Implantica AG (IMPASDB) Earnings Call Transcript & Summary

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 2 Q&A sessions. So we would ask that you please hold questions for those 2 sessions, 1 of those 2 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 2 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 to -- for you to meet in person and discuss during the breaks, during the coffee break and during the [indiscernible]. So with that, I would 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. And for those who don't already know me, I'm a surgeon, educated at Karolinska Institute, here in Stockholm. And I once developed adjustable gastric band and a rather successful business around that. And this is the founding who has been able to create this new company, Implantica. And 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 EU. 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 little bit about our eHealth platform. So we are steady, working on our, I should say, second line product, our pipeline products. And of course, the eHealth platform is something we will believe have the possibility to revolutionize health care. And this eHealth platform is then combined with a wireless energizing platform, because if you have -- you should be able to communicate with the patient chain 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 eHealth platform. So what will then this eHealth platform do? It will save cost for society because you can treat on distance, more convenient for the patients and more cost-effective, more advanced treatment. And you need then, of course, wireless powering, which the patient will do at home, maybe 5 minutes per day, for example. And the key and what is really revolutionizing health care 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 electric stimulation module that we now are currently working on to integrate in the eHealth platform, that could then be used for several of our pipeline products. And one of them is StomaRestore. People, they get a plastic bag and collect the fecal matter because they are taken away a 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 UriRestore. 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 is very burdensome disease to have because you need to put in a catheter in your own bladder every time you should urinate. Imagine 5 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 AppetiteControl product, which is a product controls appetite. Instead of taking away a big portion of the stomach, we are just very minimally 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 2, we call it, but this is a version who can also treat obesity. So you basically fold the stomach over the line of RefluxStop. And this product is actually 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. And 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. And I will then switch over to RefluxStop, which is the closest to generate more substantial revenue and also a product with rather extreme potential. So 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. And here you see how it's built. It 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 there is 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 cost 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 a rather extreme margin on this product. But the problem is that to release a medical device, it's 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's very substantial unmet need. As you can see here, it's 1 billion people take medical treatment, PPI, every year for acid reflux. 1 billion people, that's extraordinary. We don't have more than -- a little bit more than 7 billion on the planet. So 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 -- of acid reflux. And why? Because surgical procedures today, they are suboptimal. They try to compress the full 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 bloat, then people are unhappy with this type of surgery. And we have actually sold -- solved, sorry, 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's closed between the stomach and esophagus, called [ LES ] on that little picture here. Everybody believes this is weak, doesn't close properly. But in reality, it's just the position of the sphincter who is the problem. And that we solved 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're 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 is highly effective and very safe treatment. And we have superior clinical trial results. If you compare our CE study, for example, with a big metanalysis made by Karolinska Institute, 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 question 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 to severe and mild regurgitation from the beginning. And basically, it's a -- 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, they try to encircle and close the sphincter. You can see here, we compared here 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 10x more failures than in our study. They have 68% of the patients has swallowing problems. It's simply like night and day. And our product is also targeted to save lives. And the problem with these diseases that people die from cancer because this acid is coming up in the lower esophagus and it terrorized 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 needs 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. And what is even better here is that RefluxStop has 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 compared PPI drug treatment, the magnetic band, LINX, I talked about, fundoplication and RefluxStop. And they have concluded that the most cost-effective treatment of them all is RefluxStop. And 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 analyzes, the same economic model in all these countries here, and they show the same thing. We are the most cost-effective treatment. And another very, very important step why actually RefluxStop has much, much limited risk today and a multibillion-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, will be the new standard of care when it finally will get [ reimbursed ]. And we have several hospitals, 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 a real-world settings, hospital settings, the excellent results of the CE-marked study that RefluxStop have 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, health care 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 & Strategy Officer. And then we have Sarowar, yes. Sarowar is leading the Clinical Evidence and Health Economics team. And then we have Mark Cregan, who actually is the leader of the Medical Affair 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, we have some centers. This is an old slide, I didn't have any to make something new, but it's just to show some of the centers that really believe in us and do the surgery. Here, you have the presentation I talked about when they say that they have replicated the fantastic results from our CE study. And we have another presentation when they present their 4-year results. So it's another center who has reached 4-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 to achieve Ethics Committee in the countries you see here, Switzerland, Sweden, German, Italy and Norway. And I just wanted to show you a little bit of the centers that [ R&D ] already have started or are in the pipeline of start. So this is Switzerland. We have Germany. We have Sweden, Norway, [ Ersta Sjukhus, Sundsvall Sjukhus ]. We have Austria, U.K., Italy, Spain. It's more centers coming up in Italy and Spain, but it's growing rapidly. And I just show you this to give a feeling that it's happening a lot in 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 had reimbursed, but you gain the centers. So when you finally get reimbursed, then it will be, what, in Swedish, we call catch-up effect. You shake the [ butter ] and suddenly all the catch-up ends up at your plate. That's the target here. Oh, sorry, did I miss that one? Yes. So then, of course, we are quite close now to obtain -- what was my time limit? 40, 45 -- 50 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 in the 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 a nice name here, Forsell 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 the FDA regarding getting feedback on our submission. Every time you should talk to FDA, who is the approval organ in United States, every time they say, okay, 3 months next or 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 the submission. An FDA submission, that's a wall of files. It's enormous. It's hard to understand how huge it is for the 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 for year-end or slightly thereafter. And we aim to be on the U.S. market in 2025. And 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. And 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 looks really promising for this. I just wanted to give an example. You will hear me about this, of course, Italy from another our members is 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 6 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 2 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 the DRG system is a little bit less strict than in Germany, for example. 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? And 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 to 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 the IPO 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 the investment in Implantica, absolutely dramatically. RefluxStop is unstoppable.

