Welcome to the Aroa Biosurgery investor update on the findings of the recently published Symphony Randomized Controlled Trial. I'm Brian Ward, Founder and CEO of Aroa. Joining me today on the call will be Dr. Barnaby May, Aroa's Chief Scientific Officer, and joining online, Dr. Brandon Bosque. Next slide, please. A quick overview of today's format. Dr. Barnaby May will provide an overview of Symphony as well as the study design principles for this RCT. Dr. Brandon Bosque will present the clinical findings from the Symphony RCT, followed by Q&A. I will discuss the commercial significance of this evidence and the potential impacts on U.S. reimbursement before we open the floor for questions. Next slide. Just to introduce this Symphony product. As people will be aware, Symphony is a product that we've been working on for some time.
It's a product in the outpatient setting for the treatment of complex wounds, predominantly diabetic ulcers and venous ulcers, mainly treated in the outpatient setting. It's a significant opportunity in the U.S. alone, in excess of $1 billion. This market has been significantly larger than that, but with changes in the reimbursement recently, particularly a change in pricing by CMS, there's been a major reset in this market. Importantly, the patients are still required to be treated, and for Aroa, we see this as a significant opportunity for us in the future. With the change in reimbursement, where we've moved from a model where physicians were being paid as a percentage of the ASP to a model now where there's a flat payment per square centimeter.
That has meant a significant reset in terms of who's participating in this market, and the products that are going to be available. We've seen major disruption in this market over the last six months, since this change came into place at the beginning of January. With these changes now, we think Aroa is very well-positioned. What physicians are looking for is proven products with good, strong clinical evidence, but also products that are priced reasonably. Next slide, please. I'm now going to pass over to Dr. Barnaby May, and he's going to provide an overview of the Symphony product, and the design principles behind this study. Barnaby, over to you.
Yeah, thanks, Brian. Yeah, look, on the next slide, I've just sort of laid out a bit more of a description of this new product, Symphony. The Symphony device, when we sort of first imagined what this device would look like, we wanted to do something different with this device in terms of its design that would really clearly differentiate it in a relatively crowded market. What we've ended up with is a composite device. It's got layers of our ovine forestomach matrix, extracellular matrix bioscaffold technology. Then what we've done as well is include a discrete layer of high molecular weight hyaluronic acid. Now, obviously, our ovine forestomach matrix technology is now really well-validated, both when we're thinking about outpatient complex chronic wound care, so your diabetic foot ulcers, your venous leg ulcers, but also inpatient as well, when we're thinking about limb salvage, complex reconstruction.
On the next slide, I've just laid out some of the rationale behind why we wanted to incorporate high molecular weight hyaluronic acid into this new Symphony device. Hyaluronic acid, just a bit of a background to this really unique biological polymer. It's a polymer that exists in all soft tissue. It's an integral part of the extracellular matrix. Probably best well-known for its ability to retain water or moisture, right? In addition to that, it's got some really unique biological properties that lends itself really well to being a clear differentiator and giving us a little bit extra when we think about using the Symphony device to heal complex wounds. In biological terms, hyaluronic acid, well-characterized in terms of its ability to promote, stimulate angiogenesis. When we think about high molecular weight, hyaluronic acid has got a known role in modulating inflammation.
Obviously really, really important when we think about that chronic wound environment, which are chronic because they are highly inflamed wound environments. On the next slide, I've just illustrated some of our own work characterizing this new composite device, Symphony. In this particular study, we published this a couple of years ago, we were able to show that by adding high molecular weight hyaluronic acid to the Symphony device, we were able to increase significantly the rates of keratinocyte proliferation and migration. When we think about wound closure, that sort of latter stage of wound closure is when the epithelial layer, so that top layer of the dermis, actually migrates over the underlying dermis.
