Good afternoon to everyone in the U.S., and good morning to those joining us from Australia. I'm Rudi Michelson of Monsoon Communications. Welcome, and thank you for joining us for AVITA's Investor Webinar. This timing happens to follow the company's compelling pivotal top-line results for RECELL for the treatment of vitiligo last week. The efficacy was strong and a further endorsement of the RECELL technology and its commercial potential. Now, let me point out that you can submit questions using the Q&A function, and we'll get to them after the presentation. Presenting today is AVITA CEO, Dr. Mike Perry, and CFO, Michael Holder. I'll now hand over to Mike to begin the presentation.
Thanks again. Thank you, Rudi, for the introduction, and welcome everybody. Good morning, good afternoon, depending upon where you are. Next slide, please. As we are publicly traded, there was a disclosure that was just passed over. Legal disclaimers, you can read that at your leisure. This deck will be posted on our website. Next slide. A quick overview about what is AVITA Medical about. We're a regenerative medicine company. We're leading both the development and commercialization of devices as well as autologous cellular therapies in the context of skin restoration, where skin has been damaged or skin has been lost, or other elements have occurred.
We have a patented platform that we call the RECELL System or the RECELL technology, and it really represents a new paradigm in the treatment in the United States for burns. We're leveraging this platform to advance additional indications beyond burns, specifically in acute traumatic wounds as well as in vitiligo, and we have a pipeline of early research opportunities that we're looking at in cell and gene therapy. Next slide. Well, when we look at, you know, why should one invest in AVITA Medical, we've got a number of reasons looking around this circle here. Starting from number 1, we have a world-class executive team.
Our exec team has over 150 cumulative years of experience and later on in the presentation, I'll be showing a slide of this executive leadership team of the company and some of the companies that we've had experience with. Secondly, we have a best-in-class field team. Here we have very highly experienced team members. They average over 15 years in burn care experience and also many that we will be hiring additionally in the acute wounds and the vitiligo space. Thirdly, we have robust clinical outcomes. The efficacy of our platform has been very well-studied even before the pivotal trials. We consider it highly de-risked, and we've treated over 15,000 patients with the RECELL System since it was first launched.
We have proven health economic outcomes. These have been published in peer-reviewed journals, and they show that utilizing the RECELL System as opposed to the current standard of care, a split-thickness skin graft, saves money both for the patient as well as costs to the healthcare system. Moving to number five, we were the first PMA in burns in over 20 years. We are a PMA-approved Class III device. What that does is it sets a precedent, and it also creates a barrier to entry for potential competitors in that they would too have to conduct clinical trials and not utilize us as a predicate device. We have a strong intellectual property estate, 19 granted patents and 25 pending patent applications.
We have new devices or a new device in development. Next slide. Here we're seeing a quick review of how the company has grown, you know, since our approval in burns in late 2018. If you direct your attention to the right-hand side of this slide, you can see U.S. RECELL commercial growth , and it's been on a good trajectory. You can see a couple of plateaus and a decrease as well, December 2020 to June 2021. Those were due to COVID. Looking now to the left-hand side of the slide, recent accomplishments, commercial revenue growth. Year to date, we have 39% increase YoY in commercial growth.
For the second quarter of 2022, we have a 23% increase in revenue growth versus the prior year. We have the new ease of use RECELL device that has been FDA approved and recently launched, actually earlier this month. In Japan, our partner COSMOTEC has achieved PMDA approval earlier this year and have had favorable reimbursement in the country for the burns indication. Insofar as pivotal trials ongoing and top-line results recently for acute traumatic wounds or soft tissue reconstruction, we had statistically superior donor sparing that was shown as a co-primary and comparable healing rates. In our vitiligo pivotal trial, we achieved the primary effectiveness endpoint of a superiority in response rate versus that of control. Next slide, please.
Here we see some good leading indicators since we attained FDA approval at the end of calendar year 2018. If you direct your attention to the right-hand side of the slide, you see three colors and representations, and those represent the bars as well as the one blue line that are on the left-hand side. If we start at the top with the gray bars, 93% of U.S. burn surgeons are now certified for their use of the RECELL System. This means that they've gone through didactic training, they've been through practical training, and they've actually performed a case. If we look at the yellow bars and the growth there, 84% of burn centers are activated.
That means that they have achieved VAC approval or Value Analysis Committee approval and have purchased at least one RECELL device. Our goal going forward is not necessarily to get the last 15% of burn sites activated, although we will do that, but it's more on a push insofar as going deeper into existing large accounts. Then if you look at the blue line, it's number of procedures. That's 6,500 procedures since launch. Apologies for the extra zero on the 6,500 there. Overall, over $70 million in U.S. revenue since the U.S. approval. Next slide, please. Talking about the new ease-of-use device, which was approved earlier this year and has been launched.
