Welcome to the AVITA Medical Acute Wound Care Showcase 2025. As you would expect, we will be making forward-looking statements during today's presentation. Near the end of our program, we will host a Q&A session. If you have a question at any time during the webcast, simply click the Ask a Question link located at the top right corner of your webcast player, type your question, and hit Submit. Now, let's get started.
Welcome to the AVITA Showcase, where we're transforming AVITA, and our theme is healing at the speed of life. We've put together this program to help our investors, our analysts, our employees, and shareholders get a deep look at the mission and the new AVITA. We previously described ourselves as a regenerative tissue company. We have transformed how we describe ourselves as a therapeutic acute wound care company. Now, the words here are rather important. Therapeutic, what does it mean? It means we cure. We're not doing something palliative. We're not doing chronic wounds. We're doing acute wounds. An acute wound might be a burn. It might be from an industrial accident. It might be a gunshot wound. It might be from a car accident.
Those full-thickness wounds are the patients that need our products and will benefit from them by having what we thematically believe is products that heal faster, which have the benefit of getting the patient home to their family sooner, have the benefit of giving the doctor more time to treat more patients, and make the hospital more efficient. AVITA is transforming to a multi-product platform company. That said, the products that we're developing and that we're introducing and we're going to share with you today are used on the same wound, the same patient, by the same doctor, and the same hospital, and thematically have an objective, which is to speed the time to heal and to get the patient home with their family as soon as possible. Length of stay is one of our most core values and outcome expectations.
When you look at AVITA historically, we've had a proven growth trajectory. We've treated over 30,000 patients. Over the period of treating those patients, we've grown at a compound annual growth rate of 47% over the last five years. The expanded portfolio is really critical. An incredible amount of leverage is created by the fact that our sales rep, who sits with RECELL, our first and only in-category product, has the opportunity to add a lot of value to the treatment of that patient. Now, when does this all come together? It comes together April 1st, 2025, which has hit. We're in full launch of all these products. You're going to hear from patients whose lives have been changed. You're going to hear from Dr.
Katie Bush, who's the Senior Vice President of Medical Affairs, as she shares with you the breadth of scientific clinical evidence that we've built. We couldn't be more excited to be here today, and we hope you enjoy the program. AVITA Medical has become a therapeutic acute wound care company. In the last five years, you can see that not only have we grown at a compound annual growth rate of 47%, but in fact, this year, we expect to cross over into profitability on a GAAP basis in Q4. Let's talk about the product portfolio. Let me start with what I call the castle with the moat. The castle with the moat is RECELL technology. For another company to create and just duplicate what we've done with RECELL, it would take five years to get to that regulatory approval and tens of millions of dollars.
RECELL is unmatched, first and only in the category product. We have RECELL. We have RECELL GO. Now we have RECELL GO mini. With RECELL GO mini, why did we do it? The difference between RECELL, the traditional size, and RECELL GO mini is the amount of total body surface area treated. Standard RECELL or standard RECELL GO treats 10% total body surface area. RECELL GO mini treats 2.5% total body surface area. In fact, the difference in market opportunity is dramatic. There are 35,000 patients a year that need 10% or greater treatment with RECELL or RECELL GO. There are over 270,000 trauma injuries that are smaller than 480 sq cm, which is 2.5% total body surface area.
That moat gives us a place where we're adding value to the treatment, the physician's efforts to save that patient's life, and the hospital's effort to manage that patient's treatment to get out of the hospital sooner. It gives our organization, our people, a proprietary place in the operating room and in the practice of healing that patient. What we're now doing is we're building and diversifying the products that same patient needs, that same wound needs, that same doctor needs to treat that patient and get them home sooner. Let me talk about them for a second. PermeaDerm is a dressing. It's used primarily as either a temporizing treatment or as a treatment over the RECELL split-thickness skin graft combo. It's unique. It's transparent. It's got adjustable microporosity. Cohealyx is a dermal matrix. It is used for revascularization of a very deep wound. It's a collagen-based matrix.
It has very unique qualities, which you're going to see today. Cohealyx gets the patient graft ready as much as 7 days-14 days faster than other competitive dermal matrices. When you combine those two, that patient's going home sooner. What we're really doing and what we're talking about here is building out our acute wound platform, leveraging the know-how of our field commercial team. You're going to see how we got here. You can see the dermal matrix. You can see RECELL in the middle, and you can see dressings. Those are, from a macro point of view, the biggest segments. There are other product areas that are needed for us to deliver the full solution, and we're working on them. When you think about our future, where are we going? We're going to areas like wound bed hemostasis to stop the bleeding.
