Apyx Medical Corporation (APYX) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Apyx Medical Virtual KOL event. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Apyx Medical website following the conclusion of the event. I'd now like to turn the call over to your host, Charlie Goodwin, President and CEO of Apyx Medical. Please go ahead, Charlie.

Thanks, Tara, and thank you for everybody who's taking time today to join us on this call. It is my pleasure to have you here, and it is my pleasure to have Dr. Vanek here as our KOL, and I'm sure you'll find what he has to say, very exciting. Next slide, please. All right, next slide. A brief agenda of what we'll do today is, obviously, there's an introduction from me. We'll talk about the commercial launch of AYON. The majority of the time will be spent with Dr. Vanek, and he will be talking about his experience with AYON, and then we'll conclude the meeting and then open the call for Q&A at the end. Next. So at Apyx Medical, we actually view ourselves as the leader in surgical aesthetics. And surgical aesthetics is different from all other forms of aesthetics because in surgery, we actually believe that, that is the only thing that really provides durable and transformational results for patients. And the market is uniquely changed because of the GLP-1 drugs for weight loss. There are a ton of patients now that have lost a lot of weight, and they need to have -- they got loose and lax skin and they need to have a solution for that. And the AYON body contouring system along with Renuvion, we believe, provides the best technologies and the best tools to help the doctors achieve those needs. We just did get approval for AYON in May of 2025. We have successfully conducted a soft launch with key surgeons in multiple geographies all over the United States. And the results so far have been overwhelmingly positive for the performance of the technology and the console in their ORs. In September, we had said that we would start commercially selling the AYON to other doctors, and we actually have started that and are continuing that here in the fourth quarter. And then most recently, we just announced that we did file our 510(k) for the power-assisted handpiece portion of AYON that we had said that we would do, and we would expect to have that clearance sometime in the first quarter of 2026. Next slide, please. And just a reminder of the market and what is going on in procedures and a little bit in consumer behavior now. We think that AYON is uniquely positioned to lead this market and capture this tremendous growth that is coming from post-weight loss patients. And if you look at McKinsey, they talk about the GLP-1 therapies are going to exceed $100 billion by 2030. 44% of GLP-1 users spend between $2,000 and $5,000 on aesthetics, which is a 25% increase in their spend. And really important is about 63% of these patients are new to aesthetics post weight loss. And it is going to be a growing patient population for plastic surgeons to come. I think that the next decade is going to be one of the best decades that plastic surgeons have ever seen addressing the needs of these patients. But technology has actually lagged behind the industry. And if you look at body contouring technology, there has really not been any significant improvement in some of these technologies in over 20 years. And these procedural shifts are great that are happening is because a lot of patients now will need some kind of combination treatment. And that is a combination of surgical incisional surgery and body contouring surgery. And so these procedures now are more complicated. And if you look at just the ISAPS' data from last year, it shows that liposuction procedures actually declined by 10.7%, but surgical lifts were up in the 20s. And that makes all the sense in the world because the amount of laxity that these patients have is going to, in a lot of times, require some form of surgical intervention, some kind of skin incision. And a lot of times, it's accompanied by body contouring or by liposuction. And skin tightening now is the number one requested treatment post weight loss. And again, I talked about these combination treatments, and I think Dr. Vanek actually has a couple of patients that he's going to show that on later, and you can see the dramatic results from these procedures, but you can also see the complexity in getting these patients to where they need and want to be. And out of the GLP-1 users, 72% report loose skin as their top concern. And people are looking for a natural look versus a total transformational change and 57% seek treatment within 6 months post weight loss. Next slide, please. So this is AYON. And this is what we have launched, and I'd like you to formally meet her. And I would like to talk a little bit about what is in AYON from a technology point of view. There is nothing like it on the marketplace that is completely revolutionary. There is nothing that exists to have this surgical console on the marketplace today. And if you're looking at the top left of AYON, that is your traditional Bovie generator. It has monopolar and bipolar up at the top left. If you move to the top right, that is your Renuvion portion of it for skin tightening. Renuvion still remains the brains, if you will, of AYON and the Apyx One generator is that -- is the center of that. And then if you go to the console down below, it has infiltration, aspiration. It has ultrasound-assisted liposuction, and it has a closed loop for contouring. And that is what is approved today. And as I mentioned earlier, we filed the 510(k) for the power-assisted portion of that. And the 2 buttons on the right that don't have anything to them yet, those are the buttons where there can be 2 power-assisted handpieces in AYON. And I think it's important to note that we designed AYON, but we didn't actually -- we developed AYON, but we actually didn't design AYON. AYON was actually designed by a group of plastic surgeons, some top surgeons from all over the world that went through every existing technology that is out there today, and told us what they needed and wanted to have improved in a body contouring system, in a surgical system. And our engineers and our development team did an incredible job of developing this and taking care of all of these things. And everything that is in AYON from a technology point of view, the ultrasound-assisted liposuction, the closed loop for contouring, the infiltration, the aspiration, everything is best-in-class from a single technology perspective. And then everything is integrated into one surgical console and the surgical workflow for the doctor and his team is second to none. Not only can you perform individual tasks, but you can actually have simultaneous technologies going on at the same time. If you have a team that is performing this, if it is just you, then you just use each individual technology, but it is designed to be the most advanced surgical system for aesthetic surgery on the market today. And there is not a surgical procedure that the doctor cannot do with this system. Next slide, please. And the feedback that we have gotten from clinicians, and you're going to hear from one of them here in a few minutes, has been anything short of remarkable for AYON. I can't even begin to tell you how proud I am of the team that put this together. And the performance of AYON has been spectacular. In fact, I would go as far to say I have been in the medical device space for 30 years, and I have launched a tremendous amount of products and technologies, and I have never had one that has been as exciting as this and the doctors have just been static about the performance of AYON. There's a comment on here that there is no other machine like this. It is the next generation of body contouring. We have doctors that are calling it a Ferrari. We're having doctors that are calling it a Rolls-Royce, a Lamborghini. You name it, the accolades are there and the technology is unique and special. And I think that Dr. Vanek will talk a little bit about that because he used to be a KOL for one of the competing technologies for over 16 years. So the feedback has been incredible. Next slide. And the summer has been incredibly busy for us at Apyx. We've been all over talking about AYON showing AYON, having doctors in the room listening to it and the interest from the community has been spectacular. And so it is my pleasure right now to introduce for today's call, Dr. Paul Vanek. Dr. Vanek is double board-certified plastic surgeon. He's recognized by both the American Board of Surgery and the American Board of Plastic Surgery. He brings extensive training and experience across all areas of surgery and has a particular expertise in breast augmentation, advanced liposuction techniques, facial rejuvenation, laser skin treatments and comprehensive skin care. He earned his medical degree with distinction in research from the University of Rochester School of Medicine, where he also served as Chief Resident in General Surgery. Dr. Vanek then completed fellowship in plastic surgery at the University of Michigan. And currently, Dr. Vanek serves as President and CEO of Mentor Plastic Surgery & MedSpa, a practice he founded nearly 30 years ago, although it doesn't look possible if you're looking at him. During this time, he has been voted best of the best in plastic surgery 5 times by readers of the News-Herald in addition. Dr. Vanek has pioneered and implemented cutting-edge technologies, leading to the publication of multiple clinical papers and the development of innovative medical products. It is my pleasure to turn the call over to Dr. Vanek. Dr. Vanek, thank you very much.