It reduces the number of steps required by the surgeons, or their staff who may be assisting. That number of steps that is reduced is approximately 1/3. That provides for a simplified process as well as improved usability. We actually received feedback during the use of the initial RECELL device and we based upon the users, we changed some packaging and basically how one would lay out the device and utilize it. Overall, 94% of the surgeon users as well as advanced care practitioners said that the RECELL System would reduce their workload and allow them additional time to do other tasks that are required. Next slide, please. Let's talk a little bit about Japan. Directing your attention to the left-hand side of the slide.
A bit of background, our commercial partner in Japan is a company called COSMOTEC. They are owned by a company called M3. M3 is a large platform company that has contact with over 90% of Japanese physicians across specialties. The indication of burns was approved in Japan earlier this year by the PMDA, and this was based upon our U.S. pivotal trial data. So that happened in Q1. In this quarter, Q3, the MHLW, or Ministry of Health, Labor and Welfare, granted favorable reimbursement for the RECELL System, and they're off to a commercial launch. Addressing your attention to the right hand of the slide, what you see there is the patient funnel, the opportunity, for Japan.
Approximately, 250,000 patients are burned on an annual basis and require treatment for those burns in Japan. About 6,000 patients on an annual basis have severe burns, where they need a hospital admission, and may require skin grafting in order to cover the site. Approximately 1,400 patients per year have severe burns that are treated at burn centers and may be RECELL eligible. As I said, commercial launch is underway. Next slide, please. Here, we're showing our acute trauma wound opportunity. If you address your attention to the right-hand side, you see a picture of a female who was 28 years of age when the picture was taken, and she suffered a degloving injury on her leg.
You can see it post-debridement in the top photo. Below, which was about 6 months post-treatment with RECELL, you can see the healing. It's a wonderful outcome given that type of injury. If we look now to the left-hand side of the slide, the opportunity, total market opportunity, about 4.5 million patients. These are open wounds that are presented to emergency departments of hospitals. This provides for a total addressable market in the United States of $1 billion per year. These are the RECELL-eligible patients who have had traumatic events. The serviceable market is over 65,000 patients, and these are RECELL-eligible patients at high volume either trauma sites or burn centers that are co-located with trauma sites.
Overall, moving forward as we achieve the indication approval for acute traumatic wounds or soft tissue reconstruction, that will provide us with the business to encompass all acute wounds. Next slide, please. Here, we're seeing again soft tissue or acute traumatic wounds. If you address your attention to the right-hand side of the slide, on the upper picture, is a patient who was treated for necrotizing fasciitis or flesh-eating bacteria. There's a large area of skin as well as subdermal fat that has been carved out. You can see one year post RECELL treatment an excellent recovery and covering. This is an example of you know really what type of effectiveness that we see when RECELL is used in this situation.
If you direct your attention to the left-hand side of the slide, this was a study that was done for FDA submission using within-subject comparison, meaning if you look at the figure, the cartoon if you will, on the left, you see part A and part B, and that's how, you know, one was treated with RECELL and one with the control. That's how we compared within patient. The control was conventional skin grafting. So far as safety goes, our preliminary review of the safety data from this pivotal trial is consistent with our prior experience that we've seen with RECELL. Nothing new, and we're on track for FDA submission before the end of this calendar year. Next slide, please. Okay, turning now to the vitiligo opportunity.
Quick photo on the right-hand side of the slide. You can see a repigmented area that was treated with RECELL, and the negative control that did not get repigmented at all. When we look at the opportunity on the left-hand side of this slide, we see the total market ranges depending upon what source you look at, 3-3.5 million to 6.5 million patients insofar as prevalence of vitiligo in the United States. That gives us a total addressable market, meaning the prevalence of stable vitiligo. We treated only stable patients in our pivotal trial. Gives a total addressable market of approximately $5.2 billion and a serviceable market of 188,000 patients.
These are the patients that are estimated number that may be eligible at our target points of call. Those target points of call are gonna be less than 1,000 procedural dermatologists and plastic surgeons. Currently, both physicians and patients have very low satisfaction rates with current products and a great opportunity emerging for a number of companies to treat patients in this arena. Next slide, please. Again, vitiligo on track for FDA submission. It was a within-subject comparison, as you can see on the left-hand side. A white spot of vitiligo lesion was bisected, or two lesions comparable to each other were treated, one with the RECELL treatment and one with control. I'll go over which they were shortly.
