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. 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. Thank you so much. Can you hear me? Okay, great. Good afternoon, everyone. A very warm welcome to Implantica's Capital Market Day. My name is Tomas Puusepp. I've been at the board for more than six 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. 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 or 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 just get the product cleared or approved in FDA, that is one thing. Actually, when you get the methodology and new method of doing things, that's much more complicated. 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. Also when you look in FDA approval, also marks a beginning of a new chapter. We now have the opportunity actually to introduce a treatment for patients in the market, the world's biggest market for medical device. So that, I would say, is a major achievement. It creates actually significant opportunities, but it also will be a lot of hard work. Today, when you really look into what has been done, and I know that you have had a lot of question, why did it take so long time, and we have all the issues regarding COVID and so on and so forth. By really looking into what has been done and what has been achieved now, really to get the FDA clearance, it's something which is really significant. You will hear much more about that today. I will not be long, but you will hear about the journey, how we got here, 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. Last but not least is, of course, what will also be presented today. How do we make it happen now in the United States. So it is actually the plan, which I think has been spelled out quite nicely. You will see more about that. 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 opportunity we are facing right now. 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. With that, I will not be long. I would like to have the pleasure now to introduce the Founder, the CEO, Dr. Peter Forsell. Thank you. You are welcome. Is this No. Yes. Yeah, 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. Amit will take care, who is in charge of that in the United States. He will make a deep, together with Juanita, presentation how we should do this. Just to know, I have invested more than SEK 1 billion in Implantica. If anyone believes that I am not a believer. This is the second business. We had a very successful journey with the gastric band. We, in six years' time, developed a business who took 28% of all obesity surgery outside U.S. It is not the first time. Our main product is then called RefluxStop, and it is working the disease, in Swedish, suruppstötningar, acid reflux, or GERD, gastroesophageal reflux disease. It is 1 billion sufferers. It is larger than obesity. It is the largest treatment field you can find. It is absolutely enormous. It is 23% of the American population. It is 78 million Americans have this disease, just to get the magnitude here. 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 terrorizes the tissue, and it do that over and over and over again, and that is a school book example how you get cancer. If I take a gastroscope, endoscope, and I put down in any one of you who has this disease, you have 10%-20% likelihood to have pre-cancerous changes. This is absolutely incredible. 48,000 people only in Europe and United States die every year from this disease. Take breast cancer. They do anything to find the breast cancer. They do all the screening, everything. Here, they just let 48,000 people die. Hopeless. That is why the future for Implantica is not good. It is not fantastic. It is enormous. Today, you have drugs, and that takes 99-point whatever percent of the market, big portion of the market, of course, and that is really not a competitor to us. The surgery, we are targeting maybe 1% of these billion people, and we would be happy. It is not that, but for you to know, these drugs has quite a lot of serious side effects. 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 is a huge American study who shows this. So independent what you take here, you can take it for a few years, but then it is preferred to actually do something to solve this problem. In the past, surgical methods, they were all focusing on that the sphincter, the upper sphincter is weak. So acid is coming up into esophagus because it can't close properly. 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. It do the same thing. Of course, if you try to close your food passageway, it gives you 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 swollen, distended, and it is 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 restore and maintain a normal situation. People get normal again. Then you don't have reflux. Reflux is a disease. This disease is caused because this sphincter here is gliding up and is coming closer to the diaphragm here, who is divides the chest from abdomen, and you use for breathing up and down and so on. Therefore, you need to have a hole here for the esophagus to pass. When you breathe, in, out, in, out, it comes lots of pressure variations here. This is terrorizing this poor little sphincter here. They can't handle it. It's impossible. The only thing you need to do is to free dissect, move it down 5 cm distance, put our device on the outside of the stomach. Suddenly, this acts like a mechanical stop towards the diaphragm here. So you always will have this distance, and everybody's 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% fail 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 sutured the stomach from below the band to above the band. So we made a tunnel of stomach for the band. It worked perfectly. Therefore, we decided to just get it away. That means all the complications, with the gastric band, the liver could grow together, it could tilt the band, and many strange things happen in the body. Here, nothing. It's just gone, the complications. Here you see the instrument, device at the end. It's a special made we supply. We have 60 hospitals today, 1,800 surgeries is done. The clinical outcomes that we filed to FDA for the PMA, this is five-year data. 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 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. That means it's a quality stamp. Bang, we are a really serious company. That's what it means to get an FDA PMA approval. This is published, as you saw there. Quickly, results, one patient took drugs five 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 after six months, and the same after five years. It's completely stable in five years time, this procedure. To the right, you see every single patient like a line. Here you can see in comparison with the wrapping I showed you before, Nissen fundoplication, and you see the complications is like night and day. 40% can't belch and vomit. 29% have severe swallowing difficulties. We had one patient who temporarily had 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. When you then take 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. 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. You see it's basically the same results in real world and in the FDA study. It's not only to have the best treatment available, it's also cost is a very important part today. Everybody should save money. 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, LINX, fundoplication, and even the drugs. That's, of course, open doors. 38 published articles. To a large extent, this is depending on Sarowar. I don't know whether we have Sarowar here. Over in the back there. His team has been able to support the surgeons. So we have 38 articles today about this product. Implantica is not only about RefluxStop. We have developed two platform technologies. I should be honest to tell you, it's 10 years of work behind these platform technology. An eHealth platform and a wireless energizing platform. With that platform, we can monitor people's health from distance from inside the body. We can also control and make super advanced, ultra smart implants. We can take the healthcare to the next level. The whole principle for Implantica is to see how much new technology has happening outside the body and move it into the body. Because the inside the body, it's way behind. So we have made IP together with this eHealth platform for many different solutions how we can improve healthcare. That's not for today, but you should know that we have the potential to become a new Medtronic. It's lots of things in the pipeline, but now, of course, it's focused on RefluxStop, and RefluxStop. By the way, 225,000 pages of patent we have filed for this eHealth platform. You can imagine 225,000 pages, it's enormous work. I think we have the patent attorney somewhere here also listening. Sorry. Now I was too fast here. So I just want to give you two examples, though you who listened before know what it is. But when I was a young surgeon, we do experimental surgery. People had got rid of their large intestine. We took the small intestine, made a little reservoir, and we connected to anus. The problem is that from the small intestine, it comes 2-3 L of fluid. So all the liquid is sucked up in the large intestine. Therefore, these people, first of all, the reservoir got full, but it didn't empty. It was overflowing. This poor splinter can't handle it. It's like they're having the worst diarrhea you can imagine. All this is solved. So now people can get rid of this plastic bag. 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 billion. I have hard to understand it myself, just for these plastic bags. Also, people who cannot urinate, they put in a catheter in their own bladder five times per day. We have a device, and they only need a remote control, and they are done. This is just a shareholder. I own 46.5% of the company. Handelsbanken is a large investor, has supported us over the years and believe in us, which we are very happy for, of course. There has been some insurance companies and quite good investor list. In terms of the finances, we spent in cash EUR 7.5 million in half a year, which indicates EUR 15 million, but we have lots of extra FDA costs. I would say EUR 14 million. We have EUR 14.2 million in cash, which means three-year runway. If we increase the cost for the FDA launch to 50%, we would have two-year runway. Then, of course, the idea is that we should start to get revenue. Is there anything more I should say here? The gross margin. We have 98% gross margin. In this book here for half year, you see 94%. When I had my gastric banding business, we had 24%-32% net profit over six 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 what you are waiting for, the FDA, the U.S. launch. Amit will continue to take the rest. The good thing with Implantica is that we have very mature clinical data. If you are a normal U.S. company, you come out, you have one year data, and then you should launch. No surgeon wants to do tens of thousands of procedures with something you have one year experience. They need to know that this works long term. We have five-year data. That is like night and day. You can take Inspire Medical, the snoring device. They came out, and they had one year of data, and it took three, four years to get going because people are only doing a little bit to see how it works. We start from much better situation. We have already been to all the big congresses, all the meetings in the United States for four, five years, and we have today more than 100 surgeons who want to start. We are already convinced all the key surgeons in the United States that this is the best. They are just jumping up and down and waiting to start with these procedures. 