Okay, let's begin. Welcome to Aroa Biosurgery's Investor Webinar and Q&A, following the company's February 2026 business update announcement, released this morning to the ASX. Please note, participants are in a listen-only mode. There will be a presentation lasting approximately 10 minutes, followed by a Q&A session. The webinar will conclude at approximately 9:30 A.M. Australian time. If you have a question you'd like to submit, please type it in using the Q&A function. On behalf of Aroa today, we have Brian Ward, Founder and CEO. I'll hand over now to Brian. Please go ahead.
Great, thank you, and welcome to everybody to this business update. So, as you're probably aware, we're no longer required to do the quarterly cash flow reporting. So, you know, we thought that we'd take the opportunity, you know, as we go forward now, on occasions, to provide a business update on sort of key matters happening within the business. So, that's the purpose of today. So I wanna just quickly jump into the agenda. So we're gonna talk about the Myriad trauma study, which was released recently, some changes that have been happening in terms of Symphony reimbursement, you know, our commercial strategy for Symphony, and then just general momentum across the business. And I want to talk briefly about guidance as well.
So, we released the results of a trauma study from our MASTR Registry recently. So this is, for those of you that remember, this is a large, ongoing, prospective, multi-center observational study of bioscaffolds that Aroa is undertaking, looking at the use of Myriad in a wide range of different surgical procedures. So, this registry has been running now for three years or so, and we have the ability to recruit into this up to 800 patients. So we're now 450 patients into this registry, and we're really beginning to accumulate a significant amount of data in terms of how Myriad performs in a wide range of soft tissue reconstruction procedures.
We recently published a subgroup analysis of trauma patients. This was 49 patients with 61 defects in 4 U.S. Level I trauma centers. These are the trauma centers where the most severe trauma cases are treated in the U.S. And so we've got a nice group of these centers participating in the registry. What we saw with these 49 patients was that we achieved fully vascularized tissue coverage in a median of 25.5 days, typically with 1 application, and there were no device-related complications.
So a very strong result and, you know, when we compared that to what's been published in the literature with comparable products, what we see is that Myriad's clinical outcomes are at least equivalent or better with fewer complications and fewer product applications versus those other scaffolds. So, you know, one thing I will note here is that because it's a single-arm prospective study and the variety of cases is quite mixed, it's very hard to do a direct comparison with other products.
But what we've done is we've reviewed all of the published clinical literature for the key products that are being used in this area, and we're able to show that, you know, typically, as we say, clinical outcomes are very good, but critically, the complication rates are really low, and typically, we can achieve with Myriad, with a single application, what often requires multiple applications with other products. So, you know, we're really delighted with this result. I think it speaks very well to both patient outcomes, but, you know, critically for hospitals, it means that often they're only needing to take the patient once to surgery, not needing follow-ups. That has huge implications in terms of the cost, the total cost of care, you know, the time in surgery, the ongoing treatment of that patient.
So, you know, we started this as, you know, consistent with what we've seen in our, other trauma publications, but also more broadly, what we tend to see, with Myriad across a wide range of procedures where it's being used is that, you know, rapid tissue formation, single applications, and also, you know, not having, complications associated with the device treatment. So thrilled about this, and it's kind of, accumulating this body of evidence, which is, very important in terms of, gaining, clinical conviction, and conversion, of customers. So I want to talk briefly now about Symphony reimbursement. So, this is an area where there's been a range of changes coming, pretty quickly.
And, you know, what we're seeing is CMS looking to reset the reimbursement environment in the US. Now, those proposals have been met with a lot of pushback by a variety of companies, but also in some situations by, you know, providers in different settings as well. So at the moment, what they are proposing is a flat fee of $127 per square centimeter that came into place from the first of January. So this is a major reset in terms of pricing. You know, we've seen pricing, you know, $400-$500, but at the extreme end, you know, $2,000-$3,000 per square centimeter for products that really showed no difference in the efficacy of the product.
So, while that pricing has stuck, the CMS and the Medicare Administrative Contractors or the MACs had proposed to change the rules, if you like, for how these skin substitute products were reimbursed. So these rules were documented in what they call Local Coverage Determinations. And they were proposing to limit the number of applications, and also only allow products that had randomized controlled trials showing their efficacy in diabetic foot ulcers and venous ulcers to be used or to be paid for. Now, there was a lot of pushback from industry against that, and so what we've seen is those LCDs have been withdrawn. And what that means is that for the next year, you don't need to have that clinical evidence in order to support the use of your product.
