare businesses trying to penetrate the U.S. market spent years gaining access to reimbursement codes. Additionally, there are newly published studies and pathways for the treatment of patients that have non-calcified and high-risk plaques. JK, if you don't mind, we might pass to JK and we'll get a demo of the current software up for us all to have a bit of a look.
Thank you, shareholders, for joining this session.
So when John's demonstrating the software, this is the software that a clinician would use in their practice. So if there are any questions during the course of this demo, then let's have a chat about it.
Yeah, please ask it anyway.
Make it interactive and so on and so on so we can get the most out of it. But it's pretty impressive stuff. Now, the issue won't be the software. The issue will be John because he only just got back from the U.S. yesterday.
So I sound like very wise. I picked up a call one day. But I appreciate the time. I think if you look, if you remember one of the slides that Matt mentioned that showed the gray line with the scanner in the front and the gray line going across, effectively that is the standard procedure which clinicians use to assess.
Louder.
Louder.
Yeah.
Access the CCTA scan. The scan is taken, and once the scan is taken, it takes about a 10-minute period from our perspective to process the results, which you see on the screen over here. In a normal reporting instance, from the center of the screen left is effectively what the clinician is seeing. So it's very hard for them to assess the severity of the patient and where to actually focus, whether the patient's healthy or requires further treatment. What we really provide is a full assessment on a quick dashboard so that they can triage a patient pretty quickly. That's important not only in standard imaging centers, but in the emergency room and inpatient settings where patients are going with chest pain and need to either be moved into the system pretty quickly or moved out of the system because that's something else.
So what you see here is within that same 10-minute period, we process the calcium score. We look at the severity of narrowing that the AI finds, and we categorize that into different categories based on how severe that is. There's a risk score that's associated to that, one being very low risk and five being very high risk. And then there's all the high-risk plaque features that the AI is able to find within that specific patient. So you can quickly see that it's an easy way for a clinician to test. And I'd like to show this scan here because I think it's quite an easy one. If you all remember in the Boxing Day test last year when the Shane Warne Foundation said, "Everybody go for calcium score," that was great.
But if you look at this patient who had a zero calcium score, and if that patient only went for a calcium score, they would have missed severe narrowing, high-risk plaque features that patient. So the calcium score, while it's good, is not a full. It doesn't give the patient or the clinician a full story. So clicking onto this patient, and this is what the doctors normally have access to, you quickly see a few things. And the first thing is a 3D model, which is a true representation of your coronary arteries. So it's effectively removing the heart from the arteries and showing those arteries on their own. And then what happens is we overlay the findings of the AI on this coronary artery so that the clinician can actually see and use this as a roadmap to treat the patient.
Where it's important, this coronary artery tree over here, they call this the widowmaker. It delivers more than 50% of your blood to your heart. If there's a blockage or severe disease there, that's usually very crucial or critical. The doctor wants to remove it pretty quickly. The second thing is for clinicians, they're able to use this as a mechanism and how they treat the patient more effectively as well. By the patient knowing where the disease is, they're able to follow a treatment plan a lot more precisely as well. That's the first part. The second part is similar to what you saw on the dashboard, but then also additional risk scores. The diagnostic side, and this is where a lot of the AI plays a real value add, is I'll shift this marker down to this lesion over here, and I'll remove the annotations.
This is what a clinician would normally see within that part of the coronary artery, so this white piece here is a cross-section through this coronary artery, and it's really hard to justify or assess whether there's high-risk plaque, there's non-calcified plaque, and what component and what burden of that is. So they make an assessment quickly, and they move on, but if I turn this on here and I turn the plaque mask on, you can quickly see that there is a lot of high-risk plaque within this coronary feature over here, this coronary cross-section here, which means that just knowing that, the doctor can give them a specific type of medication to try and progress that or try and transform that plaque into something different, so just knowing the type of plaque it is, they've got a clear view on how to treat the patient.
And as Matt mentioned in some of the tailwinds, there's new studies now that show with these types of plaques, these are the types of medications you should be taking. The second part is what we provide is not only the composition of plaque, but the clinician can now use how much of that plaque is there to track the treatment plan over time for the patient. So you can see there's volumes and burdens on the screen. That effectively tells the clinician that we need to see less of this as we treat this patient. So it gives them a true view on the treatment process for that specific patient. Again, on the working and the workflow side of things, we really try and make it easy for the clinician. If they disagree with findings, they've got the ability to change at any one point.
