Implantica AG (IMPASDB) Earnings Call Transcript & Summary

We welcome viewers, both you who are joining us live here on site as well as those joining us live on the stream. Today, we are gathered for the Capital Markets Day of Implantica. We will hear from the company's management as well as surgeons and even patients surrounding RefluxStop that has recently gained a PMA approval from the FDA. So without further ado, I would like to welcome up Tomas Puusepp, who is the Board member of the company, who will give you all a more formal welcome. Go ahead, Tomas.

Okay. Great. Good afternoon, everyone, and a very warm welcome to Implantica's Capital Market Day. My name is Tomas Puusepp. I've been at the Board 6 -- more than 6 years now and followed Implantica very closely, both when you're looking into the vision, the beautiful vision we had, but also seeing how everything has evolved into something which is really substantial. And so I'm very pleased to be here and have a small introduction about that. Today, if you're looking also what's happened now with the FDA clearance sorry, FDA approval. I've been in the industry for 40 years. And when I look into what has been achieved also by Implantica because when you do -- when you just get the product cleared or approved in FDA, that is one thing. But that's when you get the methodology and new method of doing things, that's much more complicated. And I've been following now the work which has been done. And I can tell you, a lot of work has been done really to get where we are today. So it's a major milestone. And also when you look in FDA approval also marks the beginning of a new chapter. We now have the opportunity actually to introduce a treatment for patients in the market and the world's biggest market for medical device. So that is, I would say, is a major, major achievement. And so it creates actually significant opportunities, but it also will be a lot of hard work. So today, when you really look into what has been done, and I know that you have had a lot of questions, why did it take a long time, and we have all the issues regarding COVID and so on and so forth. But when really look into what has been done and what has been achieved now really to get the FDA clear, it's something which is really significant. So we'll hear much more about that today. I will not be long, but you will hear about the journey, how we got there. And you will also see a lot of clinical experience from the people who are here and also patients where you can actually look into what is the difference when you get this treatment. And last but not least is, of course, what will also be presented today. How do we make it happen now in the United States of America. So it's actually the plan, which I think has been spelled out quite nicely. You will see more about that. And so I hope that you will feel that today, the presentations and the information you get will also clarify a few things, but also show you what tremendous work which has been put into this and also what fantastic opportunities we are facing right now. So you as a shareholder or you who have looked into Implantica during the years, I think that this is a really nice interesting phase in the company's future. And with that, I will not be long. And so I would like to have the pleasure now to introduce the founder, the CEO, Dr. Peter Forsell.

Thank you. Is this -- yes. Welcome, everybody. I will start maybe for you a little bit more boring part because I need to give a little bit background for all new listeners. So I will repeat a little bit the basics as short as possible. But then, of course, we will dig deeper into the U.S. launch, and Amit will take care who is in charge of that in the United States. He will make a deep together with Janita presentation, how we should do this. So just to know, I've invested more than SEK 1 billion in Implantica. So if anyone believes that I'm not a believer. And this is the second business. We had a very successful journey with the [indiscernible]. We, in 6 years' time, developed a business who took 28% of all obesity surgery outside U.S. So it's not the first time. And our main product is then called RefluxStop, and it's working in the disease in Swedish severes acid reflux or GERD gastroesophagal reflux disease. And it's 1 billion sufferers. It's larger than obesity. It's the largest treatment field you can find. It's absolutely enormous. And it's out of -- it's 23% of the American population. It's 78 million Americans have this disease, just to get the magnitude here. And what is not so known by people is that this is a dangerous disease because what happens is that acid is coming up in your lower esophagus and it's standardized the tissue and you do that over and over and over again, and that's a school book example how we get cancer. So if I take a gastroscope, endoscope and I put down in any one of you who has this disease, you have 10% to 20% likelihood have precancer changes. This is absolutely incredible. 48,000 people only in Europe and United States die every year from this disease. As this is -- take breast cancer. They do anything to find a breast cancer. They do all the screening and everything. Here, they just get 48,000 people die, hopeless. That's why the future for Implantica is not good. It's not fantastic. It's enormous. So today, you have drugs, and that takes 99-point whatever percent of the market, a big portion of the market, of course, and that's really not a competitor to us. The surgery, we are targeting maybe 1% of these 1 billion people, and we would be happy. So it's not that -- but for you to know, these drugs has quite a lot of serious side effects. So if you take them long term, people die. we talk about 5% in 10 years of elderly people who take this drug who dies from this disease. It's a huge American study who shows this. So independent of what you take here, you can take it for a few years, but then it's preferred to actually do something to solve this problem. And in the past, surgical methods, they were all focusing on that the [indiscernible], the upper [ sinter ] is weak. So as it is coming up in esophagus because it can't close properly. So therefore, they made things who support the closing. You see here, you take the top part of the stomach, which we call fundus, you wrap it around to compress. Here, you have a magnetic band from LINX. LINX is called from Johnson & Johnson, you do the same thing. And of course, if you try to close your food passageway, it gives you a problem, swallowing difficulties. You can't belch, you can't vomit. You maybe could press down the food, but all the air that comes with the Saliva and food stays there and you get [ swollended ] and it's not optimal. We, on the other hand, find out the root cause why you get acid reflux. And we actually restore the normal anatomic situation. We don't treat reflux. Our device is not treating reflux at all. We just maintain -- restore and maintain a normal situation. People get normal again. And then you don't have reflux. Reflux is a disease. And this disease is caused because this splinter here is sliding up and it's coming closer to the diaphragm here who is device the chest from abdomen then you use for breathing up and down and so on. And therefore, you need to have a hole here for the esophagus to pass. And when you breathe in and out, in and out, it comes lots of pressure variations here. And this is terrorizing this poor little [indiscernible] here. They can't handle it. It's impossible. So the only thing you need to do is to free the effect, move it down 5 centimeter distance, put our device on the outside of the stomach. And suddenly, this acts like a mechanical stop towards the diaphragm here. So you always will have the distance and everybody is treated. I can tell you, LINX, our competitor in their FDA trial, we have an objective test called PH, you measure in lower esophagus for 24 hours, 36% failed this test. No one failed the test in our study, not one single patient. So when you then enclose it like this, also all the complications disappeared. So we learned from the gastric banding business that we suited the stomach from below the band to above the band. So we made a tunnel of stomach for the band and worked perfectly. So therefore, we decided to just get it away. And that means all the complications with gastric band and the liver could grow together. It could tilt the band and many strange things happen in the body. And here, nothing. It's just gone the complications. Here, you see the instrument, device at the end, is a special made we supply. We have 60 hospitals today, 1,800 surgeries is done. And the clinical outcomes that we filed to FDA for the PMA, this is 5-year data. And you should know that to get the PMA clearance for a company, that's a fantastic milestone. It's not only that we can sell in the United States, but the FDA, they come and control your company, they control the quality system, they control all the production, they control all the hospitals with the data. They do a very thorough analysis of the whole company and everything connected. And that means it's a quality stab. Bang, we are a really serious company. That's what it means to get an FDA PMA approval. And this is published, as you saw there. Quickly results. One patient took drugs 5 years after surgery. Everybody took drugs before surgery, and this patient didn't even take it for acid reflux. Here, you see the objective measurement where the PH over 24 hours, and you see goes down nicely here at 6 months and the same after 5 years. It's completely stable in 5 years' time in this procedure. And to the right, you see every single patient like a line. Here, you can see in comparison with the wrapping I showed you before, [indiscernible] duplication, you see the complications is like night and day. 40% can't [indiscernible] and vomit. 