What we showed in this study, as well as some other sort of biological highlights, was that the Symphony device had significantly increased rates of keratinocyte proliferation, which obviously lends itself really well to when we think about using this device to heal wounds. On the next slide, what I wanted to do was just sort of lay out the rationale behind the design of the RCT, which Dr. Bosque is going to dive into in the next section. In terms of laying the groundwork, the foundation for the study design, luckily for us, a lot of this is work that's already been done. In terms of published clinical studies, looking at comparative RCT data for these types of devices, so commonly referred to as CAMPs. We used to refer to them as skin substitutes.
The study design is really prefaced on the coverage guidance that's administered by CMS, and also administered by the MACs as well. What we're looking to do is enroll patients, obviously, that have a clearly defined chronic wound, i.e., this is a wound that's been open and not healing for four or more weeks. We're focusing in on diabetic foot ulcers because obviously they're part of that coverage policy issued by CMS and administered by the MACs. Just a sort of background, all of this has been well documented already in the scientific literature, the approach to these types of RCTs. With that, to take the deep dive into our own study, I'm going to hand over to Dr. Brandon Bosque.
Thank you so much, Barnaby. As Brian mentioned before, my name is Dr. Brandon Bosque. I am a board-certified foot and ankle surgeon and certified wound specialist physician, and as you can tell by my accent, I am based in the U.S. Today, I am really excited to share with you a little bit of a deeper dive of the study design, the patient population, and the outcomes of this RCT, and why it is so impactful for patients, providers, and the market alike. If we go to the next slide, it will show the title and the journal that this is published in. A bit of a wordy title as medical journals and medical articles tend to be.
A Composite Ovine Forestomach Matrix and Hyaluronic Acid CAMP for the Treatment of Wagner Grade 1 and 2 Diabetic Foot Ulcers: A Randomized Controlled Trial. As we move forward in this presentation, anytime you see OFM-HA, that is referring to the commercialized product, Symphony. As Barnaby mentioned before, the CAMP acronym is a relatively new nomenclature, which stands for cellular, acellular, and matrix-like products, which kind of encapsulates all the products in this field. Before we even dive, Lorraine, if we can go back one slide, please. Before we even dive into the meat of the study, looking at the journal and the author lineup already establishes some impact and credibility to this study. This was published in the International Wound Journal, a highly reputable and well-read journal in this space. Looking at this author lineup is part of what makes me very, very excited.
We have some titans in this field, true thought leaders, and if you are familiar and follow this space, a lot of these names will seem familiar, but especially the first author, the lead author of this study, Professor David Armstrong, has been established back in 2024 as the most cited expert in diabetic foot. We are so fortunate to have the leadership of Professor Armstrong, who is not just a thought leader or one of the top thought leaders, but arguably the thought leader in diabetic foot ulcers. Again, that already establishes credibility of this RCT before we even dive in, which we will do right now. As Dr. May mentioned before, this is a gold standard study design in this space, and generally in medicine.
This is a prospective, multicenter, parallel group, Randomized Controlled Trial, where the population is an adult population with chronic Wagner Grade 1 and Wagner Grade 2 diabetic foot ulcers. Briefly, if you are not familiar with the Wagner classification, it is a well-established classification that clinicians and payers alike utilize to basically differentiate the severity of different diabetic foot ulcers. Classically, these RCTs just looked at Wagner Grade 1s, or more superficial but full thickness wounds. The authors in this publication wanted to take things a step further and said, "Well, let us look at even more complicated wounds, Wagner Grade 2," including because this is the patient population that truly needs these types of advanced treatments. A bold move, and I think, again, lends to the strength of this particular publication. The control arm is standard of care, which involves a collagen and calcium alginate dressing.
Standard dressings that are provided for all the patients, as well as sharp debridement and off-loading. Again, all standards of care in diabetic foot ulcer treatment. The intervention arm utilizes those standard of care treatments like debridement and off-loading, but then utilizing the Symphony product as the variable change for the intervention. Then finally, all important endpoints. The primary endpoint is bolded here, the proportion of patients healed after 12 weeks, a classic endpoint in these types of studies that is important for providers and payers alike. Secondary endpoints included time to heal, how quickly are these patients healing, as well as adverse events being a secondary endpoint, which we'll talk about a little bit more. Then some tertiary or exploratory endpoints. PAR stands for percent area reduction.
