CurveBeam AI Limited ($CVB)

Thanks for standing by, and welcome to the CurveBeam AI investor webinar for the quarter ended March 2026. [Operator Instructions] On the webinar from CurveBeam AI today, we have the Managing Director and CEO, Greg Brown; CTO and COO, Arun Singh; and CFO, Ura Auckland. The presentation will last approximately 15 to 20 minutes, and then we'll take those questions. I'll hand it over to Greg to get into it.

Thanks, Matt, and welcome, everybody, to the Q3 fiscal year '26 quarterly call. Just bring your attention to the disclaimer and the use of forward-looking statements. And to the quarter 3 key highlights. So in the last quarter, we did purchase orders for 5 devices, 4 of which were HiRise. It's interesting to note that in fiscal year '24, we did 16 HiRise. In fiscal year '25, we did 16 HiRise. And in this fiscal year, year-to-date, we're at 12 HiRise. So the HiRise orders quarter-on-quarter are pretty consistent. We're finding that the variation has been in the other orders of other devices. Now what we found in this last quarter, and we had several prospects that we were trying to bring across the line before the end of the quarter, look, demand from surgeons continues to be very strong. The issue is that there's a higher capital threshold that's building within the system. And I think now we know it's related to more of the requirements around cybersecurity. There's also requirements around -- you got finance involved more now with these systems. And to a large extent, it's really driven by the fact that we've got everything from higher fuel costs. So with inflation, running a group practice or a hospital, finance is getting more involved around understanding its capital thresholds. Same with legal, especially with cybersecurity. But even though we've got this increased bureaucracy, we remain confident in our pipeline, and we're hoping that the orders that we weren't able to get across the line in Q3 will come across in Q4. Now the next item is a really critical value driver for the business. And this is the Chinese FDA or the NMPA in China. And we received our first supplemental or first lot of questions requiring some supplemental data for the file. So look, it's tracking well. It stays on our guidance of second half calendar year. But what I want us to really focus on with this China clearance is once you filed with an NPA, of course, you can promote. But for us, that milestone of meeting that regulatory step with NMPA delivers a milestone payment. But more importantly, it now qualifies us to start selling into China. And that next 2 milestones is the first 10 HiRise. That's another $1 million in milestone and round about $4.6 million in revenue just there alone. This is why we really want to build out the prospects as quickly as we can because with the next milestone, that's the next 40 HiRise, which delivers around an additional $18 million in sales and another $2 million in milestones. So it has a big contribution to how the business functions and building its value into the next fiscal year with this milestone being achieved. And this is why we continue to work with WEGO in developing sales prospects. During the quarter, we had visiting dignitaries come to Melbourne. These were leading hip and knee surgeons. And we continue to support the programs to really drive that pipeline of prospects. We have [ AOLs ] from Europe going across to support a conference that they will be running in foot and ankle, knee and hip. And we will continue to really support these programs to build out that prospect list so that we can knock off these other milestones because it has a profound impact on our ability not only to generate cash through the milestones, but revenue and quite significantly. Now that's a key program, the MNPA, but the next shot on goal here is the validation of the Stryker robotic system. And here, we've had -- in the quarter, we had 4 meetings: one with the senior executives and which the head of their senior R&D leader was there. And then we had a further 3 meetings with the senior R&D leader. And this is all to help us align on all the final clinical data requirements around compatibility. Now what we know to date is that from the regulatory perspective, we feel that's clear. We understand that. But from a commercial perspective, what was explained to us in that meeting with the executives was this is a system that does 1.5 million procedures a year. It's #1, and it's #1 because of the accuracy and the precision of the cut guide. And that's built off that CT scan. And so they want to make sure and be comfortable that the HiRise is not only equivalent, but that it's going to offer an even better cut guide going forward. So they're not standing still, they're going forward with this. And to that end, we're working on making sure that we upgrade the system, both with the post-processing tool and the latest reconstruction engine for the image, getting those through and cleared through the regulatory. And also, we've done independent validation on our movement mitigation patient stabilizer, all of that data being revalidated before we go into this final workaround for not only meeting the regulatory, but more importantly, that commercial requirement so that we have the full support of this division for -- once we have the compatibility of HiRise to the surgical robot. So it's another important program. We have definitely good alignment and good movement, and we'll continue to keep you abreast on how that program rolls out. Now in addition to that, and this is relatively new because of the top 4 robotic systems which own 85% of the total robotics market today, with the Stryker robot holding really the lion's share of about 70% of that 85%, the other 3 key robotic systems, there's one of the other major players, more of a European presence that we have started to work with in helping to validate a surgical cut guide for their total hip. So this is a program that with another top 4 robotic supplier, being able to validate their total hip replacement cut guides, I think, is a major step forward. And it really works to show just how important it is for us to broaden our partnerships as these other robotic systems try to cover [indiscernible] by delivering as good a cut guides. And we're working there with all those key players that wish to work with CT preplanning. In addition, we feel that that also brings a lot of attention because the first robot will actually be in total hip, another one of