Establishment Labs Holdings Inc. (ESTA) Earnings Call Transcript & Summary

Thank you, everyone, for joining us today. My name is Renee Gaeta, Chief Financial Officer, for Establishment Labs, and I will be moderating the event. With me today from Establishment Labs is Juan José Chacón Quirós, our Founder and Chief Executive Officer; Denise Kellermann, our Senior Director in Research, Development and Innovation; and Rosalyn d'Incelli, our VP of Clinical and Medical Affairs. I'm also honored to have Dr. Marcos Sforza and Dr. Charles Randquist joining us today. Following our event today, we'll be happy to take your questions. Before we begin, I want to remind you that Dr. Sforza, U.K. Board Certified plastic surgeon at [indiscernible] Hospital in London, and Establishment Labs Medical Advisory Board Member and an Educator in the MotivaEdge Program; and Dr. Charles Randquist is a Board Certified Plastic Surgeon at Victoriakliniken in Stockholm, Sweden and investigator in the Motiva Implants U.S. IDE Clinical Trial and an Educator in the MotivaEdge Program. Dr. Randquist is a development consultant for the MIA system project, and all statements today are based on the experience and outcomes of the IRB-approved MIA clinical study in Costa Rica. Additionally, the comments made today by management during this call will include forward-looking statements within the meanings of the federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements involve material risks and uncertainties and the company's actual results may differ materially. For a discussion of risk factors, I encourage you to review our quarterly report on Form 10-Q that we filed with the SEC on November 9, 2020, and is available on our website. The content of this webinar contains time-sensitive material, accurate only as of the date of the live broadcast, February 9, 2021. Except as required by law, Establishment Labs undertakes no obligations to revise or otherwise update any statements reflected in events and circumstances after the date of this call. And with that, it's my pleasure to turn the call over to our CEO, Juan José.

Thank you, Renee. Good afternoon, everyone. I hope everyone is healthy and continues to be safe. We spent most of this morning attending Motiva MIA procedures as part of the IRB-approved study here in Costa Rica. It is such a pleasure to witness all the progress we have made in the last few years by focusing on women's health. We've had a lot of questions about the potential and commercialization of Motiva MIA, our minimally invasive breast augmentation system. And we thought we would take some time today to walk everyone through the technology and the procedure technique as well as discuss the outcomes of the first 30 patients in our IRB-approved series. Also, Renee is going to give you a good look at some of the market research we have used to define the market opportunity and the total addressable market for this procedure. Finally, Rosalyn is going to provide some guidance on the regulatory pathway around the world. I founded Establishment Labs to bring innovation to breast augmentation and reconstruction by updating the breast implant with the latest advancements in science and technology. Just as important, I also aspire to bring exciting and innovative options to the procedure itself. Motiva MIA is our latest contribution, true technological innovation that creates a new category in aesthetics and allows a new group of women to make choices that match their lifestyle. When comparing Motiva MIA to traditional breast augmentation, there are many reasons for women to be excited. It is a minimally invasive breast enhancement procedure that can be performed in a minor surgery setting without general anesthesia, provides a natural aesthetic result that concern from disproportionate breast size or visible scars, significantly reduced postoperative pain and a fast return to daily activities, an impressive early safety and effectiveness outcomes. Even through all the breast implant industries [indiscernible], lack of product and procedure innovation from legacy companies and the challenging media coverage, breast augmentation continues to be the #1 surgical procedure in plastic surgery. In that same period, we have watched on the surgical specialties, we invent themselves through minimally invasive solutions and make once [indiscernible] procedures accessible. This type of evolution inspires us to make a similar contribution to plastic surgery and transform how surgeons approach breast enhancement and provide more value for women interested in breast aesthetics. To make it easy for everyone to visualize this concept, we have prepared a video demonstrating the Motiva MIA system, including the Ergonomix2 Diamond Implant, followed by footage from the MIA procedures performed in December, surgeon and patient testimonials, and a wealth of information regarding the initial outcomes this IRB-approved study. Let's watch it. [Presentation]