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 healthcare system. What we have been struggling with in Europe. We already have the codes, so both hospital and surgeons are actually paid. We also have the superior cost effectiveness, and we have produced 13,000 products. We have already taken the cost for 13,000 product that we will splash in the American market. The good thing with this device is that it has a market that is 10 x larger than the competition. The reason for that is that this half here is the one that is operated today. It is 30,000 procedures in the U.S., and this is the one who takes mainly the drugs and so on. On the right side here, you have those who have been damaged in the esophagus by the acid. The acid is really dangerous because the nerve ends and the muscles in your esophagus get damaged, and they cannot transport food. They are really weak, weak food transportation. You then take existing methods where you try to close, and then you come with your weak food transportation. Does it work? Unbearable swallowing difficulties. LINX, for example, they are not approved for these patients, and this is 40%-50% of all sufferers. That is double the number of patients, but this group is all the severe sufferers, all the long-term sufferers. That means in this group here, you have 10 x surgical need because they are the one who really need surgery. 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. Nine 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 do not respond to the drugs. It does not matter if you have PCAB or PPI, it does not work for them. That means 31 million people. You can see here today, it is like 30,000, so it is 0.1% of the market that is 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 EUR 2.5 billion in revenue and 300,000 surgeries. If you compare to obesity surgery before the injections came, it was about 300,000 surgeries. It is the same magnitude of treatment field, huge treatment fields. Today, it is maybe 200,000, but it is still, this market today is very compressed because it is so much side effects that no one wants to operate other ones that are absolutely necessary. Please, Amit, welcome. All right. Thank you, Peter, and thanks everyone, and thank you for joining us today. In the next 25, 30 minutes, what I would like to do is walk you through our strategy and how we are thinking about taking this product through the U.S. experience, the launch, the roadmap, 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. Bear with me. I want to start where Peter ended, because this is sometimes underestimated in terms of what it really means for the medtech field or in healthcare as such. Yes, Peter talked about how big the opportunity is, but what I want to highlight is there are two things about this opportunity. First, it's so huge just by the scope of it. If you look at different fields, there are few opportunities that can really spans to this scope. 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 GERD, no other product has been able to do. There are reasons for that, and we'll talk all about it today why. But this is to be recognized that not only it's huge, it's also untapped. It's pretty wide space. There hasn't been anything out there. If you look at other fields, 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. This really puts us even in a stronger position than any other PMA-approved technology, which is already a huge milestone. With that, I want to set some basic foundation why we are, again, so uniquely positioned. These are the driving forces that puts us in a very strong position in U.S. Number one, five to seven years of post-market experience. As Peter said, most technologies that comes with PMA approval have one, two 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 with five years, we also had it tested in 60+ hospitals in Europe. 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 number one 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 seven years of follow-up. This is very unique to our situation. It really puts us in a very strong position. Number two, over the last three to five 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 two years, three 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. 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 GIs have collectively participated in our journey through that. This is already, again, day zero, we start with that position which companies take two to three years. 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. 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. We will talk about that. Last but not the least, with our incredible gross margins, we have the plan to launch this with 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. Let's talk about what execution look like. On the front end, we are talking about establishing this technology within the first five centers of excellence. What that means, the first five off that will really allow us to scale this, meaning become the training grounds, become the centers that will unleash not only the training, but set the benchmark how this technology to be deployed in real-world setting. We want to start there, get these centers fully trained, and from there, we want to expand to next 20 accounts. 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+ accounts. 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? The very first thing there is, just two 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 on the Medicare population, so that will be subject to 6- 12 months of decision timeframe. Once we have that, the next thing we will have is start scaling with the allow more and more hospitals to scale on that front. In parallel, we have the bridge access for the hospitals we will be working with. What that means is we will have case-by-case approval mechanism with commercial payers, where new technologies typically go through and they don't have any quotes, anything. Even for those technologies early on, once 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 and it spreads. This is our plan, which we have already seen with many other technologies successfully done. That will allow us to, of course, scale reimbursement widespread in the country. So if I go to what that means, all of us in the next coming weeks and days, one of the biggest thing we are going to do is have the opportunity to launch it at the best place possible. 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 four 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 meetings. So we think this could have not been a 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 how are we rolling this out. Our first step will be to launch it in the Center of Excellence in Los Angeles with Professor Lipham at USC. He is probably arguably the most recognized surgeon in this field, who is also a pioneer in many other segments within this field. 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 are going to scale to the next 25, and then, as we said, we go further. How do we execute this? Let's talk about a team that is going to be behind this. 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 technologies, anti-reflux specialist. These are the people who hold more than 100, just between the current team we hired, 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 continue to speed up. We are going to continue to expand our team, but we already have people in the next few weeks to 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 in an implant category, it can take three to nine months before all the basic work has been done, and a hospital would allow a 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 IRB process for getting the approval process. Again, that's what I'm saying. If you're a brand-new technology, nobody knows about you, nobody has any clue how it's 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 five centers, as we talked about. We believe we can truly, again, gain speed here as well. From 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. Therefore, we put incredible effort in making sure each center we bring on board, 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. We already have a very nice blueprint of scaling this education process. We have trained more than 100 GIs and surgeons in European context. We have a team that already knows how to quickly go up and about. 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 transitional pass-through application for device. Once that's approved, it takes 6 -1 2 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 company. As more procedures are done, more insurance claims are processed, and they see the medical necessity to allow a technology like this over time. That's just showing you a little bit here. I think sometimes it's not easy to kind of see how big the opportunity is on the non-government side. You see that public government plans all put together is about 36% of the population. Private commercial is 55%. Yes, we're going to pursue multiple opportunities, one with the government, with the pass-through payment mechanism for Medicare. With the commercial payer, we have much more leeway. Just the top five payers in the commercial segment takes care of 57% of the market. The opportunity isn't trivial at all. In fact, it's very much in contrast to what you have seen and heard within the European setting, where things are more government-funded and unilateral. Here we're going to have significant access to commercial payers. We're going to work very closely with them. We're going to meet them. We're going to show them our data and get more and more claims going as we build up the volume. This can really go much faster than anything else we have seen. What does that mean? If I really bring that down to 24 months runway, we believe we are ready to 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 healthcare system and getting the volume built up. 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. That's the goal, and then getting to 100 and then several hundred is part of the journey. 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. This is unique. It's outside of U.S., we already have seen LINX being announced to be withdrawn, which is our biggest competitor right now. In the U.S., we hear from the field and from surgeons that it's been significantly reduced in the way it's been used 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. In fact, if anything, you're up against a 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. We even more clearly see an opportunity to tap into in the near term, and this should allow us to scale even faster. Maybe you can see things in a multi-year 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 no news to the surgical community. When they walk into those relationships and try to restart things, it's a matter of days versus matter of months. Those things really speed things through. As you go to the next phase, three to six months and 6 - 12, we are building that foundation step by step. If I summarize that, these are really the three 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. Repeatability, of course, within those accounts. We want these accounts to do their case number one, two, three, five, 10, 20, and see them grow from there significantly and rapidly so we can truly allow scalability in those, then go for the scaling, which can be built over hundreds of accounts. That's 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 just summarize my story with a very inspiring journey that a company 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 surgical training, having a systematic launch, starting very, very small, as you see in 2018, then growing this journey over time. Within six years, how much could you achieve if you have the right product that's de-risked in terms of experience and testing and the outcomes? How can you scale that over time very quickly? I think this is a journey that we aspire to and absolutely look forward to deliver great outcomes. With that, I'll say thank you, and over to you, Juanita. 