29% have severe swallowing difficulties. We had one patient who temporary had a mild little swallowing difficulties. It's simply like night and day. This is not small difference, a little bit better method. No, it's a revolution. And when you then take the -- to the right here is our PMA study, the outcome of our PMA study. To the left is the outcome of a big study where 22 centers in Europe put together 602 patients and combined all the data. And you can see it's basically the same. It's real world normally is much worse. You need to have a method that everybody could adapt to learn quickly. And you see it's basically the same results in real world and in the FDA study. Now it's not only to have the best treatment available. It's also cost is a very important part today. Everybody should save money. And therefore, of course, it's fantastic that you save money by switching even from the drug. The drug costs nothing, but still society would save money to operate with RefluxStop because it's so much less complications. You wipe out your kidney, they have dialysis. It's lots of things that normal people are not aware of. But in reality, we are better than all the other treatments, links from application and even the drugs. And that's, of course, open doors. 38 published articles. And to a large extent, this is depending on Sarowar. I don't know where we have Sarowar here. over in the back there. His team has been able to support the surgeons to -- so we have 38 articles today about this product. Now Implantica is not only about RefluxStop. We have developed 2 platform technologies. And I should be honest to tell you, it's 10 years, 10 years of work behind these platform technologies in eHealth platform and the wireless energizing platform. And with that platform, we can monitor people's health from distance from inside the body, and we can also control and make super advanced ultrasmart implants. We can take the health care to the next level. And the whole principle for Implantica is to see how much new technology is happening outside the body and move it into the body because inside the body is way behind. So we have made IP together with this eHealth platform for many different solutions, how we can improve health care. That's not for today, but you should know that we have the potential to become a new Medtronic. It's sort of lots of things in the pipeline. But now, of course, it's focused on RefluxStop, RefluxStop and RefluxStop. By the way, 25,000 pages of patent we have filed for this eHealth platform. You can imagine 25,000 pages, it's enormous work. And I think we have the patent authorities somewhere here also listening. Oh, sorry. Now I was too fast here. So I just want to give you 2 examples, though you who listened before I know what it is. But when I was a young surgeon, we do experimental surgery, people have got rid of the large intestine. We took the small intestine made a little reservoir and they connected to us. The problem is that from the small intestine, it comes 2 to 3 liters of fluid. So all the liquid is stacked up in the large intestine. And therefore, these people -- first of all, the reservoir got full, but it didn't empty. It was overflowing. And this poor winter didn't can't handle it. This is actually having the worst area you can imagine. And all this is solved. So now people can get rid of this plastic bag. And it's SEK 35 billion. It's $3.9 billion just for plastic bags. Then you understand how huge this is. That's $3.9 million. I have hard to understand it myself, just for these plastic bags. Also, people can't originate they put in a catheter in their own blood 5 times per day. We have a device and they only need remote control, and they are done. Yes, this is just a shareholder, own 46.5% of the company. And Handelsbanken is a large investor that has supported us over the years and believe in us, which we are very happy for, of course. And this some insurance companies and quite good investor list. In terms of the finances, we spent in cash SEK 7.5 million in half a year, which indicates SEK 15 million, but we have lots of extra FDA costs, I would say, SEK 40 million. We have SEK 42 million in cash, which means 3-year runway. So if we increase the cost for the FDA launch to 50%, we would have 2-year runway. And then, of course, the idea is that we should start to get revenue. Is there anything more I should say here? Yes, the gross margin. We have 98% gross margin. in this box here for half year, you see 94%. When I had my gastric banding business, we had 24% to 32% net profit over 6 years, between 24% and 32%. we had 25% of the cost of the sales price was the product. Imagine now you have 2%. You can imagine yourself what kind of net profit you can imagine. I will just show a couple of slides on the -- what you are waiting for, the FDA, the U.S. launch, then Amit will continue to take the rest. So the good thing with Implantica is that we have very mature clinical data. So if you are a normal U.S. company, you come out, you have 1-year data, and then you should launch. No surgeon wants to do tens of thousands of procedures with something you have 1-year experience. They need to know that this works long term. So we have 5-year data. That's like night and day. You can take Inspire Medical, the snoring device. They came out and they had 1-year data, and it took 3, 4 years to get going because people are only doing a little bit to see how it works. So we start from a much better situation. We have already been to all the big congresses, all the meetings in the United States for 4, 5 years. And we have today more than 100 surgeons want to start. We are already convinced all the key surgeons in the United States that this is the best are jumping up and down and waiting to start with this procedure. And most importantly, we have the codes. When a normal company comes, they are not paid. They have no code. They need to organize the codes to get paid to get into the health care system, what we have been struggling with in Europe. We already have the codes. So both hospitals and surgeons are actually paid. And we also have the superior cost effectiveness, and we have produced 13,000 products. We have already taken the cost for 13,000 products that we will splash in the American market. The good thing with this device is that there's a market who is 10x larger than the competition. And the reason for that is that this half here is the one who is operated today. It's 30,000 procedures in the United States, and this is the one who takes mainly the rugs and so on. On the right side here, you have those who have been damaged in the esophagus by the acid. So the acid is really dangerous because it's the nerves and the muscles in your esophagus get damaged. And they can't transport food. They are really weak, weak food transportation. And you then take existing methods where you have to close and then you come with the [ weakreek ] food transportation doesn't work. variable to difficulties. So latex, for example, they are not approved for these patients. And this is 40% to 50% of all sufferers. So that's double the number of patients, but this group is all the severe sufferers, all the long-term sufferers. And that means in this group here, we have 10x surgical need because they are the one who really need surgery. Oh, I forgot to say one thing. NICE, NHS, they study us for -- NICE is an organization to evaluate new technology. They do that for NHS. This is the most famous organization for evaluating new technology in the world. 9 months, they spend on looking at RefluxStop and their conclusion was we recommend that NHS, you take and operate this with your public hospitals. So we are today approved in the public hospitals in U.K. Here, you can see 340 million Americans, 78 million with the disease, 40% are not treated by the drugs. They don't respond to the drugs. It doesn't matter if you have PCAB or PPI or they simply -- it doesn't work for them. That means 31 million people. You can see here, today, it's like 30,000. So it's 0.1% of the market to surgery today. If you should take 1%, I would say 3% is quite a realistic target. But if you take 1%, you can see yourself, you have 2.5 billion in revenue and 300,000 surgeries. And if you compare to obesity surgery before the injections came, it was about 300,000 surgeries. It's a magnitude of treatment field, huge treatment fields. Today, it's maybe 200,000. But it's still -- this market today is very compressed because it's so much side effects that no one wants to operate other ones are absolutely necessary. Please, Amit, welcome.

