Artrya Limited (AYA.AX) Earnings Call Transcript & Summary

Welcome, everyone, to the Artrya investor call regarding the FDA clearance of our [indiscernible] Salix Coronary Plaque Module. My name is David Allen from Hawkesbury Partners, and I'll be moderating the call today. The host for today's call is John Konstantopoulos, CEO of Artrya, and he's joined by Bernie Ridgeway, Executive Chairman; and Harvey Farrington, acting CFO. This call is being recorded [Operator Instructions] Recording of the call will be in Artrya's website shortly, and this presentation will be followed by a question-and-answer session. [Operator Instructions] I'll now hand over the call to John Konstantopoulos, CEO of Atria. Please go ahead.

Thanks, David, and good morning, everybody, and welcome to this investor update where I'll be looking to provide a bit of background on this great outcome of -- that we received yesterday from the FDA for the clearance of our Salix Coronary Plaque Module. I'll also look to give a little bit of insight into what this actually means for us as a business going forward. But before I do that, as David mentioned, joining me today is our Executive Chair to my right, Bernie Ridgeway, as well as our acting CFO, Harvey Farrington, to my left. So just kicking this off, I do want to emphasize really what a seminal moment this is for us here at Artrya, getting this FDA clearance for our Coronary Plaque Module. As everybody is aware, we received the Salix coronary anatomy clearance earlier this year, which really gives us the opportunity to put a platform to report CCTA scans into a hospital system and solidify ourselves in the hospital system and with the clearance of the Coronary Plaque Module now, it enables a button at the top part of the software of the platform, and clinicians are now able to access a detailed plaque analysis that shows an overview of plaque, but really more specifically that high-risk plaque that can cause a heart attack and potentially kill you. That is done and it's processed in the same time as the Salix coronary anatomy as the scan is read, the CCTA scan is read, and that is also done at the point of care and without any humans in the loop. That's really compared to some of our competitors that have humans processing the scans. So what does that actually mean for us going forward commercially? And if I'll just take a bit of a step back and just to provide some context again on the U.S. market and why we're focusing over there. There is roughly about 4.4 million scans, CCTA scans that are performed every year in the U.S. That's growing at roughly about 6% per year, and we do expect that to extend and grow further as the guidelines kick in and a lot of the hospital systems follow a CT-first approach. But what that actually means for us is that if you look at the Salix Coronary Anatomy as well as now the cleared Salix Coronary Plaque Module, that really gives us a $4.4 billion opportunity in the U.S. going forward. So it's a really large market for us over there and really why we're focusing there as well. It's -- in our view, it's largely greenfield. And our approach into the U.S. is very structured to try get into hospital systems that are looking for this point of care, a real-time approach around plaque analysis and in the future noninvasive blood flow analysis. What it also means for us is that we now have access to a USD 950 reimbursement code. That is -- that was converted from a Category III code early this year into a category I code, and that will be fully transitioned at the end of this year. As I mentioned, the Coronary Plaque Module does bolt onto the Coronary Anatomy platform and is available immediately for clinicians to start using as soon as we start pushing this out into our respective hospital systems. And as we go forward, when the Salix Coronary Flow module is submitted to the FDA and cleared as we expect in the first quarter of next year, it will follow the same process. We enable it on the platform and clinicians will be able to access that noninvasive blood flow process and get access to another reimbursement code. The reimbursement code for us, the [ 950 ], as you see on the screen over here, does open up a significant revenue opportunity for us going forward, and it's something we're going to be very focused on going forward and how we structure our pipeline into -- going into the U.S. and then expanding from there. And if I follow that approach, many of you know that we signed the Tanner Health System agreement earlier this year, which is a 5-year commercial agreement for the Salix Coronary Anatomy platform. That gives us about USD 600,000 in revenue over the 5-year period. But what it really, really means for us is that we now have the ability to plug in these modules automatically as every time we get clearances so that they can start accessing their analysis, and we can start getting revenue through each of those respective modules. We will follow a very similar approach with Cone Health in Northeast Georgia. We're in the final process of integration with both of them, and we expect that integration to be completed in the coming months. And we'll -- in parallel, we're busy working on commercial agreements and the first of those will more than likely be in Northeast Georgia. And then following on from that will be Cone Health. And the reason we're going down this structured pathway is that it allows us to make sure that our training mechanism, our training process, our ability to onboard the clinicians and get them using the software effectively is really buttoned up and tied with [indiscernible] so that we can use this as a blueprint for other hospital systems as we go forward. The combination of these 3 hospital systems perform roughly about 15,000 scans per year, so it really does give us an opportunity for revenue in the future. And we do expect revenue from these both for the Coronary Anatomy, which we already have with Tanner Health, but more importantly, Coronary Plaque in the fourth quarter this calendar year. That also then supports our expanded approach into how we focus on getting additional partners and customers in the U.S. And as we've mentioned before, we've got a very focused approach through the SAPPHIRE study. The SAPPHIRE study really is a two-part opportunity for us: one, from a clinical perspective, where we're looking to use our plaque analysis, which we now have cleared to assess patients and identify patients at risk of heart attack and ensure how we can improve the treatment for those patients and really shift the way they are assessed, moving from this reactionary approach to more of a preventative approach so that they are treated a lot more effectively. The second part of the approach with SAPPHIRE is a very much a focused sales approach for us, where we're bringing in about 6 to 8 high-volume, high-quality U.S. centers to participate in the SAPPHIRE study. They are all -- as I mentioned, have all brand names, and we'll be looking to convert these to commercial paying customers through the course of their SAPPHIRE study. And what it really means for us is that we can in a structured way, accelerate our adoption into the U.S. through these partners but also focus more on putting customer support, customer success, account management and integration support in the U.S. as opposed to building a huge sales team over there running across the country. The combination of all these partners perform roughly about 400,000 CCTA scans per year. So it's a sizable opportunity for us, and hence, the need for us to be very structured in how we actually tackle many of these. And as we go forward over the coming months, we'll look to start announcing some of these partners to the market so that everybody is aware who we're busy working with. So David, I will stop there because there's a lot to digest, and I really want to open it up for questions. So thank you, everybody, so far, and please feel free to ask questions.

