I'm Raj Denhoy, the Chief Financial Officer of Establishment Labs. We're coming to you from Costa Rica today, and we're welcoming a few people here in the room as well as people online on the webcast. Before we begin, I just wanna put up our agenda for today. We're gonna have a session today on Mia, as everybody knows about, talking about a new concept in aesthetics. I'll have a couple of minutes here at the open, and then I'll turn it over to Juan José to talk about Mia in some detail. We'll have a video narrated by Dr. Marcos Sforza and Dr. Charles Randquist. Rosalyn Cole d'Incelli will provide an update on clinical and regulatory status for Mia.
I'll close with some information on the market potential and commercial model we have for Mia. We'll also have some Q&A for people that are here in the room. Before we begin, of course, we have the safe harbor and forward-looking statements slide, the ubiquitous slide. We also have some additional disclosures. As everybody knows, Mia is not available for sale yet, and we are undergoing an FDA study in the United States as well for our Motiva implants. I'd also point out that there are some comments made by Dr. Marcos Sforza and Dr. Charles Randquist during the video portion, and any opinions expressed by them are their own and do not necessarily reflect the views of Establishment Labs. With that, it's my pleasure to turn the call over to Juan José Chacón-Quirós.
Thank you, Raj, and thank you, everyone, for being here. I am going to talk about Mia Femtech. Most importantly, what you should understand is we are talking about a new category in aesthetics. Why is this so important? It is because we are developing a new category from the ground up. I want you to understand this as we walk through this procedure. Until now, women that have been using compensatory behaviors have had the opportunity of, you know, having a traditional breast augmentation, but it turns out most of them do not choose that.
If you look at the top three compensatory behaviors, the padded bra, this push-up bra, or the certain use of clothing or not using certain clothing, all of these things are used daily by women worldwide, and most of these women do not really have an option in traditional breast aesthetics. We are an innovation company, and that's why, you know, from the beginning, we always said, you know, we have to heal the traditional breast aesthetics market through innovation, by bringing safety, by bringing, you know, the type of options that we've been giving women since 2010. But more than that, it's time that we open a new era, an era, and we can, you know, ask new consumers to come into a new category. That's why it's so important that you understand that this is a target group. Of course, there's other compensatory behaviors.
Some women are using what is called breast contouring, which basically is makeup to create the appearance of more breast proportionality. Also, you know, boob tape, other things that, you know, have been used in the past. It's very important that you understand that this group is very large. Yet they have so many trade-offs when they use a padded bra or a push-up bra. There are certain things that, you know, they are giving away when they choose these compensatory behaviors, and we seek to provide a new option that they have never had before.
Some facts about new category creation that I think are interesting is that, you know, companies that understand that the current category is not providing the value that women are seeking for or consumers are seeking for, you know, understand eventually that they can create with technology and, you know, by understanding that consumer, that value will be created. A lot of research has been done on this, and companies that can create, define, name, and eventually execute on that new category end up with 76% of the economics, and by the way, the market cap. It is very important that you use this new category to be able to communicate to a new consumer base. That's why it's a new category, because it's a new consumer.
When we look at our strategy, our strategy is to move from the patient who's considering a breast augmentation to the consumer that is using these compensatory behaviors I was talking about before with major trade-offs, and that they see in Mia the opportunity, the value. Of course, you know, our positioning of Mia is as Femtech. We believe that Femtech well defines in a positive way what this new category can be about. In doing so, I think, you know, we're not worried about competing for market share. We are creating a new market. Some of the consumer insights that we've done, you know, over the last couple of years are very, very interesting. I would say that, you know, when we talk about Mia, you know, women can expect, you know, of course, the amazing safety results that they've historically had with Motiva.
More than that, you know, this is a true minimally invasive procedure. It's also a set of technology that allows for a preservation procedure. What does that mean? It means that we're not cutting tissue the way it is done in the existing category. We are going through a different pattern. That technique allows for less pain after the procedure because we are preserving, you know, basically the anatomical plane in a way that has not been done before.
Of course, the outcomes that we have seen so far allows us to say that, you know, the expectations are very high when it comes to ergonomics, comfort, and what they do in everyday activities. We performed a consumer study in Europe to understand if, you know, if these benefits were put in front of potential consumers, how would they view those potential benefits? We are so happy to see that, you know, these, you know, insights, 200 interviews, each one of an hour and a half with a psychologist, yielded all this information. Basically, you know, they care about the potential value proposition of Mia. We asked real Mia consumers, women who had been part of the initial series, and the confirmation of the value once again is provided.
