We're going to have an introduction from Peter, and then Jeff Ehrhardt, who heads up North America for us, is going to give us an overview of the United States and the progress we're making here. We have two panels of plastic surgeons to talk about aesthetics and reconstruction and their experience with Motiva in the United States. In the second half of the meeting, Roberto is going to talk a little bit about our innovation pipeline. We have a very timely couple of presentations from a couple of surgeons on GLP-1s in plastic surgery. Finally, we're going to have a panel with the plastic surgeons to talk about these new markets and answer some questions you might have. Finally, we're going to have a session with management where you guys can pepper us all with your questions at the end.
We will have time for Q&A throughout with the surgeons. We have microphones, and since we are webcasting, please wait for those before you ask your questions. We hope to wrap up by about 4:00, so we are going to try to keep moving along. With that, it is my pleasure to turn the call over to Peter Caldini, our CEO.
Thank you, Raj.
Two, one, two, three, four. You know, much of the day is going to be focusing on our performance and what's going on in the U.S. business. You know, I think when you look at the performance to date, and we've been off to a great start in the U.S., and I think you're going to hear directly from Jeff Ehrhardt, who runs our commercial operations in the U.S., you're also going to hear from a lot of surgeons. You're going to hear firsthand from what their experiences have been with Motiva. As I mentioned before, I mean, we're off to a great start. In a lot of stances, we're actually exceeding our expectations in the U.S. market.
You know, a lot of that, and I think it's important to highlight, is the strong results, as well as the momentum we have in the U.S., is really driven by and it's really benefiting from over 20 years of successful global innovation at Establishment Labs. A lot of what Juan José Chacón has created is really coming to market in the U.S. You know, we've sold over 4 million devices worldwide. We have over 200 patents approved, as well as pending. We also have a number of publications, really a testament to the focus on science-driven innovation. We're also the only truly global breast aesthetics company in the industry with a broad reach across over 90 markets worldwide. While we're new to the U.S. market, we clearly have a lot of history.
What we've been doing is really leveraging a lot of the learnings and capabilities that we've built over the last 20 years in our launch in the U.S. market. Now, we have a very broad portfolio of differentiated products that, quite frankly, are unmatched in the industry. You know, we are the clear leaders when it comes to innovation, and we also have the safest products in the market. We've been able to create a spectrum of products that go from reconstruction with Flora to our breast augmentation, when you look at Round and Ergo and Ergo2, to our minimally invasive platform, which is really the wave of the future with Preservé and then the premium segment, Mia. We're able to provide value and differentiation at different price points, and it's all grounded on superior performance and superior safety.
As you go across the spectrum, we add value to our surgeons, increased features to our patients, and ultimately better economics to Establishment Labs. I think when you look at the U.S. business today, we're on the early stage of the innovation. We only have right now Round and Ergo1, and we also have in terms of Flora for the recon market. We are in the early stages of this pipeline. You are going to see over the next two to three years a super cycle of innovation that's really going to help drive the revenue growth, share growth, to become a dominant player in the U.S. market. You are going to hear more about that from Jeff. As I mentioned, we have the safest product in the market. I think a number of people have seen this five-year data from the FDA study.
We have less than 1% device-related complications. In a lot of respects, we're almost 10 times better performance than what you've seen of competitive products in the same type of FDA study in the U.S. Really the foundation, not only driving true innovation, science-driven innovation, it's also around a strong safety platform. We have a global, very broad global footprint. We're across 90 countries, some through a direct business where it's our own people, our own sales and distribution capabilities where we commercialize the product. In a number of markets, we have distributors. A key milestone, obviously, is when we got approval for the U.S. market.
We're off to a tremendous start in the U.S., and a lot of it is driven by the unique products, the pipeline that we're bringing to the U.S., as well as we have the best-in-class organization in the U..S., and probably one of the best in the aesthetics industry. When you look at the O.U.S. market, I think there's always a number of questions in terms of the macroeconomic environment. There's been a little bit of choppiness, I think, in the recent past. What we've seen, especially with the tariff discussions, we haven't seen any significant impact in the type of demand. As an organization, we're going to continue to be very vigilant in terms of managing it, finding if there's any changes in that, course correcting, reallocating resources to different markets.
When you look at the O.U.S. market, a lot of this year is going to be focusing on enhancing our operational commercial capabilities while at the same time continuing to drive the minimally invasive platform to drive share in a lot of our markets, primarily in our direct markets. When I first joined Establishment Labs, what really got me excited, what really got me excited was really marrying the tremendous technology, the innovation that we have, and the strong and enhanced execution capabilities. If you look at our priorities this year, number one, our objective is to deliver on our financial targets from a revenue standpoint, as well as profitability. These are our priorities that we really use to really reallocate and allocate our resources within the organization around these priorities. You know, a lot of that is not just financial, it's also personnel.
Obviously, the U.S. is one of our key priorities for this year and beyond. We want to make sure that we continue to provide the resources within the organization and make sure we continue to fuel that growth in the U.S. Minimally invasive is a key driver for us in the O.U.S. markets with Preservé and Mia. It is really focusing on driving efficiency and profitability in the organization. We have made a lot of great strides in this area. It is not just about driving profitability. It is what I said before, enhancing a lot of our commercial and operational capabilities so we continue to drive top-line growth in the marketplace. The real foundation for this company and the legacy that JJ has created is around the innovation pipeline. We have a lot of great products and ready to be launched in the U.S.
We're also looking at what's the next generation things that we're working on. You're going to hear a lot more about that from Roberto. How are we tracking so far this year? You know, as we mentioned before, very confident in our guidance of $205 million-$210 million. You know, we believe with a strong start in the U.S., we're going to be meaningfully exceeding our $35 million. We're off to a good pace in Q2. We expect to exceed $9.5 million in revenue. You look at the O.U.S. market, we're expecting mid-single-digit growth. As I mentioned before, we really haven't seen any dynamics related to the macroeconomic environment. We launched Preservé in Latin America and Mia, and we're off to a great start, very strong initial demand, a lot of commitments from surgeons and clinics.
We continue to enhance our gross margin with the growth in the U.S., but also as we expand our portfolio into the minimally invasive platform. And we've done a lot of work as it relates to operating expenses. You know, since going back to 2023, we've reduced close to 30% operating expenses in our corporate structure, as well as O.U.S., while at the same time we're building up our capabilities in the U.S. market. A key target, and we're still on target to achieve this in 2025, is to be EBITDA positive. Looking beyond 2025, you know, with the continued growth in the U.S., with the pipeline that we have, we're expecting to continue 20% growth over the next three years. We're going to continue as an organization focusing on driving efficiency and healthy growth.
is going to be a lot of focus on the minimally invasive platform that will enable us to become a clear leader in the industry, and also a lot of focus on driving to cash flow positive in 2026. That is a quick summary of where we are as an organization. A lot of great progress in the last two years in terms of achieving profitability, but it is really built on a lot of the innovation and successful innovation we have had in the last 20 years. With that, I am going to pass it over to Jeff.
Thanks, Pete. As Pete said, we are very excited about the progress that we have made with the launch here in the United States. Almost as happy as I am about whoever put that highly sensationalized photo of me up on the screen.
We had five key priorities as we entered the launch year here in 2025. The first one being to staff the U.S. organization with best-in-class talent. I'm super excited to say that every single person in the field sales organization came from a competitive plastic surgery organization in the U.S. marketplace. Most of them had implant experience in their background. The reason why that's so important is because they not only come with relationships with plastic surgeons that we're obviously trying to target, but it also shortens the training time for them to come on board and ultimately become effective in the field and start to drive revenue. Another key thing that we needed to do is to build out a very easy-to-navigate interface for our customers in order to handle the kind of transactional volume that we anticipate in the U.S.
I'm happy to say that more than 75% of our orders go through our ordering platform, which means it's not being touched by an actual customer service agent, right? It goes through automatically. You have less errors, but also you end up with the need for a smaller customer service headcount, right? It saves us money and makes us more efficient. Related to that is that we wanted to build out permanent consignments in our targeted and our biggest and best customers in the U.S. 200 is our number, not quite midway through the year. We're well over 100 consignments placed. The reason why that's important is because that saves you a lot of money and time and efficiency in the ordering and the flow of product back and forth between the accounts, right? It's very costly to ship the devices back and forth.
Of course, if the product's on the shelf, you're more likely to be used in that plastic surgeon's practice. From an actual executional focus with the field and the commercial organization, two major initiatives here: surgeon training and engagement, as well as raising overall brand awareness in the target patient population, which I'll talk more about in just a minute. Of course, ultimately, we're trying to drive towards the $35 million-plus target that we have for this year for 2025 in the U.S. I'm sure that you saw the $6.2 million that we announced in Q1. As Pete just mentioned, right now, based on our current run rate, we'll be between $9.5 million-$10 million for Q2. I'm sure you're doing the calculation quickly in your head. That means clearly we're going to meaningfully exceed the $35 million in the U.S. this year.
From a surgeon training and engagement standpoint, this is really our major executional focus in the field. We took last year, we took four groups and it's usually 20- 25 surgeons down to our facility in Costa Rica. This year, we'll do another eight groups to the facility there. In total, we'll be over 200 surgeons by the end of the year that have spent basically two days with an immersion program, effectively learning about the data, the science, taking a tour of a manufacturing facility and trying to understand the quality of the devices and the care that goes into creating those devices. That culminates on the second day where they actually either get to participate or they observe live surgery in our surgery suite that's inside our facility. Nobody else in the industry has that kind of experience or that capability.
We're leveraging that significantly. Of course, as they leave the experience in Costa Rica, they're obviously more comfortable and they understand the devices. When a surgeon is more comfortable with a device that feels very confident in them, they ultimately, of course, tend to use more devices immediately thereafter. For those who can't attend Costa Rica, we have preceptorships or master classes. This is various investigators around the country that will essentially give them the same experience as the manufacturing tour piece of the equation. Again, two days where they get hands-on experience. They understand maybe the subtleties in technique and how to use these devices to get the best outcomes for their patients.
Of course, we're doing all the normal things like attending the regional, national, local society events, doing advisory panels and speaker events, all the stuff that you would anticipate that we'd be doing. The other major thing that we're doing is to try to drive overall brand awareness in the United States. Obviously, we haven't had an offering here until the launch in the fall. If you're following anything in plastic surgery, I think you'll see that everyone is talking about Motiva on social, right? We have our own execution website, our own postings that we do have significant pickup and reposting by not only surgeons, but patients as well. I think most powerfully, we've had more than 700 surgeons organically posting about Motiva, why they're choosing Motiva, why they're adding Motiva to their practices.
That has really driven tremendous awareness because, of course, they have their own followings within their social activities as well. Patients are also sharing their journey. We do have an influencer program that we provide a small stipend to influencers who have a certain following. Of course, we vet their content to make sure that it is on label and appropriate. We have a number of those folks that are taking advantage of that program. Again, organically, we have had tremendous pickup in the marketplace by patients talking about their journey that we had absolutely zero to do with. Probably most notably is Lindsay Arnold of Dancing with the Stars fame. Very early on, she posted about getting breast augmentation with Motiva, why she chose Motiva. It has been really powerful for us to raise overall awareness.
We have had one major execution here, and that's a partnership that we created with Megan Trainor, who was already going to get Motiva, had made the decision to do it, started posting about it. We engaged with her and created a partnership by which she did some posts as well as a podcast with her surgeon talking about Motiva and why she chose Motiva. A-list celebrities in the past absolutely did not talk about their surgical procedures and certainly not breast implant. I think you're seeing a real shift in the marketplace right now. Even yesterday, I think in the New York Times, they're talking about the era of openness or transparency, the era of transparency where people are now starting to talk about their procedures. Motiva is certainly front and center in a lot of those things.
On the Megan Trainor execution itself, her original post, which is a video, more than 1.7 million views of that, 90 pickups in various media outlets talking about her journey and her program with us, and nearly 5 billion impressions already. This started in March and will run through September. Tremendous, tremendous awareness being built by the Megan Trainor initiative. On top of that, we had a special landing page created where a patient could go and take advantage of a $250 offer as a discount off of their procedure if they got it within a certain time frame. We've had more than 3,400 people actually go in, do the lead form, which then sends their information to the surgeon that they've selected from our Find a Surgeon Finder.
Seven hundred of them have actually already had the procedure, which is really tremendous because typically it is three-plus years of consideration before somebody ultimately ends up getting an augmentation. This is three months, and we have had 700 of those folks take advantage of the offer and actually have the surgery done. We know that they have had the surgery done because they have to report it through our device tracking, right? It is completely verifiable. Overall brand awareness, all those things combined, we have had a 40% increase in search on our own site and 130,000 active visitors. When they come to our site, they are filling out the lead form, so their information goes to a surgeon they select that offers Motiva. Over 120,000 of them have searched actively for a surgeon in their area that does Motiva.
Really great pull-through on the awareness campaign there. At this point, we're in more than 1,000 practices around the United States. Only the hotbeds of South Dakota and Maine do we not have a practice yet. I think we will probably very soon. When somebody does look for Motiva, there's a high probability that there's a surgeon that provides Motiva that's readily in their area. Most importantly, obviously, is the order trend. We've had just a beautiful order trend chart. Like if I could have laid this out a year ago, said, "I would like the chart to look like this." This is exactly what you'd have said, would have suggested, right? Very consistent order trend month over month over month. This ends in April, but I can tell you if I extended it into June, the trend would look exactly the same.