All right. Thank you, Peter, and thanks, everyone, and thank you for joining us today. So in the next 30 minutes. What I would like to do is walk you through our strategy and how we are thinking about taking this product to the U.S. experience, the launch, the road map, what's to come? And what are the key milestones and things that we are really focused on in the near term and then how that scales over time. So bear with me. So I want to start where Peter ended because this is sometimes underestimated in terms of what it really means for the Medtech field or eHealth care as such. Yes, Peter talked about how big the opportunity is. But what I want to highlight is there are 2 things about this opportunity. First, it's so huge just by the scope of it. If you look at different fees, there are a few opportunities that can really stand to this scope. And then second is untapped. We are probably the only technology or currently certainly the only technology that has this unique opportunity to tap into something that over 70 years of history of good no other product has been able to do. And there are reasons for that, and we'll talk all about it today, why. But this is to be recognized that not only is huge it's also untapped. It's pretty wide space. There hasn't been anything out there. If you look at other fees, you see one after the other competitive fields, there are incremental innovations coming to the market. We don't have those challenges fortunately at this point. So this really puts us in even in a stronger position than any other PMA-approved technology, which is already a huge milestone. So with that, I want to set some basic foundation why we are, again, so uniquely positioned. And these are the driving forces that puts us in a very strong position in the U.S., number one, 5 to 7 years of post market experience. As Peter said, most technologies that comes with PMA approval have 1, 2 years of experience in the clinical setting in the U.S. under a certain trial setting. We are coming in not only in the clinical setting that we did up with 5 years, we also had it tested in 60-plus hospitals in Europe. So the question that most new technologies go through in the early phase that can this product perform as good as it performed in the clinical trial? Can it perform the same thing and deliver the same outcomes in real-world setting? This is the #1 question when a product hits the market. Fortunately, we have already been through that experience in Europe with so much data, so much experience, 1,800 patients up to 7 years of follow-up. So this is very unique to our situation. So it really puts us in a very strong position. Number two, over the last 3 to 5 years, Implantica team has been incredibly engaged on the education and scientific grounds in the market. What that means? Most companies, when they launch, they have next 2 years, 3 years to just build early relationships. You can still hire the best team in the world, but it's still going to require that engagement, that process through which you really convince the scientific community that this product has checked every box in their mind in terms of performance and reliability. So we have that position. And that, again, has been delivered through some of the top surgeons in the world, not just U.S. and more than 100 surgeons and GI have collectively participated in our journey through that. So this is already -- again, day 0, we start with that position, which companies take 2 to 3 years. So that really gives us a solid foundation. Cost effectiveness, I think we went through that pretty extensively. We are in a very strong position there. And then in terms of reimbursement, no question, U.S. is uniquely positioned to offer opportunities to new technologies where they have ability to scale faster compared to some of the other public systems. So we'll talk about that. Last but not the least, with our incredible gross margins, we have the plan to kind of launch this with 30,000, 13,000 products to be available so we can scale this faster than any other product we have seen. With that, we have a twofold strategy to execute that. So let's talk about what execution look like. On the front end, we are talking about establishing this technology within the first 5 centers of excellence. What that means? The first 5 of that will really allow us to scale this, meaning become the training grounds, become the centers that will unleash the -- not only the training, but set the benchmark how this technology to be deployed in real world setting. So we want to start there, get these centers fully trained. And from there, we want to expand to next 20 accounts. So up to 25 accounts early on, regionally distributed and then really achieve a level of success with them, which we can repeat once we get to the true scaling, which is 100-plus accounts. Now that's going to run on a foundation that's super critical in the med tech field as we know, which is reimbursement. How do we scale that? So the very first thing there is just 2 weeks into our approval, we are standing here with our reimbursement application already submitted for the device pass-through payment mechanism. It's a mechanism that allows primarily is applicable in the Medicare population. So that will be subject to 6 to 12 months of decision time frame. Once we have that, the next thing we will have is start scaling with allowed more and more hospitals to scale on that front. In parallel, we have the bridge access for the hospitals we'll be working with. What that means is we'll have case-by-case approval mechanism with commercial payers where new technologies typically go through and they don't have any courts, anything, even for those technologies early on, which you start building the claim volume once you start convincing insurance companies that there is potential in this technology. Here is the medical impact here is the medical necessity. That allows you to start creating success with those claims and they start paying for it. Eventually, it becomes policy mechanism in its stretch. So this is a plan which we have already seen with many of the technologies successfully done. And that will allow us to, of course, scale reimbursement widespread in the country. So if I kind of go to what that means, all of us in the next coming weeks and days, one of the biggest things we're going to do is have the opportunity to launch it at the best place possible. So not many companies have the ability to just have the approval and be at the most important conference in the near term. It couldn't have been more perfect timing for us. We got the approval of 4 weeks into it. We have the best and the biggest conference for us, which is American Foregut Society. So there, we are assembling the best of the surgeons you can think of GIs and then all our experienced European workforce, which is collectively going to present how effective this technology has been, this typically has been attended by more than hundreds of people historically in our previous meeting. So we think this could have not been a perfect, more perfect opportunity, timing and also the place. So this is going to really unleash our product to be launched in the U.S. Now let's talk about what are we -- how are we rolling this out. This is -- our first step will be to launch it in the center of excellence in Los Angeles with [ Professor Lytham ] at USC. He's probably arguably the most recognized surgeon in this field who is also a pioneer in many other segments within the street. So with that, once that hospital is up and running, the plan is to roll this out regionally to other centers of excellence. We have already identified some of the absolute top centers. These include some of the past presidents of American Foregut Society and the future ones. So this is probably one of the best assembly of the best of the brains you can collect in the launch stage of a new technology like this. So with that, we're going to scale to the next 25, and then, as we said, we go further. How do we execute this? So let's talk about [ Athene ] that's going to be behind this. So we already have current team members, what we are doing is we are scaling that out now and bringing people on board from sales, clinical education and then in terms of clinical trials and surgical trainings. We already have a couple of key people onboarded. We have several more in our interview process in advanced stage. We have so much demand. The interest from the experts in this field is phenomenal because they have been tracking us over the years. One of the things we have done is we have onboarded people who have 20 to 30 years of experience in sales, clinical education from competitive technology, anti-reflux specialists. These are the people who hold more than 100 -- just between the current team we hired between -- just between them, we have more than 100 hospitals, top hospitals, relationships over the last 10 years, they have built. So we are talking about walking into the hospital, having all the relationships established all the paperwork procedures figured out. And that, again, puts us in a very strong position to execute this fast. So this is going to be -- this is going to continue to speed up. We're going to continue to expand our team, but we already have people in the next few weeks, 2 months joining us. Let me walk you through just an overview of what does it mean for a hospital to allow a new technology to be entered such as this. Typically, historically, if you look at any, again, new product with -- in an implant category, it takes -- can take 3 to 9 months before every -- all the basic work has been done in a hospital would allow our technology to begin. In our case, since all the work we have done, all the relationships we have established all the education piece we have done on the data and the relationships between U.S. surgeons and the European surgeons where they come together, we believe we can really fast track through this process. The very first step is, of course, getting the commercial agreements signed off, having the clinical study protocols figured out, there is an IRD process for getting the approval process. So again, that's what I'm saying. If you're a brand-new technology, nobody knows about you, nobody has any crew house done, it typically takes that long. But again, we are going to march through this much faster than most products that you would come across. And we believe we can be on the shorter end of it within a few months, we have things up and running. We are already in dialogue with our top 5 centers as we talked about. So we believe we can truly again gain street here as well. So again, from a training standpoint, one of the key milestones as you heard about before, it could not be overestimated how much an excellent product requires excellent hands to deliver it. We are not a drug that product itself is going to do the magic. So therefore, we put incredible effort in making sure each center we bring on hold each center and the teams they carry along, they are best-in-class. They are fully trained and they have excellent work done in the early cases. So we already have a very nice blueprint of scaling this education process. We have trained more than 100 GIs and surgeons in European context. So we have a team that already knows how to quickly go up and about. So this would put a fantastic run to our launch process. Again, maybe going a little bit deeper in the reimbursement now. Just to tell you that, again, as you heard, we have quotes that already exist and applies to our procedure on the surgical procedure side for the hospital and for the physician. The device part, as I mentioned before, we already submitted our application for a transitional pass-through application for device. Once that's approved, it takes 6 to 12 months for the decision. But once that's in place, that truly allows us to go as fast and as far as we can within that Medicare world. On the commercial side, we will be putting this case-by-case process, which allows technologies to scale as they create more demand with the insurance companies as more procedures are done, more insurance claims are processed and they see the medical necessity to allow a technology like this over time. So that's just showing you a little bit here. I think it's sometimes it's not easy to kind of see how big the opportunity is on the nongovernment site. So you see that public government plans all put together is about 36% of the population. Private commercial is 55%. So yes, we're going to pursue multiple opportunities, one with the government with the pass-through payment mechanism for Medicare. But with the commercial payer, we have much more leeway, just the top 5 players in the commercial segment takes care of 57% of the market. So the opportunity is in trivial at all. In fact, it's very much in contrast to what you have seen and heard within the European setting where things have more government-funded and unilateral. So here, we're going to have significant access to commercial payers. We're going to work very closely with them. We've got to meet them. We're going to show them our data and get more and more claims going as we build up the volume. So this can really go much faster than anything else we have seen. So what does that mean? If I really bring that down to 24 months runway, I mean, we believe we are ready to kind of scale this in the first wave, which is all about getting the excellent hands fully trained ready to go. These are the people who are waiting for this technology for years right now and absolutely have the skill set and impact on the health care system and getting the volume buildup, but we want to make sure we don't run too fast and dilute our clinical outcomes, which have been phenomenal and excellent in every way. So that's the goal and then getting to 100 and then several hundred is part of the journey. So let me say, last but not the least, here, an aspect on the previous discussion. It's not common for again, new technology to come into the market and have your biggest competitor leave. So this is unique. It's outside of U.S., we already have seen links being announced to be withdrawn, which is our biggest competitor right now. And in the U.S., we hear from the field and from surgeons that has been significantly reduced in the way it's been used and historically speaking. We believe it's primarily outcomes driven, but whatever the reason is, it certainly opens up a window of opportunity, which most companies wouldn't have. If in fact, if anything, you're up against the technology that's well established, here we are creating an entry into a market which has a huge hole just recently been growing bigger and bigger. So we even more clearly see an opportunity to tap into in the near term, and this should allow us to scale even faster. So if I kind of -- maybe you can see things in a multiyear scenario, but if I focus things down to 24 months, what does the journey look like? We talked about many things. We talked about things we are doing right now in this moment, bringing the absolute best-in-class teams, people who have 20, 30 years of experience in anti-reflux space. So they are not -- no news to the surgical community. And when they walk into those relationships and try to restart things, it's a matter of days versus matter of months. So those things really speed things through. And as you kind of go to the next phase, 3 to 6 months and 6 to 12, we are building that foundation step by step. But if I summarize that, these are really the 3 things we are trying to accomplish. Number one, building a team that can truly have the relationship and ability to scale, get into the customer experience, make sure our outcomes are as excellent as we have seen. We don't want to see that diluted because that's the foundation of all the success we have seen and possibilities that we can grow this field so big. And repeatability of course, within those accounts. We want these accounts to do their case #1, 2, 3, 5, 10, 20 and see them grow from there significantly and rapidly. So we can truly allow scalability in those and then go for the scaling, which can be built over hundreds of accounts. So that's kind of how I would summarize this journey that we are planning in the next 24 months. Of course, as we see in the coming months and quarters, you will hear a lot more about the ground level execution and things we're going to do. There is a big piece that you will see in the next section, which is all about how we get to the patients directly and how we grow that demand in a multitude of spectrum. Let me kind of just summarize my story within a very inspiring journey that a company like called Shockwave Medical had. Again, we are not benchmarking in terms of sales or any kind of projections. This is truly to show you how a company with excellent products, in this case, excellent training, surgical training, having a systematic launch starting very, very small as you see and then growing this journey over time than 6 years, how much could you achieve if you have the right product that's derisked in terms of experience and testing and the outcomes how can you scale that over time very quickly. So I think this is a journey that we aspire to and absolutely look forward to deliver great outcomes. So with that, I'll say, thank you, and over to you, [indiscernible].