the top 4. So today, we had some feedback or we've had some feedback during the quarter also on the 510(k) application for the BMD module for the MDCT. We did our pre-sub. We've done our filing. We did everything according to the guidance. With deep learning AI, there's a lot of movement and change. And since we filed, there's been movement on the deep learning AI and verification and validation. Previously, the surgeon can act as the adjudicator and accept a scan for its region of interest. With the changes around guidance, we still have to validate the outputs on that deep learning AI. So we're moving quickly to complete that. With this first round of questions, though, we will miss the midyear clearance. And so we're now guiding to second half of calendar year '26. And that's because while we feel we can get the file back in relatively quickly, we just feel that if there is another round of questions, we need to be covered. So we're just doing that now as H2 calendar year '26, and that's for the BMD MDCT. The other highlight is Patrick Fisher joined the Board during the quarter. And Patrick is highly experienced in the orthopedics field. He's previously been a Senior Executive in Stryker, Wright Medical across both knee, hip and foot and ankle, which is right in our core market segment. He's presently President of Global Orthofix. We've had 2 meetings now with Patrick, and it's been a huge step forward in the commercialization experience that he brings to the Board. And we see this as a really big step forward in making sure that we craft our commercialization plans accordingly. So just showing the purchase orders year-on-year, quarter-on-quarter, remembering that HiRise has been pretty much consistent quarter-on-quarter. The difference is really other orders. So just highlighting that point. And we hope to see more of our pipeline progress over the rest of this fiscal year, knowing that we are seeing the higher hurdles in closing large capital sales, but we remain confident in our pipeline, and we had several well-advanced opportunities in the last quarter that we hope to bring in quarter 4. So on the cash, what I'd like to note is that the Q3 cash closing was around $4.3 million. We had around $5.4 million in purchase orders and receivables that were carried into the quarter. So we remain positive for the quarter, but we're prioritizing installations and receipt collection. That's a real key driver in helping us to manage our cash. And at the same time, we expect that we're able to meet our business objectives with the current cash and with the ongoing management initiatives that we're doing, while we continue to access a range of potential funding alternatives. So just to bring in mind, again, the China strategy, just laying it out, it is really critical. The quicker we can get our NPA in place, the faster we can start to drive sales in China, which will have a nice impact not only on milestone payments, but also on cash. In particular, if we can bring in $4.6 million upfront on the placement of the order and this is ex stock, we're looking at about $3.8 million just there plus the $2 million from the milestone. Then in the rest of the fiscal year, we were just trying to target the earlier we can get this through. This is the type of impact that this can have on helping us to manage our business going forward. So it just -- if you see for an NMPA approval, once we get to announce that, you will understand the relevance and the materiality of that milestone being met and what's behind that from a contribution perspective. So on the HiRise project, I wanted to include a few of the photographs. We've had those ongoing meetings through the quarter, several. We're now finalizing that expanded clinical data submission. We have the new post-processing tool and scan reconstruction engine that's going through quality. It needs to be released before we can start that trial. That's planned to occur in May. And then we also have the patient stabilizer, which you see here with the strapping. That is being validated at a third-party site before going into the trial. And the data on that is looking very good. So we're well poised to keep making -- progressing this not only in total knee, but then total hip. And we continue to align on those final clinical requirements and the clinical data that they need, not only from the regulatory perspective, but also from a commercial perspective in being assured of the cut guides at a minimum being equivalent to what they have today. So again, just to point out the BMD, it's the MDCT product, which is the first product that will come through to market with FDA clearance. When I talk about a femoral neck, this is the femoral neck. So in your hip or your femur bone, the ball is attached to the femur, that's the femoral neck. And the femoral neck is where the international standard is set for a bone mineral density test. And so there, what we did because in a surgeon's office, they don't have time like in a radiology where they're running a DEXA, they'll do it all manually. And it's 20 minutes to process that. We do it all automatically for the surgeon. And to get around the requirement to have to validate the outputs, you always allow the surgeon to then look at the region of interest and accept it as the outcome of that model. Because guidance has changed since we've filed, we do need to validate that outcome. And that's what we mean by the femoral neck. So that all the surgeon will have to do and potentially we can expand our claim on this is he may not even have to adjudicate once we finish the validation of the femoral neck assignment. We can make sure we have it as a fully automated BMD. So this strategy still remains a 2-step strategy. So we start with the MDCT. And once that product is through, we expand the access to other CT devices as a Special 510(k) for the HiRise. Again, we do have to collect a number of patients that we will do through cadaver models and do it through MDCT comparison to HiRise comparison to DEXA for the Special 510(k) filing as well. So that's where we are on the module. Again, we're now guiding from middle of the year to second half of this calendar year. So again, just finally, on those definitions of a purchase order received from a customer and then, of course, revenue where we've delivered and installed and trained an account for when we can recognize the revenue for that account. So that's the end of the presentation. Matt, I might hand it over to you for the Q&A.