Really great pickup in the marketplace. Lastly for me, and Pete mentioned the super cycle of innovation, I think a big reason why we've had such success of attracting talent from competitive organizations as well as surgeon interest in Motiva is, yes, we've meaningfully brought forward products that are what we believe are better than the existing technology that's in the marketplace today. As we expose the surgeons to this super cycle of innovation and they think about the competitive companies and we have people in our organization that have all come from those companies, we can say this with confidence, which is all the competitors in this space have basically played out whatever innovation that they were working at. It's on market now. We're just at the beginning of this cycle, right?
Every year for the next three years, essentially, depending on how the FDA processes go, we'll be bringing out either a new technology or a new indication. That is going to start here very soon. With the beginning of 2026, we'll be launching Preservé tools here in the United States. Later that year, we should, we'll file this fall for the recon indication. Typically, it is in a year. Could be a little faster, could be a little slower, right? FDA willing. We'll have the recon indication, so then we'll launch that the next cycle, the next year. We'll be able to bring forward Ergo2 and Diamond, which gives us the ability to launch Mia in the United States.
At least three to five years of new innovation that we'll be able to bring to the market that will meaningfully impact and improve the plastic surgery marketplace. With that, I'd like to go ahead and bring up Ben Newcott, who is the Head of our Surgeon Engagement, and he'll introduce our surgeon panel.
Okay, thanks, Jeff. I'd like to bring up the U.S. augmentation panel. It's a pleasure to be here today. Dr. Epstein, Dr. Steve, Dr. Pittman up there. This has been a wonderful launch so far, and we thought it would be best to bring up several of our experts to talk to you today. Dr. Mark Epstein is a plastic surgeon in private practice in Long Island, New York. Dr. Anna Steve is right here in Manhattan. Dr. Troy Pittman splits time between here and Washington, D.C. You're going to get a little, you'll get an insight into different types of practices in different areas, not just New York proper. Dr. Epstein is a longtime investigator of ours. He is going to show you some wonderfully stable results at six and seven years out.
He's been working hard over the last couple of days to get a couple of postoperative photos in there at seven years, which is really cool to see. Dr. Steve is going to talk about this cultural moment that we are in right now in breast augmentation and aesthetics. Dr. Pittman is going to talk about this long journey of tissue preservation that started when he was a resident at Georgetown and now extends into his future here. I'm not going to get up in between each speaker, but I will have a handheld microphone over there on the side. Feel free to jump in if you want. We'll have some time for Q&A after the three doctors. I've got some prepared questions in the case that the audience doesn't have a lot to ask. With that, I'd like to bring up Dr. Mark Epstein.
Thank you.
Which moves him forward, the green?
Forward.
Backwards.
Got it.
Thank you. I'm honored to be here and to be able to present my seven-year experience with Motiva implants. My relevant disclosures, I've designed some instrumentation for breast augmentation. I'm on an advisory panel for Canfield Scientific, who makes 3D imaging for breast augmentation. I'm a principal investigator, one of 22 on the breast augmentation cosmetic side. I've been performing the surgeries for about, I have seven years experience. A little bit about me, I studied biomedical electrical engineering and computer science at Northwestern. I'm certified by the American Board of Surgery and Plastic Surgery. I've been in practice just over 30 years. I perform thousands of breast augmentations. I employ both 2D and 3D imaging in my breast augmentation practice since 2008.
I have been performing a true one-day recovery breast aug that is arms over your head, out to dinner and shopping the same day as surgery for the past 21 years. I also was a co-author on this. It was the first article in a peer-reviewed publication, which describes the technology, how it works for three-dimensional breast augmentation imaging. How did I get involved in all this? I was contacted by JJ Chacón , who was at the time the CEO of Establishment Labs in 2017. I had never heard of Motiva implants. I said, "Okay, the study sounds cool. Let me do a little research." I went on the website, I did a deep dive. What I found is that Establishment Labs was doing an incredible job with the rheology, the way silicone gel flows, the mechanical properties.
It was a complete departure from everything I had known and experienced with breast implants for the past few decades. I liked the smooth silk surface technology, the QID, which is the RFID device inside. What really fascinated me the most was the mechanical properties of the gel and the fact that they match the shell to the gel to create a monoblock. The implant moves as a unit rather than all the other implants I have seen where the gel moves separately inside the shell independently. That creates eddy currents, which have certain effects on the soft tissue interaction and the ultimate aesthetic result, which I will discuss a little bit later.
What my initial observations in the study were, patients coming in, they want an implant for their breast, and I'm trying to sell them on the idea of having an experimental device, not approved in this country, to put into their breast. I thought it was going to be an uphill battle. My nurses would room the patient. They'd have a few of the Allergan implants on a table with the Motiva next to it. I'd walk in the room before I could open my mouth. Several of them said, "I want the little blue implant." It was very easy, actually, to enroll patients. Almost everyone wanted to be in the study. We had no issues with the device and placement during the study. Patient satisfaction afterwards was just about universal. What I found now after seven years is that the results are extremely stable.
I'm going to show photos of that. What I mean is the lower pole of the breast is not stretching, which preserves the upper fullness, and the breasts feel extremely natural. It's very hard to feel the implant. Normally, when you see an augmented breast, you can feel the breast tissue, and then you can feel a firmer implant underneath. In these breasts, they feel completely normal. My wife is one of the study participants. She was enrolled when we were dating, so it fell according to FDA guidelines. She has very thin compromised tissue. Her breast, you cannot feel the implant. It just feels like a breast. Patients feel that they have a much more natural breast than with any other device. 99% of the patients are absolutely thrilled with the results.
No one has gone back to me later and said, "Hey, I want these out. I want you to put in an Allergan, a Mentor, a Sientra." Device-related complications are extremely low. The safety data far exceeds that of any of the competitive devices. What we've seen here, what I've observed, is a disruption of the market on two fronts. My initial understanding of a market disruptor is a low-quality product at a reduced price that disrupts the higher-quality product at a more premium price. That's not what's happening here at all. You have disruption on two fronts. First of all, you have sustaining innovation. The competitive devices, there has been no research, no development, nothing new significant in many, many years, whereas Establishment Labs is continually pushing the limit, improving the devices, finding new ways to solve problems with women's health and breast augmentation.
The technology is superior to the competitive devices. The other thing, and this is really fascinating, using the minimally invasive technology, they have created new market disruption. Now you have all these patients out there who have been happy with their padded bras, did not want breast implants because they did not want to look like they had implants. They want just a little modest enhancement, but they do not want to go through a big surgery. Now you can offer them a Mia procedure with a very small incision, quick procedure, easy recovery, and they can achieve their goal without having to wear a padded bra. That technology has now been expanded to the Preservé, where you can use a little larger implant. The patients will think about it in terms of the small incision. After breast surgery, most patients do not care about the incision.
The real beauty about this is that you are preserving the circummammary ligament, which is like a gasket that the breast is affixed to the chest with. You are preserving all the internal ligaments and structure to the breast. You are eliminating all the malpositions and other shape contour problems that normally occur after breast surgery. Aside from the minimally invasive technique, all other breast organ procedures are disruptive. It does not matter what size the incision is. They all result in disruption of the ligamentous structure. The minimally invasive preserves, that is why they call it the preservation space, it preserves the ligamentous structure. That is the key reason why I am going to be moving to that this summer as soon as it is available.
There's also been a major paradigm shift in my practice, and I see it in a lot of my colleagues, where we went from subpectoral breast augmentation. That was my gold standard for over 30 years. I wouldn't consider going above the muscle because I didn't like the way the competitive implants were in the upper part of the breast. Without that muscle coverage, you didn't have the blending of soft tissue that you wanted. I was very concerned how the long-term results would be. Because of that, we accepted other problems going under the muscle. Now we can go above the muscle, which is now the new gold standard. The concern about the transition is no longer there. This week, I did a 74-year-old woman who's so thin, she doesn't have two fat cells to rub together.
We went above the muscle in the subfascial plane and put Motiva ergonomics in, and she looks amazing and so happy. We can perform this now in people with thin tissue where we could not do it with competitive implants. We can create narrower cleavage because normally when you go under the muscle, the muscle acts as a barrier and limits how far medially you can place that implant. Now I can go on top of the muscle and bring the cleavage in a little bit closer. I do not have animation deformities, which is when a woman contracts her pec muscle, you see the implants move. Also, a fast recovery. In my practice, it is a one-day recovery under the muscle, but for 99% of the practices out there, this is going to be a substantial improvement in recovery. Let me show my results.
This is my first patient in the study, number one. She has ergonomic implants, 340 cc. If you look at her, you will see the upper pole and the lower pole. They do not change from four months to seven years. Here is another similar patient, also ergonomic implants, again at seven years. Look at the stability. You do not see stretching of the lower pole. The crease is not dropping. You are not losing fullness in the upper pole. The breast is staying the same seven years out. Now we are going to some of my six-year follow-ups because we just started seven years in May, so I have only got a few in the seven-year area. Again, same degree of stability. Another patient, 285 cc ergonomics. Again, very stable. These are all different types of breasts. Here is a patient with a little bit more compromise to her soft tissue.
Again, very, very stable results. Thank you. Anyone has any questions, my contact information is here, or you can reach me through Establishment Labs. If you go on my website, epsteinplasticsurgery.com, under Motiva in the video gallery is a nice eight-minute video where I explain the rheology in very, very simple terms that anyone can understand without a technical background. If you want to know what the magic of the gel is, it is an eight-minute video, but it is definitely well worth watching. Thank you.
I'm going to talk a little bit about the culture shift in breast augmentation and the new era of breast aesthetics. My practice is based here in New York City. We have a luxury practice. I'm going to talk a little bit about the Park Avenue look and the experience that women are expecting. This is our typical Park Avenue patient. She has her Hermès bag on one arm and her son on the other. She's looking for the most natural-looking result in breast augmentation with minimal downtime. Cost is no object, and she wants the best available option on the market. To her right is a patient who flew from out of country for this Park Avenue look, desiring that natural-looking breast with minimal downtime. Shown here, she's three months postoperative.
She chose Motiva for its natural shape, currently the only slightly teardrop-shaped available implant in the market, and the option to have these implants placed above the muscle with very minimal downtime. Before Motiva implants, my patients typically had no knowledge of their breast implant brand. Now my patient intake forms look like this. Patients requesting Motiva implants. Patients requesting maybe fat transfer or Motiva implants, which is interesting because typically patients perceive fat transfer as a more safe alternative to implants. Here we have patients categorizing Motiva implants alongside fat transfer. They truly feel it is a safer option. When we look at the data, it is. In the first six months since the FDA approval, I had a total of 167 breast implant-based cases. 155 of those patients chose Motiva.
As you can imagine, most of these patients actually had their initial surgery booked, expecting a different implant brand. Many of these patients chose to change their implant brand after they already had a procedure planned. Since this timeline, my practice has shifted to be 99% Motiva implants. The only patients that I do not use Motiva implants for are typically those who either have too large of an implant required that does not come in the Motiva profile. We are certainly seeing a shift in the type of implants that women are requesting. Most patients are requesting smaller volumes, more subtle volume changes, maybe that one cup up type appearance that the Motiva mini implants offer. I have two primary demographics. The first is a young woman who has never had children, is looking for just a little bit more volume. She is shown above here.
She has the round-shaped implant placed above the muscle in the mini profile. The bottom patient is a postpartum woman who felt like she lost all shape and volume after breastfeeding. This is a mom who wants to be very discreet and wants most women and other women around her not to know she's had breast augmentation. She chose the Ergo profile and again had the implants placed above the muscle. Neither of these two patients are patients who would have been candidates for their implants to be placed above the muscle prior to Motiva implants. For me, there's been certainly a market expansion in women who are considering this a safer and less invasive alternative with minimal downtime. This is just a testimonial from the first Motiva breast augmentation patient. She had actually been booked for surgery.
After the FDA announcement of approval, she had decided that she preferred to wait for Motiva implants. They were FDA approved, but not available to us yet. We actually moved her surgical date. I think the most compelling thing here is she says that she wanted to minimize recovery time. We adjusted her surgical plan. Because of the Motiva technology, she was able to qualify for over-the-muscle implants, which was less invasive and preferred for her. You can see on the other side her before and after results, pre-op, days after the procedure, and six months after the procedure compared to a patient who had traditional implants. I think the most telling thing here is to look at where it's days after.
You can see the Motiva breast implant patient who has her implants placed above the muscle, days after the procedure looks great. The traditional brand, you can see days after the procedure placed under the muscle, her breasts look distorted. This lasts a significant amount of time for women, three to six months, six months to a year, depending on the implant size. Motiva is really changing the game in terms of the ability for these patients to have quick, quick changes and less recovery time and fairly immediate results with excellent sustained results over time, as Dr. Epstein has showed, and also superior safety. I'll hand things over to Dr. Pittman, who's going to expand a little bit more on that difference between above and below the muscle.