We know that the expectations are matched by the results, and when we see, you know, the way women are speaking about Mia and how they talk about that experience is fundamentally different to what we've heard, you know, in the last 60 years of breast aesthetics. It is very important to us that, you know, this new consumer becomes an advocate that is able to bring about the type of, you know, of word of mouth consideration that we think is going to allow for this to grow. What is our strategy? You know, the strategy is, in this year, to understand consumers. We've been doing a lot of work on that, as you have seen.
We've also wanted to understand what is the real market sizing, you know, understanding, you know, willingness to pay and also the business requirements that we will need. We also are moving into creating our pipeline of clinics. Remember, not everyone is going to have access to Mia. Only the centers that can provide the experience that, you know, Mia consumers expect. That's why we've already been creating this pipeline. We already started training some of these centers, and we are working to move ahead of regulatory approvals to have enough centers to begin our launch. With that, we can connect with consumers in a completely different way.
We have a 360 plan that we will put in place once we launch with, of course, public relations, you know, a full digital portfolio of assets, out-of-home, you know, activations, and the work that we will do through our partner clinics. A very fundamentally different approach than what the existing category does. This is possible because of the technologies that we have. There are so many patents behind Mia system, not only the Ergonomix2 Diamond implant, its chemistry that is so unique that allows this implant to be injected. This is a, you know, a first in breast surgery that an implant is actually injected. You will see that in the video that we are going to watch.
This is also, you know, the way the inflatable balloon works, the way it allows for the space creation without destroying tissue around it. All of these tools are proprietary to us and will allow us to, you know, create a safe space for our partner clinics to invest and continue to grow. I will now show a video by Dr. Marcos Sforza and Dr. Charles Randquist. Dr. Sforza is a member of our medical advisory board, and Dr. Charles Randquist is a plastic surgeon from Sweden who's been working on ideas related to bringing about a new type of minimally invasive technique in breast surgery for over two decades. Let's watch this video so that you can see all these great technologies at work.
The procedure starts with an infiltration that's done with a tumescent technique using a bulb tip cannula.
This bulb tip cannula has been patented by Establishment Labs and has been used in several publications, peer-reviewed publications. The safety of the bulb tip cannula allows a large volume of fluids to be used to guarantee complete anesthesia and hemostasis during the procedure. After having administered local anesthesia and under light sedation, the procedure starts with an incision smaller than an inch, very well hidden in the axilla, basically using a preexisting crease in the armpit. The procedure was previously marked, and the technique was defined by the Motiva marking tool. The beginning of the procedure starts with insertion of the Motiva Channel Dissector. The Motiva Channel Dissector is going to define where the pocket's intended to be. The audience will notice that we are gonna introduce very new concepts in breast techniques, which is called tissue preservation techniques.
We are gonna define a new procedure where it's possible to preserve the attachments and connections between the breast and the underlying tissue. That's why this first design pattern tool, it's very important. It creates a 3-D channel that will allow the second stage of the procedure to dissect precise pockets in a minimally invasive technique. Immediately after the removal of the Motiva Channel Dissector, the new developed Motiva Inflatable Balloon is inserted through the same scar in the armpit.
The Motiva Inflatable Balloon will have three main functions in this process. The first one is to find a very precise pocket as the surgeon can control the size of the pocket to match the size of the implants. The second, and in my opinion, most important thing, this is the beginning of a breast tissue preservation technique. There is no undermining. The tissue is naturally and smoothly separated, creating a perfect pocket, preserving all the retaining ligaments and structures around the implants. Third, but not least, there is a hemostatic component that when the balloon is in place, it stop any future bleedings and helping the safety of the procedure.
Doing our research and the hundreds of cases that we performed to really define this procedure and get the procedure ready for surgeons all over the world, we understood that a straight channel dissector was fundamental because it was the beginning of a process that can guarantee that the pocket will always be in the right place. Now we are getting to the really exciting part of the procedure. Now it's where Motiva is at its best and shows the capacity of innovation of the Motiva engineers and team behind this project. The Motiva Injector and the Ergonomix2 Diamond are really revolutionary tools. As you can see on the video, there is a fully no-touch technique. Acquiring the implant from the blister and delivering into the pocket without any contact to the surgeon's gloves. This is very important for patient safety.
The newly developed Ergonomix2 Diamond implant is the next generation of implants from Establishment Labs. These implants have enhanced mechanical properties that allow it to be safely compressed into a nozzle with less than an inch, of course, allowing a very small incision that will be completely hidden in the armpits. This SmoothSilk technology has been the base of the success of all Establishment Labs implants because of its low inflammatory characteristics that have been proved in several papers to have the lowest capsular contracture rates amidst all the implants in the market today. It's also important to say that these implants have a unique shape. They are symmetrical, which means that there is no front and back, eliminating any risks of flipping and malpositioning of the implants.