Even patients that maybe didn't heal the whole way, how much were those wounds reduced in area and size? Then QOL stands for the quality of life. We know that this type of disease state is quite epidemic globally, and it affects the quality of life for patients and their families alike. On the next slide, we're going to talk a little bit more about the patient journey. A patient walks into one of our investigator sites. They have had a diabetic foot ulcer for greater than four weeks, establishing chronicity. Then they're screened and enrolled. They provide their informed consent. Another element of this study that adds to the credibility and strength is that there is a two-week run-in period during that screening. What happens during that? Well, first, the investigators will provide standard of care.
They will try to maximize the ability for these patients to heal within that timeframe, so that if they heal greater than 30% during that two-week run-in, they're withheld from the study. They're considered a screen failure. In that time, they're also looking at their laboratory values, different imaging. As Dr. May mentioned before, want to make sure that their kidney function, their blood flow, they're free of infection, all these elements are well controlled so that we can minimize any confounding variables that we know that the treatment is what's truly differentiating the healing statistics for these patients and not necessarily poor blood flow or infection or any of those elements. Once patients meet that screening criteria, they are then randomized at TV1, or treatment visit 1, into standard of care or the Symphony groups.
From there, they are treated weekly with either product, depending on the group that they are established into, until they either heal or up to TV 13, which is 12 treatment weeks, again, a standard for these types of studies. Then from there, another strength of this study is if a patient squeaks to the finish line and they heal, there is still a two-week moratorium, if you will, for them to come back and establish that their wound remains healed. So it's not just are we healing wounds, but is it a durably healed wound that can stand the test of time? Because we know recurrence rates for diabetic foot ulcers is truly through the roof. On the next slide, we'll talk about the numbers.
We had 197 patients that provided their consent to be part of the study, that were identified as potentially eligible and screened, and then they were whittled down to 143, where 54 patients were considered screen failures, whether because their blood sugar was too high, kidney function wasn't adequate, or if they did improve greater than 30%, again, to establish chronicity of the wound and also to ensure that they have a reasonable chance of healing, regardless of which treatment group they're in. There was about a one-to-one ratio for them to be applied into the two groups. Now, what we're looking at here is the larger pool of the mITT, which stands for Modified Intent-to-Treat. This is all patients that were randomized and treated, regardless of if they were removed for the study due to an adverse event or a loss to follow-up.
All that data is kept to ensure a truly holistic view at this population. Then the next population is established as the per-protocol population. Those are the patients that followed the protocol to the T. They completed the whole study. In these types of studies, to have the most accurate view of the outcomes, you want to look at both the patients that maybe didn't complete the entire study or had some potential, some protocol deviations for a realistic view of this patient population. But then also you want to look at the per-protocol population, so that it's the subgroup that is everyone from A to Z, if you will, in terms of the treatment of the study. The next slide, we'll look at the variables of the patients themselves.
Things like age, their BMI, how long they've had diabetes, if they've had previous diabetic foot ulcers, if they've recurred, what their creatinine or their kidney function is like, their hemoglobin A1C, which, if you're not familiar, is basically a three-month look at how controlled or not your diabetes is. Again, we don't want to give a graduate level course on statistics, but one way that we could more or less objectively determine if two data sets are about the same or comparable, that there's not much of a difference, is something called the P value, which is that column you're seeing on the far right there. P values will always be less than 1, but anything higher than 0.05 is considered not statistically significant, meaning that the two groups are roughly the same statistically in terms of the differences.
You'll see a few elements here that are bolded here. Those are some variables where there was statistically significant difference between the groups. I'll walk through them briefly right now. The first one, as you see bolded at the top, is diabetes duration in years. The group that received Symphony had, on average, a duration of diabetes for greater than 18 years, where standard of care was just over 15 years. Professor David Armstrong and a lot of the literature established different risk factors for patients to have diabetic foot ulcers and limb loss, and how long you have diabetes is one prominent risk factor for poorly healing wounds and limb loss. In this group, Symphony had patients that had diabetes much longer, making them at higher risk for poor healing. The next variable is history of recurrence of these diabetic foot ulcers.
