Hello, welcome to Implantica's Capital Market Day. Thank you for attending in person and also for attending via our webcast. The agenda for the day is behind me. As you can see, we will have two Q&A sessions, so we would ask that you please hold questions for those two sessions, one of those two sessions. If you are watching via the webcast, please submit your questions at the bottom of the page. You have an area where you can submit them. I wanted to say a special thank you to two of our board members who have come and traveled to the CMD and joined us. We have our Chairman, Liselott Kilaas, as well as board member, Tomas Puusepp, and they are going to be available for you to meet in person and discuss during the breaks, during the coffee break, and during the apero. With that, I'd like to hand over right now to Peter Forsell, Dr. Peter Forsell, the CEO and founder of Implantica. Thank you very much. So Implantica is all about bringing advanced technology into the body. For those who don't already know me, I'm a surgeon, educated at Karolinska Institutet here in Stockholm, and I once developed adjustable gastric band and a rather successful business around that. This is the founder who has been able to create this new company, Implantica. It's not only me in this company, we are actually around 70 people and fantastic, competent people. We have been able to find absolutely top talent, and we had a really good team who can drive this forward. So I have formulated a few questions which I have a feeling the investors would like to know, and one is: when will RefluxStop get its U.S. FDA approval? And when will we reach higher revenue levels? And does the management still believe that RefluxStop is a blockbuster product? And how is the risk for failure today compared to at the IPO? And when will you release your next product? And I hope we will try to shed some light on these questions during the presentation here. I will not answer them immediately. They will be following during the presentation. And our first priority, that's our U.S. launch of RefluxStop, and also, of course, the reimbursement in E.U. And that has full priority, and as you know, the pandemic has taken a little bit of the resources, and therefore, there's no question what is the priority in this company. But I still would like to show you a little bit about the other stuff shortly, what we have in this company. And it's clear that RefluxStop has the potential to actually finance all our pipeline development. So first, let's talk a bit about our e-health platform. We are steady working on, our, so say, second line product, our pipeline products, and of course, the e-health platform is something we will believe have the possibility to revolutionize healthcare. This e-health platform is then combined with a wireless energizing platform, because if you have, you should be able to communicate with the patient, change treatment on distance and so on, but you need lots of power suddenly, and you can't cut people open every month, change battery, doesn't work. Also, what we are doing right now is integrating a stimulation system in our e-health, platform. What will then this e-health platform do? Well, it will save cost for society because you can treat on distance. More convenient for the patients and more cost effective, more advanced treatments. You need then, of course, wireless powering, which the patient will do at home, maybe five minutes per day, for example. And the key and what is really revolutionizing healthcare compared to today's status, is that we can actually treat on distance. This is many, many years of work to be able to fulfill all the data security requirement, all the GDPR, all these strange rules they have nowadays, to actually be able to change treatment on distance. And that would be a fantastic achievement when this is released. And the pipeline here with the electric stimulation module that we now are currently working on to integrate in the e-health platform, that could then be used for several of our pipeline products, and one of them is Stoma Restore. You know, people, they get a plastic bag and collect the fecal matter because they have taken away part of the intestine, and it's actually nearly 1 million people who have that surgery every year. And the business, just for plastic bags, only plastic bags and the self-adhesive it's mounted on, is $3 billion, just for plastic bags. Then you understand how important this product may be because they don't need this plastic bag anymore. We connect to anus, we have open and close function, reservoir, everything is normal again. We also have UryRestore. That's a product who can empty the urinary bladder in patients who can't empty their own bladder. For example, you have a traffic accident, you get a spinal cord injury, you have a multiple sclerosis disease, and this-... It is very burdensome disease to have, because you need to put in a catheter in your own bladder every time you should urinate. Imagine five times per day, you take a catheter and insert it in your own bladder. That's not easy. This is history if we can release our product. We empty with the remote control, and no catheters is needed anymore. We also are working on our appetite control product, which is a product controls appetite. Instead of taking away a big portion of the stomach, and we are just very mini-invasive surgery, very risk-free. We just control appetite by stretching the stomach wall. The same way the natural body reacts when the stomach gets full, it starts to stretch, start to be full, and then you feel, "Oh, I'm full now." We have currently tested our food sensor on living pigs, and that's quite a landmark achievement, because that's the key for this product, is to be able to control how much people are eating. We also have another product, RefluxStop Two, we call it, but this is a version who can also treat obesity. So you basically fold the stomach over a line of RefluxStop. And this product is actually the next in line to be released, and we target to do that a year after the U.S. launch. And that will then be able to treat both reflux and obesity initially, before you later on can get it approved only for obesity. We also have a fantastic pipeline. We have an enormous amount of patents, nearly 2,000 patent cases, and we have more than 300 inventions. During 3 years of market analysis, product analysis, production analysis, and prototyping, we have selected 40, what we believe is strong, viable product candidates. That's the platform of Implantica. That's why we say we should become the world leader in smart medical implants. I will then switch over to RefluxStop, which is the closest to generate more substantial revenue, and also a product with rather extreme potential. RefluxStop is very safe. It's reliable, it's uncomplicated. Looks like this. It's just solid silicone, rounded, can't hurt anything, can't damage anything, will not break. It's not like breast implants, suddenly they break, they leak. Very, very safe and reliable. It's not complicated electronics that could break tomorrow. Nothing nearly could go wrong with this product, theoretically, huh? Here you see how it's built. It's built in pieces. You have a little suture around it, and we believe this is nearly as optimal you can get, because this product... Here you see, by the way, on an X-ray, you see esophagus coming down, and then you see the product to the right side, the little darker there. And then you see a very full stomach with gas, the white, and you see the black is the stomach rest filled with contrast medium. So what is now fantastic with this product? Of course, it is that it has a really high gross margin. I mean, this costs EUR 13 to produce. It's sold for EUR 5,900. We have to pay a little bit for the packaging as well, but still, it's rather extreme margin on this product. But the problem is that to release a medical device is not about the cost of the product, it's about all the people you need, all the effort you need to create this company. It's very, very expensive business. Here you see 94% gross margin last both half year and quarter. Also, RefluxStop has a very large addressable market. I would call it enormous, actually, and it very substantial unmet need. So you can see here, it's 1 billion people take medical treatment, PPI, every year for acid reflux. One billion people, that's extraordinary. We, we don't have more than, a bit more than 7 billion on the planet. So it's, it's absolutely incredible market space here. And RefluxStop is designed to be superior to the competition, and it has the potential to revolutionize the treatment in, or of acid reflux. And why? Because surgical procedures today, they are suboptimal. They try to compress the food passageway and believe if we just close, then we have no leakage of acid coming up. However, the problem is that this is people's food passageway, and therefore, they will have swallowing problems. They can't belch, they can't vomit, they get gas bloating. People are unhappy with this type of surgery. And we have actually solved the cause why you get acid reflux. And it's not about the problem with the sphincter. You have no pointer on this or anything, no? So what you can see here is the sphincter that close between the stomach and the esophagus, called LES on that little picture here. Everybody believe this is weak, doesn't close properly, but in reality, it's just the position of the sphincter is the problem. That we solve by placing our device to reinforcing the top part of the stomach, placed outside of the stomach. You are not going into the food passageway, you are not open anything, it's just placed on the outside in a pouch... So RefluxStop has then shown in the trials and clinical experience we have so far, which is more than 500 cases so far, that it's highly effective and very safe treatment. And we have superior clinical trial results. If you compare our CE study, for example, with a big meta-analysis made by Karolinska Institutet, it's like night and day. And the results we know now are maintained over time. We have 5-year results today, and it continues to be fantastic results. Here you can see 4-year results. This is a questionnaire you ask patients how they feel, and you can see they are fantastically well treated, these patients. Excellent scores. Here you can see regurgitation. The blue part means you have no regurgitation anymore, and you can see they had moderate, severe, and mild regurgitation from the beginning. And basically, it's very—it's a few patients who maybe is not perfectly treated. That's all. And you can see, if you compare to the main device competitor from LINX, sorry, from J&J, called LINX, which is a magnetic band that tried to encircle and close this hiatus. You can see here, we have compared their FDA study with our CE study, and it's like night and day. I mean, 42% of their patients still have acid coming up and too low pH in lower esophagus. This is 10 times more failures than in our study. They have 68% of the patients have swallowing problems. It's simply like night and day. Our product is also targeted to save lives. The problem with this disease is that people die from cancer, because this acid is coming up in lower esophagus, and it terrorize the tissue over and over and over again, and that's exactly how you get cancer. 48,000 people die only in Europe and United States based on esophageal adenocarcinoma. 48,000 people, absolutely impossible, can't go on like this. Something need to be done. Drugs doesn't protect you from the cancer. You can look in the literature, there is no proof whatsoever. Actually, this cancer, since PPI introduced 1988, this cancer form has increased tenfold in 40 years. It's absolutely impossible to have it like this. What is even better here is that RefluxStop has proven, proven, actually, to be the most cost-effective treatment of all treatments. We have University of York, who is a very well-known center for health economics. They have made an analysis of treatment with acid reflux, and they compare PPI drug treatment, the magnetic band, LINX I talked about, fundoplication, and RefluxStop. They have concluded that the most cost-effective treatment of them all is RefluxStop. This has been published in one of the best magazines available, Journal of Medical Economics. That's a complete landmark. It's such a milestone that is hard to understand. This will open the door when we come to all the payers and should get our product paid for. Because today, we are allowed to sell, but no one pays, because that's a separate system to get someone to pay. So we have redone the same excellent analysis, the same economic model in all these countries here, and they show the same thing. We are the most cost-effective treatment. And, the another very, very important step, why actually RefluxStop has much, much limited risk today and a multi-billion dollar opportunity, is because we have gained acceptance among the key opinion leaders. We have conquered the world. We have the best surgeons, the most experienced, the center of excellence. They strongly believe that RefluxStop is the new treatment, that will be the new standard of care when it finally will get reimbursed. And we have several hospital, for example, Inselspital, the largest university hospital in Switzerland. They stand up at the big congress and say, "Yes, we have been able to replicate it in the real-world settings, hospital settings, the excellent results of the CMOC study that RefluxStop had from the beginning." And that's really an achievement. So what we are doing right now is to go from the stage, being allowed to sell, to actually get paid for to sell. And that's a process where we need the health economics I just talked about. That's done, we can say book. The second thing is the clinical evidence. We need to have enough clinical evidence to convince the payers, governmental bodies, healthcare, insurance companies, different in different countries, they should be convinced this is the best treatment, now we need to pay for this. That's what we are working on. We have full teams. Leader is Amit. He sits in the front here, you can stand up. He is the leader of this team, the Chief Market Access and Strategy Officer. And then we have Sarovar is... Yeah, Sarovar is leading the clinical evidence and health economics team, and then we have Mark Cregan, who actually is the leader of the medical affairs team. And we have built a super professional team. We talk about super people here. You can read their CVs later, but it's absolutely best you can find, and that's why it's going so well for Implantica for the moment. So here you have some centers. This is an old slide. I didn't have energy to make something new, but it's just to show some of the centers that really believe in us and do this surgery. Here you have the presentation I talked about when they say that they have replicated the fantastic results from our SEA study, and we have another presentation when they present their four-year results, so it's another center who has reached four-year results of RefluxStop. So we also have studies, and you will hear more about this here from our other people here, but we have a big study we call the Restore, and we have been shaped to achieve ethical committee in the countries you see here, Switzerland, Sweden, Germany, Italy, and Norway. And I just wanted to show you a little bit of the centers that are in the order they have started or are in the pipeline of start. So this is Switzerland, we have Germany, we have Sweden, Norway, Ersta Sjukhus, Sundsvalls Sjukhus. We have Austria, UK, Italy, Spain. It's more centers coming up in Italy and Spain, but it's growing rapidly. I just show you this to give a feeling that it's happening a lot with Implantica. But because they don't get paid, it's not mass production of surgeries, it's focused amount of surgeries, only possible until you get reimbursed, but you gain the centers. So when you finally get reimbursed, then it will be what in Swedish we call ketchup effect. You know, you shake the bottle, and suddenly all the ketchup ends up on your plate, huh? That's the target here. Oh, sorry, did I miss that one? Yeah, so then, of course, we are quite close now to obtain... What was my time limit? 