Thank you. It's a pleasure to be here today. Let's talk about the quest for the perfect breast. It's really filled with dogma, devices, and drama. I think you've heard all of the unique things about Motiva today. I think it becomes even more special and more unique and more disruptive when you know where we came from. This is my mentor, Dr. Scott Spear. I trained with him at Georgetown. I'm not sure any of us would be here today without him. I know I certainly would not be here today without him. He was really an innovator. He's kind of the godfather of breast surgery. Scott was not dogmatic. He was very into technology, new ideas, which is sometimes unusual amongst plastic surgeons. We kind of are taught things one way, and we just do that over and over again.
He was extremely excited about Motiva. Unfortunately, before his untimely death, he was going to be the principal investigator for the U.S. trial. In 2014, I was Director of Breast Reconstruction at Georgetown. We thought, why don't we try something new? Why don't we try to start reconstructing breasts with the implants in front of the muscle? Without cutting the muscle, without stretching the muscle, it was much more comfortable for patients. This really became, although we were told we were crazy, a game changer in breast reconstruction, not disrupting that pectoralis muscle, not lifting it off the chest wall. Recovery was much quicker. Women could actually have their mastectomy surgery and their reconstruction with an implant at the same time and be home in their own bed that night. The implant anatomically should replace the breast.
Everything we do in plastic surgery is about recreating like with like. I always joked with the patients that God put the breast in front of the muscle because she thought it was way more comfortable that way. With this faster recovery, we're going to talk about animation deformity. It was a game changer in reconstruction. Because of the implant technology at the time, there was a question about long-term rippling. These were mastectomy patients who often had very thin flaps, very thin skin. Putting the older devices in, they oftentimes were afflicted with rippling or capsular contracture, scar tissue that forms around the muscle. We were really required to use some type of mesh or human skin or pig skin or something to really try to support that implant to try and prevent capsular contracture and rippling.
Here's our evolution of breast augmentation. We started with implants in front of the muscle. When the moratorium happened and surgeons were using saline implants on a regular basis, those looked like water balloons under the skin. Everything transitioned to putting the implants under the muscle to hide the implant. That carried through after the moratorium, something called a dual plane, or as Kylie Jenner puts it, half under the muscle. That's where the implant is under the muscle at the top and under the breast at the bottom. The problem with a dual plane is you have this downward force vector. Particularly active women who work out a lot, their muscle is constantly contracting against the implant. It drives those implants down and out and leads to higher revision rates. Now we're back to in front of the muscle.
Why? Let's talk a little bit about FDA and the implants. In 1962, Cronin and Gerow did, they invented the first breast implant, which was really out of, even at the end of World War II, Japanese prostitutes were injecting their breasts with free silicone because they thought that American GI soldiers would like a bigger-breasted woman. In 1962, Cronin and Gerow thought, OK, we can invent something that will actually enhance the breast. In 1976, Congress passed the Medical Device Amendment to the Food and Drug Cosmetic Act. That was the act that said you had to put the ingredients of everything on wrappers. These medical devices, they did not really know what to do with them. Every device that existed in 1976 was kind of grandfathered into that without any requirements with studies.
In 1988, this was right after the first Dow Corning lawsuit, which happened in 1984. In 1988, the FDA said, we should classify the implants as class three devices. FDA categorizes class three devices as something that is potentially harmful to the person receiving the medical device or the person putting it in. That is a little bit of an incendiary comment. It was not that the devices were being reclassified. This was the first time they were truly classified. Fast forward to 1990, the big Connie Chung face-to-face interview, where Connie Chung interviewed women who said, I have illness from my implants. My implants are comfortable. This was really the boiling point. In 1991, the FDA said, we need studies. Everybody has 90 days. Every implant manufacturer has 90 days to submit their plan for a study.
Now, these studies take years to actually complete and years to devise. Ninety days is kind of unreasonable. The FDA went forward and said, you can't sell your implants if you don't have your 90-day study in. What happened? We ended up in a moratorium where no silicone implants could be used outside of breast reconstruction, outside of a study. Everyone started getting saline implants. In 2006, after probably more studies than have been done on any medical device, the implants come back on. In 1997, BIA-ALCL is introduced. There's an FDA alert. The WHO by 2016 recognized ALCL as an actual disease. We fought so long. The implants came back on the market. Now there was something new. You could get cancer from breast implants. That's exactly what the lay press actually came up. That was the words that they used.
They were highly linked to the Allergan BIOCELL Texture devices. The FDA hosted a general meeting where women who were afflicted with either ALCL, BII, which really is breast implant illness, which came out of the internet, there were these very emotional testimonies at that meeting. That ended up in a voluntary recall of implants. You see where I'm going with this. It's the same thing happening again. Here we are in 2019 thinking, are we going to be in another moratorium? Enter Motiva. This has been a game changer for augmentation because all of the things that I said with reconstruction, these problems are solved. We don't worry about long-term rippling. We don't worry about capsular contracture. We don't need a mesh. This is the animation deformity that Dr. Epstein and Dr. Steve were talking about.
Right, together.
No, this lady joked when I saw her in the office that this was her bar trick. In all honesty, she plays with the New York Philharmonic. This is incredibly bothersome to her because as she's playing her instrument, her breasts are bouncing around. With preservation breast augmentation, we're able to put those implants in front of the muscle. The patient here on the left, this is the ideal patient. These are women, just like Dr. Steve said, these are women that work out. They want to not have their implants bouncing around. They don't want their muscles disrupted. These are all thin women who, with the old devices, would be afflicted with rippling and the potential for capsular contracture. That's all I have.
Thank you. Thank you very much, panel. We do not have much time for questions. Dr. Steve, I wanted to ask one of you. If the audience has any, please feel free. We seem to be sitting in the middle of a cultural moment, the culture, the era of transparency, as RealSelf has said. The New York Times put out an article about the Kylie and Kris Jenner effect, which could be impacting our space right now. I would love to just get your thoughts on the mindset of patients you see coming into your practice. Maybe you could comment on whether volumes have changed up or down over the last year, what the climate is like. What is that cultural conversation? That is the real heart of this question.
I think the culture is shifting totally into that culture of transparency and women so generously sharing their stories for other women to learn. I think that's where a lot of all of the work that you've done for your direct-to-consumer works really well because those women who are sharing their stories are talking about Motiva implants. Patients like Kylie Jenner, who opened up, and she certainly has influence, I don't think there's a negative impact that she has not received Motiva implants because she had her implants placed at a time when they were not available here. I think the sort of juncture between that culture of transparency and women seeing Motiva implants as the safest option is going to be great for brand recognition and women talking more and more about this.
I think you're going to see that patients start to demand this brand because it's the safest one available.
Yes.
Yeah, thank you, Sam Eiber, BTIG. Appreciate the panelists' presentations. Clearly, you guys are convinced on the move to above the muscle. Curious where the rest of the surgical community is. On that shift, is there a learning curve associated with above the muscle and subfascial placement? Is that unique to Motiva? Can you use that technique with other implants?
That's a great question. For anyone who does subpectoral, they'd be experienced doing dual plane. When you do a dual plane, you're essentially doing a subfascial dissection partway up the muscle. The technical skills involved to go, whether you're subfascial or above the fascia and go subglandular, is very simple. I would say 100% of surgeons who are capable of going under the muscle can easily adopt on the fly and pivot to above the muscle without any difficulty. The question is, the surgeons need to be educated, just as I present my own transition from being astonished there is no indication to ever go above the muscle to now I really can't think of an indication to go below the muscle. That will just take a matter of time. I think Peter Caldini's prediction of 20% growth over three years is extremely conservative.
I'm with the patients. I'm with the ones, the consumers. We have been, since approval, 100% of my patients have booked the implant. Half my practice is revision, half is primary. Interestingly enough, patients who come in with ruptured implants that are entitled to a replacement device for free under warranty by a competitive company are still selecting Motiva. My prediction, which was back in 2017, holds today. I think in three years or so, somewhere between 60%-80% of the implants in this country will be Motiva. That will continue to increase because there is such a strong disparity in technology results. Patients are now calling my office, and they're asking for Motiva. In the past, they didn't ask for Allergan or Mentor. I can't think of one time that it happened. Now they're asking for Motiva. The patients know about it.
They're online. They're seeing the social media. It is snowballing very fast.
It's clear that happy patients talk about how happy they are. They now have platforms to do it. The TikTok, the social media craze, is able to move this information in ways like never before. Dr. Pittman, I thought you might have a comment. One other thing is, maybe one other point of contextualizing this is, why did implants start going under the muscle in the first place? Anything else you might have to add?
I think to expand upon what Dr. Epstein was saying to your question is, any surgeon can place the implant in front of the muscle. What's absolutely essential, though, is that you respect the boundaries of the breast when you're putting it in front of the muscle. Because if you make a big pocket in front of the muscle, that implant can go anywhere. It can go into the armpit. I think one of the things that Motiva and Establishment Labs has done with their education program is saying, we have a great device. The device can be placed in front of the muscle. They're very specific about the anatomy. If you're going to do this operation successfully, this is how you do it. I think that's what makes the commitment from the company.
If you have really great devices and they're not used correctly, it can be a big disaster. They have really doubled down on education and innovation.
Got a question over here. I can repeat the question if you want to.
Josh, thanks.
Josh Jennings from TD Cowen. Echo the thank you for the presentations and the education. Dr. Epstein, you just mentioned that you were patiently or maybe enthusiastically awaiting the approvals of the Preservé minimally invasive instrumentation. I was hoping to just hear from the panelists about your potential adoption trends and how quickly a minimally invasive approach with Preservé could become standard of care in your practice.
For primary augmentation, I anticipate my adoption to be 100%. Again, it's not about the small incision. Preservé is a 2 cm incision. Two centimeter on the breast or 4 cm where you can't see it, trust me, the women are not going to care. Going forward, before the surgery, they say, oh, that's better. Trust me, after, that's not going to be the selling point. The selling point is the fact that you are preserving all the anatomy. You have a boundary. As Dr. Pittman just said, what he said is extremely, extremely important. When you go beyond the border of the breast, beyond that circummammary ligament, the footprint of the breast, what's going to happen is you are going to create potentially uncorrectable problems.
Women are going to have to be reined in a little bit about when they come in and they say, but I want this size implant. I tell the patients, if I were to do that, I would have to over dissect past your breast to fit this implant. You are going to have problems. That stops that discussion. When you're doing the Preservé, you'll be telling them it will not be possible to put in that large an implant. If you do, you're going to need a procedure that's going to destroy your breast. They have to make a decision. Do they want to go down a rabbit hole of multiple revisions later or have a procedure that they're going to get a lot of good years and not be paying for multiple revisions?
This is going to rein in a lot of these ones who do like the Kylie Jenner. You cannot fit a 445 cc implant within the border of her breast. It's impossible. I think this is going to do a better service for women's health. Some women will have to be reined in a little bit on their expectations.
I think when you look at the two primary patient populations, women who are young, have never had children, they've often never had surgery before. Women who are mothers, they have kids. Both of those patient populations, I call all my patients the night before surgery. They say to me, I'm not worried about the surgery. I'm worried about the general anesthesia. I'm worried I'm not going to wake up. I think from that perspective, one of the very unique components of Preservé is it can be done without general anesthesia. That again leans into the safety. There are a lot of women out there who just simply would not have an elective aesthetic procedure if they have to go to sleep for it. I think in that way, there is market expansion that we haven't even touched yet.
We'll get to market expansion in a future panel here today. Any other questions from the audience?
Can I bring up one point?
One more point, and then we'll move on.
One point in economics that I use as a selling point when I'm talking about Motiva. I tell patients the rupture rate on these implants is a lot less than other implants. When it's a young patient, implants are not going to last forever. Most women are going to see more than one operation in their lifetime. I tell them when the 10-year safety data comes out, my prediction is it's going to be a dramatic difference. On that assumption, you're going to need less revisions, less surgeries in your lifespan. It now becomes a fiscally less expensive procedure than with a competitive device, even though I charge more for Motiva. That has swayed no one. Everyone still pays the premium price. I haven't had one person pick a competitive device since approval.
You're opening a can of worms talking about price for this audience. Thank you, U.S. panel on breast augmentation. With that, I'll bring Jeff back up to talk about reconstruction.
Thanks again to the panel. Moving on to breast reconstruction opportunity in the United States. Obviously, we do not have the indication yet. Therefore, we can't promote. We are seeing a very small amount of off-label usage already. It typically follows where somebody's using our Flora tissue expander, which obviously is approved for reconstruction. We anticipate that we would get approval sometime, as I said before, we're going to submit late this fall. FDA typically takes about a year. It could be a little bit faster given that we're already on market and approved for augmentation. This reconstruction is a reloading here. It is a significant opportunity for us because the reconstruction market is very stable and grows at about 2%, absolutely steadily.
If you longitudinally look through the data and you take out the noise of the COVID years, it just sort of marches on at about a 2% growth rate every year. Although the procedure count is significantly lower than augmentation, given that the price points in the hospital are usually 25%-30% higher, as well as you have the opportunity to include tissue expanders into that case, that procedure actually could end up being worth, from a revenue standpoint, about three times what an augmentation case could. You net through all that. The actual revenue opportunity is at least as much, if not slightly more, than the augmentation opportunity. Again, we anticipate approval sometime in 2026 with a full launch then in early 2027.