You'll quickly see it makes changes to the coronary arteries and then propagates to the whole report, which improves workflow. It makes them a lot more efficient around workflow. There's key features which support the product roadmap. They can now add stents to the product. You can see it's added a stent to the specific lesion, and that improves the reporting. They can add bypass grafts, and that all sets the foundation for future products that Matt mentioned. That also then finally moves to the raw scans, which they can assess, but ultimately the digital report, which is automatically written within that same 10-minute period, and they can make changes accordingly. What they don't get currently is a full view on plaque and the type of plaque and how much of it is.
Just having the composition and the volumes gives us access to that $950 US dollars that Matt mentioned earlier within the US. I'll stop there. It's quite a lot. This is the software that's used currently in practice here in Australia. It's getting a lot of interest in the US because not only the ability to assess plaque at the point of care, but to optimize workflow. As Bernie mentioned, I got back from the US yesterday. Some of the key health systems that I've been speaking to have waitlists of up to about six weeks before patients can get a scan. Having a system like this allows them to expedite that as well. You get the diagnostic side, but then you get the productivity side as well.
So, you can see there that the SCP, or the plaque product, a lot of the development work's already done for that. So, that's the next 510(k) application that we'll have in the first half of next year. Yeah, Chris.
Other than the speed of delivery, what are the key different changes to the other products on the market?
That's a good question. I mean, the speed of delivery is a big one because of the time in the point of care. We've also worked heavily around our plaque assessment, being able to show that within that same delivery period. There's a piece of work that's been worked heavily together with Dr. Girish Dwivedi out of the Harry Perkins Institute, which is called plaque dispersion, which means it's not only looking at whether plaque is localized or spread across the vessel, it then basically looks at how much of that spread influences treatment regimens. And that's very, very novel to anybody else in the world. There's nobody else doing that. So that allows us to not only give the patient the ability to, the clinician's ability to treat the patient, but then scale up treatment or dial down treatment based on that.
I do want to make maybe not underpin how important the speed of this is because it underpins the whole product roadmap. If you look at some of our competitors that do a plaque assessment in, let's say, 2-24 hours, we run everything in parallel, which means that once our blood flow assessment comes on, we get the same result in that same 10-minute period. So it's not waiting 24 hours for plaque and then another 24 hours for FFR. You get everything in the same 10-minute period.
Yeah. I'll just also add the feedback we're getting from clinicians. It's the control they like. They can change things. It's their report. It's not somebody else's report that's been sent off and received back. They have that control after that 10 minutes, and they can modify it and change it wherever they like.
Okay. Last question.
Please.
The software has adapted to the report. The second method on the TME report that you sent away, would the clinician get a similar report back? They just had 24, 48 hours. Is that your report is actually in the office?
Yeah. So that, forgive me if I'm wrong, JK, but they will get essentially this report, but it's something that they can't question or query or analyze themselves. So they would get something similar to our report, but it's somebody else's done it for them. And if they disagree with it, they have to go back and ask for another report.
They could update the 100 reports and then get another screen and update those as well.
Yeah. So they can generate multiple reports from here. They could change it to another report.
They can't change it. They're fully volunteers.
Yeah, it is. Yeah.
I mean, that's one of the big negatives of the competition. The feedback we're getting from clinicians in this stage is that they don't have control over the reporting. So they've got to accept the report as it's delivered to them by our competition. And the other issue is the cost of delivery because they had assumed it would, because the scan is sent off to their premises and it's worked up, AI applied to it, sent back to the clinician. There's a cost associated with that. So one of our competitors is actually charging more than the reimbursement. So it's actually costing the hospital system or the healthcare system to use it, whereas we're fully cloud-based and we can share in that reimbursement with the health system.
Yeah. I mean, I'll just add, and maybe to answer some of Chris's questions as well. The top gray line that was on Matt's chart, that line has to be done independently of a plaque assessment mod. They still have to do a CCTA report because it looks at everything in the coronary arteries. The second line, which is where the competitors play, that is only giving a plaque report. That doesn't give a CCTA report. So effectively, the doctor has two systems running now, one to do a CCTA report and one to do a plaque report and one to do an FFR report. We have combined everything into a single platform. So effectively, it combines the two lines into one. So it's a major differentiator for clinicians that they don't have to have multiple screens open.
There's obviously extra cost associated to having multiple systems open as well. To answer the question, Kim, this report here is not only the plaque report, it's also the CCTA report in one. All of these changes, if I make the change over here, let's say, for example, I want to add a bypass graft, I can add a graft to that or just say whatever. This isn't available in, you can see it's added a bypass graft. Now, this isn't available in our competing solutions because we're trying to make sure that we're keeping the clinician reporting for a single platform throughout the entire process instead of having multiple systems.