We want antimicrobial added to some of our products, like adding them to the dermal matrix or adding them to PermeaDerm to either prevent or treat an infection. Wound depth assessment matters. We're working on that. Of course, the big one, scar after the fact. We want to find ways for that healing to produce very low scar tissue. When you see us today, we've transformed into a therapeutic acute wound care company. What we did is we're gathering the areas of other products and technologies that the physician needs to treat that same patient, that same wound, and get them home sooner. Let's take a look at what this means economically. When you use all of these products, and we're going to use a 10%-20% total body surface area example, because that, on average, is what we end up treating.
Go to the full-thickness wound on the right, and you can see that if you use two RECELL kits into that case, it's as much as $13,000. That's two RECELL kits. However, if you have up to 4,000 sq cm of dermal matrix and you have up to 4,000 sq cm of dressing to cover, it can yield $57,000 of revenue from the case, which is, from a total available market point of view, it's dramatic. When you put all this together, we were a $455 million total available market or TAM in burns only. Then we broadened to trauma and all the skin grafts that need to be treated there, and that market opportunity became $1.3 billion. Then we added dermal matrix and the biosynthetic dressing of PermeaDerm. Now, in the U.S., we have a $3.5 billion total available market or TAM.
We do all this, by the way, not having added virtually any headcount this year and do not plan on adding it next year. As I mentioned earlier, core to our values is the science. Core to our values is the clinical studies that we do, the podium presentations that get made, the abstracts that get submitted, and from all of the possible clinical evidence we can create. That is a typical event for us. It comes from our orientation and culture. Most specifically, it is led by our Senior Vice President of Medical Affairs, Dr. Katie Bush. She is now going to share all of that with you.
Hi, my name is Dr. Katie Bush, and I'm the Senior Vice President of Scientific and Medical Affairs at AVITA Medical. Today, we're going to be talking about the AVITA Medical portfolio. I'd like for you to imagine surviving a severe burn injury on both of your legs. Now imagine experiencing a large, painful wound on your back created to treat your injury. This is the reality of skin grafting. For many patients, the healing journey can be just as traumatic as the injury itself. At AVITA Medical, we're changing that reality.
2018, I had a really sharp pain in my left armpit. It started to turn into flu-like symptoms. The pain was there, but then I started to have fever and just started to feel really ill. I went another 24 hours, went to another doctor. That doctor, after listening to my symptoms, said, "Okay, we've got something internal. We need to send her straight to St. Joe's ." When they removed the bandages, it was all purple and blistery, and they realized it was necrotizing fasciitis. I was rushed into surgery, and after all of their debriding and trying to figure out where all the dead tissue had been, I had lost 30% of my soft tissue. I did survive, obviously, and I was put into a medically induced coma. They had to do several surgeries in the next few days to debride the dead skin cells.
At that point, they decided to go ahead and send me to the Arizona Burn Center. I was there for about two months. Due to that significant size and my stubbornness to really want to get home, my surgeon and doctor thought that I was actually a prime candidate for RECELL. I cried when they came into my room and said, "You were given permission for this amazing treatment." I thought, "Oh my God, I'm so lucky." The number one benefit was it helped me heal faster. I mean, I definitely had a lot of setbacks in my healing, and it definitely helped me move so much more forward so that I can get home to my children when I was in the hospital. That was my number one goal. I had to get home.
Our technologies are reshaping what's possible in acute wound care, helping patients heal faster with less trauma and getting them back to their life sooner. It began with our flagship product, RECELL, and with our growing portfolio, we are now able to offer a solution of products to support more patients and in more phases of their healing journey. This includes PermeaDerm, a temporary biosynthetic dressing, and Cohealyx, a collagen dermal matrix. Year- over- year, we continue to grow our body of evidence on the clinical effectiveness of our products. This expanding evidence base reinforces our market credibility. It supports our commercial growth and highlights real-world value that we deliver to our patients, clinicians, and payers. Now let's talk about the RECELL advantage. For decades, traditional skin grafting has been the standard of care for deep acute wounds.
