Good day, and thank you for standing by. Welcome to the PermeaDerm KOL webinar. At this time, all participants are in a listen only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. I would now like to hand the conference over to your speaker today, Ben Atkins, Vice President of Investor Relations at AVITA.
Thank you, and welcome to the AVITA Medical PermeaDerm Key Opinion Leader webinar. Today, we will be reviewing data and cases from our PermeaDerm-I study, which evaluated PermeaDerm as a wound temporizer compared with cadaveric allograft. Before we begin, I'd like to remind you that today's call will include forward-looking statements regarding AVITA's current expectations about future events. Please refer to slide three for additional details. I should also like to add that this presentation will include images of burns and wounds. It's now my pleasure to hand over to Katie Bush, AVITA Medical Senior Vice President of Scientific and Medical Affairs.
Thank you, Ben. Today's discussion will focus on our PermeaDerm-I clinical study readout and two surgeons' clinical experience with the product as part of our broader AVITA portfolio. Joining us today are Dr. Anju Saraswat, Assistant Professor of Surgery at Wake Forest University School of Medicine and Assistant Medical Director of the Atrium Health Wake Forest Baptist Burn Center. Also, Dr. Christina Sharon, a burn and acute care surgeon and the Burn Director at Baton Rouge General in Louisiana. In a moment, Dr. Saraswat will provide an overview of our clinical trial results. Dr. Sharon will provide her experience using PermeaDerm as part of the AVITA portfolio. We will then open the line for questions. Before I hand over the presentation to Dr. Saraswat, let me provide some background information on how PermeaDerm fits in the AVITA portfolio.
At AVITA Medical, our purpose is healing at the speed of light, helping patients heal sooner and return to their lives faster. To achieve that, we have built a portfolio of three complementary technologies that support clinicians across the continuum of acute wound care, from preparing and stabilizing the wound with PermeaDerm, rebuilding the wound with Cohealyx, to ultimately restoring the patient's skin with RECELL. Individually, each product addresses a critical stage of treatment. Together, they provide a more comprehensive approach proven to improve clinical outcomes while reducing the burden of care to the patient and hospital. Across the portfolio, more than 225 publications together with a growing number of company-sponsored and investigator-initiated studies continue to strengthen the evidence base supporting our technologies.
Today's data builds on that body of evidence, complementing the recent interim results from our multicenter Cohealyx-I study, the webinar for which is available on our website. Today's focus is PermeaDerm. We will review its role as a temporizer, a concept central to the PermeaDerm-I trial, and discuss how it can help surgeons stabilize and protect the wound before final reconstruction. When we've discussed PermeaDerm previously, we've described it as protecting and stabilizing the wound. Let me explain why that's important. Definitive wound closure is always the goal, but in many cases, it is not possible immediately. A patient may require further stabilization, the wound bed may just not be ready yet, or donor skin may be limited. That is where temporization fits. PermeaDerm provides temporary wound coverage that helps bridge the period between excision and definitive closure, maintaining a protective environment until reconstruction can proceed.
This clinical role is central to the PermeaDerm-I study we'll discuss today and reflects how the product is increasingly being positioned in practice as an alternative to allograft during this critical stage of care. Cadaveric allografts have been used for temporization for more than a century and remain a familiar option in burn care when definitive closure is not yet possible. They are one of the oldest approaches in burn care. While widely used, allografts require frozen storage, tissue tracking, and thawing before application, which adds time and complexity in the operating room. Tissue characteristics can also vary from donor to donor, including thickness and consistency, and they are available only in certain sizes based on donor harvesting capabilities. In addition, because they are human-derived, allografts carry a risk of disease transmission and immunogenic response.
PermeaDerm is a modern approach to temporization, a biosynthetic wound matrix designed to provide temporary coverage, similar to allograft, yet reducing the logistic burden of human donor tissue. PermeaDerm mimics key features of native skin through a bilayer structure that protects the wound, allows oxygen exchange, and supports healing. It is fully removed prior to definitive closure, making it a temporary bridge rather than a permanent implant. PermeaDerm is also transparent. This allows at-a-glance wound assessment with a clear view to the wound healing process, minimizing disruption to the patient, the wound, or the product itself. I will now turn the presentation over to Dr. Saraswat to review the PermeaDerm-I clinical trial results.