2:40 P.M., so I have 60 minutes. Fantastic. So, we are in the process to obtain U.S. market launch, and that's, of course, when you look at success stories from previous companies, you understand that the U.S. market is very special. First of all, the market is enormous. Secondly, it's easier to get sales already from the day you get approved. So this is really something heavy to get the U.S. approval, and we are currently preparing for that. Also, we have other markets we are focusing on, like Canada, like U.K., for example, and currently, we have NICE, the big organization, to support NHS, who is the National Health Service there, to analyze RefluxStop. So here you see a little bit the markets we have entered. We do not sell everywhere. We do not sell to Middle East. We focus strictly on high-class centers. We don't sell to mid centers. We only should have the centers of excellence. That's our target. Because FDA, they look at all our data worldwide, and they force us to report any complication happening in any hospital all over the world. If we don't do that, it's fraud. You get to prison. This is a fact. Therefore, only high-quality centers, smaller number of centers, very good focused market which we control, that's what we are doing here. Here you can see from NICE homepage that, oh, it's even NICE name here, for the RefluxStop procedure. They know how to do this in NICE, actually. But this is what you can see on the homepage of NICE, and it's an ongoing evaluation of RefluxStop. Also, we have had a last meeting, we hope, with FDA regarding getting feedback on our submission. You know, every time you should talk to FDA, who is the approval organ in United States, every time they say, "Okay, 3 months." Next, well, then we get, after 3 months, we get the answer to our question. If you want another question, 3 months, and then it goes on like this. So we have spent 9 months asking FDA different things to really clarify how they want this submission. You know, an FDA submission, that's a wall of files. It, it's enormous. It's, it's, it's hard to understand how huge it is for a medical implant to do an FDA submission. And we now have everything we want to know from FDA. We are following their guidelines, preparing the final steps, doing some final tests they wanted us to do, and when we are confident everything in place, we will file, and hopefully, this will be before year-end or slightly thereafter. We aim to be on the U.S. market in 2025. Here is a little bit how we already have started to prepare the U.S. market. We have actually been very, very successful to make RefluxStop known in the U.S. market. We are running around on the big key congresses. We have been able to establish really deep relationship with super key surgeons, for example, Professor Lipham at University of Southern California, who was the former president of this type of surgery in United States. And he tells us we have been incredibly successful with our social media work, because when he, in his center of reflux surgery in California, he has patient asking for RefluxStop every week... So it's very, very successful so far. We have a big meeting now coming up in United States, and it, it looks really promising for this. I just wanted to give an example. You will hear more about this, of course, Italy, from, another of our members. Here's Andrea. Maybe you can stand up. Also, he is the boss of the Italian market. And, I just take the opportunity to give you a little overview, because we, less than six months ago, we sold to the first hospital in Italy. And, second center in Italy, third center in Italy, fourth center in Italy, and now it's another two centers lined up. So everything goes quite well when surgeons really are interested. And it's a little bit easier in the Italian market because their DRG system is a little bit less strict than in Germany, for example. You know, they have a system that every code gets a certain amount of money, and if you follow this very strictly, no one can pay for anything until you are approved. So we believe that RefluxStop has a really strong potential to become the new standard of care in the treatment of acid reflux. And I think it's quite many of the surgeons who do this procedure that actually believe the same. So do you want to join the journey? Is the question here. You know, the difference to sell a product when no one have money to pay, or sell a product when suddenly there is money to pay, that's like night and day. So we talk at, you know, so many times higher possibilities for sales. It's enormous, basically. And that you get when you have 1 billion sufferers. So the risk that RefluxStop should fail has dramatically been reduced since that deal, because now we know that we have fantastic long-term results. We have all these KOLs. We know we are more cost-effective. All this has reduced the risk for an investment in Implantica absolutely dramatically. RefluxStop is unstoppable. Huh? Thank you. I would like to give a warm welcome to Professor Lars Lundell. If you could please come to the stage. I hope you are mic'd up. Oh, definitely. Professor Lundell is a legend in reflux management. He has led many clinical studies in the field. He's a former professor at Karolinska Institute, and he will be discussing the unmet need. Thank you very much. Thank you very much. Good afternoon, ladies and gentlemen. Now I will bring you back to reality, and I will give you perspective on the disease, which you will discuss and you heard a lot about already. But it's always difficult for you, as a lay person, to really understand the complexity and the huge burden that this disease inflicts on the patients that are affected. Now, first of all, let's say, what, what, what are we talking about? We're talking about a disease that doesn't shorten patient's life, but it just ruins it, and I can tell you why. This is a disease that is characterized by too much reflux of gastric content into the esophagus during too long period of the 24 hours a day. That is what it's all about. And what happens then? Well, if the dis... This noxious material comes into the distal esophagus, it may macroscopically damage the mucosa, which you can see when you look into the esophagus through the endoscope, and then we call it esophagitis. And when this noxious material reaches the nerve endings underneath the epithelium, it triggers these pain receptors that is then eliciting signals into the brain, and you feel heartburn or acid regurgitation. Even more often, you can't see anything in the esophagus, but if you look microscopically into the epithelium, you can see that there is a swelling of the intercellular spaces, and protons and other noxious material is diffusing into the same area, eliciting the same signals in the afferent fibers. And there are different components of the juice that is refluxed into the esophagus that may cause similar types of stimuli that reaches the brain, and you got symptoms. Well, then you can say, "Well, there are different manifestations of the disease." There are the esophagitis, the endoscopy positive cases, there are endoscopy negative cases. If you regurgitate into the respiratory tree, you got cough, you got asthma, and you got other things. You can develop Barrett's esophagus, which is the precondition for developing adenocarcinoma of the esophagus. But the patient doesn't care because the symptom is the problem. The patient doesn't care how the esophagus looks like. The patient is caring about the symptoms because the symptoms destroys these people's life. Well, what kind of comparison can we make? Well, in fact, we can measure quality of life. And this is one of the best validated instruments we have, developed in Sweden, by the way, and that is called the PDWB. And if we look into the happy Swedes or Finns or whatever, you see it in the blue here, around 100. And if we focus on the area just below, you see here, we have patients with heart failure, and then you got even worse, down to the level of psychiatric illnesses. Then you are in the range of 85. Where do reflux patients come? Here. Untreated, ladies and gentlemen. We are not talking about hypertension or diabetes, we're talking about serious impairment of quality of life. And this is a worldwide disease. If we compare the point prevalence during a, from 1990 to 2019, you see, we have the high prevalence areas in mid, in Central and South America. We have it around the southern part of the Mediterranean and up to India. We have the moderate prevalence areas, like we have here in Sweden and the United States. But if you look carefully into the left-hand side of the slide, you see, you see the same increase in numbers over a certain defined time period. So it's a continuously increasing disease, and it's a worldwide disease. This, these are the figures, just to bring things into perspective. How many of the adults and how many offices, how many visits into the GP's office, et cetera, et cetera, that you can count on? We know exactly which are the predictive factors. Males are doing worse, the obese are doing worse, and there are a lot of other factors. Smoking, for instance. This is very much related to lifestyle factors. And how easy is it to affect lifestyles? Just tell me, because I don't know. This is also not only a symptom burden, this is an economic burden to the society and the healthcare system. These figures just gives you a perspective. What are we talking about? The main driver here is the cost of medication and hospital costs. These are the two factors. I will come back to you a little bit later because you can sit down in the office behind your computer, and you can make excellent calculations. How valid are those calculations? Not very much so. But we have done prospective collection of all costs in the management of these disease, of these patients. These are the true figures that you should really pay attention to, and I will go through them a very, a little bit earlier. This just gives you a flavor of what kind of costs we're talking about. Billions! $ billions a month. Now, let me just show you the pathogenesis, genesis, a little bit about the pathogen. Why do reflux disease develop? We do have an area where we know for sure that these are factors that can be controlled in one way or the other. One is the lower esophageal sphincter, shown to the left hand, to the right-hand side of the slide, comprising of two components: the circular smooth muscles of the distal esophagus and the sling fibers of the stomach. Right? It's a tone which prevents reflux. The same type of sphincter function as we have in the lower end of the GI tract. Okay? Then we have the valve mechanism. This is a simple mechanical valve mechanism that is strengthened by the sling fibers of the stomach. And then we have the crural part of the diaphragm. Now, the interesting thing here is the crus to the left-hand side here. They represent the external component of the lower esophageal sphincter. So we have an external and internal component of the lower esophageal sphincter. And this is a fundamentally important mechanism in the development of reflux disease and also a unique option for effective long-term treatment and cure. Hiatal hernia, have you heard about? If you have a hiatal hernia, you see, the external sphincter, caused by the diaphragm, is separated from the internal sphincter, which is a fundamentally important mechanism because that facilitates reflux. And hiatal hernia occurs with... it is very much dependent on, for instance, weight development. The more obese, the bigger is the hiatal hernia, for instance. How is reflux disease treated worldwide? It is treated by acid inhibition and developed here in Sweden, omeprazole in 1979, and launched in the 1980s. And after that, there have been huge efforts in order to increase the potency and duration of acid inhibition, as illustrated here on the family slide. But the message here is pharma has been incapable of developing a more potent acid inhibitory drug than omeprazole, basically. Therefore, and that has usually been forgotten, that most reflux patients are fairly satisfied with proton pump inhibition therapy, but at least 25% are unhappy. At least 25% are unhappy. So what we can say, there is a great, great unmet need for effective therapy for a large number of patients with reflux disease, because PPIs are not effective. And secondly, we have a problem with long-term use. We're not talking about five years per-period treatment, we're talking about a lifelong treatment because and there is no cure. And of course, the longer you treat, the more side effects you can get. Surgical therapy, by tradition, affects a number of fundamental components of the pathogenesis of reflux disease, which means you can offer cure. Because as you see here, we do the repair the hiatal hernia and repair the crus. We do a fundoplication, we wrap this, the upper part of the stomach around the esophagus, enhancing the efficacy of the lower esophageal sphincter. But there are a variety of different techniques. It can be done partially, it can be total, and it can be done anteriorly, it can be done posterior. The problem is that if we do it correctly in high volume expert centers, we, if we do a prospective collection of all costs associated with surgical treatment, we reach a break-even compared to omeprazole after 3-5 years. The problem, and we know for sure, it does matter how you do the fundoplication, because if you do a posterior part or a partial part, you don't have the side effects if you do a total fundoplication. So the message to you is, it does matter who's doing it and how it is done. I will come back to the implication. This is just an example. You've got less bloating, you've got less flatulence by posterior partial compared to a total. But if we apply this to the entire society, to a community, you see there are a lot of problems, a lot of problems with anti-reflux surgery. There are difficulties, there are drawbacks, which you need to take into account. These are the positive predictive factors. If you're a male, you're doing better, if you're young, you're doing better, if you have. The type of fundoplication is important, and it is important where you are operated on. The wish list, ladies and gentlemen, is the following: The message to you is to find the advantages and comprehend the advantages of anti-reflux surgery, but it has to be much easier. The access has to be much easier. The procedure technique has to be easier to learn, to perform, and to master. It has to be easier to standardize it, allowing the patient to return to a normal life with normal quality, close to being one of the happiest population, like in Finland. We have to, of course, minimize the side effects, and we have to convince the healthcare providers, and then implement these technologies on a larger scale. Thank you very much for your attention. I'm happy to take questions at the due time. Professor Lehmann from Klinikum Friedrichshafen, leading anti-reflux surgeon. He actually is our biggest user and has performed over 125 RefluxStop procedures. Thank you very much. Thank you very much, ladies and gentlemen. Yes, I'm coming from a regional district hospital in southern Germany, and we are focusing in our work on anti-reflux surgery. I'm seeing every year about 400 new patients, and out of those, we operate on 150-200. Two and a half years ago, I was confronted with RefluxStop. Since we are performing our reflux, anti-reflux surgery, then since more than 10 years, I was looking at that and was completely convinced about this idea, what's behind that. You heard we have done so far, up to yesterday, 125 cases, which is almost 1/4 of all RefluxStop implantations. So I can tell you what we are really looking at. You heard about the unmet need in gastroesophageal diseases and these treatment options and the opportunities now for new innovations. What are the objectives here for me? To share my surgeon's perspective about the current reflux treatment options and the unmet needs. I would like to share with you my recent experiences about this new procedure, and of course, my opinion about evidence needs to establish this therapy. You heard all these things. I'm looking here again. We have the increasing prevalence in the Western societies. We have the failure of the medication so far in medication-based treatment to control symptoms and quality of life. It's really very interesting if you look into the German market. 84 million people living in Germany, more than 11 million people are treated for GERD every day... And we have around 7,000 operations only. So this is a huge difference between patients needed to treat and operative procedures for those patients. You heard that the actual standard operative care has some drawbacks, and we are looking for a better solution, for better operation to get symptom relief and quality of life, and we have these adverse events or these side effects in the actual operation techniques. There's clearly, as you heard, the unmet needs among patients to eliminate the symptoms, with almost no adverse events. And you heard about this, and I just told you, we have this large number of patients who are well-controlled and are very happy with PPIs. We have at least one-third of all patients who are unhappy, and only less than 1%, I would say, around 0.1% of all patients get any operative procedure so far in the Western world countries. We heard about this already, about the recently three-year data, efficacy, and safety, which has been introduced and shown at different conferences. Now I would like to show you our first data. We started, as I said, in July 2021 with our patients, and we looked now at 79 patients within the last one and a half years, from June 2021 to November 2022. The most important points are here. If you look at disease history, 8.5 years of disease, average duration of PPI therapy at around five years and even more, 10, 12, 15 years patients. More than 45% of all patients we have included now in our study had an active esophagitis, although they were using PPI therapy. In our patient selection, we have more than 15% of all our patients had any other technique before that, so any other anti-reflux surgery done. Now we look at this very important data, GERD, HRQOL, quality of life score, and the quality of life score for our patients was around 21. This is the score, and now we look at what happens now. In this duration of almost 11-month follow-up with a larger area where we look at we get the HRQOL score from 21.5 down to 1.6, and 1.6 is healthy population. Same as with PPI use. 79 patients started into this study, and only two needed PPIs during our follow-up period. This is fantastic. We don't know if these two, do they have reflux again, or is it still symptoms? A lot of patients come into our hospital or into my outpatient clinic and tell me about GERD, GERD symptoms. But if you look at them and if you test them, they don't have real GERD, they have something else which is not GERD. And so maybe these two who are back on PPIs, they don't have GERD, they have something else. They feel a kind of acid on the tip of their tongue. That sounds a little bit strange, but a lot of people have this impression. Adverse events. The question here was reflux symptoms. As I said, well, we have three patients who have the impression that they have reflux. Again, mild symptoms or occasional symptoms. And this is the summary of our data. We have no severe esophageal dilation. This is very, very important. If you look at the other operation procedures, like LINX or fundoplication, where you wrap around something around the LES, you, and a lot of patients have gathered dilatation of the esophagus above that, which is bad on the long run because it leads to a dysfunction of the esophagus. We have a reoperation rate after we closed our first look at our data of 1.2% reoperation because we had one patient who lost his device. And the only thing what this patient felt was that he got reflux again, and looking at X-rays and looking at the whole situation, we found out that the RefluxStop device was gone. It was, it penetrated through the gastric wall, and then it disappeared with normal bowel movements. And that's it. Nothing happens, no complication at all, not really anything what the patient would suffer from. And of course, we have no device-related severe adverse