Okay, let's get underway. Welcome to Aroa Biosurgery's Investor Update on the findings of the recently published MASTRR interim analysis. Joining us today are Brian Ward, CEO and Founder of Aroa, Dr. Barnaby May, our Chief Scientific Officer, and joining from the U.S., Surgeon and MASTRR Study Chair, Dr. Tracee Short. Please submit any questions using the Q&A function. If you'd prefer to ask your question live, you may use the Raise Hand function. Please note that this session is being recorded, and I will now hand over to Brian to begin.
Welcome. Thanks for joining today, and it's an absolute pleasure to be here and present the interim analysis of our MASTRR study. We've got a great lineup this morning. I'm going to provide a little bit of introduction at the beginning, and then Barnaby May is going to provide an overview and some background of the MASTRR registry. We're then going to move on to Dr. Short. Dr. Short will review the analysis of the interim analysis of the study, and then take some questions, and then I'll wrap up in terms of what this means for us commercially. I'm delighted to have you here, and I hope this is an informative session. Let's move forward. Just in terms of these types of products, like Myriad bioscaffolds, they have an established history of use in surgery.
If you look across the field, there's a wide range of different products, and I think surgeons are not sure the extent to which these technologies are proven. At Aroa, we've taken clinical evidence very seriously, and we believe having high-quality clinical evidence is absolutely imperative to adoption of these products. For many of these products, there's not high-quality, large-scale clinical data. There's limited evidence in terms of whether each product works in a particular procedure, and the ability of these products to work across a wide range of procedures. There's also some clinical conditions that are very challenging. In more straightforward situations, these products may be effective, but may be less effective in more challenging situations. We believe there's a great opportunity to provide a lot better evidence, and that evidence gives surgeons confidence about use.
Also, if you can do that, then there's recognition of the value that they can bring both to patients, and to hospitals. If you show that, then you uncover the possibility to use these products more extensively in a wider range of cases. We've invested in clinical evidence, and I think today we're going to review the outcomes of the large MASTRR registry, which we've been running. Next slide, please. I'd like to introduce Dr. Barnaby May. Barnaby is our Chief Scientific Officer.
Barnaby has a PhD from the University of Canterbury. He's been with Aroa almost since the beginning. He did his postdoc at UCSF in San Francisco, spent eight years there, and then came back and joined Aroa. Barnaby has been the instigator of this MASTRR study. It's been his baby. He's done a fantastic job at getting this registry up and running. And we're really starting to see that this is delivering significant value for us. Barnaby, I'll hand it over to you, to provide an overview.
Yeah. Cheers, Brian. Look, I'll be brief. If you want to advance the slide please, Brian. I'll be brief. The intent of me jumping on the line, just to give a bit more context, particularly to the intent of the MASTRR registry in terms of study design, and just sort of, I suppose set the scene for the most recent publication from this large database of clinical outcomes using the Myriad products. Going into this, winding back the clock about 2019, we wanted to embark and develop clinical evidence to support safety and efficacy of our Myriad family of products.
What we wanted to do in terms of study design was set up a framework where we could collect patient outcomes from reconstructive procedures where Myriad had been used, and build up a dataset across the spectrum of surgical procedures where we see our products being used, that would allow us to do individual subgroup analyses across the sort of the spectrum of surgical subspecialties where we see the Myriad products being used. If you wouldn't mind, Brian, just advancing. Yeah, thank you. Yeah, in terms of study design, we've taken a little bit of a different approach with the MASTRR registry study in terms of study design. If we think most typically with prospective studies, prospective single arm or RCT, in terms of their study design, most typically what will happen with those types of studies is you end up using a very narrow inclusion/exclusion criteria.
The reason being that invariably these are comparative studies, by narrowing the scope of your inclusion/exclusion criteria, you can reduce the heterogeneity in the patient population that gets enrolled into these types of studies. That's fantastic in terms of an approach where you're comparing outcomes between, for instance, two different interventions. However, the drawback of that approach is that you end up excluding all of those patients and all of those defects that would otherwise be managed with your particular device. For example, if we think about our typical patient population, where the Myriad products get used, invariably these are complex patients. For example, diabetes, vascular disease, the patients may be on immune suppressants. Those types of patients would most typically be excluded from a traditional prospective study design.