Thank you. I would like to give a warm welcome to Professor Lars Lundell, if you could please come to the stage. I hope your mic is working. 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 a 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 are we talking about? We are talking about a disease that doesn't shorten patients' 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 this noxious material comes into the distal esophagus, it may microscopically damage the mucosa, which you can see when you look into the esophagus through the endoscope, and then we call it a esophagitis. And when the 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 now the 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, you got a cough, you got asthma, and you've got other things. You can develop Barrette'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 PGWB. And if we look into the happy [ suites or fins ] 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 patient 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 Central and South America, we have it around the southern part of the Mediterranean and up to India. And 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 the same increase in numbers over a certain defined time period. So it's a continuously increasing disease, and it's a worldwide disease. And 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? And 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. And this is very much related to lifestyle factors. And how easy is it to affect lifestyle? Just tell me, because I don't know. This is not only a symptom burden, this is an economic burden to the society and the health care system. And these figures just gives you a perspective. And what are we talking about? And the main driver here is the cost of medication and hospital costs. These are the 2 factors. And 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 prospectively collection of all costs in the management of the disease -- of these patients. And these are the true figures that you should really pay attention to, and I will go through them very -- a little bit earlier. But this just gives you a flavor of what kind of costs we're talking about. Billions, billions of dollars a month. Now let me just show you the pathogenesis, a little bit about the pathogen. Why do reflux disease develop? And 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 -- to the right-hand side of the slide, comprising of 2 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. And the interesting thing here is the [ crus ] to the left-hand side here, they represent the external component of the lowers of 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 it? 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 is -- it's 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 '79 and launched in the '80s. 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, pharmacy 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 yield. We're not talking about 5-year period treatment. We're talking about the lifelong treatment because we -- 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 a cure because as you see here, we do repair the hiatal hernia and repair the crus. We do a fundoplication, we wrap the upper part of the stomach around the esophagus, enhancing the efficacy of the lower esophageal sphincter. But there 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 breakeven compared to omeprazole after 3 to 5 years. The problem, and we know for sure, it doesn't 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. And I will come back to the implication. This is just an example. You've got less bloating, you got less flatulence, by posterior partial compared to total. But if we apply this to the entire society, to a community, you see there a lot of problems. A lot of problems within reflux surgery. So there are difficulties, there are drawbacks, which you need to take into account. And these are the positive predictive factors. If you're a male, you're doing better. If you're younger, doing better. If you have the -- type of fundoplication is important, and it is important where you are operated on. So the wishlist, 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. And 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 health care providers, and then implement these technologies on a larger scale. So 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, 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 to 200. And 2.5 years ago, I was confronted with RefluxStop. And since we are performing our reflux -- anti-reflux surgery 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. And 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 show and to share with you my recent experiences about this new procedure. And of course, my opinion about evidence needed 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. And 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 operations to get symptom relief and quality of life, and we have these adverse events or these side effects and 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 both large number of patients who are well controlled and are very happy with PPIs. We have at least 1/3 of all patients who are unhappy and only less than 1%, I would say, around 0.1%, of all patients get any operative procedures so far in the Western world countries. We heard about this already about the recently 3-year data efficacy and safety, which has been introduced and shown at different conferences. And now I would like to show you our first data, we started, as I said, in July '21 with our patients. And we looked now at 79 patients within the last 1.5 years from June '21 to November '22. And the most important points are here. If you look at disease history, 8.5 years of disease, average duration of PPI therapy at around 5 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. Also, they were using PPI therapy. And 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. And now we look at this very important data, GERD-HRQL 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. And this duration of almost 11 month follow-up with a larger area where we look at, we got the HRQL 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 2 needed PPIs during our follow-up period. This is fantastic. And we don't know if these 2, do they have reflux again or is it still symptoms. A lot of patients coming to 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 2 who get -- 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 3 patients who have the impression that they have reflux. Again, mild symptoms or occasional symptoms. And these are -- this is the summary of our data. We have no -- 0 postoperative esophageal dilatation. 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 -- in a lot of patients, you get a 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 1 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 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 no 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. There -- 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'd like to take a moment and actually hear firsthand from people who have been operated with RefluxStop. Some of our patients, their stories and hear how their experience is, 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. Thank you very much. Yes, if you could just stand on these table. Thank you. So we have Diana Helfer. She's from Switzerland. And David Walsh and Pauline, they're both from England. And if I could just ask you, what were you experiencing before? What were your acid reflect symptoms? What sort of...