Thank you, Katie. As surgeons, we need temporary wound coverage that bridges excision and definitive skin grafting. Traditionally, that role has been filled by allograft, but allograft has limitations, including cost, availability, and workflow. The question we wanted to answer was straightforward: Can PermeaDerm provide a clinically comparable alternative while reducing the cost of care? That's the rationale behind the PermeaDerm-I study. This is a randomized controlled trial involving 40 patients with wounds covering up to 30% of total body surface area. Following excision, patients received either PermeaDerm or allograft during the temporization period before undergoing split-thickness skin grafting. Patients were then followed for eight weeks. Importantly, we looked at multiple endpoints. We evaluated what matters in clinical practice: graft take, healing, inflammation, adverse events, and surgeon experience.
We also measured the practical aspects that matter to hospitals, including preparation time, application time, and the cost of treating the wound. Taken together, these endpoints were designed to determine whether PermeaDerm could deliver comparable clinical performance while offering meaningful economic advantages over allograft. Collectively, 11 burn centers contributed data to the study and are listed here on this slide. The participation of multiple investigators across diverse institutions and patient populations help demonstrate that these findings are representative of real-world burn and wound care, rather than the experience of a single center. Turning to the results, the primary endpoint of the study was met. PermeaDerm reduced treatment cost by 70% compared with allograft, and that difference was statistically significant. If you look at the chart on the left, the difference is immediately apparent.
On a cost per percent TBSA treated basis, the mean cost was $148.70 for PermeaDerm versus $497.10 for allograft. For clinicians and hospitals, that's a meaningful result. It demonstrates that PermeaDerm can deliver the temporary wound coverage we need while substantially reducing the cost of care. Put another way, PermeaDerm reduced costs by approximately $348 for every 1% of TBSA treated, highlighting the potential economic impact in routine clinical practice. The workflow benefits were just as compelling as the cost findings. PermeaDerm reduced preparation time by nearly 96% compared with allograft. The reason is straightforward. Unlike allograft, PermeaDerm does not require tissue tracking, thawing, or meshing, so it's ready for use immediately. Once in the hands of the surgeons, application time was comparable between the two groups. The key question, of course, is whether those economic and workflow advantages came at the expense of healing.
Based on these results, the answer is no. Healing outcomes were highly comparable between the two groups. At one week following grafting, approximately 94% of PermeaDerm patients achieved at least 95% graft take, essentially the same as allograft. By eight weeks, all patients in both groups had achieved wound healing, demonstrating comparable progression to definitive closure. Taken together, these findings show that PermeaDerm delivered meaningful cost and workflow advantages while maintaining the outcomes surgeons expect when using temporary wound coverage. As these products are used in medically complex burn patients, safety is an extremely important part of the study. Reassuringly, there were no PermeaDerm-related adverse events, and overall, adverse events were numerically lower with PermeaDerm than allograft, including fewer study area events. Wound bed biopsies also showed no meaningful differences in inflammation between groups. Overall, these findings support the safety of PermeaDerm as a temporary wound coverage option.
Investigators and patients both reported high satisfaction with PermeaDerm, with 100% in each group rating it satisfied or very satisfied. This is an important practical signal, suggesting the product is well-tolerated by patients and easy to incorporate into a surgeon's operative workflow. The aggregate data we've reviewed is supported by what we observed in individual patients. This slide shows a comparative case example illustrating how PermeaDerm performed relative to allograft. These two patients were similar in age and had wounds with similar size, mechanisms of injury, as well as wound location. Following excision of these full-thickness burns down to fat, both wounds required temporary coverage before autograft placement. As you can see, both products provided effective wound protection throughout the first several days. An important difference, however, is that PermeaDerm is transparent, allowing the surgeon to directly visualize the wound bed without removing the dressing.
That visibility can make ongoing assessment easier while maintaining wound coverage, something that isn't readily available with allograft on the wound bed. At one week, the PermeaDerm and allograft were removed, and autograft was applied. The images on the right of the screen are eight week follow-up and demonstrate comparable healing outcomes. This representative case illustrates that PermeaDerm provided effective interim coverage in a manner that was clinically comparable to allograft, with the added practical advantage of visualization of the wound bed without removal of the product. Taken together, the data from the trial suggests that PermeaDerm delivered comparable clinical results with less workflow burden and lower cost. We saw comparable graft take and healing, no difference in safety or inflammatory profile, and high satisfaction from both surgeons and patients.
From a practical standpoint, PermeaDerm also simplified workflow by eliminating thawing, meshing, and tissue bank logistics while remaining easy to integrate into clinical protocols. PermeaDerm is also predictable as it comes in standardized configurations, unlike allograft, which can vary in size and thickness depending on donor and vendor. PermeaDerm is a synthetic product that is not subject to the supply constraints or donor availability limitations that can possibly be associated with cadaver skin. Economically, the product demonstrated a 70% reduction in product cost. Together, these findings support PermeaDerm as a temporizing option with meaningful operational and economic advantages. I will now pass over the presentation to Dr. Sharon, who will be talking about her clinical experience with the product.