We need to go back to the reimbursement slide, talk with the 3 products.

Apologies for that. Thank you, John. [Operator Instructions] Now your first question comes from Nick Fabio. It's my understanding that AYA is the first to market with no human in the loop. Do you need studies with updated tech in order to achieve the same? Do you think that heart flow at least we clearly need to do new studies with updated tech to achieve the same 8- to 15-minute turnaround time as you? And how long would those take?

Yes. Thanks, Nick. Yes. So we are the first to market with a point-of-care near real-time solution, and we've -- when we started this company, we effectively built all our technology around the cloud and to be able to turn that around in 8 to 10 minutes. So what that means is for our competitors to achieve this process, they would have to re-architect their platform to be able to process that in the same 8 to 10 minutes, which means that there will be obviously a lot of technical work involved in that. But also, they would need to run a new FDA study as well as have a new FDA submission to and clearance to get that new architecture cleared so that they could run into the market.

And a follow-on question, John, in relation to the commercial aspects. And what is your proposed margin sharing between yourself and the hospital groups? And are you expecting that's going to change or increase over time?

Yes, it's a great question. Look, we -- our rationale behind that is we do want to make these hospital systems profit centers so that they can scale their CCTA volumes and ideally bring on more CT scanners to increase their ability to take a CT-first approach. Look, the $200, we feel, is a reasonable amount to reimburse them with, where we're providing a high-quality product. So -- as well as giving them enough money to be profitable. The one thing we do have to be a little cautious about is that if we discount too much on our pricing, what ends up happening is CMS rerates the reimbursement code to account for too much profitability into our support system. So we feel that is a fair amount back so that they can grow their margins and grow their volumes as well as for us to have a pricing point that reflects the quality product that we have.

The next question from Andrew Wilkinson of Venn Brown. In relation to your costs going into financial year 2026, could you give us an indication of where those are going to be as you prepare for the flow application and SAPPHIRE onboarding?