Okay. My acid reflux was terrible. I've 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 supposed to use at the NHS, which was 30 milligrams a day. But it wasn't working as well. So speaking to the consultant, I was put on 60 milligrams a day, 30 in the morning, 30 at night. And it just carried down. I was having -- it's effect of nonmotility. So nothing was going down when I swallowed. I have to always have the water to help push it down. It's affected my 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 1.5 hours maybe, that I had to sit up, move around. I was actually on 2 cushions, welt cushions that were lifting me as high as possible. And I have a bed that lifted as well. And it was horrendous. The quality of life, as we mentioned, was terrible. And I looked into different things with the NHS and they could offer was fundoplication, but because the mortality was so bad, that wasn't really an option.

Okay. Thank you. Diana, maybe we can give the mic over to you. If you could tell you your experience before.

Well, in my case, it also started maybe 20 years ago. And first, the first effects were my teeth, actually, because enamels started going away over the time. And they saw 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 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 had to put me on PPIs. But -- well, it didn't really help, I also have a 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.

Yes. 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. And 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 was that? Why would you prefer RefluxStop over fundoplication or LINX, would you say? Did you have any information about the others?

Yes. And everything I read about, it was really not that -- it was not an option for me. I had no sympathies for him.

And how has your life changed since then? How is it -- how soon after you got RefluxStop were you feeling better?

Well, it changed my life immediately. Of course, the first day or the first week, it was still -- because of the operation, I still had some pains, but that all went away. And regarding reflux, it stopped immediately.

And can you eat everything you want? Or 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 that it took around?

Maybe 6 weeks, yes. And then it was really good.

So 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. And 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. Maybe we can -- and maybe you could tell us, David, about your experience. How did you get to know RefluxStop? And why did you choose that surgery? And you hold the mic up.

We looked around on the Internet, and we saw RefluxStop suddenly and some of the things that have been mentioned. We found out that Paul Goldsmith in Manchester was starting to do the RefluxStop, and we contacted the [indiscernible] 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, too, and the RefluxStop was the only answer. And from the day it was done on the 28th of February, I've not had any [indiscernible] at all from going from the highest. It's just been brilliant. Everything has been wonderful. And if anyone needs it, I'd recommend it to anyone.

