Thank you for standing by, and welcome to the AVITA Medical Cohealyx KOL Investor Webinar. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star one one on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star one one again. As a reminder, today's program is being recorded. Now I'd like to introduce your host for today's program, Ben Atkins. Please go ahead, sir.
Thank you, and welcome to the AVITA Medical Cohealyx Key Opinion Leader Webinar. Today, we will be reviewing an interim analysis from our Cohealyx-I study, which evaluated time to autografting against a literature-derived performance benchmark. 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 3 for additional details. It's now my pleasure to introduce our speakers. Joining us today are Dr. Derek Bell, Professor of Surgery and Burn Director for the Kessler Burn Center at the University of Rochester Medical Center, Dr. Lourdes Castañón, Clinical Associate Professor of Surgery and Director of the Burn Program at Banner – University Medical Center Tucson, affiliated with the University of Arizona College of Medicine, Cary Vance, Interim CEO of AVITA Medical, and Katie Bush, Senior Vice President of Scientific and Medical Affairs.
We'll begin today's discussion with opening remarks from Cary Vance. Cary, over to you.
Thank you, Ben. Acute wound care today is complex and resource-intensive. Patients often require multiple procedures over extended periods, and variability in the path to closure can drive longer hospital stays, higher complication risk, and increased cost. At AVITA, we are a hospital-based acute wound care company. We are focused on a concentrated set of burn and trauma centers where we have deep relationships and a consistent clinical presence. Growth in this business is driven less by adding new accounts and more by increasing utilization within the accounts we already serve, the same clinicians using our products across multiple patients over time. That's the foundation of our strategy. Built on that is our portfolio of three complementary technologies. RECELL, our spray-on skin technology, which enables skin regeneration at the point of care. Cohealyx, a dermal matrix that prepares the wound bed, and PermeaDerm, which protects and stabilizes the wound.
Individually, each of these products has clinical value, but the real strength is how they are used together on the same patient by the same clinician, optimizing the full healing pathway from wound bed preparation to dermal repair to skin coverage. The goal is straightforward, accelerate progression to closure and healing, what we call at AVITA, healing at the speed of life. That matters clinically, but it also matters economically, improving hospital workflow, reducing length of stay, and lowering cost of care. As we look at that pathway, one of the key bottlenecks remains wound bed preparation. Delays at that stage extend care and increase risk. That's where Cohealyx is designed to play a role, enabling faster, more reliable progression to grafting. Where we continue to see a bottleneck today is in preparing the wound bed for closure.
Delays at that stage drive prolonged care, higher risk, and increased resource utilization. That's exactly where Cohealyx is designed to play a role, enabling faster, more reliable progression to grafting. Today, we'll share early data from our Cohealyx-I multi-center study, including an interim look at time to grafting. As we improve that step, we also expand the opportunity to utilize our broader portfolio, increasing value per patient, and strengthening our leadership in acute wound care. With that, I'll turn it over to Katie.
Thanks, Cary. Before we get into the data, I do want to take a moment to ground everyone in a key concept that underpins the Cohealyx-I trial. In the treatment of deep injuries, a skin graft is used on the injury site, which originates from a donor site on the patient. This skin graft has limited vascular supply, and in order for it to successfully take, the wound bed has to be properly prepared. It needs to be vascularized, it needs to be stable and ready to support that graft. If that doesn't happen, the graft will not take, and the wound will not heal. In practice, the preparation of the recipient site or optimization of that site is often what drives a delay in treatment.
While skin grafting is a standard and effective approach for wound healing, the rate-limiting step is getting the wound bed to a point where grafting is actually possible. What we've seen consistently across our ReCell clinical trials, published data, and real-world use is that clinicians are trying to solve the problem of wound bed optimization with dermal matrices. In fact, more than one-third of patients in our ReCell trials and over 40% in published data sets receive a dermal matrix as part of their treatment. The need is clear, but limitation of current solutions is time. In a meta-analysis review of literature, time to grafting with dermal matrices averaged approximately 33 days. That delay has real consequences, including increased risk of complications, longer hospital stays, and overall higher cost of care. That's the problem Cohealyx was designed to address by enabling faster progression to grafting.