Yes. So at the moment, our June quarter, we burned roughly about $5 million for the quarter. We do expect that to come down to that the pre-June quarter area of spend, and we're closely monitoring our spend going forward to make sure that we're putting the money in the right areas to accelerate things like the SCF submission and clearance and then putting the right people on the ground to -- in the U.S. to accelerate, as I mentioned, the Tanner Health, Cone Northeast Georgia contracts and in SAPPHIRE. So we see the cost being roughly where it is currently, and we'll monitor that over time as well, and we continue to do that.

Following on that question, Matt Darling's question is in relation to Tanner Health. And will you be announcing when the first revenue rebate will be coming from them? And when do you expect that will be?

Look, I think we -- as soon as we have the first plaque scan processed, I think we will let the market know that we've had that first invoice for plaque. And what mechanism that takes, we'll work through that.

Next question from [ Mr. Duff ]. In terms of the time line to commercialization, how long do you think it might be before some of the SAPPHIRE study participants start to become commercial customers and sign commercial agreements?

Yes. So we're busy working with them at the moment through refinalizing the SAPPHIRE protocol, which then goes into a clinical review board within each of the hospital systems. So we're expecting all of that to be done by the end of this year and really kicking off the study early next year, and then we'll start working with each of those hospital systems and focusing on one or 2 to bring them into commercial agreements over the first 2 quarters of next year.

Just going back to Tanner. The next question from Jeremy Bendyke. Is there any guide from Tanner about the number of scans that they're likely to do? And will -- do you think that's going to displace some of the existing 15,000 scans? And how would you therefore extrapolate that across the broader market?

Look, they have given us numbers. They've asked us to keep those numbers confidential. So that's why we've wrapped that up into roughly that 15,000 scans. I don't think -- it won't displace the number of scans they perform. It will increase the number of scans they perform because they're trying to shift away from some of the more invasive procedures that they're currently running and only calcium scores and trying to bring more of that volume into the CTA or CCTA process because of the ability to now look at that high risk plaque.

We've got a couple of questions about competing products. One of them is around your competitive moat. And related to that is what can you tell us about the competing offerings? And how do you see that in terms of what you're bringing to market?

So we've said before that if you look at most of our competitors, they provide either plaque analysis or a blood flow analysis. They very much have a human in the loop approach, which means that they've got to send the scan off to an off-site center in the U.S. where they have people working on the scans, and the turnaround time is roughly 24 hours and at times, 48 hours later. So they've got a similar loop approach. That is a fixed report, so they cannot adjust -- the clinician cannot adjust it, which means they've got to use 2 separate platforms, 1 to report the CCTA and the other to report either plaque or money based on blood flow. And the third thing is because of how they're structured, the way they charge is more than the reimbursement. So it really makes a lot of the hospital centers -- if not all the hospital centers cost centers, so they're losing money per scan. Our approach has always been to provide a near real-time point-of-care solution, which allows the clinicians to report off a single platform, pass through the scans into that platform that they can report the CCTA within that 8 to 10 minutes, provide a plaque analysis in the same 8 to 10 minutes, so they can effectively treat the patient on the same day and as well as providing them a noninvasive blood flow assessment within the same 8 to 10 minutes so that they make better decisions on where and when the patient should or should not be going for an invasive procedure. So it's very much the focus for us, point of care real time so that they can improve their workflow efficiency. They can improve throughput, but they can also improve how patients are being treated at that point of care.

In regard to Simon's question here in relation to what's the read-through in terms of AAA on valuations of what our competitors are doing. Some shareholders would be aware that Heart Flow recently IPO-ed on the NASDAQ. They went to market at $19 per share. Their shares have been trading over 50% above that IPO price. They went to market to raise $200 million. They raised $317 million. And our understanding is the book was heavily oversubscribed. But more importantly, they currently have a valuation of around USD 2.4 billion, USD 2.5 billion. And you can go back and check their filing document. They confirmed a lot of the things that we've been saying around what they're charging for their scans. So they are charging more than the reimbursement. And they did sort of roughly 120,000, 125,000 scans last year, which is less than sort of 2% of the market. So it's a pretty greenfield market, and that's what our main competitor is doing, bearing in mind that the 99% of the revenue comes from the flow product and we're going to be -- we're releasing the plaque product in the U.S. So we're not directly competing with Heart Flow. We will -- once we have the flow module approved, which John said earlier, should happen in the first quarter of next calendar year. But we'll be the only company out there offering a point-of-care approach for both plaque and flow.