And how quickly were you able to eat again normally?

At night. I had the operation around 12, I think the lunch time, was it? Yes. I was back in the ward at 3, and I was eating by 6 p.m.

Salmon and mashed potatoes?

That's 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. [indiscernible] we're all suffering from it. And Pauline, if I could ask you, maybe you could have the mic. How has this affected your family life? And have you seen -- what sort of change have you seen in David?

Yes. Well, the change has been dramatic because he can now sleep in the evening. He is not [ often ] eating yogurts and not trying to pacify the acid. I know he is 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. So all that has changed for the better. Like night and day, like that man said before, night and day. And 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. Yes.

Okay. Well, thank you very much. We thank you for coming and sharing your story with us. And yes, anybody in the audience who wants RefluxStop, we have doctors that we can refer you to. 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? But I don't know if anyone -- any 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 has sort of guided your choice of patient, if you will? Low-hanging fruits is a bad term, but you know what I mean. Are there some patients that you've -- were there in such bad condition that you had to do this? And is the impact, therefore, much greater in the results do you think?

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 time, 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 mortality in the esophagus and it still works. And LINX, for example, sphincter augmentation, the magnetic sphincter augmentation, we don't use that or we don't implant that in any patient with any kind of motility disorders. That's my experience over the years. We have to have taking several LINX out of the patient and try to unhedge or convert that to [indiscernible]. Or meanwhile, we convert them to RefluxStop. So what are the exclusion criterias, 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 is no exclusion concerning age, especially on -- if you look at the -- 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 RefluxStop.

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 what 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 an investment period into a profitable period, how are your thoughts on sort of balancing that investment program versus focusing on getting to the -- to commercial ground with RefluxStop? And the background is, of course, that 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. 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?

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.

So my idea was to present them all, but I missed it when they talked about U.K. So sorry for that. Yes, any more questions?

[ 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?

Well, other -- or the history of 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 of premalignant 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 those, 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, yes. And if we have other patients with severe disorders, and I forgot neurologic diseases like patients with really severe MS, for example, we don't do any kind of operation on those and -- because they have severe motility disorders of their whole gastrointestinal tract. That's something we don't want to complicate that, okay? That was 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 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 with 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 sutures, how strong in the sutures, how to do the suture itself. And then some people implant measures, different kind of measures, permanent measures, long-time resolvable measures, short-term resolvable measures. This debate last for years, and it's not over. It's still is 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 to the 90-degree fundoplication of Dor, prepares like Dor. So 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 paralyze the fundus to the esophagus, to the distal esophagus, and the LES, the sphincters around here. And then we have -- this stretch on my fundus exactly as long as we would like to have it around 5 centimeters. And when we have paralyzed that, it covers about 120 to 150 degrees of the left-sided surface of the esophagus. And then here, on this part, there comes now our implant device, and we create a kind of a tobacco sac with the fundus. And then we close the tobacco sac 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 in this part, in the last 4 to 5 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. 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 minimal invasive. It's completely done laparoscopic. Meanwhile, we do a little bit robot, it's possible on both ways, yes.

And it takes how many minutes?

Question is how big is the hiatal hernia. We have done no hiatal hernia up to 8 centimeters, then it takes 90 minutes, 100 minutes. If it's a very small hiatal hernia, it's only 1 suture on the hiatal hernia repair, it's about 60, 70 minutes. Yes.

So we have some video clip short runs 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 short snips of [indiscernible], yes.

Can I go?

Yes.

Dr. Lehmann, I was wondering about -- you said that more studies are needed and so forth. Do you know -- have you received any note from the authorities when -- what do they want, what do they need in order to start pay for these patients to do these procedures?

You mean the whole setting of randomized controlled trials or registry trials? Or...

Yes, just, do you know what needs to happen in order for this to be achieved?

Yes. 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.