Obviously, there is no front and back, so it doesn't matter how the implants are deployed, they will provide always a great shape. Finally, it was very interesting to us that were involved in this study to understand that with this new symmetrical shape, we achieve greater projections with smaller volumes, allowing the patients to have even better results with the smaller and smaller implants. I have said that many times during MIA presentations that I personally never had performed an axillary procedure in my life, and I found that so easy. Why? Basically because I was not performing axillary breast surgery. The key point here for everyone to understand is that MIA, it's not a breast surgery. It's a breast procedure that is done through a minimally invasive scar in the armpits. This changes everything.
It's also important to say, as you could all see in the video, that the surgery is performed in a very calm way. The surgeon has no rush. He's moving from one side to the other, and the entire procedure is performed in less than 15 minutes. That's the difference of doing a procedure and a surgery. It's safety, it's calm, and the patient is very lightly sedated, ready to go home. As you could all see, MIA is a revolutionary way of creating a precise pocket, a revolutionary way of inserting an implant in a minimalistic, easy and replicable way. Meaning this is an incredible new procedure designed for women that want quick recovery, safety and good results. The procedure is now done. The breasts look amazing.
As you can see, the patient is comfortably talking to her surgeon, ready, almost ready to have a cup of tea and to go home. It's incredible.
Hello everyone. I'm Dr. Charles Randquist from Stockholm, Sweden. I'm extremely proud being part of this event, sharing my views of the Mia procedure. A procedure that, under local anesthesia, as you could see, is able to create a beautiful proportional breast, one, two cups bigger than prior to the surgery. With this said, I'd like to share with you some before and after photos. First, start off with a video that really shows the fast recovery after this short procedure. The video we're showing now shows exactly what I envisioned 17 years ago. A young patient walking out 10 minutes after the procedure under local anesthesia, and look at her. With that face smiling, having one to two cups bigger breasts that are proportional, well-balanced.
More importantly, a procedure that's done in a safe, predictable way, where the journey enables her to get back to work or her family with no downtime. This is truly magical and precisely what we want women to experience having the Mia procedure. This is a new way of thinking. The concept is based on creating proportional, well-balanced breasts that look natural. Hiding the scars in the armpit, not stigmatizing them. Creating a beautification, which is a feminine way, not a sexual way, or in any way perceived as vulgar. It's something that I've experienced for the last 30 years being in this business, most women desire. Something that makes them happy, that extra cup size, where they normally would wear a push-up bra. All of these breasts look well-balanced to their bodies, and there are no stigmatizing scars.
I'll get back to that, looking at these videos, showing how well-hidden these scars are. It is important. Why? Because scars matter. It is a stigmata, not just for the woman herself, but how she's perceived by the surrounding. As you can see, they're well hidden, and these are photos after approximately six months. I could not wish for a result that's better. What I wanna share with you now is a couple of videos showing the results. For us as surgeons, this is extremely important because it shows the stability of these implants over time. It also shows how the scars have faded even more, and how the breasts keep their proportional, well-balanced look on that chest over time. Finishing this session, I wanna share with you three beautiful testimonies by Carolina and Pamela, and Rebecca.
All of them sharing their past recoveries and how it has changed their lives in a very positive way. I do believe this is essential, and please listen to the words, because this is truly quality of life, but more importantly, the journey, which is a very pleasant one, compared to what we know as the common breast augmentation, what we see regularly today. With that said, watch and enjoy. As you've seen from the operation, the before and after photos, the beautiful testimonies, this procedure has proven itself, not just short-term, but long-term, which is extremely important for a surgeon. More importantly, the patient satisfaction, the surgeon satisfaction is beyond our expectations. I do believe that the Mia procedure is what every surgeon would like to have in their practice.
Being able to create a proportional, beautiful, well-balanced breast with less downtime, fast recovery, less risk short and long term. With that said, welcome to New Era. Thank you very much.
Wow, huh? Before I hand it over to Rosalyn Cole d'Incelli, our VP of Global Clinical, Medical, and Regulatory, I would like to talk a little bit about what we just saw, which is, you know, to tell you that we began this journey with Mia almost a decade ago. The initial concept led us to create all of this technology, then led us to create a technique that could be standardized, that it is now easily replicable and that delivers great outcomes. Our belief that there was a consumer that was interested in this is now matched by, you know, the outcomes. I mean, you when you see those testimonies, what you hear is, you know, a group of women who were using compensatory behaviors and they just were not happy with the trade-offs, eventually make this decision and are having this amazing experience.
To us, you know, this is exactly what we think is a new category. It is about a new consumer, and we believe it can be developed into the next generation of growth and new dynamics in breast aesthetics. Ros will basically tell you how we plan to do this from, you know, clinical regulatory perspective.