Thank you. Hi, nice to meet all of you, and thank you for the opportunity to speak to you today. I get the exciting part of being able to explain to you today kind of what the U.S. market looks like and what our plans are to take as much of it as we possibly can and how we're going to do that. So if we just start out first, about today, about 89% of Americans, first before anything else, when they don't feel well, go to the Internet to find out what could possibly be wrong with them. It's a little bit different than the European market, which has launched a few products a few times in, but 89% listens to Dr. Google and then go to their physician for advice. Once they've gone to their physician, 75% of those people that have gone will go back after their appointment to verify their diagnosis and what was prescribed to them and if there's anything better out there. Now the view is very different because it's a direct-to-consumer market, meaning as a medical device, even though I'm prescription only, I can advertise directly to the consumer. Now anybody that's been to the U.S. and [indiscernible] TV has seen all the pharmaceutical commercials. I tell you it works because those guys know how to sell and so do we. So as Amit and Peter have both spoken before and told you guys search and awareness. We've been working on that for 3-plus years. Our surgeons in the U.S. completely understand the mechanism of action. To Peter's point, we are not changing anything about the anatomy. We're correcting it. It's an anatomical problem. The body is failed anatomically can't be fixed by drugs. That's a bandaid to last for a period of time until it gets so bad, it doesn't work anymore. We are the solution to that. We're taking the natural function of the body in restoring it. So we're not giving you something that is unnatural. We're not trying to wrap anything around anything. We're just putting it where along and keeping it there, so it can function normally again. That's a great message to an American consumer. Americans are all about natural, all about trying to be in as healthy as the possible plan. And there's a huge, huge resistance against drugs at the moment, which is live pharmaceutical companies now are coming out with PCAP. It's not going to convince anybody. Everybody is starting to understand that this is a mechanical failure and cannot be resolved with drugs. It's just prolonging the problem, it actually makes it more serious when you have to have a search to be later in life ones better. Second is our GI referrals. We've not only been working on our surgeons, but part of our referral community is the GIs. They refer directly to our surgeons. So we've been targeting them. The slide that Amit showed earlier of the panel that we have for American Foregut Society includes 4 of the top GIs in the U.S. These are the guys that are publishing on everything. There's already one publication submitted to a conference later this year based on European data, done analytically by American GIs. So a huge advantage there as well. Last part is patient empowerment. So this is the part that we'll focus on mostly today. I'll touch on the other pieces. But how are we going to reach these guys? Now there's everything from direct-to-consumer campaigns can include everything essentially online. And we're going to touch on that now. So this is just showing the American Foregut Society meeting from last year. We had a sold-out room of 120 surgeons sitting in one room last year, listening to this before the product ever came to the U.S. Incredible questions. Everybody is super excited. We are excited with them. And so that is a great start right there. Moving on to this. So the very first thing is there's a lot of channels we can use to get to patients, and we're going to use them all. So starting with PR, there's ads, there's social media, there's our website. There's print materials we can bring up in there's work to mouth. So what is the goal of it all? The very first piece is nobody came off in our door and come sit down and have a couple of coffee with us and say, "Hey, Implantica, it's nice to meet you". We want to create that environment online. And we've already started. So you will see the very first part is we're going to have an amazing website that is going to launch within a few weeks. That website will be split between Europe and U.S. because in Europe, we cannot do direct-to-consumer marketing, but in the U.S., we can. So for the U.S. market, here's Implantica, Nice to meet you. Here's RefluxStop, the new product. The idea is to create a very state-of-the-art user-friendly communication space where people feel comfortable where they come for their knowledge. Now once you introduce yourself, we're going to put a ton of information out there, PR, social media, we're going to be everywhere. So what do people go to ask their questions. So we created a contact us page on the backside of our website where they can reach our customer service directly. So we can actually answer questions that they may have. Some of those questions might be, where can I get it near me. So when you go into our new website, -- and you click in, you can see a slide pop up, it's going to say we're now available in the U.S. If you'd like to know when it will be available in a later year you, please put your name on a resale here. That creates a massive patient database. We will use that database as we open clinics to drive those populations to those specific clinics. We also -- where can I get it? Let me know where I can get it. So as we grow our clinics, not in the beginning because that wouldn't be fair to patients, we will have a mapping on the back end of our website where you can put in your zip code and we'll tell you where you can find the closest surgeon to you, which helps drive those patients faster and with that decision-making process. Now what is the data say? We have that on there as well, but now we have to make it to its user friendly, meaning that the general public can understand the data as wanting to put a publication in front of a physician, different thing to present that data to the public. People in the U.S. are very data driven. So we have created our website in such a way that speaks and tells that story. And they read all about it. So when we're in the news, and we're creating patient stories, patients actual experiences you'll hear from [ Sally ] today. Those stories will actually live online. So people can actually hear from other patients and get their experience directly from another patient. So our new websites coming soon. This is kind of a sneak preview and just kind of shows you all of the features that I kind of spoke about very quickly. So public relations. We know how to do this. We've done it in Europe, even though we can do direct-to-consumer marketing in Europe. Implantica has been in Saga, Sky News, Daily Express, media sites, BBC Radio within everywhere. We used our surgeons in Europe to actually present, talk about and do these things. We know how to do this. We're going to duplicate that in the U.S. We already have a massive list of all of the journalists for the last year that has been speaking about GERD that has written articles about GERD. We know all the largest television stations. We know where we need to go. We have those contacts built. So it's just a matter of execution. That's where surgery happens, you should see a lot about us in the news in the U.S. We also created our patient-focused communication tools. So you'll set print material, really, do we still need that today? Yes, we do. We needed for that work to mouth we were talking about. So in the U.S., the person with the biggest problem wins. So how do we help our patients win? I go to my doctor, I have this horrible problem. He recommends his amazing product. He has made a beautiful brochure. I take that grocer. I leave that office. I'm going to tell everybody I know, and I'm going to show them exactly what I'm going to get. That is work to mark. That's grassroot marketing, and we're going to drive it that way. We've created everything from trifold that you can look through in doctors' offices, all the way through to beautiful patient grocer that literally tells them everything is going to happen before surgery, after surgery, what they can expect recovery times everything, and that is in print form. On the website itself, we've also created a place where they can click a button and say, downgrade information to share with my physician or my referring physician. So we're helping the patient take information to the actual surgeon and asking them for the product. [ KOL ] training and education tools, marketing has also been involved in that. And then I just talked about how we want to drive training and make sure that it's consistently and well done. So we get the results and the outcomes that we've been seeing. These are the tools that we are helping create to make that happen. For the U.S., we've also gone to transforming our branding. So this is our current packaging going to hospitals in Europe. That's our new packaging that will be going to hospitals in the U.S. So it's a repositioning of our branding, specifically high-quality product, expensive product and expensive-looking packaging. So all of these things together essentially will help drive. It's very difficult in a short period of time to give you a full focus. But I hope that I highlighted kind of the top things that we are thinking about and working on. We're very excited. It's an incredible product, and it differentiates itself really, really well from anything and everything else there. Nobody else can claim that they are actually restoring the natural anatomy of the body. We're the only one who can actually claim that. And you'll see other people are trying, it's not working. We're super excited. It's a fantastic product to market. I'm super excited to be here. And thank you very much for the opportunity to speak to you today.