Thank you so much, Charlie, what a gracious introduction. I want to start by thanking you all for your attention today. My general background includes research fellowships in biophysics at Cal Berkeley at the B-field unit in microwave radiation and radiowave research. Bioelectromagnetics has been integrated into my life before I got into medical school. During medical school, I worked in animal labs and published articles in bioelectromagnetics. And this has led me directly to my enthusiasm for something that was on the theoretical horizon, but didn't manifest until the Apyx company put together this most incredible platform. I have to say, as a person who's been a background in electromagnetics in surgery since the '80s, there is nothing more exciting than when 2015 hit and they rolled out this incredible system called Renuvion. Then it was called J-Plasma. Even the 1.0 handpieces, which were now in the 2.0 development of handpiece delivery, the 1.0 handpieces were so efficacious in tightening in an environment in which patients were clamoring for something more, but there was nothing on the horizon for over 20 years since the advent of ultrasound-assisted liposuction in its third generation. Now in fourth generation, the Apyx UAL system is the first step of a great innovation in tightening the body and collaborating with the regular surgery of plastic surgery. Then the add-on, the secret sauce is the UAL surgery, then the Renuvion helium plasma. So when you look at my practice in the Midwest, I've been in practice since '96. There have been a lot of changes based upon the last years of the advent of GLP-1s and GIP inhibitors. As you saw in the slides that Charlie shared with us, in my practice, it's about 60%. And depending upon who you survey around the country, the penetration of these drugs is ubiquitous in our society because people are looking for weight loss avenues. But in the wake of the weight loss or even before they've achieved their weight loss permanent goals, they often initiate the inquiry about what am I going to do with this loose skin, my arms, my neck, my breast, my abdomen, my thighs. And that's where my practice has been for a long time. So I have a practice that has a nurse practitioner. I have an OR team of a PA, a circulator, a scrub. I have board-certified anesthesiology. So I have a crack team that's very familiar with the paradigm of body contouring and facial rejuvenation surgery. My most common procedures have been UAL-associated body contouring. And once the Renuvion paradigm came on the market, it was something me and a host of other busy liposuction doctors that did body contouring and neck and face rejuvenation. We grabbed on to it once it demonstrated efficacy. So us early adopters have been encouraged by the kind of science commitment that Apyx has demonstrated with over 90 publications that show things like are there worsening outcomes with using this energy. And the clear definition in a publication I authored last year was that we add Renuvion with our Apyx UAL, and we have no differences in adverse events, meaning the risks of surgery are not enhanced by adding something that's revolutionary. That sole conclusion was pretty evident to those of us who are already using it before we codified it with science. But essentially, the surgical methods, when you go to the next slide, you look in the operating room and you see that we -- the surgeons have pieced together this technology, that technology and other technology and their time consuming to set up. They are a bit dizzying to initiate, but when we can put it all together with the tower that you saw a few minutes ago in one harmonious device, it's wheeled into the operating room. It plugs in, in 2 centers with regular AC power, and it gives me a complete suite of treatment parameters in which I can execute the entire case from that. Of course, there's instrumentation and expertise, and there are the staff members that are the scrubs and the circulators that get everything ready. But in terms of simplifying the start-up, all those individual pieces of material that you see is stacked up on different trays, boxes, carts. They are a thing of the past now that AYON is on the market. So the nonsurgical methods that we have that are -- the patients are clamoring for, "Can you please put this device on my skin and can I walk out looking 30 pounds lighter and 30 years younger." That is something that is a market niche because people have the hope that nonoperative methods are going to take their loose skin and their post weight loss body problems and have the magic trick that, that's going to work. But those freezing techniques, the radiowave techniques, the ultrasonic external techniques, they do not -- simply do not perform to the level of the patient satisfaction that they have set as expectations nor clearly the clinicians that have experience with these devices. Those devices have a niche for spa events and for modest enhancement, but they have nothing to do with what's actually happening in the major body contouring post weight loss patient. That's the strike zone of my practice. Right down the middle strike zone, patients come in. They need complex procedures for arm lifts, neck lifts, facelifts, tummy tucks, breast lifts, thigh lifts. But now we can say the skin we took away is no better than the skin we left behind. We've been saying that for 40 years in body contouring. But with the advent of the AYON, Renuvion UAL, the efficiency of the fat dissolution. I mean you essentially say, well, what's UAL. Ultrasound-assisted liposuction means I pass a 3-millimeter probe that selectively pops my fat cell, bursts it in situ, changes the fat geography, I can then evacuate that reliably with very low blood loss and then I follow on immediately with a helium plasma revolution through another small 3-millimeter cannula that's passed smoothly under the skin. In doing so, it creates results that you're going to see in our next slide. In a single procedure, we're able to take a patient who does not have the best body habitus but who's had her 48-year-old 3 children. She says, "This is my 1-year follow-up, use my selfies and tell a woman that she really can restore her body to incredible harmony and make herself really love her body." This is an example of what's called high definition in which we sculpted the abdomen musculature with the advent of ultrasonic liposuction. We do a tummy tuck to tighten her muscles and remove some skin that was disillusioned by 3 children. And then we add the -- again, the secret sauce is the AYON, Renuvion helium plasma. That is the true method of taking loose skin and restoring it to what you're seeing in these pictures before and after. These are 1-year follow-ups. Along the way, they have no increased risks or no increased duration of recovery from a regular traditional surgery, but they're getting the kind of transcend picture that my colleagues and I across the country are achieving. Go to the next slide, please. This is -- this next patient is the first person in the Midwest that had the true suite deployed in a single surgery. On the right picture in her own view is her 6-week follow-up. So the person who says they may be skeptical, you can say to yourself, well, there's no way that, that's the same person, except it is. I did it yesterday, too, a person who's 61 years old, I circumferentially treated her body. I used