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 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. 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 a European market, which I've launched a few products a few times in. But 89% listens to Dr. Google and then go to their physician for advice. Once they have 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 is anything better out there. The U.S. is very different because it is a direct-to-consumer market, meaning as a medical device, even though I am prescription only, I can advertise directly to the consumer. Anybody that has been to the U.S. and has sat and watched TV has seen all the pharmaceutical commercials. It tells you it works because those guys know how to sell, and so do we. As Amit and Peter have both spoken before and told you guys, surgeon awareness. We have been working on that for 3+ 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 are correcting it. It is an anatomical problem. The body has failed anatomically, can not be fixed by drugs. That is a band-aid. It will last for a period of time until it gets so bad that it does not work anymore. We are the solution to that. We are taking the natural function of the body and restoring it. We are not giving you something that is unnatural. We are not trying to wrap anything around anything. We are just putting it where it belongs and keeping it there so it can function normally again. That is a great message to an American consumer. Americans are all about natural, all about trying to be as healthy as they possibly can. There is a huge resistance against drugs at the moment, which is why pharmaceutical companies now are coming out with PCAB. It is not going to convince anybody. Everybody is starting to understand that this is a mechanical failure and can not be resolved with drugs. It is just prolonging the problem, which actually makes it more serious when you have to have a surgery later in life. Earlier is better. Second is our GI referrals. We have not only been working on our surgeons, but part of our referral community is the GIs. They refer directly to our surgeons, so we have been targeting them. The slide that Amit showed earlier of the panel that we have for American Foregut Society includes four of the top GIs in the U.S. These are the guys that are publishing on everything. There is already one publication submitted to a conference later this year based on European data done analytically by American GIs. Huge advantage there as well. Last part is patient empowerment. This is the part that we will focus on mostly today. I will touch on the other pieces, but how are we going to reach these guys? There is everything from direct-to-consumer campaigns can include everything essentially online, and we are going to touch on that now. 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 that is a great start right there. Moving on to this. The very first thing is there are a lot of channels we can use to get to patients, and we are going to use them all. Starting with PR, there are ads, there is social media, there is our website, there are print materials we can bring out, and there is word of mouth. What is the goal of it all? The very first piece is nobody can knock on our door and come sit down and have a cup of coffee with us and say, "Hey, Implantica, nice to meet you." We want to create that environment online, and we've already started. 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. 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. Once you introduced yourself, we're going to put a ton of information out there, PR, social media. We're going to be everywhere. Where do people go to ask their questions? 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?" When you go onto our new website and you click in, you're going to see a flag pop up that'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 center near you, please put your name and address on 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." 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. What does the data say? We have that on there as well, but now we had to make it so it's user-friendly, meaning that the general public can understand the data. It's one thing 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. We have created our website in such a way that it speaks and tells that story. Then read all about it. When we're in the news and we're creating patient stories, patients' actual experiences, you'll hear from Sally today, Sally-Ann, those stories will actually live online, so people can actually hear from other patients and get their experience directly from another patient. Our new website is coming soon. This is kind of a sneak preview and just kind of shows you all of the features that I spoke about very quickly. Public relations. We know how to do this. We've done it in Europe, even though we can't do direct-to-consumer marketing in Europe. Implantica has been in Saga, Sky News, Daily Express, Reader's Digest, BBC Radio. We've been everywhere. We used our surgeons in Europe to actually present, talk about, and do these things. We know how to do this. We are 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 is just a matter of execution. That first surgery happens, you should see a lot about us in the news in the U.S. We also created patient-focused communication tools. You will say, "Print material, really? Do we still need that today?" Yes, we do. We need it for that word of mouth we were talking about. In the U.S., the person with the biggest problem wins. How do we help our patients win? I go to my doctor, I have this horrible problem. He recommends this amazing product. He hands me this beautiful brochure. I take that brochure, I leave that office. I am going to tell everybody I know, and I am going to show them exactly what I am going to get. That is word of mouth. That is grassroot marketing, and we are going to drive it that way. We have created everything from tri-folds that you can look through in doctor's offices, all the way through to beautiful patient brochure that literally tells them everything that 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 have also created a place where they can click a button and say, "Download information to share with my physician or my referring physician." We are helping the patient take information to the actual surgeon and asking him for the product. KOL training and education tools. Marketing has also been involved in that. Amit has talked about how we want to drive training and make sure that it is consistently and well done so we get the results and the outcomes that we have been seeing. These are the tools that we are helping create to make that happen. For the U.S., we have also gone to transforming our branding. This is our current packaging going to hospitals in Europe. That is our new packaging that will be going to hospitals in the U.S. It is a repositioning of our branding, specifically high-quality product, expensive product, and expensive-looking packaging. All of these things together essentially will help drive. It is very difficult in a short period of time to give you a full focus, but I hope that I highlighted the top things that we are thinking about and working on. We are very excited. It is 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 are the only one who can actually claim that, and you will see other people are trying. It is not working. We are super excited. It is a fantastic product to market. I am super excited to be here, and thank you very much for the opportunity to speak to you today. Thank you very much, 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. Peter, very intimate here. I thought you all could just stand over there. Yeah, we could. We will have this sort of dynamic. 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? You basically see from the results, so to say, that we are not a small, little improvement. We are like night and day in terms of outcome, and that's because we understand how it really works. 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 has understood how you really should do this. It's all like Juanita and I said, both, I think, it's all about restoring the anatomic position. You can say the whole problem is because the sphincter is gliding up to the diaphragm and get this pressure variation from the breathing affecting it. We solve that, and then people treat themself. 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. It's always hard. Yes, please do. I think two-folds, like you said, what is going to be the journey like? I think, as I said, there are so many milestones ahead of us, and compared to a technology that is brand new, 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 five 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 do not want to put a certain timeline to it, but we are already ahead in terms of reaching out. We are already working on the timelines. We already have a training program finalized for the first five, so we are just marching through. I think in the coming weeks and months, I am sure, through Peter's investor calls, we will talk more about the timelines. So that is on the execution speed. But on the reimbursement side, as I said, this is not to be underestimated. We are working on two parallel paths. It is 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 three, which is what happens with new innovations. So for the device part, we are working on two levels. One is CMS pass-through payment. That 6-12 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. In parallel, we are from day one implementing bridge access program for the hospitals to get claims submitted to insurance companies. 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. More awareness means more approvals, and that more approvals with the data we will 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 with the U.K. It took us some time to get them on board, but we were able to get this unique decision from them. I think it is four weeks into launch, so I would not 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, it is phenomenal. So if that gives you some context. Juanita, if I turn to you. Yes. As you mentioned, the big difference between the European market and the U.S. market is that you can market direct-to-consumer in the U.S. market. I am curious because we are living in a digital age. Yes That is becoming all the more digital. What are the most important platforms that you will market there? Social media, is it TikTok? Please go on. I think there are platforms that are ideal for it, and we will probably focus first on the platforms like LinkedIn or even Instagram, where we can actually market to people in a specific geographic area. Geographic targeting. Although we will nationally announce to make the big splash and get everybody very aware that we are here, it is kind of unfair to patients to offer something that they cannot get to. Your regional marketing becomes super important, meaning regional television stations, regional newspapers, and then of course, social media. You will see us very active in social media. We have a very strong social media presence and platform today, which we have to split. We will have a U.S.