Avita Medical, Inc. Common StockRCEL
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Avita Medical, Inc. Common Stock KOL event

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Operator

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 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. I would now like to hand the conference over to your speaker today, Ben Atkins, Vice President of Investor Relations at AVITA.

Ben AtkinsVP of Investor Relations

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 3 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.

Katie BushSVP 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.

Katie BushSVP of Scientific and Medical Affairs

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.

Katie BushSVP of Scientific and Medical Affairs

Today's data builds on that body of evidence, complementing the recent interim results from our multicenter Cohealyx-1 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.

Katie BushSVP of Scientific and Medical Affairs

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.

Katie BushSVP of Scientific and Medical Affairs

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.

Anju SaraswatAssistant Professor of Surgery

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 8 weeks. Importantly, we looked at multiple endpoints. We evaluated what matters in clinical practice: graft take, healing, inflammation, adverse events, and surgeon experience.

Anju SaraswatAssistant Professor of Surgery

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.

Anju SaraswatAssistant Professor of Surgery

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.

Anju SaraswatAssistant Professor of Surgery

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.

Anju SaraswatAssistant Professor of Surgery

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.

Anju SaraswatAssistant Professor of Surgery

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 8-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.

Anju SaraswatAssistant Professor of Surgery

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.

SharonBurn Director

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.

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