Hi, everyone. I'm Dr. Charles Randquist, and I'm a plastic surgery from Stockholm, Sweden. For the last 20 years, I've been working as a KOL, key opinion leader, and a medical educator in plastic surgery, mainly on the topic of breast surgery. I've had the pleasure of sharing my concepts on best practices in breast surgery with great surgeons from all over the world visiting my clinic in Stockholm based on the experience I've gained over the year with different implants and surgical techniques. During my career, I've traveled extensively around the world. And in Asia, I was often confronted with a challenge: patients did not want visible scars, general anesthesia or unnatural, operated-looking breasts. I always envisioned a minimal invasive breast enhancement procedure with implants, instruments and a technique that would be fast, predictable with less visible scars, achieving natural-looking breasts, enhancing the quality of life in a safe way, meeting, specifically, those patients' desires. I'm, of course, extremely happy and proud after many years of collaboration and product development with Establishment Labs and their amazing team in this revolutionary project that we've done exactly this. All our objectives were met, and we were able to move forward with surgeries, starting more than a year ago in Japan. The Motiva MIA series we performed last December, the age in that group ranged between 18 and 42 years with a BMI between 17 to 23.7 and an average of 20.43. The range of prior bra sizes were 32A to 36C with an average of 34B. These were patients with a low BMI looking for small to medium enhancement of their breasts to fill up their bra. Now based on the international bra measurement system, patients had a range of 1 to 3 cups up with an average of 1.64 cup increase and with a volume increase between 170% to 230% from the preop volume. Noticeable is that over 2/3 of the patients achieved a final result of over 1 cup up augmentation even though we were using smaller implants than usually used in primary breast augs. The trend of patient recovery time was very satisfactory from surgeon and patient perspective, ranging from 79 minutes the first day to 28 minutes on day 5, especially comparing average recovery time of a breast augmentation under general anesthesia, that normally is around 4 hours. They reported they were able to return to normal activities in less than 2 days after the procedure. And the patient satisfaction level were very high with an average of 94.6 on a scale of 100, measured using the BREAST-Q system at 1-month follow-up. Let's look at some pictures. These are the first cases that were performed in Tokyo, Japan on December 17, 2019. So more than a year ago. And as you can see, patients are photographed from different angles, showing results preoperative, 2 weeks postop and 6 months postop. And already then, we understood that we were able to achieve the results we desired for. And this is patient B after 3 months. And as you can see, she's got a beautiful result with a nice enhancement of her breast tissue. Looking at the series we performed in Costa Rica last year in December, starting with a patient that went 1 cup up, you can see that the desire of achieving a natural looking breasts were achieved, where there is more upper pole volume, lower pole volume, a more balanced proportion look according to her hips, waist and shoulders. From all different angles, I dare to say this is a beautiful result. This is another patient with 2 cups up. She has nice, beautiful-looking breasts prior to surgery, but desires, of course, a more apportion look according to her hips and her waist. So the balance between width of the breast and the rest of the body was achieved in a very nice way, as you can see, with more upper pole volume, lower pole volume and overall, a better look. This is patient number 3 that went 3 cups up. And as you can see, she had beautiful natural looking breasts prior to surgery, but desired something that was more proportional to the rest of her body figuration. And I dare to say that this patient also has a very natural look after surgery, but with the desired more upper pole volume, lower pole volume and more projection. What's important to understand is that when we show these before and after pictures, they just give one way of looking at it. And that's not very often the way patients look at themselves or perceive themselves. This is a different way of presenting results, which very often patients find more pleasant because it doesn't look so medical in its way. And it also presents the possibilities of patients understanding more what 1 cup up would mean for them wearing a bra or a bikini. So these are very colorful ways of presenting before and after results to patients in a way which they understand will give them that added quality of life. This patient had 3 cups up, 250% volume increase. And as you can see, just by looking at her and looking at the photos, this is a great result. So my key takeaways of these initial 30 patients is that we have proven the concept of a minimalistic, safe, predictable, minimally invasive breast augmentation procedure without general anesthesia with less surgery time compared to average traditional breast surgeries and with a fast recovery without any stigma from the procedure. Furthermore and extremely important is that we've seen that surgeons in an easy way can reproduce the concepts of MIA in how to in an accurate way select the right patients and implants for MIA and deliver amazing results. And with a quick learning curve. So as you will hear in some of the testimonies, patients' experience exceeded their expectations, and the outcomes are also meeting and exceeding our expectations as plastic surgeons. So thank you for listening, and I'm looking forward to receiving any questions later on. Thank you very much. [Presentation]