In this data, we achieved our primary endpoint on statistical superiority versus control. A preliminary review of safety here also shows consistency with what we've seen previously for RECELL. On the right-hand side of the slide, you can see what we did for the primary endpoint, that was defined as the proportion of study sites achieving over 80% repigmentation for RECELL-treated sites as opposed to control at 24 weeks. The treatment arm had laser ablation of the white patch, RECELL treatment at a 1:20 concentration and a narrowband UVB light. The control had only narrowband UVB light. Next slide. We also have a new RECELL device that is being worked on, that is going to be key for our launch in vitiligo.
We anticipate FDA submission in the second half of next year, of this new automated device, and FDA approval one year following. That'll be in the second half of 2024. Also, this new automated device will be protected by new intellectual property, which gives us another hurdle for potential competitors. Next slide, please. Here, we see the pipeline overall, and if you look at these bars running horizontally, what you see from the top, acute thermal burns as well as burns using RECELL in Japan, have both been launched and are selling. Vitiligo and soft tissue or traumatic wounds have both hit their pivotal endpoints, and we'll be submitting PMAs for each of these indications very shortly.
We also have early-stage research programs, one in epidermolysis bullosa with the Gates Center for Regenerative Medicine at the University of Colorado, and we're exploring rejuvenation of skin cells, and that's ongoing in collaboration with the Houston Methodist Research Institute. Insofar as the platform goes, we have innovation there too. We have been using, as I said earlier in this presentation, the improved device, which was the ease-of-use device. We're working on the fully automated device for vitiligo initially, and then to have a fully automated device for the other indications as well thereafter. Next slide, please. Just to be clear, so you can see what the milestones are going forward.
For vitiligo, initially, we have FDA submission in the second half of this year, so by the end of this calendar year, and FDA approval in the second half of next year. For acute traumatic wounds or soft tissue reconstruction, we have FDA submission similar to vitiligo, by the end of this calendar year, and FDA approval again in the second half of next year, 2023. Insofar as the automated RECELL device goes for vitiligo, we have an FDA submission target of the second half of next year, 2023, with FDA approval anticipated in the second half of 2024. Next slide, please.
The current platform really has a significant market opportunity going forward, about a $600 million opportunity in burns, approximately a $1 billion opportunity in acute traumatic wounds, and a $5.2 billion total addressable market, if you will, or market opportunity in vitiligo. These are the ones that are really de-risked compared to the cell and gene therapy indications, which are earlier and come with the usual amount of risk. These de-risked indications give us combined approximately a $7 billion total addressable market moving forward. Next slide. A little bit about corporate. Next, please. Here, a quick financial overview. As you can see here, we have data from 2018, when we had our fiscal year ending June 30th through 2021.
We did a stub year where we had the fiscal year ending December 31st, and we have the period ended June 30th of this calendar year. You can see commercial sales are directionally moving very well. Total revenue, another line that you can see, is moving very nicely, and somewhat, you know, the numbers fluctuate there based upon BARDA sales, especially the 2021 $7.75 million that was received for the stocking order for the national stockpile. Cash and cash equivalents at the period ended June 30th, we had over $90 million in cash. We have nine analysts that follow us. Pretty good for a small company.
We're traded both on the Nasdaq as well as on the Australian Securities Exchange. Next slide, please. Here you can see our executive leadership team, and below them, the number of years of experience that I spoke to in one of my first slides, as well as some examples of where they have worked previously. Again, if you wanna look at that more intensively, the deck will be posted on our website, and you'll be able to go into that in detail. Next slide. Risk factors and disclosures because we are public. Next slide. Important safety information required to put up because we are actively selling the product. Final slide. We are really a revolutionary treatment, and we're using an autologous platform, the patient's own skin, to achieve life-changing outcomes.
Here on the right-hand side, you see a patient. His name is Zed. He's from the U.K., and you can see his scald burn in the white circle, and then pretty much scarless healing across his chest and abdomen. With that, I'll conclude the formal part of my presentation, and I'd like to open it up to Q&A.
Okay. Thank you, Mike. We'll now move to questions and answers. We've already got a number of questions, and we'll do our best to get through those. If you do have questions, you can continue to submit them by using the Q&A function. I'll hand over to Michael Holder to host the Q&A session.
Thank you, Rudi. And for the host of this webinar, if you're able to allow me to start my video, I will show my video. Hopefully that won't be too distracting to the audience and take away from the presentation. But until then, I'll just. Oh, here we go. Perfect. Thank you. Okay. Mike, we have a number of questions that have come in over the course of the webinar, essentially about our two indications, acute traumatic wounds and vitiligo that ask, now that we have received top-line results, how do things flow from here in terms of submission, approval, launch, and reimbursement codes?