The Motiva device, as you've currently heard, and you're going to hear from some reconstruction surgeons here in just a minute, is very well suited for this patient type. The surface technology really creates a soft, pliable capsule that's great in that patient type, the 100% fill monoblock technology. All really combines for a great offering for the patient from an implant selection standpoint. With the Flora tissue expander, it's the only one MRI conditional, so it can be used during radiation. You get the opportunity to get a more targeted radiation protocol for that patient. It's much safer and can be more effective because of that. You're already seeing really prestigious institutions like MD Anderson starting the publications to put publications out relative to the things that I just discussed.
I think we're going to hear from some of that from Dr. Hammond. Obviously, there are other publications already around the rest of the world saying these same things. When you have an institution like MD Anderson, it really solidifies the fact that this is really great data and a great offering for these patients. With that, I'll go ahead and bring Ben back up to introduce our recon panel.
OK, thanks a lot, Jeff. Doctors Hammond and Karp, would love for you to join me on the stage in those two middle seats if possible. Great, tremendous opportunity for us here in the U.S. in breast reconstruction. Happy to present these two panelists today. Dr. Dennis Hammond is a, we like to call him, a serial investigator. He's been involved in almost every clinical trial in this space in the U.S. going back 20 years now. He'll talk about his experience. He's also a co-developer of our Flora technology. He'll give you a good insight into the why, how, and what of that device. He's from Grand Rapids, Michigan. He joins us today. Then we'll bring up Dr. Nolan Karp. He is also, I should have said, they're both investigators on the implant trial. It'll be a little forward-looking on what you might expect.
We obviously do not have that indication yet for implants. Dr. Nolan Karp is here at NYU right here in the city. With that, I will bring up Dr. Hammond. Thank you.
Good morning, everyone. I am Dennis Hammond from Grand Rapids, Michigan. I am in private practice in Grand Rapids. I have been in practice for 33 years. I have had a very active academic side to my practice, mostly because of my previous training. I have been involved, as we said, in just about every implant study that has come down the road over the years. I am very familiar with the technology, designed one of the early expanders. That is one of the things that drew me to Motiva, to try to put this in perspective. The silicone crisis of the early 1990s basically halted all innovation related to the use of these things that we call breast implants. At that point, it was basically a silicone bag. We argued a little bit about what the surface should look like. All of that stopped.
That is one of the reasons I became so enamored with Motiva and JJ, who deserves a ton of credit for building this company from nothing. He said, we need to take innovation forward. It is time. We are past the 1990s. Here is what we are going to do. They came up with the implant. The implant, the advantages that you have seen, the silk surface, the reality, the way that it interacts with the shell. The expander is that on steroids. An initial expander in the old days was basically a round balloon with a remote valve. That was it. The expander really offered a lot of opportunity to make it better, to make it work better for our patients. This is what we came up with. The advantages, it may look simple.
The advantages that you're looking at in this particular device are that it's got a shape. When the expander is in the breast after the mastectomy's been done, the breast has a reasonable-looking shape to it, as opposed to a round ball, which is what it used to in the old days. It's got the silk surface. The silk surface prevents the formation of the scar around the device. It keeps the complication of capsular contracture exceedingly low, which is a huge advantage in reconstruction. The other thing is this valve. You can see that metal valve. That's how the expander is filled. When it's in a patient, you find a needle, and you can go through the skin into that valve and blow that expander up, inflate it gradually over time until you get to the volume that you want.
Traditionally, that valve was first external to the device. Then it was built into the device. It is metal. Because it is metal, that means that the patient cannot have an MRI while the device is in place. It really complicates radiation therapy planning because you have to remember these patients are cancer patients. We came up with a way to make that valve without using any metal. I know that sounds simple, but that is like building the iPhone back in the day. It was a huge step forward in the design of these devices. Some simple things, putting tabs on the expander so that the expander cannot rotate, another big step. All that together has created now a device which is uniquely suited for preparation of that pocket for the placement of a Motiva implant.
Just real briefly, the way that this valve finder was made, there's a little valve finder. You hover over the valve when the expander's in place. It uses an RFID coil, which is something that was part of the original Motiva implants. There's a signal that's sent to that coil that then comes back to the finder. That's how you can locate the location of that valve so that you can stick a needle in it successfully and you don't miss and perhaps stick a needle somewhere else and puncture the device. That took years to develop. God bless them, they did. This is an example of the planning that goes into somebody who's going to have radiation therapy because this can happen many times. A patient has a mastectomy because of cancer. Lymph nodes are positive. They decide they want to give radiation.
Radiation damages tissue. You have to be very careful with how that radiation is delivered to the target area, which is the area where you want to kill cancer cells. That valve can scatter that radiation. That metal valve can scatter that radiation and complicate the delivery of that and increase complications. With no metal in the valve, now all of a sudden, that radiation planning process can occur much more seemingly. As you'll see, studies have already shown this is an advantage. This is an example of an MRI of a patient that has a Motiva expander in. No problems at all with obscuring of the breast tissue or creating a signal that creates a starburst effect so you can't see the breast. Again, big step forward. These have been used here in the United States. I've been using them myself.
This comes out of a place no less significant than MD Anderson with Dr. Clemens, one of the first articles that's now been published back in 2025. One of the things that I would point out here is this right here. Because it was able to allow the radiation beam to hone in more precisely on that tissue, you went from a 4-cm window to a 1-cm window, which means that you could target that radiation much better. It decreased the irradiation to the healthy tissues by 60%. That's massive because radiation damages tissue. We've got to be able to control that to achieve good results. The other thing is, it's a little bit hard to see. I'll just read it for you. There were six patients in the cohort that had the regular expanders that needed to have an MRI.
They had to go back to surgery to have the expander removed because you could not get an MRI. Have you ever heard? I remember MRI is a very strong magnet. People have accidentally brought an oxygen tank by the MRI, and the magnetism has smashed the oxygen tank through the wall into the machine. It is extremely dangerous. You cannot get an MRI if there are magnets involved. No magnet here. There were three patients in the Motiva cohort that just went ahead and had their MRI with no problem because it is MRI conditional. You can get the MRI, can radiation plan, huge advantages. As well, there is some basic data from these studies. One just came out today, as a matter of fact, from Austria. Another one is coming out from Spain. The tissue expander is performing beautifully. It is actually holding down complications.
You have less infection, less seroma. It facilitates really streamlined use. Just to demonstrate visually so that you can see how this works, this is a lady that's going to have a bilateral mastectomy. The markings you can see on the left there, the little purple dot is where the valve is located. That has to stay up here. That expander has to stay positioned where you want it. It can't rotate around, which is why it's got the tabs on it to hold it in place. This is the expander. That's what it looks like in the patient after she's had the mastectomy. The skin and the nipple is preserved. There's no reason to take that. That's one of the modern approaches to breast surgery now. Everything inside is gone. The breast and the fat is gone.
That expander is basically holding that space open. It's doing it with style now. There's no scar. The valve can be easily located. The expander won't rotate. All of those are big advantages. This is what it looks like after that expander has set for a bit. The idea is that expander now just holds that space open while the soft tissue is healing. You can come back, take that out, put your Motiva implant, and that's your reconstruction. That's the concept, that first-stage tissue expander, second-stage implant, and things like fat grafting. Here's an example of a lady that's had a breast reconstruction. As you've heard, when Nolan and I first went into practice, as he's going to tell you, we made bumps. I mean, it wasn't anything remotely that looked like a breast.
Now we can make people look better after a bilateral mastectomy than when they started. When you start talking about promoting women's health and making proper treatment with mastectomy acceptable, these are key elements in achieving that goal. Here's another example. This lady has had a bilateral mastectomy, nipple-sparing mastectomy. She underwent tissue expander, Flora tissue expander with implant reconstruction. She's got a very beautiful result. She looks almost like our Park Avenue breast augmentations that we see. This is where we're at with the use of the Flora. I think it's a big step forward and an important part of the portfolio for this particular company. Thank you very much.
Thank you, Dr. Hammond. Dr. Karp.
All righty. I'm Nolan Karp. I'm here in New York. Curiously, Dennis and I, we were talking about it. We started literally the exact same time. We've gone through all the steps the exact same time. A lot of things have happened that really have changed things. Obviously, we had to deal with the silicone moratorium. Just in terms of the breast surgery, in about 2006 or 2007, we started doing nipple sparings. We started to be able to save the nipple. There was no reason to take the nipple if the breast cancer was not in the nipple. Breast support products came. There's been a tremendous amount of innovation in breast support products. Curiously, there was no innovation, none, and a lot Dennis touched on, having to do with the moratorium, et cetera, on actually breast implants.
In the past, I used to spend a great deal of time when I was talking to the patients on kind of lowering the bar, trying to set realistic expectations. This was disappointing to the patient. The patient would find out that they were going to get maybe sort of a blob or amount that looked good in clothes. When they woke up in the morning and looked in the mirror, it did not look anything really like a breast. More recently, when we have had all these innovations, again, innovations not in the implants, but in the technique of doing surgery, nipple sparing, breast support products, we can do the reconstruction a lot of times actually in one stage. Sometimes we would even out even using a tissue expander. All these things happen.
I started saying to myself, is it realistic for me to make my reconstructive breast surgery goals and expectations the same as the aesthetic? The patients actually expect that. When the patients are thinking about a breast implant, they're looking at magazines. They're seeing the Kylie Jenner. I mean, this is what they see. We are plastic surgeons. Ultimately, we want to get the best results for our patients, which is reconstructive and which is aesthetic. The goal now, it's not even been 2025. It was even before 2025. It has become more realistic now, is can we make the reconstructive breast as good or better than the native breast, as Dennis has shown you in some of his cases? The problem is breast implant technology has not kept up with the patient and marketing expectations. Our implants have not changed in 30 years.
We are now doing above-the-muscle reconstruction. Above-the-muscle reconstruction is a little bit harder than breast augmentation because in breast augmentation, you still have the breast above the muscle. You have skin, you have breast, an implant, and the muscle. In breast reconstruction, you basically just have the skin and then the implant. What kind of implant you have actually really matters. An implant that does not ripple, an implant that retains its shape really matters. Why are we interested in Motiva implants? They feel more natural. When I started in this study, I first saw the Motiva implant in 2017. I was at a meeting in Korea. It was unrelated to breast implants. It was actually a microsurgical meeting. There was the Motiva rep at a table. I felt the implants, and I am like, oh my god, these are great.
When are we going to get these in America? I actually went to somebody's office and watched him do five breast augmentations using Motiva implants. I was kind of completely hooked on it. I was just, how can I get involved in this? When I enrolled patients, it was super easy to enroll the patients. I just literally sat the patient down. I said, close your eyes. I put one of the reconstructive implants that we always used and a Motiva implant, one in one hand, one in the other hand. I just said, which implant would you like in your body for the next 20 or so years? 95% of them picked a Motiva implant. Every single one of them wanted to be in the study. I've never been in a study where it was so easy to enroll patients.
They just said, give me the paperwork. I want to enroll. We're like, well, you know it's an FDA study. We have to do a little more than that. So besides feeling better, the Motiva implants ripple less, very rare capsular contracture. I'm not going to go into capsular contracture that much. Scarring around the breast implant, hardening around the breast implant, this is your body saying, hey, this is a foreign body. I'm going to make scar around this implant. Almost never happens with Motiva implants. Whereas with the other implants, you can dispute the data. It's at least 10% or 15% of the time. It's a big headache when it happens. In addition, for whatever reason, I've been doing this for, we've started this right at COVID in May of 2020. I've not seen a single rupture in a Motiva implant.
We're still early. Five years is still early. But we haven't seen a single rupture. Our market, I think this has been touched on by some of the other people, about 100,000 cases a year. 85% are implant-based. Some patients are going to get two implants. They're going to get tissue expanders, Dennis said, and then an implant. It's concentrated in high-volume centers. It's a little bit different. If we decide we're going to, if Motiva is approved, then I expect if they are, they will be approved because they're already approved for the cosmetic cases, the reconstructive cases where I hate to say it, but you actually need them much more, will get approved. Our institution will switch pretty much overnight. Here's just some sample cases. This is a 41-year-old right breast cancer. This was actually still done in the subpectoral position.
This is a round, full-profile Motiva implant, post-op result on the right. One could argue that she actually looks better than she did preoperative. Another patient, a little more challenging, bigger patient. Again, this is prepectoral. This is now above the muscle, preop and post-op. This is a slightly complicated case, somebody with a mutation, kind of big breast, double triple D, not really a good candidate for nipple sparing. We did a breast reduction first and then a direct implant, one-stage implant reconstruction, no tissue expander with the ergonomic Motiva 550. I've done 60 cases of breast reconstruction, Motiva implants, longest follow-up now, probably about 54 months, probably a little longer than that. We've had no complications related to implants themselves. Our complication profile overall for the patients was what we see in breast reconstruction.
What we mean by that is you might have complications from the mastectomy or from other components of the operation. We have not had complications related to implant. Patient satisfaction is super high. There were no cases of revision surgery related to pain or discomfort attributed to the implants. My only regret with this study is that, unfortunately, it ended. We expanded. We started with 30, then went to 50, then went to 60. The FDA said, no, you cannot let them do any more implants. That is the maximum % we can get out of one institution. I was just very sad. The minute this ended, and I had patients I could not offer the Motiva implant to, it was kind of a little bit of a bummer. That is about it. Thank you.