All right. Thank you, Greg. As you mentioned, [ free run ] in the audience [Operator Instructions]. For Greg, the first question comes back to the sales. So why are orders sluggish compared to last year? And what's the company got in place or planning to mitigate that?

Look, I think the orders on HiRise are pretty consistent. It's been other devices that has varied. And I shared those numbers, 16 in fiscal year '24, 16 in fiscal year '25 and 12 year-to-date. So what we've seen is that that surgeon demand is stable, but it's these capital approval thresholds that are getting stricter and even more so with the geopolitical concerns around inflation. And so it's leading to more layers of approval. So we're seeing more bureaucracy in bringing through these capital equipment decisions. We feel that this is primarily more of a timing issue than we're not losing prospects. It's just a timing issue in bringing it to close. So today, one of the things that we're doing, we're running a promotion. But more importantly, we're really also working on some of the market access issues around reimbursement to help reducing risk around return on investment. And the market access issues are usually reimbursement friction that can be caused for preauthorization. And this can be a significant administrative burden for a new prospect. Now most of the existing users will have had enough patients through their system where they've got well set up, they've got a good reimbursement position. But it represents right now maybe 1% of our market. What we've got to do is for all the new prospects is make sure that this market access doesn't become as gating an item as it is today. So we want to reduce the risks around that and ensure that we can help them address that because these pre-authorizations for these surgeons, if they get declined, they can have a 15- to 20-minute peer-to-peer review with the medical director of that payer for one patient. And yet they would have most probably processed that patient for their osteoarthritis in 1/3 or 1/2 the time. So it becomes quite a significant burden on them for getting that preauthorization in place. The good news is that nearly all of those P2P reviews, if they're prepared to put in the time on enough patients, eventually they'll allow preauthorization to go through, but it takes a lot of work. There's a lot of clinical documentation that they have to prepare. The peer-to-peer is where they really take a lot of the time from the surgeon. Now in a larger practice, and I'm now talking a big practice, they can have billing departments and they can have a significant effect in helping to take away the risk because they've got a division that can focus on getting those pre-authorizations in place. So to that end, we're addressing this with in foot and ankle. We've got so much data there. If you look at bunion correction and flat foot, it would be up to 60% of the scanning in foot and ankle. So we're really working on, and we've got so much data published now, in those 2 conditions that with the right case studies done independently of the company, and they can talk to how they did their reimbursement, they can talk to the clinical case, the outcomes. These case studies can be very valuable tools, not only for the payer in the form of the medical director, but also for the surgeons in getting comfortable that they know the process and how they can manage and reduce that risk on the pre-authorizations. But it's a fair bit of work. We need to bring in some market access resources to really help streamline that. But the dividends on that, I think, will really help reduce the sales cycle going forward. Now in knee and hip, likewise, there's actually a higher hurdle there for preauthorization often. And it's around the fact that there's a lot more radiation involved in a hip scan. And part of the pre-authorization is around managing that radiation exposure. So they really scrutinize that for medical necessity more so than they would in foot and ankle and knee. So today, the guidelines in foot and ankle, knee and hip are still X-ray, weight-bearing X-ray or MRI. And you need a failed x-ray to be able to really argue that for foot and ankle. And I think we've got some really good case studies that we can build in those bunion correction and flat foot that will really help streamline that process for the majority of their workflow. But it's going to be in the knee and hip area which, again, it's really -- it's more in the complex cases that they're going to get CT through. And that's where there's known deformity in the joint, there's revision surgery or there's potential loosening, but it's the minority of the cases today, and it can be a higher hurdle. But that's the CT on its own. We're not talking weight being there, but we will collect more and more data there. What really breaks through that issue is Mako. And Mako has a big impact in the fact that the Mako itself needs to be preauthorized for that patient. That helps get the justification of the CT and the radiation. But more importantly, it's that there's a percentage of those patients and it's a minority that will get covered for the CT scan for a Mako. But with a co-pay, the doc is still getting around $440 for that scan. And that's the average that's published. Now where it's an out-of-pocket, then often the patients are prepared to pay around that $400 to $500 mark as an out-of-pocket expense. So to the surgeon, whether there's coverage at $240 that they're getting from a Medicare patient, the co-pay is topping it up to that average of $440. Where it's out of pocket, it's still within that realm that they're prepared to pay. Where you see it's really getting hammered is in the hospitals because often those radiology departments put in a facility fee, and they can charge anywhere from $1,000 to $2,000. So it will really push the workload very much to our segment, which is that group surgeon practice. So we see this as a positive in the fact that with Mako, it really does help reduce the risk of those return on investments. And to give you an example of that, they're getting an average of 440 scans a day and they're doing 5 a day, maybe 10 patients but 5 scans, that's like $11,000 a week. You just covered your lease. It's a really big step forward in reducing any risk around return on investment. So Mako has a big impact on knee and hip. And of course, we have our programs for really driving that utilization in foot and ankle. Thanks, Matt.