Okay. For the next portion of our presentation, I'm going to talk you through the market research and current estimates for the Motiva MIA opportunity. Let me start by discussing our findings on the total addressable market for our minimally invasive breast augmentation. Minimally invasive should create new category in breast aesthetics. When we set out to quantify the total addressable market for MIA globally, we started by trying to understand women's perceptions on breast augmentation and look to determine their predisposition to pursue a minimally invasive approach compared to the traditional breast augmentation surgery. To do that, we commissioned multiple studies from third-party firms, their analysis, which included over 4,300 subjects across 11 key countries. The cohorts included women's aged 18 to 55. Based on those findings, we estimate that the global market size for MIA to be 1.9 million annual procedures. It is interesting to note that of the 1.9 million women, we believe to consider the Motiva MIA system, about 50% of them are made up of women who are aware of the traditional breast augmentation but would not seek that procedure. They would, however, opt for MIA if available. The primary factor subjects mentioned to support their mindset included no requirement for general anesthesia, fast recovery, natural and proportionate breast appearance and no visible scars. On the next slide, we wanted to show a comparison of the current total addressable market, the new potential MIA market and the combined opportunity for Establishment Labs. If we take the 1.9 million procedures and assume a range of prices in different regions of the world for the Motiva MIA system, this translates to a potential total addressable market of $4 billion to $5 billion globally. The combined addressable market for Establishment Labs would increase from approximately $1.2 million to $1.5 million today to $4.6 billion to $5.8 billion. Our estimates of the total addressable market for the MIA system is based on this survey of women ages 18 to 55 who indicated that they would consider the Motiva MIA procedure in the next 12 months, and has been normalized for consumers only wanting augmentation for 1 cup up. On the next slide, you can see how this $4 billion to $5 billion market of minimally invasive aesthetics breaks out geographically. Again, these figures were derived from women seeking a 1 cup up and who said that they would consider Motiva MIA procedure in the next 12 months. The largest market at 31% is the Middle East Asia Africa region, Europe follows with 29% of the total addressable market, then North America at 24% and South America at 16%. Important to highlight that within the MEAA region, China comprises approximately half of the total region and is the largest single country. Therefore, followed by the United States. Both countries which we expect to have huge expansion for Motiva Implants. Here is another way that we've actually framed the U.S. patient opportunity. We continue to develop market research and look for ways to compare and contrast results. We leverage third-party data on the U.S. population, segmented it for adult women ages 20 to 54 and with a minimum household income of $50,000. Then applying further segmentation for women actively wearing padded bras and potentially interested in minimally invasive procedures. This alternative view closely validated the third-party market research previously discussed. While the results are still early, I think you can see why we are so excited about the opportunity for the Motiva MIA system to transform and expand the existing breast aesthetics market for Establishment Labs. Given the paradigm share [indiscernible] that Motiva represents, [ we believe ] that the new cohort of women will [ undergo ] breast augmentation for the very first time. The Establishment Labs team has worked tirelessly to advance this breakthrough technology, and we believe that it has expanded -- sorry, we believe that it will expand our already comprehensive product portfolio and differentiate us as a market leader going forward. And with that, I pass it over to Rosalyn to discuss our regulatory path forward.