Thank you, Dr. Karp. OK. Question for Dr. Hammond. And please keep any questions coming. Malavika has a mic over here. But regarding MRI-compatible tissue expanders, why would you not use an MRI-compatible tissue expander? And what do you think the market does long-term in adopting this technology?
I would always use an MRI-compatible tissue expander at this point because it's an option. Before the Flora, it wasn't. That wasn't even on anybody's radar screen, actually, to try to do that. You can get by with it. Like the study showed, there are several patients who literally had to go back to surgery to have their expanders removed in order to allow proper screening. The way that would happen is, say, a patient comes back after the operation and they're having double vision or they're dizzy. You're concerned about whether or not they're a brain metastasis. That's way, way, way more important than having your expander. You've got to have your expander out in order to evaluate for that. That's kind of the medical bit that goes with that.
I would always use an MRI conditional expander if I had it available to me. And I do.
Dr. Karp, a question for you. You mentioned the demands of the reconstructive patient expecting better or at least as good a breast after surgery. What role do recon patients have in selecting their implants, not just with you, but with others? This could be a question for you to follow up on as well, Dr. Hammond. What role do patients generally have in that selection process?
It's the same thing as the augmentation patients. Prior to the Motiva implants, the patients rarely asked, sometimes they would ask, but rarely asked which company's implants. Now that we have the Motiva implants, a lot of patients come in, well, can I get the Motiva implant? They know they're approved. I have to say to them, they're not approved for breast reconstruction. You can use them, what's called off-label. I happen to be at an institution that doesn't want us really to do that. You can use them with the appropriate informed consent that it's off-label. They do ask for them. I think that we will switch to them completely. I mean, we have a bunch of patients. We're five years out.
We have a pretty good track record, not to mention the fact that there's, what, 4 million Motiva implants implanted around the world. Even when we started this study, there were over a million implants. It was in 88 or 89 countries. It was pretty easy to have patients agree to have the implants put in.
Dr. Hammond, any different in your practice when patients come in and say, I want this out of my reconstruction? Are they part of that process? Or do you drive that conversation?
We drive the result. We want to try to give the best result we can. Just to dovetail what Nolan said, there's just kind of an inherent desire to kind of keep it all in the same family. You wouldn't put a Ford transmission in a Dodge drive system, right? If you've got a Flora tissue expander, then you would want a Motiva implant because it's all the same company. That just kind of makes sense.
Maybe more of a business question here. Reconstruction is a little different from augmentation, where you're dealing with private practitioners who can tomorrow decide they want to use a new device. When you work at a big institution, as you do, what are generally the processes that someone needs to go through if you're a plastic surgeon to get access to these devices? Is it immediate? Or does it take some time?
I mean, we can get the, on a case-by-case basis, we can get the device. But we need more than that because it's a headache to do it that way. We need to establish a consignment and a stock of the devices. So we have to kind of negotiate. We have a value-based medicine committee. It's not a problem when you have a device that's clearly better. And actually, the difference in price, if there is a difference in price, is minimal when you consider the overall cost of a case. The difference in price might be a few hundred dollars max. Whereas the overall cost of these cases is like a five-figure number, probably $20,000. So it's like maybe 1% of the cost of a case. I don't see it as being, I think once they're approved, we'll have them approved. We'll have them available.
I think the biggest problem is, can you guys put up with the demand? Because the demand will get bigger faster. I think having been to Costa Rica and having seen the original factory and the new factory, I think you guys are ready.
Dr. Hammond, anything to add? There's a question. OK.
It's actually Anthony Petrone, Mizuho. Thank you for the insights. And thanks for sharing your thoughts on reconstruction. It's a follow-up on a business end. When you think about insurance coverage for mastectomy with a new platform coming in, does this fall under a DRG? Do you think when we get the Preservé that you'll actually need a dedicated sort of reimbursement sort of role in for a new platform? Or is it going to kind of slot in under existing kind of codes that are out there? Thanks.
Preservé is really an org thing. It's really more for the breast augmentation. It's not so much for the recon. We can say the whole idea is when you're doing a mastectomy, you're taking the whole breast out. Whereas Preservé is really about preserving the anatomy when you're doing a breast augmentation. In terms of coverage, we've never had, I at least personally never had any coverage. The federal law, 1998 law, that really very broadly covers breast reconstruction. We've never had any problems with any of the implants. I mean, even more expensive than the implants actually are breast support, either devices or implants or dermis. We've actually never had any trouble with getting any of that covered.
Just to dovetail on that, in Michigan, it does not matter what device I use. What they will say is, you are doing a tissue expander breast reconstruction? Yeah. They do not care what tissue expander I use. That is kind of bundled into the whole system. To answer your question, no, I do not think there will be a barrier to using the Flora versus another one. The barrier will be to get it into the hospital in the first place. What I had to do in my hospital is go sit before the VAT committee and outline all of these advantages. They seem to be very concerned with their floor space for some reason in the hospital. They do not want to clear out room on a shelf to put the devices on. I had to explain to them what the advantage was. They vote on it.
You get it into your hospital. Probably at the hospitals, somebody will have to champion that process to make it available in institutions.
That is often the plastic surgeon fighting on behalf of his or her patients. We thank you for that. I am going to turn it over now to Roberta. Thank you very much, panelists. We will talk a little bit more about, in the future and in the engineering section, some of these preservation techniques and how they may apply to breast reconstruction.
Hello, everyone. Thank you so much for being here. Being in this company since the very beginning, you can imagine both the feeling of proud and the feeling of how gratifying it is to listen to these surgeons showing their experiences and how our innovations have changed the way that they are doing their procedures and how we have been able to raise the bar for the benefit of our patients. That is a very gratifying moment for us. I am very happy to be back here. Let's see. I have one of the best jobs in the company, which is to lead all the efforts that we do in research, development, and innovation. It is an honor to be back here to tell you now about what is going to be coming next in our pipeline of innovation.
In July, it's going to be seven years that we were standing here precisely to get this going. It was becoming a publicly traded company in order to get the funds to start our clinical trial. I want to start here because this does make a difference. We can talk about all the technology in the world that we can improve and everything. If we cannot see the outcomes in the real world, it would not mean anything. This is a very important part of what I'm going to be talking about in the future. It is how, not only in the most rigorous study in the United States under the FDA, also adding value to the scientific and clinical evidence that we have been building. For more than a decade, there was no implant introduced in this market.
Coming up with these numbers really makes a difference. Why? Because it's the platform that we're going to be using to continue innovating. Now, that is from the U.S. I also want to make sure that we all understand that it is consistent around the entire world. There are more than 160 publications that speak about Motiva scientifically and clinically that verify that the innovations and the different terms and technology that we're building and bringing into the real world make a difference. You can see how consistent these numbers are. This is a meta-analysis removing all the possible bias that there is in the literature. This is very objective. As well, there are independent registries like in Australia, Sweden, different countries in Europe that resemble and are consistent to these results. Designing with a purpose for us makes a huge difference.
Understanding what are the benefits that we have in our surface to be able to say that we have a less than 1% complication rate makes a huge difference to show us where do we have to keep going and what are the things that we have been doing good and how do we raise the bar even more. When we think about minimal invasive procedure, it's not only about the moment at the operating room. It is what is going to happen after the patient leaves that room. The surface that we build and we have the evidence to show that it's less inflammatory makes, at a cell level, our point of start. That will make us possible to have a faster healing.
Having a faster healing of the tissue surrounding the breast makes a huge difference on how that patient is going to go back to her lifestyle. Starting from there, also we needed to make sure that we had the proper technology on the mechanical properties of the surface in order to be able to introduce it to smaller incisions every time possible. How do we make it possible to remove any scar from the breast and still have a breast enhancement? The way that we had to rethink about the chemistry that we were putting our implants and the geometries, the physics, the mechanical properties all got together. Having that purposely designed implants makes a huge difference.
How we can make, as we did when we brought an implant that had a little blue on it, that was significantly different from what the industry was used to do. That was a very clear differentiator, the blue that we brought in our implants, making sure that we have a way of identifying that the barrier that is very important for safety over the years, it's present in the entire implants. A visual barrier, it's equal to better safety. A geometry that makes a difference, you can see here for the Mia procedure, we were able to create an implant that will project more with less silicone at the end. That is extremely beneficial for the patient, minimizing the touch points during the procedure that the surgeon can have with the implant. That will also improve the safety.
All that, we're moving out from just being able to create a platform of a product that is going to be on the patient for many years, raising the bar, being able to increase all the different things that we consider are important for that behavior of the implant, which is the addendum of the breast to the surrounding natural structures of the breast. You can see how we have been raising the bar, increasing our safety, and being able to design with the purpose, a shell that will go with the gel to make sure that we can do it under a minimal invasive by enhancing the ergonomic concept, the adaptability, the natural dynamics of the breast, and the evolution that we have taken.
It is going away from just designing that implant, but designing a platform that would allow us to provide a safer, more standardized, and replicable procedure. With the ergonomics concept, we were able to start our journey on minimal invasive, minimizing the scar, using different tools in order to improve the experience of the patients. This is how we have been evolving to then continue the benefits of the ergonomic platform with the ergonomics too that increases that properties, as I've been pointing out. That is how we were able to create this minimal invasive platform that we are putting in three different pillars. The first one is the Mia. It was the first one that we started with. It has been already launched in many cities with great success.
That allows us to understand the behavior of this technology with the surrounding tissues and the benefits of it. After that, we were able to create a procedure that will have a larger reach, but maintaining the most important principles, the geometries of the implants, how we can reduce the size, having good projections, good outcomes. How can we increase the use of this technology? In 2023, we started our clinical trial that I'll be sharing more. For GEM, for the glute, all the questioning and all the fears of a gluteal augmentation that is known very, very clearly worldwide, we have been able to maximize the safety of the procedure in a standardized way and a replicable way in order to minimize those risks.
By creating a very thought platform, we have been able to provide the tools in order to be more precise on how we are doing the procedure. Doctors have been talking about all these natural structures of the ligaments, circummammary ligaments, Cooper ligaments. It is basically rewriting the way that we're thinking about how to bring the addendum of a breast in a safe way that will maximize that behavior between the device and the tissue surrounding. Here you see a very comprehensive platform that starts since the marking of the procedure. How do we create a way of minimizing the possible errors that a regular plastic surgeon can perform this procedure? By doing this, we have been able to increase the way that we are educating our surgeons.
It is impressive to see surgeons with no experience in transaxillary procedures to be able to do a Mia even faster than the time that it will take an expert surgeon transaxillary trained. This is to showcase what we see in a Mia procedure. Clearly you see that the access is under the armpit. We create the channel separator in order to, without damaging the tissue, go and create a tunnel, a three-dimensional space that then is going to be used with the balloon. Literally injecting just by pressing a button, that implant is propelled into the space that we created. By doing that, we learn how we could then use it in the pressure bay technique that is changing the axis on an inframammary approach. The amount of time that it's taking, it's less than five minutes. What Dr.
Steve said, I think it makes a huge difference. The ability to use local anesthesia, the recovery of that, minimizing that, it's extremely significant. You can see the patients here. Here we're removing any scar from the breast. When you see the armpit, it is actually hard to see which are the scars because there are some folds already there. We're using one of those folds. In the Preservé case, also the scar is very similar. Traditional breast augmentation, if you compare the way that the process is done, we respect it a lot. It is what we have been learning how to improve.
The way of moving now into a system that will allow us to create these results and using pressure bay to go all the way up to four cups, while Mia, it's developed in order to do one or two cup size up. The possibility of using the system in order to create a faster recovery for the patient, it's really making a huge difference for us. You can see the difference between these two technologies. This is a summary of the clinical data that we have collected from our study that it was a three-year follow-up. When you see the results, it's actually hard to believe. Dr. Pittman said we used to be called crazy when we started doing this.
We're so used to that word because when you're doing things differently, when you're bringing new technologies, that's exactly the first thing that you're going to be called. With very good clinical data supporting this, look at the capcon rate and the rupture rate. Is this a surprise? It's not. For us, it's not because we have been really thinking about how do we minimize, even though we had already a very low capsular contracture rate, by using a system that will minimize even more the interaction that can possibly bring anything to increase that capcon, reducing it. This is not a surprise. Also, having a system that deploys it without the risk of rupturing, of course, also minimizes that. Sometimes I know that serials are hard to believe, but this is the information that we have.
I think that that will be in the future also very consistent. Yeah, I think that one of the progresses that we're going to be having now is that we're starting to see how the platform that we develop for the breast has other applications. This is some pictures that we used from our clinical study that we started, IRB clinical study approved, that we started in 2023. This year, we're going to have already two years of follow-up. The patients are doing extremely, extremely nice. You can see there's a different tool because we're going between the muscles. We have to design a tool that will allow us to get to that space. We're leveraging the platform for the injectable that we have for Mia, the injector that we have for Mia.
You can see right there on the table the results that we're getting. This is a patient. This is six-month follow-up. What you can see here is that it's not a huge augmentation. It's just a little volumization of the glute. Look at the scar. Traditionally, I don't know if you've seen this, but when you get a gluteal augmentation with an implant, you get two scars because of the risk of infection, because of the access to the muscles. We were able to move all to one scar. The scar is less than 3 cm. Also, the procedure is done in less than five minutes itself. It is no general anesthesia. It's a spinal block. Then we do some blocking on the muscle in order to minimize the pain management.