Of course, you've gone over several of those things, but maybe if you could repeat that first for acute traumatic wounds with an emphasis on reimbursement codes, that would be great.
Sure. Yeah, I'll start off with acute traumatic wounds. Submission will be, as I just mentioned in the slide, toward the end of this year, this calendar year. We anticipate approval in the second half of next year, 2023. So far as launch, we anticipate that will occur relatively quickly following approval, certainly within the first 6 months. Insofar as reimbursement, this one is a very easy one in that we will be able to utilize the CPT codes, the DRG codes, etc., that have already been approved for burns because these are similarly acute wounds. Same procedure, same use, just a different set of physicians, trauma docs, as opposed to burn docs.
Moving on to vitiligo, the same. Submission will be before the end of this calendar year. We'll have approval we're anticipating by the second half of next calendar year. Insofar as launch goes, it's going to be a little, you know, more complicated than the soft tissue which follows burns, because this is a new category. Yes, you know, there is one JAK inhibitor that is now approved for the treatment of vitiligo. However, moving forward here, we're going to have a phased launch starting off with cash pay. Then we'll be going for reimbursement and that can take, you know, some time, because it's not a well-trodden path yet.
You know, let's say 18 months, 2 years till we get that reimbursement fully in place. Then a full launch including reimbursed as well as cash pay.
Can you comment further, Mike, on the automated device and how it impacts our launch plans in vitiligo?
Yeah, absolutely. The automated device, number one, you noticed that the submission would be second half of next year, 2023, with approval anticipated in the second half of 2024. Insofar as launching in general, you know, a large launch of, you know, approximately 1,000 interventional dermatologists and plastic surgeons, we're likely going to be waiting for that approved automated device until we have the full launch. That should come at around the same time or before we have reimbursement. With the cash pay, we can go at that, you know, fairly immediately following approval, but it will be a phased launch.
Erin, our Chief Commercial Officer, and her team are now working on the exact plans on how we're going to be taking that forward. I'll be able to give you more detail as in future presentations or discussions.
Thank you. Will the company consider partnering, given the deterioration in biotech valuations? You know, given the capital intensive nature of rolling out new indications, will we consider partnering options in vitiligo or otherwise?
The answer is, we have plans to go it alone that work within a constrained and realistic budget for a company such as ours. At the same time, we're going to be quite opportunistic and we will look at opportunities to potentially partner, especially, I would say, on the very large TAM, total addressable market, of vitiligo. That said, you know, again, I wanna reiterate that we have a go alone strategy that fits within our budget and within our current depressed market cap, if you will. I'm hoping that that will turn around soon, and we're gonna be opportunistic going forward.
Given the completion of the recent soft tissue and vitiligo trials, how can investors anticipate R&D spend will drop in the future on a prospective basis?
Well, in general, I'll start off Michael, and then I'll pass it right back to you as our CFO. R&D will be, you know, trailing off. At the same time, we do have many opportunities with the RECELL platform to go after other new indications. You know, I wouldn't expect our R&D to go down to zero or anything like that. Also, with the current environment with fewer investment groups investing in growth stocks right now, obviously we're going to, you know, be careful in the context of, for example, going into clinical trials with our biologics that include our cell and gene therapy products in EB and in regeneration. Michael, do you wanna comment additionally on this?
We do anticipate R&D decreasing in the outer years. However, even though our soft tissue and vitiligo trials have been completed, there are intensive ongoing efforts that we'll be undertaking through submission. In addition, we do have the automated device that we're working on that will take some material expenditures. We do contemplate an automated device for non-vitiligo in the acute wound space as well. It is intended to decrease over time, and that will accrue to our benefit in terms of our bottom line in the future. Just reading through the questions here. A number of questions about our plans internationally.
Yeah, Mike, what are our plans internationally for RECELL?
I guess what I've been very consistent in saying, and I'll reiterate it. Well, number one, internationally, we are moving forward with Japan and our partner COSMOTEC. When I'm getting the question of international expansion, generally, it's back into territories and countries where we were selling previously, Europe, when the UK was in Europe, as well as Australia. What we have said and what we continue to believe is that once we have our final pivotal data, which will be later this year from both the clinical trials in vitiligo and in the acute traumatic wounds or soft tissue reconstruction, we'll be evaluating that opportunity. It's a large job to go in, for example, and negotiate reimbursement in every country for various opportunities.
We've got to weigh that against what we're going to be doing and what the return on investment is going to be for the company and the value that we can create for shareholders. We'll continue to evaluate that, and we will continue to keep you updated.