Our approach with Cohealyx has been to build evidence in a stepwise, data-driven way. We started with preclinical work, followed by clinical case series and real-world experience. Now with the Cohealyx-I multi-center clinical trial, we're generating higher quality clinical evidence. Across each of these stages, we've seen a consistent signal, a meaningful reduction in time to grafting. In the interim analysis of Cohealyx-I, we are seeing a significant decrease in time to grafting compared to the objective performance goal based on currently used dermal matrices. At this point, I think it's most valuable to hear directly from the surgeons who are using Cohealyx in practice and who participated in the trial.
Dr. Derek Bell, a burn, plastic, and reconstructive surgeon from the University of Rochester Medical Center in Rochester, New York, and Dr. Lourdes Castañón, a burn and trauma surgeon from the University of Arizona, Department of Surgery, and College of Medicine. They'll walk through their clinical study experience and how this translates at the bedside. With that, I'll turn it over to Dr. Bell and Dr. Castañón.
Thank you, Katie. As Katie mentioned, there's a clear need in clinical practice for better solutions to prepare the wound bed and get patients to closure more efficiently. That's what led to this multi-center study evaluating Cohealyx with full-thickness wounds. I've previously worked with AVITA on prior RECELL studies, and I was particularly interested in utilizing this Cohealyx study because this is a real barrier in getting our patients to closure in a timely manner. The goal of this study was to evaluate the ability of Cohealyx to advance wounds to the preparation and readiness stage for closure. The study enrolled patients across 20 centers, including many high-volume verified burn centers, which gives us this data set that reflects our real practices within our country.
The Cohealyx-I trial evaluates Cohealyx with a standard two-stage treatment approach consistent with how we manage many of our full-thickness burns. I often utilize a two-stage approach with my patients with a variety of different acellular dermal matrices in doing so. In this study, the primary endpoint was the time to skin grafting. Essentially, how quickly can we get this patient from its initial treatment stage to the time of closure? Cohealyx was first applied to the wound bed, and once the wound is ready, then the patients proceed to definitive closure with split-thickness skin grafting, often in combination with RECELL. This is a critical milestone. The faster we can get the closure, the better the service for the patient. We evaluated this against the literature-reported mean of 33 days, with 28 days being the lower bound of the confidence interval representing the objective performance goals.
This benchmark was established based on published data currently utilized with different dermal matrices, including but not limited to PolyNovo BTM, Integra, and MatriDerm. These are many of the products that we use in our practices. These studies were selected because they have sufficient published data to establish a reliable, evidence-based benchmark, which serves as a meaningful reference point for how patients are typically managed. The study includes a broad patient population without restrictions to patient condition or wound size, which makes the findings highly predictable to our everyday practices. In addition to time to grafting, the study also evaluated time to healing, scar outcomes, and of course, the safety profile, which is important in any studies. Again, our targeted patient population was acute full-thickness wounds that required staged procedures without limitation to size, with endpoints being wound healing, scar assessment, and safety.
This slide summarizes the primary endpoint, which is the time to skin grafting. We see from this that there's a clear reduction compared with the meta-analytic control. The mean time decreases from 33 days with control matrices to 13.6 days with Cohealyx. This difference is almost 20 days, three weeks, essentially. This magnitude is significantly meaningful. The reduction in time by nearly three weeks significantly changes the course of patient care, including the risk of complications and overall utilization of our resources. The faster we can get our patients healed, the better it is for the patients because it mitigates risk of infection, mitigates utilization of resources within our community with prolonged wound healing, nursing, time in the hospital, et cetera. Looking beyond the mean, the median time was 11 days, which reflects where most patients are falling.
This suggests that there's an effect that's not driven by a small number of early cases, but is pretty consistent across our cohort. The earliest time to grafting that we saw was five days. The P value was less than 0.001, which indicates that this is clinically and statistically significant data. This is a great slide. Building on our earlier time to grafting results, it shows how this translates across our entire cohort. Most of the patients were grafted within a relatively tight window. About 72%, or three-quarters, were grafted within 14 days, 25% of those patients were grafted within the first week. This isn't just an average effect. It reflects how the majority of patients are progressing throughout the study. There's a clear clustering in the 7-14-day range, which aligns with the median of 11 days.