Thanks, Greg. A question that's come through touching on Mako is for the Mako validation, is a new clinical study needed for validation? If so, how many patients and how long would that study take?

So that's what we're working to find out. So at this point in time, there will be the commercial requirement, which we're working through the Head of R&D to get comfortable. And they're going to want to see different patients with more of the abnormality than just normal patients. So they'll be wanting to really test the cut guides in the abnormal cases, the higher BMIs. And that's from the commercial side. From the regulatory side, it's pretty straightforward. We know what we need there. So we feel that once we know what drives the commercial requirement, we'll understand because you set your acceptance criteria and then you power the study from that. And until we have those acceptance criteria that we'll be working with them on, then we can work out how big a study is needed, and we can look to -- we've got several sites that we can move to quickly.

The next question that's come through is of the $5.4 million in purchase orders mentioned earlier, how much has been recognized as receipts from customers?

The $5.4 million is what we carried in -- do you want to cover that, Ura?

Yes. Well, that's what we've carried into the new quarter. I mean we're working on -- we don't give forecasts, and not all of that $5.4 million is going to appear in Q4. We're working on installations and we're working on collections, and we definitely expect a stronger Q4 than Q3. But, look, at this stage, that's really all we can indicate.

Another question has come through. In the 4Q, there was mention around nondilutive funding opportunities, including debt and strategic investment. Greg, can you just give a little bit more color around that?

Yes. Look, we're looking at multiple options. And yes, look, we have ongoing programs, and we're looking at all options for cash requirements and managing the business. I can't go into too much detail at this point there. I will give more information when it's appropriate.

Greg, in your first answer, you mentioned around market access. Can you just elaborate on what you mean by that? And does this mean you're locked out of the market, so to speak, or otherwise?

Yes. Look, by market access, we don't mean that you're locked out of the market. What it means is there's a process of securing reimbursement, and that's coding, clinical adoption so that providers can use and get paid for a device. And your regulatory approvals allow you to promote your product, but for a device without a strong market access or well-established reimbursement, it can struggle commercially. So what we're talking about here is really making sure that these docs get paid. And so hospitals and doctors will hesitate if they don't think they're going to get paid for that scan. The economics just don't work for them, then they end up with big significant admin burdens and a lot of peer-to-peer review for their patients. So what we are really focusing on there is the fact that market access is that creating the demand of the scan for that patient and making sure it gets paid. That's what we're referring to. It's not like you're getting stopped to go into the market. It's just what is the catalyst to really drive that utilization and adoption of your device in the market. And it's really talking to the reimbursement friction that we experience right now because the Category 1 code is in place, the payment is in place, the coverage is in place. But with preauthorization, that added an extra layer that now requires before they can take that scan to have a preauthorization from the payer. And it's really streamlining that process. Because very few, if they do get denied, won't get covered eventually. They just got to go on the phone and spend time with the peer reviews. They're going to spend more time in the clinical justification for it. There's a lot more work around their ICD-10 coding. There's a lot more documentation required. So the more that we can streamline that administrative workload and prevent those delays, electronic preapprovals once you can get support through the local policies of payers can really help streamline that. So the doc has that preauthorization even before the doctor comes. But it takes a lot of work. A lot of our early adopters have put in the time and they've got good reimbursement out of it. But it takes a while to build it, especially because pre-authorizations have been increasing in their hurdles. And we're not the only ones. I mean in orthopedics, even MRI is having a lot of problems with preauthorization. So if you do a search in the literature, there's actually publications on just the issues that preauthorization is creating for CT and MRI, some of the more expensive imaging. So that's what I mean by market access. And market access is really a different skill set that you need within your team. One of the biggest drivers to guarantee your market access is governing society clinical guidelines. So if you can deliver an AOFAS or an AOS medical guideline adopting the use of CT in flat foot or bunion correction or in a particular type of knee surgery, that can have an enormous catalyst effect in getting the preauthorization because a lot of preauthorization is all about meeting medical necessity for that patient. So that's the skill set, the payer-on-payer contact. It's being able to sit down and work with a medical director in an area where we've got a lot of devices and breach the skids on policy based on the data that we've got already, especially in foot and ankle. But it's a different skill set. It's not like a sales rep going to an account, they're going to payers. And it can -- it's proved in the past for me, especially with [ IG ], that was a major driver to traction from getting out of early adopters, which for 3 years, the sales were the same. And then as soon as you get that traction where the policies are covering, you get the traction in adoption and you get well beyond your early adopters. So that's what I mean by market access, and that's the skill set that we really want to build and add to the company to make sure that once that's in place, that's like getting your Apache helicopters, then you're bringing your ground troops.