Thank you. Moving on, Andrew Wilkinson of Venn Brown has a follow-up question around competitors. And is your SAPPHIRE study going to be similar to the Heart Flow DECIDE study where they found the use of HPA to drive treatment decisions could lead to a 15% reduction in the risk of cardiac event in patients.

Yes. So the DECIDE study is very much looking at the benefit of plaque analysis. We've structured ours slightly different to that probably in 2 -- or probably in 3 parts. The first part is, as I mentioned, to look at cardiovascular risk and how we can change treatment, which is different to that. Second one is we do have our novel plaque dispersion score, which further adjusts risk for patient and changes and further adjusts treatment for the patient. And the third one is we are comparing it to standard stenosis reads, which means we're trying to show that through our point-of-care real-time approach, we can really improve throughput and workflow efficiency for patients in a clinical setting. So there are differences and the site is running its course, but we're very much focusing on the benefits of SAPPHIRE at the moment.

The next question is relation to your team. [ Jacques ] has been working with the company as an external consultant, playing a key role in the U.S. market. Do you have any plans to bring him on full time or provide other incentives to help manage the risks related to that?

Look, [ Jack Soho ] has been a nonexecutive director for the last 3.5 years or more than 3.5, but around 3.5 years. He's a cardiologist. He has a great presence in the health care sector in the U.S. and he's been very helpful. He's not an external consultant. He runs a consulting business on his own. But he has been contributing a lot as our U.S.-based nonexec director, where we've got other full-time staff in the U.S. and we have other people working with us as well. So there's no risk around Jack in any way, shape or form.

The next question from Amina Rosenberg in relation to your timing. What can you tell us about the FDA submission timing for flow module? And what learnings can you bring from the SCA and SCP submissions to potentially accelerate that time frame?

Yes. Thanks, Ami. Look, our plan, as I mentioned, is still end of this -- or end of November this year to look for submitting the Coronary Flow Product with clearance at the end of -- in the first quarter next year. And what we've learned very much from SCA is that if we work hard upfront around putting a quality submission in and running the right quality studies, that accelerates it at the back end. So -- and it's very much the same process we're following with Salix Coronary Flow and making sure that we simplify our approach into those studies as well as the information we're conveying to the FDA. So it's an ongoing process of following those -- that process where do the hard work upfront and accelerate it at the back end.

The next question from Peter Valhausen. What are you hearing when it comes to U.S. hospitals and competitors in the market? And why do you believe that they would prefer to you as your offering?

Yes. Look, it's going back to the earlier statement from both Bernie and I, the point-of-care realtime is a major value proposition for us because they can read scans a lot faster and many of the hospital systems in the U.S. have a minimum of 4 weeks wait time, and some of them have up to 8 weeks, which means for patients coming for a CCTA scan. So they can't wait additional 24 or 48 hours for results to come back because that accentuates that wait time. What we're really hearing is that our ability to provide a CCTA report and results in an 8 to 10 minutes period as well as a plaque analysis and in the future noninvasive blood flow analysis can really accelerate and help them reduce those wait times. It also helps them shift the patients a lot faster to the right procedures where a lot of these hospital systems put a big focus on like stents or bypass grafts. So we see a lot of interest because of our point-of-care real-time approach to improve that, both the clinical workflow process but also where patients are being sent. The third thing is that because we are discounting of the reimbursement, they are feeling very comfortable now that they are becoming profit centers and can increase their CCTA volumes as opposed to considering whether they should put a patient through a plaque analysis or a blood flow analysis from a competitive product. We have a financial question now from Christopher Graham. Given the commercial rollout started, do you expect you're going to need to raise more capital at some point? Or do you plan to fund capital requirements from future revenues at this rate?