Juanita, you will actually remain on stage along with Peter and Amit as we will have a little Q&A. Questions from the audience will be handled at the panel towards the end of the Capital Markets Day.

So Peter, very intimate here. I thought you all could just add and we'll have this sort of dynamic. So Peter, I thought I could begin with you. You talked a lot about RefluxStop compared to other treatments. But if you could put it into simple terms, what makes RefluxStop so different?

I mean you basically see from the results, so to say, that we are not a smaller improvement. We are like night and day in terms of outcome, and that's because we understand how it really works. And when you understand that, then it's easy to do the product. The others have not -- over 70 years in this business and operations and methods coming and going, no one to understand how you really should do this. And it's all like Juanita and I said, both, I think, it's all about restoring anatomic positions. You can say the whole problem is because the winter is lining up to the diaphragm and get the pressure variation from the breathing affecting it. So we solve that and then people treat themselves.

As we go on to Amit, what is the plan for getting U.S. hospitals and insurers to pay for RefluxStop? And roughly, how long do you think that could take?

Great question. So I mean, I think twofold, like you said, what's going to be the journey like? I think as I said, there are kind of so many milestones ahead of us. And I mean, compared to a technology that is branding, we are accelerated at all levels, if I can oversimplify this. What that means in this particular field is the ability for us to train the top 5 centers, as I said, and then from there multiply. That speed of execution, I think, is all about our key focus right now. And I think we can do this really fast. I don't want to put like a certain time line to it, but we are already ahead in terms of reaching out. We are already working on the time lines. We already have a training program finalized for the first 5. So we are just marching through. And I think in the coming weeks and months, I'm sure through Peter's investor calls, we'll talk more about the time lines. So that's on the execution speed. But on the reimbursement side, as I said, this is not to be underestimated. We are working on 2 parallel paths. It's very unique to U.S. market in general. But because we already have hospital and physician codes that we can leverage, the only piece we are working on is device versus all 3, which is what happens with new innovations. So for the device part, we are working on 2 levels. One is CMS pass-through payment. That 6 to 12 months, we should have the decision. So we are very confident. We feel we have all the incredible data. But of course, decision will be seen soon. And on the -- in parallel, we are from day 1, implementing Bridge access program for the hospitals to get claims submitted to insurance companies. And as more and more claims go in, there will be discussions about, is it a medically necessary product? What does it do? How is it different, like all the things we discussed today. And we have, again, a very strong foundation here. There is nothing like RefluxStop in the market. So that should speed things through with the insurance as well. And more awareness means more approvals and that more approvals with the data we'll submit also means scalability, meaning you can expect insurances to set out some policies, which says RefluxStop for these patient groups are covered, like what we saw in the U.K. It took us some time to get them on board, but we were able to get this unique decision from them. So I think it really is 4 weeks into launch. So I wouldn't go too far in saying too many things. But in terms of confidence, in terms of what we are seeing, the kind of response we are seeing with hospitals, I mean, it's phenomenal. So if that gives you some context.

Juanita, if I turn to you, as you mentioned, the big difference between the European market and the U.S. market is that you can market directly to the consumer in the U.S. market. And I'm curious because we are living in a digital age that is becoming all the more digital. What are the most important platforms that you will market there, social media, TikTok and so on.

I think there are platforms that are ideal for it, and we'll probably focus first on the platforms like LinkedIn or even Instagram, where we can actually market to people in a specific geographic area. So geographic targeting. Although we will nationally announce to make the big splash and get everybody very aware that we're here, it's kind of unfair to patients to offer something that they can't get to. So your regional marketing becomes super important, meaning regional television stations, regional newspapers and then, of course, social media. And you'll see us very active in social media. We have a very strong social media presence and platform today, which we have to split. So we'll have a U.S.-specific platform because we can do direct-to-consumer marketing, which we're very excited about. The other thing that's very important and should not be left out is the -- we have to search engine optimize. We have to. meaning we want our information that Implantica is putting out to come up first when you do a search, whether that is a search on GERD, whether that's a search on surgery, whether that's a search on RefluxStop itself. That way, we control the message to the market and to the people, which is the very most important part. So when you talk about social media, that's probably where the misinformation is most likely to happen, and that's where we really want to focus on that part. But yes, it's all the social media channels, Instagram, LinkedIn first, we'll move further on to Facebook and the others, but their numbers have kind of come down. So we're focusing on the ones that have the highest visitors from the U.S. basically at this point. And then we drive everybody back to our website because that's where the source of knowledge is basically going to sit. So super exciting stuff.

Thank you very much, Juanita. And Peter, perhaps the last question for this Q&A. If you're standing here a year from now, what sort of milestones would need to happen for you to call this a success?

That was a good question.

That's a great question.

Of course, my goal is to get all these hospitals now trained and up and running. That's for me the most key. We sort of build the platform for the expansion independent if we get a decision from that they pay after 6 months or 12 months or if it's even longer, we just build our business. We grow and when we finally get paid, it will be a fantastic situation. That's -- and with the private insurance companies, it will come from day 1 to maybe up to 2 years. The most hard, difficult ones to convince will take 2 years maybe. And then there will be a line of insurance companies who start to pay over -- so 1 year from now, we probably will have a very good situation with many insurance companies who pays and we will have started our 25 centers shop.

A shorter answer than I perhaps expected. So I even have time for another one. So Amit, as Peter said in the presentation, there's 13,000, if I'm not mistaken, units ready to splash on the market. But considering that demand may grow, can you actually keep up if you need to scale up in terms of training surgeons or even making new devices?

Well, I think the beauty of our product is it's quick to make. So we are going in with 98% -- up to 98% of gross margins that allows us to scale really fast. I mean imagine a company with a smart implant where they have to invest tens of thousands of dollars, sometimes certainly a few thousand dollars to build one product. We are talking about incredible situation better than drugs where the -- so our margins are kind of beating those standards. That certainly allows us to scale fast. Another good thing we didn't talk about today is we are moving our manufacturing to the U.S. So we are in the process of doing that. And once that is up and running, beyond these 13,000, we could produce very fast, any numbers we want. So that puts us in a pretty good place. We've been...

Maybe I can add, there is actually a special tool built for an automatic machine. So you put silicon in one end and out comes [indiscernible], and it's just how many products you want to do. It's not a problem.

Well, thank you very much, Peter, Amit and Juanita. We'll now be moving on, and we'll listen to Dr. John [indiscernible] here about clinical validation and RefluxStop in the U.S. So I'll...

[indiscernible] the most respected surgeon in the whole of the United States. And he is the one who will do the first surgery. So former President of [indiscernible] Society.

What an introduction. Let's get it.

Well, thank you. I appreciate the opportunity to speak briefly here about reflux, which is one of my passions. It's reflux that's ultimately leading to what we're seeing, at least here in the United States is an epidemic in esophageal cancer. And so anything we can do to kind of control reflux will help considerably. Issue I'm having at the moment, though, is I can't see the slides, which will make it a little more difficult. There we go. All right. Well we can get beyond that picture of me, that's just terrific. So next slide, please. There we go. So for those that don't know, reflux is really a huge problem here in the United States. As you can see from this slide, estimates put it at about 20% of the American population. But in certain regions, especially in the South, Midwest, that can reach up to 30% of the population are suffering from reflux. Many of these patients, up to 40% aren't controlled with any combination of the current medications that are out on the market, which leave millions and millions of patients here just in the United States that aren't happy with the treatment they're currently receiving. And so for decades, there has been this unmet need for some procedure to help with their reflux. We've also seen an increase in the demand for surgical procedures for reflux over the last couple of decades. This is partly due to a rising obesity epidemic here within the United States and globally, I would argue. It's also partly due to an aging population. There's also with social media, greater awareness and diagnosis of reflux and the problems that it causes. So the end result is there's more patients seeking permanent relief. They really just aren't as interested as they used to be in a temporary acid suppression. There's a lot of concern also out there right now about the long-term effects of any of these antacid medications, whether that be osteoporosis or kidney damage, you name it. Patients are concerned. And more and more, we're seeing patients coming in just to get off of these medications. The other thing we've learned over this last, I would say, decade or maybe 15 years is that reflux is a mechanical problem. I think there's this perception out there that reflux is due to simply having too much acid in the stomach. Well, that's definitely not true. Everybody has about the same amount of acid in their stomach. Reflux simply is just a mechanical problem. And so a mechanical problem really deserves a mechanical fix, which obviously is surgery. So again, really up to 40% of patients with reflux out there are seeking some alternative, which leave millions of patients. This is a mechanical problem and surgery really is a fit here to help these patients. So next slide, please. So we -- the American Foregut Society, which Peter already mentioned, I was one of the past presidents, the Founding President of the society, have put a lot of time into really delving into what is causing reflux. For a long time, I think most people believe, most surgeons, most gastroenterologists believe that this was a problem with the lower esophageal sphincter. They sort of oversimplified this disease. So the American Foregut Society in this diagram right here on the right is a publication from the American Foregut Society, really delve deep into what is the mechanical issue going on here. And what we have learned over this last, I would say, 5 to 10 years is not only is GERD a mechanical problem, but the normal anatomic barrier is actually composed of 3 things, not just the lower esophageal sphincter. The hiatal hernia or the integrity of the Kearl diaphragm is a big part of this disease. Yes, the lower esophageal sphincter is important. But in addition, there's also this thing called the esophageal or gastroesophageal flat valve and angle his, which are incredibly important in preventing reflux. So we've gained a lot of knowledge on what the mechanical problem is, which helps us ultimately obviously determine what the mechanical fix is. Next slide. And so like I said, for decades, dating back to probably 1950 and really perpetuated by my institution, USC and my mentor, Tom DeMeester, we all thought this disease was just the lower esophageal sphincter. And all our treatments focused really on different ways to tighten up that lower esophageal sphincter. Fast forward to where we are today, we're in a much better position now that we understand that the disease is really part lower esophageal sphincter. The majority is that integrity of the Kearl diaphragm as well as maintaining that angle of his, which then leads to the gastroesophageal flat valve. So surgery is ideally positioned to fix all of those components. Next slide. So here's kind of the time line that I was referring to earlier dating back to the 1950s, where we really thought this disease was focused on just the lower esophageal sphincter. And Rudolph Nissen was sort of first to the market here with his procedure, which was called the Nissen fundoplication. And again, all these procedures basically focused on tightening the lower esophageal sphincter, and that's what Nissen fundoplication did. If you're not familiar with that procedure, it involved wrapping the top of the stomach 360 degrees around the end of the esophagus where that sincture was to tighten up the lower esophageal sphincter. Over time, surgeons modified that procedure in different variations, either from the door fund application to a 2-pay fund application, which we're still wrapping the stomach around the end of the esophagus to tighten up that lower esophageal sphincter. We tried for probably at least 2 decades, different endoscopic procedures where we go in and either inject stuff into the lower esophageal sphincter or again, trying to wrap the stomach around that lower esophageal sphincter to tighten it up. Surgeons then came out with something called magnetic sphincter augmentation, which is a little -- almost looks like a bracelet of magnetic beads that we would place around the end of the esophagus. -- force of attraction of those beads coming together would squeeze the lower esophageal sphincter. Now all of these things helped with reflux. They all seem to stop reflux. But the trade-off here was, as you can imagine, if you're tightening up the end of the esophagus, that's going to lead to some other issues. And those other issues or side effects were mainly dysphagia. Patients' food was sticking when they swallowed because it was so tight, especially with Nissen fundoplication and links. As a result of that, patients couldn't belch or vomit normally. They would get gas and bloating. And then the biggest thing was all of these procedures had a very high recurrence rate. Studies show that Nissen fundoplication within 5 to 10 years fails in upwards of 30% to 50%. So what we were doing initially stopped reflux but with a big trade-off and still a fairly significant recurrence rate. RefluxStop is very different. RefluxStop does not tighten the lower esophageal sphincter. It reconstructs the lower esophageal sphincter but without tightening it. It also fixes the hiatal hernia, restores that angle of his and flat valve. So it really accomplishes all 3 things in regards to reconstructing or fixing that normal GERD barrier. So it is a very unique approach, which already has been demonstrated in Europe to have much lower side effects, meaning the dysphagia, gas bloat and inability to belch and vomit. And at least preliminary data shows that it may indeed have a lower recurrence rate of reflux at that 5- to 10-year mark post surgery. So next slide. So again, just to kind of summarize all that, RefluxStop does have the unique position to actually fix all 3 components of that GERD barrier without the significant side effects that we see with all the other procedures I listed on the previous slide. Because of the use in Europe, we're in a unique position here in the United States that we've already got a lot of long-term data, including 5-year prospective trial that was done in Europe, in addition to real-world experience then at multiple centers throughout Europe. I will also point out that this is a unique procedure in another way. This procedure got FDA approval here in the United States without any U.S. data. That is very rare. And the reason it got approval because of the data that it was so strong coming out of Europe. But in my 30 years of doing this, I don't think I've ever seen a procedure or an implant here in the United States get approval without U.S. data. So again, I think this is a very unique procedure that has the ability to restore all the defective components of that barrier without the significant side effects that we see with our current procedures here in the United States. So next slide. So I think I probably outlived my 10 minutes or whatever I was allotted. So I think we'll stop here and see what questions you may have.