Greg, just on to...

And Mako has a big impact for knee and hip in solving that very quickly for us. So yes, we'll be moving very quickly on Mako to have troops.

And for understanding the impact of WEGO, especially for cash, how likely is it that the HiRise could get Chinese FDA by Q3 this calendar year?

So we're guiding to second half calendar year, and so '26. Regulatory is so hard to predict. What we are doing is doing as much support to have as much of our prospect pipeline built so that we can hit those milestones very quickly after that first NMPA announcement. Having said that, and while we are guiding to the second half, look, I think based on where we are and the data that we are required to supply on that file, we're optimistic that it's possible to be achieved in Q3, but we're guiding to second half.

Last one, Greg. Why does the Stryker robots return on investment over present hip and knee scanning -- surely both of...

A lot of that -- yes. And we covered a little bit of that before. I mean a lot of that knee and hip, especially hip, it's one of the things in the papers that you read, the CT and the radiation dose with CT at the hip, there's a lot more scrutiny around medical necessity before they'll approve the use of a CT over existing X-ray. And even MRI comes under a lot more scrutiny because it's more expensive, but radiation is a big issue for CT. What we're finding though is that with Mako and its preauthorization, it justifies the radiation for a CT scan. Likewise, I'd say more of the minority than the majority, but the minority of those patients will also get their CT covered. And for those patients, then with the co-pay, they'll be able to get their CT scan. And the co-pay could be anything as low as $15 to another $200 depending on what the payer, whether it's private or Medicare. But that co-pay helps and then, of course, the out-of-pocket. And that out-of-pocket around the $400 to $500 seems to be well supported. And they run a program, Stryker, the scan, plan, Mako can. And it had a nice impact on their consumer campaign where for supplying that co-pay or that out-of-pocket expense, they got their planning covered. And it really delivered a nice payment to the surgeons. And if you look at the -- what's published out there, the average is around $440 per scan. And when a knee surgeon or a hip surgeon if they're doing 5 scans or 10 scans a day, even if only half were paid out of either a co-pay or out-of-pocket, then you've got 5x $400. That's significant revenue. I mean you've really covered your lease in the first week. Everything else is in profit. So that's the difference Mako can make in expediting the knee and hip side. On the other side where you don't have Mako, yes, you've got to go through preauthorization. You've got to deal with the medical necessity. And we don't have the guidelines to support that. You've got to have failed x-ray before you can really justify it. You've got to have the right documentation in the ICD-10 that documents that there's an abnormal joint or there's a revision surgery or there's other complicating factors to get the justification for that CT. And that's significant preauthorization reimbursement friction. And really with Mako, that really removes it. And it delivers a very nice revenue. And that's why we feel the whole log jam starts to break for us is once we've got the Mako, it really does solve a lot of those preauthorization issues.

Thanks, Greg. I'll just hand it back to you to provide a closing comment before we wrap up.

Yes. Look, thanks, Matt. We're making progress on 2 key shots on goal. The first one being the Stryker robotic system validation. We're getting progress. We've now got to -- we've got our best foot forward with the product and what we've validated, what we're clearing through our quality system. And we're able to now plan out a solution. It's not just regulatory, which is where we were, understanding that they need both now. We can collect the extra data to give them that confidence to get the full support. The other one is WEGO. And if we can really deliver on that CFDA in Q3, that has a really good impact on how we manage the business going forward. So thanks, everybody, for your time and look forward to giving the update in July.