Thank you, Juan, and thank you all for being here today. I am excited to bring you some of our clinical data and our experience so far with Mia. I should note, it's important for you to be aware all of the images in here are real Mia patients. These are not models. These are real Mia consumers, Mia participants. They have amazing outcomes. Looking at our clinical series in Costa Rica, it's a 1-year study currently going through 2. The subjects are almost at 2 years or about 1.5 years. We enrolled 100 participants, and it's a rigorous trial, so a lot of the similar endpoints and pivotal trials that are used in the US. BREAST-Q and a lot of similar complication collection, Kaplan-Meier, all of that.
With 100 participants through one year, we have 98% compliance, which is very impressive. Taking a look at how that breaks down, looking at the demographics, which is similar to pretty much what we're targeting. The mean age is 29 years with a range of 18-44. BMI average is 22. As you can see, many of these participants, most of them are professional women, professionally employed and also college graduates, so educated women that are choosing this procedure. Through the series, as you know, this is the first time it's ever been used. We've gleaned ways to make it much more efficient. This reflects essentially the end of the series of getting the procedure time, so skin to skin, at 15 minutes or less safely and predictably.
The time to discharge, meaning the time in recovery, the time in the clinic office after to 15 minutes or less. These are both unheard of in traditional augmentation discussions. Through 1 year, Kaplan-Meier data we have collected, and it's very, very robust because we have such good follow-up. Essentially 0% complications in all of the key areas, the two key ones of capsular contracture and rupture. We have 2% in breast pain, which is to be expected on occasion, and 1% in malposition. Very, very low complications. I must note this is still a study that is in progress and does not necessarily reflect how the safety or effectiveness of the device. This is an interim look at what the data is thus far in the group.
Surgeon satisfaction, 90% of the surgeons, and there were 15 surgeons that participated in this series, from around the world, and none of them have had experience with transaxillary approach or the Mia before. Keep in mind this is the first time doing this. Satisfaction was very high with how quickly they were able to adopt it and use it, with 10% neither satisfied or unsatisfied. That was more related to their patient selection as opposed to the actual procedure. This is some of the measures of the validated scales that we've used in the study. On the left side is the POSAS scale, which measures scarring and regular skin tone.
It has a bunch of different measures, but essentially the top two lines show how the participants viewed their scar, with 1 actually being the best, meaning non-perceptible, 1 being normal skin, 10 being not good skin, lots of scarring. As you can see, this early on, they feel like it's almost like normal skin. The surgeon is the very bottom one with the combined. On the right is the BREAST-Q. It's two of the scales from the BREAST-Q. We did many of the scales of the BREAST-Q. This is two of the measures that are key to outcome. As you can see, we measured pre-op, pre-procedure, breast satisfaction. Satisfaction with your breast, how satisfied are you? 41% were satisfied. Post-procedure at 1 year, 85%. That's more than double are satisfied.
Looking at the post-op, as far as the overall procedure, the overall outcome, we couldn't measure that pre-op, but almost 90% are satisfied with that. Here is one of our study participants, and the videos you saw before are also all study participants, our bride and rock climber and ballerina. This just shows a participant at pre-op, pre-procedure, and then 1 month, 6 months, and 12 months. You can see it's a very stable result, staying right where it was put, and a very nice result for this participant. This is that same participant, and it shows a different view of it, where you can see kind of in the axillary, there's no scar there. Also, you can see how proportionate her result is with her body and how natural that slope is. Very natural results.
This is taking a look at a different patient under MRI. Traditionally, surgeons don't put SmoothSilk over the muscle in the subglandular placement because generally there's higher complications, especially capsular contracture. However, SmoothSilk has shown over more than a decade that it can be safely used over the muscle and even through transaxillary with very, very low complications. This MRI demonstrates and shows you where the implants are properly placed over the muscle and right where we want them. As far as after the study, patients, participants will be followed through 2 years, and we are continuing to do cases in Costa Rica. We've refined the procedure even less than 15 minutes. As far as globally, we're targeting the approval in EU is a priority right now.
To be clear, the implant is already approved. The Ergonomix2 Diamond is already approved for the last 2 years. We are waiting on the tools to be approved, and that's once Annex XVI is adopted and agreed upon in EU, which is supposed to be very shortly. We are ready to go. We've already addressed all of the questions related to it. We're hopeful that as soon as regulatory timelines line up, that we'll be prepared for EU, which we're targeting at early half or first half of 2023. In other geographies, we're ongoing. Some were already approved and we're using it, multiple countries in Latin America and going into Asia-Pacific. We're moving forward in other areas as well.