While effective, it's highly invasive, it's extremely painful, and it's often limited by how much healthy donor skin is available. What many people don't realize is that the donor site itself can end up being more painful and problematic than the original injury, especially for those with comorbidities limiting their healing capacity. RECELL is changing the paradigm of grafting. Instead of taking that large section of healthy skin, RECELL requires only a small sample. This sample is processed using the RECELL device into a sprayable suspension of skin cells, which is then applied directly to the wound bed. You can think of it like reseeding a lawn rather than laying down rolls of sod. Tiny cells are sprayed across the area where they rapidly repopulate and regenerate the skin, encouraging healing from within as well as the wound margins.
The RECELL system is designed to be used at the point of care, eliminating the need for external labs. That's a major advantage compared to other cell-based approaches, which require off-site expansion, increasing both cost and time to treatment. Across three pivotal randomized controlled trials, we've demonstrated skin sparing of up to 97.5%. In our first pivotal study of over 100 patients, we found that 1 sq cm of donor skin was sufficient to treat 80 sq cm of injury. To put that into perspective, a skin sample the size of a business card could treat my entire back. The benefits do not just stop at skin sparing. We've also observed faster donor site healing and significantly less pain compared to traditional skin grafting. Also, the cosmetic outcomes at the RECELL donor sites in these studies were significantly better than those seen with traditional skin grafting.
You can see this in the clinical image on the right of a patient in our trial. The same patient had a donor site used for RECELL and a donor site taken for the traditional skin grafting technique. I think you know which one you would choose for yourself or a loved one. Beyond the significant reduction in donor site burden, positive clinical outcomes have been achieved using RECELL across multiple wound sizes as well as etiologies. Data shows that when RECELL is incorporated into treatment, healing can occur and be accelerated at the cellular level, and return of repigmentation is clinically meaningful as well as meaningful for that patient. The case shown on this slide illustrates the visible difference in healing and cosmetic outcomes when comparing traditional grafting to spray on skin for the treatment of a partial thickness burn.
The results demonstrate excellent healing and skin repigmentation, and in the RECELL group, without the meshed appearance. From a health economics perspective, the benefits are just as compelling. Incorporating RECELL into burn care protocols has been shown to significantly reduce hospital length of stay, and published data supports an average cost savings of $37,000 per patient for those with less than 50% total body surface area burn injuries. Now, I would like to introduce you to Dr. Jeffrey Carter to share his experience with you using RECELL to treat burn injuries.
My name is Dr. Jeffrey Carter. I'm the medical director at University Medical Center of New Orleans, and I'm on faculty at Louisiana State University. The case is a 31-year-old female who suffered burn injuries to her face and to her airway. She required intubation and ventilatory management for her airway injury. As for her face, we initially proceeded with excision and placement of autologous skin cell suspension using the RECELL kit. After about six days, her face was closed, meaning that the wound was initially healed. Over the following weeks, she began to repigment. When you look at the photos, you'll notice that she has retained organic movement of her face and is doing well today.
Thank you, Dr. Carter. Now I would like to talk with you about PermeaDerm, which is a biosynthetic dressing that replicates the function of lost epidermis until healing occurs. The features of PermeaDerm make it a versatile dressing for use across various wound types and stages of wound care, from donor sites and partial thickness injuries that heal after PermeaDerm is placed to wounds that have been treated with RECELL and also as a temporizing dressing following surgical excision of necrotic or devitalized tissue before a skin graft can be placed. The dressing can be used in all of these types of wounds based on its unique bilayer structure. The outer layer provides protection from bacteria and trauma while allowing oxygen to pass through to the wound bed at a rate that's similar to natural skin.
This is critical for promoting cell growth, protein synthesis, blood vessel formation, and ultimately healing. That precise oxygen permeability is what inspired the name PermeaDerm. The inner layer includes a 3D micro support matrix that is coated with a bioactive compound that enhances wound adherence and supports the healing process. The innovative design of PermeaDerm provides simplicity and results in clinical success. PermeaDerm is a conformable and flexible material that is extremely easy to apply. This means fast application in the OR or bedside, which enables broad use across provider types and care settings. For hands, gloves are available as seen being used in the pediatric hand burn in this slide. Having a glove makes this anatomically challenging area easy to dress, especially in this population.