And we'll just add more modules into that platform over in Go. I think just for everybody and also online, just to fully understand, I mean, so JK's running this through the Wi-Fi, through a Zoom call, through a Teams call, and it's performing the way it is. So that's what we talk about. We've spent a fair bit of energy and effort getting a commercial-ready product for the medical industry, and that's where we're up to.
So John, are you able to pull up the FFR slide just to give people a bit of a look at that?
While we're doing that, we have a couple of questions, I think, Danny, but we might have to try and get some volume on here to get those questions. That could create an echo. Unless you want to type them on the chat, Danny, and we'll give Danny some last minute questions.
I'm happy to ask them if you like, so.
We can't hear Danny.
Can you try to unmute?
Can you hear me now?
One second, Danny.
I need to unmute.
Yeah, can you unmute?
Can you hear me?
Danny, can you hear me?
I can hear you, JK. Can you hear me?
Yeah.
Mr. Chairperson, we do have some questions. The first one is from shareholder Nick Huntley. Thank you for taking my question. Based on the new slide deck uploaded today, forecast first revenues calendar year 2025, do you need to raise capital again to get you there?
I'm just getting excited.
Sorry, I didn't do a multiple question.
Sorry, Mr. Chairperson, I'm getting some echo.
Go ahead, Danny.
Okay. Do you want me to repeat the first question?
No, no, we got that.
Second question. Okay. The second question is also from shareholder Nick Huntley. How many scans have been completed at the Cardiac Centre over a quarter and the revenue? What is the scan mix currently? SCP, SCF, SCA, and SCP?
So I can answer part of that. As of the end of the last quarter, we'd, correct me if I'm wrong, Mark, around about 547 scans. We can't give the revenue on that openly, but because they were the first customer we had, we discounted that heavily to work closely with them. The scan mix has predominantly been through one single scanner, and we've been processing those on an ongoing basis. We've also only used SCA effectively with the Cardiac Centre because in Australia, the understanding of plaque volumes isn't as well, it's not as mature as it is in the U.S. So the clinicians report very much on plaque composition and less on the burdens and volumes.
I think I can add to that by saying that, and we've always maintained this position that situation for the industry here, and we'll never make any money out of doing deals here in Australia. That's why we're firmly focused on the U.S., where there is an attractive reimbursement regime.
Thank you. The next question is also from shareholder Nick Huntley. The question is, are the reimbursement payments one-off for patients or every scan, including follow-up scans, as part of management treatment?
Yeah, it's a good question, and Jack, Dr. Sokolov can also jump in. If there's a CCTA scan that's done, we will charge for every patient that goes for a CCTA scan for the Salix Coronary Anatomy product. For the Salix Coronary Plaque, ideally, in an ideal scenario, every patient should be getting that because it also forms a better assessment on what the disease profile is for that patient going forward, but we've been conservative in making the assumption that 70% of patients that go for a scan will have the Salix Coronary Plaque assessment and get that reimbursement for Salix Coronary Plaque. If the clinician wants to assess the patient further, let's say in two or three months, and they do another plaque assessment, they will be charged for that same patient another reimbursement for that specific patient.
This is Jacques Sokolov. What JK has mentioned is absolutely correct, and what is, I think, going to become more common is you're going to see serial scans for progressive reasons, so the patient population gets subsegmented into a lesion that is significant enough to then get a flow analysis after a characterization of the lesion. That lesion may even be, you may even see an intervention, such as a stent, for instance. You'll see a pre- and post-procedure scan over some period of time. So it is very much related to the number of scans, and that patient may have numerous scans over a three-month period of time.
Thank you. The next question is also from Andrew Wilkinson. And the question is, can clinicians overlay earlier scans to easily compare scans taken over time, so to see how a condition is progressing or improving due to treatment?
Yeah, that's a good question and that sort of follows on from, I think, the question Nick Huntley asked. As part of our roadmap, we do have what we call delta assessment, which means a patient will go for a scan on day zero and three months or six months later, if they come for a second scan, we'll be able to show whether the disease has progressed or regressed and that's important from a monitoring and a treatment pathway so currently, we don't have that, but it is definitely part of our roadmap for something that we need to bring in.