events. We have no reoperation in this time period. We have no 30- or 90-day morbidity, no reoperations during this time, and of course, we have no mortality. So conclusion of our first results, we have evidence that this device is safe and effective in the management of GERD, and we have significant improvements in PPI use and quality of life in our follow-up period. And now, where are we? If you look at this pyramid, you see right now about the evidence and the quality of scientific data. At this time, we are here in this area, and where we have to go to is case control studies, cohort studies, and most important, RCTs. That's the way where we have to go to, and this is relevant, and this is our future.... and we are looking to do this. So we need further studies on the safety and effectiveness needed for the validation of this new technique, as you heard before, and the gold standard are randomized controlled trials against the current treatment, like Toupet Nissen fundoplication or a LINX procedure, and that's the way we go to. Thank you very much. Now, we would like to take a moment and actually hear firsthand from people who have been operated with RefluxStop. Some of our patients, with their stories, and hear how their experiences, if they're better, if they're worse. If I could please invite Diana Helfer and David Walsh and his wife, Pauline, to the stage. Okay, we have a microphone. Join me. If you could stand in front of this table, please. Sure. Thank you very much. Yes, if you just stand on these tables. Thank you. Mm-hmm. So we have Diana Helfer, she's from Switzerland, and David Walsh and Pauline, they're both from England. Mm-hmm. And if I could just ask you, what were you experiencing before? What were your acid reflux symptoms? What sort of- It's on? Yes. Okay. My acid reflux was terrible. I'd had it for over 20 years. Tried various over-the-counter remedies, and then I was on the PPI, as has been mentioned. I was on that for a long, long time, and I was on the highest dose that we used, both use at the NHS, which was 30 milligrams a day. But it was not working at all. So speaking to the consultant, I was put on 60 milligrams a day, 30 in the morning, 30 at night. And that is... It just carried on. I was having. It's affected my motility, so nothing was going down when I swallowed. I had to always have the water to help push it down. It affected my Barrett's Esophagus, which I've had for quite a long time now. Also, I'm asthmatic, and I couldn't. The cough was getting worse. They were treating me for asthma, more and more, giving me more and more things for the asthma, and it wasn't really that. And I've also lost a few teeth because the acid was coming into my mouth and affecting the gums. It wasn't good at all. Sleeping, I could do an hour and a half, maybe, then I had to sit up, move around. I was actually on two cushions, wedge cushions, that would lift me as high as possible, and I had a bed that lifted as well, and it was horrendous. The quality of life has been mentioned, was terrible. And I looked into different things with the NHS, and all I could offer was fundoplication, but because the motility was so bad, that wasn't really an option. Okay, thank you. Diana, maybe we can give the microphone over to you. If you could tell your experience before. Well, in my case, it also started maybe 20 years ago, and the first effects were my teeth, actually, because enamel started going away over the time, and they thought it was acid coming up. But, because I was quite young by the time, they didn't take it seriously. But well, the story goes on, and it became even harder and, regarding my personal life, when, when I'm at work, and I have to do quite a lot of meetings, so, I always had problems, maybe after 5 minutes already speaking, because my voice became very hoarse. And I always had to ensure that there is water or tea or, tea with honey, to ensure that I could speak for the entire time. And that's really, that's gone now, and I'm very happy about that. And also, about my teeth, it really became quite hard and difficult, and they said to me, they had to put me on PPIs, but well, it didn't really help. I also had quite a high dose of PPIs, and I also started suffering from side effects of the PPIs, actually, which was mostly, again, heartburn and being bloated all the time, and that was really, really difficult. Yeah. Were you offered an operation for reflux as well, or? Only actually 2 years ago, yes, and they actually told me first about the fundoplication and the LINX, which wasn't actually an option for me. I wasn't happy with that. Then, I came to Dr. Zehetner, which we saw on one of the slides, and he told me about the opportunity of RefluxStop, and that was the one I chose. Why, why was that? Why, why, why would you prefer RefluxStop over fundoplication, over LINX, do you—would you say? Did you- Everything- Have any information about the others, yes? Yeah, yes, and everything I read about it, it was really not. It was not an option for me. And how- I had no sympathies for him. And how has your life changed since then? How soon after you got RefluxStop were you feeling better? Well, it changed my life immediately. Of course, the first day or the first weeks, it was still because of the operation. I still had some pains, but that all went away, and regarding reflux, it stopped immediately. Can you eat everything you want, or do you—you don't have problems with that? I can eat whatever I want, yes. Yes. That's really not a problem anymore. Okay, great. And so your recovery, how long do you think it took around? Oh, maybe 6 weeks. Okay. Yeah, and then it was really good. A big change from before? It was a really big change, and the funniest thing actually also was, I was able to burp again, which I wasn't before. Okay. Another thing was, if you finally realize that there is no longer acid in your mouth all the time, it's such a relief because I didn't know anymore how it was without having acid in my mouth. Okay. Thank you. Mm-hmm. Maybe we could, and maybe you could tell us, David, about your experience. How did you get to know RefluxStop, and, and why did you choose that surgery? And hold the mic up. Yeah. We looked around on the internet, didn't we? Mm-hmm. And saw RefluxStop and the LINX and the things that have been mentioned. We found out that Paul Goldsmith in Manchester was starting to do the RefluxStop, and we contacted the Spire Hospital in Manchester, and we got in contact with him. He looked into my condition and found that nothing else would do. The fundoplication wouldn't work, LINX was very unlikely to, and the RefluxStop was the only answer. And from the day it was done on the twenty-eighth of February, I've not had any Lanza episode at all from going from the highest. It's just been brilliant. Everything's been wonderful, and if anyone needs it, I'd recommend it to anyone. How quickly were you able to eat again normally? That night. That- The operation around 12, I think. Mid lunchtime, was it? Mm-hmm. Yeah. I was back in the ward at 3:00, and I was eating by 6:00 P.M. Mm-hmm. Yeah. Salmon and mashed potato. It was wonderful. There's nothing I can say, but just brilliant. Do you have any symptoms today? Any symptoms anymore? Only if I drink a lot of champagne. Okay. Well, like we all. We're all suffering from it. Pauline, if I could ask you- Yeah. Maybe you could give the mic to Pauline, please. How has this affected your family life, and what sort of change have you seen in David? Yeah, well, the change has been dramatic because he can now sleep of an evening. He's not up and eating yogurts and that, trying to pacify the acid. I know he's asleep, and he's not in pain or discomfort, so that's much better. We can socialize a bit more. It was difficult to arrange to meet friends for meals and drinks, and have the same meals. Yes, if we were cooking at home, I'd be cooking a meal for everybody else and a bland, tasteless meal for Dave. Tasteless. All that, all that has changed for the better. Like night and day, like that man said before, night and day. More vitality and energy the next day because he's not as tired. Not as grumpy. Maybe not as grumpy. So, it's just been an absolute blessing to have it done. Yeah. Okay. Well, thank you very much. We thank you for coming and sharing your story with us. And yeah, anybody in the audience who wants a RefluxStop, we have a doctor we can refer you to. Thank you. Thank you for presenting it. Yeah. Yes. Thank you. So now... We actually have a question and answer section. Maybe, Peter, you would like to come up? Do you still have your microphone? Correct me. Yes. But I don't know if anyone in the audience has. Yes, please. Two questions, please. One for Dr. Lehmann. I'm just curious if there were any specific inclusion or exclusion criteria that, you know, that has sort of guided your choice of patient, if you will. Low-hanging fruit is a bad term, but you know what I mean. Are there some patients that you've— Were this in such bad condition that you had to do this, or is it— And is the impact therefore much greater in the results, do you think? Mm-hmm. Okay, well, first, who is coming to our office? Who is coming to our outpatient clinic? It's only a very few people who are sent by their GI specialists. Only a very few. Most GI specialists decline any kind of operation. That's number one. Number two, about exclusion criteria. There's almost no exclusion criteria compared to other operations. ... other techniques. So for example, for Nissen fundoplication, the 360-degree wrap, I usually try to avoid that for every patient who has any kind of motility disorders in the esophagus. Most patients with a long history of several years, 10 years, 15, 20 years of reflux, and taking PPIs over the long term, they almost everybody has a motility disorder. That's a major exclusion criteria, and this doesn't exist for RefluxStop. We have patients with almost no motility in the esophagus, and it still works. And, LINX, for example, the sphincter augmentation, the magnetic sphincter augmentation, we don't use that, or we don't implant that in any patient with any kind of dysmotility disorders. That's my experience over the years. We have taken several links out of the patient and had to convert that to Toupet, or meanwhile, we convert them to RefluxStop. So what are the exclusion criteria? Like the general exclusion criteria for every kind of anti-reflux operation, history of any malignant diseases, for example, we try not to do this, and then people with severe autoimmune diseases. And there is a rule, hands off, concerning anti-reflux surgery of patients with any kind of autoimmune diseases like rheumatoid arthritis or something like that. So that's the only exclusion criteria, nothing else. And there's no exclusion concerning age, especially. If you look at our patients, we have people at the age of 78, having received a RefluxStop. That's possible, and we have young patients at the age of 25 having received a RefluxStop. Thank you. And for Peter, you mentioned at the outset that you are alongside RefluxStop also investigating and investing in the entire eHealth platform and other products. I'm just curious, I mean, given where the market is and what the entire, not just your share price, but everybody's sort of looking to sort of shorten the time from in investment period into a profitable period, how are your thoughts on sort of balancing that investment program versus focusing on getting to the commercial ground with RefluxStop? And the background is, of course, the shorter to profit, the better in general in this type of market environment. So the answer is that we are aligned. We will further reduce the money spent on the other technologies and give higher priority to RefluxStop. And we are coming closer now. You know, we have done so much groundwork, so we are coming closer to that actually could take off. And, of course, we want to spend our resources to mostly on that, of course. So I think we have the same feeling. Any other questions? Thank you. Maybe I can say, I forgot to present one of my members here, so the head of U.K., Simon, could you stand up, please? He'll be speaking later. My idea was to present them all, but I missed it when we talked about UK, so sorry for that. Yeah, any more questions? Yeah. Rutger Smith. I just didn't get the rationale for excluding autoimmune diseases and prior malignancies. That's one question. The other thing is, maybe it's later in the agenda, but otherwise, could you, Dr. Lehmann, just briefly describe the operational procedure for this? Okay. Well, other or the history of pre-malignant diseases prior to this kind of operation, it's simply that, for example, we have patients who had some cancer in the esophagus taken out there with any minimal invasive procedure endoscopically, for example, that's what I mean, or the same with pre-malignant diseases in the stomach. So we don't want to combine different entities or different diseases. It has nothing to do with acid-related diseases, not this, not like that. So if we have a Barrett's Esophagus, which has gone relatively far towards any cancer treatment, then we discuss that with the patient. Yeah. And if we have other patients with severe disorders, and I forgot the neurologic diseases, like patients with really severe MS, for example, we don't do any kind of operation on those. Because they have severe motility disorders of their whole gastrointestinal tract. That's something we don't want to complicate that. Okay, that was the number one. The number two is: how does the operation work? Meanwhile, we know that most patients have hiatal hernias, and the hiatal hernia itself is about 80% of the whole story, and the last 20%, 25% of the story of doing any anti-reflux procedure is reconstructing or supporting the LES. So most of the work which is done is reconstructing the hiatal hernia. In other words, the procedure, how does it work? So first, we liberate the or we free the whole esophagus and the hiatal hernia, and we operate on the hiatal hernia. We have to free the distal esophagus within, into the mediastinum of about 10 centimeters, so that we can lengthen the esophagus for a long stretch, going back into the abdomen. That's number one. That's the one key component of the operation. The second then is reconstructing the hiatal hernia, repairing the hiatal hernia, and there is still a strong debate between what kind of, of sutures, how strong the sutures, how to do the suture itself, and then some people implant meshes, different kind of meshes, permanent meshes, long-term resorbable meshes, short-term resorbable meshes. This debate still lasts for years, and it's not, it's not over. It's still, it's a big debate. I have my personal experience, my personal opinion on that. That's the next, key part of this operation, hiatal hernia repair. And then the third part is fundoplication. Fundoplication means that here in this operation, we do something relatively simple or similar, similar to the 90-degree fundoplication of Dor, prepared like Dor. So if, if you look here at my hand, we have the esophagus, and then we have the fundus of the stomach here. And what we do is that we plicate the fundus to the esophagus, to the distal esophagus, and the LES, the sphincter, is around here. And then we have this stitch on my fundus, exactly as long as we would like to have it, around 5 centimeters. And when we have plicated that, it covers about 120-150 degrees of the left-sided surface of the esophagus. And then here, on this part, there comes now our implant, the device, and we create a kind of a tobacco sack with a fundus, and then we close the tobacco sack with the implant inside. And then the implant stays here. Now, the question is: how does it work? It's always a very important question, and we can't completely answer this. My personal experience is we increase the tension of the muscle of the esophagus here on this, in this part, on the last four to five centimeters of the esophagus. We have a little bit of pressure here on the esophagus, but it's not really something what you can really measure. And then it works like a nut bolt, meaning that if you have a nut bolt here, this can't go up back again. It's impossible, or it should be prevented, and that's a major key of the whole operation. It's the same with the fundoplication. It works like a nut bolt. It's not only our compressing the esophagus and trying to strengthen the part of the esophagus and strengthen the LES. It's more also like a nut bolt, that so that this part doesn't get, go back again, and you have a hiatal hernia recurrence again, and this should be prevented. That's how it should work or how it works. Can you achieve this through a laparoscopic procedure? It's completely done minimally invasive. It's completely done laparoscopic. Meanwhile, we do it with a robot. It's possible on both ways, yeah. It takes how many minutes? Question is, how big is the hiatal hernia? We have done now hiatal hernias up to 8 centimeters, then it takes 90-100 minutes. If it's a very small hiatal hernia, it's only one suture on the hiatal hernia repair, it's about 60-70 minutes. Yeah. So we have some video clips, short ones, that maybe we can show after the break. They need some preparation for that, but I can show you a little bit how the operation looks like. We have shorter snips, so to say. Yeah? Can I go? Yes. So, Dr. Lehmann, I was wondering about you said that more studies are needed and so forth. Do you know, have you received any notice from the, you know, authorities? What do they want? What do they need in order to start this pay for these patients to do these procedures? You mean the whole setting of randomized controlled trials or registry trials, or? Yeah, yeah, I just do you know what needs to happen in order for this to be achieved? Yeah. As I said before, well, if you would like, or if you want to publish real evidence-based research work, you need large case studies, large registry studies. That's number one. Number two, you have to compare it to standard operative care, like Nissen, for example, and these are the randomized controlled trials which have to be done. And, this is, or this is the way how we convince, we can convince the whole academic world that this treatment works. Thank you. And, Peter Forsell, I