the suite of energies and then the technology of really reinstilling fat in another area that we call Brazilian butter cliff. But the AYON Apyx technology gives me every tool at my disposal to bring the state-of-the-art from what you see of taking her skin above her belly button, treating that 3-dimensionally with UAL, infusion of fluid, safely evacuating her fat layer and then transcendly taking the AYON helium plasma and treating her skin so she gets that circumference. I have many other patients in this circumstance that have achieved these goals. But really, the investor for you that are thinking is this the real deal? I can assure you as a person who's been in this market since 1989 that this is the real deal. We have waited for something like this and the performance of this is never underperformed in patients -- excuse me, in clinicians that are in this vertical. We totally see this and say, I got to get that as soon as they can get it. So I talk to patients and doctors all over the country at this point because I have a robust practice. But what we're really responding to is the GLP-1 patient. This patient lost her weight on her own, lost 83 pounds, but she's stuck in this body now. But the GLP-1s that we see are a very persistent presence in our market. Our American Society has said to us all, we want to be thinner, but we can't get there because we have a lot of pressures on our diet and on our lifestyle that are in our food chain that are precluding us from making a difference. But the GLP and GIP administration, including on the horizon, even a pill that's got efficacy across the board, my patients are coming as a pipeline, either in the wake of using GLPs or they're seeking a solution that they're not finding with their current insurance paradigm. So they're coming directly to my practice to have GLP-1s by me supervised, and they may be 6 months, 12 months, 2 years out from the pipeline of having surgery, but they already know when they show up at 350 pounds that if they -- should they get to their ideal body weight that they're going to have some negative consequences that before did not have a very good solution. We just did amputation procedures that had hopefully properly placed scars, but we could never do anything about their severe laxity. And so this example is just one of many in my practice that have manifested these kind of transformations. In my practice, about 40% of my patients are using GLP-1s. We suspend them for 2 weeks prior to surgery. Many patients after this transformation may go to micro-dosing, but their concept is once they've reestablished their relationship with food, we often wean them off because they so love their body, they say, "I'm not going back." So GLP-1s can be a postoperative use or the patients are so delighted with their new body habitus that they may just wean themselves off. So there are off-ramps for GLPs. But in general, the patients' desires are, "I want to never go back to where I was." And so GLPs are an integral portion of my perioperative discussion. When we see that search terms for SEO, patients are no longer naive to the notion that they have both search terms direct type into top line Google, but they have an awareness that these devices, these drugs are not utilized. And so goes it with UAL and AYON and Renuvion, top search terms are, they're finding me because they type the word Renuvion into Google, and I'm a local user. When they see other things that are consequences like Ozempic face, Ozempic buttock, that is a consequence, not of the drug per se, but of the actual outcome of the drug, which is to deflate this body into the degree you see on the picture on the left. But the tightening manifestation is how -- what is my solution for this body. So what I see is the experience of the system. I've done -- the last 7 weeks, I have done 9 major body procedures. This procedure took 8 hours. I have a practice that does not involve Renuvion or AYON, but I have other patients that are looking at their side breast and say, "I want to tighten the skin there when they get a breast augmentation," or they have a rhinoplasty and says, "Can you do something about my neck." So I use this agent under their neck in a minimally invasive way through 3 small incisions. I use it on the arms to get the arms that were loose to take away the redundancy and then use UAL and AYON on the arms. So each procedure that has been so fantastically explosive growth, except for liposuction. Liposuction has gone down because people are disillusioned with the notion that if I suck up my fat, I'm going have hanging skin. Now the paradigm is we can take that hanging skin and we can make it tightened with FDA approval with an indication of a device that's very reliable. So combining these procedures with traditional procedural plastic surgery and UAL and Renuvion helium plasma tightening has been something we've never been able to offer patients with such authority or with such self-assurance that you really can get the results that are seeing right in front of your eyes. The impact on my practice has been an efficiency. The UAL that I've had as a traditional previous user of another technology, I see that about a 60% enhancement in my speed of getting to clinical endpoint. If you know what I mean is I have to use time on target with the device that oscillates with ultrasound. It took a certain amount of minutes, let's say, 10 per zone. Now I'm down to 3 to 4 minutes per zone because of my UAL intraoperative time. What does that mean? Shorter procedure times. I'm getting this result that's so transcendent. And then I add on top of it the manifestation of the helium plasma effects. They're just making such an impact on my patient. And the patient is so grateful. They say, "I just don't even believe that I was going to get here. And that 2 weeks ago, you told me I could do this." You can look on Mentor Plastic Surgery on Instagram, and you can see these patient testimonials that are up there. And if you type in or search other UAL Renuvion users, they have equally marvelous. I don't want to say that I'm the king of the world, but I have such a regard for the technology that Apyx has brought to me, and they also onboard us, they teach us how to use it. We collaborate, we're talking to each other, talk about a commitment to as a business partner to make us successful. I have to say that Apyx from the jump has been a collaborative physician with a private practitioner like me. The general feedback I get, my staff is happy, the technology is easy to turn over in terms of its cleaning and sterilization. There are no issues with it. The support from this company is incredible. The representatives that are responsive, the resources I have at my fingertips have made an incredible impact on my practice. My staff onboarding for how to market it to my patients, soup to nuts, this patient has been a business partner since we engaged 9 years ago, and I've had such an incredible run with this. I -- my enthusiasm is a sincere Eagle Scout appeal to those of you who think is this company, what they say, you can ask anybody who's onboarded this synergy, they just say it's transformative. Now I can talk all day on this. So I'm going to open this up if Charlie would like to come back, and we can go back and forth with some system elements or any clinical decision or any business discussion that's germane to this conversation.