Okay. And the final question is also from Andrew Wilkinson. Are the competitors you mentioned working on upgrading their platforms to remove humans from the loop and allow clinicians to edit their report?
Why don't you let me answer that one? Because at least in the United States, the FDA has to certify what's called a Class 3 certification for automatic reading. And the FDA has been absolutely reluctant to remove the clinician, whether it's a radiologist or cardiologist, from an automatic read. There are a whole variety of reasons for that. But at the end of the day, there's no question that the AI technology can read the scan, most likely, in many instances, better than the human. But the human's got the judgment. And we glossed over one thing a little more quickly than maybe we should have, and that's the inflammation piece. That hot and cold plaque that JK went over, that's transformational.
This is the only technology of all the different companies that are out there that can look at what an inflammatory plaque is at the heart of what causes strokes and heart attacks. And that's not going to be determined by an AI judgment at this point. And really, what we're doing is we're really giving the clinician, cardiologist, or radiologist, and eventually the patient, the ability to really look at the disease process much more effectively than they can without the technology. So no, you're not replacing the doctor.
Thank you very much. That completes the questions.
Thanks, Daniel. I'll just quickly show one slide just so that our shareholders have a clear view on what Salix Coronary Flow looks like. I'm just going to find my remote here now. There we go, so the third product which we're working on is Salix Coronary Flow, which is a non-invasive assessment of looking at the blood flow through a specific lesion, and there's only a certain band where patients will go for this test, and it's usually when the doctor's uncertain on whether the lesion is obstructive or not, and the current process is that if the clinician's uncertain, they'll send their patient on for an invasive procedure where they put a catheter in the patient's leg or arm, and they use a wire to go assess the severity of that lesion.
As part of what we've built is, of the same CCTA scan, we're able to do that same blood flow assessment in a 10-minute period, and what you can see here is a mock-up of the screen I demoed live, but this now overlays the blood flow on the coronary artery, and it really gives the clinician a quick view at any one point, at any lesion, what the blood flow drop, the pressure drop is across that lesion so they can make a better-informed decision on whether that patient should go for a further invasive procedure, whether it's a coronary angiogram or a stent or anything else, so we've said it so many times that over 40% of patients that go for an invasive coronary angiogram have never needed it.
This is now effectively that gatekeeper to make sure that if they are going for it, they really need it.
The other important thing here is that once we fully develop the plaque and the FFR or the blood flow assessment, all that work is done upfront in the same 10 minutes of the same CT scan. So when a clinician wants to access that, they've got the patient in there, done the scan. They'll click on the plaque assessment, get that. That initiates a reimbursement of $950. And then they'll click on the FFR assessment and want that. And that's another $1,017 reimbursement. So there's no extra work for Artrya in that. It's all done upfront in the same 10 minutes. So the cost of actually generating that further reimbursement is very, very small. And that's basically satisfied by the time we get approvals. So that when we do get the necessary approvals, then we can generate revenue fairly quickly post-op.
So we're trying to get in front of that crisis. And that reimbursement person is highly experienced in this exact area. Yeah.
All right. Thanks, JK. And clearly, for those that are in the room afterwards, we can show you a bit more on the big screen in the boardroom. But here on slide 10, just for me to sort of round out, it's pretty clear what our priorities are for calendar year 2025. So we're very clearly focused on the US market, obviously an attractive reimbursement landscape. Actually, that market will continue to engage with the FDA to approve our current application, which is SCA, followed on by our SCP, which you've seen a lot of the development is done. It's now really around clinical trials and building on the FDA and that sort of thing. And then, of course, we'll follow on with the SCF. That's quite a tight timeframe, but we're working hard to get that done.
We'll also look to secure our U.S. revenues as soon as we can post the FDA clearance of our SCA product. And we'll continue to expand our client base in Australia as a good corporate citizen in Australia and to validate Salix because that helps us as well with the U.S. as we validate our group and use our U.S. pipeline with our strategic hospital groups. In closing, I'd just like to say sincere thanks to our team for their dedication and hard work and also to our partners for their invaluable support. And finally, to you, the shareholders, I'd like to thank you for your support over my first 15 months to get us to where we are today. And we really are standing on the precipice here, I think. So we look forward, energized as ever, and ready to drive our progress forward.
Thanks, Matt. So that concludes the informal part of the meeting. So we'll now get on to the more boring part. And we'll open the meeting. I've been advised we have a forum present and a complete meeting open. So the proxies eligible to vote at this meeting is now tabled. And I draw your attention to the screen showing a summary of proxies. The company has received valid proxies from 75-odd shareholders, holding a total of approximately 36 million shares, representing 40% of issue capital of the company. The specific voting preferences indicated by proxies who had either directed their voting preferences or had left their voting preferences open to be cast by the nominated representative or the chairman are available for inspection.