PermeaDerm stays in place until healing is complete, minimizing dressing changes and helping patients resume daily activities sooner, including showering, which is an advantage over other dressings. In a study presented at the American Burn Association conference this year, PermeaDerm was found to significantly reduce the number of dressing changes needed versus conventional dressings. Another important point to note is that PermeaDerm does not adhere to uninjured skin, which minimizes the trauma during dressing changes. When used in the management of surgically excised full-thickness wounds with the goal of temporizing the wound bed until a skin graft can be applied, it provides several significant clinical and cost advantages compared to the standard of care cadaver skin. First, it does not require any type of preparation in the OR, such as thawing, and there is no risk for human disease transmission or tissue tracking because it's not human-based.
Also, it allows for wound bed visualization without the need to disrupt the dressing. Additionally, there is a significant cost advantage with PermeaDerm compared to cadaver skin. For a 1,000-centimeter-squared wound that's seen in these images, there's up to a 76% reduction in cost, leading to a 4x cost savings. For gloves, the cost savings is even more, approximating 10x. To build on our data and further support market adoption, we've launched a multicenter clinical study, PermeaDerm One, which is designed to evaluate PermeaDerm as a temporary wound covering compared to cadaver tissue. The study is designed to assess the reduction in cost when PermeaDerm is used in place of human cadaver skin. In addition, we'll be collecting secondary data on several critical clinical metrics, including operative time, time to grafting, healing, length of stay, and safety outcomes.
We are also supporting investigator-initiated studies on PermeaDerm focused on different wound types with over 20 presentations and five publications that are slated in 2025. These studies reflect our ongoing commitment to generating high-quality evidence that supports the clinical and economic value of our solutions. I'd like to introduce you to Rich Raymond, who has extensive experience using PermeaDerm to treat partial thickness burns at his burn center.
Our experience with PermeaDerm, we have used this on over 200 patients in our burn center, and we continue to use it whenever patients present and are appropriate for this type of treatment. This patient came in through the emergency room. The wound was debrided through light debridement, and then the PermeaDerm was applied to the thigh. On post-op day three, in general, this is the typical healing of a partial thickness wound. What's been great during this entire time, even though it's been nine days, for the family and the patient, there was really not much else to do. After the application, that product was left in place, and it was secured and covered with some basic simple dressings.
The care needed by our provider team, our nursing staff, and I'm sure, absolutely sure, from the family and the parents caring for this wound on a two-year-old, we're very thankful that they didn't have to completely remove dressings, wash a wound bed with a child that is not understanding, and it's traumatic for the child and the parents. A lot of benefits too during this nine days that are included in these photos. Post-op day 21, this patient looks great. Almost immediately after application of the product, it has impacted our length of stay. It's significantly decreased the workload for our staff when we're not taking someone to a hydrotherapy table or tub or even in an hour or two hours of a full dressing change, washing the wound bed, administering multiple medications, just supply costs, staff costs.
Once this is applied, it's a simple take off the gauze, look at it, put something cheap back on. For the patient, it's been very beneficial too. Wound bed manipulation can set back wound healing. You don't really manipulate it. It stays in place, and you evaluate through the product. You can see it, touch it, feel it. You can see all those things.
Thank you, Rich, for sharing your experiences with PermeaDerm. Now let's shift gears and talk about the newest addition to our portfolio, a dermal matrix, Cohealyx. Dermal matrices play an important role in wound bed preparation for full-thickness wounds. They're often used to improve the wound bed quality, providing a dermal-like base to help cover avascular structures such as exposed tendon or exposed bone, or to mitigate contour defects in very deep wounds. In clinical practice, dermal matrices are applied to the wound bed after surgical excision, and then in a second surgery, the wound bed is skin grafted. The time between these two surgeries is typically between 14 and 28 days and is really dictated by the speed in which the dermal matrix can be repopulated with cells and revascularized with blood vessels to support the skin graft.
As we all know, timely healing is critical in managing the risk of wound complications such as infection and scarring. The longer the wound remains open, the more chances for these complications, as well as burden on healthcare resource utilization. To address this limitation, we have added a unique collagen-based dermal matrix to our portfolio that was designed specifically to advance wound bed revascularization and readiness for definitive closure. This dermal matrix was selected through rigorous internal laboratory testing and outperformed 10 other platforms, including some of which that are commercially available. Why does Cohealyx excel? It has a lot to do with the intentional design features and the precise control over the processing techniques. Cohealyx is derived from young bovine dermis and contains collagen type I and III.