-specific platform because we can do direct-to-consumer marketing, which we are very excited about. The other thing that is very important and should not be left out is 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 is a search on surgery, whether that is 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. When you talk about social media, that is probably where the misinformation is most likely to happen, and that is where we really want to focus on that part. But yes, it is all the social media channels, Instagram, LinkedIn first. We will move further on to Facebook and the others, but their numbers have kind of come down. We are focusing on the ones that have the highest visitors from the U.S. basically at this point. Then we drive everybody back to our website because that is where the source of knowledge is basically going to sit. Super exciting stuff. Thank you very much, Juanita. Peter, perhaps the last question for this Q&A. If you are standing here a year from now, what sort of milestones would need to happen for you to call this a success? Oh, that was a good question. It is a great question. Of course, my goal is to get all these hospitals now trained and up and running. That is, for me, the most key. We sort of build the platform for the expansion independent. If we get a decision that they pay after six months or 12 months, or if it is even longer, we just build our business. We grow, and when we finally get paid, it will be a fantastic situation. And with the private insurance companies, it will come from day one to maybe up to two years. The most hard, difficult ones to convince will take two years maybe, and then there will be a line of insurance companies who start to pay. So one year from now, we probably will have a very good situation with many insurance companies who pay us, and we will have started our 25 centers, hopefully. A shorter answer than I perhaps expected. So I even have time for another one. Amit, as Peter said in the presentation, there's 13,000, if I'm not mistaken- Yeah units ready to sort of 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. We are going in with up to 98% of gross margins. That allows us to scale really fast. 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. Our margins are kind of beating those standards. That certainly allows us to scale fast. Another good thing we did not talk about today is we are moving our manufacturing to the U.S. 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. That puts us in a pretty good place. We have been conscious about- Maybe I can add, there is actually a special tool built for an automatic machine. You put silicone in one end, and out comes butcher. It is just how many products you want to do. It is not a problem. Well, thank you very much, Peter, Amit, and Juanita. We will now be moving on, and we will listen to Dr. John Lipham here about clinical validation and RefluxStop in the U.S. I will simply- Just to repeat. Oh This is the most respected surgeon in the whole of U.S. And he is the one who will do the first surgery. Former president of American Foregut Society. What an introduction. Let's hear 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 U.S., as an epidemic in esophageal cancer. Anything we can do to control reflux will help considerably. The 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. Next slide, please. There we go. 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%, are not 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 are not happy with the treatment they are currently receiving. For decades, there has been this unmet need for some procedure to help with their reflux. We have 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 is also partly due to an aging population. There is also, with social media, greater awareness and diagnosis of reflux and the problems that it causes. The end result is there are more patients seeking permanent relief. They really just are not as interested as they used to be in a temporary acid suppression. There is 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 are seeing patients coming in just to get off of these medications. The other thing we have learned over this last, I would say, decade or maybe 15 years, is that reflux is a mechanical problem. I think there is this perception out there that reflux is due to simply having too much acid in the stomach. That is 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. 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. Next slide, please. 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. The American Foregut Society, and 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. What we have learned over this last, I would say, 5 - 10 years, is not only is GERD a mechanical problem, but the normal anatomic barrier is actually composed of three things, not just the lower esophageal sphincter. The hiatal hernia, or the integrity of the crural diaphragm, is a big part of this disease. Yes, the lower esophageal sphincter is important, but in addition, there is also this thing called the esophageal or gastroesophageal flap valve, and angle of His, which are incredibly important in preventing reflux. We have gained a lot of knowledge on what the mechanical problem is, which helps us ultimately, obviously, determine what the mechanical fix is. Next slide. 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. All our treatments focused really on different ways to tighten up that lower esophageal sphincter. Fast-forward to where we are today, we are 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 crural diaphragm, as well as maintaining that angle of His, which then leads to the gastroesophageal flap valve. Surgery is ideally positioned to fix all of those components. Next slide. Here is kind of the timeline 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. Rudolph Nissen was sort of first to the market here with his procedure, which was called a Nissen fundoplication. Again, all these procedures basically focused on tightening the lower esophageal sphincter, and that is what Nissen fundoplication did. If you are not familiar with that procedure, it involved wrapping the top of the stomach 360 degrees around the end of the esophagus where that sphincter was to tighten up the lower esophageal sphincter. Over time, surgeons modified that procedure in different variations, either from the Dor fundoplication to a Toupet fundoplication, which were still wrapping the stomach around the end of the esophagus to tighten up that lower esophageal sphincter. We tried for probably at least two decades, different endoscopic procedures where we go in and either inject stuff into the lower esophageal sphincter or again, try 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. All of these things helped with reflux. They all seemed to stop reflux. But the trade-off here was, as you can imagine, if you are tightening up the end of the esophagus, that is going to lead to some other issues. 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 LINX. As a result of that, patients could not belch or vomit normally. They would get gas and bloating. The biggest thing was all of these procedures had a very high recurrence rate. Studies show that Nissen fundoplication within 5-10 years fails in upwards of 30%-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. It restores that angle of His and flap valve. So it really accomplishes all three things in regards to reconstructing or fixing that normal GERD barrier. 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. At least preliminary data shows that it may indeed have a lower recurrence rate of reflux at that 5 - 10 year mark post-surgery. Next slide. Again, just to kind of summarize all that, RefluxStop does have the unique position to actually fix all three 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 U.S. that we've already got a lot of long-term data, including five-year prospective trial that was done in Europe, in addition to real-world experience done 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. The reason it got approval because of the data that it was so strong coming out of Europe. 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. 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. Next slide. I think I probably outlived my 10 minutes or whatever I was allotted. I think we'll stop here and see what questions you may have. Question at the end. I think it would be good for him to- Yeah they can ask questions directly to him. That it's good. Very well. We can open up the floor for this Q&A session, specifically, for Dr. Lipham. We can show him personally. Yeah, of course. Because There he is. a really good source for information, and who knows the U.S. market in and out. Yeah. 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. 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. Yeah, you've 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. Mm-hmm. What have you seen from U.S. peers so far? 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 annual American Foregut Society every year for the last probably two or three 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. When you're addressed, you may wait for a microphone. Can you describe the differences between, you have now PCABs from Phathom, I think the company is called, that is sold a lot in the U.S. Can you describe what you think the differences are, even that you don't have a long time for Phathom? 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 PEPCID 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. 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. A lot of these patients, that 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. I don't think PCABs are the answer to this problem at all, because again, it's a mechanical problem. I nvestor and a retired surgeon. This is a huge market, so 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. 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 cured and disappear. It stops the money rolling in. Yeah, I guess you're right, 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. 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, 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, one more. Over there. Yes, Dr. Lipham, 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? We also heard that you might be the first surgeon to operate in the U.S. Do you have any plans when that will happen? Well, good question. The one unique advantage RefluxStop has over every other procedure that we currently have today to treat reflux is the lack of dysphagia. What that does is it opens up this door for this huge percentage of patients that have poor esophageal motility. There is 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 LINX, we are almost certainly going to create horrible dysphagia, and these patients will not be able to eat. But because RefluxStop takes a different angle at treating this disease, we are not seeing the dysphagia issues. It has been shown in Europe that this is a great procedure for those patients with a weak esophagus. Already we are 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. If you were to ask me what percentage of these patients that I am currently seeing could be a candidate for RefluxStop, as of right now, I think almost all of them. I really do not 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 have 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. Now that we have gotten FDA approval, that waiting list has tripled. We just got to get product, obviously, here to USC in Los Angeles. We have got to get through the hospital finances and the IRB, but I would expect we could easily do our first implant sometime in October. Mm-hmm. Do we have more questions from the audience? Yes, over there. Hi, thank you. Filip Wiberg from Pareto. I just had one question around other surgeons in the U.S. as well. A lot of excitement, obviously, but I was wondering if we take the opposite side there, what is the main pushback that you are getting on this, or the main questions that are raised that you think could be stopping a broader adoption? Well, I think that is a great question. I think the only hesitation I have heard from surgeons, at least initially, this is dating back a couple of years now, but initially, they were unclear at the mechanism of the actual implant, the RefluxStop 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 have shown is that the RefluxStop 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 flap valve how it should be, and then more importantly, because of the ball up against the diaphragm there, it is preventing recurrence of the hiatal hernia, which is our number one reason why any of these anti-reflux procedures fail. It is not because of failure of the Nissen or the LINX or whatever, it is recurrence of the hiatal hernia in 90% of the cases. Once that has been explained to them, I think any hesitation goes away. Mm-hmm. Are there any more questions from the audience? Yes. From a procedural point of view, once you are educated, how easy or complicated is this procedure? How long 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 are experienced at fixing the hiatal hernia, restoring the integrity of the crura, and sewing, which all of them are going to be, this procedure is no more difficult, per se, for experienced, what I will call Foregut or GERD surgeons. As far as the time that it takes to do it, I have only done it in a 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 has 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. 