Where a proxy vote has been given to the chairman with the instructions to vote in favor of a resolution in accordance with the directions on the proxy form, I intend to vote in favor of the resolution. Any undirected proxies will be voted in favor of a resolution. So a copy of the Notice of Meeting convening this meeting has previously been made available to all shareholders and sets out in detail the nature and purpose of the resolutions being considered at today's meeting. I propose to take the notice as read. I do not propose reading every resolution in full but will refer to the resolution as set out in the Notice of Meeting. After each resolution is displayed on the screen, I will invite questions from the Board, and I will be limiting questions to the motion being considered.
I would ask that you state your name for the record when you address the meeting. If a question is asked, which in my opinion does not relate to the motion which is before the meeting, I will rule that question is inadmissible. In my capacity as Chair, and in accordance with ASX Governance Guidelines, I will today request that a poll is taken on each of the resolutions being considered. We will conduct the poll at the end of the meeting and after we have put each of the resolutions to shareholders. So agenda item number one is receiving the financial statements. The first item on the agenda is to receive and consider the financial statements for the year ended 30th of June 2024, consisting of the director's report, the financial report, the director's declaration, and the auditor's report.
We have both John Ward and Frances Arnold from the company's auditors, as I mentioned earlier. John and Fran are available to answer any questions specific to the conduct of the audit. Are there any questions or comments in relation to the reports under consideration? There's no requirement for a vote on this item, so we shall proceed to the second item of business, which is resolution one, the adoption of the remuneration report. The Corporations Act requires that a resolution be put to members to adopt the remuneration report as disclosed in the director's report section of the 2024 annual financial report. In accordance with the legislation, the vote on the resolution is advisory only and does not bind the directors of the company. However, the Board will take the outcome of the vote into consideration when reviewing the remuneration practices and policies of the company.
I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. So I now formally move the motion that resolution one be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution? In my capacity as Chairman, I call for a poll on this resolution to be held at the end of the meeting. Moving on to resolution two, the re-election of Dr. Jacques Sokolov as the director. The second resolution seeks the approval of shareholders for the re-election of Dr. Jacques Sokolov as the director of the company. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. I now formally move the motion that resolution two be put to the meeting in the form set out in the Notice of Meeting.
Is there any discussion on this resolution? Well, welcome back, Jack. But I'll call for a poll anyway on a resolution to be held at the end of the meeting. The next two resolutions deal with the ratification of prior issues of performance options to strategic partners. So resolution three is actually the ratification of prior issue of performance rights, performance options, I should say, to Cone Health. This seeks shareholder approval ratification for the issue of 1.18 million performance options to Cone Health Ventures. I now refer shareholders to the screen displaying the resolution full and valid proxy results. I now formally move the motion that resolution three be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution? I'll call for a poll on this resolution to be held at the end of the meeting.
So, resolution four is concerned with the ratification of prior issue of performance options to Tanner Health and seeks ratification from shareholders for the issue of 1.18 million performance options to HealthLiant Ventures, an affiliate of the Tanner Health System. And people, like we call it, Tanner Health have actually invested in their recent placement. So that's good validation that they're using our integrated software into their system, and they're prepared to back the company as well. So that's a great compliment in what we're doing. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. I now formally move the motion that resolution four be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution?
I call for a poll on this resolution to be held at the end of the meeting. Resolution 5, approval of 7.1A mandate. The fifth resolution is a special resolution and seeks the approval of shareholders for additional capacity of up to 10% of the issued capital. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. I now formally move the motion that Resolution 5 be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution? I call for a poll on this resolution to be held at the end of the meeting. The sixth and seventh resolutions seek shareholder approval for the issue of options in lieu of cash consideration for services rendered, and Resolution 6 is for the issue of options to services rendered by Beat Capital Advisory.
This resolution seeks shareholder approval for the issue of 231,000 options to Beat Capital Advisory as consideration for services rendered. I now refer shareholders to the screen displaying the resolution in full and the proxy results. I now formally move the motion that Resolution 6 be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution? I call for a poll on this resolution to be held at the end of the meeting. And the other person we're working with is Enrico Petrillo, which is known here as L. Da Vinci. And the resolution seeks shareholder approval for the issue of 231,000 options to L. Da Vinci LLC as consideration for services rendered. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results.