Now, you know, we see these changes as being, you know, coming into place over some time. So while they have been withdrawn now, we certainly know this is the direction of travel, from CMS, and we think that, you know, that they will be put into place at some stage. So this is leading to a lot of market disruption, in this segment. So, with the resetting of pricing and the likely introduction of RCTs, we see that, many of the current players in this market, are not going to be viable or able to participate, within this market. And, you know, this is obviously gonna change the dynamics in the market. It positions Symphony very well, for this new environment.
So we're really excited about what it may mean for Symphony going forward. You know, what we do expect over the rest of this year is that, you know, there may be some changes. So we're aware of, you know, maybe the requirements coming into place for, you know, for RCTs, you know, potentially the number of applications that are allowed changing, and maybe even the payment levels changing. So, you know, we don't believe that the reimbursement arrangements are fully settled and that they you know we're sort of prepared for some changes in those, over the rest of the course of the year.
I think one thing that we do feel very confident about is that we think that with the pricing that we have, the fact that we are concluding the RCT with Symphony, and that, you know, we can flex our strategy based on changes that happen in the environment, we think that Symphony is very well positioned, you know, for the changes in this environment as they come into place. So all in all, you know, certainly for the next year, we're in a you know, a very competitive position. We feel that we can begin to get on and sell Symphony, and that the changes that do come into place, you know, should favor Symphony.
From a commercial strategy perspective, our current full-time reps are in inpatient procedures in hospitals. They're already in the hospital environment. What we're going to be doing is focusing on hospital outpatient departments. So many hospitals also have associated outpatient departments that are, you know, down the corridor or up or down a floor within a hospital. We're asking our inpatient sales reps to also call on these hospital outpatient departments. It fits very well with our existing sales footprint. You know, in addition to this, you know, there may also be opportunities for us to do, you know, a variety of distribution and partnerships in areas that we are not covering or don't intend to cover in the future.
There's a number of different sites of care, where this may be the case. This is something that we're exploring. You know, we're excited about this. We think there's some great opportunities here. I think the important thing with Symphony is that, particularly for our own sales team, you know, it's something that's added to their existing offering, something that should be out, they should be able to sell, in addition to what they're doing, and, should, you know, increase their, sales productivity and efficiency. So we think it's a really nice add, to their portfolio and, will put them in a very good position, going forward. So just sort of when you pull all those things together, you know, what we're seeing is, you know, great success with Myriad, both clinically but also from a sales perspective.
You know, being successful broadly across a wide range of soft tissue procedures, you know, particularly seeing good traction in trauma, good traction in lower limb salvage procedures, which are the key procedures in hospitals. The evidence for our platform technology is building strongly. So, you know, strong evidence coming through for Myriad. We think that the results that will come through from Symphony are also gonna support the use of Aroa ECM as well. You know, Symphony is a significant new opportunity for this, and we think, you know, that could really move the dial for sales over the coming year, so we're very excited about that. And, you know, with TELA Bio, you know, TELA's an important component of our business.
You know, obviously, it's a very, you know, lucrative part of our business for us and, you know, a significant contributor to our overall profitability. So there's a group of things here that are coming together really nicely to build momentum going into next year. Just want to talk about guidance. So, at the beginning of the year, we put guidance out for revenue, $92 million-$100 million on a constant currency basis, and normalized EBITDA of $5 million-$8 million. Looking at where we are at the year now, so we're, you know, two months to run, we've got a pretty good view of how things look in terms of where we're gonna end up at the full year.
And, you know, we're seeing, you know, the actual sales track towards the upper end of both revenue, and, and EBITDA. So, you know, thrilled about how that's tracking. You know, certainly coming off the back of, you know, strong sales for Myriad, really helping to drive that. So, you know, a good, you know, good finish to the year and, you know, very excited about how that sets us up for the coming financial year. So I'm gonna pause there and open things up for questions.
Thank you, Brian. So we'll now move on to the Q&A session, so you're able to type your questions in, and I can see that we do have a couple through now. So we have a question from Susan Robinson, and she's asked: How does the new flat rate compare with our costs and our present charging in the market?
Yeah. So the flat rate is good for us. I mean, you know, it's certainly, when you sort of think about the economics, the reimbursement is $127 for doctors, and then, you know, within both settings, both the physician office and the hospital outpatient department, the price is gonna be the same, so that's a change. You know, our selling price is gonna be, you know, significantly less than that, but still in a position where we're able to achieve, you know, very high margins. So, you know, I think it's for some product ranges where their cost of goods is very high, and also where there's a number of different layers in distribution and selling, I think it puts a lot of pressure on those companies in terms of pricing.