And Peter Forsell, I have a question regarding FDA. Has there been any shift in personnel or anything that -- because my understanding was they were very eager about this project, given the acceptance of the European CA study to use that. But still, this keeps dragging on a little bit. I just wonder, it has to be in a shift somehow that makes it -- that they might be a little bit skeptical? Or what's your signals there?

No, there is no skeptics. 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 trial, so to 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 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, so to 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 we have done huge work on this. 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 say, is it okay? And if you don't do that, you risk to redo everything. And every time you do this, it takes 3 months. So everything looks really good with the FDA. It's just that FDA is a little bit tougher organization, they ask for more things. If you should do bio-comparability testing, they should, of course, have more products done. Everything is a little bit extra. Extra everything, so to say. But everything looks really good and -- in terms of the team, you can say half of the FDA team, the last time was the same, but there was some new -- there was a new doctor, for example. And they say, it's like talking to Telia. It's huge organization and many, many people. So -- 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 last quarter or first quarter, that's what we see right now to be the filing date of this submission. And then it will take some time. So that is not in our hands.

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. to ramp up sales in parallel of that, waiting for those studies? Or I mean how much share can you take before those randomized trials are conducted?

So we are -- I mean, now I go with the other people's speech because we have different people coming and presenting. But we are actually starting up now 2 randomized trials. And that will happen right now that we will provide, we have the committee approved 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 if this could be expanded to some shorter U.S. trial as well. But in U.S. in Europe, in Germany, for example, you have a code for a specific procedure, that's the money we get. If you come with something else, difficult. But in U.S., they have a much more easier system. So I think Amit will show you a little bit few stories based on U.S. approval. So 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." And it's many ways to get business early in U.S. that you can't get in Europe or even before randomized trail.

If I may just say something on that point. I think when you say randomized trail requirement, that's not necessarily I think given the cost of technology. There are few categories of [indiscernible] where randomized trails are requirement.

So we may not see that entirely for our technology. We believe, actually, we will be ahead of that requirement. And I'm going to cover some of that.

I have a question to Dr. Lehmann, regarding the patient with complication, just 1.2% of your old patients with the device imploding into the stomach. Did you study the mechanism of this, what's happened? And did you hear of the same cases in another centers? In this case, how many?

Yes. 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 have 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 gastric wall into the stomach. And it's really -- 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 with respect to the primary operation?

So our patients have the impression of having reflux again 9 months after the operation. And I know from another case this patient had the impression of reflux again 2 weeks after the operation. And this has to be a technical failure, a technical mistake done by the surgeon.

Maybe I can -- am I on the mic? Yes. So 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. 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 try to make a time glass, hour-glass of the stomach, you 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 -- very logical, of course. And if you do it 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 a 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 have a suture and you have put things down, the patients are still treated for some time. So they don't connect so well. So therefore, you are still -- it doesn't become a direct connection normally between the symptoms at this. It takes some time to regain the symptoms, so to 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 wall during surgery, but that's a specific case. I mean normally you should not need to damage anything. But this is -- as I said, it is a little bit of a learning curve. It's like whatever you should do if you are a painter, electrician, whatever, you need to train a bit before you become good. 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're 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 meet back here in 15 minutes.

Thank you very much. [Break]

Welcome back to our CMD. We would like to start with 1 or 2 video presentations of the surgeries since we had a couple of questions on that. And then after that, we'll continue with our program. [Presentation]

Okay. Thank you. Any more question relating to the procedure?

Peter, do you want to take your laptop? 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 Kukreja, who is our Chief Market Access & Strategy Officer. He has led commercial roles and market access at innovative medical technology companies, including Masimo and Second Sights among others.