What we have done in setting up the Myriad registry study is that we have ended up with a much more real-world snapshot of patient outcomes, and particularly in the context of today's presentation, safety outcomes with our devices. Next slide, please. Just a snapshot of where we are to date with the registry study. This is obviously an ongoing study. We have an ethics approval to include up to 15 U.S. sites and up to 800 patients. As you will see from this slide, we have got a wide range of different sites that are utilizing the Myriad products and then enrolling and capturing patient data from those surgical interventions. The interim analysis that was recently published, and Dr. Short will talk about shortly, was a sort of a halfway mark.
What we wanted to do with this particular study was present the safety outcomes across the wide range of different surgical procedures where we see our products being utilized. Next slide, please. The other great thing about the Myriad registry is that it has been an amazing resource for us to produce high-quality scientific publications assessing the safety and efficacy of our devices across a range of surgical procedures where we see the Myriad products being utilized. The most recent publication is the seventh in the series of publications that have come out of the MASTRR registry data set. Next slide, please. A bit of a snapshot. What have we learned to date? The first publication out of this study was the lower publication looking at limb salvage, so lower extremity complex reconstruction. That was 130 complex defects managed with the Myriad products.
We have also published data from the Ohio State University Burn Center looking at the use of Myriad to reconstruct deep partial thickness burns. We have done a publication from four different Level I trauma centers looking at the management and reconstruction of traumatic injuries with our Myriad products. We have also done a really interesting comparative study looking at the differences between outcomes from pilonidal sinus disease reconstruction, either with or without the application of Myriad devices, and showing in that study that we could significantly reduce postoperative complications where the Myriad products were used. Next slide, please. Without further ado, the reason we have all joined the call this morning is to hear from Dr. Short in an overview of the most recent publication from the Myriad registry data set.
Just by way of introduction, Dr. Short is a U.S.-based burn Surgeon with over a decade's experience in reconstructive surgery, burn surgery, and also a focus on atypical wounds, including hidradenitis suppurativa. Dr. Short received her medical degree from the University of Texas Health Science Center and then completed a residency at the University of Pittsburgh Medical Center. Dr. Short undertook a burn surgery fellowship at the University of North Carolina. Several years ago, we managed to recruit Dr. Short to serve as study chair for the MASTRR registry study. In that role, Dr. Short provides independent sort of oversight and guidance to the study execution. Without further ado, I will pass over to you, Dr. Short.
Thank you so much for the introduction, and good morning to those of you all who are on. We can go to the next slide. I am super excited to be able to present the data. As a user of the product and then being able to step into the role of study chair, it has been interesting to see the progression and the consistency to which people have been getting results in the various forms that they choose to utilize it in. As Dr. May had instructed, I am going to present our interim results from the MASTRR registry, which is going to look at what the safety measures outcomes have been across 474 soft tissue defects. We can go to the next slide. As he mentioned, this is a compilation of about 411 patients, or subjects, as you will see in the top slide, representing 474 defects.
Of this slide, I am going to go through the various numbers. As I go to each one, what I wanted to reference is the height of the benefit of a registry. The fact that we have 10 sites participating and a median BMI of 28, so basically, these were not small patients overall. 35% of them had diabetes, 30% had vascular disease, and 91% would not qualify to have operations at a surgery center. That is what an ASA Grade II or a higher means. We are looking at, as he mentioned, with a registry, you are looking at a cross-section of all of the patients or subjects that it could be utilized on, not simply excluding the healthy ones. Now when we look at the defects, as I stated, we had 474 defects. Of those 474, almost 60% of them were over a month old.
We are not talking new wounds, which are usually easy to resolve. We are talking wounds that had been present for at least 30 days. 88% of them had a CDC Grade II or higher. 11% had exposed structures, meaning tendon, bone, hardware, something along a vascular bundle. These were complex wounds. 15% had osteomyelitis, meaning there was a bone infection present in the defect at the time of application, and the mean area covered in the Myriad was 24 centimeters squared. Next slide. One of the things that I, excuse me. One of the things that both the registry indicates and my personal experience indicates is that median application of the product is one needed to get a wound closed. Of the utilization in the registry, 65% were for dermal reconstruction, meaning it is applied topically to help regenerate or reconstruct a dermis.