Dr. Vanek, thank you very much. Thank you for all of your comments and I'm still amazed by that picture that is up on the screen right now that just shows how difficult these procedures are and how transformative they are in the right hands. That's for sure. We'll go ahead and take questions, and we'll answer anybody's questions that you have right now.

Great. Thank you, Charlie and Dr. Vanek. [Operator Instructions]

If there's not one that comes directly to mind, I'm happy to say that with the onboard of the power lipo add-on, I am enthusiastically awaiting that. I'm anticipating its launch in the first quarter of the year. Yesterday, I did a case with fat transfer to the buttocks and using a power lipo material, we are able to use that technology to both take out fat, process it in real time and reinstill it in another body area. So having a state-of-the-art ergonomic power lipo device, which I held in my hand in the recent American Society of Plastic Surgery meeting, I had that in my hands in New Orleans just this past weekend. So I'm very enthusiastic about its implementation.

Thanks, Dr. Vanek. So we have a question from Sam Eiber of BTIG.

Thank you for putting this KOL event together and for sharing your thoughts, the picture you're showing right now is -- looks very transformational. And Dr. Vanek, if I'm listening right, it sounds like a lot of that is being driven by maybe some of the changes on the UAL technology. So would love to hear your thoughts on maybe if that's the case, is it more of a function of the UAL being more powerful? What else is driving such dramatic changes versus maybe some more legacy UAL technologies?