have a question regarding FDA. Has there been any shift in personnel or anything that... Because my understanding was they, they were very eager about this project, given the acceptance of the European CE study to use that, but still, this keeps dragging on a little bit. I just wonder, it has to be been any shift somehow that makes it that they might be a little bit skeptical, or what, what's your signals there? ... No, there is no skepticism. It's just that our consultants, they say that you should ask FDA everything in advance. We, for example, should do a cadaver study. That means we should bring 15 surgeons in U.S., they should come one day, and they should do the training on the cadaver, and they say, answer what you think about this procedure. That's standard. We call usability trials, let's say. And then, we had just the intention to do this, but then our consultants say: No, no, no, FDA, they, you need to be really careful. If you have not asked them in advance, they could come and say, "Sorry, I don't like your sentence here in the protocol. Please redo." So what we have done, we have specified everything and gone through, and it's a limited amount of questions you can ask FDA. It's called a pre-submission supplement, let's say. You ask more and more questions, and there is a limited amount of questions you can ask. You can only ask them in a specific way, very broad. And what we have been doing is to have them to approve all the work we have done. So, you know, we have done huge work on this user. It's not only it's protocol, it's risk analysis, it's exactly describing what you should ask the surgeons. All is huge bureaucratic, huge paperwork, and just supply everything to FDA and say, "Is it okay?" And if you don't do that, you risk to redo everything. And every time you do this, it takes three months. So, everything looks really good with FDA. It, it, you know, it's just that FDA is a little bit tougher organization. They ask for more things. If you should do, you know, biocompatibility testing, they should, of course, have more products done. You know, everything is a little bit extra, extra everything, so to say. But everything looks really good. In terms of the team, you can say half of the FDA team last time was the same, but there was a new doctor, for example, and it's like talking to Telia, you know, it's a huge organization and many people. But everything looks absolutely good. It's just that we have a little bit more work based on the answers we got. We had the last meeting in August. So what we are doing now is to do a few more tests, a few more things that they asked us to do, and that's what we are doing right now, then we will file. And if that is before year-end or first quarter, but it is, you know, last quarter or first quarter, that's what we see right now, to be the filing date of this submission. And then, you know, it will take some time. So that is not in our hands, you know, it's- And just one more. It's on when you get your authorization, if it's approved later, as I understand it now, I mean, in order to get full reimbursement, you will need to do a randomized trial in the U.S. And then I wonder, so, I mean, how will it be as slow in the U.S., you know, to ramp up, you know, sales in parallel of that, waiting for those studies or- That, that's the key. Because, I mean, how much share of the- can you take before those randomized trials are conducted? So we are, I mean, now I've got a little bit to other people's speech, because we have, you know, different people coming and present things. But we are actually starting up now two randomized trials, and that will happen right now, we will provide, you know, we have to commit, they approve, and we have selected the centers and so on. So it's, we are already doing it in Europe to save time, and then we see, you know, if this could be expanded to some shorter U.S. trial as well. But in U.S., in Europe, you know, it's in Germany, for example, you have a code for a specific procedure, that's the money you get. If you come with something else, difficult, huh? But in U.S., they have a much more easier system. I think Amit will show you a little bit of success stories based on U.S. approval. In U.S., it will go like this from the beginning, because it's so much easier, and you can just call the insurance company, "Hey, I want to do this procedure instead of this." It is many ways to get business early in U.S. that you can't get in Europe. Even before randomized study. Or even before randomized study, yeah. If I may just say something on that point. You know, I think you, when you say randomized trials are a requirement, that's not necessarily applicable across the technologies. There are very few categories of products where randomized trials are required. So we may not see that entirely for our technology. You know, we believe, actually, we will be ahead of that requirements, and I'm going to cover some of that. I have a question to Dr. Lehmann regarding the patient with complication, this 1.2% of your old patients, with the device imploding into the stomach. Did you study the mechanism of this, what's happened? Yeah, um- Did you hear, did you hear of the same cases in another centers? Yes. Yes. And in this case, how many? Yeah. It's the number is very low. I know from 5 cases, which is 1%. And the reason for these migrations might be learning curve. So in our patient, we had the impression, looking at the video taken of this operation again, maybe the tobacco sac was closed too tight, so there was too much pressure on the gastric wall, and it just went the easiest way, and the easy way is going through the through the gastric wall into the stomach. And it's really it's a, maybe it's a question of technique, and I know from other cases, from 2 other cases, they had some injury to the gastric wall before that. And but we are in a learning curve, and since the last 50 patients in my hospital, we haven't had any problem at all. Is there any time rule, regarding this, complication? Yeah. -with respect to the primary of operation? Our patient had the impression of having reflux again, nine months after the operation. I know from another case, this patient had the impression of reflux again, two weeks after the operation. This has to be a technical failure, a technical mistake done by the surgeon. Yeah. Thank you. Maybe I can... Am I on the mic? Yeah. So, you know, we have a CE Mark study with 50 patients, and they have now 6 years, and we have so far no migration. And the cases we have had, we think we have identified either an injury to the stomach or that it actually has been sutured a bit too tight. And if you saw the product, it's done in 5 pieces. And the reason... Wait, I have a deep pocket. So this one here, it's actually in pieces like this, huh? And the reason for that is that we know from the gastric band business, because I developed that business, as you know, and we know that the gastric band had problems, that it sometimes eats its way. You know, you try to make a time glass, hour glass of the stomach, and therefore put pressure on the stomach, and sometimes the band could go through. And they find out, basically, in the literature, you can find support for that is a pressure problem. If you have... The more pressure you have on the stomach, the higher the risk, of course. It's very logical, of course. And if you do it, you know, the CE Mark study, I joined 47 of the 50 surgeries, so I, of course, ensured that nothing was done too tight, and then you have no problem. So I think we have high likelihood that this problem is related to the pressure you apply. But because it's in pieces, it's not such an important complication because it just pass out like food. And like you said, this patient, he noticed after 9 months, most likely, this was done before 1 month. But because you have all the fibrotic tissue and, you know, you, you have suture and you have put things down, the patient are still treated for some time, so they don't connect so well, you know? So, so therefore, you, you are still... It, it doesn't become a direct connection normally between the symptoms and this. It takes some time to regain the symptoms, let's say. So it was not related to a perforation of the wall? I mean, we know one case where the doctor told us that he had damaged the wall, you know, during surgery, but that's specific case. I mean, normally, you should not need to damage anything, you know, but this is... I said it's a little bit a learning curve. It's like whatever you should do, if you're a painter, electrician, whatever, you know, you need to train a bit before you become good. That, that's just part of life, but that is not really... it's not a device problem more, it's more, to some extent, of course, it's device problem, but when we know these things, we are now developing, which also Mark will talk about the training program, where we really, really carefully, we go through and we establish a much better training to try to reduce these incidents. Thank you. Any other questions? Okay, maybe we can pause for a 15-minute coffee break and restroom break. Thank you very much. We'll meet back here in 15 minutes. Thank you very much. Welcome back to our CMD. We would like to start with one or two video presentations of the surgeries, since we had a couple of questions on that. Then after that, we'll continue with our program. Here you see it's a special instrument. We have to introduce it in the device, and this is the stomach. Here we have esophagus, and they are sutured together. And then you close now this pouch, so it stays in the position you have planned here. And behind here is the diaphragm, you see. So this is esophagus, this one, and here is stomach, and it's placed invaginated in the stomach wall. What's the point of having it in four pieces? Is it just that they can grip it? No. If the surgeons suture this pocket too tight, this pocket will actually now, when you close it, it will hang like a teardrop into the stomach cavity. So imagine you have the stomach like this. And I will take my little device again here. Two seconds before we start next. You take this device outside the stomach, and then you close it, and you suture so it's closed. Then it hangs like a teardrop in here. If this pocket now is too tight, this could be forced to eat its way through and enter into the stomach cavity. And what happens then, is that this fall into pieces and come out like food. People doesn't need to reoperate. That's sort of the purpose. You can take the next one, you need to run with double speed. Two times speed on that next video. Okay, so here you now see esophagus, and this is the stomach, and they are now adhering, you know, just the stomach to esophagus. And in this case, it's a special suture who is barbed, it's called V-Loc. So it has some hooks. You see, it's some hooks on the suture here, so it's some keep in place. And this is double speed or? It's not possible right now. Not possible. Oh, okay, then this video is a bit long. I think it's, like, four minutes or something. But you can see the principle. Maybe we can maybe just... You see, you suture all along esophagus, you put them together, and you make two rows of sutures to hold them in place. And that's the fundament for the after then placing the device in the outside the stomach cavity in this pocket. So you see the principle. You just make some small, nice sutures here, and you go all the way up. I think we can maybe stop there, oh. Okay, thank you. Yeah, I don't know if there was any more question relating to the procedure. No. Peter, do you want to take your laptop? Okay. Thanks. Okay, so now we're going to shift back to the Implantica team. We're going to be introducing our market access strategy and accomplishments by various members of our experienced team. We'd start with Amit Kakkad, who is our Chief Market Access and Strategy Officer. He has led commercial roles and market access at innovative medical technology companies, including Masimo and Second Sight, among others. Check the mic is working. Thanks, Nicole, and thanks, everyone, for joining us today and giving us the opportunity to really share our vision on what we are doing at Implantica, but essentially how we bring it to reality and try to collaborate in ways that are needed at this point. What I'm gonna spend next 20 minutes on today is not necessarily what you already heard. You know, you heard some incredible information about how we see this product meeting an unmet need that is so profound worldwide, and having an impact on patients' life in ways that are probably unimaginable. When I joined, when I got into this venture, it was very hard for me to realize what it means to have such a disease. I spent a lot of time in cardiovascular, neurology, ophthalmology. I never really knew what it means. And when you do that, it just makes it so real. I mean, I think we heard it, we heard it. We are lucky to have Professor Lundell with us, who is the world authority on, you know, in this disease condition, and hear firsthand what it means. So I'm really privileged in that way. You know, we want to certainly share that burden of disease condition, what it means. And then we had, of course, our world leader in doing RefluxStop cases, Dr. Lehmann, who shared what it means from his perspective doing it, and then our patients who actually can truly tell us what it means, does it have an impact or not? So I think we heard so much on that front, and the only thing I can conclude from that at this point, knowing what we know, and we have a lot more to know, but knowing what we know, we know we are doing the right thing, we are on the right track. There are very few products that can establish such level of rigor early on in the process, in such a short amount of time, getting the kind of partners we have on the clinical end and on the execution end. So I'm kind of really thrilled about showing you the other side of the story. Another side is, you know, any such opportunity needs to eventually be a business. That's why we are here, and I think we can appreciate that we need to turn this into a business. So the question is: how do we turn this incredible opportunity into a business? And what will it take? What milestones we need to accomplish? We heard some amazing questions this morning, and I hope to address some of that, and then my rest of my team will continue on that path. So if I can have the next slide here. So, of course, you know, it is, it is always revolutionary, when you, when you see some amazing outcomes like what we have seen. But I would say, I think the confidence we have as a team, spending this much time we have, we have spent in the field, seeing patient outcomes, seeing the responses from the top-notch leaders of the world in GERD, one thing is becoming clear: we are reaching an inflection point where we start to see adoption, where we start to see centers of excellence in Europe, in the leading countries we are focusing in, trying to really appreciate what this device does, and they want to learn a lot more, and we will get to that point as well. But it certainly indicates we are at the inflection point where things starts to, you know, shape up really well. So how is this the business? Let's talk about the financial aspects. We talked about this in the morning, and I have actually more conservative figures than Professor Lundell, and you heard from Dr. Lehmann and even our CEO. What I, but I want to show you is there are about 20 million people, and I'm only focusing on Europe and U.S., and Canada included, if you want to extend that. But the idea here is to look at the opportunity, which is near term, something we can truly impact, and something that's reachable within the massive amount of work we are doing in order to create adoption, create market access, get reimbursed by payers around the world. So about 20 million out of 50 million people who are chronic users of PPI. We heard about PPI all day long. So, PPI's chronic users, people who are on higher dose, long-term, about 50 million, more than 50 million in Europe and U.S. combined, 20 million of those are not getting any benefit or having a severe, severely low level of benefit. If I go with some of the figures that were quoted this morning, 25%, at least on a conservative level, of that number is still not getting any kind of optimal treatment to be very, very conservative. So what does that mean? If I see the whole market as 100 billion dollar euros market at the price point we sell our device in Europe, which has potential to be much higher in the U.S., that is still a massive, massive opportunity. I can't think of many disease condition, having worked in very innovative spaces of this nature and magnitude. So this is certainly from a business point of view as well, a very, very strong focus we wanna keep, keep, keep going. So if I just translate in all of this into simple conclusions, one out of 100 patients today, severely ill, who are eligible, who should be treated in an ideal setting, are getting this therapy. So one out of 100. My simple statement here is, you know, if we can turn that into 10 out of 100, not 25%, but 10% of this truly unmet need, true, true patient group that we can help with, you know, we are looking at a very, very large market here. So that said, I think market opportunity for this field is probably unprecedented. Now, let me quickly get into some history here. I think you heard about so much innovation has happened historically and over the last 70 years, when truly the very first treatment that came to existence, it was invented. From that to today, a lot has happened in this field, and we have to appreciate the complexity of this field. So if you look at the first part, where you have traditional procedures completely done without any devices, and you have a number of those from the 1950s to all the way to the 1960s, a lot of new technique came. Some of those are still existing and working well to a certain degree, just like PPIs, but not really addressing the need of this chronic population where things are not effective and, you know, it continues. So you then, you get into the next phase, which is all about device invention. So from early to late 1970s to all the way early 2000s, twenty eleven, in this case, you saw many innovations coming