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 intercede with a question here. The learning curve might be simple, but how hard is it- To do the procedure to learn the procedure? Well, I don't think it's hard to learn this procedure at all because, again, 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, Foregut surgeons, they already have these abilities. So it's not hard, no. Mm. To the audience then, is there any more questions? No, it does not seem that way. I will finish off with this one then. How is RefluxStop different for patients who can't tolerate other devices, like those with weak swallowing motility? 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 LINX is it's not metal, it's not magnets. It has no restrictions on MRI, which is a big problem for LINX. 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 LINX itself, when LINX erodes, 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 foul. So I think there's a lot of unique advantages beyond the fact that it's addressing all three components of the barrier without creating a lot of side effects. Mm. I just noticed we have another question from the audience over there. Thanks. Just to follow up on one of the points from before. So you said that RefluxStop could be applicable to all your current patients, but how would you then decide who gets it? 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. 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, paraesophageal 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 dysmotility or weak esophagus group. Again, I really don't see any exclusion criteria. Now, ultimately, we need to verify that here in the U.S. 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 Dr. Google search or ChatGPT, and they know what they want. In my mind, if I don't see an exclusion criteria, then they're a candidate for whatever they want. 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 is one. Yes, over there. Yeah, thanks for t aking the question here. Looking a bit to the future, you are one of the experts in the field and have experience for years and years. Seeing what we hear all the time about the excellent outcomes for the patients 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. I think it definitely has that ability or possibility to transform our GERD treatment. I am excited to get it in the U.S. here. We actually have time for one more question from the audience, if there is any. It does not seem that way. Thank you very much, Dr. Lipham. We will now be moving on. Soon, actually from Peter, a question. No? No, no. No? You said goodbye, okay. No, I just wanted to say thank you. I was saying, you're waving a bit. My bad. All right. Thank you, everybody. Thank you. Have a good day. Thank you very much, Dr. Lipham. We will now be hearing more from the company, and it's Simon Freedman who will give us a market update on Europe. Yeah, 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. That's also sadly to say for Dr. Ahmed, who, in Imperial College London in U.K. They just couldn't fly. That means that Dr. Ahmed will join online later. I will take the speech about Europe that was intended for- Of course. Here you go. Thank you. I have already told you that we have 60 centers. You should know that in Europe, everything is done in a study format today. We are starting to get more and more reimbursement. That is to say, more and more hospitals actually pay for the product. It is not a real market, this, so to say. In reality, if you go to Germany, for example, and say, "No one pays for the product." Okay? You cannot give away the product. That does not work. You then do a study. 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. That means maybe one out of 20 centers or so are willing to do this, because it is just so much burden with the big study to collect data, to do all this work. That is the situation we have now. Those centers, the 60, they are the enthusiasts, those who really want to give the patients their best treatment. These centers we have today, the top of the line, where the surgeon is willing to sacrifice a big effort for a study. The good thing for us is that we have been able to collect all this data, and that is why we have this fantastic situation in the United States, where we have tons of data. We have 38 published articles. It comes also with a huge advantage for us. We are starting then to get more and more real sales in Europe. I just wanted to give a little update. 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. Then you need to know that hospitals get paid in two systems. One is that you get a 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 gives you a certain amount. In Germany, you are paid exactly what you do, nothing else. Here they switched to budget system because of COVID. They were bankrupt. So it is a budget system. It means that it takes one, two 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." The next year you do 80. That is how it works in a budget system. You need to negotiate step by step. So it is not like you day one, "Oh, we are approved in the public hospitals. We sell like crazy." They have a budget to think about. He is showing here how he has been managed to create three private hospitals. He has four active NHS hospitals, and he has another four who are starting to come through and should be trained, so to say. So it is starting to take off even in this budget system, and then it will increase step by step. 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 is lots of published. Most patients in U.K. actually know about RefluxStop today. 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 Germany, sorry, I am 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 InEK reporting hospital, because InEK is the healthcare body that decides the amount of money you get, and that is totally based on the real cost. So this InEK reporting hospital is a small amount of hospital. 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. This is a market of 12,000 procedures maybe, so it is a huge market. It is enough for going break even just to have Germany, for example. It is a big market. U.K., I already talked about. In Italy, it is completely budget system. DRG is old and outdated. Here, it is not enough to have the best treatment. When we had the best treatment, it was resistance. "Oh, this costs too much money." Suddenly we published an article about Italian healthcare system, how they save money by operating with RefluxStop. They actually save money. What happened then? Tender win. Suddenly we have now EUR 2.3 million in paid surgeries in Italy. So also here, it is starting to take off. I took an example, Spain, because it is quite an interesting country. It is the opposite of Sweden, you can say. In Sweden, it is only the administrative people who decides. Time is gone when the surgeon could decide what treatment he should give to the patient. It is just the admin who says, "Oh, this device, this is too expensive. We can not 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 is too expensive. So Sweden, they are taking the elevator down to the basement in quality of healthcare because it is not any longer the treatment who is deciding. It is only the cost. In Spain, it is complete opposite. If the surgeon say, "I would like to do RefluxStop," he can do RefluxStop. But the admin people say, "You should know we have very limited money now, this with the budget, so you can only do one per month." "Okay," the surgeon says, "I do one per month." Next year he come back and say, "I want to do two per month next year, and the next year I want to do four per month." That is how it works in the budget system, and that show you here we have 20 centers in Spain. That is incredible. It is not very rich country, but still 20. That shows you when the surgeons and patients decide, then it will be lots of people doing. It is 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 very good market in one, two years, I would say. We, of course, have other markets. We have not sold in Middle East because we wanted to ensure highest quality for FDA. We Latin America, Brazil, Japan, and so on. It is all market that will come sooner or later, but for now, we are just focusing on U.S. It is U.S. Because that is so important, so powerful, and that opens doors. When you come and get approved in U.S., Canada says, "Okay." Come to us. We are okay with the U.S. approval. It has opened so many markets because this is a quality stamp, as I said before. 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. 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. I just want to show this to see if I succeed here. Yes. Here comes the little device in here now, and it is placed on the top part of the stomach, a little pouch. You see then he starts here. We hold it with our little instrument, and then he suture now. He has placed the top suture already in advance here, a loose one. Now he suture a tobacco pouch suture, you can call it. So you enclose this completely in stomach wall. It just disappears. No side effects. It is just gone. This is sort of the key to this. It is many things with this procedure and device, actually is quite genius. Then you just take it slowly here, step by step, and you close. I wanted just to give a little bit feeling what it is all about. This is Dr. Zehetner from Bern in Switzerland who done this procedure. This doesn't hurt. It is not like the skin. It is not like you are suturing in the skin. But you see here now, you have a big package here who act towards the diaphragm. This is the diaphragm. This is like a mechanical stop towards the diaphragm. So it is absolutely really nice. Yes. That is me. That's you. Okay. Good afternoon, everybody. I'm Dr. Daniel Sánchez. 