In 9.7%, it was utilized to help augment fistula and fistula repair, and in 25%, it was used as an implant. If we further break down the defects, 22% or 22.6%, excuse me, represented diabetic foot ulcers, 16.5% were traumatic, 11.2% was an ostomy takedown, meaning we are taking down a colonic ostomy, an ileostomy, and repairing that fascial defect. 10.8% was for pilonidal disease. Of note, for those of you all who may be on the call that are not clinical, we are talking about a wound that is not known for being clean. In 10.8% that represented the pilonidal cases, 9.7% were for pressure injury, and 9.7% were for fistulas. Next slide. I am going to do this slide to kind of preface what is going to come next. One of the things about any safety analysis is we standardize what an adverse event is.
Anytime someone is enrolled in a study, any adverse event, whether it is related or unrelated to the intervention, still has to be reported. This is across the board. What that allows for you to do is then kind of categorize what was the severity of the adverse event, and that is classified from one being mild to five being death. It also forces the participant to look at, or the clinician to look at causality. An adverse event may be unrelated to utilization of a product. It may be probable, possible, causal. You are kind of looking at what was the likelihood that this event was related to utilization of the Myriad, and then what was the likelihood that this was not related. That is what this next set of slides will be. Next slide.
If you look at definitively device-related adverse events, there were zero. Which from a product utilization in a complex wound bed in complex patients, says a lot. Of 474 defects, there was one probable device-related, meaning we cannot say it is not, but we also could not say it was definitively related. We are talking about one. This represented a median follow-up period of 27 weeks. That also by having a registry set up, we are able to get follow-up periods that we are not typically able to sustain consistently in your traditional RCT. We usually lose people to follow-up. Within the MASTRR registry, we were able to get a 27.1 follow-up period week-wise. As you can see, though, there may have been a reported AE that may have caused death, it was not related to product utilization. Next slide.
If we look at the adverse events or AEs, my apologies, I will use those interchangeably. If we look at the AEs that were index defect-related, it boiled down to deep tissue infection, superficial infection, and 0% at graft loss. Again, we are not looking at a product-related problem. If I put a product in a wound that is infected and then I grow a culture that says it is infected, that is still reportable, but it does not mean that it is related to the product.
We are looking at 32% were just incidental AEs, meaning they were adverse events that had nothing to even do potentially with a wound, but they are still reportable. 11.9% had defect-related AEs, but they were not in defects that had utilization of the Myriad. Next slide. This can be a little busy. We are going to break this down and go left to right across the screen. The blue box simply indicates that there is the 474 total pool of subjects that had utilized, excuse me, wound defects that had utilized the Myriad product within the registry.
The bigger the band indicates the higher of the prevalence. That next column is what category of challenge was being addressed, the largest being the dermal reconstruction. Remember, I had mentioned that a few slides back. Then came your implantation, and then came fistula augmentation. In this middle column, it breaks down each of those segments into, well, what type of dermal reconstruction. Then that is where it breaks down, you will see at the top, into burn wounds, diabetic foot ulcers. If you look at your next biggest category, it is the red with the pilonidal sinus. Then it gets down into your traumatic wounds.
Then it gets down into your ostomy takedowns. Excuse me. Then as we move forward to the end, which is where we are talking about from a safety standpoint, you are looking at your index defects. They are all less than 5%. Remember, the only one that was probable landed in the allergic reaction category, but these are all very low percentages. You could say, well, you have a 3.2% for dehiscence, but here is what I want to let you know about pilonidal disease. Those wounds often dehisce with or without product. It is just the nature of the location, the closure, and the tension that is present. Having a 3.2%, in the grand scheme of things, one, is not definitive, and two, it is innate with the disease process. Next slide. How does the deep tissue infection rate for Myriad compare?