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. So what I'm going to spend the next 20 minutes on today is not necessarily what you already heard. 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 lives 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 are lucky to have Professor Lundell with us, who is the world authority on -- in this disease condition and hear firsthand what it means. So I'm really privileged in that way. 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 are 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 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 our 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, it is always revolutionary 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 spend 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 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. But what I want to show you is that 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 PPIs chronic user, 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 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 EUR 100 billion 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 want to keep going. So if I just translate all of this into simple conclusions, 1 out of 100 patients today, severely ill who are eligible, who should be treated in an ideal setting, are getting this therapy. So 1 out of 100. My simple statement here is, if we can turn that into 10 out of 100, not 25%, but 10% of this truly unmet need, true patient group that we can help with, 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 when 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 50s to all the way to 60s. 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 it continues. So you then you get into the next phase, which is all about device inventions. So from early -- late '70s to all the way early 2000 -- 2011 in this case. You saw many innovations coming in, and they were trying to make the point that we can have electrical stimulation solution. We can have magnetic sphincter, you'd put a titanium ring around the esophagus. There are a lot of complex and interesting innovation. 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 the 70 years, based on what we have seen so far, 550-ish patients data, we have experience from the CE 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 3 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 to first-hand experience of what that means. So it's not necessarily a problem that requires electrical solution and 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 3 aspects of reflux issues, the anti-reflux barrier that we looked at 3 components, we are touching all 3 at the same time. And hopefully, this will validate -- 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-plus cases. We have 5-year data on our CE 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 go after is pretty locked. Why is it locked? Because we don't have the necessarily the key to unlock it. And this is 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 to 20 years, what has changed dramatically is we have different -- 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've got health technology assessment institutions. They are funded by government tens of millions of dollars 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 -- this -- 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 it to 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 road map, and I divided that in 5 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 the 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-plus cases went so well long-term data from CE study, long-term data from -- or relatively long-term data from other real-world cases where we have up to 4 years now is phenomenal. This is -- this doesn't happen with every product. So that gives us this extra confidence. So 500-plus cases, all these countries doing well. Next point, we need to have exceptional patient experience. As Peter mentioned, FDA and other regulators and payers, insurance companies, health system today really want to see early phase. Is this data robust? Can we believe that? We're going to make a national policy, and we're going to start paying tens of millions of euros or dollars 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 innovation come to the market every day. Our health systems can not afford to pay for every product. So this is becoming more and more of a challenge as economically our society and the worldwide, I would say, in Western world, especially our health care cost continue to rise and rise and rise. U.S. particularly even more. But this is a huge, huge need. We need to demonstrate our scientific -- 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 a big validation of what we're doing. Number three, robust clinical outcomes effectiveness, and this is about publication. It's not enough if you can think about it, it's the ladder. I think Dr. Lehmann had this pyramid in his presentation. If you're presenting data in a conference is 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 1 is great, but you've got to go to step 2 and step 3 and step 4. 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 9 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 2 are about -- are these data sets validated in a more rigorous environment? As I said, you've got to continue to 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 -- to have the best access to the market. We don't want to have a few patients paid here and a few patients paid there or even 1% of our market. If you want to go for the full market, you have to get the best-in-class evidence. And that's why we are doing randomized -- 2 randomized studies, as you see, as Peter announced, we are working very actively in a very short amount of time, those are going to 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 want to highlight 1 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. There -- most of that business is still built on nonrandomized 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 this 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 want to simplify this slide for you. What I'm trying to show here is you've got -- all these are institutions, the 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 a health care 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 '90s, early 2000, maybe there were 3 or 4, in last 15 to 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. Their 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 is the limit. Sky is 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 going to 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 2 levels where we certainly need political influence because any disease condition should be recognized as a problem. One of the biggest problems 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 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 how health care systems make decision about these, running one of the biggest hospitals 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're going to GPs. They're going to their gastroenterologists, GIs. And this holds roughly more than 95% of the market. If these people are not aware about our therapy, they're never going to refer them anywhere. They will keep them on PPIs forever. So this is why the other focus we have is we want to 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 these patients get timely informed about when there is a new therapy is 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, this is a 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 Lundell said, one of the solutions we need is turn this therapy, turn this process 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. I just want to highlight, I think this has been presented before. So we've got 100-plus centers right now that our target in Europe. 15 of those are already onboarded in the last nearly 18 to 24 months. 30-plus advanced discussion, which we expect to bring on board. So as I said, we really started 2 years ago. So now we are taking off. The interest is incredible, and we are going to 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 really again saying, this is rather more last 6 months since we are building 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 that allows communication -- 2-way communication. We are doing a lot of seminars and campaigns. So some numbers there, but this is really the beginning. This really has taken off. We are working on very exciting projects, and you will see some of that being -- updates coming up in the coming months. Similar. I mean it's 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 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 off. So this is a story of a product called UroLift just a disclaimer, all this information, sometimes you're trying to gather can be not perfect. So some of those are also estimations. But this is the big picture. Big picture is here. They got CE Mark in 2009. 20 -- 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 4,000, EUR 5,000 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. I think they acquired 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 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 looking at from nowhere, they get into $27 million, roughly $100 million business. And within 4 years, they get acquired for $1.1 billion. And then 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 (sic) [ for snoring ] . Amazing story. 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's Form 10, they get CE Mark within 3 years from existence. They do a first trial in 2014, 4 years -- 4, 5 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 to be 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. It's not a small thing. And I have to say, by doing this, we feel actually extremely confident that we -- our trial designs, everything is aligned with what they really want to see and how they want to see, we know how to do it well, do it fast and get it done. So that's our really objective. Again, amazing story, and you can please it, as I said, factually, please double check, but this is the current overall status of something like this. Last slide, where does Reflux stop and how do we see ourselves progressing? In 2018, we get CE Marked. I would take 2, 3 years out because we truly launched in 2021, 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 on board, and I think it's way more than we actually hoped for. So 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 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 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 want it to -- we will continue to rise in that that level of confidence in adoption, but this is really done well. 2023, we have 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 scaled to the levels we want. And hopefully, that's the time when we truly establish this therapy. So I would say, I think, overall, the derisking of a technology happens over a lifetime, something like this. We have some great examples as you are seeing, 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 are under the pressure of proving adoption, they start diluting the focus of quality. And I think this is something we have strictly as a company, as a management team, committed to itself that we know what's the right path and that's the one we're going 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. Sarowar 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 (sic) [ 11 years ] at AstraZeneca here in Sweden.