Just to finish, something that we have been working on since 2010, we brought the RFID technology into our implants. That was launched in Europe in 2014. An evolution of this, Dr. Hammond was explaining how we used that platform in the Flora tissue expander that we are extremely proud of and how it has changed the way that breast reconstruction is being done. I think that still there's a lot of impact that it will have. What we did for the breast implant is that we converted that passive technology of radio frequency into the beginning of what it will be, a platform to start collecting data with biosensors. We're starting to get our first data on the GEM study. All the patients that participated in the GEM study had the temperature sensor.
We started collecting information that has never been collected. We also have some patients that have it in the breast. It is very impressive, the difference and the behavior. We have collected the 24 circadian cycle and the capabilities that this platform can bring us to the future. We believe that it will be extremely, extremely valuable for breast health. With that, I would like to now pass it over to Juan José Chacón, our founder and captain of all this. Very nice to be here. Thank you so much for being here too.
Thank you, Roberto. And so glad to be here. Last time I was here was July 19th, 2018. The day we went public, first company from Central America. So it means a lot to be back here, especially with these amazing plastic surgeons that are here, basically to give us the insights that we need, not only on the technology that we have today, but what's coming after. I think one of the really interesting things is that with the advent of GLP-1s, there's been a profound transformation, not only in society, but also in the market for medical devices. For some time, probably there was a lumping of aesthetics within that group. One of the things we're going to do today is we're going to have two amazing plastic surgeons, Dr. Sachin Shridharani and Dr.
Johnny Franco, who are going to talk about the impact of GLP-1 agonists in plastic surgery. Please, both of you, can you come here? Dr. Franco, why don't you come first? Thank you again. Could we have the presentation, please?
Awesome. I'm Dr. Johnny Franco in Austin, Texas. I'll tell you this. Weight loss revolution has been a personal passion project of mine. I actually started the journey in about 2022. I'm down about 90 lbs over the past three years. We integrated this into our practice. At this point, we see anywhere between 1,500-2,000 weight loss patients a month in the office. I think one of the things that's been super unique for us is starting so early on the curve. If you think about 2022, it was just a whisper before this kind of wave came in. I think I've had the fortunate opportunity to, one, live it, and then two, be able to see our patients of where they've been in this journey.
I'll give you my case of why I truly think that there's a second cosmetic wave coming for those in the industry and for practices that truly adopt this, that truly empower this. Really, really uniquely have to speak to these patients in a different way. There are just amazing opportunities. There are real challenges. You've seen some of these. This is where I think Motiva has a few really unique opportunities to treat some of these challenges that are going to be confronting patients. As great as this is, there are going to be some new frontiers. We're seeing mature issues in really young patients.
We have to think about how are we going to treat them over the next not 20, 30 of their years when they came in at 40, 50, or 60, but how are we going to treat them for the next 80 years of their life? I think a few points have already been made about that. When you think about this weight loss revolution, why is it such a chord? There's nothing that has ever reached so many people. I don't think that there's been a treatment in the healthcare field since penicillin that has such a ripple effect in the healthcare industry. I mean, we're going to see changes because of these medications for the rest of my career, at least. So many people are involved. If you look at how many Americans are interested, at least half.
I feel like the other 30%-40% in that group probably just pushed the wrong button. If you look at the aesthetic industry itself, one of the things we're looking at is how many people are in it. Because so many people are trying to just improve this. And you see the indications of these just increasing every day. One of the big changes here, if you think about this, the spend in weight loss, right? 11% of aesthetic spend is on weight loss medications and lifestyle. A few people, including Dr. Steve, already talked about this. You're seeing this pivot, right? 11% in just three years. I mean, that's a meteoric rise. I mean, that's massive. You are going to see this whole kind of move.
We've seen in our practice, whether it's BBLs, whether it's gym, whether it's these things, is this different movement in terms of what patients are desiring, this fit and fabulous life because their lifestyle has changed. They want their appearance to follow that trend. I think this is where there's opportunities. If you can speak to this, little downtime, really subtle, sexy changes that follow that lifetime flow, I think are huge. The local anesthesia, the subtle changes, the making of the procedure is very simple. Some of our surgeons are super talented. I think they downplayed their skills of how challenging some of these procedures are. That's what Motiva has done, is really taken a way to decrease complications to make this super easy for patients along this. I do think there's a ripple effect in this spend, right?
How are you going to actually move them from these aesthetic patients along that journey? This journey here, I think, is complex. I think it's more complex than most people realize. There are all sorts of places to be along this journey. Anybody who's been in Texas thinks about this as a Bucky's every 90 mi in terms of things. The idea behind this is that there's the weight loss, but it's so much more than this. There are so many spots to be a part of this journey. This is where I think, and I'll show you, the Ozempic breast is going to be a massive part. Ozempic butt is going to be a massive thing. Those subtle changes that Robert just showed, that's what a lot of our patients are looking for. They're not looking for a massive change.
They're just looking to targetly restore the volume that they had lost in a simple procedure that does not have problems, that has little downtime, that gets them back right away. It's just, are they living that squat life or that plastic surgery life? I think there's a lot of places for plastic surgeons and the aesthetic industry to be a part of this journey. If you think about how many people are part of this, and plastic surgeons tend to be a little bit slower adopters, but you see 60% of med spas are doing these, 35% of aesthetic offices. Even the Aesthetic Society has made a big push. Dr. Karp is part of that committee and is committed to training the wellness and those type of things to our members so they can be leaders in this.
I think there are so many opportunities for us to be leaders of this throughout their entire journey. Because as a few people have said, how do we guide them throughout this? I mean, it is a perfect world, right? Here is your ultimate goal. Let us take you from step one all the way to the finish line throughout that entire journey. I think that is really huge. For people that think this is going away, this is a little graph of some of the medications and clinical trials now. The Triple G will hit the market likely next year. We have an oral medication coming to the market this year. The Triple G will be equivalent to bariatric surgery in terms of weight loss. The effects that you are going to see are only going to continue to rise over time.
I've been working on this concept called the Ozempification of Aesthetics. This is so exciting because if you think about it, there's so many changes coming. You have this unique patient population. I used to think this is just our weight loss patients. It's not true because we've never had so many young patients with weight loss issues. We've never had this number of patients coming into the industry. I think there's really unique challenges. How are we treating these younger patients with mature issues? We also have some evolving treatments. This is where a company like Establishment Labs is really looking at how can we treat these new issues in an effective way for them. I think the people in industry, in plastic surgeons, that adopt these and realize these challenges and really find solutions for them are going to thrive.
They're going to be that group that really feeds into that second cosmetic wave. If you look at it from a pure business standpoint, the amount of this Ozempification, when our most visited page on our website is Ozempic face, Ozempic butt skyrocketed. With Ozempic face, 250,000 impressions in the first three days it went live, which shows you how many people are already searching for these terms. This was mind-blowing when I pulled this for a talk recently. Look at this rise of search terms for the Ozempic weight loss, right? This isn't the medications themselves. This is just for the treatment, Ozempic face, Ozempic breast, Ozempic butt, to exactly the things you're talking about, but a straight line up in terms of the amount of people searching for solutions for these Ozempic side effects. Super interesting in terms of things coming.
Lastly, just to leave you with something is this idea of aesthetic naive patients. You have 40%-60% of patients that are on these GLPs are new to the aesthetic industry, new to your office. I'll tell you, it's hard to move them over. It's challenging. It's got to be specific. This is why I think when you can do unique things that speak to them in a very good way, I think it's going to be on us as providers, as surgeons, and the industry to help guide that and train people. Yeah, speak to them in a way that truly resonates and helps guide them through this. You see this demand coming. You truly see the second wave. There are a few other studies out there that are starting to show some of these trends of people looking for solutions for this.
Super excited to be a part of this. I think that we're only scratching the surface. I think there's a massive second wave of cosmetics coming to the industry for those people that really embrace this. Thank you, guys.
Thanks so much, Johnny. I think Dr. Franco's enthusiasm and passion always shines through in a great way. My name is Sachin Shridharani. I'm a plastic surgeon based here in New York City. Also, I'm excited to talk to you about something we've been incredibly enthusiastic about, which is understanding the GLP-1s and their impacts on plastic surgery. Just take you kind of through a little bit of a journey with our practice. Firstly, I have a few different roles in the world of aesthetics. I'm the founder of LUXURGERY . We're the confluence of luxury and aesthetic surgery and have a true focus on really curating an experience that we try to think is unlike any other in aesthetic medicine and aesthetic plastic surgery. I'm also Associate Clinical Professor of Plastic Surgery at WashU. Finally, Chief Medical Officer of Skin Spirit.
We've partnered with private equity and are backed by KKR and L'Oréal, recently bought a sizable stake in our organization, 650 employees, 55 clinics throughout the U.S., and focus on non-surgical aesthetics along with minimally invasive aesthetics. Really, all three of those different roles afford me the opportunity to see people that come into the clinic in a few different lights. Do we see them as a patient? Do we see them as a customer? Do we see them as a client? One of the things that all three of these individuals seeking aesthetic procedures have in common is that they pose us as clinicians with a challenge. Those challenges are basically, I want the most effective treatment that you have, the least amount of downtime, minimal to no adverse events performed by the most experienced person in the world. Finally, is it free?
That's what patients are often seeking. Of course, these challenges then we have imposed to our partners in industry, for example, like JJ and Nick Lewin and the folks at Establishment Labs, to come up with complex solutions to this problem, to give us incredibly innovative technologies with tremendously low amount of downtime and, again, a phenomenal safety profile. Because really, the industry is impacted at a very global level by anything that is a poor outcome. The margin for error in aesthetics is incredibly minimal. Patients really have tremendously high expectations. It helps us think about how do we curate what I call in the treatment phase, which is patients are tremendously vulnerable. They're really looking to create a bond during this time point. Why this ties in is just sort of a walkthrough of a portion of our clinic.
What it really starts to lend way is when we think about true innovation and how now GLP-1s are going to impact plastic surgery. We already realize at a top-line level that excisional procedures are on the rise unlike any other. We started to see tremendous amounts of growth in the injectable sector over the last several years. Neuromodulator treatments are the most frequently performed cosmetic treatments, followed second by dermal fillers. As we've seen the GLP-1s now being introduced into aesthetics, we're starting to see that there's a slight correction there. Surgical procedures that we historically were not performing nearly that much of have come onto a shocking increase in rise, which is obviously something that makes us as surgeons who use our scalpel instead of a syringe incredibly happy. What impact does that have in general for patients during that treatment phase?
Firstly, the advent of GLP-1s is something incredibly interesting to me. Out of my practice, we published the first paper in the plastic surgery literature as a systematic review just on kind of the impact that we would have on or what the impact of these processes or these medications will have on aesthetic plastic surgery. You already heard some really great top-line data from Johnny so I'll spare you from having to hear those points again. Really, and fundamentally, there is a tremendous amount of value that we're seeing in GLP-1s. With that said, that volume loss and the overall weight loss that occurs leaves patients with a new problem that they really were not maybe expecting before. That is where, as JJ already astutely mentioned, this whole concept of weight loss and wellness and thinking about decline in aesthetics is actually quite the opposite.
After patients go through that initial decline in 10%-15%-20% of body mass index and subcutaneous fat, they're left with something that is basically an empty balloon. Think about the skin of the breast analogous to the rubber of the balloon. The air filling that balloon is like the glandular tissue and fat filling the skin. If we let air out of a balloon very simply, it starts to droop and sag. Although patients are really excited about the new overall body shape they have, they're coming in now and saying, "What am I going to do with this loose skin?" There is a tremendous amount of interest in volumization in these areas and then thinking about how can we use novel technologies, minimally invasive technologies that optimize the patient experience and safety and efficacy, but still give the patient what they're looking for.
We're starting to satisfy those new challenges that we're seeing that are coming to us in an incredibly rapid-fire fashion because of the fact that these GLP-1s have exploded on the scene and are clearly not going anywhere anytime soon. Now our technologies have to start to rise. Knowing that we have a tremendous and robust pipeline that you heard from Roberto about already tells us that we are very, very well poised to be able to help volumize these patients, treat them with these areas that are deflated, and give them a really beautiful outcome with minimal downtime and minimal adverse events. This is just an example of a patient. This is actually, though, a massive weight loss patient, not a GLP-1 patient. One of the things that you can see is that there are tremendous challenges at times with the volume loss.
This patient comes in and says, "I've never looked better in clothes, but I feel incredibly a loss of femininity, a loss of my overall volume, and I don't feel like myself. I have this amazing overall volume loss journey, weight loss journey, but I still have issues and concerns about intimacy or being in clothes that would try to make me feel a bit more comfortable." What can we do?
Being able to treat these patients in a single treatment fashion, volumizing the breast, for example, with our Motiva implants and being able to do a lift simultaneously and knowing that we have a tremendous overall safety profile in these otherwise challenging cases is something that gives us a lot of confidence as plastic surgeons to be able to partner and use these products because, again, of the safety, efficacy, data, and the ability to have them not have as aggressive of a procedure. Just an example, again, of one of the patients here. You can see them approximately six months out with the Motiva implants. These are just case examples of that in general. In summary, our GLP-1s are here to stay. You already heard about how they're going to be combined with multimodal type of approaches or multiple medications packed into the weight loss component.