But, you know, with our cost structure, with our commercial strategy, we're in a very good position.
Great. So we just have a question here around TELA Bio. If they were to enter administration, what would that mean for us and our sales force?
Yeah, look, you know, TELA Bio, as you're probably aware, raised some funding at the end of last year, and, you know, that should give them, you know, a couple of years' runway. You know, they're still continuing to grow at, you know, a reasonable clip. And you know, they are expecting to transition towards profitability. So, you know, we've got confidence in TELA Bio in terms of being commercially successful. You know, if you think about, you know, if they were to go out of business, then, you know, our sense is that, you know, it's a very valuable portfolio of products that they've built there. So, you know, you know, $80 million or so of revenue, you know, strong growth, very good clinical results.
So, that asset, if you like, is valuable in the hands of a, you know, number of players. So, you know, we don't. You know, at the moment, we feel pretty good about that, and, you know, we see this as a product that still has a very long way to run, and will be successful.
Okay, and, we've got a question here from Paul Palumbo. Just in terms of, when you mentioned moving the dial around Symphony sales, could you just give an outline and some context of what investors can expect there?
Yeah. I think, you know, if you look forward over the coming year, and I don't want to talk numbers, but just sort of directionally, I think, you know, we would expect Symphony to at least have the same sort of growth trajectory as we've seen with Myriad previously. Now, you know, we haven't really been in a position in the past where Symphony was in a favorable reimbursement environment. We've also been in a situation where there was a number of players that were in that market, and the incentives were skewed. So that whole environment's been reset. So you know, we could expect Symphony to perform much better than that.
I think it's early days, and it will depend a little bit on where the CMS holds the course, with reimbursement, and, you know, the rate at which, companies either, exit from this area or, you know, the number of, players that are left in the market. But, you know, I think it's at least as good as we've seen with Symph- with, Myriad, but, you know, I'd like to think it's a lot better than that.
Great. So, Michael Wu would like to know whether the withdrawal of the LCDs at this stage is affecting any go-to-market plans for Symphony.
No, it's not, and on the contrary, really, I think it's given us a lot more confidence. You know, so what it means for most companies is that while the pricing requirement has changed, and so there's a cap on pricing, the requirement for an RCT is not there. So it may have held up, you know, if the LCDs were still in place, it may have held up, you know, our ability to get Symphony reimbursed because, you know, we hadn't published the clinical results from the RCT. I think, and now they've been withdrawn, that's not an impediment, so, you know, it puts us in a good position. But, you know, as I said earlier, I, you know, we do believe that the requirement for RCTs is likely to be reintroduced further down the line.
Okay, Scott Orchard would like to hear from you just around profitability.
Sorry, I missed that, Sarah. What was the last word?
Just your comments on profitability and our path to profitability.
Yeah, so look, we've been, you know, we are profitable, and we have been transitioning towards profitability. Guidance has us, you know, being profitable this year. So, you know, $5 million-$8 million in EBITDA. We've been, you know, cash flow positive for the last four quarters, and we'll be cash flow positive for the full year. So, you know, I think we're a long way through that transition now to be profitable on an ongoing basis. So, you know, we're not in a situation where, you know, we're. You know, we need to go back and continue to raise money. I think we've got very good prospects, and that, you know, the level of profitability should increase over the coming years.
Great. So Paul Palumbo has asked, when will the results of the Symphony RCT be published?
Yeah. So we've. The study's wrapped up, and we've been going through the sort of phase of getting all the data together, working with the CRO, to lock the database and get that prepared for statistical analysis. So, that's, you know, that'll happen over the next month or so. So, you know, I think with everything going in the right direction, we should have that by the end of the fiscal year.
Right. Okay, so that concludes the questions. So I'll just hand over to you, Brian, now to close out the webinar.
Thanks, Sarah. Look, you know, I think the high-level takeaway from this is, you know, we sort of feel like we're in a great position. So, Myriad performing really well, you know, Symphony now opening up a large opportunity for us, you know, an upgrade to guidance or, you know, guidance being towards the top end as well. So I think coming out of, you know, financial year 2026 with a lot of good things happening and setting us up for, you know, a strong FY 2027. So thanks for attending, and look forward to, you know, delivering the full year results in May.
Excellent. Thank you everyone, for attending.