Thank you, Dr. Saraswat. I have been familiar with AVITA through RECELL, and over time, I have come to appreciate the value of having options that support patients across the full wound healing pathway. In my practice, I start with the end in mind, building a plan around how I will prepare the wound bed, rebuild the tissue, and ultimately get skin on these patients and back to their lives. What intrigued me about PermeaDerm was its potential role as an alternative to allograft for temporary wound coverage. It gives me a practical way to assess whether the wound is ready for grafting or whether additional excision is needed. From an operative standpoint, reducing logistics in the OR and saving money for the hospital is always welcome. I will be sharing two cases from my practice with you today in which I used PermeaDerm, Cohealyx, and RECELL.
I will focus primarily on the PermeaDerm component, but also discuss the final outcomes for these patients. This illustrates how the AVITA portfolio can be used across the continuum of care in a patient with an extensive 45% TBSA area burn. Given the severity of the injury, it is clear from admission that definitive closure would need to occur in stages. That made temporary wound coverage an important part of the treatment strategy while we stabilized the patient and prepared the wound bed for reconstruction. These images are post excision of the wound, and PermeaDerm was applied as a temporary wound covering. Clinical assessment of this wound indicates a clean wound bed, and there were no signs of active infection. Unfortunately, with this patient, due to other injuries, there was a delayed time to first excision debridement, and the patient was at risk for infection and wound conversion.
One of the advantages I value most about PermeaDerm is its transparency. It allows me to directly visualize the wound bed without removing the product, making it easier to assess tissue viability and determine whether additional excision is needed. In this patient, that visibility proved valuable. It confirmed that portions of the wound converted and required further excision, while other areas had developed a healthy, well-vascularized wound bed. You can see on the arm how well vascularized the wound bed is, but that an area on the back needed additional excision. We then reapplied PermeaDerm following the re-excision of the back and left the PermeaDerm on the arm in place. Once the wound bed was optimized, we transitioned to definitive reconstruction.
Cohealyx was used to further support the wound bed, followed by a 6: 1 wide mesh split-thickness skin graft and RECELL together with cultured epithelial autografts to achieve definitive closure. The patient was discharged on day 48 with 98% wound closure, and these photographs at 71 days demonstrate an excellent overall outcome. For me, this case highlights how the AVITA portfolio can work together. PermeaDerm to protect and assess the wound during temporization, Cohealyx to optimize the wound bed, and RECELL to help achieve definitive closure. This is another example in which the full portfolio was used. The patient presented with 22% TBSA burns involving both lower extremities and the hand. After excision, PermeaDerm was used to provide temporary wound coverage while allowing us to determine whether any additional excision would be necessary before definitive closure.
One feature I would like to highlight is the PermeaDerm glove shown on the right. Hands can be particularly challenging to dress because of their complex anatomy. The glove conforms well to the hand, provides uniform coverage, and is much more efficient than individually wrapping each finger. After eight days of temporization, the wound bed was ready for definitive reconstruction. At that point, we proceeded with skin grafting and RECELL with Cohealyx to support the healing environment. Again, this illustrates how the products are used sequentially, with each serving a distinct purpose as the patient progresses through treatment. By 30 days, the vast majority of the wounds had healed, with only a few areas still open, which can happen following wide mesh autografting, especially over subcutaneous fat. Rather than leaving those areas to heal on their own, I applied small strips of Cohealyx to support continued closure and to fill defects.
This is an example of how I use Cohealyx beyond the initial procedure to help manage the final stages of healing when needed. At the 45-day follow-up visit, the patient was healed. There was some hyperemia, which is expected in the lower extremities, and this gradually dissipates over time. In my experience, PermeaDerm is a useful tool that allows me to temporize patients with confidence. In my experience, it is clinically predictable, easy to use in the OR, and straightforward for my staff to manage afterwards.
It helps me assess the wound bed in real time and gives me a clear path to proceed to grafting with confidence. I will now turn it over to Katie for final remarks.
Thank you, Dr. Saraswat and Dr. Sharon, for sharing your experience and walking us through the data. Taken together, the clinical study and these real-world cases reinforce three key themes: strong clinical performance, a simpler workflow, and a meaningful economic advantage. We believe those attributes position PermeaDerm as a compelling alternative to allograft and an important part of AVITA's acute wound care portfolio. We will now open the call for questions. I will be moderating today's discussion, and we encourage you to direct your questions to our surgeons on the study results, the clinical data, or their practice experience using PermeaDerm in burn care. Operator, please open the line for questions.