This gives you kind of an idea of estimated projected timelines. These are just projected based off of the estimated timeline of regulatory approval. You can see in Latin America, we have some 2023-2024. It should really be 2022-2024. Europe, 2023-2024. APAC, you can see. U.S., again, I'll talk about on the next slide. This, again, is a projection based off of what the pathway that we believe we will take, which is this. We will work with the FDA to determine the best pathway to bring Mia to the U.S. as quickly as we can once we receive our PMA approval of our current Motiva devices.
We expect that we will submit a pre-sub and a supplement related to this, and then we will work with FDA and intend to use some of the results from our international experience in these robust studies that we're doing to help support that approval. We will keep you posted on that process as we go. Thank you. Turn it over to Raj Denhoy, CFO.
Thank you, Roz. I'm batting last here. I wanna provide a little bit of some of the work we've also done in sizing the market potential for Mia, as well as some information on the commercial model, which we're pursuing with the product. As many of you might remember, back in February of last year, we did some initial market assessment work around Mia. We surveyed 4,300 women around the world. What we found was there was 1.9 million women a year in those markets that were interested in getting the procedure, 50% of which were new to the category. They would not have considered breast augmentation prior to that. Again, this is work which we had done last year and the year before.
Using that information, we sized the market, the total addressable market for us, including Mia, at about $4.5 billion-$6 billion. Part of what we've wanted to do since this initial work was to kind of revalidate whether some of these numbers were in fact true. As part of the ongoing consumer research that we've done, we've gone country by country, we've done several countries at this point, to look at demand within each of these geographies. What we started with is we've surveyed women 25-54, high household income, with cup sizes of A to B, and also women that have not previously been augmented.
What we've done is we've exposed the concept of Mia to them, and we've asked whether they wanted to have Mia and whether they would actually get it within the next 12 months if it was available. We've done this work now in several countries, one of which is Japan. It's a very busy slide, but the sort of takeaway is the bottom of that triangle is that in Japan, I think there's 155,000 women who are interested in getting the Mia procedure, 133,000 of which have said they will get it in the next 12 months.
What is, I think, important about this slide, if you consider what is happening in Japan right now, there is something on the order of about 5,000 breast augmentations being done currently in Japan. With the Mia concept, with all the benefits of Mia, it unlocks a significantly larger market for us and for the technology. We did similar work in Switzerland. Again, we came up with 41,000 women who are interested in the procedure, and about 18,000 of them were interested in getting it in the next 12 months were it available. One interesting finding from Switzerland was that we actually asked women if there was financing available, some other purchase support system available, and that number went up by 80%.
The 18,000 went up by 80%, suggesting that if it was easier for women to pay for the procedure, they might be willing to do it even more so. But the takeaway from these two slides, you know, between Switzerland and Japan, there's almost 200,000 women are interested in getting the procedure. Which again, I think in our minds really validates some of the earlier work we did on whether there is truly a market for this. You know, we looked also at women's willingness to pay for the procedure. What we found generally in these geographies was about 1.5-2 times the price of a traditional breast augmentation is what women would pay for Mia.
Really, you know, using that as a basis, we really sort of looked at this is largely being validated on the consumer side, right? There is interest among women to get this. They're willing to pay premium prices relative to what current breast augmentations are currently going for. But the other big, you know, element to this is the partners, right? The centers that will actually do these procedures. We have done quite a bit of work in trying to understand what they need as well and how we can satisfy them. This really just shows, you know, history of Establishment Labs and our innovation that we brought to market.
What's interesting about this is that in every step up along the way here, we have realized better value for us as a company, but also offered more value to our partners. You know, each of the steps between Round to Ergonomix to Ergonomix2 was anywhere from a 30% to 40% to 50% uplift in price that we received. Mia is gonna be a step even further than that. What's interesting though is that even though it's more valuable for us as a company, we think it's a lot more valuable for our surgeon partners as well.
What we tried to show in this analysis is that looking at the revenue that a surgeon will make per hour doing Mia versus a traditional or premium breast augmentation, so a higher end breast augmentation, you can see it's 5-6 times more revenue per hour that a surgeon can make doing Mia. Again, it's being driven by the fact that, you know, the procedures are more expensive, and they take simply a lot less time, 15 minutes versus about 64 minutes. What's interesting though is that what makes that model work though is that the surgeons stay busy, right? That they can actually do these procedures every 15 minutes. This is a study we did earlier this year where we had one surgeon essentially do 10 cases in under 5 hours.
The procedure you just saw was done in 11 minutes. These procedures were done in 8 minutes skin to skin. In 4 hours and 38 minutes, the surgeon was able to do 10 patients. I believe this was a very calm, sort of very similar to what you saw. This wasn't rushed. It really proves that if you can keep the surgeon busy, economically can be very powerful. You think about doing 10 Mia procedures on a Friday morning, surgeon would walk home by lunch with literally tens of thousands of dollars of revenue that they would have made. The economic engine is also powerful for us as a company, right?