Question at the end, but...

I think it would be good for [indiscernible]

Very well. We can open up the store for this Q&A session specifically for Dr. [indiscernible].

We can show him...

Of course. There he is.

Really good source for information and who knows the U.S. market in and out. And it's good for the crowd to be able to ask some questions if they have.

Of course, we'll open the crowd for this Q&A session. I will open up with one question here, though, give everyone time to think up their own. So John, once RefluxStop has become available in the U.S., why is it a treatment that you're looking forward to offering to your patients?

Well, I think it's mainly because of the side effect profile. Like I said, every other procedure that we've tried creates either significant dysphagia or problems with belching and vomiting, which causes gas and bloating. And for a surgeon, that's sort of an albatross around the neck. Yes, you stopped that patient's reflux, but they're still coming back to your office weekly, if not monthly, complaining of dysphagia, gas and bloating and all of this. So I'm excited really mainly because of the side effect profile as well as what I believe is going to be a lower recurrence rate of reflux over time.

What have you seen from U.S. peers so far? How are they -- how would you describe their interest in RefluxStop.

I would say it's exactly the same. It has been no problem here in the United States getting surgeons excited about this. They are very familiar with RefluxStop. The data has been presented at the American -- the Annual American Foret Society every year for the last probably 2 or 3 years. So they're excited to get it in their hands.

Well, we'll open up the floor now to questions from the audience, and there will be a microphone that will be flying here. So when you're addressed, you may wait for a microphone.

Can you describe the differences between -- you have now P-CABs from [indiscernible]. I think the company is called that it sold a lot in the U.S. Can you describe what you think the differences are even that it's not -- you don't have a long time for [indiscernible]?

PCABs are available also here in the United States. And PCABs suppress acid just similar to PPIs and H2 blockers, so that's Nexium and Pepsid and stuff like that. The problem is, and I think a lot of patients as well as gastroenterologists don't realize this that the medications, whether it's a PCAB or proton pump inhibitors, they don't stop reflux. All they're doing is sort of masking the symptoms of reflux. They're suppressing acid and it's acid that causes the burning symptoms that people get. But the reflux continues. So if you have 100 episodes of reflux, you can go on double the dose of a PCAB or a PPI and you're still going to have reflux, 100 episodes of reflux. So a lot of these patients at 40% that are not happy with their medications, it's largely due to what we call regurgitative symptoms, which is they're still feeling the reflux come up, even though it doesn't have as much acid in it. So I don't think PCABs are the answer to this problem at all because, again, it's a mechanical problem.

[indiscernible] investor, I'm a retired surgeon. This is a huge market. So there are many -- there's room for many approaches. Maybe I am a bit overly cynical, but my view on the U.S. market is that money rains. So why would a hospital let the patient off the hook with PPIs and PCABs. When they return time and time again and brings in money, let them have the RefluxStop operation and they are chewed and disappear. It stops the money rolling in.

Yes. I mean, I guess you're right from a -- and that's been shown the burden, the financial burden here in the United States because of reflux is huge, and that's mainly because patients still have problems on medications. Surgery corrects that. and you're right, they won't come to the hospitals. But what's driving the market here in the United States is more the payers than it is the hospitals. The hospitals really don't have any say in how the patient is treated. It's the payers. And so I think if anything, the payers, once they see the long-term financial benefit of a surgical procedure like this that doesn't have the side effects, doesn't -- maybe has a lower recurrence rate. Financially, that's going to be exciting to the payers. The hospitals don't have any say in it.

Do we have any more questions from the audience? Yes, none more.

Yes, Dr. [indiscernible], we just heard today that you have a huge clinic and about 1,100 patients are being treated there every year. If we look at the RefluxStop procedure, how many of those 1,100 would you think could be RefluxStop in that case? And we also heard that you might be the first surgeon to operate in the U.S. And do you have any plans when that will happen?

Well, good question. The one unique advantage that RefluxStop has over every other procedure that we currently have today to treat reflux is the lack of dysphagia. So what that does is it opens up this door for this huge percentage of patients that have poor esophageal motility. So there's probably at least 30% of patients with reflux, if not more, that the reflux has damaged their esophagus and their esophagus is now weak. Well, it puts them in a position where if we do any of the procedures I listed on the screen before from Nissen to links, we are almost certainly going to create horrible dysphagia and these patients won't be able to eat. But because RefluxStop takes a different angle at treating this disease, we are not seeing the dysphagia issues. And so it's been shown in Europe that this is a great procedure for those patients with a weak esophagus. So already, we're ahead of the game with any other procedure because now we can do these patients with poor esophageal motility. It also has been shown to work in the patients with much more severe reflux and normal motility. So if you were to ask me what percentage of these patients that I'm currently seeing could be a candidate for ReluxStop, as of right now, I think almost all of them. I really don't see any major exclusion criteria. The FDA obviously has approved this with precautions, which are not contraindications here in the United States. But I think the procedure will be applicable to these patients that the FDA currently lists as precautions. Now in regards to when are we going to do our first implant, we've already got a waiting list of dozens, if not 100 patients that have heard FDA -- well, actually even predating FDA approval patients were signing up on a waiting list. And now that we've gotten FDA approval, that waiting list has like tripled. So we just got to get product, obviously, here at the USC in Los Angeles. We've got to get through the hospital finances and the IRB, but I would expect we could easily do our first implant sometime in October.

Do we have more questions from the audience?

Yes. Phillip from Pareto. I just had one question around other surgeons in the U.S. as well. So a lot of excitement, obviously, but I was wondering if we take the opposite side there. Like what is the main pushback that you're getting on this or like the main questions that are raised that you think could be like stopping a broader adoption?

Well, I think that's a great question. And I think the only hesitation I've heard from surgeons, at least initially, so this is dating back a couple of years now. But initially, they were unclear at the mechanism of the actual implant, the reflux stop ball. They were confused on what exactly it was doing. throughout the experience from Europe and some work we did on cadavers, I think what we've shown is that the reflux stop keeps that whole anti-reflux barrier complex stable in the abdomen. So it keeps the angle of his where it needs to be, which then results in keeping the gastroesophageal flat valve, how it should be. And then more importantly, because of the ball up against the diaphragm there, it's preventing recurrence of the hiatal hernia, which is our #1 reason why any of these anti-reflux procedures fail. It's not because of failure of the Nissen or the links or whatever, it's recurrence of the hiatal hernia in 90% of the cases. And so once that has been explained to them, I think any hesitation goes away.