in, and they were trying to make the point that, you know, we can have electrical stimulation solution. We can have magnetic sphincter. You put a titanium ring around the esophagus. There are a lot of complex and interesting innovations. I would say all of those were interesting at some point, given that what they were doing. But the reality is, you saw the numbers, none of that really made a big impact. So what is missing? So RefluxStop comes into the picture in 2018. We got the CE mark. We have proven ourselves to be safe and effective. And if you see what we have accomplished in these 70 years, based on what we have seen so far, 550-ish patients' data. We have experience from the SE study, 5-year data on, and we have the real-world cases from Dr. Lehmann and many surgeons around Europe. This is the only therapy that essentially is trying to look at the problem differently, looking at the root cause of the GERD. Why is it happening? The whole anatomical discussion we had this morning, and Peter showed some other examples. Why those three components of the physiology get distorted, and sometimes it feels like it's a simple solution. All you have to do is put it back in its place, and it's all good. And we heard from some of our patients through first-hand experience of what that means. It's not necessarily a problem that requires electrical solution and, you know, complex equations to be put into the stomach. A solution that is as simple as ours, a design which is using the product material, it's so well-established, so well-accepted. You have the safety aspects really well addressed. I mean, this is one of the finest products in that category to have a material being used, which is so simple and effective. You're doing all three aspects of reflux issues, the anti-reflux barrier that we looked at, three components. We are touching all three at the same time, and hopefully, this will validate, it gets validated over time as we do more and more cases. So what's holding us back? We have a fantastic product. We have already 500+ cases. We have five-year data on our SE study. So what's holding us back from reaching the potential we believe? Well, I think the answer you heard, we have the sales opportunity that we can, we can go after, is pretty locked. Why is it locked? Because we don't have necessarily the key to unlock it, and this is my, my rest of this, presentation about... What do we need? We need to answer some questions for the market. We need to answer, we have the CE Mark, which means we can sell. That doesn't mean a hospital can buy our product. We need to answer the question, who will pay for this technology? How much? What's the criteria? Not every case gets paid. If you have reimbursement, that doesn't mean you have 100% of the market. There are many medical criteria to go through. There is a separate category of requirements for each new technology that comes to the market. So it's a long way, but that doesn't mean it can't be accomplished. This is where we are focusing. That's why we emphasize we want to be getting the best-in-class reimbursement for our product, and looks like we are on the right track. And let me give you some more perspective on why is it necessary. You know, if you look back 20 years, 25 years, physician would come in, look at the new technology, they like it, they run some experiments, they do a couple of cases. They can talk to the hospital management team, and that's where the adoption happens. Everybody likes the product, it starts getting... And the uptake starts to take place. In the last 15-20 years, what has changed dramatically is we have a shift of power from physician to different stakeholders. Now, you don't make the decision simply based on what physician wants. In most countries, the system has become a lot more complex. As you see here, you got health technology assessment institutions. They are funded by government, $10s of millions every year, to look at any new technology that gets CE mark or FDA approval, any kind, and evaluate the potential. Are these products having the right level of evidence? Is the pricing okay? Are they going to be cost-effective if we deploy this? Are they really medically necessary? Given all the solutions we have, do we need to do anything different? Should we increase our portfolio of products to be offered? So there is a rigorous assessment going on. Same thing happens with the hospital boards. There is a rigorous environment there. You have a team of experts from finance, from operations, from clinical, medical, and they all sit together and evaluate, should we adopt a new technology in our hospital? Will we be cost-effective or not? So that's kind of what you see around this, some of the aspects they evaluate. So it's not the same thing as it used to be, which is why you see more and more companies talk about reimbursement, how critical that is. And the moment you become an implantable technology, which is the highest risk-level procedure or medical evaluation, in the process, you start to go into the domain where the standards of acceptance are going to be higher and higher and higher. So we are looking at the highest level of rigor we need to put into our processes to see success. So let me kind of get into now, what do we need from a market access standpoint? Now we know the environment. Okay, it's changed, and we have to deal with a lot, and some of the questions went into the direction, what it means to have... Or do we know what payers want? I think there was a question this morning, do we know what they want? Do we know how to get there, and what kind of work we have to engage in? So let me get into a roadmap, and I divided that in five levels before we can claim market access success. So you see, the very first is KOLs and clinical validation. Every technology, any product, be it an implant or not, but implant being higher risk, requires higher level of rigor. It's not enough to test it and see, study only in a very controlled environment. They want to see what does the real-world data look like. We want to see, if I adopt a technology and I don't have any more control, does it still work? And some of the stories you heard this morning, they are from real-world cases. So our confidence level is enormous at this point, knowing 500+ cases went so well. Long-term data from C study, long-term data from or relatively long-term data from other real-world cases, where we have up to four years now, is phenomenal. This- this doesn't happen with every product, so, so that gives us this extra confidence. So 500+ cases, all these countries doing well. Next point, we need to have exceptional patient experience. As Peter mentioned, you know, FDA and other regulators and payers, insurance companies, health systems today really want to see early phase data. Is this data robust? Can we believe that? We're gonna make a national policy, and we're gonna start paying tens of millions EUR or USD every year for a new product, which they can't reverse. So they want to have the highest level of confidence that this product is necessary, this product has extraordinary outcomes, and this product is well designed to be cost-effective for the system in the long run. Hundreds of innovations come to the market every day. Our health systems cannot afford to pay for every product, so this is becoming more and more of a challenge as economically, our society and you know, worldwide, I would say in Western world especially, our healthcare costs continue to rise and rise and rise. U.S., particularly, even more. But this is a huge, huge, need. We need to demonstrate scientifically, that our outcomes are robust and well accepted in that community. That's why we... You continue to see, probably through our press releases and activities, we are attending some of the top-notch conferences, medical society conferences, where our data has been phenomenally well accepted, presented, and we are getting incredible support from those places. So this is, this is a big validation of what we are doing. Number three, robust clinical outcomes, effectiveness, and this is about publication. It's not enough, if you can think about it, it's a ladder. I think Dr. Lehmann had this pyramid in his presentation. If you're presenting data in a conference, it's great. That means you have started your scientific activity. But it's not good enough until it's published in a reputed journal. So step one is great, but you've got to go to step two and step three and step four. So that process has already kicked off. We have more than 20 papers already being submitted, reviewed, 200 patients-plus worth of data that's coming out. So you will see all of this is coming out because we are working on it, and believe it or not, each paper can take up to nine months to be published from the time you start. It's an incredible amount of work. So scientific rigor is very high. We are only targeting very, very reputed journals in our space, so we can move fast rather than doing average journals, and that requires more validation and more... So we are shooting for only the best of the stuff. So I'll continue to move. The last 4 and 5, these two are about, are these data sets validated in a more rigorous environment? As I said, you know, you've got to continue go up the ladder. There was a question this morning: Do we need a randomized controlled trial? Absolutely. We need a randomized controlled trial to have the best access to the market. We don't want to have a few patients paid here and few patients paid there, or even a 1% of our market. If you wanna go for the full market, you have to get the best-in-class evidence, and that's why we are doing two randomized studies, as you see, as Peter announced. We are working very actively in very short amount of time; those are gonna be kicked off in Europe. Then we have European study, then we have another registry. These are real-world data collection from centers like Dr. Lehmann's. So that's the mission we are on, and I just wanna highlight one thing for you. Some of the competitors we have in the market, you think about the magnetic sphincter and other kind of products. In the history of 15, up to 15 years of their commercial process since they have launched, none of these companies took on a mission for evidence generation or showing that we can go through the rigor of such a trial, even as of today. They are... Most of that business is still built on non-randomized trial, non-scalable registry data, and so on. So there are a lot of limitations on that end, and we have gotten to a point where we believe we are going all in. We have the confidence from the top KOLs. The progress we have made in the true launch time, which is post-COVID. If you really count when we launched, we didn't launch in 2018. We truly launched in late July, July or August, mid-2021. That's when truly we started to commercialize, because COVID was disappearing, elective cases were coming back, and we were getting adoption, we were getting interest from the hospital leadership teams, why this product is necessary to be integrated. What we have accomplished in just such a short amount of time, where we have, if I can, get to this slide, where we have already started interacting with some of these institutions. So I just wanna simplify this slide for you. What I'm trying to show here is, you got... All these are institutions, their names, that represent data evaluation. So if you go to Germany, you have 1 or 2 institutions here that will look at your data, evaluate, put a report out, and say, "Should this be introduced in the healthcare system or not?" You have 1 from Sweden, 1 from U.K., maybe 10 from other countries. So this did not exist, nearly did not exist in late 1990s. Early 2000s, maybe there were 3 or 4. In last 15-20 years, there are nearly 100 institutions established across Europe and U.S., that are required to sign off and say, "This product shows great validation of clinical work. The patient outcomes are really well. It's well-tested in registries. Real-world data is solid. The randomized trial data validates and revalidates long term." That's what you need today in order to make an impact. And once you have that, sky's the limit. Sky's the limit to explore. But until you have these people behind you, institutions behind you, CE Mark is the beginning of it. So this doesn't mean the same thing in the U.S. U.S. is a lot more open, and I will get to that in a minute, but this is where you start worldwide. Wherever you start, whichever country you start, you've got to go through these institutions and get them behind you. This is what we are working on. Now, I'm gonna run through some of these slides. One thing that we can't emphasize more, and Peter did that really well in his presentation, we need data that is highest quality, but highest quality data comes from best centers, best surgeons, that truly knows how to establish this field. And this is where we are focusing. We are focusing on the top two levels, where we certainly need political influence, because any disease condition should be recognized as a problem. One of the biggest problem with our field is, when you talk about acid reflux, people think lifestyle. People don't take it seriously. In fact, some institutions, large, reputed institutions, wouldn't take it seriously. So you have to educate the system. You have to have that political rigor in your process to make sure your voice is heard and you are accepted in the system. So that's what we are. We are focusing on collaborating with the top-notch leaders in the world. And then second, which is we have national and regional KOLs. These are the experts like Dr. Lehmann, who are top of the art. They are involved into decision-making of, you know, how healthcare systems make decision about these, running one of the biggest, biggest hospitals and, and providing that competence to the... and validation to our process. The second piece here, we are also focusing on how do we generate more interest in the therapy, because if so many patients are having this issue, where are they going? They are going to GPs. They are going to their gastroenterologist, GIs, and this holds roughly more than 95% of the market. If these people are not aware about our therapy, they are never gonna refer them anywhere. They will keep them on, on PPIs forever. So this is why the other focus we have is, we wanna go to every country we do, all the major hospitals we work with, and partner with the GI space, so the referral process starts kicking in. And they, these patients get timely informed about when there is a new therapies available. You heard from one of our patients, how she learned about this therapy. She learned about this therapy by going, reading a lot, probably, one of the GPs was involved in the process. So you have to create that connection, which basically unlocks the referrals and then brings back awareness and confidence that there is a validated therapy that can go. And then once you have done that, that this is scalable business. This is hundreds of centers coming on board because it's been standardized, it's easy. Easy is the word of the day. I really like Professor Linden said, "One of the solutions we need is turn this therapy, turn this pros- procedure into a very easy process to deploy." And that will come with... You will hear a great training program that we are putting in place, but that's, that doesn't come overnight. You've got to start somewhere. You establish it, you establish the standards, you publish those standards, and then comes next, which is scalability. So that's why our focus is on the best of the best centers. So a lot of KOLs joining us. Just want to highlight, I think this has been presented before, so we've got 100+ centers right now that are target in Europe. Fifteen of those are already onboarded in the last nearly 18-24 months. 30+ advanced discussions, which we expect to come—to bring on board. So, and as I said, we really started two years ago, so now we are taking off. The interest is incredible, and we are gonna be very, very selective in how many centers we choose, under what standards and qualifications. So we have a big wave coming up, and we are excited about it, but this is also a huge responsibility, so we do not compromise our strategic plans for U.S. and other markets. So just kind of, you know, really, again, saying this is, this is rather more last six months since we are building our, our, teams, our competencies in different countries we are launching. This is where we have direct-to-consumer advertisement, speaking to them under the laws allow, that allows, communication, two-way communication. We are doing a lot of seminars and campaigns. So some numbers there, but this is really the beginning. This really is taking off. We are working on very exciting projects, and you will see some of that, updates coming up in the coming months. Similar, I mean, it's a no-brainer for us that we were rewarded as most innovative device in Europe, but I think it's also a privilege that we have to take seriously because a lot of customers, a lot of patients come to us and say, "Oh, we heard that this has been... This is very innovative." And sometimes innovative means it's not tested properly, or it's too early to use, or it's too limited in information. So we have to, you know, start creating a lot of awareness and campaigns around this so people really start understanding how advanced stage we are in such a short amount of time. Last section. So all of this is good, but then what does it mean in commercial reality? Has there been companies doing this, and have they really proven themselves to be successful at the end after doing all of this? This is years and millions of dollars going in. What is the validation here? And I want to show you rather recent stories, what happened and how they pulled that one up. So this is a story of a product called UroLift. Just a disclaimer, you know, all this information, sometimes you're trying to gather can be not perfect. So, you know, some of those are also estimations, but this is the big picture. Big picture is here. They got CE Mark in 2009. 