Thank you, Renee, and good afternoon, everyone. I am pleased to share current status and pathway for the Motiva system for the various regions. Please note that some of this information is an anticipated pathway and all will be subject to the applicable regulatory requirements of each country. This slide represents the MIA system regulatory status and process of the full system. The Ergonomix2 Diamond implant is a Class [ III ] and already has CE Mark approval. The MIA Balloon is a Class IIA and the MIA Injector is a Class IIB. All of the technical documentation and testing is complete. And the Motiva MIA system has received regulatory approval already in Costa Rica as well as Free Sale Certificate to commence regulatory approvals in the markets that require it. As far as time lines for [indiscernible], registrations in Latin American countries are underway for those expected for the Motiva MIA system to be launched in 2020 and 2023. CE Mark has already been received for Ergonomix2 Diamond. This is the implant that is part of the Motiva MIA system. And we expect approval for the tools and market access in early 2022. In the various Asian countries, we expect regulatory approvals for Motiva MIA system in 2022 and '23. [indiscernible] China and the United States, regulatory approvals will be based on the ongoing regulatory processes that are currently on [ the way ]. So potential approval dates could take place in 2023 to 2024 for China and 2024 to 2025 for the United States. Although in both cases, we will provide updates as interactions take place with the National Medical Products Administration in China and the Food and Drug Administration in the United States. Looking more specifically at the United States, we plan to pursue FDA approval during and right subsequent to our PMA approval for the Ergonomix2 Impact, which is currently ongoing. We will work with FDA to determine the best pathway, which will likely include a pre-submission discussion and a PMA supplement. The data we are collecting to the various studies will be used to help support approvals in the United States as well as other regions. Looking at these clinical studies. The collective results of this data set will be supportive. We have already completed -- or there's already completed an independent [indiscernible] patient series in Japan, which Dr. Randquist referenced earlier. There are also multiple clinical studies in process. We have enrolled a patient IRB-approved [ prospectus ] in Costa Rica and recently received approval to extend it to a total of 100 patients, which we began enrolling earlier [indiscernible]. We plan to complete that enrollment for that study by the first half of this year. We will commence additional IRB-approved multicenter studies in Thailand in the second half of 2021 and may extend those studies to other countries as well. Collectively, these will provide a robust clinical data set to demonstrate the clinical utilities, patient experience, safety and effectiveness of Motiva MIA as well as provide support for [indiscernible] regulatory clearances. With that, I'd like to turn it back to Juan José for closing remarks.

Thanks, Rosalyn. Before, we open it up for questions, I'd like to express my gratitude to our business partners, plastic surgeons around the world for their ongoing commitment to Establishment Labs. Our success with this initial 30 patients of these IRB-approved series marks a significant achievement as we advance this revolutionary platform for breast aesthetics. This is truly a new category in aesthetics, and we'll continue to work to make the best of this opportunity. With that, I'd like to turn it over to Renee to lead the question-and-answer discussion. Renee?

Okay, everyone. What we're going to do is allow the opportunity for questions to be provided via the Q&A function through Zoom, and then we'll also allow the opportunity to open up the live audio for additional questions. So please enter your questions through the Q&A chart or raise your hand if indicated that you would like to ask a question live. But just give me one moment, I'll find out questions. Okay. Our first question comes from Matt Taylor of UBS.

I have 2 questions. One was just, obviously, noticed with the market research that you did that you were assuming a higher price for the MIA Implants. Can you talk about how you arrived that what the price range could be? Did you do some market testing for that? And would love to hear any feedback from the other folks there as to how that would play out.

So Renee, do you want to me -- I can start, or you can start and then I can follow after that. And maybe Marcos can provide also your views because you're a practicing surgeon in London and you have a very active practice.

Go ahead, Juan José. You can start.