I would say to you, because of the LIFT technology, we modify or I should say, the software modifies itself as we're administering the power. It senses the impedance change in the fat as it's having ultrasonic dissolution. Because of that, we're able to be -- we're able to reach the endpoint. Now Charlie, I will defer to you as to what I can disclose in terms of proprietary information as to what is the direct reason. But the short answer to you, Sam, is when I see that the end clinical endpoint on this UAL goes more efficiently, I'm actually more efficiently eliminating fat, which is the density -- 5 densities: fat, blood vessels, nerves, collagen and lymphatics. If I can more efficiently reduce this, it leaves behind for me these other stromal elements that we have left behind safely, have selectively preserved them so that those are the recipient energies for the efficiency and delivery of the radiofrequency helium plasma. That energy of their helium plasma heats the tissue to a certain temperature in 0.41 -- 0.04 seconds and doesn't cook them or make them destroyed. If I can more efficiently remove the resistors of electronic energy and radiofrequency helium plasma, I can more efficiently, and I see it in this picture, having done a lot of cases with the other UAL technology and getting this case as its first one. This is the first one that's now 7 weeks out. I know for a fact that the previous UAL interaction and the previous RF helium plasma energy gets a certain amount. But this is a whiz-bang outcome because -- and I'm attributing it to the efficacy of the UAL component. So your insightful observation, Sam, is exactly on point as a surgical scientist. Would you like to add to that, Charlie?

Yes, Sam, it's a great question, and Dr. Vanek is exactly right in his explanation. Because the LIFT technology is more efficient than traditional ultrasonic technologies, it actually does less damage to the surrounding tissues and because it uses less heat to separate the fat like Dr. Vanek was talking about, and that makes the fibroseptal network more intact. And because that is now more intact and more receptive to Renuvion, it actually does a better job of tightening the skin. So it's a combination of both technologies actually working better that are allowing the surgeons to have these kind of results because of that. But it is a direct function of the improvements that we made in the ultrasonic technology that lead to this being able to use better. So Dr. Vanek was right on, and you didn't disclose anything that you weren't supposed to. So it's all good there.

Very good. Maybe I can just ask a follow-up here, and I'll leave it open to both of you. But in terms of capturing more, I guess, practice economics versus before with just Renuvion because you have the added capabilities of fat removal and along with tissue contraction and electrosurgical capabilities, wondering what device utilization can maybe look like going forward now that you have AYON and you can essentially do more procedures versus maybe before when you just had Renuvion.

Okay. So there's 2 components to this answer. If I don't mind jumping in. Is that okay, Charlie?

Please.

The first component is there's an efficiency in time motion of having one car drive into the garage than having 5 cars driving in and working on the same element or 5 mechanics. So the tower itself is an efficiency in time motion. Then the execution component with the UAL as I'm seeing it is more efficient in time motion. The integrated components are more efficient. The patient selection is a bit broader, so my funnel is a little bigger. The patients are auto selecting for a practice like mine that is energy-based, and they're very wisdom to the idea that old-fashioned liposuction is essentially so 2003, which is the advent of the ultrasonic energy of the third generation. We're in the fourth generation now. Fourth is that the volume driver for my practice -- in my own personal practice has gone up because now I have these 2 components of UAL state-of-the-art and especially Renuvion. So the market position has been enhanced because of my availability to the state of the art. So it self-perpetuates. The surgeons recognize its efficacy. They promote it in their own channels. But then that results in search engine optimization that has patients now searching top line Google search for the Renuvion helium plasma concept and where to find it. So there's multi-levels in which I've had a practice funnel enhancement.

Yes. And the other thing, too, Sam, that we're hearing from other doctors is because of the LIFT technology, because of its working more efficiently and Dr. Vanek already alluded to the time savings having with that, but because it goes through tissue easier, the patients are having less bruising, less pain and quicker recoveries also, and so that obviously helps in everything because as patients start to talk about these procedures and these technologies and have better experiences with them where they have less downtime, they have less pain, they have faster healing that just brings more patients to Dr. Vanek's office and other users' office that want to have the same results and want to have it because the issue is that to have this kind of transformation, the only way that you can do that is in the hands of a plastic surgeon.

That's a true statement. We have a lot of posers in this country. There's no cream that does this. There's no exercise. I mean the patients come in with great recrimination to say, "Look what has happened to me." And they used to have no solution, but this technological innovation, combined with plastic surgical technology and expertise, can make this kind of transformation happen in every ZIP code in the United States and around the world.

Our next question comes from Matt Hewitt at Craig-Hallum.

Thank you for hosting this event. And Paul, thank you very much for your time. Maybe first off, you've talked about the time efficiencies and some of the other areas. But from a practice perspective, are you finding that it is making you more efficient where maybe you've got less people in the room when you're performing a procedure on someone or you're able to get more patients in during the day. What else are you seeing?