These collagens are critical in all stages of healing, with type III being linked to initial phase of healing, helping to recruit cells to the wound bed and to deposit additional collagens, as well as linked to reduced scarring. When placed in the wound bed, the matrix has a controlled resorption rate that provides this initial scaffold or initial matrix that helps to guide cell infiltration and blood vessel formation. The material is one of the thickest bioengineered matrices available for wound management, helping to provide volumetric build at the wound site. It is easy to use as it conforms well to the wound, and it integrates with standard aftercare procedures. Lastly, the material is cost-effective as the source material and processing techniques enable economical pricing, expanding access to this advanced technology.
Part of our internal testing included the use of a porcine full-thickness wound model to evaluate wound bed preparation and skin grafting outcomes. Full-thickness wounds were created, and the dermal matrices were applied. The image provided shows you macroscopically how different the materials look post-application at day zero and then their healing trajectory up to one week post-skin grafting. When quantifying the data one week post-grafting, we found that on average, wounds managed with Cohealyx had an average of 97% skin graft take, whereas this was lower for competitor one and two at 85% and 68%. Additionally, it's worthy to point out the low standard deviation observed for Cohealyx, which demonstrates consistency and low variability compared to the two other products. This demonstrates that the Cohealyx-managed wounds were indeed ready for skin grafting at seven days.
Cohealyx was launched in April, and we are actively collaborating with surgeons to develop evidence and clinical validation of the results that we saw in our preclinical models. We have initiated a post-market multicenter study, Cohealyx One, which is designed to specifically evaluate wound bed preparation for definitive closure and patient recovery timelines when Cohealyx is used in the management of full-thickness wounds. We anticipate up to 20 centers participating in the trial with primary completion in 2025. I'd like to introduce Dr. Scott Hultman, who will be sharing his experiences with using Cohealyx as well as RECELL and PermeaDerm.
I'm Scott Hultman, Chair of Plastic Surgery at WakeMed Hospitals in Raleigh, North Carolina, and I'd like to share with you a case of a 62-year-old man who had a very complicated right leg wound. He had an aortic dissection that required vascular surgery, and during that process, he ended up with an ischemic leg that required fasciotomies. Not only did he have to have his blood flow restored, but he then had significant debridement of most of the muscles of his lateral and anterior compartment in his leg. We used negative pressure wound therapy for a couple of weeks until we felt that it was vascularized enough to support Cohealyx. We eventually established a nice vascularized bed onto which we could then apply skin grafts. We were able to successfully treat the three-dimensional part of the wound with our Cohealyx dermal replacement.
We were able to skin graft the wound with a widely meshed graft and spray-on skin, and then we could also treat our donor sites with PermeaDerm, which is another alternative that's used for temporary skin closure. We have looked at the benefits of using spray-on skin, and there's no question that this is the event that then allows the patient to be ready for discharge. This is what facilitates wound closure and shortens that length of stay sometimes by up to a week. The ability to close a wound with less skin graft is incredibly helpful for the patient. There really is no price that you can put on a decreased donor site with less pain and a quicker wound healing time, but also financially, the length of stays are shortened considerably, with every day being important to the patient.
We were able to prevent this patient from having an amputation. In the end, he was able to literally walk out of the hospital. Again, you can't put a price on the quality of life for that patient, his ability to re-enter the workforce, and to participate in society. Having all of these products available to us has really changed our perception on which legs we can save and which ones we can't. This has allowed us to push the envelope and effect limb salvage that wasn't possible even a few years ago.
Thank you, Dr. Hultman. You really demonstrated how this all comes together. Now we have, in our next segment, patient experiences that we want to share with you who absolutely had their lives transformed by the products that we've been sharing with you today.
Back in September of 2019, early morning, still dark outside. There was a glow coming from the front door, and I wear glasses, so I didn't have them on. I got up to check it out because I couldn't tell quite sure what was going on. There was a fire right there on my front porch, already blazing. We started choking on the smoke, and we knew we had to run out the front door quick before we passed out from the smoke inhalation. My girlfriend ends up getting helicopter lifted off to the hospital. Unfortunately, she died a few hours later. I was taken off in an ambulance and then put into a two-week induced medical coma and had 90% of my body burned. 75% of that was third degree.
The doctor couldn't use normal means to graft with because I didn't have enough good skin. So they ended up using RECELL, which had only been approved at UAB two weeks prior to my accident. My doctor believes, and he told me, that if he believes that if it weren't for RECELL, he doesn't think I would have survived. RECELL, to my knowledge, has been very, very beneficial just for the main fact that without it, I'd probably be dead. It looks a lot more normal compared to cultured skin, which tends to lose its pigmentation. I'm a huge fan.