If you look at the scalability of revenue, and this just shows what one clinic doing 6-10 cases per week at $2,500-$3,500 ASP. One clinic on annual basis would represent about $600,000-$1.5 million in revenue. Again, you can just scale this, right? You multiply it by five and you're at $3.5 million-$7.5 million, and then you multiply it by ten. As we start to train more clinics and we make this more widely available, the economic engine for us as a company is also quite powerful. Really just to wrap up, you know, on this section.
You know, for 2023 and beyond, the way to think about Mia for us as a company is that we are investing currently in this new category creation and aesthetics. It is about building consumer awareness and then converting that awareness into procedures. Converting it to procedures. We're partnering with clinics. We're explaining the economic model. We're working with them on ways to capture consumer demand. Importantly, this idea of scale, right? It doesn't take many clinics, as you've seen, if they're properly organized, they're efficient, the patients are there, you know, the economic engine can be quite powerful. If you think about, you know, the near term for us and the way we think about it in terms of finances for us, 2023. This is important, is really about proving the model for us.
It's about gathering information, understanding that the model works, and then sharing that evidence with investors, with surgeons, demonstrating that we can create this category, that new patients are showing up. Having proven that model, which we think we will in 2023, it's about taking that information and scaling this as you move into 2024 and beyond. With that, I will turn it back over to Juan José.
Thank you, Raj, and thank you, Roz. I would say that most important takeaway from today is that Mia is real. When we see the technology, when we see the procedure, when we see the outcomes, but especially when you think about that we are creating value for these new consumers. Why? Because they are, you know, leaving behind all of these compensatory mechanisms and giving more value to this new quality of life that they can encounter. Beyond that, we are creating value for the partner centers that are going to be with us in creating this amazing experience for consumers. Beyond that, we are going to create a lot of value to shareholders because this opportunity brings about a new consumer base. As you saw in the numbers that Raj showed, this can be extremely important. This dynamism for, you know, breast aesthetics has never happened before.
We think that, you know, perhaps the industry focused on, you know, consumers of a very small segment, when in fact, most of the consumers potentially are unlocked by Mia. We believe in this, and we will work to execute this in 2023 and beyond. We are in the last steps of the final regulatory approvals, and we believe that this can become the biggest opportunity in breast aesthetics in 60 years, since 1962, when the first breast augmentation happened. Thank you very much. Now we will take your Q&A.
Yep. We will take a few questions here from people in the room. Just to level set, we wanna keep the Q&A obviously related to Mia and what we've talked about today, and so, given the timing relative to third quarter and the fourth quarter and guidance and things, we'd rather you didn't ask questions on that, so we didn't have to refuse to answer them. With that, we'll take. I guess we can start with Marie right there.
All right. Thank you so much for hosting this. Marie Thibault from BTIG. Very impressive procedures and market opportunity. Would like to just start here with how many centers you have trained. It sound like you're ready to go for a European launch. A little more detail on existing use. It sounds like you are in Latin America and parts of APAC at this point, so any more detail there would be helpful.
I think at this point, what we are ready to say is that we have began the training of centers that will eventually launch with us in different geographies. Furthermore, we continue to learn from, you know, performing more procedures both in Costa Rica and also, you know, eventually in other geographies. Remember, we did do procedures in Japan in 2019, and we plan to do more there ahead of a product launch. The most important thing I would say is that we are also putting together the existing centers so that we can train enough centers per week, per month, per year, to be able to scale the way Raj Denhoy showed. The reality is that we don't need thousands of centers to be able to get to the revenue numbers that we believe are applicable to this opportunity.
Josh.
Oh, thanks, Raj. Josh Jennings from Cowen. Thanks for inviting us down to this beautiful country and hosting this event. Just two questions. One on the no-touch technique and just the importance of that and how differentiated that is. My understanding is that the potential bacterial contamination contribute to capsular contracture, maybe even ALCL. I think some have hypothesized that you're eliminating that completely. But maybe just to verify that and just what the benefits are of this no-touch technique. Then secondly, on the supplemental PMA filing pathway potential, it seems as if other breast implant manufacturers when they've introduced a new product, I think most recently Mentor increased the fill of their implants, and I think they got that through as a supplemental PMA.
This is mostly, I mean, the same shell, same gel technology, but just a different surgical approach, which I don't think the FDA approves surgical techniques. Just wanted to better understand how optimistic you are around the supplemental PMA pathway. I know that's a little bit out there, but thank you very much for taking the questions.