If we go product by product, at the top you will have our Myriad product within the MASTRR registry sample size being 474. Remember, our deep tissue rate of infection was 0.7%. What I want you to look at is there is not another study that comes close to having a low deep tissue infection rate when we are all looking at similar wound types. When it comes to the various wounds, burns, if you are throwing in, it does not come close. Right now we are looking at less than 1%, and the next closest rate is close to 17%. Next slide. Excuse me.
Right. Tracee, can we open it up for some questions and answers? Sarah—
Absolutely.
—I will pass it back to you to pose the questions.
Yes, absolutely. If you have any questions, please just use the Q&A function. If you prefer, you can raise your hand to ask the question in person. First of all, Dr. Short, how important is this type of evidence in influencing clinician decisions on using a product?
For me, from a clinical standpoint, one of the things when you are looking at your traditional RCTs, how Dr. May had illustrated in his slides, the gold standard that we talk about is a traditional randomized control trial. But one of the challenges is most of the people that keep us scratching our heads and wondering how we are going to get wounds closed would never qualify to be put in a randomized control trial. Partly because you are worried about outcomes. They do not fit the inclusion criteria. You do not want to put anything that may be coming in infected while you are trialing a product because it would negatively skew things. One of the things that I think has been amazing in the design is that simple utilization puts you into the study and into the data.
Now it allows me to say, "Okay, this is real world. I can see that you have had osteo, I can see that you have had tendon and bone exposed, and you have got this kind of outcome in this clinical scenario." I think it makes it more applicable to my actual clinical decision-making. Because at the end of the day, when I am trying to figure out what is going to be best for the patient, I need to be able to know that it is going to work in this patient population, and not only in the most strict and pristine of criteria. I think it makes the product utilization more low-hanging fruit, and easier to trust the outcomes that it would work in a particular patient population.
Excellent. Thank you for that very full answer. We have now got Shane Storey, who would like to ask his question live. He is one of our ASX healthcare analysts. Shane, I am just going to put you off mute, and you can ask your question live.
Can you hear me?
Yes.
Hi. Thank you. Just a question for Dr. Short, please. Of the 119 cases where the device was implanted, could you talk to the major anatomical applications there?
Okay. I lost you. I do not know if I am the only one, but you cut out.
Sorry. I will try again. It was a question relating to the 119 implant cases. Just maybe some commentary on the major anatomical applications where that was done, please.
Right. So that was in a circumstance in which the product was laid as an overlay or an underlay, meaning we would sew down the Myriad and then do a closure over, so then in that case, it would be utilized as an implant.
In many of the studies I noticed, and even the studies that have been broken out of MASTRR, I've noticed across the whole group that the number of applications here is really about one. I guess my question then is, typically comparing to what would have been used if you didn't have Myriad, how many applications would typically be seen in other products?
Yeah.
Then another question.
Go for it.
My final part of that question then is, in many cases, can you see that as being a one and done, and how many subsequent procedures might Myriad have saved?
Right. The interesting part is going to be in which wound category as far as what's traditional. For example, in the classic diabetic foot ulcer model, what we have seen happen out of several wound care clinics is these patients would be getting product applied on a weekly basis. Then maybe after a month or so, they would have a big debridement, and then another product would be placed. In that case, we may be looking at double-digit application of product before something was utilized to actually augment the wound.
If we look at a burn patient, or your complex wounds, oftentimes you may be looking at a procedure that you're like, "It needs to be clean," right? Because many of the products that were commonly used and preferred, the wound bed had to be pristine for utilization because it was prone to infection. If you look at that product, then that means you went a trip to the operating room, you had something that was used to temporize. Then you would take the patient back to the operating room once the wound bed was clean, and then you would put a competitor product on. That product requires pristine or close to sterile technique when changing dressings because it is highly prone to infection. Once it's infected, that's it, right? Now you're back to debridement and putting new product down.
With the ultimate goal then, you've got a wound bed that is vascular with good granulation tissue. It's already done the angiogenic process, and now you do a skin graft on top. That was kind of the traditional model. It was not my favorite model because it required so much hand-holding in order to get the patient from start to finish. One of the things that I think Myriad encompasses is that, one, you can put it in without being pristine, right? You've put it over structures, you can put it in with product.