All of the above. For example, a patient that used to have a small problem that said, "I can't do anything for that." In the scope of putting them through an entire larger procedure, let's just say a person has some loose skin under their chin or neck that I'd say, "Look, the RF devices, the ultrasound devices externally, they're not going to get to what you want." And we didn't have a modality of treatment that would bring them into that next interval of improvement. I'm able to do that in the office now under local anesthetic. It was unavailable until 2016, 2015. So that's one throughput interval. Because of Ohio revised code, there's a specificity of the amount of staff you have in a typical operating room. So that is not per se a requirement, but I'm not needing an assistance to do these cases that's with an innovation, you often need technical support or as you're alluding to, Matt, you're needing more something. This does not need more something. All the something is in the tower. The device is a unit. You just plug in the hand piece and it's ready to go. It's intuitive to use, so there's not a long ramp-up or learning curve for people that have some reluctance in the world of energy distribution to tissues, we clearly help you steward this onboarding with both the trainers as well as complete availability of KOLs like me in the country. We're willing to take calls because I think we're true believers. The final portion of it is my staff can with a straight face say your procedure may have a slightly longer procedure time because of the energy administration, but it does not result in an increased time duration of recovery. So those time savings that patients say, "Okay, I have to go through more to get more." The answer is you get to go through more about the same to get more. And that proposition essentially says to the patient, this makes total sense. I should be in a practice that has a Renuvion RF device in it. And if I'm -- my competitors that don't even have it implemented, they're not in the game. They're not in the same sphere of discussion, SEO search engine, research and top line explosive growth in body contouring that we're experiencing with these energy devices. I hope I answered your question, Matt.

Absolutely. That's very helpful. And then maybe just one follow-up. And I realize it's early days since we started using AYON. But what types of procedures? Is it across your entire platform? Or have you focused at least early on in a very specific subset of the procedures you offer to your practice?

Well, let's be clear. I've been using this device since 2016. So this is not early days for me. I published the largest series of abdominoplasties with UAL and Renuvion in the world. So that's a 7-year data analysis. My colleagues and I around the country have been using this for years. So this is the first of its kind in which the whole unit has put together. It's early days for the UAL performance. And as a KOL for other ultrasound energy devices, I have a great deal of Gestalt understanding of how that device works and an understanding of its physics. So seeing its performance from the very first cases, as you alluded to, seeing it so performed is extremely exciting for me, who's got a lot of objectivity and scientific skepticism to see it work like this is very exciting. I know next is more cases because people look at what's going on at those of us who are plugged into the world of bioelectromagnetics and plastic surgery.

Our next question comes from Alex Fuhrman at Lucid Capital Markets.

Charlie, you mentioned you've seen a lot of interest in the AYON system, maybe the most you've seen in anything in your career. I'm curious who you've really been seeing the most interest from and who's actually been placing orders? Is it mostly customers of yours that already have the Apyx generator in place and understand the value of Renuvion or has it been a lot of new customers that you're talking to here?

Yes. No, thanks, Alex, it's a good question. So if you look at the customers that we have sold units to between now and the end of the year, there's 3 buckets of customers. The first one is people who already had an Apyx One and just want to get the rest of Renuvion. There's another group of customers that had our previous generation RS3 that need to upgrade to the Apyx One and then get the rest of AYON. And then there's obviously customers that don't have any of our technologies and want an AYON system. And I would say if you put the first 2 of those together, we're probably at about 80% of our existing customers so far and probably about 20% of people who did not have our technology at all. That's probably about where it comes out to in the sales that we've had so far.

Okay. That's really helpful, Charlie. And then how should we think about the pending application here for the handheld power lipo. It seems to me like that's a pretty big value-add for the new system here. So are physicians that are buying it today, are they going out on a limb a little bit, assuming that this is going to be ready for use in Q1? Are you talking to a lot of physicians that maybe will be ready to pull the trigger after that approval goes through?

Yes. Look, I think that you've got -- first, the power assist handpiece is truly important. I think Dr. Vanek talked about it, the importance of retreating the fat and getting the fat out after you separate it with UAL. They either do it with a power-assisted handpiece or they do it with straight suction. And a lot of the top body contouring doctors all over the world use the power-assisted device to get that out. So there's no question that the power assist is complete, if you will, the body contouring system of Renuvion. That being said, we sold quite a few without anybody even seen what the power assist looked like and I think it was partially because we, as a company, Dr. Vanek talked about dealing with us as a company, we believe in evidence-based medicine. We've always tried to treat our customers as true surgical partners because if their surgical business grows, so does ours. And so there was a level of trust there. But as Dr. Vanek also mentioned, we just came back, both of us were in New Orleans this past weekend at Plastic Surgery at the meeting and we had our power-assist handpieces available for doctors to see and put in their hands and to basically show them obviously, with the sign that we don't have, that it's pending FDA approval, and it's not available yet, and we can't sell them yet or take orders for them yet or anything like that, but the doctors got to see what we have done. And I think there's also just a sense from the surgeon community that we didn't design this. This was designed by the top body contouring doctor all over the world that came up with the things that they did not like or care for or needed improvement on the existing technologies and power assist, obviously, was one of those. And so I think there's a level of comfort, if you will, from a lot of the top doctors because they know who these doctors are and they know that they are very good body contouring surgeons, and they're comfortable with the work that they're going to do and the improvements that are going to be made for this and everything else on the system when you look at it is state of the art. Dr. Vanek showed in his slide what the OR looked like before. You can see that looks archaic in so many different ways when you compare it to the sophistication, the elegance, the everything that goes with AYON. And so I just think that there are a lot of people that are willing to go, "All right, I will buy this now. I will wait for it. We're not going to charge them anything to activate their power-assisted handpiece when it comes because that's not the way that we work. And so I just think that there's a lot of people that are willing to get in line and to get the system now knowing that when they get this, it's going to be what they expect. And in most cases, everything has exceeded their expectations.