I now formally move the motion that Resolution 7 be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution? Just for the benefit of shareholders, Enrico and Carsten, Beat Capital, and Enrico Petrillo, they've been really critical in us. You might remember that during the course of my address, I mentioned that we're dealing with a number of much larger health systems in the US. They've introduced those health systems to us, and on John's visit to the US just this last week or so, he met with all of those different health systems, and in some cases, it's the second and third meeting we've had with them.
And if we just focused on those alone, then we don't have to have a major sales force in the U.S. going forward because they've introduced us to health systems and keeps us busy for the next few years. So it's a good investment that we've got these guys working with us. So I'll call for a poll on this resolution to be held at the end of the meeting. The final resolution seeks shareholder approval to increase the maximum number of securities that may be issued under the company's Performance Rights and Option Plan to a maximum of 7,875,000 securities. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. I now formally move the motion that Resolution 8 be put to the meeting in the form set out in the Notice of Meeting. Is there any discussion on this resolution?
I will say, as Chair, that it is very important that we have the ability to incentivize staff, and particularly with the top-end talent that we have in this company, both in the U.S. and here, and everyone in the company from top down, are incentivized around delivering those outcomes for calendar 2025, which Matt outlined in his address, so we're all aligned from the Board down, so I call for a poll on this resolution to be held at the end of the meeting, so a little bit of info. I've got to run through this as a formality. The poll on the resolutions, as advised, all resolutions for consideration at today's meeting will now be decided by a poll of shareholder votes. I'll ask Jonathan Lamb from our Automic Group to act as returning officer.
Recent changes to the Corporations Act have changed the law in relation to the obligations of proxies to vote, where a poll is called on any resolution. If the proxy is the Chair of the meeting at which the resolution is voted on, the proxy must vote on a poll, and the vote must be as directed. If the proxy is not the Chair of the meeting, the proxy need not vote on the poll. But if the proxy does so, the proxy must be voted as directed. You can follow all that. If you are a proxy holder with open votes, you may vote as you wish. You've been handed a ballot paper for the poll on registration this morning, and the resolution upon which the poll has been taken is to be set out on a ballot paper by you. That is Resolutions 1 to 8.
You should record your vote now by placing a cross in either the for or against square on the paper. You should also print on the ballot paper your name. If you are a proxy, the name of the shareholder for whom you are representative or attorney. If you hold multiple proxies, please state this, and we will complete the information from the proxies. So we'll just take a little while while people cast their votes. All with Jonathan? Yes, sir. Everyone's cast their votes? Very good. I therefore declare that the poll closed, and the results of the poll will be announced to the ASX later today. Shareholders are entitled to ask questions or make comments on the management of the company. Do any shareholders wish to avail themselves of this opportunity? They're more than happy to take questions. Yes.
Obviously, we all want the approval from the U.S. If things don't work out, is there a plan B?
There's always plans B, C, and D. But I think on this particular occurrence, it's more a matter of time rather than if we will get this approval. We have plenty of opportunity elsewhere in the world, but nothing is as lucrative as the U.S. market. So that is our primary focus. We've put in so much rigor and effort into this current FDA application that if we were to be rejected, we would have already heard that news, I think. We haven't heard from the FDA yet, but we're expecting to work through the process with them, and it's really just a matter of time, I think.
But there is always a plan B, C, and D in other markets in the world we would approach and that sort of thing, but that isn't in our current workflow consideration.
I think you'll add to that. And Jack, you might say a few words on this as well. But the FDA want to approve things, but they want to approve things that are safe. So they've got to work through a process with companies like us, but they're not the big ogre. I mean, that's why we've had the Q-Sub meetings, is to agree the roadmap that needed to be satisfied to get approval. So it's really engagement with the FDA and working through the process, which is what we're doing. And we expect to, on the latest application, we expect to hear back within the next couple of days just what the next step is. But it won't be another. So as Matt said, we would have already heard that.
So just having gone through.
Jack, any thoughts on your side?
Sure. Thank you, Bernie. Having gone through multiple, multiple FDA processes and sitting on several Boards that are going through FDA processes, Bernie's comments and Matt's comments could not be more accurate. The FDA has gone from several years ago approving multiple indications with one application to really approving very singular focus with very singular focus, certain aspects of a software as medicine, etc.