Obviously, you are going to debride the wound bed, but it is not like I need to be culture negative before I say, "Okay, now I am going to apply the Myriad." It can also be changed, like I do not have to have white glove service and sterile technique every dressing change, hoping and praying that it is going to last from week -to -week in between dressing changes. It does give an ability to manage a lot of things as an outpatient. It gives things the ability to do a lot of salvage, even if it may not be the most pristine of wound bed situations.
I think the last part of your question was how many procedures does this ultimately save someone from needing to undergo to get a wound closed. If we are looking at that classic model of debride, temporize, debride, place product, hope product works, and then come back and graft, you could be, at a minimum, saving that one procedure where you are not needing to do the whole temporize to product. If we are speaking in the DFU space, we are looking at you are saving a month's worth of procedures in order to get wounds closed.
Thank you very much.
And—
Okay.
May I do one add, Sarah?
Mm-hmm. Yeah, sure.
One of the things that this kind of highlights, and I am not certain where everyone on the call is coming from, but here in the U.S., there has been a recent change in how wounds are reimbursed. From a standpoint of what can I do to get a wound healed that now will be reimbursable from an insurance standpoint, and would still allow for the ability for the patient to not maybe have to come in as often, or would be amenable to having home care. Having a product where you can put it down with very low needs to reapply and very low infection rates is definitely favorable.
Excellent point. Okay, now we do have a few more questions that have come through. Andrew Gracie has noted that the infection rate at 0.7% is remarkable. We agree, Andrew. What do you attribute the low rate to?
I think it is a combination. I think the fact that it is an actual dermal structure. I think the fact that it has come from a space that was not pristine, right? It comes from a forestomach, so we are not talking about an area that was sterile. I think that may contribute to its robustness. I do not know, Barnaby, if that has actually been studied as to why it is so infection resistant or not infection prone. I do know if you look at just the texture and consistencies, it is more like a dermis than, say, one of the competitors that is highly known for becoming infected. It does not look like or feel like a strong dermal tissue, and so that may be one of the differences, but I will defer the potential details to our scientist.
Yeah. Thanks, Dr. Short. Maybe just one other comment from me. It is a great question, and we do get this question a lot from clinicians, from users of our technology. The way I think about it is that, most likely, the major cause of this amazing low infection rate that we are seeing is the fact that we can revascularize our Myriad devices so quickly, right? Relative to some of the older style technologies in the bio-scaffold space. Some of those devices, their rate of cellular infiltration and revascularization is relatively slow, so you are looking four to eight weeks, right?
And obviously, during that period while that graft is being revascularized, it is at risk of bacterial contamination and then infection developing, just because you do not have the blood supply there to protect the graft from infection, right? When we look at the vascularization rates of the Myriad devices, typically it is a lot shorter. So you can see the graft revascularize in a week in some instances, right? So you are shortening that time it takes for the body's own immune defenses to be delivered to that graft, and I think that is probably one of the key drivers to the low infection rates that we are seeing.
Excellent. Okay. Let us move on to some more questions. We have a question here from Shane Solly. Can you discuss the economic benefits for healthcare systems by changing to using the Aroa product?
Is that to me?
Yes.
Okay.
From your perspective, that would be great.
From an economic standpoint, especially with the wound changes that have happened here lately, I think it is nothing but favorable. If you look at what products are now being reimbursed for, the ability to prove that the product works by having wound closure within a specified period of time, and then this sort of need to reapply not existing with the product, I think that definitely makes it favorable. If you look at, I think, the latest is that you have to be able to show that you can get the wounds closed within, what was it, 31 days, 42 days? It is some random number. I do not know where the number came from. But in a wound application standpoint, it would fit the bill. Then from a reimbursement standpoint, with a lot of our systems are going to value-based.
If you look at, okay, if we are putting X amount towards wound closure, if I can get the wound closed with the single application, then even if that product was slightly more, it would still have more value, because I can put the product on and they can discharge. Then I am saving in hospital day stays. In the weird way that American insurance and reimbursement works, it is a win, whether it is an inpatient or outpatient. Because there were multiple instances where we can put a product in and the whole process, the patient did not require an inpatient stay. That decreases costs, especially if they do not have the best payers. I mean, I think it is favorable all around.