How many patients had a history where they had a diabetic foot ulcer, it healed, and then it happened and recurred again? In this instance, the standard of care group had more patients that fell into that category with statistical significance. The final one, as I mentioned before, probably in my opinion, the most important, hemoglobin A1C. Again, if you're not familiar with A1C, a normal person without diabetes will be about 5%. A patient with diabetes that's well controlled is generally between 6% and 7%. Once you get above 8%, that's when you're generally referred to or considered an uncontrolled diabetic. As you can see here, with high statistical significance, 0.004, the Symphony group had a higher A1C above that 8 mark.
Again, that means, if anything, the Symphony group was at a bit of a disadvantage to heal, simply by the metric that their sugar was more poorly controlled than the standard of care group. Overall, in this demographic look at the patients, they were roughly the same except for those 3 metrics. If anything, it put Symphony at a longer shot or more of an uphill road to get these patients to heal. On the next slide, we'll look at the variability between the wounds themselves. If you can see here, not much bolded, and if you look at the P values, everything is above 0.05.
The take home here is the different variables for the wounds themselves, the size, how long they've had their wound, where the wound is anatomically, and most importantly, the Wagner Grade, 1 being slightly less severe, and 2 being a more severe group, was about the same between the groups. That's exactly the ideal structure of a Randomized Controlled Trial, where there's not much difference and the groups are quite comparable. That was very important that the Grade 1 and Grade 2 was comparable, that there wasn't one group that had more severe wounds than the other. That lends itself to a more accurate statistical evaluation between the two. Now let's talk about the all-important outcomes. That's what we're all here to.
If we go to the next slide, we look at the first primary endpoint, and the primary endpoint was the incidence of wound closure at 12 weeks. We could see in that larger intent to treat group, which included patients that had various kind of issues during the study, there was a highly significant correlation to patients healing, a higher proportion of patients healing at the 12-week mark treated with Symphony versus standard of care, 46% versus 24%. Again, we look at that P value, and it's not just 0.05, but 0.008, meaning that it is highly unlikely that these numbers were per chance, that it's very likely that it is because of the treatment as to why we're seeing this difference.
Similarly, in the more strict per-protocol group, we are still seeing a statistically significant higher incidence in healing in the Symphony group versus the standard of care group, 54% healed in the Symphony group versus about a third of the patients in the standard of care alone group. Again, this showed with even a few categories that were lending to more complex patients being in the Symphony group compared to standard of care. The next endpoint on the next slide is a secondary endpoint of time to healing. Before we established that more patients were healing compared to standard of care utilizing Symphony, but how quick are they healing? Is it about the same, or are Symphony-treated patients healing faster? In this analysis, we found that that is indeed the case.
Now, in this slide here, the lower numbers is kind of the better outcome. As you can see here, 67.4 median time to heal in days for the Symphony group versus 75.2 for standard of care and the mITT, the larger group, and the more strict per-protocol group, about 65.4 days to heal versus 73.2 days in the standard of care. This is a Kaplan-Meier curve on the right, which is kind of an estimation of the probability of closure, with a function of time. Again, not only are they healing more patients in this study, but Symphony is healing them faster with statistical significance. In the next slide, we're going to look at another secondary endpoint. Clinical efficacy is key and very important, but obviously safety is just as important and some may argue is more important.
In this secondary endpoint, we look at adverse events. If you're not familiar with how adverse events kind of work in these types of trials, pretty much anything negative that happens to a patient can be considered an adverse event. I go into the doctor's office, I get my diabetic foot wound treated, I walk out, I trip, and I break my hip. That's considered an adverse event, even if it has nothing to do with the study. If they get a cold, if they go to the hospital with the flu, that's all considered adverse events. This slide here encompasses all that. Now, there's a subset of adverse events that is related to the index ulcer, whether it's related to the product or not. If you have any issues to the index ulcer, that would be an index ulcer-related adverse event.