Sure. Thank you, Josh. I will answer the first question and JJ might wanna add, but absolutely correct on the no-touch technique. This is the first truly no-touch technique. Even using, you know, the current insertion sleeve, there is touch involved once it's in and manipulation. The benefits are just that you reduce the bacterial contamination on the surface. Also, you reduce the impact of the damage to the shell on manual manipulation. Increasing longevity of the implant, the implant shell, it really does create the safest environment for the implant. So you're correct on all of that outcome. Looking at the pathway, yes, it is true. It's we are projecting that we should be able to add it in. We're gonna have to work with FDA on that, and so it's uncertain yet how they'll view it.
It is the implant, essentially the same. It's the delivery system that would be an accessory to a Class III device. What would need to be demonstrated, we'll work with them and make sure we demonstrate that.
Yeah. What I'll add to that is that it is not only the no-touch technique. It's the fact that you're completely standardizing the delivery method. If you look at iatrogenic ruptures, they are important. You know, most of the ruptures that you see today, at least with Motiva implants, because we get these devices back, although we have such a small number of ruptures. When we get these devices back, we are examining these devices, and we often find that, you know, it was either, you know, a needle or a retractor or a metallic object that ruptured that implant and the surgeon couldn't know. It was probably a very small rupture.
What we are doing here is completely eliminating that risk, and I think this is going to, you know, have a big effect downstream in the number of ruptures that we will see. Furthermore, what, you know, Rosalyn was saying is absolutely true. You know, this is the first time you have a true no-touch technique. It is possible because of all these technologies that we have created around the injector and also because of that diamond implant. Remember, there's no, you know, front or back. So when you're, you are injecting, you don't need to worry about that at all.
I think I had another question from Marie.
Sure. Also intriguing, you know, the demographics you talked about in the patients in the IRB study. Curious about how those kind of demographics are gonna impact your marketing. Also curious to know what women wanna know about the procedure. It's novel, right? What do they wanna know to get comfortable with getting the procedure?
It's very interesting because it truly is a new consumer base. What we have found in the insights is that, you know, a lot of these women, you know, were not looking for a traditional breast augmentation, so their views on safety are not tarnished by the legacy of the industry. They kinda like take it for granted that this is going to be a safe procedure. They also tend to say that, you know, they trust and they wanna do this with the best partner. That's why, you know, we are only going to partner with the best of the best when it comes to the centers that can deliver on that experience. When we look at demographics, you know, it is no surprise to us that during the IRB series, we had, you know, such a compact group.
You know, beyond that, you know, in the patients that we've been doing since, we've had, you know, women that 62 years old and said, "You know, it's finally time for me to do this." We find that there's so many reasons why women that were using compensatory behaviors, eventually say, you know, it's time to move on from that. The other thing that I think is really interesting is that, you know, now that we can ask, beyond the IRB series, these consumers a lot more questions, we're finding that, for instance, the same day of the procedure, they went to the movies. A student, a law student told us, "I continued studying that day, which, you know, shortly after I came home." Other ones were saying, "You know, next day I had a birthday party.
I still went to it. You know, maybe the exercise part, and for good reason, is left for later, but their social lifestyle continues. I think that's going to have a big effect on women that want to enter this category. I mean, you saw the bride. It's an amazing story. By the way, that's actually an engineer. The fact that you see her, you know, lifting her arm shows you how, you know, she was enjoying that day with no pain. The surgical stigma is the last thing that we should talk about is that you look at the aesthetic results, and they don't look like they had a breast augmentation. They don't look like they had something done. I think that's where all of aesthetics is going.
I think, you know, what we are doing is also in line with, you know, the new generations of aesthetic consumers want to go.
Normalizing cosmetic surgery and aesthetic surgery. Just to add, also to your question, as far as marketing efforts, absolutely targeting kind of that range, this kind of the very tech-oriented consumers and the ones that are on social media, those pick up on it quickly. One of the other items they focused on a lot was not doing general anesthesia. They really liked the fact that it was done under local. Even in the series alone, once the earlier subjects, participants did it, they came back and said, "My friend wants to participate too. Could she enroll? Or, you know, my sister, my everyone." It was very quick kind of word of mouth on the grassroots marketing end.
Two quick follow-ups for you, Raj. Just on the partner center dynamic. I mean, it sounded like your team, your whole team's gonna be selective in terms of who you partner with. Just wanted to hear a little bit more about that strategy, maybe ensuring good outcomes initially, but then would you broaden that, or should we be thinking about, you know, Mia centers popping up regionally and they would be kind of exclusive partnerships within the plastic surgery community?
I think the important thing to consider there is that, you know, as we showed, the economics are most powerful when clinics commit to this, when they become true partners in this, right? Part of it is understanding the different dynamics of different types of clinics and whether they have the capacity to organize to understand the value of this, to work with us in that demand creation and ultimately, you know, moving that into procedures. It is a select type of clinic, a select type of surgeon who can do that. I would offer that, you know, we're gonna continue to be selective in that way.