Excellent. We also have Shane Storey again, who would like to ask his question live. I will unmute Shane to ask that question.
Yeah. Thanks. Happy to be back. I'm lousy at typing, so I have to ask my questions live. My question really relates to the cases for partial thickness burns, where I noticed that I think only one of the defects ended up with a split thickness skin graft. Is that down to the product, or would a low rate of skin grafting have been already expected for that type of injury?
The challenge with partial thickness is that partial thickness is a very broad category. Partial thickness could be everything from this wound would have healed no matter what you did to it because it was a superficial partial.
Down to a deep partial where, in some areas, the dermis may be injured, but it needed some assistance in regeneration. In this particular, I think most of these cases were from Ohio State, and looking at the photos that came from that subset of the registry. I think what it helps to do is it helps give a wound bed that allows for augmentation and healing. Will we ever be able to say, would this wound have converted and required a split thickness skin graft? We will not know, right? There's so much that goes into the dynamics of burn wound healing. But what we can say is, of the deep partial burns that it was utilized in, only one required grafting.
From that standpoint, it puts it in that same category of, if I'm going to put something on, right, if it doesn't inhibit wound healing and it could optimize to the point where we can now put the necessary components in that wound bed that allows for the dermal regeneration and the natural sort of re-epithelialization, then it's a win-win. But that category is a challenge across the board. That is not specific to Myriad. But what we can say is, only one needed to be grafted. The challenge becomes is, how deep is the deep partial thickness?
Thanks, Dr. Short.
Brett Rock has asked, how does Myriad data compare to other biologic scaffold study data?
Well, the interesting part is, and [Mark, I believe we are the only registry that has had this number of defects enrolled. If you look at having another study, I think the next closest study to us was in the hundreds. Is that correct, Dr. May? I want to say it was in the high hundreds. Again, it's not across wounds, it's not across different wound categories. If you look at the utilization, you have a podiatrist, you have colorectal surgeons, you have trauma surgeons, you have burn surgeons, you've got plastic surgeons that are all contributing to this database that really allows for that surgeon to be able to see their patient population in the included defects within the study. I don't believe there's a study like this out there. What do you say, Barnaby?
Yeah, no, you're right, Tracee. It's a great question, just to frame it for you. To our knowledge, this is the largest prospective data set that includes inpatient complex reconstruction with a biologic, right? Maybe just to add some more color to that. When you look in the published literature, at tissue-based or tissue-derived bioscaffolds, that are used for soft tissue reconstruction and wound healing, the vast majority of those publications are actually from outpatient wound care, right? Where you do see publications that are focused on inpatient complex reconstruction, it's slim pickings, right? There's a very small body of evidence to support the other biologic-derived bioscaffolds in this space. When you look at those papers, though, the key difference is really around the reapplication rates, which is a question we addressed earlier.
For example, in the lower extremity or limb salvage publication that we did a couple of years ago out of data from the MASTRR registry, we included in that publication an analysis and a review of the literature focusing in on, okay, well, what is being published for other tissue-derived bio-scaffolds in this space? That was one of the key differences that really popped out of that analysis, is that some of these other tissue-derived bio-scaffolds, they were reporting the need to do repeat inpatient reapplications of these devices, anywhere from four product applications all the way up to, from memory, I think the highest was about 14 applications of a product. So that is what has come out of the literature when you compare this MASTRR data set with the existing inpatient publications for tissue-derived bio-scaffolds.
Okay, we also have Brenton Anderson, who is from Bell Potter. He would like to ask his question live. I will unmute you now, Brenton.
Thank you. My question to Dr. Short is around the DFU cohort. I noticed that included 75 Wagner Grade III or IV wounds, which, as far as we are looking at, that is quite severe. You are typically going to be getting abscesses, osteomyelitis, gangrene, that type of thing in there. I see there was no adverse events in the treatment-emergent adverse events for that subgroup. Can you just speak to that? That seems exceptional from that side.