Yes, it's a question we get asked a lot at the moment, David. It's -- we all know it's the Board's responsibility to make sure the company is well funded to take advantage of the opportunities in front of us. And we're looking at a number of options. One of the things we haven't mentioned is that we've got a $5 million R&D tax rebate coming back in -- or by the end of October this year. But we're looking at a number of options there to make sure the company is well funded. And there was a question earlier around -- from Andrew, I think talking about cash flow. We expect to have -- when we hit FY '27, we expect to have all 3 approvals in place, being SCA, SCP and SCF. With all those 3 approvals in place, we expect to get to a little bit better than breakeven in FY '27. And that's made -- that's all built around Tanner Northeast Georgia Cone at 15,000 scans. So any other commercial customers, such as the SAPPHIRE partners we bring on will add to that.

Next question from Ricky White. I understand you run your own models. With the advancements of AI, have you seen new AI models benefiting the accuracy of your results? And do you see that potentially reducing your costs? For example, the market with [ drop for GPT 5 ] being a cheaper model to run compared to some of the older models.

That's a great question and we get asked a lot as well. Look, we -- we've got a great data science team that are consistently looking at a lot of the new architectures models that come in and assessing whether they will make a difference to our models to improve them. We're very focused on making sure that we keep training those models to improve and be more accurate over time. But yes, we are assessing a lot of these going forward. The one thing to note, though, is that any time we do change to a new architecture or new model, that effectively needs a brand-new FDA submission, maybe a abridged submission, but we're just making sure that if we go down this pathway that the upside in accuracy and upside in performance really covers that ability to go back to the FDA and get a new clearance.

Following that from Tanu Jain analyst at Petra. Congratulations, team. Could you talk about the volume growth just from SCA you've seen over the last year with your first Australian customer? And could you talk about your expectations for volume growth in the U.S. with your first customer, Tanner Health, both in general volumes and also with workflow efficiency provided by SCA?

Yes, look, our first customer, The Cardiac Centre, the small center in [indiscernible], New South Wales. They perform, I probably say about 2,500 scans per year. So it's not a huge volume for us. It was never really about the volumes, to be honest, here in Australia. It was more about getting the product in, getting the feedback from clinicians and also showing credibility with regards to a very mature health care system that we could take the learnings from here into the U.S. So as we bring on Lumus Imaging and Sonic Health, we'll start to see a growth in those volumes, but it won't be substantial because we are just very much focused on those 3. With regards to the second part of the question on do we see growth in the U.S. and what that looks like, look, as we bring Tanner onboard, we'll start to see an increase in those volumes. We will start getting those volumes running through the SCA platform based on the current volume that they have and then start looking to transition, as I mentioned earlier, a lot of the invasive procedures and calcium scores into CCTA. And similar to bringing on Northeast Georgia, that will add into the volume as well as KONE, which will get us up to that 15,000 scans per year at full run rate. And then that obviously means from a SAPPHIRE perspective, we bring on each of those partners. And I won't mention them yet because we'll start making some of those announcements. But if you think of the 400,000 scans that they all perform per year between 6 to 8 of those hospital systems, its entirety, if you average that out, it's anywhere between 60,000 and 80,000 scans per customer that they perform.

And [indiscernible] right...

Yes. I mean just -- it's a good point. And maybe just as a reiteration of what that actually means for us. So on the screen that you see in front of you here, we've got the 3 pillars there for the CCTA reimbursement, the plaque module reimbursement as well as the flow reimbursement. For every patient that comes through a system, so if you think of all 15,000 patients from those 3 partners coming -- that we've got and we're working with at the moment, all 15,000 will be processed by the Coronary Anatomy platform and will charge is roughly about USD 50 per patient. About 70% -- that's a conservative assessment. About 70% of patients will have plaque of some sort and will go for a plaque analysis, and we'll charge that through the Coronary Plaque Module. So that 70% of those 10,000, so 7,000 will be charged the coronary plaque fee of about $750 and 35% -- or 35% of the patients going through from the 15,000 will go through a blood flow assessment. And same thing, we'll charge about 20% discount of that reimbursement rates. So the blended rate across all of these modules when coronary flow is cleared is about $850 per patient for every patient in U.S. for every patient going through a hospital system.