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from Ryan Zimmerman with U.S. Bancorp BTIG. He may proceed.
Hi, this is Izzy on for Ryan. Thank you for taking the questions. Dr. Saraswat, Dr. Sharon, thank you for the time today. I just wanted to start to pose a question to either of you, actually, but the study started with patients that have 30% TBSA. I was curious if you think the results that you have seen from the data would be able to generalize into larger burns.
Dr. Saraswat, do you want to go ahead and field that question?
Sure. I would be happy to. Just to clarify the question, you are asking can the product be used for burns larger than 30% TBSA?
Yeah. Do you think that the results are generalizable into burns above that 30% TBSA, and potentially, is there plans to study in that population?
The short answer is yes. This was the first study demonstrating the usefulness as an alternative to allograft. This is something that if, for a patient with a larger TBSA, we would absolutely use allograft to temporize the wound bed. I think it would be something that we could easily interchange with PermeaDerm. As PermeaDerm, we highlighted, has benefits compared to allograft, and it is easy to use.
Got it. Thank you.
Dr.
Oh, go ahead.
I was just going to ask if Dr. Sharon had any other comments to make.
I agree with Dr. Saraswat. I have actually used it personally on 45, 60%, 70% TBSAs and have had really good outcomes. I think it does translate.
Thank you. Just as a follow-up, are there any wound characteristics or potentially patient profiles where you would still prefer to use allograft over PermeaDerm, or any limitations to PermeaDerm in your experience so far? Thanks for taking the questions.
Dr. Saraswat, do you want to go ahead and answer first, and then Dr. Sharon, if you have any additional comments?
Sure. I was kind of running through my head all the reasons I would use allograft. Really, I cannot think of a situation where I would not use PermeaDerm instead, especially because, as Dr. Sharon highlighted, you can see right through it and evaluate the wound bed. You can oftentimes make decisions with a shorter timeline, with the ultimate goal of getting these patients grafted and out of the hospital and healed faster. I honestly cannot think of a limitation to this.
I would echo that statement. I quite honestly don't even use allograft anymore. I've predominantly transitioned to all PermeaDerm for temporization.
Thank you. As a reminder, to ask a question, please press star one one on your telephone. Our next question comes from Josh Jennings with TD Cowen. You may proceed.
Hi, good afternoon. Thanks for taking the questions and thanks for sharing all your insights, doctors. I wanted to just, I think you've answered this already, but just to formally put it on the tape. If costs were identical across the products, PermeaDerm and cadaveric allograft, it sounds like you'd still use PermeaDerm, and I think your answers in the presentation made that clear, but just to check that box.
Dr. Saraswat, do you want to lead and Dr. Sharon follow?
Sure. We've kind of both echoed the same thing, that it's a great product to use. allograft really doesn't have any advantages over it. The other thing I would add is that we have to keep a certain amount of allograft on stock, and that's just kind of predicting. Say we have several large burns that would use up that supply very quickly versus PermeaDerm. We don't have those type of supply constraints. There's a lot of frustration that is involved with allograft varying based on your vendor, and you can get different sizes, and you still have to put work into preparing the product before application. As surgeons, when we're trying to coordinate all the components in the operating room, we have to task somebody with, "Okay, you have to wait for this product to thaw, and then you have to unwrap it.
It's in multiple layers. You then have to mesh it." That's kind of expecting that the person that you're tasking that to knows how to do that properly. With PermeaDerm, it's very easy. It's, "We need this product. Please open it." Then you just kind of put your hand out and it's available. Again, I don't use allograft very often. I was happy to be part of the study, because it really does demonstrate the usefulness as an alternative to allograft.
Yeah, I think the ease of use, like Dr. Saraswat was saying, it comes in a variety of different sizes, and then it's just very easy. You pull it off your shelf, you apply it to the wound bed, it stretches. Even, I think, the largest is 15 by 30 inches. That's like, I'm not going to convert that right now. Like 72 by 30-something centimeters square. If you stretch it like it's supposed to be applied, that actually increases the amount of coverage you can do, too. So it's ease of use, and it can stretch beyond as far as centimeters squared coverage than what's actually on the product. So, it's pretty fantastic.
I appreciate those answers. Thank you. More than I had bargained for, but those are fantastic. Wanted to just ask about just whether PermeaDerm is doing something biologically different than cadaveric allograft. Just looking at the case presentation, it just looked like there's potential, and maybe there's some earlier data that's out there that was presented at prior burn meetings about earlier vascular ingrowth and maybe some more organized tissue formation and decreased inflammation that PermeaDerm is affording these wounds and potentially generating a healthier wound bed before the next step. Wanted to bounce that off of you, and I just have one more follow-up.