Right. Are you able to go back a slide? Or two slides, actually. One more. If you look at from the DFU cohort, one of the things that there is nothing in that category. I think it speaks to, one, having a good surgical wound bed that has been cleaned and prepped, and then two, being able to, as Dr. May had mentioned, I think when he was replying to the question from Shane Storey, you are starting that process of you are not having to open the wound on a daily basis to do wound care, and then the process of healing is beginning the day of application. But yes, in that DFU category, there were no associated index AEs associated with that group.
Thank you.
Okay, and we have a question here from Shane Solly. "What is the learning curve like for clinicians, and do they have any thoughts about application of the product elsewhere in the health system for other indications?
No. The thing about it is, it literally is the easiest thing to apply. If you've used any other dermal matrices that was maybe complicated and had all the steps, and you had to change gloves, and you needed to lay down sterile towels. It's not that. We've all been there, if you are the clinician on the call. I have been there, and I knew that there had to be a better way of finding a product to make it easier. It literally is, you open it in the pack. It is hydrated on the back table, with a simple saline solution. It's actually meshed now. Back when we were first using it, I was like, "Well, I'm going to mesh it." Because burn surgeons, we get creative with all kinds of things.
You hydrate it on the back table, you do your wound bed prep, and you lay the product in. I staple along the sides to secure, but I'm not like an over-stapler. It literally just needs to be secured. It can be placed under negative pressure. It can be placed with a bolster dressing. You can do your basic wound care dressing, and whatever your usual is. For most people, when they followed up depended on my clinic schedule. They may have their first take-down anywhere from four to seven days from whenever we did the operation, because it would be based on when they would be following up in my next clinic. But it works well under negative pressure. Just like you would do any other dressing change, I put a non-adherent layer down, and then I put a black foam on top. And it can be stacked.
One of the things that you have a challenge with trying to get some of the really thick, like the silicone-backed products, they don't really fit into contours well. From a practicality standpoint, you don't have that challenge. I had a gentleman who had a wound on a shin that had his tibia exposed. Excuse me. We stacked the product down into the defect because it was like a reverse cone. Layered the product down in there, and then put a wound vac on top of all of it.
It is the easiest thing to manage and care for. In any wounds where I may have had any concerns or questions, even on that dressing change, I would typically then utilize a hypochlorous, put it back in a dressing, and then I don't do another one for another three, four days, or until they're following back up a week in clinic. I don't want to say, like I love the old infomercial. I don't want to go all the way to say it's a set it and forget it, but it's as close as you could get to a set it and forget it.
Great. We've also got another question here from Michael Holland. He has asked, "Does the MASTRR registry design exclude any types of patients, or are all patients using Myriad products at the study centers eligible for inclusion?
Any utilization in. I'm sorry. Go ahead, Barnaby. I saw you came off mute.
Oh, yeah. You take it as well, Dr. Short, yeah.
Any utilization at the center, you would obviously screen them. But they were capable of being included within the study, as long as they were inpatient at the site and being managed in the various diagnoses.
Yeah. The only inclusion/exclusion criteria that is relevant is the contraindication which is listed on the Myriad IFU, which is basically to exclude folks with known allergies to sheep tissue, which are very, very few, I have not met one yet, or for application of the devices in third degree burns, per our instructions for use. But otherwise, it is everyone, as long as they are being managed at a participating site.
Okay, and Brett Rock has asked, "Is the study changing clinician behavior and product preference?
I know it has for me. It's funny, I do a lot of consulting work within burn now, and so it's given me the ability to see how other hospital systems work with products and various depth burns. I think it's an interesting place to be, because normally you only know your institutions that you've trained at or worked at. One of the centers, literally, they've been pulling things and moving divisions, because wound care management and burn has changed so significantly.
From a practice standpoint, for me, something that allows for a wound to be debrided and on its way to closing in one procedure, definitely has become more favorable in an era where staying in the hospital isn't preferred by anybody. Patients don't want to be there because they can't rest, because we tell them the hospital isn't a place to rest. Which is weird when you think about, well, what was hospital stays in the past, and what may they be in other places? I think it definitely is contributing when you can look at safety data, outcomes data, and then also bringing in what has to be utilized inside the American system of healthcare, which is your economic data.