Yes. I think, Matt, that's a really good question because it is complex when you do this type of market research globally to get meaningful data. And that's why as part of this market research, we wanted to know how much the change in pricing would affect the access in the market. So what we realized is that there was very little movement in the number of women willing or unwilling to participate based on pricing, which really shows that they value the procedure. I think that is a very good understanding of what we could get in the future as we go to these different countries. Now it is important to realize if we just take one average selling price, we are taking into consideration that there will be regions with more price sensibility than others. So that is all taken into account in that calculation of the TAM. But I think that it is important to realize that we've been able to create more value over time for this industry. And as we have done so and invested in our technologies, we've been able to get the value that we expect from. Now from a surgeon perspective as well, you have to realize that you can do so many more of these procedures per day. So for any plastic surgeon, getting this new group of patients, new group of patients and so many of them, I think it's going to be an amazing opportunity for the entire plastic surgery community to be part of this experience. And perhaps Dr. Sforza can also comment on the premium pricing of this procedure.

Yes, Matt. I actually don't know how much this cost. I haven't been told. But I definitely agree with the fact that this is going to be a premium procedure. And then actually, if it's going to happen all of plastic surgeons -- because it's going to move us from the commodity surgery that everybody does to a new type of procedure and what traditionally was thought to be ideally moving to outside of the hospitals to a more office space where we are allowed to do much more procedures a day and that's a really key element for me. And the second very, very important point for me is that -- we're going to speak about the rest of the Q&A the kind of the recovery and the patient experience that actually really multiply the opportunities. But -- and also opening this new kind of markets where I will always say, these are patients that would never come to me to do a breast surgery, and now they say, "Oh, there is something really special, and we want to be part of it."

Got it. Can I ask one follow-up?

Yes, please.

Great. So I thought the testimonials were very impressive in terms of the commentary on pain levels and the pressure and just the overall experience. And so I guess, I'm wondering 2 things. One is for folks from Establishment for the doctors, do you think that, that kind of experience will resonate and lead to more word-of-mouth referrals? If you could speak to how kind of strong those are versus what you normally hear? And then also, what do we know about longer-term outcomes? And how do you think this will stack up to your strong safety record in the traditional implants?

Yes. I think a lot of things in there, but I'll try to get to all of it. One of the interesting things about this patient series in Costa Rica is that most of those women are professionals and very active. They have a day job. They have so much things to do, going to the gym, doing exercise. You saw one of those a renowned project manager. And what we see is that, of course, if you have that type of lifestyle, you don't want to be off from work. You don't want to be off from the gym. There are so many different things that are appealing from this procedure to them. And once we get to, additionally, your discharge from the center in less than an hour, you have very low pain levels, all of these things, of course, you can imagine these women and telling others, you should do this. And although this is going to be very strongly a digital play, we're going to use social media and digital assets to make sure we communicate about the -- about this opportunity because one of the most important things to be found out is awareness. So we need to create that awareness. A lot of it could be created by word of mouth, and that would be phenomenal, but also we do plan to use digital assets to be able to create even more awareness. The other part, I think it's very interesting, potentially, Dr. Randquist or Marcos talked about this, is the patient experience because it is kind of like very different from what you get from a traditional breast augmentation. And maybe -- Dr. Randquist, maybe you can tell us about that.

Okay. So basically, look, Matt, it's a game changer, right? Like, the reality and then in the last couple of days, we've been doing [indiscernible] already of the extension of the trial. So it's so incredible. We finished the surgery by the time that we are -- the patient's on the recovery to home, she's already having a cup of tea. And by the time we are bringing the second patient or the patient after to the OR, that previous patient's going home. Matt, this is something like unseen in plastic surgery. And that's something that it really reflects what the testimonial words were saying, they were pain free, they were not -- one thing, you may do have time to talk, get nauseated. Nausea. All those patients that -- after surgery, they felt nauseated. Like, they're having a worst hangover of their lives. Like this, there is nothing. You literally like less than 1 hour, you are going home on your own feet. So it's really incredible, Matt.