I'd like to jump in with one more thing besides that answer, Charlie. This power-assisted device, once you have it in your hand as a surgeon, it is not an also-ran. You think about something that's emerging, they took the best of the best, the ideas of the best top surgeons, but they also discarded some of the elements that are the source of frustration and failure for devices that have up to a 30% disability rate. What I mean is the device you have has a 1 in 3 chance of breaking down today, which is an incredible uncertainty and frustration. So those devices have chronically been the underperformance metric, the underperformance touch point for having to have lots of backups and a lot of time motion wasted. The way the mechanics are this device, I've spoken with the engineers, we've reviewed things, this thing is a very exciting innovation, and it doesn't have the failure points that the other power-assisted devices have suffered from. So I want to congratulate out loud to the engineers and developers and what an incredible innovation this is going to have when it does deploy.

Our next question comes from Dave Turkaly at Citizens JMP.

I just wanted to clarify something here. So it sounds like this is for kind of the emerging heavy-lifting patients. And I just wanted to get your thoughts, Dr. Vanek on some of the other technologies out there, whether they be ultrasound or RF or laser based. Do you use any of those things maybe like people that don't have as much of a problem or do you have any of those other technologies? And do you plan to keep those for maybe a separate class of patients?

That's an insightful question, Dave. The following way is to think of it: There are certain technologies that rise and fall as they emerge for either they have intellectual property that sounds promising. I have trialed and utilized many technologies over the last 30 years. Most of the time, when I implement one, it is after I've seen the biophysics and electromagnetics interaction with tissue, either a scientific basis, not purely the empiric clinical result. And what I mean in a little sarcasm is a claim of a box does not mean the box does it when you get it in your hands. But that being said, for example, you enumerated laser lipo. Laser lipo has some very significant negatives in that. It overheats the tissue and is fraught with higher theoretical and actual complication rates. So that was the device that wasn't so smart when it was implemented. Even though it sounded like the whiz-bang of laser this or laser that. Lasers have an incredible position in my practice for skin resurfacing and as a KOL for Sciton. I can attribute to a great deal of outcome improvement with lasers. But other devices that are radiofrequency, monopolar, bipolar ultrasound combined with needle distribution, all these devices, I have great familiarity with. Some of them are implemented in my practice. Some of them never made the cut for implementation because of either their practical discussion with other users in advance of my deploying them or their theoretical descriptions and energy and bioelectromagnetics did not seem to meet the threshold. But since the advent of helium plasma, it theoretically met the criterion of my own for implementation. Number two, it practically met my implementation because when I saw it used in person and saw the technical and clinical scientific descriptions, it immediately said this will work, and it did work. On my first case that I saw, it looked like a 2-month follow-up on a previous liposuction patient because the UAL device used was the traditional one and then the RF energy that was used on it made the patient right in the operating room look like they've recovered 2 months of post-op therapy. So it is an amazing innovation that since its time of deployment has really performed as -- even better performed than I expected. That's why I implemented immediately.

Yes. And Dave, just so you know, Dave, the other thing too, is Dr. Vanek is showing some pretty incredible before and afters, but AYON can be used on anybody that is having a surgical procedure. So it doesn't have to be this dramatic or this, as you said, heavy lifting. It can be on your standard run of body contouring patient also because there's not a surgical procedure that it can't do, and you would still use those advanced technologies to get the best result because again, remember, the patient is going to have less bruising, quicker healing, less down time all of that. But it's only for a surgical perspective. Obviously, none of the noninvasive treatments, that's a different story. We're only talking surgery here.

Yes, thank you for cleaning it up for me, Charlie. Every patient that sees me that wants a little nip or tuck, some of them can be done in the office like we did before, but now I can give them more tightening. So a person who's BMI is darn near perfect, but has a little laxity. I'm able to just use the AYON, Renuvion portion of it and don't even have to take any fat out. So I have every tool in my pallet as a painter of making their body go from here to there. If they're darn near perfect, we can enhance them in a very minimally invasive way with great efficacy and confidence.

Just one quick follow-up. You said -- I think I heard you say 8 hours. I was not aware of the plastic surgeons that spend that kind of OR time, but I think you said you've done 9 major patients so far. I guess as you look at this, is that -- I imagine those are again heavy lifting, but like what sort of an average time you had expected -- like how many patients could you see or what the average time that you would think would be reasonable for surgeon like yourself?