When you look at Artrya and the AI-enabled CCTA capabilities that we talked about and the three or four different products that we're moving forward, you just have to take them in a sequential way so that you don't bite off more than you can chew and the FDA feels comfortable that you've basically trained these large language models effectively and that ultimately you're not going to harm the patient. The AI piece of this, as it relates to the FDA, is very scary to them because, as someone asked and very appropriately, could this replace doctors? Could this replace humans? Could this actually do things that could harm people? And the answer is, unchecked, you can do anything. There's a lot of checks and balances here.
Our technology involves hundreds and hundreds and hundreds, sometimes thousands of scans in training these models so that what we conclude is absolutely accurate. What we conclude is very much focused and not overexpansive, and when we look at two or three or four applications, we have the data to support those two or three or four applications, and we'll do it sequentially, not all at one time, so to make a long story short, I think Artrya and all of us have learned the FDA has a very deliberate way of doing things. I think Matt's totally in touch with all this. Our team is very good. The Board is absolutely preoccupied with providing as much guidance as we can, and I agree with Matt. It's only a matter of when, not if.
But that when could be a little more protracted given the complexity of AI, especially in the cardiac area. So to make a long, long story short, we will get there. I think we'll have a superior product, and we have to basically support our clinical studies long enough so that we basically can generate the revenue that we know we can achieve.
This FDA application is the first in a series of FDA applications. So it's very important to us. And Matt and the team have been rebuilding credibility with the FDA. The first go around didn't work, and there are obvious reasons for that. But in this case here, we're establishing a very good relationship with the FDA, where we've had very professional people involved on our side and so on. But this is only the first application.
So as we pointed out with that product roadmap, we've got to get product approved. We've got to get the flow product approved and so on. So this is a pretty intense process, and we've set some pretty tight guidelines in terms of or milestones in terms of getting approvals through the FDA during calendar 2025. And the reason we've done that is because, and I think Andrew Wilkinson asked the question around competition and so on, we've got to assume that the competition is working hard and so on to do things in a point-of-care type approach. But they're going to have to go through the similar approvals that we're going through. But to be first to market, and largely the US, it is a greenfield market because HeartFlow clearly have very little market penetration in that country. So it's an amazing opportunity.
I've never seen anything like it, but it's an amazing opportunity. And that's why we're going hard during the course of calendar 2025 and why we've set those really tight deadlines. Matt and the team are going to be working their backsides off to achieve those milestones. But it really is important that if we slow down our cash burn and take longer to get there, then we might not be first to market with that point-of-care product. So really important that we have that strategy and so on. So long-winded answer to your question, Jerry, but does that help? Any other questions? Yeah.
Chair, and thanks for my name. I've got a couple of questions. First one is, has the company made any inquiries or any steps to do some environmental standards given the political change in America and how those changes in nominations of various random mates may affect how the FDA works after January 6? And as a subset of that question, I know Americans from my last job. I know the American economy hates outsiders and wants to put as much weight in it as many as possible. And has the company made any inquiries and sending up a U.S.-based entity to represent its investment?
Yeah. So Jack.
I'll be very happy to answer that question, Bernie. First of all, that's an excellent question. I was going to actually pose that question because I'm sure every investor is thinking about the same thing. At the end of the day, there's several macro trends and then a couple of micro trends, and we pretty much address the micro trends. I'll talk about the macro trends for a quick second. With President Trump being elected, he's very much a transactional president, always has been. Whether that's good, bad, or indifferent depends upon where you sit on the side of the transaction. The bottom line is, after he was elected, the capital markets substantially opened up. The ability to basically raise money became apparently much more likely.
The financial constipation that we've been experiencing largely since the pandemic, I think, will ease in the next 12, 24, even 36-month period of time for the capital markets in general. We've seen a significant bull market in the equities and in the bond market even in the last three weeks. But having said all that, the things that are most important to us are really regulatory environments. And that includes the HHS secretary, which may be Robert F. Kennedy, which is an interesting choice on a number of levels. Dr. Oz, who's head of CMS, which is the Centers for Medicare and Medicaid, and then the head of the FDA, who's critical, and that's a fellow by the name of Marty Makary. I actually know the proposed individual for the FDA personally, so I basically think that's positive for us if actually just knowing him is actually a positive.
And I think that is. As far as RFK and Dr. Oz, I can't make a comment. I don't think they're going to have an impact on what we're doing at the level that really is going to be material. I may live to eat those words later, but I'm much more focused on the financial markets, and I'm much more focused on the regulatory FDA piece, and I'm also more focused on the transactional nature of what we're dealing with in terms of the capital markets. So in general, long-winded way of saying, I think the election of President Trump actually serves us better than the election of the Democrats, and I think that's largely because we will see, if we are successful doing what we want to do, a more receptive market for our company in general, so I hope that answers your question.