Are there any more questions from the audience?

Yes. Procedural point of view, once you are educated, how easy or complicated is this procedure? How long time does an operation take, do you think?

Well, I think that for surgeons that are experienced in doing anti-reflux surgery, this really is no different for them. As long as they're experienced at fixing the hiatal hernia, restoring the integrity of the and swing, which all of them are going to be, this procedure is no more difficult per se for experienced what I'll call [indiscernible] GERD surgeons. As far as the time that it takes to do it, I've only done it in the cadaver at this point. It took me about an hour to do it, which is maybe 10 minutes longer than it takes me to do any of the other procedures that were listed on the screen. So yes, there's got to be some education and training to get these surgeons up to speed on patient selection as well as exact technique because there are some nuances. But I think it should be a pretty fast learning curve, especially for these first 25, 40 centers, which are already experienced in doing these anti-reflux procedures.

I will intervene with a question here. The learning curve might be simple, but how hard is it to learn the procedure.

Well, I don't think it's hard to learn this procedure at all because, again, this is -- it has all the techniques that we're currently doing with many of our other anti-reflux procedures. It's now all put into one procedure. So for experienced GERD surgeons, forget surgeons, they already have these abilities. So it's not hard, no.

To the audience then, is there any more questions? No, it does not seem that way. So I will finish off with this one then. How is RefluxStop different for patients who can't tolerate other devices like those with weeks following [indiscernible].

Well, I think that's a huge thing is the motility issue because everything else squeezes the end of the esophagus, which is going to lead to even more dysphagia. And with somebody with poor motility, they do not do well. So the main huge advantage, like I said, is these patients with bad esophageal motility. The other advantage this procedure has specifically over Lynx is it's not metal, it's not magnets. It has no restrictions on MRI, which is a big problem for Lynx. I think yet another unique advantage is when there is problems, some of these procedures aren't easy to reverse, whereas this would be easy to reverse. And then lastly, especially comparing it to Lynx itself, when links erode, that's a big problem for us to try to get that device out. When this erodes, it just breaks apart, passes in the GI tract. It's no harm, no fall. So I think there's a lot of unique advantages beyond the fact that it's addressing all 3 components of the barrier without creating a lot of side effects.

If we have another question from the audience over there.

Follow-up on one of the points from before. So you said this that RefluxStop could be applicable to all your current patients. But how would you then decide who gets it? And additionally, one point that was raised earlier in one of the presentations that a lot of the patients already know what they want when they come in. Like how big of a factor is that when you're deciding of what procedure to go for?

Well, that's a good question. As we sit here today, like I said earlier, I don't really see any exclusion criteria for this procedure. There's already data on using it from Europe in patients with big hiatal hernias, paresophageal hernias, most of the stomach in the chest. That's generally our worst or most severe reflux group, and it's already been shown to work in that group. It's been shown to work in the dismotility or weak esophagus group. So again, I really don't see any exclusion criteria. Now ultimately, we need to verify that here in the United States also, especially to have the FDA lift those precautions. How we decide which procedure for which patient I'll be honest with you, I don't decide. We have an informed discussion with the patient. Many of them already come in, having done their doctor Google search or ChatGPT, and they know what they want. And in my mind, if I don't see an exclusion criteria, then they're a candidate for whatever they want. So it's really an informed discussion with the patient based on data circling around the exclusion criteria, if there are any.

We have time for one more question from the audience, if there's one.

Looking a bit to the future, I mean, you are one of the experts in the field and have experience for years and years and seeing what we hear all the time about the excellent outcomes for the patient and that this RefluxStop procedure can treat most problems that these patients have. What is your view, your own personal view regarding the possibility of RefluxStop transforming the total market and becoming standard of care?

Well, I definitely think it has the potential to do that, at least based on the European data. This is light years better than what we've been doing for the last almost 80 years now. So I think it definitely has that ability or possibility to transform our GERD treatment. So I'm excited to get it in the United States here.

We actually have time for one more question from the audience, if there is any. It doesn't seem that way. Thank you very much, Dr. [indiscernible]. We'll now be moving on. So actually from Peter, a question.

Speaker 15 No, no, no.

You're saying goodbye.

Thank you. I was waving a bit.

My bad.

Thank you. Have a good day.

Thank you very much, Dr. [indiscernible]. So we will now be hearing more from the company, and it's Simon Friedman, who will give us a market update on Europe.

Yes. And actually, I'm sorry to say, but it's problems with the traffic in U.K. so he didn't make it. It's the control people who control the flights who is totally out, so he couldn't come here. And that's also sadly to say for Dr. Ahmed, Imperial College in U.K. They just couldn't fly. And that means that Dr. Ahmed will join online later, and I will take the speech about Europe that was intended for...

Of course.

Thank you. Yes. So you already -- I've already told you that we have 60 centers. And it's -- but you should know that in Europe, everything is done in a study format today. We are starting to get more and more reimbursement. That's to say, more and more hospitals actually pay for the product. So we -- but it's still -- it's not a real market, so to say. In reality, if you go to Germany, for example, and say, no one pays for the product, okay? And you cannot give away the product, that doesn't work. So you then do a study. And of course, that means for the surgeon that they could get paid for the study. So the product will not be so costly then, but it also means lots of work for them. So that means maybe 1 out of 20 centers or so are willing to do this because it's just so much burden with a big study to collect data, to do all this work. So that's the situation we have now. Those centers, the 60, they are the enthusiasts, those who really want to give the patients the best treatment. The centers we have today, the top, top of the line, where the surgeon is willing to sacrifice a big effort for a study. But the good thing for us is that we have been able to collect all the data. And that's why we have this fantastic situation in the United States, where we have tons of data. We have 38 published articles. So it comes also with a huge advantage for us. And we are starting then to get more and more real sales in Europe. And I just wanted to give you a little update. This is -- Simon is actually our sales representative in U.K. So therefore, he has put together a little bit the situation. You know that we -- not a long time ago, got approval for the NHS public hospitals. And then you need to know that in hospitals, we are paid in 2 systems. One is that you get the budget. Here is the amount of money, do whatever you want. This is what you get, [ Finito ]. The other one is to say, now you do this procedure and you get this money. You do this procedure, you get another amount. And every procedure give you a certain amount. In Germany, you are paid exactly what you do, nothing else. Here, they switched to a budget system because of COVID, they were bankrupt. So it's a budget system. It means that it takes 1, 2 years. One year, you say, okay, you can do 20 RefluxStop this year. Next year, you say, this is such a good method I need to do 40. And next year, you do 80. That's how it works in the budget system. You need to negotiate step by step. So it's not like your day 1, oh, we are approved in the public hospitals, we sell like [indiscernible]. They have a budget to think about. But he is showing here how he has managed to create 3 private hospitals. He has 4 active NHS hospitals, and he has another 4 who is starting to come through and should be trained. So it's starting to take off even in this budget system, and then it will increase step by step. And here, it will be some real income going forward, so to say. And we have done lots of -- Juanita is in charge here, but we have done lots of marketing, of course, and it's lots of publishing. So most patients in U.K. actually know about RefluxStop today. And if we then look at Germany, for example, we actually have got the code. But to that code, you need actually to have an amount of money. And to get the money in U.K. -- Germany, sorry, I'm confused now. In Germany, you base that on real cost. So you need to do a certain amount of surgeries and then you need to do that in so-called [ ENETS ] reporting hospital because ENETS is the health care body that decides the amount of money you get, and that is totally based on the real cost. So the ENETS reporting hospital is a small amount of hospitals, they report exactly how much does a RefluxStop procedure cost and then the hospital get exactly that amount, which means that because we never sell with discount, we sell for EUR 5,900 in Europe, we will get this amount when we finally get approved. And this is a market of 12,000 procedures maybe. So it's a huge market. It's is enough for breakeven just to have Germany, for example. It's a big market. U.K., I already talked about. In Italy, it's completely budget system. DRG is old and outdated. Here, it's not enough to have the best treatment. When we had the best treatment, it was a resistance. Oh, this cost too much money. Suddenly, we published an article about the Italian health care system, how they save money by operating with RefluxStop. They actually save money. And what happened then, tender win, tender win, tender win, tender win. And suddenly, we have now 2.3 million in paid surgeries in Italy. So also here, it's starting to take off. And I took an example, Spain because it's quite an interesting country. it's the opposite of Sweden, you can say. In Sweden, it's only the administrative people who decides. Time is gone when the surgeon could decide what treatment should give to the patient. It's just the admin who says, "Oh, this device, this is too expensive, we can't do that. You have a dementia medicine developed in Sweden who is approved all over the world, but no one can get it in Sweden. It's too expensive. So Sweden, they are taking the elevator down to the basement in quality of health care because it's not any longer the treatment who's deciding. It's only the cost. In Spain, it's complete opposite. If the surgeons say, I would like to do RefluxStop, he can do RefluxStop. But the other people say, you should know we have very limited month in now the Sweden budgets, so you can only do 1 per month. Okay? The surgeon says, I do 1 per month. Next year, they come back and say, I want to do 2 months next year. And this year, I want to do 4 months. That's how it works in the budget system. And that shows you here, we have 20 centers in Spain. That's incredible. It's not a very rich country, but still and that shows you when the surgeons and patients decide, then it will be lots of people doing. It's the economical factors we need to manage. And we are on a good way. U.S. is, of course, completely different animal. It goes much quicker, much bigger everything. But still, Europe will become also a very good market in 1, 2 years, I would say. Yes, we, of course, have other markets. We have not sold in Middle East because we wanted to ensure highest quality for FDA with Latin America, Brazil, Japan and so on. It's all markets that will come sooner or later. But for now, we are just focusing on U.S. It's U.S., U.S., U.S., U.S. because that's so important, so powerful and that opens doors. When you come and get approved in U.S., Canada says, okay, come to us, we're okay with the U.S. approval. It has opened so many markets because this is a quality standard, as I said before. Yes, I just wanted to take the opportunity to show you a little part of the procedure. I know everybody loves to see a little bit of surgery. So to the introduction here to the surgeons, I wanted to show you a little bit. This is a keyhole surgery, and this is a little portion now when they introduce the device. So I just want to show this to see if I succeed here, yes. So here comes the little device in here now, and it's placed on the top part of the stomach little pouch. And you see then he starts here, we hold it with our little instrument. And then he sure now, he has placed a top suture already in advance here, you lose one and now he sure yes, tobacco pouch sure, you can call it. So you see then -- so you can close this completely in stomach wall. It just disappears. No side effects. It's just gone. And this is sort of the key to this. So it's many things with this procedure and device actually is quite genius. And then you just take it slowly here step by step and you close. So I wanted just to give a little bit feeling what it's all about. This is Dr. [indiscernible] from Bern in Switzerland, who've done this procedure. And this doesn't hurt. It's not like the skin. You're not -- it's not like you're sitting in the skin. But you see here now, you have a big package here who act towards the [indiscernible]. This is [indiscernible]. And this is like a mechanical stop towards the [indiscernible]. So it's absolutely really nice. Yes?