2009 to 2014, all the base work that we are doing. This is. These are the years when all these institutions I showed you started to grow. They were asking: Where is the data? Where are the trials? Where is this? Where is that? They had no reimbursement. This is a EUR 4 thousand or EUR 5 thousand product, I think back then. Might be a different price now. They spent 5-6 years just bringing the right people on board, getting the right data sets, massive number of publications, build the right registries, real-world evidence, as we discussed, get the randomized controlled data. They get FDA approval. They, I think they required FDA... FDA required them to do that kind of some of the clinical work. We are even stronger in that way because FDA is not really requiring us to do a randomized trial yet. We probably will need none of that for any of that. That randomized trial is really the highest standard for full market access, so that... We are being confident enough to pull that off in a speedy way, which is why we are designing all these studies now, so we are ready in 2-3 years. But this story tells you it can be done. I mean, you're, you're looking at from nowhere, they get into 27, roughly $100 million business, and within 4 years, they get acquired for $1.1 billion. And there, there are a couple of other examples. I wouldn't say many, but if you do the right things at the right time and you have the validation process well implemented, which is what we are trying to do, and I think compared to many other very successful ventures, I feel that we are on the right track and doing the right things at the right time. So hopefully, we pull this off and are comparable to something like this. This is another major success story. This is Inspire Medical. It's an instant implant for CPAP. Amazing story. You know, they start... Say again? For snoring. Yes, for snoring. Sorry, for snoring. This is a very similar story as well. You see, 2007, the company is formed, then they get CE Mark, you know, within three years from existence. They do a first trial in 2014. Four years, four, five years is the typical time when I would say some amazing technologies really know that whatever we did in the CE study, in the regulatory space, by working with experts and the top KOLs, we have enough confidence to take the risk of doing a randomized trial, not at a small scale, but pan-European scale. And we are also collaborating with payers, or at least getting their feedback. This is unheard of, just, because some of you may not be into this world too much, these health technology assessments are a one-way street. You go to them, you tell them what do you want, and they will tell you, "I want everything," and then you're stuck with that. To take that kind of ambition and be there and ask them that, "Hey, we have the confidence to pull this off," is not a small thing. And I have to say, you know, by doing this, we feel actually extremely confident that we are our trial designs, everything is aligned with what they really want to see and how they want to see. We now have to do it well, do it fast, and get it done. So that's our really objective. Again, you know, amazing story, and you can please, and as I said, factually, please double-check, but this is the current overall status of something like this. Last slide. Where is RefluxStop, and how do we see ourselves, you know, progressing? 2018, we get CE mark. I would take 2, 3 years out because we truly launched in 2021, not, not 2018, because of COVID. So if you really see what we have done, we have already introduced the product and got the top KOLs, the best in class we could think of. Everyone is, is on board, and I think it's way more than we actually hoped for. So this, this... We couldn't be in a stronger position to say: Has this technology gone through a validation process incredibly well? Yes. Second phase, 2022, top-level initial KOLs and COEs onboarding. This is. You start calling something center of excellence when they have shown you data that they are actually great KOLs. They are great surgeons who are not only doing generally well in terms of field, and they are, they are thought leaders, but they can actually implement things in a way that are scalable. We have... This was our first center with Dr. Lehmann, where we had the scalability. Even if it's not reimbursed, you can deploy a new technology under certain circumstances where you have to convince the hospital team. It's, it's much harder, but it can be done, and you will be only finding limited number of centers to do that. We got that done. We multiplied that. Now we have roughly, I would say, 10 plus centers, and we are looking at another 10 plus to come on board. This is- this could not be stronger. I mean, we wanted to... We will continue to rise in that level of confidence and adoption, but this is really done well. 2023, we are this year. I don't know how many companies are out there that have published or been accepted, their data has been accepted in top 20-30 conferences in their fields worldwide, and we are talking about North America and Europe primarily. We were not prepared to see that kind of success. I have to be honest. But when you see that, you get more confidence and more confidence, and then you start really leveraging everything you take and think about speeding things up. That's why we are committing to randomized trials, which is the fastest way to get there, because we want the whole market. And by the time we launch in the U.S., we believe, not only U.S., I would say U.S., Japan, of course, we are targeting Middle East at that time, in 2025, 2026 onwards. That is the time we want to scale, because by that time, we want our program, our training program, to be super well-established. We have the rigor to scale. We'll have the team and forces behind us, and most importantly, our worldwide, the top KOLs, will be able to claim the success can be repeated, can be, can be, you know, scaled to the levels we want, and hopefully, that's the time when we, when we truly establish this therapy. So I would say, you know, I think overall, the de-risking of a technology happens over a lifetime, something like this. We have some great examples, as you have seen. You can find more. But are you following that curve? Are you taking the right step at the right time, or are you jumping the gun sometimes? Because many companies, under the pressure of proving adoption, they start diluting the focus of quality. And I think this is something we have strictly, you know, as a company, as a management team, committed to itself that we know what's the right path, and that's the one we want to take. So with that, I want to thank you, and sorry for taking a little bit longer. Thank you, Amit. Next up, we have Dr. Sarovar Golam. He is VP Payer Evidence and Health Economics at Implantica. He is a medical doctor by training and has spent the last 10 years at AstraZeneca here in Sweden. Eleven years. 11 years. Sorry, got that wrong. And he's led the global payer evidence at AstraZeneca for several flagship products, building them into multibillion-dollar drugs. Thanks, Nicole, and thank you very much for your patience, listening. So, I will walk you through some, some really, execution-level, information that we are doing or we plan to do or how we will do. So it's more, a micro level rather than macro level, like Amit, Peter, and other speakers, presented. So it's, it's more about what is my team is doing, and my colleague, Mark, will, come after me. We are working very, much in an aligned way and almost together. So these are more about execution level. So what is the treatment goal if you see from a patient's point of view? It's very simple. Patient wants symptom relief with fewer side effects, and they want that these two should last longer time period, right? 3 year, 5 year, 10 year, 15 years. This is a very simple expectation, right?... But what is the existing treatment reality? Yes, we get some symptom relief that our surgeons and other speakers told. But in some cases, there are high rates of side effects. And often we see there is a waning effect of treatment in 3-5 years or beyond 5 years, meaning the treatment effect doesn't last over time, 10 years or 15 years. That is the reality, unfortunate reality. And we have lots of literature, variable literature, on that. And what is the reality that potentially RefluxStop can offer? So far, Peter mentioned that we have 1-year data, 3-year data, 5-year data, and some of the patients are having 6 years data as well. And we have, from real life, almost 500 cases, and we know some of these patients also reached 3+ year evidence. So if you take both our CE Mark study and our real-world 500 cases experience, it is, it is really, surprising that RefluxStop is potentially changing the reality. Very few side effects with a fantastic symptom relief, and these results are consistent over 3-5 years now. So that is the opportunity of RefluxStop. That is the potential of RefluxStop, what it can do. It can change the treatment paradigm. So that is our, our, goal to achieve and how we, we want to do and what we are doing. That is my, next few slides. So from my side, and, partly from medical side as well, we believe we need a winning combination of team, and that we have, we believe. Medical, payer, and commercial execution. That's the three areas that needs to be aligned. Our audience is different payer organizations like TLV in Sweden or NICE in U.K. We need many, many center of excellence hospitals. With these broader categories of audience, payer evidence, medical affairs, and commercial execution, these three team should work and get the excellent execution. Now, from payer's point of view, from TLV or NICE or HASS or German payers or U.S. payers, the questions are very simple. Only four questions they ask. Only four questions. What is the burden of reflux disease? Is it really serious disease? And you heard from Professor Lundell, it's, it's really, really, really a burdensome disease, right? Not only in terms of number, but in terms of patient level sufferings. Second question is, why we need another new intervention, new technology, meaning the unmet need. Third question is, what is the clinical value of this, this new technology? What this new technology can offer? Is it the quality of life is very good? Is it the side effects are rare or very low? What specific this new technology can offer? And the fourth question is also very important, and specifically Europe and North America. If we cannot address this fourth question, it is very less likely that we will get reimbursement. That the question is, what is the economic value of this new technology? Why healthcare system should pay more for this new technology? These are the simple four questions that we are trying to address. And how do we can address these four questions? The only way is generating evidence, generating data, right? So that we are doing. So what is our goal? That's also very simple and aligned with the questions in the previous slide. Establish the burden of disease and unmet need. Establish the differentiated clinical value perception, meaning why RefluxStop is better than our predecessor. Demonstrate a clear patient-centric benefit. What patient get out of this? I mean, if they get RefluxStop instead of fundoplication, what are the additional benefit patient will get? That has to be clearly generated. And of course, we have to establish the quantifiable economic benefits. If RefluxStop used by a patient, how much money can be saved to the patient and to the healthcare system? So these are the data that we are generating. And just to give you a more simplified version, we are generating four buckets of evidence, both from randomized clinical trial, real-world studies, case series. The first bucket is evidence that will support and establish RefluxStop's value. The second bucket is that evidence that will differentiate us from fundoplication and other treatment options. Third bucket is evidence to defend the price ambition. You already heard, RefluxStop, we have a price ambition to achieve. We have to defend that by our clinical and economic data. And finally, we need to generate evidence that will show that RefluxStop works in the long term. And all these four buckets are started and up and running in different forms. This is a very high level overview you already know and heard from, others. We already have 1-year CE mark study that is published. 3-5-year follow-up data are now currently available. 3-year data is submitted as a manuscript. We are doing continuous case series with center of excellence, like Dr. Lehmann here. We are getting this different centers of excellence publications, data, and sharing with experts and patients and relevant stakeholders. Our registry is up and running. My colleague, Mark, will talk about that. Of course, we have multiple RCTs that protocols are currently being either under development or we are already sharing with the relevant stakeholders. So this is the, I would say, very strong, consistent program, clinical program, that RefluxStop is currently holding. And now, how we do this. So this is even more field-level execution, I should say. We are having more than 15 projects commissioned to prove the burden of disease, systematic literature review, real-world data synthesis, database analysis, all those kinds of projects, where we are getting 20+ academic and public institutes involved in these countries, as you can see, and we are having expert surgeons and GIs from European Union countries. We are aiming that we already achieved part of that, significant part of that. We are aiming to have 50 publications this year, that it will include abstracts and manuscripts together. And all this evidence and experience will go to our country-specific file when we will file reimbursement application to Spain or Italy or UK, that this all will contribute to that file. And that is the execution plan that we are already following. It is just to give you some numbers, and we aim next year, even higher than these numbers. You see some of the logos here. These are actually the biggest conferences in the world. If you think about biggest conference in surgical world, that is the SAGES conference in North America. If you think about biggest conference in gastroenterology, that is the DDW conference, or you can see some of the regional conference, like Swiss College of Surgeons or Kirurgvecken in Sweden, something like that. So I'm showing this because we have participated every possible conferences in the world, biggest top-tier conferences, as well as very much country-specific, smaller-sized conferences. Because we did, because we wanted to share our data, and at the same time, we did because we are generating our data. And this data actually giving more and more confidence not only to the surgeons, but also to the patients and payers as well. So we have to gain confidence from surgeons, from patients, and from payers. It's nothing only about surgeons, I should say. The middle one, it is just a kind of showing that what is our level of submission quarter by quarter, and we are almost on track. I should say we should probably exceed. As of now, 35 conference abstracts submitted in leading conferences. We received... Most of the abstracts are actually received oral presentation. As you know, in conferences, oral presentation gets more audience than poster and others. So we got 25 oral and poster presentations, and as of now, 15 manuscripts are published or under submission for this year. We already published 3, 3, 2-3 articles before this 15. This is our published article that Peter already showed. It is a cost effectiveness analysis for RefluxStop, based on UK healthcare system. We have two papers, economic analysis, that we completed and submitted for UK. And same analysis we have completed for other countries, Italy, Spain, Switzerland, Sweden and Norway. And Switzerland, Sweden, these economic analysis are accepted to present to the largest payer conference. It is called ISPOR, and Norway is being submitted to a Norwegian conference. This is another important area that, some of our, other speakers talked about. This is called a special subgroup of reflux patients. They are dysmotility. We have our, patient here. He had also dysmotility disorder. This is a patient has very little hope with the current, treatment options now, and it is surprising that RefluxStop showed promising results in this subgroup. We submitted 3 independent publications that will come out soon to tell the surgical community that these patients can to be treated very well with RefluxStop. This is my last slide, and just to give you, again, very specific execution-level information. We are aiming 50 publications, and payer submission in UK is already ongoing in 2023. The same, target we are doing in 2024, we are also aiming at least to start 2 EU countries payer submission process. And finally, 2025 will be our probably busiest year, when we will launch all of our activities in U.S. Specifically from my team's side, we will launch a significant number of U.S.