Yeah. I can certainly take that question. Part of the PermeaDerm study was that we actually did tissue biopsies of PermeaDerm beds as well as the allograft beds and looked at all of the components that you mentioned. We did not see any differences with what the beds were doing. But likely what you are seeing, especially in the clinical cases that were presented, is the fact that you can visualize the wound bed versus with the cadaver, you can't see what that wound surface looks like. I don't know, Dr. Sharon or Dr. Saraswat, if you have anything you want to add clinically with visualization of the bed.
But from a histological standpoint, that was something that was important for us to look at, and so we have that data as well as the clinical data that was presented today that we'll be sharing.
I think the only thing for me is the time to definitive closure. That is the difference in that regard. That may be related to closing that wound bed sooner. If you start to get skin or skin substitute process followed by skin, I'm doing that faster at that day three, day four of temporization, versus when I was using allograft, I was waiting a little longer. I don't know if that contributes to it or not, but.
Appreciate that. Then just lastly, AVITA today and prior to today has discussed with the investor community about RECELL, PermeaDerm, and Cohealyx as an integrated acute wound care platform rather than standalone products. It sounds like that platform approach is resonating with both of you, but from today's presentation and in your remarks. Just want to double back on that and make sure I'm interpreting your comments correctly. Maybe just share with us how much buzz out there that you've heard from colleagues at other centers or even within your own centers about this RECELL, PermeaDerm, Cohealyx platform approach versus standalone products and how AVITA can continue the momentum here with this portfolio approach. Thank you.
Dr. Sharon, do you want to lead off this one?
Absolutely. I'm not going to say I have converted 100% to Cohealyx as my every single time I need a skin substitute, it's my go-to. But I can say it is 85% of the time. What do I mean by that? I think it is a great combination, PermeaDerm temporization, Cohealyx for skin substitute, if there's any subcutaneous fat exposure, and followed by skin graft and RECELL. In that continuum, why do I choose to do that? Cohealyx is somewhat incorporated into the wound bed about day three. I'm finding no later by day eight, day nine, I'm ready to put skin. If I can temporize for three days, if there's any elements of fat, I put Cohealyx.
I'm ready for skin grafting and definitive closure at worst case scenario, day 10, which for me, you're talking about length of stay, definitive closure, improved scarring and contracture. The faster I can get somebody healed, the better long-term outcomes are, and getting patients out of the hospital. The wound care for Cohealyx, in my experience, has been very easy for my staff. I have a protocol. We follow the protocol. It's not labor intensive. It conforms to the wound bed. It makes axillas, necks, joint spaces, things that are very difficult to get other skin subs to stick to. It's fantastic, in my opinion. There are some wound beds that I don't put Cohealyx on, but that's another conversation for another day, like my contracture releases, for example. But I think it is a great portfolio, a great overall wound augmenter.
Sometimes may have to reapply, but I think any product does that. I've done a lot of burn cases with all three, and I've had a significant decrease length of stay overall since I transitioned to doing majority of Cohealyx.
Dr. Saraswat, do you have anything that you would like to add?
I would just quickly add that almost all of us, as a surgeon, we create some sort of pathway or algorithm in our mind, depending on what type of burn we're dealing with. There's so many factors that go into the characteristic of the burn. The main thing is it a complex deeper burn or a large burn? Or is it a simple burn where we can immediately go into autografting? In terms of looking at the full complement or the portfolio that's available through AVITA, all three components would be something that we would, thinking about our flow sheet or algorithm in terms of what are we trying to cover, we would use the three distinct products kind of all together and integrated within our workflow because it covers these complex wounds.
The only time we'd want to temporize a wound is any number of reasons of why it would make it complex. It's a large TBSA, it's a deeper burn. We're not sure how viable the wound bed is. Usually that's the case when it's a deeper burn. So the PermeaDerm will help temporize it. As Dr. Sharon said, we can then quickly turn around and apply a dermal substitute, which would be Cohealyx. Cohealyx is not a product that needs to stay on for three to five weeks, which is advertised with other dermal substitutes that are on the market. Then finally, RECELL. RECELL we use for a full rainbow of different issues for patients. But for the complex patient, for the large TBSA, it's a very easy go-to for many people across the country.
In thinking about the type of wound that you would want to use each product for, you'll find that you kind of would use all three of them for the same type of patient.
Really appreciate those answers. Thank you.
Thank you. That concludes the Q&A session, and this concludes the conference. Thank you for your participation. You may now disconnect.