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 an 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 six European centers. This is important, with a follow-up of up to. Sorry. Up to There's a big button. Big button? Okay. Next one. Big button. This study was published in "Nature Scientific Reports." It's a very high impact journal in medicine. This is the list of surgeons 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 a large hiatal hernias, more than 3 cm. Okay. The mean hiatal hernia size was more than 5 cm. If we analyze the results related to procedure and device related reoperations, 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 compared with the standard of care fundoplication, or Nissen fundoplication, or partial fundoplication, as Dr. Lipham said before, the hiatal hernia recurrence is more than 15%. It is more than tenfold higher than with the RefluxStop. If we compare, this slide has been shown before, will be quickly. If we compare the outcomes with this real-world series, compare with the five-year safety in the FDA PMA, the results are very comparable. So almost equal. This shows that in real patients, in daily surgery, the results are reproducible. And it has been commented before that if you have a low number of reoperation, this leads to cost effectiveness. It has been demonstrated, these studies are in the right, that the RefluxStop is most cost effective treatment for acid reflux, more than standard of care, food application, more than LINX, and more than long life PPI medical treatment, taking account even of the collateral effects of these drugs. In conclusion, the experience of this showed in this work shows that RefluxStop is safe, even in difficult to treat patient, for example, patient with large hiatal hernias. That the rates of reoperation is low, is less than 2%. The real world outcomes are equals the FDA submitted studies, and that's important. It has been commented before that RefluxStop is more cost effective than standard of care in U.S. and Europe. And that's all. Thank you. Thank you very much, Dr. Sánchez. 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. My apologies for not being with you this afternoon. I am 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. 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 a quarter even up to three quarters of these patients, develop a condition called ineffective esophageal motility. What this basically means is the chronic acid exposure in the esophagus leads to a weakening of the esophageal muscles. The muscle of the esophagus becomes less good and less strong at contracting. The esophagus is weak, and that actually creates more problems because now the acid stays in the esophagus. It cannot go back down into the stomach because the esophagus is not contracting strongly enough. Secondly, these patients also develop on top of the reflux symptoms with heartburn, but they also develop symptoms associated with difficulty in swallowing. A lot of patients who come to my clinic will not just mention that they are 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 is called NICE, which approves all procedures and treatments that we are allowed to use in the National Health Service, gave RefluxStop approval for it to be used as a procedure to treat acid reflux in patients with ineffective esophageal motility. That is 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. That is because standard antireflux surgeries, including LINX, lead to a constriction or a narrowing at the bottom of the esophagus, whether it is with a wrap or whether it is 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. 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. There has been a number of publications showing the benefits of RefluxStop in the population with ineffective esophageal motility. You can see from this slide, there are three papers. One of them is currently under review, but with excellent results in these patients who have IEM. Next slide, please. What's really interesting is this slide. As I mentioned to you, people who have IEM will have dysphagia, which basically means difficulty in swallowing. 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. That's really a very good result indeed. Thanks. Next slide. One other tool we have in medicine is a scoring system. 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. We can again see from this publication that there is 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. 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. 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. This is definitely a very promising option for sufferers of GERD with IEM. Next slide, please. That's it. Very much, Ahmed Ahmed. As 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. Daniel Sánchez, but also Mrs. Sally-Ann Werner, who is a patient. Welcome. Could you show me? Yeah. Thank you. Could you show him again? Could we show Ahmed Ahmed as well? Yes. Because he's patient, I think. Yes, you too. Okay. I present myself one more time. Before I presented myself as a surgeon, now I present myself as a patient. I have been suffering from reflux for many years, and three months ago, I decided to operate, not to myself, obviously. To be operated, but I think the biggest expert we have in actually, that is Georg Tödtke, and well, I'm here, and I am ready to ask your questions. Just to clarify, you became a patient after you became a surgeon for RefluxStop. First became a surgeon for many years, and three months ago, I became a patient. Interesting. We have two patients here and also two surgeons. Yeah, patients. Okay. But only three people. I thought we could begin with you, Sally-Ann, because you are the new face here after all. Can you tell us a little bit about your condition with acid reflux? What was life before RefluxStop? I've had it for about 21 years, and I was up most nights, two or three nights a week anyway, with acid reflux. I used to have to have pillows behind my back, maybe five, so I'm sitting up so I can sleep. Then if I slip down, because you sleep, I would end up waking up with reflux, and it wouldn't just be a little bit. I'd be in the bathroom reaching, and my eyes would be streaming. I'd wake my husband up, and he'd come and ask me if I was okay. Not okay. It was horrible. Really horrible. We'd go on holiday. I couldn't eat late at night. I'd have to eat early because if we ate late at night, I knew I'd be up, and I'd be suffering. We'd go for a walk so I could digest all my food, and I'd still end up sitting up some nights with acid reflux. It was really horrible. So that was the before. After? After, great. Perfect. Perfect. I cannot recommend it enough, honestly. I can now go out, I can have a curry at 10:00 P.M. I can have a G&T, I am not getting acid reflux at all. I stopped taking the medication about two weeks before the operation, which was advised, I have not took any medication since. Nothing. I do not get no acid reflux, that has just improved my life so much. It has. You said you would recommend RefluxStop. I would recommend it 100%. Well, what- I'd give it to everybody who needed it. I would because it's absolutely brilliant. It really is. It has improved my life, and it's improved my husband's life because he doesn't have to keep getting up with me on a night now. Ahmed Ahmed, if I understood Peter here correctly, you were the surgeon who worked on Sally-Ann, and hearing this, what's your reaction? Well, it's what every surgeon wants to hear, right? Because we're here to help our patients, and you guys provide us with the tools, and it's a real pleasure and honor for me to be able to do my job properly, especially when existing treatments. I can tell you, 20 years of doing this, and I've been doing fundoplications, LINX, I've never seen patients as happy as I see them after RefluxStop. I'm not just saying that because I'm a proponent, but it's actually quite a difference when you get patients who are not miserable after anti-reflux surgery because normally they are. Could you elaborate a little bit on those differences after the fact between RefluxStop and older surgical options? Yes, absolutely. One of the most common side effects, again, as John mentioned during his talk, with anti-reflux surgery, whether it's fundoplication or with LINX, it's always been that patients really get problems with swallowing afterwards. They get, especially with solids, it could take weeks, months for that to get better. They get bloating. They feel very gassy. It's really quite a miserable few months, and for some of them, it never gets better. But one of the key things that I noticed when I started doing RefluxStop a few years ago is that we just don't see it. It's amazing. How do you decide which patients are right for RefluxStop and which aren't? To be honest with you, of course, in the U.K., patients who have ineffective esophageal motility, they are obviously perfect for RefluxStop because we cannot use anything else for them. Having said that, anybody who has reflux who wants to have surgery, I would suggest RefluxStop for them. It will work for anybody. Where surgery and the patient meet is in you, Sánchez, because you are a little bit of both. Yes. If we start with the Sally-Ann story here, how do you identify with that? Yes, completely. Yes. In my case, to choose this operation was due to collateral effects of medication. Nevertheless, after more than, I think, me and my team, we have operated about 60 patients in Spain, and after three years of surgery, I was looking at my patients at the consultation room. One-month follow-up, they enter the consult with a smile, and as Dr. Ahmed commented before, the milestone, the most important thing I can say is that they do not have any dysphagia. No dysphagia. I have been for more than 25 years, performing Nissen, Toupet, and kinds of fundoplication, and sometimes we know that dysphagia is a collateral effect of these kind of surgeries. I have not seen serious dysphagia in my patient, nor me. I'm not dysphagia. Can I assume it a little bit right then, that you were sold on RefluxStop sort of by your own patients? Yeah. Yeah. Interesting. We've gone through what made you do it, but could you tell us more about, being a patient, how has that changed the way you talk to your own patients now about the surgery? Yeah. It helps to be more empathic with the patients, and communication is easier. It is a curious situation for me, a new situation, to explain to a patient what the patient is explaining to me what happens with him, with her, and it is the same I felt the first weeks. Really, I have a very smooth postoperative. I think at 10, 15 days, I was making a normal life. One thing to remark is that it is about quality of life. We have spoken about that before. GERD impairs quality of life in a very, very high measure. Yeah. You have to have dinner early. You have regurgitation when you are in supine. You cannot take a glass of wine. When you feel good, when you have no reflux, your quality of life, and that is quality of life, to drink wine, to have a good dinner, changes. Mm. Is that exactly what you would say to U.S. surgeons who are on the fence about this procedure, or would you word it differently? Yeah. I would encourage them to adopt this technique because, in my experience, and not only my experience, but the large data we have seen, showed here, they must say that this is a safe and this efficient procedure. I would like to say, now as a surgeon, one thing, about what captured me to be a fan of RefluxStop as a surgeon, and later as a patient, and this is the way of training. I think it is the first time in my life as a surgeon that a technique is absolutely, sorry, it is very, very- Structured structured. Yeah. I think that one of the points of the exit of this surgery is the training program, is that all surgeons make the procedure the same way. That's very important. Mm. Ahmed, as a fellow surgeon, do you agree to this? Yes, absolutely. I have to compliment the team at Implantica because they take a lot of effort to ensure that the surgeons are properly trained, and all of us do it the same way. As a surgeon, to get that degree of training, I've never seen it in my life before for any other procedure, so many thanks to Implantica. Equally, as we become mentors, then equally, as mentors, we also get trained to train other people properly. So it's really very intensive, but very good because everything is monitored from capturing our videos. They get analyzed, criticized, and then you get feedback, so it's really, really excellent. Mm. Sally-Ann, what would you tell U.S. patients who are on the fence about this