Excellent. Thank you. I think that concludes all the clinically focused questions. We do have a question here from Tim Richardson, but I think that leads into what Brian's going to cover next in terms of the impact on revenue and overall growth of the company. Thank you for the questions, and those very full answers, Dr. Short. I'll now hand over to Brian to continue with the end of the session.
Great. Thank you, Sarah, and thank you, Dr. Short. Great presentation and your experience and insights are very valuable. I just want to summarize what we take away from this in terms of Aroa as a company, and how we think about this affecting our commercial activity. I think what we now recognize is that the MASTRR registry is a very important commercial asset for Aroa. As was mentioned during the discussion, this is the largest prospective evidence base for products in this category, and I think that is incredibly helpful. It supports our commercial activities and provides a level of credibility, I think, that is incredibly important. Particularly important now as we progress in commercialization of our products. I think most surgeons rightly are conservative in their use of products and skeptical about claims made by salespeople.
And so being able to now present compelling data that shows that the product works, that applications are typically low based on a large number of patients. And importantly, Myriad can be used in a wide range of cases, demonstrated by the breadth of cases in the registry. And in those really challenging cases, those cases which are contaminated, where there is likely to be infection present, but also in the ones that are really tricky to address. So where you are trying to heal tissue over bone and tendon.
So now our salespeople, our commercial team, can turn up, talk to surgeons about this, but then also show them case examples and show them clinical data based on a wide number of patients. So that supports the claims that they are making. So I think this puts us in a very unique position. I think the data that we have is unique. It is important in terms of differentiating ourselves from competing products. I think our ability to show data that shows an extremely low level of complication is incredibly important, and that is very unique to the Myriad product range.
I think when you then look at who are the stakeholders for buying our products, not only are they clinicians, are there administrators within hospitals. And us now being able to have data that supports our case when we go to hospital administrators and say, "These products should be bought into a hospital." We can support that with outcome data, and off the back of that outcome data, we can begin to show them the difference that this makes in terms of the value that we can bring to the hospitals, the cost savings, the operational improvements that they can have as well.
So, it is clinical data, it is economic data that is important. And I think all of that adds up to us being able to increase sales, and accelerate our rate of success. And I think what we have seen over the last 12 months is Myriad has grown very strongly. 54% year -on -year last year. It is tracking very strongly this year. And we are excited about the potential for Myriad, what it can do for patients, what it can do for surgeons, and also what it can do for hospitals. So next slide, please. So we have only got a few minutes, and I can take maybe one or two questions. So Sarah, if I can pass it back to you.
Yes, sure. So, Michael Holland has just asked, commented, "Given some of the comments made on the call, are there any future plans to do health economic studies?
Yeah. So, really good question. And health economics is absolutely critical. So we've got activities on a number of fronts there. In some of the papers that we've published to date, there's some economic analysis of the use of Myriad and the applications of its use, and particularly around the number of applications. So, every time you're applying a product, you're paying for the cost of the product, but you're also taking the patient back to the surgery. You have theater time, surgeon time. So those savings can be profound.
The cost of infections is also very high as well. So we have models now where we can demonstrate that. We're also looking at hospitals where historically they may have used a different product, they've transitioned to Myriad, and we have specific examples of what the costs were before and after with Myriad. So that's a body of evidence that we're now building, and that's particularly important as we talk to hospitals, as we talk to hospital systems, and GPOs.
Okay.
So Sarah, maybe one more question, and then I think we need to wrap up.
Yeah. Well, we actually don't have any more questions, so—
Okay.
—I'll hand it over to you to conclude.
Great. Well, look, hopefully today's been helpful. A good summary of the data. I think we will talk a little bit more about this. We're going to run an investor day in November in Sydney, and we're going to talk about the wider range of studies we have and some more information on the interim analysis. I also want to let you know that our Symphony RCT was published earlier in the week. We are going to run a similar webinar next Monday to summarize the outcomes from that.
We're super excited about that study. We think that puts Symphony in a fantastic position with the changing reimbursement landscape. For outpatient skin substitute use, it's going to be incredibly important to have strong clinical data, and we're going to present that data in a webinar and explain the implications of it. I'm going to finish up there. Thank you everybody for joining. Hope it was helpful, and look forward to your attendance again.