Injectables are going to turn into one of those elements with the weight loss medication where we'll look at greater longevity so patients don't have to do them weekly. You're seeing oral formulations that will start to rival the efficacy of the injectable formulation. All of that means that we are well poised as plastic surgeons to see a tremendous amount of influx because patients want to look good in and out of their clothes, and they're not going to walk around with an empty balloon. That is what's going to give us a unique opportunity to use, again, novel technologies with high efficacy, high safety profile, minimal downtime. Unfortunately, they probably won't be free. With that said, thank you all very much.
Okay. I would like to call Dr. Steve, Dr. Epstein, and Dr. Pittman back here to the stage. I think I'll give it to you guys here, and I'll move over here so I can give you some room. In this next panel, I think what we would like to do is to have a discussion around market expansion because I think it's one of the most important things. Plastic surgery for many years has suffered from the lack of innovation. Of course, that has had an impact in the size of the market for plastic surgery treatments. What we saw today in that first presentation that Roberto gave about that minimally invasive platform and where that is going, I would like to hear what you guys have to say when you see that platform and you think about the future.
As you know, Mia is already in the market, is in more than 50 cities around the world and growing every month. Preservé has been launched in many regions and select markets. We are under clinical study when it comes to GEM. These things are real. How do you think those will impact your practice? How do you think it will mean to the way you price this and also you communicate those? I think you have.
I would say in our practice, it was interesting since I had the chance to go to Costa Rica and was actually with a couple of you. I actually started doing more local procedures after we chatted. It was super interesting to me. One, how big of an obstacle anesthesia was for patients, how receptive they were. For us, we haven't decreased our prices. We've considered it a premium package in terms of doing this. It goes to the whole movement of rapid recovery. People don't want any downtime. Sometimes people just don't want somebody to have to take care of them for an extended period of time. Anesthesia is the biggest reason that people have a little bit of that hangover. It takes them a little bit longer to get going. I think that's been super exciting.
I'll tell you as a plastic surgeon, this has been a really exciting time. I mean, between the transparency trend, which has taken off like wildfire, and you see more of this coming to light, people sharing their journeys, I think with Motiva really changing things and just having great conversations, whether people agree or not, I mean, the fact that we're talking about this, I think, is absolutely huge. You've seen, and obviously, I'm biased, but truly believe that the GLPs have led to this huge conversation because you've seen this movement. I mean, the timing couldn't have been better for you guys because in terms of this kind of whole fit and fabulous change stuff and the movement away from being so big and something this subtle, sexy has really taken off.
I think that the timing has been a perfect storm that you guys probably couldn't have planned any better.
I think the one thing that stuck with me was when we were in Costa Rica the first time, we were asking how we're going to incorporate Preservé and Mia into our practice. Your answer was, "You haven't seen those people yet." I think that's something that's really exciting is that there are all of these women who are wearing push-up bras who are sitting in their home saying, "If there was only a way to kind of fill this bra out and not have surgery under anesthesia, I'd love that." That's what's exciting is that there are all of these women that we're going to be able to open the market to who we don't even see in our practice yet.
Sure. I think those are two incredible points. I think if we just take kind of a bigger step back and take a look at this. When you talk about market expansion, innovation, these are two elements that have been incredibly lacking in aesthetics. Most of the innovation has come in the non-surgical sector because surgical procedures, really, the innovation are just expansion of new techniques, not necessarily new technologies per se. That's why you've seen so much in the injectables, new neurotoxins, new dermal fillers, new devices, tightening. All of those things are device-based that actually have a lot of science to drive them. Surgical innovation usually just occurs in advancement in techniques until you have something truly novel, like a new device or a new implant that's being used in a completely different way. The word innovation gets thrown around quite a bit.
It is why even this multi-billion-dollar industry has still been so underpenetrated. If you look at the data, 6%-8% of Americans undergo an aesthetic procedure. That is it. When you think about the number of people, as Dr. Pittman already alluded to, that are out there waiting for a different type of technology or a different procedure with less downtime that taps into what they are looking for, there is a huge opportunity in market expansion as opposed to what we usually do, which is just cannibalize our internal databases and just keep offering the same people multiple different types of procedures. That is what has historically happened. There is an unmet need which can be met because of these novel advances.
Yeah. Let me add something more to that. I think one of the most exciting things from today was the announcement that we will begin early experience with Preservé this year here in the United States, which I think is way ahead of the expectations that many people had. When we look at it already, we had the first launch in Brazil in February, followed by launches in Europe and the Middle East. Then we launched in more select countries in Latin America and now the United States. I would like to ask Dr. Steve and Dr. Epstein about breast tissue preservation. Dr. Pittman presented on it. I think the wave towards preservation and these types of patients and what it could mean.
I think the information is out there, and it's readily obtainable. Women are going to drive this. They're going to find the information, and they're going to be the ones asking for the procedure. There are going to be those who adopt it and those who don't. Those who don't, they're going to see their practices decline dramatically. Those who do adopt the procedure, this is just like open to laparoscopic surgery. This is where the future is going. The Motiva device is engineered to be most ideal for the minimally invasive preservation approach. That's going to become the gold standard.
You know, I think we're all surgeons, and we love surgery, but no patient loves surgery. If you can have an injectable breast implant, which is exactly what's coming, I think that's a huge market expansion for women who otherwise wouldn't have even considered surgery. I would say before I spoke about having two primary types of patients, I would add a third in that the weight loss patients, they look like postpartum women in the amount of volume loss they have. In my practice, even with the Park Avenue look and these very lean women, at least 60%-70% of our patients are taking these medications, even when they're very fit women, just to be a little bit thinner.
The consequences of that are those women have dramatic volume loss that they do not want to tolerate from the perspective of feeling like they are too young to look that way.
Yeah. One additional thing we wanted to add is just last weekend, we were in Paris in the first minimally invasive breast meeting worldwide. This was an amazing opportunity because it had two tracks. One was breast reconstruction with robotics, endoscopy. The other track was pretty much all about Motiva's incorporation of minimally invasive into aesthetics. One of the interesting things is that in that meeting, we had people presenting on the use of Mia in breast reconstruction. I think that's something that we should all remember is that if you're doing, for instance, robotic breast surgery, eventually an injectable implant is a huge solution for that type of technique and beyond. There's also this changing of expectations of the recent patients that is looking more and more like aesthetics.
Beyond that commercial, what I would like to do is go further into GEM because that's been an indication that's been only for a very few, very courageous plastic surgeons, usually one or two per city. You have had access to the procedure and seeing it. I would like to see not only on the GLP-1 population, but also in the day-to-day patients what impact it could have on that.
I mean, I'm someone that does butt implants. It's interesting because we'll have people come visit our office because in training, most people didn't see it, didn't do it. One of the things that I think is so exciting when I've talked to your team about this is that I think this is another huge opportunity for market expansion because a lot of people don't do it because of our moral compass that if we haven't been trained, we don't feel good. Like we can do this reproducibly. We're typically not going to offer it to patients.
When you make this very systematic, that it's step by step in terms of this, I think you're going to have so many people wanting to because I have people come up to me all the time or they DM me and they're like, "Hey, can I come watch and learn this? I have so many patients that need this now that they've lost weight. I don't want to just jump in and try this." I think having a standard approach and then you guys would roll it out just like you're doing now. We're like, "Hey, here be some center of excellences. Here's some of the trip stuff," and then being able to do that. I think the Ozempic butt, it's been absolutely mind-blowing to me how many people have asked for this.
People ask me all the time because a big part of my practice is lipo fat transfers. Have BBLs gone away? I’m like, "Absolutely not. We’ll do more BBLs this year than I ever have in my career." Most people, what they want has changed in terms of desires. It’s more shape over size now. This, I think, falls right in line with GEM.
I think to your point, one of the things we see all the time with women who have deflated breasts who come into the office and they say, "I want to have fat put in my breast," is we can't shape your breasts with fat. We need to use something like an implant to shape the breast. It's the same thing with the Ozempic butt. There's so much skin laxity that just filling that with fat is not going to work. We have to have something more projecting.
Yeah. There is the other part that I think it would be interesting to discuss, which is the GEM can be used for women, but also for men. I think that's something that has been overlooked because we've been primarily devoted to women's health. As part of everything that we are developing, I think that's the other very interesting part.
Offering a minimally invasive procedure has a huge impact on your practice. Thirty years ago, I was doing a lot of hand surgery, and I was doing carpal tunnel releases. When I went to endoscopic, where my patients had minimal discomfort and a mechanic could work a day or two later, my volume in 12 months went up tenfold. It stayed that way until I stopped doing hand surgery. Why should this be any different than that? I think once we're offering the Mia procedure with sedation or local, however you want to do it, and the Preservé, I expect the same thing in my practice, a very, very substantial uptick in volume.
I think being a women's health company, there are a lot of similarities in where you entered the market with a breast implant that was safer in a time when there was a lot of concern and hesitation and mistrust of the implant industry. I think similarly, there is concern around the safety of things like BBL, which is the fat transfer to the buttock. There are a lot of similarities in the ability to bring a safer product to the market, which I think is a really valuable thing for not only women's health, but also just creating opportunities for patients that they see these aesthetic solutions as something that's less risky.
Yes. At this point, because we have a few minutes, anyone wants to ask any questions from the audience? Josh?
Thanks a lot, Josh Jennings from TD Cowen. Appreciate the insights and the outlook for GLP-1s creating a next wave of aesthetic procedures. I was just hoping to get a sense of what you're seeing already. I know we're still early in the adoption of GLP-1s in the United States. I think the metric you shared was 12% of the population have adult population as trialed. Are you seeing the beginnings of this wave and any percentages of cases of GLP-1s outside of maybe the lean population that's using GLP-1s to get even leaner on the Park Avenue side?
I'll tell you, in our practice, since we've been doing this for about three years, the journey for our patient is typically this. They'll come in, and at the very beginning, because at the very beginning, right, it was your own patients, but now we just get patients from all over. The very new ones, these aesthetic naive, the 40%-60% that are new to the practice, they'll be like, "Oh, I'm not interested in any of that foo-foo stuff. I'm just here to lose a little weight, just trying to get into a spot." The two things that we've seen is one, we've seen more men come into our offices, for sure. It's always 8%-10%, and this is the new wave, and then it's the same thing two or three years from now. I truly think that's going to change.
From a timeline, I'll tell you what happens is that it takes about six to nine months to move them into your injectable med spa treatment stuff. The better you can be about speaking to them and happy to answer questions about that because it was a learning curve for us. From surgery, it was about a year. Some of that is us making sure that people are stable, not having the rebound. Because if you're going to do a bigger surgery, and depending on how much weight they lost, there are a few medical things that we make people accomplish, meet, and stabilize before we do some of these surgeries. I'll tell you, in our practice personally, I used to do, we were talking about this earlier, one or two of these kind of circumferential lifts, arm lifts, thigh lifts a month. It was funny.
Yesterday in our office, I did a circumferential lift and then a thigh lift on another patient. My partner did a thigh lift in the room next door and then did a butt lift. I mean, typically, those individually would be one surgery that happens a month. Here it was in one day, we did four of them. That has become a routine spot in our practice. I think it's changing. I think the big timeline is six to nine months for med spa, about a year for surgeries. I think this is where it's going to be on us to educate those new patients and really have that conversation going because they're not just going to magically move.
Sachin.
Sure. I think I'd echo a lot of what Dr. Franco said. The use of these medications can be used to optimize patients, right? What we mean by medical optimization is elevated BMIs, having patients on these medications, allowing them to get to a healthy weight where we know that their body mass index falls within a range where we can then mitigate and offset some of the complications and adverse events that we're accustomed to seeing. We started prescribing these quite some time ago over the last couple of years. It's not just for the lean patient who wants to be leaner, right? We keep talking about, we're talking about the Park Avenue element. It's New York City, the ongoing joke, you can never be too skinny or too rich, right? Patients want to be leaner.
Now we're taking a look at patients who are slightly heavier set, optimizing them, getting to something that's stable, using that then as a maintenance dose and carrying them through the journey and allowing them to get a safer surgical procedure. The answer is yes. We are seeing this consistently higher. I think you'll start to see data and statistics that we put out from American Society of Plastic Surgeons, American Society of Aesthetic Plastic Surgeons, sort of our governing bodies. You'll start to see that a lot of these surgical procedures are on the rise that either plateaued or declined over the last decade plus. That is really where we're starting to see that explosion occur, which gives us, again, unique opportunities for novel technologies.
Yeah. Next question.
Mike Matson, Needham & Company. Just with regard to the GLP-1 patients that get the breast augmentation procedures, are you able to use Mia, Preservé, or do you feel like there's a need to develop some type of other more specialized procedure for those patients?
I find very unique is that the shape of the Ergo implant actually spares a lot of women the need for a breast lift because that implant placed above the muscle means that they actually do not need that incision pattern of a traditional breast lift. A lot of patients come in thinking that they need a breast lift and they really do not want those scars. With volume restoration using the right shaped implant, they do not actually need that. I think that the technology to meet the need already exists. I think there is also a whole nother culture way of coming of longevity medicine and people taking these GLP-1s not for weight loss, but for cardioprotective benefits and the idea of longevity medicine.
I think that is also coming with the consequence of still these volume loss changes that a large portion of the population is suffering from.