I had a normal busy day working. I came home, and nothing out of the ordinary was going on. I went to light a candle, and the spark of the lighter blew up the house that I was in. I was placed in a medically induced coma for about three weeks. The doctor, Dr. Foster, really vouched for me and really took care of me when I was in a coma. I was burned 53% of my body, second, third, and fourth degree, my hands, my face, my arms, and my lower extremities. The only viable skin that I had was on my back, and having to do surgery after surgery after surgery, I'd still have healing time.
He realized that RECELL could benefit my healing time to be shortened so I can have surgery consistent rather than having to stay in the hospital longer and without having to be in a coma even longer. Not only was the healing time so much faster, but the way that I look today is because of RECELL, and I don't have that alligator skin look. Dr. Foster, when we had all of our interviews with the news media and stuff, I always remember what he said. He said, "A year from now, you'd be hard-pressed to tell that she was ever even burned." He made that dream entirely come true. I mean, I do have scars. You can physically see them, but because of the RECELL, because of them pushing it, I was able to use it in a larger surface area, and it shows it's proof.
Everything that RECELL has done for me, everything that my doctor has done for me, everything that the burn unit has done, it's proof.
What you just saw were the high points of what it is that drives the AVITA culture and makes me emotional every time I see it, does not matter how many times. With that, let me wrap it all up for you today. What we are sharing with you is a transformation of AVITA, a regenerative tissue company with one product, to a therapeutic acute wound care company from a $450 million TAM to a $3.5 billion TAM U.S. only. This is our time. Everything's in place. The team's in place, the sales model's in place, inventory, all sizes of PermeaDerm, all sizes of Cohealyx, RECELL, RECELL GO, RECELL GO mini. We are ready to go. As many of you know, we released earnings last week. I'd like to take a moment and just highlight essential big takeaways.
We had $18.5 million in commercial revenue, which was a 67% increase from Q1 a year ago. We transformed our selling model to better focus on selling our expanded portfolio and to make our sales force more efficient. We did an operational review and reduced operating expenses by about $2.5 million a quarter going forward. That is $10 million annualized, $7.5 million between now and the end of the year. We reaffirmed our guidance from $100 million- $106 million, same as before. Same as before, we are projecting crossover, break-even, profitability gap Q4. The financial guidance for the year we confirmed for 2025, and with the portfolio we have, the organization that we have presently, we are positioned for long-term growth and profitability. We expect to accumulate cash throughout 2026 and 2027 onward. This is really a great time for AVITA. All right.
We've reached the interactive portion of the program today. I hope that you've enjoyed learning more about the transformation of AVITA. Now we're going to move to some Q&A. You can make some questions in the upper right-hand corner of the live stream and send them in. We'll answer as many as we have time for. I'm looking forward to sharing those thoughts with you. Here we go. Jessica.
Thank you, Jim. The first question is, could you share how you are transforming the commercial organization?
Yes. Transforming the commercial organization is rather important to executing the new strategy of therapeutic acute wound care. In the beginning, with only a single product, RECELL, we were often having two people attend an acute burn case. In the beginning, that is a very necessary model. We're teaching a new procedure. It's a first-in-category product. As we go along, some things change. Our customers become much more proficient. Of course, that RECELL with a split-thickness skin graft is used in a two-stage procedure, and we were only part of the second stage. Now, under the therapeutic acute wound care strategy that we are implementing, the two stages, the first stage, when you debride and you build a dermal matrix and you have to revascularize, is part of the procedure we need to be in and our salespeople need to be part of.
We still need to support time-to-time questions related to the application of RECELL with the split-thickness skin graft and to apply potentially the PermeaDerm biosynthetic dressing afterwards. This constitutes a different form of selling model, one that is not so service-oriented per se because, frankly, the customers have matured in their utilization, and we need them to do more in the course of the two cases. In structural speaking, we've actually become more efficient from 108 to 82 people in the field, but more field sales positions than we had before. A very necessary time to change to sell these other products and participate more fully in the procedure, and it's more efficient.
Can you provide insights into the launch and adoption of Cohealyx, such as time to approval, key issues, how many accounts have adopted since launch, and the rest of 2025 outlook?