If we look here, the adverse events, as you would expect for this type of trial, were about the same in general between the two groups, 51% in standard of care, 50% for the Symphony group, but these last three bullets are kind of the important ones here. There was a higher incidence of infection overall in the standard of care group, as you can see, 17% compared to 13%. More importantly, the deeper, more serious infections, there was only one in the Symphony group, sevenfold increase in the standard of care group. Thankfully, nobody in this study suffered a major amputation, but one patient suffered a minor amputation in the Symphony group and a threefold increase in the standard of care group.
Again, this is impactful because it shows and highlights the safety of this product, and it validates a lot of the OFM publications that preceded this very rigorous RCT. On the final slide here, at least for me, again, I have to joke and say that this type of imagery I kind of see every Tuesday, if you will. I can imagine some of the folks on the webinar here might be a little taken aback by these wounds, but this is exactly the type of patient and the type of wound that could be so difficult to treat, and can cause the loss of life and limb for patients, quite literally.
This is one patient that was treated with Symphony in this trial, a 58-year-old male with a Wagner Grade 2 or more severe diabetic foot ulcer on the bottom or plantar aspect of their right foot. The first picture, Panel A, is when they presented. By Panel B, there was already an 84% reduction in the wound size after just one treatment with Symphony. Panel C shows by week three, a 90% closure of the wound at that point. By week four, after only three treatments of Symphony, that wound that has been persistent for at least six weeks has completely healed and epithelialized. More importantly, when they came back for their healing confirmation visit in two weeks, that wound was found to be durable and still epithelialized and closed. Again, not all patients require 12 weeks of treatment, up to TV 13.
Some healed even faster than that. Here is a complicated wound where three applications of Symphony, and the patient had a phenomenal outcome. To show you the summary here of everything that we chatted about, then I will kick things over to Brian. We will go to the next slide. Again, to summarize, Symphony plus the standard of care of debridement and offloading was found to be effective in both Wagner Grade 1 and the more complicated Wagner Grade 2 diabetic foot ulcers in this population. There was a statistically significant increase in the incidence of wound closure in the Symphony group compared to standard of care, with a relative delta between the two groups, 57% more closure in the diabetic foot ulcer versus standard of care when you look at them comparatively. A statistically significant reduction in time to heal.
Even if you heal by just one week, that is much less cost to the patient, to the healthcare system, and it also improves the patient's quality of life. Now the provider can put a new patient in there, because as Brian mentioned before, there is no shortage of patients that require care in diabetic foot ulcers. Importantly, the safety metrics were very favorable, with no unexpected device-related adverse events for Symphony. Overall, a lower incidence of infection, especially more complicated, deeper infection in Symphony compared to standard of care. Again, that just continues to validate the already established OFM safety profile from previous prospective and retrospective studies. Hopefully the team at Aroa and other investigators can look at that more deeply in future studies and analyses. Thank you so much.
I'm going to pass things over to Brian, but I'll be available to answer questions at the end of our call. Brian, you're muted there. Yep, there we go. Still muted, Brian. There we go.
A sticky button there. Thanks, Brandon. Just a reminder, if you have questions, please submit your questions through the Q&A function, and we'll take those questions shortly. I just want to talk briefly about the implications of this. If you could just roll forward, please, Lorraine. What does this mean? I think at the beginning of Brandon's presentation, he outlined the design of the study and the people involved in running this study. I think we've certainly engaged with a top-tier CRO to undertake this study. The authors on the publication are second to none in terms of leadership in this field. I think, as Brandon said, I think we come away with a data set that is very good, but also reviewed by leaders in this field.