This consistency is important as it suggests a predictable pathway rather than just a few early responders within the study. There are some outliers, which is expected, and this reflects what we see in our clinical practices. This may be reflective of some patient-specific factors, patients that may be more sick or have more complex wounds. This is not surprising. Overall, this reinforces that there's a consistent and accelerated timeline to grafting for this subset of patients. Beyond just the clinical outcomes, this reflects that the investigator experience is pretty good across the cohort. The satisfaction of the investigators was 90% either being satisfied or very satisfied. None of the responders were very dissatisfied, and only 10% were either dissatisfied or neutral. This suggests that the experience with the product is reproducible across the patients, and it isn't just limited to a subset. Satisfaction is not just subjective.
It reflects how the technology performs in routine practice, how this integrates with our workflow, and whether this is consistent in its results. When investigators are consistently satisfied, they're more likely to continue to use this product and incorporate this into our practices. This is something you need to think about when utilization across many centers throughout this country. This is my first patient I utilized in this trial. It's a 62-year-old gentleman who had flame burns to his trunk. Total surface area was almost 500 sq cm. He also had a history of COPD. Here he is at presentation. Upon entrance into the operating room, he had third-degree burns throughout the majority of this area.
The area that you're looking at is his right torso, with his head and shoulder to the right, and his hip to the left. Here he is after excision. You can see that there's a healthy appearing wound bed that's going to be accepting of the graft. Here's the application of the Cohealyx. I affix it along the perimeter sparingly using skin staples and then moisten the product with saline so it conforms to the wound bed uniformly. You see that small red dot in the middle? It's a biopsy site for the study. Here's this patient at 11 days, and he's determined to be appropriate for autologous grafting. You can see that there's nice granulation tissue throughout the majority of the wound bed.
I know that this is going to be ideal for accepting a graft. I put split-thickness sheet grafts on him. The reason why I roll up is because the residents tend to put the grafts upside down. These are split-thickness sheet grafts, extremely thin, 0.004 of an inch. There they are applied to the wound bed. I affix them further with a wound vac. Here's the patient 7 days post-op. After the vac takedown, you can see his excellent adherence to the grafts throughout. Here he is at 14 days post-op, and you can barely discern that this patient was even grafted. At 8 weeks post-op, you can see the majority of this is the same color and consistency as the unburned skin. He has some areas that are a little bit hyperpigmented. However, this is smooth, soft, and supple. He has a fantastic result.
What are the key takeaways? First, Cohealyx serves as a dermal matrix. We're optimizing the wound bed prior to grafting, which is translating to shorter times to definitive coverage compared to our historically published controlled acellular dermal matrices. Secondly, our primary endpoint is designed to capture efficiency and how quickly these patients progress to closure. This is clinically meaningful. In this study, the investigators were satisfied or very satisfied with the quality of the wound and the time to grafting with the Cohealyx. Now I will be passing this over to my good friend and colleague, Dr. Castañón, who will discuss her experiences with Cohealyx. I thank you for this opportunity.
Thank you, Dr. Bell. At our center in Arizona, we treated four patients, and I will be presenting on our initial experience. This was a 55-year-old male with an upper leg wound with a necrotizing soft tissue infection, or NSTI. The patient underwent surgical excision to healthy margins, followed by Cohealyx placement. It is important to note that this patient was critically ill. Their comorbidities included heart failure, cirrhosis, obesity, all which are known factors to delayed wound healing. Clinical progress was monitored, and you can see the incorporation of Cohealyx six days following application in the leftmost image. On postoperative day 13, the wound bed appeared red, vascularized, and suitable for skin grafting. In addition to the clinical observations, we conducted histological analysis to better understand what's happening in the wound bed prior to grafting.
At day 13, a small sample was biopsied from the center of the wound bed.