Sure, I can. Let's recall that we received approval for Cohealyx in late December, and we started two activities. One activity was a limited market release, and the other was to prepare for the Cohealyx One post-market study, which is currently under enrollment. It has approved IRBs, not all of the sites yet, but the majority of them. We wanted to do cases so that we got case experience and human use of the product. That has gone really well. We've done a couple dozen during Q1. One of the things that was probably most reassuring is the experience we had during the preclinical portion of Cohealyx is that the patients were often graft-ready within 7 minutes-10 minutes. Excuse me, 7 days-10 days. That is 7 days-10 days faster than the other competitive products. We're really motivated and excited about it.
Now, on April 1st, we moved into the full launch of Cohealyx. And the full launch of Cohealyx means we have all the sizes, including the 700 sq cm sheets. You need three of those for 10% total body surface area. So with that, we've been approaching accounts during the last six weeks. We have had several get through VAC already, to our surprise. One, notably, a major hospital on the West Coast got through within 72 hours. We're negotiating some consignment agreements as we speak. So we're having a very, I'd say, positive reception. It's a little bit early to be releasing a number of accounts yet, but we're really encouraged, and it is performing as we expected.
Can you explain the strategy behind the new manufacturing and distribution agreement with Stedical Scientific?
Yes, I can. The biosynthetic dressing known as PermeaDerm was being manufactured by a third party for Stedical. What was evident is that that third party had a cost structure that was much higher than Stedical could make it for with us. We collaborated on insourcing the PermeaDerm into our Ventura facility. What the consequence of that is, Stedical basically has access to the product for their global distribution outside the United States at a much lower cost of goods. We received an extra 10% of ASP as a consequence. We now split the ASP, whatever it is, at a 60% basis. Stedical, of course, pays for the cost to make it. That makes it so that we could be much more competitive and more profitable.
Are the PermeaDerm and Cohealyx One studies on track, and when are interim results anticipated?
Simply answered, both studies have a significant amount of their sites enrolling, and they are actively screening and enrolling, so in both cases. We expect to finish enrollment and have follow-up accomplished during this calendar year. Now, the speed at which they enroll is there is, of course, protocols. At the same time, we do not have to wait till the end to see interim results. These are both post-market studies. We are allowed to take case series from them, interest study time, so they will make it to podiums and abstracts along the way. We will be able to use shorter cohorts of the patients that are in the study to help us promote both products. It is really an optimally designed study to both accomplish long-term publications, but also provide us near-term clinical use cases.
As a follow-up to that, what will the study results do in terms of coverage, adoption? How do you expect clinicians to respond to these studies?
Clinicians in the first instance, they're different, of course. First, Cohealyx does something that the other dermal matrix don't do, it appears, based on the preclinical data. It is getting patients graft-ready in 7 days-10 days. That has the consequence of getting the wound closed sooner and graft sooner and out of the hospital sooner. Physicians react very positively to that concept because it turns out it's great for the patient. The doctor is available to treat more patients. Economically, it is more efficient for the hospital. In the case of Cohealyx, the reaction has been extremely positive. In the case of PermeaDerm, it has so many uses, but in fact, it's unique in a couple of different ways. It's a feature benefit almost. It is see-through. When I say it's transparent, I mean you can see through it.
Its microporosity can be adjusted for the patient. That's important because you need air to get into that graft site to heal, and you need the exudate to be able to come out of the wound so it can heal more effectively. The combination of those two adds a significant strength to our product portfolio. At the same time, we're able to be quite cost-effective in both cases because the way we've structured our agreements with both of these technologies, we can compete whenever we need to economically. That is also a benefit to the hospital.
Is the intention to have PermeaDerm and Cohealyx approved in all current RECELL accounts?
It is our intention. That would be the perfect outcome to have them all use all three. That is our objective. Of course, that will take time, and it's very difficult to get a 100% share of any product in today's world, but we feel very good about the competitiveness of this combo.
Can you share your outlook for AVITA Medical's ability to execute on the large trauma full-thickness skin opportunity after building a foundation in 2024 and launching RECELL GO mini?
You know, the trauma opportunity in the level one and two trauma centers is really quite huge. If you recall earlier, I mentioned that the reason we did RECELL GO mini is that in our full-thickness skin defect PMA trial, the average wound was under 400 sq cm, which is 2.5% in size, not 10%. The physicians, A, want to use RECELL more readily when they're not wasting it with something that treats 10% and they need 2.5%. That's number one. Number two, the dermal matrix of Cohealyx is applicable to other indications beyond a full-thickness skin graft. That gives our sales team the opportunity to sell it for other indications to the physician. The same is true of PermeaDerm.