-focused evidence generation project. Thanks. I stop here. Thank you. Thank you, Tarar. ...Next up, we have Dr. Mark Cregan. He is a former professor from Australia and discovered stem cells in breast milk. He led medical affairs at Medela, and he led US clinical and commercial activities at MedAxos. Thank you, Nicole. Yes, so I come a very interesting pathway to Implantica, and it's given me a very unique insight into the needs of a company trying to commercialize a new product. I've seen this many times. Now, evidence generation and medical excellence is clearly fundamentally key to that, to achieving that success. So what I'm gonna talk about here is how you take this medical data, and also, to a degree, the training, as a runway to reimbursement and commercial success. I just want to clarify that you've seen Sarovar's presentation just then. We're basically, as he mentioned, two sides of the same coin. My role is very much to work with Peter on developing the studies and the training quality, and to scale that and to execute this, so we have this high quality data flowing into the studies, so that then Sarovar and his team could then take that data and sort of package it up for the audience. So that is one very large angle of what we do. The second angle is also the surgical training, bringing excellence to the surgery. And finally, we are also responsible in medical affairs for the clinical regulatory side, so to speak. That is the developing the clinical documentation and all the regulations and procedures associated with things like a PMA submission. So I think it goes without saying that you've pretty much heard it from every presentation so far, we need the data for the reimbursements. We also need it for regulatory purposes as well, making sure that we validate the safety and efficacy of the product to the European bodies, also to the FDA moving forward. So there are effectively four pillars to why we might need this clinical data. As I mentioned, there is regulatory. That is to demonstrate the long-term safety and effectiveness of RefluxStop. So this is tracking your product in the market, and when you have a new implantable device, as we have, it's important that we track this on as many patients as possible, at least in these early years. Secondly, is for payers. I think we've heard an awful lot about them already, but that's to demonstrate the clinical superiority of RefluxStop over existing standards of care treatments. But there's also, importantly, marketing promotion advocacy. We haven't talked about that quite as much. Amit touched on it, but it's also very important to get consensus amongst the clinicians, amongst the societies. Societies are key in payer decision into payer decisions. As we move into America, you're gonna see the major societies over there are going to be absolutely essential in advocating for your product, and that is how you get your reimbursement. Then finally, there's also sales support, and this is... This is not just convincing the doctors. If you go back 10, 20 years, it used to be just convincing the doctors, as Amit said. They go into the hospital, they try a couple of cases, and they, then it gets purchased. These days, you're always going through gatekeepers, administrative gatekeepers. In the United States, it's called value analysis committees. In Europe, they have the same kind of thing in all the hospitals. So you need to show superior clinical outcomes and the value of your product to convince the administrative bureaucracies inside the hospital to purchase. So what is our evidence generation plan for RefluxStop so we can see the full potential? First of all, we have the RefluxStop EU registry, and that is, that is ongoing. That is, that has already started. That is, we are aiming for 500 plus patients, and that we currently have 10, 11 centers signed up, and with most of those with ethics approval, and Peter already presented some of that information out. So that is just collecting the data as per our IFU, and that is, you know, all the data that needs to be collected to show the safety and efficacy. And we're aiming to have around 500 patients in that, and that is based here in Europe. We've also got about to start 2 RCTs. The first RCT is, is versus Nissen fundoplication. This is the, as you've seen this morning, or sorry, earlier this afternoon, you've seen this procedure as the what... As a procedure of taking the actual fundus, wrapping it around the esophagus, and it's somewhat old and dated procedure, coming from the 1960s, but that is still considered to be the standard of care. So that is the, that is the study we're planning to implement, in a number of centers in Europe, and we should be starting this soon. The next one is actually an RCT versus PPIs, and this is a very innovative protocol whereby we show the value of the product, value of RefluxStop over just keeping a patient on PPIs. And this will be a study that will be dominantly based out of the U.K., led by Oxford, and we're aiming for 150 patients in that particular study.... The fourth pillar, and this is like the data we've already seen from, from Dr. Lehmann this morning. His own data, the clinical experience data, but that is supporting our key opinion leaders, the believers, the clinical believers in the product, to collect data to show the clinical value of the product. And so these are called investigator-initiated trial, trials, and these will be of very design, depending upon the nature of the discussion with the various surgeon, how they'd like to collect their data. And finally, we also have in the works, a post PMA approval study. Now, one of the things that the FDA imposes on us is the requirement to track the data, track the product, track RefluxStop, its performance in the market, somewhat similar to what we do in the registry here in Europe. What we are proposing, we will do a 200-patient, single-arm study in the US to show the product is working as advertised. Nextly, that is the study side. What I'd like to quickly show you now is how we're bringing surgical excellence to the table. I mean, getting surgeons to perform to the highest standard requires training. This is a somewhat different procedure. The Forsell procedure has been devised by Peter and refined as we've gone along with the leading surgeons in the field. And it's now at a point where we have settled on a procedure that is best practice, and that's what we need to bring in as standard. And then that is how once we have that as the standard, that is how we expand out to all the other surgeons and train to a method. That method is called OSATS. And that OSATS method is a method of standardizing a structured training. It breaks the surgery down into bite-sized pieces, and you actually assess according to standards of each of those bite-sized pieces. It's a well-accepted and peer-reviewed method of training in surgery. And so we will have a different level of progression. As the surgeons get more experienced, we will bring in a proctor, that is an experienced surgeon, like Dr. Lehmann, and who is confident and capable of training to this high standard, has enough experience to correct a surgeon who may need help correcting their methodology. And so we propose to have the RefluxStop novices proctored for 10 cases, and this will be through what... We're bringing in a learning management, so we can actually train, do the training online, and the first few cases will be in person, and then there will be video support moving forward. And so we will have 10 cases proctored. We will assess according to the standardized surgical OSATS method, training method. And then, once they reach a certain standard, we will say, "Okay, you've qualified as a RefluxStop novice." Then we will keep proctoring, we'll keep training them. And then, another bunch of cases and more training, they will become a hosting site, so they will be able to start showing procedures to other surgeons. Then, another set of cases, more training by the experienced surgeons, and then they will become a proctor. In other words, now, somebody who is suitably good at the technique, that they will be able to travel and then proctor new surgeons in the procedure. And then finally, we will be bringing in the RefluxStop Centers of Excellence, and this will be the proctors who have been collecting data and clearly show over a number of years, they have their patients have excellent outcomes. So right now, and an important point here is right now, we are only working with centers that have the potential to reach this center of excellence level. This is what we've been talking about, these high-performing surgeons, high-performing centers. And then, once we have the... We're through the FDA approval process, once we have the procedure of training well-established, once we have sufficient surgeons trained as proctors, we will be in a position to expand this out. Now, another message I want to give you, and this is the clinical experience message. You've seen some of this data already, but one important point is, we are now seeing data flow in from a number of different sources. So we have our CE-mark study. We have Dr. Lehmann. We've seen some of his data from him this morning. We have Dr. Borbély in Inselspital in Bern. We have Professor Jürg Zehetner from Inselspital in Bern. And we have seen multi-year data from these clinical experiences in these four areas, four surgeons, and we're seeing consistent performance. So we're very confident, beyond confident, now in the clinical performance of, of RefluxStop. In fact, if I take two of the key measures, one is the GERD HR QL measure. This is the GERD... Basically, it's a questionnaire of symptoms, questionnaire of how the patient is feeling following surgery. And we have, on the top left, you can see in the C study, the scores drop and are maintained low for four years. This is this top level, this is top left graph here. It goes down, the GERD HR QL scores go down. They stay down for four years. On the far side, there we have Professor Zehetner's data, and you can see it's the same result. The GERD score stays low down for three years. Dr. Lehmann, this is almost exactly the same graph we just showed you this morning. Stays down, I think that was out to 1 year. Was that, Dr. Lehmann? Yep. And here is Dr. Borbély. Here is his 2 years data, stays down after 2 years. Consistent performance across centers. And then the second measure is also the PPI usage. And so if we look at the CE Mark study, you see at 3 years, all the patients stayed off PPIs. If you look at Dr. Borbély, again, of 19 patients in his 2-year study, 18 remained off PPIs out at 2 years. And then finally, In Dr. Lehmann's data, which you saw this morning, 97.5% stayed off after 1 year. So again, consistent performance. We see this over and over again. And I've been in this business a while now, and it's rare you see a product performing in the high 90s. It's just almost unheard of. So to summarize, you know, the studies, the data will support a faster RefluxStop reimbursement. We've come a long way in executing our strategic plan for this reimbursement, and our Center of Excellence training program will really make sure we deliver on surgical quality to support that. And we, we've got all these studies planned now, including these two RCTs, to make sure we build a solid case for reimbursement. Which will, of course, give us substantial sales expansion once executed. Thank you all very much. Thank you very much, Mark. We have next up, Andrea Arguini. He is the Business and Therapy Development Director for Italy, Business Head of Italy, and he spent over 20 years at Medtronic, managing all phases of go-to-market for various products. Thank you. Thank you, Nicole. So thank you. We are moving now from the global perspective to local perspective, your country level, and we are moving to Italy. Health is everyone's rights, protected by Italian constitution, and that is fundamental for the country, in Italy. Patient can choose the hospital to be treated with the best quality available, and they have no cost to spend. The hospital remuneration in Italy is based on a national reimbursement classification code, that is DRG, and it is more or less common in the biggest country in Europe. And the reimbursement amount is fixed for any surgery and cover all the hospital costs. But now, if you look on the patient side, all the patient with a GERD, you learn in this afternoon, that stay in this part with the medication. In Italy, we have more than 7 million people that stay with PPI, and more than 4 million people take PPIs regularly, every day, at maximum level. Gastroenterologists keep the patient more or less here and don't move to the surgery. When the patient move to the surgeons and ask for a definitive solution, the surgeons is looking for the criteria for inclusion or exclusion. In Italy, we have 3 main surgical options. The gold standard is the Nissen fundoplication, plus we have LINX from this 15 years, and the RefluxStop from these years. Surgeon in Italy are always looking for an alternative to existing therapies because they are looking for fewer side effects and better quality of life for their patients. If you look on the side effect, RefluxStop has the lower side effect, and this is the key driver for the significant interest of RefluxStop in Italy. Surgeons have the freedom to choose the best option for the patient, and they negotiate internal to the hospital to push for one procedure or another. So when we talk about the efficacy and the side effect of the therapy, they are very interested in the side effect because they care about the dysphagia prevalently. So we start this year to sell in Italy, and they get a great acceptance by Italian KOLs, due to the low rate side effect and the maximum efficacy. So far, we have four centers started, and the 15 patients implanted in these four centers have excellent results. They stop completely the PPI use, they have no reflux episode and no side effects within six months. More centers are targeted during this year, and we will double the center by the end of this year. The excellent results and cost saving will allow us to scale more rapidly also next year and onward. So the first six months, four centers started. We double in the second half of 2023, the number of centers, and we plan to double again the number of centers for the next year, in 2024. And the market has a huge... The potential of the market is huge. Currently, in Italy, we've done, they done the 7,600 procedure, and 99.9% is Nissen fundoplication. But if you look at the potential of this procedure, if we offer a better treatment option with low side effect. The market is more than 10,000 patients per year. I give you an example what happened in a hospital in the south. It is a national center of research, is a gastroenterological hospital, is close to Bari, in Puglia, and this is the De Bellis Hospital. We start in May, we support them with a proctor. Professor Zehetner was there. We make the training, and we support the hospital to make also a campaign, the campaign on the local TV and newspaper, where the hospital had to open a dedicated ambulatory for RefluxStop patients. For reflux patient, in general, may focus on RefluxStop after 10,000 of patients starting calling the hospital. So now that hospital, we starting in May. During the last, the summer, the hospital opened an ambulatory. Every Monday morning, one physician, two nurses, are dedicated to visit these patients coming from all the region around. So the needs for the patient is huge, and they are waiting for a solution. If we are able to show directly to the patient, the potentiality, the potentiality, and the low side effect, and the long-term data of this therapy, the business is growing faster and faster. So the fast expansion of number center is showing the enormous potential of RefluxStop in Italy. And Italy is definitely an interesting market for RefluxStop. Thank you. Thank you, Andrea. Our last speaker today is Simon Freeman. He's the Business and Therapy Development Director for UK. Before, earlier in his career, he actually established LINX Magnetic Sphincter Band business in Europe while he worked at Torax Medical, so that's our main device competitor. He's very experienced in this field. Good afternoon. I'm very aware that I'm the last speaker. I'm between you and the drinks, so it's not always a good position to be in. Let's start with the NHS. The NHS is the largest single-payer healthcare system in the world. The budget of the NHS is GBP 130 billion a year. You know, it really is really important, but not just important in the UK, it's actually important globally as well. I'll come on to talk about a bit there in a moment. The NHS is funny, that I think the British people love the NHS more than the Royal Family, more than the BBC, more than beer? Probably not more than beer, but anyway, the NHS is really appreciated by the population. Part of the NHS is NICE, and NICE is the body that evaluates new technologies, new drugs, and so on. Peter already showed the slide that NICE is already making an assessment of the Forsell RefluxStop procedure. And that... Why is that important? Obviously, that's important for the UK, but it's actually important globally. NICE is a body that is recognized globally, and the advice that NICE gives is taken on board by other countries in Europe, and probably most importantly, by the FDA as well. So it has a huge potential to impact our business. It's complicated. You know, there's lots of steps. The first thing we had to do was to meet with NICE and establish how we were gonna do our submission for RefluxStop. That's been done. Then we had to get the NICE notified. That can't be done by us. That can only be done by a physician. Again, that's something that we've done. They've now started the review process, and we have submitted with our medical access support, and Sara has done a huge amount of work to do the submission and get the ball rolling for the review. And now we have to wait until they give their advice. So I'm not sure exactly how long that's gonna take. I'd imagine it'll be next year sometime. So the U.K. is a slightly unusual market because we have the NHS, which covers everybody. It's free at the point of delivery, nobody has to pay. But you also, in the U.K., have a choice. There's a private market, and in fact, the private market is also split into two, because there's a cash pay part. If you want treatment, if you want an anti-reflux operation, you can go and pay to have the operation, but there's also an insured market. Most of the people who are insured are insured through their employer. We've already entered this market, and in fact, we have two active centers, and one of the patients from the UK was treated in a center in Manchester, very successfully. Nice to hear. And we have some success in that private cash pay market, but we will also be applying for what's called a CCSD code, and that will allow insured patients to also get access to RefluxStop. So we have two, as I said, existing centers. In fact, we have two centers that are approved, St. Jonathan, Elizabeth, and Nuffield. They're both in London. They both have approval to start. They just haven't started yet. They will be starting this year. And then we have a whole bunch of other centers who are on our radar, including Cleveland Clinic in London, which will be a really, really important center for us. I'm sure you're all aware of Cleveland Clinic. It's a global healthcare brand, and in fact, their hospital is across the road from Buckingham Palace, and if you get a room on the top floor, you can see into the Queen's garden. Well, actually, sorry, the King's