procedure? Just go for it. It's a little operation. Well, to me, it was a little operation, but it's improved my life no end, and I would tell them to go for it 100%. Mm-hmm. Well, thank you very much, Sally-Ann. I think, Dr. Sánchez, you will remain here on stage. Thank you. as we also invite up the company for the last Q&A panel here, where we will also be opening up the floor here for questions. Sure. I think you can stay. Yeah? Yes. You are the key person here. I already asked this, of course, to Dr. Sánchez, but I thought I could ask the management here as well, the same question. What would you tell a surgeon watching today who's still on the fence? Peter, go for it. I would say it is like a revolution of this treatment field. It has going on for a very long time with lots of side effects and complications, and people are not happy. You switch one problem to another problem, but that is not what you want. You want to get rid of your first problem. I would say because we have made all these studies in Europe, we have all this data, we have enough clinical evidence to convince everybody, and that is the key. You heard here, Dr. Lipham, for example, it is all about, and you decided to do this on your. You get to operate yourself. That is all about that we have these fantastic results. We have this evidence. It is like building a house. You need to start with a fundament, and you need to start with. Then you can start to build a house. Then you have the real. We have built a really, really strong fundament. Would you like to jump in there? I'd like to add maybe a different perspective because that's exactly, I think, the foundation for surgeons to see this. Maybe a personal experience. When I joined five years ago, roughly, one of my first question to GI surgeon was why we see in other areas like bariatric or cardiovascular and whatnot, urology, why there is 3%, 4% of surgical penetration. Typically, if you see, that's the range, which is hundreds of thousands of procedure in those field. Here we see relatively such a big market, but it should be the biggest market of all, given how big it is. The consistent response I got was that we need a solution that truly can deliver the excellent outcomes patient expect. I think to me, that really stuck with me and, over the years, as I saw our outcomes being truly outperforming anything else I have seen, I think that became real. That became real to the surgical community, that became real to our GIs. I think one of the great questions today was, why GIs wouldn't refer. The reality is, if they refer 1%, we are talking about 790,000 patients in the U.S. alone. I think we don't need 99%. They can keep 99%, but if they can start thinking of this technology that can help 1%, you're talking about probably the biggest market. This happened in bariatric process as well, where it was a very small market and then sleeve took over when it became effective. Today it's majority of the procedure. It can happen, and we have seen in other fields. Hopefully, that's what they're going to see as surgeons more and more adopt this. Most importantly, the outcomes. We open up the floor for questions from the audience. I want to ask if it is applicable for the patient that has been operated with the different kind of methods that probably did not work as well as you hoped. The treatment was not working as good as it should have. Can answer yes on that. There is a study from one German and Swiss center combined, where they have made 30 cases, and they have reoperated different other methods. You have the LINX magnetic band, you take it out, and you do a RefluxStop, or you have a fundoplication, you take the wrap away, and you redo it the proper way. And it works perfectly. Good results, no problem. Of course, every time you do a procedure the second time, it is a little bit increased complication rate. That is just part of life. But overall, it works really, really nice to do reoperations. Sorry. Can I? I have experience with two cases of reverse from Nissen fundoplication to RefluxStop. As Dr. Forsell says, it is something more difficult because you have to dismount. You have to take the anatomy, the stomach to normal anatomy. But if you achieve this, it is like a primary RefluxStop operation. Up to now, more than one year, my patients are doing very well. No reflux and no dysphagia. Would anyone else like to add something to that? I don't know. Ahmed, maybe. Have you operated any redos? Me? Yes. I've done two LINX to RefluxStop and exactly. You have to first clean up all the scarring left behind by the LINX. But once you get it to normal anatomy, it's straightforward to convert it to a RefluxStop. Do we have more questions from the audience? Yes. Thank you. We heard that you are going to start with these five top centers in the U.S., and we heard from Dr. Lipham there, that center is doing about 1,000 procedures each year. I was just wondering about the total volumes at these five centers, and then when you get to these additional ones, up to 25, how big of the total market is that of these 30,000 procedures that is done annually currently? I would say when we now start to go from collecting clinical evidence to execution to really build a commercial business, I do not think investors will be unhappy with us. You need to know, it is two weeks and we got this approval, and we will now go out and test these 25 centers. It is a bit early to answer detailed questions about forecasts. We will come step by step with this information, but we also need to build a bit more experience. Yeah, if I just add to that, I think, the bottom line is we are starting with the biggest centers in the reflux space. All 25, not just the first five, but the 25 we are targeting, these are the biggest volume centers. I think one thing that may have come across well, but I will emphasize what John was saying, that for the IEM-type patients, there was no option. Or primarily, there was not really an ideal option. So those patients were not even coming into the hospital. We believe a combination of, like Peter said, once these centers are trained, not only they are going to be taking a big volume of what they are doing today, but you also have the opportunity for IEM patient where we think, strategically speaking, with the medical necessity towards insurance and all, that is a population where you have really no legit option, no optimal outcome-driven procedure. There we might even get a quicker access to open these accounts to start picking up. But training first, as you heard, I think the foundation of everything we are doing and saying is that those excellent outcomes. We want to make sure those are trained well, but I think it can really grow from the five to 25 in that timeframe and we take on the volumes. But could you just give a guesstimate Oh, hold on. A microphone coming. Sorry. I think the question is just very interesting. Could you just give a guesstimate, of these 25 centers, how large share of the current operations in the U.S. are performed there? Is it 5%, 10%, 50%? What we are trying to say is that the actual market for our product is 10 x larger. I understand. It is not so valuable to know if they do 500 in average or 700 in average, because the market is much, much larger for us. I think we need to build the experience from the five centers to try to give you a bit more detailed forecast how we could look, the expansion, going forward. But it is clear, you can calculate if you have a price of EUR 8,000 and you have 30,000 procedures, it is still several billions of revenue in Swedish. It is a huge market even in the compressed state it is today. Even without the IEM, even with all these complications, it is still a huge business. Do we have more questions from the audience? Yes. Thank you for the presentation and for the different objectives that we got today. My question is concerning, is this the only path of launching that is on the table? Is there other business opportunities like licensing to different markets like you presented before in Japan, Canada, the Middle East, or is it something that the team is open for when it comes to partnership or licensing? Absolutely. Peter, you said it already. Maybe I can emphasize and you add to that. Absolutely. We are already flooded with inquiries from worldwide markets saying we want to get either some kind of dealership or should they be our distributor, should they be helping us out in commercialization. We are already getting so many requests. Now, if you look at some of the other breakthrough technologies that have changed the whole field in those areas, they are not that many products that were as revolutionary in the impact that this can have. We have to start somewhere. We have to create a benchmark. We have to establish this procedure. I think once that happens in the U.S., all the other markets will become much more accessible and can replicate themselves. But yes, if you look at Middle East, if you look at Latin America, Japan, Canada, these are obvious next targets, but we have requests from much more beyond. That is how we are looking at it. Anything else, Peter, to add? No. I think the main focus now is U.S., because U.S. is such a huge opportunity, and we need to put all our resources to U.S. right now. Of course, we, in parallel, are doing the groundwork for the other regions. We have a little team who do the approval, regulatory stuff to get approved and all these things. That is going on in parallel. But the business activities that has to wait now. For now, we should prove ourselves here in the U.S., make investors super happy, and create huge revenue. That is the goal. I think two seats away from you, there were questions. Yes. I have a question for Dr. Ahmed in the U.K. Seeing that you have the NICE recommendations this couple of years, and I have seen you on the web being very positive to RefluxStop like you are witnessing today. And apparently, there is quite a good substantial amount of patients which have been helped and are happy and have been documented in the media. However, your volumes do not seem to ramp up, looking at all the positive surrounding criteria. I wonder what your view is. What will it take to ramp up in the U.K.? Are all your patients private payers or private insurance payers? How do you see RefluxStop in the U.K. next year and maybe the year after that? Thank you very much for your question. The U.K. is a very, should we say, conservative market. We are very slow at adopting new technology, and that is probably one of the reasons why the cases are increasing, perhaps at a slower rate. But at the same time, I know that there is a lot of surgeons who are being trained in doing the procedure, so I think as they start doing more of these cases, the numbers are going to go up and up in the U.K. As we have heard already, it is NICE recommended for ineffective esophageal motility, so that is also going to increase the number of cases. Probably the most interesting situation in the U.K. is patients are actually self-referring. It is not a question that what happens is a patient does not come to me in the clinic, and then I say to them, "Have you thought about RefluxStop?" Patients hear about RefluxStop, they then go to their primary care doctors and actually ask for RefluxStop. The primary care doctor then looks up who is doing it, or more often than not, the patient will actually even say to the primary care doctor, "Look, this is a surgeon I have heard about. He is offering RefluxStop in the NHS. Please refer me to this surgeon." That is happening a lot. The only sad part is because of the NHS system, our waiting lists are long, and that also means that the high demand has not equaled in vastly accelerated number of cases. But it is catching up slowly. But it will definitely, I think year on year, there's going to be an increased number