What we see is the formation of dermal-like tissue layer consistent with the proposed mechanism of action of Cohealyx, supportive of effective graft preparation. Importantly, these findings align with the preclinical data, giving confidence that the product is translating as expected into the clinical setting. Here we can see the outcomes for this patient on the left at 12 weeks post-skin grafting, having favorable skin graft take, cosmetic outcome, and durability. Overall, my takeaways from my experience with Cohealyx to date include one, it supports progression to skin grafting within clinically meaningful time frames. Two, across both the trial and my clinical practice, I am seeing consistent performance in a range of complex patients with time to grafting beginning to trend below the median observed in the study, as I am getting more comfortable with what this product can do.
Thank you to Dr. Bell and Dr. Castañón for sharing both the interim data and their clinical experience with Cohealyx. This slide outlines how we're building and communicating the data set over time. We begin with early readouts in 2026, sharing single center results and histology to establish initial clinical signal. With the interim analysis, we're now incorporating these data into abstracts for upcoming conferences throughout the year. In October of this year, the full data set will become available, and from there we will expand to multi-center presentations at major conferences in 2027, covering safety, efficacy, and broader scientific validation. In parallel, we're targeting publication, providing peer-reviewed validation of the data. Overall, this strategy allows us to communicate the data from initial readouts through full validation. With that, I'll hand it back to Cary to provide some closing remarks.
Thanks, Katie, and thank you to Dr. Bell and Dr. Castañón for your insights and for sharing your clinical experience. Let me close with a few key takeaways. First, Cohealyx is addressing a critical step in the pathway. We are redefining wound bed preparation with faster, more predictable progression to grafting. Second, the interim data support both the clinical performance and the commercial potential of Cohealyx. This is not just about outcomes, it's about how those outcomes translate into real-world use. Third, we're seeing strong surgeon satisfaction, and that matters because adoption in this market is driven by clinical confidence and repeat use within existing accounts. Finally, this drives greater value per patient. It reinforces our procedure-based platform with clear milestones ahead as we continue to build the data set and expand visibility. Stepping back, what this reflects is progress.
Progress in how we support clinicians, progress in how we improve patient care, and progress in how we build a more valuable, more integrated acute wound care platform. With that, let's open the line for questions.
Certainly. Our first question for today comes from the line of Ryan Zimmerman from BTIG. Your question please.
Good afternoon, and thanks for taking the questions. Can you hear me okay?
Yes. Hi, Ryan.
Great. For the physicians on the call, I appreciate you guys sharing your experience with us. Maybe the first question, I'll ask both upfront, but the first question, just why have traditional dermal matrices taken longer in your view, and what's unique in your view about Cohealyx that enhances that time to skin graft? The second question I'll ask upfront is, historically, AVITA has been a one-product company, right, with the RECELL device, which has been very effective in burn care. Now with Cohealyx and PermeaDerm, there is more potential to use those in conjunction with the RECELL device. But I'm just curious if you foresee using Cohealyx for all the cases where you would use a RECELL device, and just how to think about the utilization of these additional products in conjunction with the RECELL device. Thanks for taking my questions.
Thanks. This is Derek Bell from Rochester. To answer your first question, I think that in my hands the reason other products have taken longer to integrate is in part their composition. A lot of these products is consistent with the 33 days, and I think that the time to vascularization just takes a long period of time. With other products, I have tried to push the envelope and graft them sooner than three weeks, and the grafts fail. I don't think that they incorporate and imbibe and establish angiogenesis and vascular ingrowth as readily as Cohealyx does.
Great. The second question.
I have changed my practice. I've had experience with a couple different ones. What has changed for me is the early incorporation onto the tissue. I've been using it in combination with RECELL, and four-to-one grafting. I will say with the combination of both products, I no longer do a two-to-one, three-to-one graft. I've been, for the most part, doing a four-to-one with RECELL on top of the product, and we've had really great results. For us, length of stay is a big issue. We are one of two centers in Arizona, and we have a high volume. For us, we want to get them out of the hospital as soon as possible. This combination goes along with our practice, getting them out of the hospital as soon as we can.
Just to follow up, do you anticipate for all of the burn cases you're using a RECELL today or is there a size limit or a TBSA threshold you think about using Cohealyx and PermeaDerm or Cohealyx, either one, relative to maybe the size parameters you use the RECELL device for?