If I may say something that I think the whole procedure as such, per se, is a different dimension of breast augmentation compared to traditional breast augmentation we've seen for the last 55 years. The big difference is really that these patients go in and go out. And most procedures today are performed submuscular. It is subglandular, which basically is logically where the breast enhancement should be done if the implants were the right ones. And this is exactly what we have right now. So we're able to enhance where there is need for volume. It's not supposed to be under the muscle. It's supposed to be above the muscle. And this is above the muscle. And the big advantage with this is that it doesn't impair with any type of sport activities or daily activities. There's no muscle animation that affects the implant. It looks very natural. And the recovery is very, very fast due to the fact that the way the procedure is done with small implants, giving the type of projection and quite a nontraumatic surgery, the patients go back into daily life immediately basically. And that's something we anticipated, but with the first 30 patients, we're actually to see this with numbers and data. And it's very safe. Today, breast enhancements aren't really growing worldwide compared to a lot of other procedures, mainly in noninvasive procedures. And this is as close to a noninvasive procedure, I believe, we can get. And therefore, over time, I think this will be like an avalanche. It's going to be the type of thing where women who desire a cup or 2 bigger definitely would like to have this. Why? Because there's less downtime, far less pain and hardly any visible scars over time. So I believe that we're seeing the future.

Okay. Thank you, Matt. Next, I would like to open the line for Chris Cooley from Stephens.

Can you hear me okay now?

Yes.

Super. Well, thank you for sharing the clinical presentation with us today. This is extremely exciting. Just 2 questions for me. Juan José or Renee, I was curious as it pertains to the market opportunity, if you could -- if you saw any differences across the different age groups in terms of their interest level for the MIA -- Motiva MIA technique. I'm curious if there was a greater attraction in a younger patient or an older patient or if this was similar in terms of the overall response rate across the various age groups within that range which you presented to us. And then for Dr. Sforza and Dr. Randquist, very, very impressive results. But just curious as well, longer term, ask you if you might want to speculate here a little bit, just based upon the positioning and the type of the implant, could we assume that from maybe a cosmesis perspective that this technique would be less prone to some of the complications that we've seen historically with traditional breast implant surgery? Just kind of curious how we think about the longer-term results here as well.

So Renee, do you want to start with the age groups in the market research?

Super. With regards to the age groups that we looked at, we certainly went across the demographics from 18 to 55 and can appreciate that different age groups within that range might have a difficult mindset towards minimally invasive and also if there are the best-suited patients for the procedure with some skin laxity, et cetera, so which might be geared toward the younger patient, but I think what we saw was really an intrigue and an interest across the board [indiscernible]. And then you can also notice in the market research that we did, we also kind of focused just that 1 cup up. But you can see from the results that we had in Costa Rica within the 30 patients, we actually got more volume than that. So we're continuing to expand our market research and dig into more detail and hope to have an outcome in the future.

Yes. And perhaps to -- I'm sorry, Matt, I did not address the long-term safety in your question, not that I didn't want to. So let's just -- as a refresh, we have our Ergonomix2 platform. Within that platform, we have the second generation of our best-selling product, Ergonomix, but also we have this new diamond-shape implant. Now what's really important to understand is that Ergonomix2 platform builds on all the safety that we have shown over the years with a smooth silk surface now with over 10 years in the market, over 1 million implants out there and less than 1% of the operations due to capsular contracture or rupture. These implants share the same manufacturing processes. They share the same surface. So when you look at the risk perspective, I think it's a great feeling because we didn't change those things that we got right in 2010. Now I'll let Dr. Sforza talk about the clinical part, but I think that we have good reason to believe that with the information we've gotten from all the patients who received Ergonomix2 Implants and also Diamond Implants over the last 1.5 years that the results are not less than what we have seen before.