of procedures being done in the U.K. In terms of the private market, yes, again, that is also picking up as well. But most of my cases you ask me are, whether they're private or rather self-pay or NHS, mine are mostly NHS. Yes, of course. Over there. Maybe I missed out on this, but pricing, what does this gadget cost? In Europe, it's sold for EUR 5,900. That's comparable to $6,900. Then we have added 1,000 premium because of all the increased legal cases you will have in the U.S., so we're targeting $7,900 in the U.S. This is just a target price. Initial view could change, but that's our goal. Okay. Then just to lighten things up a bit. Neither Dr. Lipham nor Dr. Ahmed could provide an exclusion criteria, but I think I can offer one. I have a perfectly healthy mother that unfortunately suffers from GERD. She would love to have this procedure. The problem is, we hope she will turn 103 in the spring. I think she will be excluded. Don't give up. Any comment on that, Ahmed? If she wants the operation and she's fit, I'll do it. Send her over. All right. Are there any more questions from the audience? Yes, over there. Hi. I just had a question on generating additional clinical evidence. Previously, you talked about this randomized controlled trial against Nissen to do that head-to-head, and you set that on pause for a while. It seems quite important for the reimbursement part in the U.S. to have that. It's kind of undeniable evidence to have a head-to-head trial. Now you're just comparing your own trial versus other trials for Nissen. What's the plan for that now? Are you planning to start that up, and could you provide some form of timeline for that? Absolutely. We will start that as soon as possible now. We have been waiting because FDA is a very sensitive organ, and if we started the randomized trial, we were worried that they will say, "Oh, nice you do randomized trial. Let's wait for that one." We really wanted our approval now, so we said we wait. That was the advice from our advisor, [Hogan Lovells], who said, "Wait, wait. Get approval, then you can do the study." We are starting study now. We have just made some updates on the protocol. You learn by experience during this journey, so we have made some small updates to the protocols. We will refile the protocol now to do all the different ethics committee, and then they have a little handling time. It could be one month, it could be two months, and then we can start to operate with this randomized trial. Exactly like planned. Only European patients, or will you now try to include some U.S. patients as well? You are absolutely right. We are expanding the study to U.S. Any more questions from the audience? No, it would appear not. So yes, over there. Maybe I missed out, but I am not certain about the reimbursement process in the U.S. Where are we and what codes do you have now? Do they give you full reimbursement? If not, when will that happen, and when will the insurance companies and Medicare give you full- I think it is a mid question, but I can just start to say that the procedure is paid SEK 10,000 + to the hospitals. That is part of the healthcare system. They do the surgery, they get paid. They can do as much surgeries as they want, and they get paid. The same for the surgeons. They get SEK 1,000 +, and it is a little bit depending on the different codes. They have different codes. They will be paid. There is no restriction except the device. The device is what we are talking about when we talk about reimbursement here. Then it works like this, that if you start to operate in United States with all these insured patients, and the insurance company get an application, then you got an appeal, and they got a second appeal, and they got a new patient, an appeal, a second appeal, new patient, new- and then it goes on like this, then they give up. They realize this is the new trend. This is the new technology. It is a commercial system. I need to adapt. Otherwise, the patient will leave my insurance and go to someone else who provide this operation. Therefore, we know from experience of other products and experience from our advisors that in two years' time, we will go from zero payment to 75% of insurance companies to pay. That is our target based on strong experience, so to say. Then on top of that, we are applying for what Amit call here is transitional program. So it is a pass-through program. This program will give us full pay for the device. This handling time for that is 6 - 12 months. That is for Medicare. That is the public sector in United States. When Medicare says, "We give you pay," then 50% approximately of the insurance company will say, "Okay, we also pay." They sort of follow the guidelines for Medicare, approximately half. So there you will also then have 75% approximately who pays. This handling time is 6 - 12 months. There is no 100% guarantee we will get it. We just fulfill all the criteria. We know that Shockwave Medical got it after eight months, but we cannot say. But we have two parallels pathways. So of course, if we get suddenly after six months paid for 75% of the products, this other phase is less important, this to get them to pay more and more because they switch right away then. It is a very solid plan. It is hard to see how you can fail because there is plan A, plan B. I just want to continue on that. So you mean that if an insurer denies in the beginning, then you will not get paid? Exactly, for the device. That is why we have produced 13,000 devices. So we are willing to take the risk that we will not be paid. And there is in the beginning, you are allowed, you cannot give devices for free because that is bribing, so to say. But there is a system, a bridge access program in U.S., where you force the hospitals to apply and appeal, and appeal. And when they have done this, then they fulfill the requirement to be repaid by us. So we stand the cost for these devices, and then it will successively be more and more and more and more who get actually paid. That is why we have made 13,000 products, because the insurance companies will just be bombarded, because the doctors, the hospitals, they can do any amount. They can operate like crazy. They have no limitation because they will always be paid. That is why the insurance companies will quickly give up because it is a commercial system. They cannot sit there as an insurance company who do not pay for the surgery that people want. They will just switch insurance then. So that is why this plan is rock solid, and a normal company cannot do this. If you have a pacemaker and it cost you $4,000 to produce, you cannot do 13,000 pacemakers because it is too costly. But we have a plan A and B that combined gives a very, very strong position. Yeah. I think Peter said it all, so maybe it is clear enough. But I think maybe I add a non-technical view on this that can help further take this point. I think you again have to understand that if you are a new technology in the U.S. with a PMA, usually you do not have any quotes. You have nothing. Most of the time you start from scratch, meaning the two things out of three, hospital payment, physician payment, and device payment, you start on all three from zero. We are not doing that. We have two things already checked, and it is a blessing that it has happened like that because our procedure very much depends on things that are done in these existing procedures. We have the qualified path there, which takes away so much of our challenges in establishing reimbursement. This is the perfect storm, if I can say it like that. You have hospital payment, you have physician payment on the device path, like Peter explained, and I think in a more formal way. You usually have insurance. We have 1,000 payers in the U.S. If you just think about it, in Germany or Sweden or even if you take the county level, you are talking about one to 20 payers. In the U.S., we have 1,000+ payers. Now, the majority of them are very small, but if you look at the top five commercial payers, that is like 50% coverage. If you start getting traction in these payers, and it happens exactly like Peter said, you submit a claim. If it gets denied, you have the ability to go back into the healthcare system and say, "Hey, you denied this claim, but here is a new technology, and this is the reason why this patient has no other option." Take IEM, this mortality issue. If any payer can say, "We have found another technology that should have been used," we have a weak position. But as you heard, there is nothing else out there which is compelling enough. We think we are going to have a small group of patients. Well, this is very large, but we are going to have a group of patients where we are going to see success very fast. It can go from, just imaginatively, a figure could be 10% success to 50% and then 75% in a very quick timeframe as the data is compelling enough. Same thing on the normal population where they do have alternatives, but the side effects, as you heard from our surgeons, are so dramatic. There also, they have a very compelling story that, hey, these patients have already looked at these options and this does not make sense, or it does not qualify subject to the medical necessity. That is how they build the case. I would say the U.S. system is just very open. It allows you to go back and keep fighting your claim. You can go up to four or five times to the insurance company if they keep denying. The whole idea is huge movement to convince payers that, hey, this technology is very well justified for your GERD patients on a very clear ground, on superiority level, and that is how you kind of expect them to start paying for it. This is very normal for the device part with any technology. It is not just like we are special. On that third piece, on the device part, you take any new innovation, most of those go through the exact same path. However, they do not have five to seven years of data. They do not have such great momentum with surgical societies and clinical support. We do think, to Peter's point, we are in a very good position that we will start to build that success with payers fast. Of course, the payers, they do not look at just one operation. They look over a five-year period of time or even 10-year period of time, and if they can find out that they save money by switching to another procedure, that of course simplifies their decision a lot. That is why we have this article in the U.S., for example, showing that they actually save money. Even the drugs is more expensive because you have all these complications. People's kidney get completely damaged, and they have dialysis. You have a dialysis patient. They cost enormous amount of money and so on. That is why- Peter, I am sorry, but I must interrupt you. We are very much running out of time. Okay, got it. So if there are any more questions from the audience, then you are free to ask them during the mingle upstairs later. We will have to wrap this up. Thank you very much, Amit. Thank you very much, Dr. Sánchez. Thank you very much, Dr. Ahmed. You will give some closing remarks as I understand it, Peter? Yeah. Thank you. I think we have said it all, basically. I think it is very exciting times. We at Implantica are really looking forward to this. We have been working so hard to build the platform for this, and now we hope that it is like, [Non-English content]. We hope that we should be able to enter into a real execution phase and really get into the commercial state in a different way that we have done before. We, of course, appreciate all of you supporting this company, supporting us, and we are very happy for that and hope that will continue. We just want to thank you very much for listening and coming here, and we will then have a little apero now, so you can drink and take something to eat, hopefully. Yeah, thank you for coming, simply.