We think it puts us in very good shape, no matter who we engage with now, to present this data. I think, as Brandon said, the results clearly demonstrate the efficacy of Symphony and safety, and that's important for physicians when they're looking at what product do they adopt. I think increasingly now, with more of a spotlight on the selection of treatments and why physicians are choosing particular treatments, having robust data that stands behind the product is becoming increasingly important. We're very well-positioned now to defend the product and to show why Symphony should be selected. I think, interestingly, with this study, we've stretched the study a little bit by both combining the more simple Wagner Grade 1s and then also the more complex Wagner Grade 2s. That's unusual, and I think that's really lifting the bar on what's been done previously.
When physicians are using this product now, these types of products are under a lot more scrutiny from reimbursers. We've seen over the last couple of years, CMS rigorously auditing the use of these products by physicians. Clinicians can say their product selection is based on clinical efficacy, and not simply based on efficacy and potentially financial benefits. That puts us in a very good position. We're using this data now to support the coverage of Symphony through payers. Importantly, Symphony is already covered by Medicare, and that's a transition period happening this year and potentially next year. Increasingly, we see that payers are going to require this type of data in order to ensure ongoing payment. We feel that this study now future-proofs Symphony and positions us very well going forward.
Outside of CMS, it is important that products are also covered by private payers. We have initiated a process with private payers to use this study to ensure that Symphony is covered, and that is a process that we are working through with each of those private payers. That is important for physicians to know that these products are covered, that their reimbursement is going to be provided, and they do not risk that reimbursement being denied. That provides confidence in terms of selecting products and using products, and making sure that they are going to be paid in the future. All of this taken together now puts Symphony in a very strong position, not just now, but also over the medium term. Providers can know that if they bring Symphony into their hospital, into their practice, then it is going to be paid for.
Paid for now, but then also paid for in the future. They are not bringing in a product where there is uncertainty about how that may work in the future. If you take that all together, really, we have all the pieces in place here now for Symphony to start to unlock sales and position us well for the future. That is going to improve and increase over the next 6-18 months. Next slide, please. I am going to open it up for questions now. Let us just go to the first question. Is the current shakeout in the outpatient market creating some short-term delays for Aroa to sell Symphony? Maybe I will take that question. I think the answer is yes. I think there is certainly been a lot of disruption in the market. I think there is been provider hesitancy in terms of using these products.
I think that we are starting to see that settle down, and we think the disruption that has happened will start to lessen as we go into the beginning of next year. But certainly, in the last 12 months, there is been a lot of change and there is certainly a big shakeout happening in this market. We have seen a number of companies exit from this market, and we are really starting to see it reset. We think the combination for Symphony of now having good evidence, but also being available at a reasonable price point, positions us really well. Another question here from Andrew Gracey. There is much variation in diabetic ulcers clinical studies. How would you rate the efficacy versus other studies? Is the real benefit in the Wagner 2 wounds? Brandon, I will pass that to you.
Yeah. Thank you, Brian. I think there is a couple of questions based off this. It does become a little bit difficult to directly compare apples to apples, even different RCTs within this field, because there are some nuances. As one for instance, there was a similar RCT in another product where the standard of care was not truly standardized across all of the patients that received it. Some of them got an alginate dressing, some of them got a different type of dressing, some got running water, some got saline. So those types of elements make it quite difficult to make an apples-to-apples comparison. But overall, looking at the results of this RCT to other comparable RCTs, it is either about the same or there is an element of improvement compared to those RCTs.
But again, I think talking to payers and providers alike that are dissecting and digesting these types of studies, I do not think many would look to directly compare them specifically because that is not how the studies are designed. The take home there is that these results broadly either mirror or appear to be more compelling than other RCTs. But again, it is not always the easiest apples-to-apples comparison. Brian, I did-
Brandon.
Yeah.
Sorry.
Go ahead. No, no. Go ahead. I am sorry.
Yeah. Another question. Can you disaggregate the results by Wagner Grade 1 and Wagner Grade 2?
I am assuming you mean like, kind of a, I guess maybe like a subgroup analyses. Is that
I think so. Yeah.