It gives us a much stronger presence in the trauma center to help the physician with more patients, sometimes in combo and sometimes maybe just one. It is really a much better selling platform for our team.
Is there a possibility of RECELL being used cosmetically in the future, such as facelifts, scar revisions, etc.?
Those are very different questions. In the case of dermatology, I don't think I see the company going in that direction. It is used today in some scar revision cases, and I think there's a future there, and we'll invest in some additional clinical work in that respect. I don't think we see it becoming a dermatology product. That's why we were very deliberate in redefining the company, a therapeutic acute wound care company. I think scar revision fits under that definition.
How should investors think about current guidance?
I think the key for current guidance, first and foremost, we have a new AVITA on April 1st. We've gone from a $500 million or less TAM 12 months ago to a $3.5 billion TAM going forward April 1st. We have products that are uniquely competitive, both in terms of how the patient reacts to them, Cohealyx, faster time to graft, PermeaDerm, very appropriate dressing post-grafting, and a sales force that's designed to sell it. The new AVITA begins April 1. That's one way I think investors should see the future of the company. The second is we're very committed to profitability. One of the things we were able to do as we redesigned the sales force is we realized we didn't need quite as many people as we had, both commercially and some places inside the company. We reduced expenses by $2.5 million a quarter.
That's $10 million annualized. Our burden or our hurdle to get to profitability in Q4 has become materially lower. I think the prospect of achieving the guidance that we've provided and achieving crossover profitability and accumulating cash is our guidance, and we are very committed to it.
RECELL short interest is at an all-time high. What are your thoughts on this, and why should investors reconsider given the upcoming catalyst?
You know, short interest is one of those things that's very outside of the company's control, of course. It was at an all-time high, as I understand it. At the same time, investors should be looking at what we're doing with this company and the progress we're making. Independent of whether they're short or long, the future is bright for AVITA. We have incredibly powerful products that are on the market, ready to go now. We're not waiting for future approval. We're not waiting to redesign the organization. We have evaluations going on every day. The combination, the synergy is going to produce a thriving, profitable company.
Should shareholders anticipate any additional funding solutions, or is the strategy to remain self-funded and cash-generating from Q4 2025 onward?
I think the strategy is for us to stay in a self-funding mode. That said, working capital, not profitability, is one of those things that we have to learn how to manage. That could cause us to have some need for cash in outquarters, but not significant.
You once said that AVITA was selling roughly 1,000 cartridges per month. Has that changed with the availability of RECELL GO mini? What is the margin on the mini?
Two very separate questions. Yes, the last three quarters, we averaged about 3,000 kits per month. The mini launched in mid-February. We have been on the market under eight weeks. That includes evaluations, and it includes VACs and those types of things. It has not materially impacted volume yet. That said, we have a lot of activity in the trauma accounts going with evaluations and some early conversions. With respect to the gross profit, the cost of making the mini is very close to what it costs to make the standard kit. We sell it for about $1,000 less, which causes us to be in a low 80% gross profit. It is still quite profitable.
This looks to be like the last question. Can you provide a high-level view of where you'd like the company to be in five years?
You know, I can. The company in five years is going to be including other areas of treatment. It's going to be a thriving, profitable, growing company. Our global strategy will emerge. It is going to be an exciting five years for AVITA . Let me provide a few takeaways to that question. We have a multi-product strategy across a $3.5 billion acute wound care opportunity now. Not to be, now. Our platform expansion is driving case-level revenue growth and deeper hospital adoption. The opportunity for us to get leverage off of our selling efforts has really never been higher. Cohealyx and PermeaDerm address critical adjacent needs to RECELL, broadening our market impact. We expect to generate free cash flow in the second half of 2025 and achieve profitability on a GAAP basis by Q4. The time has never been better for AVITA .
Our clinical and economic evidence continues to build across burn and trauma. We already have the most significant foundation of clinical evidence of anyone in our field. It is part of our core. Just as healing those patients you saw today is part of our core and part of our mission in providing more ways to treat and provide our physicians with the tools they need to get those patients with the same wound, the same patient, home to their family sooner. Thank you.