You know, of course, we can't deny, you know, if people are interested in those kinds of things, but we are looking for a commitment on the part of our partners if they would like to be involved with us on this journey. So I would think about it again, there will likely be a smaller number, but they will be again efficient, operating at higher capacity. As Juan José mentioned, we don't need that many to generate the types of revenue that we're looking for.
Yeah. The important thing here is to understand that we are going to create awareness with these consumers. Most importantly, our job is to convert it into, you know, Mia consumers, and that's the real job. You know, that's exactly what, you know, this industry has lacked. It has focused on those that walk through the door. For the first time, we have that shiny object that is going to allow us to create an awareness that will match the conversion levels that we need. Very interesting from these same consumers is that, you know, the length of time at the center from walking in to leaving is, you know, 90 minutes on average. So very short.
Again, it just speaks to how this is a real consumer product. The value that we create for that consumer, for the partner clinic, and for our shareholders is what we are focused on. That's why getting on year one, you know, that awareness to conversion mechanism right, making it as efficient as possible, so our cost of, you know, of acquisition, you know, is efficient, is what it is about. Our first year will be qualitative. I think then, I mean, you saw the scalability. The numbers can be as big as we want.
Great. I just wonder, one follow-up on Japan, just those stats that, like, 155,000 women potentially wanting to move forward with Mia. I'm assuming that that's due to the elimination of breast scarring. But maybe you could just help us think through that, maybe repeat those stats. Is it 5,000 breast implants annually today going to 30x with the introduction of Mia, potentially, but is that the primary driver and is-
It's about injections, hyaluronic acid. Yeah. Maybe I'll give you a little bit of background on that because I think it is important. In 2013, we were in Japan. We felt very happy because it looked like we were about to become market leaders in Japan. It was going to be one of our first countries. We realized that the numbers did not match our expectations for such a rich society and a pretty large country. We realized that most of that market had converted to hyaluronic acid injections. You know, these consumers were paying twice as much for that procedure, a procedure that only lasts for a couple of years, and that ended up being unsafe.
Basically, after a few of these, you know, there's so much fibrosis that, you know, you cannot do breast screening. The breasts become hard. We said, "This is so incredible." That's when we said, "That tells us about a new potential consumer." What we wanted to solve in Japan eventually became so much bigger than that, 'cause that Japanese consumer, you know, is so sophisticated that they didn't see a real answer with breast augmentation. Now we understand that when they see Mia, they see it as something that it is appealing, and they're willing to pay a lot more for it. You saw the numbers. You know, I think that it reflects the kind of opportunity that this is.
If we have time, maybe one more question.
Two quick ones. Japan, do you have enough? Like, are there enough plastic surgeons to do this? The second question, are there clinics that have that are doing Mia somewhere in Costa Rica or other Latin American countries where you have a gauge for what the mix looks like of traditional. You know, what patients are choosing between regular augmentation and Mia, if that has shaped your view of what the mix might look like, 50/50 or?
If we follow, you know, the research, you know, we would think that for the Mia consumer base, you would have half of them being new entrants, full new entrants into the category. That the other half would be women who are already in the consideration phase of breast augmentation, and they say, "This is so much more appealing for me, although I understand that it will come at a different price point." The interesting thing in the Japanese market is in aesthetics, it is led by groups, not by individual plastic surgeons. These groups have, you know, many clinics. You know, we're talking about, you know, groups that have 20, 30, 50, even 100 clinics throughout Japan. You don't need so many partners to be able to scale this in Japan.
There are enough doctors there?
There are enough plastic surgeons, and their setup in terms of business, it actually makes it a lot easier to scale because these clinics already have marketing directors, you know. They're already marketing other procedures to consumers in the way that they would market Mia to consumers.
Just back to my second question. Do you guys have any clinics that would be an example yet of what their mix has looked like or too early?
We don't have, at this point, enough information to give you a straight answer, but our view is that, you know, if we look at all the market research, is that eventually this will be at least as big as to what they are doing right now with breast augmentation.
From a procedure number.
At a different price point.
Yes.
A different value point.
Well, we are out of time, so, I'd like to thank everyone for joining us. I don't know, Juan José, is there anything you'd like to say at the end?
I would like to thank everyone for coming to Costa Rica. It's always great to have people at headquarters to meet our team. I also want to take the opportunity to meet everyone, you know, in Establishment Labs with you, because it's, you know, it's a great opportunity. It's been quite a journey over the last decade to get to this, and I just wanna tell you how much we are focused on not only developing this new category but making sure that we get it right. The opportunity is just too big. Thank you.
Great. Thank you, everybody, and thank you for joining us on the webcast.