And if you want anything more detailed, I certainly can respond, but thank you.
In relation to doing business in the U.S., we have a subsidiary that's already established in the U.S. called Artrya USA Inc. John is moving to the U.S. next year as well, but the response that we've been getting out of demonstrating the software to the actual market in the U.S. has been outstanding, so we don't see any trouble in terms of people taking on the software because they're very excited by, particularly, the roadmap, which includes FFR. To have a point-of-care market FFR analysis is what, to use their words, that's a game changer, and so on, so there's a lot of excitement. I mean, John, you can add to that because you've just been there, and we really haven't had a negative in terms of displaying the software to potential end users.
Yeah, and it's a good question, and the one thing I will say is that the nervousness isn't around foreigners in the U.S. That's more about them thinking that we think we know what to do in the US going from here to the US. That's partly how we're moving there. The major thing is that it's starting to bring the right people in the US to actually help you do the work a lot effectively as well. That's part of the two, Dr. Professor Enrico Petrillo from Harvard, who is one of the guys we've spoken about, Carsten Weiss, this group that Bernie mentioned, that's going to help with cost reimbursement. It's bringing the right people in the US to help structure the business over there. As Bernie mentioned, the feedback we've gotten thus far is, when is FDA clearance coming, as opposed to why the software?
It's more when, as opposed to software, is not going to work because they do see a massive benefit of point-of-care as opposed to smart operating solutions.
If I can come in, I think two answers you've given. I'm really from a clinician's perspective. Not from a big strategic perspective. Not from a what, sorry? A greater strategic perspective. From my experience in my last job, non-American companies have very different American companies with decision makers who actually hold back external competition, and so there is the possibility that hand may hold back this external market leader while the other ones catch up.
That's not, that's not. That's. I understand the question. I've run businesses in the US previously as well. By having Enrico and Carsten on board, we're going into the CEO level and someone in the organization, which I haven't named them, but they're large health systems there, and the door is wide open. Now, I'm not going to sit here and say that there's not going to be any negativity or old boy network that gets in the way sometimes. I'm not going to say that, but the response has been overwhelmingly positive because we've got Jack there.
We've got Carsten and Enrico, and John will be moving there, and as we go forward, we'll beef up Artrya USA with US-based people and so on, so we're not just this little company from West Perth that's going to try and take over the US by fly in, fly out type approach. So people on the ground, working with the customers and the clients there and so on. As I said, not to say that we're not going to run into some negativity because of the old boy network and so on that does exist here, which is very real.
Yeah. If I can just add in the one thing which always ends up cleaning up, I think you mentioned again, those are valid points, is dollars. And dollars is revenue and dollars are profit in the U.S. It's very much a payer-driven system over there, as you know. And when our competing solutions are cost centers to a lot of these systems, as in they're losing money, and we are able to make them profit centers, that old boy network , Bernie mentioned, tends to disappear because while they're trying to keep, they may be trying to keep their friends in, if it's at the risk of that modality being a cost center, they're going to quickly run into an issue. That's one of the biggest things we see.
We've calculated basically on a system that's generating about 10,000 scans per year, that's roughly about a $3 million upside in profit for a center like that. So for any center, that's a lot of profit benefit by replacing a competing solution.
Thank you. I just had one more local question. How will patients in Western Australia at the moment receive scan given that there's a service provider in these type of labs? Two ways. One is they could go and visit Envision Medical Imaging. And both Matt and I mentioned during our addresses that we're dealing with some large radiology providers here in Australia. Once we get commercial agreements with them, then people across Australia, including WA, will be able to go for a scan. Once they've worked through, they'll put it into a single practice first, and then they'll gradually roll it out across the network. So if you want to scan now, you go and visit. But hopefully, within the next few months, you'll be able to go to a range of different radiology providers across Australia.
Just to reassure you, I'm asking for a friend.
And just to reassure you, my scan is actually going through, and it's right now.
You can refer to the addresses.
You can. Absolutely. Yeah.
Thank you.
Okay.
Any further questions? Okay. As I know of, no other formal business has been notified to be dealt with today. That concludes the formal business of the meeting. I thank you all for your attendance and formally declare the meeting closed. That's a wrap.
Okay? Done. Thank you.
Thank you, Mr. Chairman.
Thank you.