You know, if I just might add to that. You know, our management team has a significant amount of international experience with leading medical device and biotech and pharmaceutical companies. You know, we take the opportunity very seriously. We continue to evaluate it very closely, and it's as Mike said, it's a matter of what's best in terms of the bottom line over the long run.
Thanks, Mike.
There are a number of questions about, in essence, you know, congratulations on the revenue growth you've realized in the last several quarters. Albeit, it appears that your market share of the overall TAM is probably not as high as what you would have anticipated it being at this point in the company's life cycle. You know, what are your comments, Mike, around that? Any sort of lessons learned or experience that you could share to sort of explain where we are?
Yes, some that we can explain where we are. Number one, I would say that, you know, we launched in a formal launch in January 2019. As we were on that steep upward climb in revenue, we were completely derailed by COVID. You know, while we continued to grow, over a number of quarters were flat to prior quarters, we didn't lose, but we weren't gaining in the way that we anticipated. Number two, you know, I've said for a long time, we've been, I would say reiterating constantly that we're the first PMA approved in 20 years in burns.
While that has a positive relative to innovation and a better standard of practice for the patients and some cost savings relative to health economics for the healthcare system, it also provides a situation where you have some very, let's say, experienced physicians who are more reluctant to go with quick adoption because they've not seen the type of innovation that happens, for example, every year in the cardiovascular sector for just an example or in oncology. This is a sector that really hasn't had that innovation. We thought that was gonna be a great advantage to us. As it turns out, that adoption curve is taking a little longer.
We do anticipate that we're going to get there, that peak revenues may even be higher than we had anticipated in the beginning, but it's gonna just take us longer to get there. As we launch soft tissue and vitiligo, pending FDA approval, those indications are substantially larger than burns. We believe that we're going to see nice uptake there, and it's really gonna dwarf the burns business.
Thank you. Given the suppressed share price and cash now sub $90 million, with the need to likely increase spend on new indications, what financing options is the company considering, the detriment there would be raising capital at current share prices?
Good question. I would say that to start, we're not in a situation right now where we have our backs against the wall in any way, shape, or form. We've got over two years of runway. The landscape and value of the company can change and hopefully will change over that time to provide different opportunities to bring cash into the company if needed. We're going to continue to monitor that, and I'm glad we don't have those tough choices that many companies do right now, where it's extraordinarily difficult as well as crazy dilutive to sell shares at these depressed prices for equity. Don't wanna take on too much debt.
I would say that if given our situation and where we are, you know, post-approval, in a good position to be launching two new indications, my first go-to, if we did need cash, would probably be some sort of synthetic royalty. As opposed to straight debt or equity. Let's hope that situation changes over the next couple of years.
Yeah. If I just might add to that.
Sure.
As Mike said, we don't need to raise capital anytime in the near future. Looking at our planned milestones with regulatory approval for vitiligo and acute traumatic wounds in the second half of 2023, you know, our focus is on continuing to execute and hit milestones. We think we're undervalued and that our share price will appreciate accordingly and provide us, if needed, a more favorable share price environment to raise capital. As Mike mentioned, there's no shortage of alternatives to equity, including royalty financing and debt financing. Currently, we have no debt, and we would take on quite seriously the notion of bringing on debt, but it is an option out there that would be non-dilutive.
We're also, as previously mentioned, you know, we're looking at our spend very carefully, looking to cut back, where possible and prudent without negatively impacting our top line. You know, we continue to do that well and make progress. You know, we're very mindful of creating a line of sight to profitability. Although we haven't announced that timeframe publicly, we do see that in the coming years. We've always built this business for middle to long run share value appreciation in terms of the team we have in place and the strategic decisions that we've made.
I would just add that something that has changed more recently is that, you know, pre-COVID, as well as during COVID, what investors in the United States were looking for as opposed to investors in Australia, the U.S. was looking for top line growth, as opposed to profitability, and Australians were generally looking at time to profitability. Now, there is alignment between the U.S. and Australia, and all are looking to time to profitability. Reiterating what Michael just said, we are really interrogating our spend, making sure we're doing it on the most high value opportunities and, letting others that are of lesser value to the company, basically, you know, let them sit for now, because reaching profitability as soon as possible is now very important to all of our investors.
Okay. I'm just scrolling to see if there's any additional questions that have come in that are in and about what we've talked about. Just bear with me for a few seconds here. I think we've covered everything. Yes, that's it.
Great. Well, again, I'd like to thank everybody for their participation and their attention during this last hour. Have a good rest of your day.
Thank you.