Garden now. So yeah, that's a real privilege. But I think the top floors, rooms are there, the most expensive, obviously, because they have the best view. That's the private market. Then in the NHS, you know, that's where the big opportunity is. The private market is important because it's actually relatively quick to access, but it only represents about, in terms of global treatment, about 10% of the market, although that's about half of the anti-reflux surgeries. But of course, in the long term, it's the NHS where the big, where the big prize is, because the NHS treats 90% of the, 90% of the patients in the UK. We started with some, you know, preparation, going out to meet people, and that was very successful. We started discussions with about 10 NHS hospitals, and in fact, a couple of weeks ago, we did actually start with our first NHS hospitals, which is a massive milestone for the company, a massive milestone for the product. I think a real endorsement of the technology. And what's interesting is that, you know, we have a whole, you know, other slate of hospitals and surgeons who are interested in using RefluxStop, and it's exactly as Andrea said, it's about the lack of side effects is a massive selling point, but the other one is about dysmotility. You know, if you go and speak to the gastroenterologist and ask them about, you know, their patient, the profile of the patients and what they do with the patients, and what they will tell you is, somewhere between 20% and 40% of chronic reflux patients have dysmotility, so they, their swallowing function is compromised, and those patients are not good candidates for the existing treatments. And RefluxStop is a fantastic option for those patients, and so there is a huge opportunity there, and it's basically allowed us to get into NHS hospitals. So I think the way in is dysmotility. The expansion opportunity is the really, really good side effect profile. And this is my last slide. So this tries to encapsulate that exactly what I just said. So we're positioning RefluxStop for ineffective esophageal motility or dysmotility, because they don't have-- those patients don't have good options. You know, they can't really have a fundoplication. They can't really have a LINX. And you know, obviously, I introduced the LINX. I know all about that technology, and it can be a good option for the right patients, but not for dysmotility patients. So that unmet need is something that the NHS is really interested in, and actually, it goes back to the NICE evaluation. Because when NICE evaluates things, they wanna know, is this something that there's already lots of treatments for? Because they're less likely to approve something if those patients have already got lots of options. Well, these patients don't have a lot of options, so we are positive and hopeful that NICE will give us, you know, a positive guidance because we can treat patients who don't currently have good options. So that's the first phase, and we've kind of, you know, we're kind of halfway through that phase. We've started the NHS. Obviously, we've got more NHS centers to open. The second phase is using that lack of postop, you know, postop problems. And in fact, the NHS surgeon, who did 4 cases in one day, said to me, I went to see him the next day, and he said, he said the lack of postop dysphagia was striking. You know, in virtually every patient who has anti-reflux surgery will get some difficulty swallowing. It's a normal, expected post-operative state for the patient. And he said, "3 of the, 3 of the 4 patients, you know, it was like they didn't have an operation. Their reflux was gone, but they had no side effects whatsoever." He said it was absolutely astonishing, and I think that's the reason why people are so enthusiastic about this product. And actually, it's not just the surgeons, it's the gastroenterologists as well, because, you know, the gastroenterologists have these patients with dysmotility. They don't know what to do with them. They don't know where to send them. You know, the PPIs don't work. The patients are not good candidates for existing surgical options, and we're coming along, we have the solution. So I think that's a fantastic place to be. So that, that lack of postop dysphagia is a big competitive advantage, and that will allow us to gain share of the existing market and, you know, get really good, high volume, clinical data. And then that leads us to the third phase, which is to get, obviously, positive guidance from NICE and access to a much, much bigger, cohort of patients. Rather than taking share from the 4,500 existing patients, what we wanna do is access the group above in the funnel, which is more than 100,000 patients. That's where the real opportunity is. That's where we're gonna go in the long term. So I, I look forward to coming back at some point in the future and talking about how we're getting into that space. So thanks very much. Okay, we've actually gone over our time limit, so if anyone wants to squeeze in a quick question? Yes. I don't know if we have the microphone. Okay, thank you. Maybe Dr. Fridman touched upon it. When it comes to randomized clinical trials. Maybe Dr. Fridman touched upon this. When it comes to randomized clinical trials, I mean, there are non-PPI responders. Why maybe I'm ignorant about what the company has achieved, but why not make a study with these PPI non-responders, and they being their own control? Yeah, absolutely. But it's, of course, even better if we can prove that we are better than all patients. ... Yeah, you don't get any comparison with other surgical procedures, so- Can I use the microphone? As you may know, we have done a couple of those trials already. For instance, world's largest comparative study between Nissen reflux surgery and PPI use. And, if you wanna do such a trial, you need more than 500 patients, if you do a reasonable and honest power calculation. The second—the first question with regard to PPI refractory GERD, there is one study showing excellent superiority of Nissen reflux, traditional Nissen reflux surgery in 25+25+25 patients. Small study, still accepted and published in New England Journal of Medicine, showing superiority of Nissen reflux surgery, but more importantly, no significant effect of adjusting the dose or adding an anti-motility stimulating drugs or whatever. So in fact, there is no medical alternative in refractory, PPI refractory GERD. So this is the ideal study if you want to show superiority. But if you should show superiority in, you know, the unselected PPI responders of GERD, chronic responders, then you have to have a big, big trial. More than 500 patients, to be honest. So, it's a strategic decision, where to go. Okay. Maybe I can just speak out. How does the payment system work in the U.S., if, when you are being approved in the U.S. by the FDA? How does the reimbursement system work then? Amit? I think, Amit, maybe it's the best- Yeah, yeah, no, sure. So I think it's a great question. But it's different from Europe, if I can start there. It's, it's a lot more streamlined, and, and you can almost say that the harmonization across the country between the private payers, Medicare, which is the largest public payer in the U.S., they follow very similar systems. So if you get a decision from one payer, it really multiplies very quickly. So that is a huge advantage. You will see, as you know, I was kind of... One of the point I was making is, everything we are doing in Europe is gonna be ready to be plugged in that system, where we need a code, where we need payment system, will be tied to that code, and then we'll have coverage policy. Coverage policy basically means every payer in the US will look at the same data and make a decision. What happens is, when companies launch, they don't have these randomized trials, they don't have real-world studies, they don't have hundreds of publications. Then they say, "No, no, no, no, no, you got to start from all over, step by step by step." So our whole strategy here is get as ready as you can be. The trials we are speaking, you know, we are really expediting. We haven't talked about timelines, but those trials are going to be highly expedited. We already have, thought through, you know, how we're gonna put it in the right place and right time. So hopefully, that is a plug-in play system. And, we believe that with the private segment, we will have even faster adoption because they are... Just to give you an idea, one of the competitors, we have this, you know, LINX. They have never done a trial of anything like this, and for the last 12 years, they've been selling in the U.S. It's an extremely painful process. It's a step. Every patient who you treat, it goes through an evaluation because they don't have the systematic data across the board. And many of that is not getting paid. It gets rejected every time they do that, and payers are getting-- there's a lot of data published. You can search and check reimbursement for this product, and you will find dozens of policies by large payers, including Medicare, which is the government payer, saying, "Why are we not seeing this is validated in a proper study? Why are we not seeing this is done, so we are not gonna pay for it?" It's being rejected, you know, year after year after year. So I think this is where we will be dominating the market with the strategy we have. So that's the plan. So yes, it's gonna be quite very quick to uptake. It still takes time. You still got to do the basic work, but we are not talking years, we are talking months to, you know, get into the system. Any other questions? Yes. Okay. I was wondering about Novo's Wegovy and Lilly's drug. Do you have any indication? I mean, my suspicion is that it might work against GERD, and because, you know, you lose weight. You know, I have GERD myself, and that was the solution for me, was to lose some weight. And I was just wondering, I mean, will this, would it be these patients that use these medications, can they be included in this randomized trial, or is it smarter to keep them off the trials? Do you know anything about this? If there's any, you know- Maybe I can- Yeah, sure. Answer that. I did my doctorate in biochemistry, focusing on metabolism. I've got a very strong feeling that these weight loss drugs are gonna have downstream consequences. The popularity now is simply because we haven't seen the long-term side effects of what these drugs will do. You're gonna see a lot of bounce back. In other words, they're working now because it's still so early in the process. But also, I really don't have a feeling that these things are a, you know, a magic pill to solve all obesity. I really do feel that like, they'll bounce back. Last, please. I mean, since we believe that this is a lifestyle, you know, connected disease or caused by lifestyle changes, we do also believe that if we interfere with the lifestyle, if we change the lifestyle, then we can, we can manage the disease. And stop smoking doesn't work, reducing weight doesn't work. Whatever could you offer? I mean, on a population basis, that has been studied in Norway. If we study reflux-related symptoms, and in obese versus lean, is more common in obese, and for those few who could consistently lose weight in women, you can probably, if you squeeze the data hard, to see a significant effect. Whereas in randomized controlled clinical trials, weight reduction up to 10% shorter doesn't affect symptom, symptomatology at all. You're lucky! But it could well be a single event, unfortunately. Yeah. So we don't have the evidence to say weight reduction is fundamentally important. It's good, probably, for general reasons and for health reasons, so please reduce weight- Yeah. How easy it is. But you cannot, you know, introduce this as a selection criteria when you do clinical trials. Yeah. I'm sorry to say. No, it's fine. Just because it seems like it's miracle drugs, and, you know- Yeah, that's fine, but it's good to reduce weight for cardiovascular things. Yeah. Diabetes, mostly, but don't think that it cures your reflux disease. Okay, and just one more question here on the indices. Needs to be charged. So I was wondering, might there be some payers that might, you know, require 10, 15 years of follow-up before they push the button, so to speak? Because it seems like... And I was also wondering, the health economic studies, as I understand it, they're based on the assumption that you make the operation, and you don't need to do it again. So because I understand that it's possible that like the sphincter or, you know, the device, it might be some movement over time, that it, you know, you never know. We're a few years into this now, but who knows in 10 years if it will last? I was wondering if some payers perhaps think like this, that they want to see more, a few more years or, you know, five more years. I don't know. I can honestly say that you are wrong in both comments here. So, first of all, you know, those companies that have been working 10, 15 years, that's because they have not done it the right way. If you don't do things the right way, if you don't create your data the right way, or your product is not good enough, then you can struggle forever, you know? If you have a product that is not good. But if you have a good product, you do it the right way, it doesn't take any 10, 15 years. What was now the, the last one? Now my brain... What was your second point? Redos are included. Yeah. Oh, yes, sorry. This is, of course, included. All the complications are included in the healthcare analysis. So you compare the total cost, all the side effects, the PPI, all the side effects with the LINX. If you need to do meta dilatation of esophagus in 18%, for example, all these costs are there. Every reoperation. So this is a complete analysis for society, what is the long-term cost of this procedure? Okay, and when is this reoperation modeled in then? I mean, because it's a guess. Anyone's guess, I guess, who- No, no, this is based on the 3-year results. Can answer. Maybe I can take it. I understand your concern. The interesting part is payers worldwide, they have to take a decision right today. So what is the standard practice? They take the decision based on the currently available data. Whatever it is, clinical data, economic data, cost data, whatever it is. And that is why economic analysis is a reiterative process. I mean, we will do this economic analysis 3-year, 5-year later again. So most of the payers, they accept what is the currently available data. And part of your question is whether we considered all these side effects, reoperation and all those. Yes, and this is enormous number of variables are included in this analysis. I mean, if I tell you, it's more than 100 variables are included in the analysis. It's not only one or two variables. So all complications are included, that is possible. And RefluxStop cost-effectiveness is actually driven by only two things: one, the higher quality of life, and two, is very low side effects. That's the two strong variable, what made RefluxStop cost-effective and economically lucrative. ... Does that answer your question? Yeah. Thank you. And can I just add one more point there? I think one question-- or one aspect of your question was also, you know, payers. What do they think, how do they look at something like this early stage? Because we are, you know, five-year-old, not fifteen-year-old. Fundamentally, all payers worldwide are making decisions, and then reviewing them as an ongoing basis. So it's not... When you get reimbursed, it's not a lifetime decision, right? So but they have-- there are innovation pathways. Some of the programs I mentioned, they're innovation pathways, meaning for new innovation, early, the products that are in our stage, if you have rigorous data, if you have high-quality data, they accept with certain standards, which we are actually checking because we are speaking to them very actively. I mean, believe me, this is a very painful process. You don't want to engage with them because they want everything. But, you know, we are ready. The data we have, the confidence we have, with that, we are approaching them, which is usually not done by most companies. We're getting that, and we are ready to sign off on some of the demands they have put in place. The other thing is, we are prepared that they're gonna look at this three years after they approve the first time, six years, 10 years. So this is an ongoing process, which is why, as I was saying before, one of this competitive technology is now being reviewed after so many years, and they're saying: "Oh, we supported it, but now we got to go back because it hasn't been validated the way they wanted it." So it's. You start somewhere. I mean, as we are looking at if we have 100,000 patients in a country, they're not gonna let us treat 100,000. They're gonna let us treat 5,000, 20,000, 30,000, and every time they reevaluate. So it's just a process on an ongoing basis. Thanks. Thanks. Okay. No other questions? Did you want- I hope you understand now that Implantica is not only about me. Implantica is about a fantastic group of people. We have the absolutely highest competence, and we are in the front edge, and we know how to do this. And I think that's really an important message of this meeting here today. Of course, when you have, you know, 40 products in your pipeline, and you have e-health platforms that will revolutionize healthcare, you have a long-term potential that is rather unlimited. But as an investor, you often have a more short-term perspective, but it's nice to have. We will create, and we will build these systems, even if it's go step by step. Of course, when you have a product like this, I hope you have understood that this is a unique product. It's so uncomplicated, so simple, and so powerful results. I mean, with a marketplace of 1 billion sufferers, try to find such a product. It doesn't exist. It's a unique opportunity, and that's what we have tried to present here today. Yeah. Otherwise, we thank you very, very much for coming, and I think we have some- Yes. Refreshments. Thank you very much, everyone. You can ask questions, you know, to all the team, to the board members, to me, Nicole, and at the same time here, you can take something to drink and... Yeah. Okay, thank you. Thank you.