Mark brought up a great point because those patients are challenging because the tissue is already so thin and somewhat been destroyed by the inflation and deflation. If you think about it, if you can minimize the trauma to that, you're preserving whatever is left, even if it's been stretched just a little bit. I think we're just scratching the surface of maximizing it.
I think you asked an incredible question, and I'm going to tell you why. Separate minimally invasive in your mind from amount of scar, okay? Let's say I have a patient who's lost weight and the breast clearly, even a blind person can look, face them and say, "You need a lift," okay? Would I do the minimally invasive? The answer is yes. I'll tell you why. Yes, I'm going to make big incisions for the lift. Remember, the minimally invasive, a side benefit is the small scar. The real purpose to do it is the preservation of the internal anatomy. When you do a lift, you are not technically in the breast. There's a very fine layer of fascia on the surface of the breast that separates it from the skin and the subcutaneous fat.
The fat right under the skin is not breast tissue, it's fat. If you're in that plane, you can do that lift. You've already put the implant in. You've preserved all the ligaments. Now you've got a preserved breast, and now you're just rearranging the skin envelope. It's a separate issue. It's not about the issue with the scars. It's about how can you put the implant into the breast in the least destructive way to preserve the long-term results. The lift is just going to redress the skin on top. What happens with that breast long-term is not going to be due to whether you removed too much skin or the skin loosens up, whatever. It's going to be, did you destroy the ligaments inside that breast? Are you going to get a change in the breast parenchyma now slipping off that implant?
That is where I would still advocate for the minimally invasive approach. Using the preserve approach, you do not need the preserve to put that implant in and then do the lift at the same time of the same surgery. You brought up an absolutely awesome question. Thank you.
Yeah. To be clear, the Preservé is augmentation up to four sizes, but also, which was very pertinent to that question, it also includes the hybrid breast, breast tissue preservation augmentation, and the mastopexy breast tissue preservation. It does have that opportunity. I think there is another, Allen.
Thanks for the question. Allen Gong, JPMorgan. You kind of actually addressed part of my question here, but my question was kind of around if you do, again, like a Google search of minimally invasive breast augmentation, you will get practices advertising their procedures being minimally invasive. There have been techniques like transaxial that are arguably less invasive over the years. You have talked about how it is not just about having the smaller scar, it is about the preservation. When it comes to changing the hearts and minds of other physicians who will say, "I already have an approach that works for me. My skill level is higher than everyone else." What would you do to kind of convince those doctors?
Were you a surgeon in your past life? Because surgeons tend to be very egotistical. There are those who change and evolve with the market and with technology, and everyone on this panel is like that. There are those who say, "Hey, this is the way I do it. I've done it this way because in my hands," that's the expression, "In my hands, it's always worked." You mentioned minimally invasive, small incision. Yes, small incision clearly is minimally invasive. Years ago, I used to do transaxial breast aug, small incision, but inside I was doing all the same destructive stuff, destroying the ligaments to create the pocket. If someone said, "I do transax minimally invasive and I use some dissectors and I make my pocket," yes, you're doing a minimally invasive procedure.
I'm doing a minimally invasive procedure, but unlike you, I'm preserving the internal ligamentous anatomy of the breast. Going forward, my results are going to last longer and look better than your results will. That's the difference. It's not just the small scar. The whole key that is turning everything upside down here is the idea that you can completely preserve the circummammary ligament and all the ligaments inside.
I think patients are what's going to change a surgeon's mind because when Dr. Steve and Dr. Pittman are scheduled up for six or nine months and they're doing 250 breast augs a year and somebody else is doing 20 because patients are demanding, patients are asking for this and they're not doing it, that's what's going to move them.
I think that is the total shift that comes along with this culture of transparency is you could have surgeons' egos clashing forever. We live in an era where patients know more than they've ever known about the technology. That is really aligned with the direct-to-consumer marketing. Patients are going to demand this of surgeons. Those who do not evolve will be left behind because patients are more knowledgeable than they've ever been.
I'm good.
All right. On that note, I think we'd like to thank you all for participating in this panel. Let's give you a round of applause. I think next we are planning to Q&A from management. These boys will get up here. We have a few minutes here just to wrap up. If anybody had any questions for management, if you don't, that's fine too. We thought maybe we'd give you a couple of minutes. We have first question right here.
Harrison Parsons, Stevens. At a recent conference, you noted that ergonomics makes up nearly or around 60% of U.S. implant volume. Has that trend stayed relatively consistent over the past few months? How does that mix help you better understand the U.S. consumer from a competitive standpoint, given you've noted most of competition is based on primarily around pricing discounts?
Yeah, so I'll take that question. That ratio of 60-40 ergonomic to round has pretty much stayed very consistent since day one. It moves around a little bit as we bring on new surgeons. Each surgeon, like you heard from Dr. Steve, has a certain sort of look that they go for, that type of patient in their practice. That is a very different look if you're in Dallas, Texas, right? That regional difference or the actual practice that that surgeon has that comes into the equation with us does move it around a little bit, but it's one or two percentage points one way or the other. The second part of the question.
Just around how that mix informs your strategy from a competitive perspective given the price points between the Round and Ergo implants?
Yeah, I don't know if it really affects our particular strategy in terms of we're trying to satisfy the market demand. If that particular practice or patient is looking for a full upper pole round look, we're happy to provide that device to them. If somebody is looking for a more natural teardrop shape, then we're obviously happy to do that as well. I don't know if we're really going to try to steer that one way or the other versus just try to satisfy the demand.
Just a clarification question on the regulatory submission for Preservé. Do you also need the Ergo2 implant to enable the Preservé procedure? Can you use the existing Round and Ergo implants? In terms of the commercial strategy, are you going to be taking a Mia-like approach where you're certifying centers and they're buying into the program, or is it going to be a broad-based sort of launch?
First on the regulatory piece, I think it's important to realize that Preservé can be done with the Ergonomics implant and with the Ergonomics2 implant. The Ergonomics2 implant allows for more advanced applications that are very specific. You can do breast augmentation up to four cups with breast tissue preservation with the Ergonomics device that has been already approved in the U.S., plus the other mastopexy breast tissue preservation and the hybrid breast tissue preservation. Those will be part of this. The important thing also is to realize that as we do these early experiences, we will be getting a lot of information back from these first centers, and that will be used to tailor the strategy for the eventual launch. Yeah.
Just to be very clear, because we've sort of mentioned it, this early experience group, so some of the surgeons here as well as another group, they will gain access to the Preservé tools in advance of the broad general launch that will happen early next year. As JJ said, that will help inform our strategy from what's the training necessary to get somebody off the ground, what's the pricing, what are the cost savings in terms of the procedure time, the OR time, anesthesia, et cetera, et cetera. That will help inform our overall pricing strategy as well.
Yeah, as I mentioned earlier today, I think a lot of the learnings that we get is from what's going on outside the U.S. We just launched Preservé. As we launch in each region, we've been adapting that strategy. We're going to apply a lot of those learnings in terms of how we launch it in the U.S. from a strategic standpoint.
Thanks for the presentation feedback. Two questions. One on revision, the revision pricing is double that of augmentation. Maybe just a little bit on how that's going to play in the gross margins next couple of years as that comes into play. That would be question one. Question two is on Preservé, the economics for practice economics. I think with the Mia centers, the price point was about $3,500, meaning revenue to Establishment Labs. The price point was about $10,000-$12,000 for practices. Is that sort of the right way to think about a Preservé clinic once we start to get going there? Thanks.
I can answer the question on the reconstruction approval. Much like augmentation in the United States, the cost of making these devices for us, for the United States, is essentially the same, right, as it is everywhere. The reconstruction approval, it's the same devices, right? As was noted, the prices in reconstruction are significantly higher. The price for an implant can be well north of $1,000 in reconstruction, where it's $650 or so for us on average in aesthetics, so quite a bit higher. Gross margins will be higher, right, significantly higher in reconstruction. You asked about Preservé as well, the pricing on Preservé. I don't know if you want to take that.
I think it's early to talk about pricing of Preservé in the United States. I think as Pete was saying, we are collecting a wealth of information from the international market from the launch of Preservé. Some of the early learnings from the international market is that when practices adopt Preservé, what they're doing is upselling those procedures. With all the benefits that the patients see in breast tissue preservation and also the downtime changes, the speed of the procedure itself, that allows those practices to charge about 20-30% more than they're charging for their normal augmentations. Remember, Preservé is more for your day-to-day. Mia is market expansion. Preservé is really more for the day-to-day. The willingness to pay of those two patients is different.
Going back to what Pete was saying, with all of that information that we are gathering, we will be collecting it. With the information from the first group in the U.S., we'll put together something. I think I gave you an indication of where this is going.
Josh.
Thanks, Raj. Josh Jennings from TD Cowen. Just wanted to ask about the reception of the pricing strategy. I mean, it seems from all the trends you guys have laid out over the last number of months and today that there isn't much friction. You're having strong adoption ramp. I think you said over 1,000 surgeons already are in the customer base. When there is friction, how much is there? Or has it not been an issue at all? I think there were some concerns before the launch of a premium product. Are these plastic surgeons using the adoption motif as an opportunity to take their procedure pricing up? Is that actually creating a tailwind, the premium price strategy for ergonomics at least? Thanks.
Yeah, so we have not.
We have not had significant pushback on our pricing strategy. We've been very transparent about what that strategy is. It does command a bit of a premium relative to the other products in the category. It's hard to say exactly what that is because the other companies actually allow their individual reps to negotiate price. We've taken that out of the equation. We have a very transparent three-tier structure based on the volume of commitment that they have with us. That seems to have gone very well in the marketplace and enabled us to command that premium. Relative to that, nearly all practices are, and it somewhat depends on how they do the actual pricing within their practice because that can vary. In general, yes, surgeons are taking a premium on procedures that are done with Motiva relative to the other products in the category.
Generally, it's about $1,000, but for some of them, it's as much as $3,000 more for that procedure. Yes, probably a bit of a tailwind for us.
Mike Matson, Needham & Company. It was good to hear from the super fans you had here in terms of surgeons. I guess what are you hearing from the surgeons that are kind of reluctant to adopt Motiva for whatever reason? What's the common objections? What can you do to sort of overcome that? I mean, it seems like the data is really strong. You seem to have a better product. Is it just simply a classic case of early adopters versus later adopters?
That's exactly the answer, right? You've heard some very progressive cutting-edge surgeons here today that obviously have been early adopters. I would say it's falling exactly into that sort of typical pattern, right? Early adopters, the innovators. We're probably at the tail end of that sort of part of the curve. We're starting to gain sort of the general masses. You heard Dr. Epstein talk about people who say, "In my hands, I'm doing great work with whatever this thing is." That's the late adopter crowd, and we'll get to them at some point. Right now, there's not really significant pushback that we don't feel like we have a very solid answer for.
One really important thing is that the speed of adoption that we've seen over the last 15 years per market and how fast we become market leaders is definitely turbocharged by the ability of consumers to ask for Motiva. I think one of the things you heard today very clearly is that not only do you have this wave of transparency, you also have this wave of patient education. The fact that these patients are coming and asking for Motiva by name, eventually, if you're not a user, what you do is like, "How many patients am I losing for not using Motiva?" That is where that group starts to break out.
Follow-up just on the broader market trends. Just where do you think we are in the cycle for aesthetics broadly, breast augmentation? How much, I guess, pent-up demand do you think there is out there just considering it's been a slow market? Do you think we need a rate cut to sort of get things going? Thanks.
You know, I think it depends on the market. I think when you look at the U.S., I do not think that that is one of the obstacles. I think we have seen a little bit different in a lot of the markets. I think there has been a lot of different fluctuation in the macroeconomic standpoint. Like we said before, I mean, I think for the most part, it is stabilized. I think there are still some questions out there, especially with all the tariff discussions. I think certainly on a global basis, we see it fairly stable. I do not think it is something that we need to kind of drive the growth.
Yeah, specifically in the U.S., we're not seeing any slowdown at all right now. In fact, we're seeing the opposite. The surgeons we engage with are talking about very long booking times, three months, six months, some outside of a year to get a consult with them. I think the market in the U.S. is very healthy and only getting better.
Allen Gong, JPMorgan. I guess I'd had a quick question on kind of the competitive landscape. You're kind of entering a market that was dominated by two much larger diversified players. I'm just kind of curious, in reaction to having a new entrant, the disruption that's happening around the third player on the market, if you're seeing kind of any renewed activity or anything of note on the competitive front, just kind of in response to the launch that you're having.
In short, not really. If you really look at where those companies are right now, they're all either de-emphasizing their breast implant portfolio or they're sort of, like in the case of Mentor, sort of nothing really new from them for a long time, although the Boost device, which has actually done fairly well for them. But Sientra Tiger is definitely in a withdrawal from the breast implant space, so much so that they've really de-emphasized it in their sales rep's comp plan. If a rep's not getting paid on it, they're probably not talking about it, right? Allergan has just gone through a major reshuffle across their entire organization, again, sort of de-emphasizing that part of their portfolio even further. For us, I think it's an ideal time to enter the marketplace.
If there are no more questions, we want to thank everyone for joining us here in the room and also on the webcast. We will be here for a few minutes also. If anybody wants to have some refreshments and chat, we will be here for the next few minutes. Thank you again for joining us.