I'm Dr. Daniel Sanchez. I'm a Spanish surgeon from one of these hospitals that Dr. Forsell showed us. I'm a consultant surgeon, and I have been operating performing reflux surgery from, I think, more than 20 years. It's honor for me to present you this large study. This is a RefluxStop safety study, analyzing outcomes in a cohort of 602 patients from 22 centers in 6 European centers. And this is important with a follow-up of up to -- sorry, up to -- okay. This study was published in NATO scientific reports. It's a very high-impact journal of medicine. This is the list of Sons participating and the list of the centers recruiting patients. Well, I said we recruited 602 patients. And the aim or the first objective was to analyze the adverse effects, making a retrospective analysis. These are the participation centers sorted by number of cases. And these are the baseline demographics of the patients. I would like to remark that more than 30% of patients had large hiatal hernias, more than 3 centimeters, okay? And the mean hiatal hernia size was more than 5 centimeters, yes. If we analyze the results related to procedure and device related with operations, I would like to remark that we have only less than 2%, 1.99%, of cases of reoperation, and only 1.33% was due to hiatal hernia recurrence. When we compare with standard of care fundoplication or [indiscernible] fundoplication or partial duplication, as Dr. Lipham said before, the hiatal hernia recurrence is more than 15%. I mean it is more than tenfold higher than with RefluxStop. If we compare -- this slide has been shown before, will be quickly. If we compare the outcomes with this real-world series compared with the 5-year safety in the [ FDA PMA ], the results are very comparable. So almost equal. So this shows that in real patients, in daily clinical -- daily surgery, the results are reproductive also. And it has been commented before that if you have a low number of reoperation, this leads to cost effectiveness. So it has been demonstrated these studies are in the right, that RefluxStop is the most cost-effective treatment for acid reflux more than standard of care for fundoplication, more than LINX and more than long-life PPI medical treatment, taking account even of the collateral effects of these drugs. So in conclusion, the experience of this, showed in this work shows that RefluxStop is safe, even in difficult-to-treat patients, for example, patients with large hiatal hernias; that the rates of reoperation is low, less than 2%; that real-world outcomes are equals the FDA-submitted study. And that's important. It has been commented before that RefluxStop is more cost-effective than standard of care in U.S. and Europe. That's all. Thank you.

Thank you very much, Dr. Sanchez. Next person who will be speaking is Ahmed Ahmed, and it's about the physician's perspective. Ahmed, are you with us?

Yes. Can you hear me?

Yes. Go ahead.

Excellent. Again, apologies, I cannot be with you. We had some issues with air traffic control at London Heathrow, which meant that all flights were canceled. So my apologies for not being with you this afternoon. I'm going to talk a little bit about RefluxStop surgery for the treatment of gastroesophageal reflux disease in patients with ineffective esophageal motility. Next slide, please. So I think the key takeaway points for the audience really is that in patients who suffer from acid reflux, or I should say, chronic acid reflux, a substantial proportion of them, ranging from maybe 1/4 even up to 3/4 of these patients, develop a condition called ineffective esophageal motility. And what this basically means is the chronic acid exposure in the esophagus leads to a weakening of the esophageal muscles. And so the muscle of the esophagus becomes less good and less strong at contracting. And so the esophagus is weak. And that actually creates more problems because now the acid stays in the esophagus, it can't go back down into the stomach because the esophagus is not contracting strongly enough. And secondly, these patients also develop on top of the reflux symptoms with heartburn, but they also develop symptoms associated with difficulty in swallowing. So a lot of patients who come to my clinic will not just mention that they're getting heartburn, but may also have problems with swallow function. Thank you. Next slide, please. In the U.K., which is where I practice, at Imperial College, in 2025, the National Institute for Health and Care Excellence, it's called NICE, which approves all procedures and treatments that we are allowed to use in the National Health Surveys, gave RefluxStop approval for it to be used as a procedure to treat acid reflux in patients with ineffective esophageal motility. And that's really quite a groundbreaking moment. Because till now, as you heard from Dr. Lipham, all the operations that were being done for reflux were really not suitable for patients with IEM. And that's because standard anti-reflux surgeries, including LINX, lead to a constriction or a narrowing at the bottom of the esophagus, whether it's with a wrap or whether it's with the magnets. But if you have a poorly functioning esophagus and you make the bottom even more narrow, you can imagine it's going to make the symptoms much worse, especially swallowing symptoms. And NICE realized that RefluxStop was the only procedure that actually doesn't do that at all because you're not constricting the bottom of the esophagus. Next slide, please. And there has been a number of publications showing the benefits of RefluxStop in the population with ineffective esophageal motility. So you can see from this slide, there are 3 papers, one of them is currently under review, but with excellent results in these patients who have IEM. Next slide, please. And what's really interesting is this slide. So I mentioned a few people who have IEM will have dysphagia, which basically means difficulty in swallowing. And what's really interesting is when you do RefluxStop in some of these patients, you actually improve their swallowing and you get that reversal of poor swallowing. And that's really a very good result indeed. Thanks. Next slide. One other tool we have in medicine is a scoring system. So this is called the GERD-HRQL. This is a very widely used scoring system, which assesses severity of acid reflux. It's a questionnaire, which patients are asked to fill before surgery and after surgery. And we can again see from this publication that there's a massive improvement in the health-related quality of life from reflux score, up to 89% improvement in the score when you compare before and after RefluxStop. Next slide, please. So in summary, what I want to mention to you is that RefluxStop effectively treats reflux in this very specific population of patients who have reflux as well as ineffective esophageal motility. And there's good data which shows that there's improvement in the GERD-HRQL scores, people who had problems swallowing before surgery, after surgery, that gets a lot better. And so this is definitely a very promising option for sufferers of GERD with IEM. Next slide, please. And that's it.

Thank you very much, Ahmed Ahmed. If we move on now to the next point here in the schedule, we have a Q&A and a patient story. And we invite up not only Dr. Sanchez, but also Mrs. Sallyann Warner, who is a patient. Welcome. Could we show Ahmed Ahmed as well? Yes.

I present myself one more time. Before I presented myself as a surgeon, I present myself as a patient. So I have been suffering from reflux for many years. And 3 months ago, I decided to operate, not myself, obviously. And to be operated, but I think the biggest expert we have actually is [indiscernible]. And well, I'm here and great to ask a few questions.

So just to clarify, you became a patient after you became a surgeon for reflux.

I first became a surgeon for many years, and 3 months ago, I became a patient.