Turning now to your rollout. And so a follow-up from Tanu Jain. Is the process and the training you're now putting in place in relation to reimbursement and billing for customers such as Tanner pre-authorizations? And then also after that, what resources have you been adding in the last quarter to support that rollout?

Yes. We brought on an ex Heart Flow person that used to run their reimbursement, and she's been helping us since the beginning of this year to really, a, structure our understanding of the reimbursement landscape in U.S., which, as everybody knows, is quite complex, but then also set up the blueprint for us to take to each of the hospital systems like a Tanner or Northeast Georgia Cone, so that when -- now that we've got plaque cleared, that they are set up to reimburse for it. So we'll -- what we've done with her is really put a process in place that they can see their revenue cycle and their billing platform to be able to preauthorize plaque when a patient comes in for it, so that by the time the patient is at the doctor and the doctor clicks on the plaque analysis button, they get reimbursed straight away. And that's ongoing work and we're fine-tuning that process at the moment, and we are working with Tanner Health at the moment on that as well. And we'll do that with others as we bring them on the board so that everybody is comfortable with that process as well.

A couple of questions around future expansion. One is in relation to what other products might you be able to bolt on to the platform after flow is approved? And related to that, would you consider partnering with a pharmaceutical company?

Yes. So post the plaque module being cleared, our future road map very much starts looking at the structural sites. So it starts looking into the aortic valves, the ventricles and a lot of the other areas where there are -- there's a large amount of money being paid in the U.S. to -- for these procedures as well as a large amount of reimbursement, and that further differentiates us PAUSE from our competitors as well. Going back to the pharma question, yes, we are always considering whether it's worth being in a pharma in, specifically with the SAPPHIRE study. When we start to look to show a differentiation in treatment or how we can change treatment, that will definitely benefit as well as interest a lot of the pharma companies. We've held off on that for now until we've got all the collaborators on the SAPPHIRE study and we'll start looking to pharma going forward in the future.

We have a question around the access to the plaque testing here in Australia. Whereabouts is that available for Australian patients and including is that available in Perth?

So at the moment, we're -- we have that in The Cardiac Centre in New South Wales, where we'll have that in Sydney at Lumus Imaging as well, and then in Brisbane for Sonic Healthcare. And that will roll out across the system -- their system here in Australia. We still do have a partnership with Envision Medical Imaging, but -- here in Perth, but we're very focused on making sure that those patients going there are asking for a Salix analysis first as well as then asking -- getting that result from them as well.

And then a follow-on from Amina Rosenberg. What are you see the biggest risk to your story now and what keeps you up at night? For instance, is it the slow hospital adoption of volumes of scans that might defer your breakeven point? Is it fair to secure the FDA clearance? Is it cash runway? Or is it a competitive response? Or is it something else?

Look, and this is what keeps me up at night is the -- we need to really start working on our -- sorry, we need to start accelerating our need to get the right customer support team in the U.S. We've got a great product, and we have a really good feedback from clinicians in the U.S. about the product. We now need to start putting the customer success, customer support and integration experts on the ground over there. So that customers have the ability to talk to them in their time as well as instead of ours here in Australia. So that's something we're working actively on at the moment, and we'll start accelerating that now that we've got the clearance of plaque.

I think one of the other things -- one of the other good pieces of feedback is that there are hospital systems in the U.S. that currently use Heart Flow, and they've stated that once our modules are approved, then they will switch over to using Artrya. One of the key things that we're doing there is to -- when you talk about taking a product to market, it really has to address the number of pain points for the customer. And we've been doing that by streamlining their workflow, taking costs out, taking away frustration and as John said earlier, turning it from a cost center into a profit center, and that point-of-care approach where they've got a report that the clinicians using a report that he can monitor or he or she can alter, change in any way, shape or form, sign it off as their report and have control of their patient. These things are really important to the clinicians in the U.S. So we're really addressing a number of pain points there. In terms of the cash, no issues there. In terms of the FDA clearance, we had a CP cleared in sort of record time. And as John said earlier, there are a number of learnings from the SCA and SCP applications, and we've got increased confidence that we'll be able to get flow through as well in that sort of time frame that we mentioned in the first quarter of calendar next year. So there can be delays in adoption, but we've been getting very, very strong responses from demonstrating the software to U.S. clinicians. And we haven't had one clinician say to wise, look, this is -- we don't like this. It's the other way around. And so this technology is required in the U.S.