Yeah. This particular study did not do that specifically, to look at kind of a subgroup of Wagner Grade 1 versus Wagner Grade 2. It was more of an aggregate. But again, for future studies, that might be something that we would want to do, either just look at Wagner Grade 2 or dive in deeply into a breakdown of the Wagner Grade 1 and Wagner Grade 2. Before these studies are undergone, they undergo a statistical analysis plan, so everything is kind of preset, so there's no element of bias when you're doing statistics.
Prior to that subgroup analyses was not planned for ahead of time, so we just looked more broadly at Wagner Grade 1 and Wagner Grade 2. But I think that would be a potentially compelling study to look either at just Wagner Grade 2s in the future or do a bit of a subgroup analyses there.
Another question for you, Brandon. Many competing product RCTs have focused on Wagner Grade 1 ulcers. How much does including Grade 2 wounds here increase your confidence in using Symphony for more complex wounds that you see in practice?
Yeah, that's a great question, Brian, and I'll be honest with you, a lot of times, a Wagner Grade 1 diabetic foot ulcer does not keep me up at night often, right? A lot of times they'll heal a bit more predictably. There was, quite a few years ago, an RCT that was done where it was just Wagner 1s, and the healing rates were through the roof. Most people just kind of rolled their eyes at it and said, "Well, those wounds will probably heal probably fine on their own." That's why it was very compelling and a bit bold to add Wagner 2s in this study because, for me, those are the types of wounds, Wagner 2, that I would be reaching for these products, where I would need an advanced treatment.
I'm going to fight payers and whoever for my patients to get those advanced treatments. To Brian's question, I think it is bold, and I think it is more impactful to, for those more complex Wagner 2s to see this type of data set that doesn't just go look at the more simplified Wagner 1s. Yeah, this, it's much more compelling because Wagner 2 DFUs are exactly the types of patients that would more readily need this type of treatment versus standard of care.
Thank you. Barnaby, a question for you. What intellectual property does Aroa own for Symphony?
Yeah, great question, Brian. Yes. Quite some time ago, we secured intellectual property that covers our, what we call our layered family of products. This includes Symphony, but also Myriad Matrix as well. Some years back, we developed a very novel manufacturing process which allows us to create these multilayered devices, Myriad Matrix, Symphony, and we are able to secure intellectual property to give ourselves protection around that technology, that approach. It particularly called out devices like Symphony, where we are including that layer of, in this case, high molecular weight, hyaluronic acid, in between those layers of ovine forestomach matrix.
Another question for you, Barnaby. Have you started engaging the MACs on the study results? If yes, how are they responding? If no, what is the forward timeline?
Yes, we have started engaging all of the private payers, excuse me, CMS and also the MACs. Getting a response out of a lot of these entities is a little uncertain. They have all received the information. Have we heard anything back? No. Is that surprising? No. Yes, in terms of the horizon, across all of the different private payers, across all of the different MACs and also CMS, they all run their own relatively independent processes in terms of reviewing this type of material. Some of the private payers, they may review and provide feedback in the three to six month timeframe. And so yeah, for us as an organization, that is the timeframe that we are working towards.
Thank you. There are a few other more commercial questions here, and I think we will not respond directly to those today. We are running an investor day in late November. And we will be able to dig into the details of reimbursement and how our commercial build-out is shaping up for Symphony. So we will leave those questions until that time, and we can provide more detail on that at that time. In terms of clinical questions, I think we have come to an end there. So, I would like to thank both Barnaby and Brandon for joining us today, providing a great overview of the study. As I said, we are at the end of November. We will provide our half-year results and an update on the commercial activities, and reimbursement as it relates to Symphony.
I think it is fair to say, the first half of the year, we have seen significant disruption in this market. I think that reset is happening slowly. Certainly for us, our guidance for Symphony was low, and I think we are really looking at Symphony to really start to make a meaningful impact in the next financial year. But certainly off to a reasonable start. I am going to conclude the webinar there now, and thank you everybody for joining. We look forward to speaking with you again in the future. Thank you.
Thank you, Brian.