It's reasonable to do one case on one person for 8 hours because I can do 7 ZIP codes in the same surgery with safety and low blood loss, and they go home and I saw her the next morning. So she's walking in her own power. So to be clear about case duration and anesthesia, I can do a one-hour procedure on someone's abdomen or a one-hour procedure on their flanks. So each zone is dependent -- the time duration is depending somewhat on their BMI and their tissue characteristics. But some cases can be done awake under local. The case you're seeing in this shot here is something that's done surgically in the operating room for patient satisfaction and safety. The case duration that patients are looking for means, I can use this device on all parts of her body. She's actually going to come back she said and do her arms after this. So they're also the spectacle of transformation, means, "Oh, I can do my arms too?" "Yes, come back in a couple of weeks, we'll do your arms." That's a quick turnaround, Dave.

So we're going to move to questions from the webcast. So I'll turn it over to Jeremy Feffer at LifeSci Advisors to read those.

I'll probably take one here. There are a couple of questions here asking about how AYON compares to Inmode's BodyTite in terms of clinical outcomes, patient experience and ease of use for practitioners. Are there specific advantages or limitations that stand out in real-world feedback?

Well, hold on, before I let Dr. Vanek answer that question, I just want to delineate though, between BodyTite and AYON because AYON doesn't actually compete with BodyTite. AYON is a complete surgical platform. BodyTite is a modality that's used to tighten skin, that uses RF to tighten skin. So BodyTite competes with Renuvion -- the Renuvion portion, but it doesn't have anything to do with anything, any of the rest of AYON. And so I'll let Dr. Vanek take the rest. I just wanted to delineate that portion of it.

I'm glad you did that so what should I say, diplomatically and expertly. I don't want to get into the realm of knocking other modalities. But my friends and I who deployed BodyTite have had a great deal of disappointment in that. It was rolled out as a device you could delegate in most states because it's a radio frequency needle device. But then the reality of it is it can really only be used because it's so painful to administer that the only way to use it is essentially in the operating room anyway. So the notion of having it as a spa treatment or a topical local procedure that is then administered to a patient with comfort, ease and great efficacy has, I think, substantially underperformed. So the tightening they see is not to the degree that you can when you have a helium plasma interaction with soft tissue. It's nowhere in any way, as Charlie said, does it do anything with the fat layer and its appearance. It does give some skin tone improvements after the recovery, but it doesn't give -- what I think is so manifest in front of your eyes is such a substantial intervention. The last thing is it just can't do -- based on the theory of physics and tissue interaction, it doesn't have the bioelectromagnetic position to do what plasma does to interstitial tissue. It just doesn't have the ability. So it has a market niche. It has a cache. It has a lot of marketing in terms of its claim, but its performance, I think, is just not in the same category especially if you line it up directly with Renuvion outcome and BodyTite best-of-class outcomes. So it's almost self-evident that it's a device that's in the business unit or in the sphere body contouring, but that's where the rest of it is, is the show horse and a donkey.

So maybe one more. I think we have time for one more here. Dr. Vanek, for patients expressing interest in body contouring, how many of these are existing patients? Or are they new to your practice? Do you see this AYON really as being a driver of new volumes to your practice?

That's a great question. That's a question that I can straight up answer. It's been a direct driver of volume to my practice. There are patients who have lost weight that I may have done one thing on them 5 years ago. And because they have a contact with my practice, they say, "Oh, tell me about the AYON and Renuvion." Now the AYON is only months old. The Renuvion has been present in my practice. So I have gotten a surge of individual patients that come back and say, "Oh, you have this. I wanted my legs done. I did my arms 3 years ago." So the -- like I said earlier, the top line Google search for Ozempic face, Ozempic buttock, there's explosive growth in the search engine awareness of tightening procedures. So the laxity terminology, if you look at the curves, there's -- it's almost 3x higher more searches for that kind of outcome. And when I'm positioned in the market to have Renuvion, it absolutely puts me in a position of driving patients into my practice, which then the whole algorithm of, do you want to lose more weight? Okay, we'll put you on GLP-1s. Do you want to -- have you reached your body goal endpoints? All right, we're going to talk about treating your laxity. This availability has been a tremendous boon to my practice in general. When my friends and on boards that I've heard as a KOL, I get to talk to these people who are implementing this technology in their practice. They have a great enthusiasm for what they're able to achieve that they could not achieve before. And we've been chasing it for my whole careers. This is my 30th year in practice.

Dr. Vanek, thank you for that. I think we are now at the top of the hour. Charlie, I'll turn it back to you for closing remarks.

No, I would just like to thank everybody for their time today, for their interest in Apyx. I'd especially like to thank Dr. Vanek for his time. And thank you to the LifeSci group for putting this all together. I appreciate everybody's support, and we're just going to keep focusing on letting everybody know about this wonderful technology, and keep bringing this to surgeons all over the world. So thank you all for your time, and thanks to everybody at Apyx for doing everything that you do to make all of this possible. I appreciate it a lot.