We've just got a -- I think it's a final question. When do you expect the first plaque test is going to be run by Tanner Health?

Yes, we still expect that in the fourth quarter of this year. So we're busy working to get that done at the moment.

And then lastly, do you have any other hospitals that have been waiting for the plaque module to come onboard? And how do you think it changes the value proposition now that you can go to market with that as well?

Yes. Look, we're getting a lot of interest to be honest. We had a Board meeting a little while back. And we've had so much interest around our product and our solutions, specifically because, as I mentioned, it's point of care and real-time for plaque and blood flow that we've had to scale back that pipeline and really focus on the 3 that we have as well as SAPPHIRE. So yes, we're getting a lot of interest in the product, and that will -- we'll start monitoring that and bringing that on in a structured manner in the future. Yes.

I think from a business point of view, really focused on Tanner, Northeast Georgia Cone and then upscaling that into the SAPPHIRE partners and really staying focused on that group because -- and the Board meeting John was referring to was some months ago, where we as the Board said, "Look, let's delete a number of these people off the list because we can't service them at the moment. So let's focus on making sure that we've got the SAPPHIRE partners onboarded and as commercial customers." And because they're doing 400,000 scans a year, there's years of build-out for us just on those alone. We'll have -- we already have inbound inquiry from others outside of that SAPPHIRE group. And -- but -- so there's -- we just need a very disciplined approach in terms of a rollout in the U.S., and we don't need to put a whole lot of arms and legs and boots on the ground in the U.S. sales and marketing people because we've already got this group captured. And we'll announce who they are as we go forward so that you can see that they're high-quality, well-respected groups in the U.S. that want to partner with us on this SAPPHIRE study.

David, just before you jump, I just want to just answer Chris to first question around inclisiran and Ozempic. And there's others like Repatha and a few others that are in the space now that have been cleared and showing really good positive outcomes effects for transforming plaque into more stable types of plaque. So yes, there is the ability for us to baseline that, especially with things like inclisiran or Repatha for the high-risk plaque that they are using specifically for that necrotic core low attenuation plaque to convert to more of a stable plaque. So that is something we are considering. And as I mentioned earlier, as part of the SAPPHIRE, we'll look to some of the big pharma companies that are producing these drugs to see how we can do that. Yes, it's a good question. Thank you.

And David, I think one of the other things that we haven't mentioned on the call today is around our focus on coronary artery disease in women as part of the SAPPHIRE study. So 9 million women die every year from coronary artery; disease, and it does present differently in women to what it does in men. But most of the data is actually based on male population. So 57% of the data that we submitted to the FDA on the SAP application was on women. And we've got a key focus as part of the SAPPHIRE study on coronary artery disease in women, led by Dr. Rachel Bonded of Common Spirit in Phoenix. So really key focus there for us going forward and a bit of a differentiator as well.

Yes. And I guys get back to the Christopher's question, really showing how these drugs impact that population where there is a lot of disparity on how they treat it, I think is going to be important for us going forward as well. And as well as our differentiation to plaque and our dispersion score, which was published and -- peer reviewed and published recently is a great mechanism for us to show the differentiation not only as a product but also into, as I mentioned, this underserved population.

Thanks, John. There's no further questions on the line. So I'll leave you now to make some closing remarks.

Thanks, David. Look, and I appreciate the call and questions today from everybody. It's a great place where we are at the moment with the clearance of our Salix Coronary Plaque Module. And we're going to be working really hard going forward now in the coming months to make sure that we can accelerate the adoption of the module now that it's cleared and start setting ourselves up for success running into the new year and then bringing on the 3 hospital partners this calendar year. So thank you, everybody, and I appreciate your time today.

That concludes the call. Thank you for participating. You may now disconnect.