Yes. So I think we could separate answering both questions like what we would say is the surgical traditional complication like infection or bleeding. We can separate implants-related complications and now the technique-related complications, which -- because we're using new tools, right? So we are over this period where we could easily analyze the surgical complications like bleeding, infection. So these implants can be used, and there is absolutely no more, if not way less, complications related to the surgery and related to implants. And in regards to MIA, actually, we have not seen any complications related to the tools or to the surgical technique [indiscernible]. And of course, as Renee said that the complications related to the Diamond Implant itself, probably there are people using for a little bit over a longer time, but because [ it's the same platform ], I don't see a problem. But what is going to be important is that there is an irrefutable truth in plastic surgery that all surgeons are going to say the same: smaller implants, less complications. And that's what, I think, this procedure also is going to achieve because you could see on the [indiscernible] that some patients got 3 cup size more, but instead of getting 3 cup size more with over [ 200 cc ] implants of any sort of traditional breast augmentation, they were getting that with less than about [ 200 cc ] implants or less. So I think that's the game changer because we [ would be able to do that ] to not only those with ideal cup size patients but all groups of patients with smaller implants. And I want to remind you, smaller implants, less complications.

Yes. I think it would be important to have Denise, our Senior Director of RDI, talk about all the testings that was done with tools because I think there's a lot of work that was put into that and the importance of this super ergonomic Diamond Implant.

Sure. Thank you, JJ. It's important to understand that the MIA system is a combination. It's not only the tools and not only the implants, but how they interact together. So the Diamond Implant part of the Ergonomix2 platform introduced new benefits in addition to the benefits that Ergonomix already provided to the patients, including [indiscernible] Ergonomix for the patients [indiscernible] accommodate better in the pocket. It gives you a better outcome, requiring less volume of [indiscernible]. We have been able to do a lot of the computer simulations that modeled [indiscernible] implant that brings additional benefits and additional comfort to the patient. As Dr. Sforza was saying, less volume, less complications, but we wanted to make sure that with less volume, we could provide the aesthetic outcome for the patients who are looking for it. So this implant with its symmetrical shape actually pushes that projection on the bottom part of the implant towards the front, giving more projection with the same volume. And of course, the tools have been thoroughly tested. They underwent testing for all the requirements and all standards that are required by the international law. And it's very important to understand that we cannot say with 100% certainty that they are always safe and effective and we're proving it with the series in Costa Rica and Japan.

Okay. Next up, we have -- next up, we have Josh Jennings from Cowen.

I was hoping to ask Dr. Sforza. I think you mentioned that you haven't performed transaxillary breast implants prior to Motiva MIA procedures. I was hoping if you could just explain to us why that's the case and maybe help us understand what percentage of breast implant procedures do you think are performed using a transaxillary approach today?

Hi, Josh. Look, I -- as I said, who knows me, that's true. I've never done a transaxillary and -- in my life. I've seen a couple with Dr. [indiscernible] in Korea doing breast [indiscernible] and that's it. But I think the key now is that this is not a transaxillary breast augmentation. I think that's why it was so easy for me to do it because this is not -- this move from surgery to procedure. And then with the tools, it was just like a new thing that I was learning as any other surgeon would learn. So I -- as I say, like, I did my first [ case ] in December and then I was [ commenting ] to the people. When I got [indiscernible] that this patient is MIA. And like, intrinsically, myself, I was, like, thinking, oh, 20% of my patients now are totally MIA, like, just by doing a couple of cases in December. So I feel that, that's really the thing. But I think the key is that I was never [ biased ] about anything because I never done transaxillary augmentation. So for me, it's like a learning a new thing, like learning a new injection, learning a new type of surgery. And then moving out from surgery to procedure, that what makes you feel so comfortable because it is actually a procedure.

Thanks for that. And maybe for Renee and Juan José, can you -- thanks for sharing all the details on regulatory pathways and timelines. I was hoping if you can maybe give us a little bit more detail just in terms of Europe, specifically in 2022? Can you detail the steps towards that commercialization process that you have to take before you fully launch Motiva MIA in Europe outside of the Costa Rica and Thailand IRBs, the more clinical data you need to accrue or -- what are the next steps for commercialization?