I'll be honest with you, I've been experimenting since I started playing with the product, and I have pretty much applied it in different locations. We've had a couple of areas, for example, traditionally, the hands or the feet tend to have much thicker skin, and I would opt for a dermal matrix that's a little bit heavier. We have had some cases where we had an avulsion of a finger, and it worked really nicely. There are other sensitive areas such as the dorsum of the hand or the face. We've had a couple face cases just recently, and it accommodates. Like I said, I've been kind of pushing, and this is only my experience with the cases that I've been working. I've actually stacked the product and was able to gain a little bit more of a height using it.
It's very versatile in the sense that it, because it absorbs quickly, I'm able to visualize what it's going to look like and I'm able to stack, so I'm able to better contour it to the wound. Yeah, at least in our practice, we've been using that a lot more than any of the other products since we started.
Thank you. Appreciate it.
Thank you. As a reminder, ladies and gentlemen, if you have a question at this time, please press star one one on your telephone. Our next question comes from the line of Frank Takkinen from Lake Street Capital Markets. Your question, please.
Great. Thank you for taking the questions, and thank you all for the great presentation. I was hoping to start with one maybe a little outside of it or I guess related to the clinical side, but a little bit outside of it. One key barrier to adoption is consistently VAC committee approvals. I was curious if each of you could speak about that process at your respective sites. At the risk of having you kind of theorize for other VACs and understanding they're all unique, do you feel the current clinical data as well as today's data is enough to start having more standard of care level VAC approvals across the greater industry?
Thanks for the question, Frank. For me, I think that we have a pretty stringent VAC committee. I think for me, being part of the trial and be able to corroborate this data, in conjunction with people at other burn centers that I know well, I know that this data is legitimate. I think for me, that helps to get the product through the VAC committee as well. I think the price point on it is always a sticking point with our VAC committees. I think the price point is good and that it's far better than that of other products that are lesser quality products for the reasons I stated.
I can add to that we recently had to go through the Lumere process, and for us, we're part of Banner, so we're in multiple states. If we approve a product, it's approved on multiple hospitals within the system. It helped us that we were part of the study because we were able to review our data with the committee. They keep track of all this information, so they were very impressed. We had no issues attaining that. Yes, the data that's out there, the experience that we're having with it is very positive and is being very well received.
That's helpful. Then maybe just one last one, and thank you again. Is there a reason to still use other dermal matrices in light of today's data, and then obviously the price point, Dr. Bell, that you recently referenced? Then maybe one last one I'll sneak in there, too. Any other data that is on your wish list for Cohealyx as you think about adoption?
I think that in using other products, I think that the needle is going to swing for me. I think that those other products will probably go by the wayside. I think the product is very good because it conforms nicely as well. In some of these wounds it can be really challenging because of the concavities. I think that it's a benefit as well. I don't see limitations in its usage, and I think other products will go by the wayside.
For us, it goes along with our workflow. Like I said, we have a very large focus on length of stay in our cost center, and it works really nicely in terms of integration and early discharge. It is a product that you could actually see incorporating almost immediately. Even identifying if it's working or not working is very easy to identify early on by our staff. We're training our staff to identify this. We have a relationship with our LTAC, so that helps with our length of stay as well. They are aware of what the product should look like. The fact that it incorporates quickly, you know if it's working or not.
It certainly does help significantly, as opposed to other products where you have to wait anywhere from 3-4 weeks before you even consider putting a skin graft on it, just because it takes time for it to fully granulate and be a good wound source for a skin graft.
Great. Thank you, guys.
Thank you. As a reminder, if you do have a question at this time, please press star one one. This does conclude the question and answer session of today's program. I'd like to hand the program back to Cary for any further remarks.
Thank you, operator. We appreciate everyone's time and attendance and engagement today. We're really excited about what we're doing at the company. We're really appreciative of Dr. Bell and Dr. Castañón, and we look forward to speaking to you all next month when we announce our Q1 earnings and having further discussion. Thank you. Have a good evening.
Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.