11 years.

11 years. Sorry, I got that wrong. And he's led the global payer evidence at AstraZeneca for several flagship products, building them into a multibillion-dollar drug.

Thanks, Nicole, and thank you very much for your patience listening. So I will walk you through some really execution level information that we are doing or we planned 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 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 2 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 to 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 -- valuable 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-plus year evidence. So if you take both our CE Mark study and our real-world 500 cases experience, 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 to 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 goal to achieve and how 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 care and commercial execution. That's the 3 areas that needs to be aligned. And our audience is different payer organizations like TLV in Sweden or NICE in the U.K. We need many, many center of excellence hospitals. And with these broader categories of audience, payer evidence, medical affairs and commercial execution, these 3 teams should work and get the excellent execution. And now from payer's point of view, from TLV or NICE or HUS or German payers or U.S. payers, the questions are very simple. Only 4 questions they ask. Only 4 questions. What is the burden of reflux disease? Is it really serious disease? And you heard from Professor Lundell. 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 new technology? What this new technology can offer? Is it that 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 health care systems should pay more for this new technology? These are the simple 4 questions that we are trying to address. And how we can address these 4 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 patients 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 health care system? So these are the data that we are generating. And just to give you a more simplified version, we are generating 4 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 or 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 4 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- to 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 center of excellences publications, data and sharing with experts and patients and relevant stakeholders. Our registry is up and running. My colleague, Mark will talk about that. And 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-plus 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 a part of that -- significant part of that. We are aiming to have 50 publications this year that 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 U.K. 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 Chirurgischen 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 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 2 to 3 articles before this 15. This is our published article that Peter already showed. It is a cost effectiveness analysis for RefluxStop based on U.K. health care system. We have 2 papers, economic analysis that we completed and submitted for U.K. 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 has been submitted to a Norwegian conference. So 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 who has very little hope with the current treatment options now. And it is surprising that RefluxStop showed promising results in this subgroup, and we submitted 3 independent publications that will come out soon to tell the surgical community that these patients can be treated very well with RefluxStop. And 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 U.K. 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 side, we will launch a significant number of U.S.-focused evidence generation project. Thanks, I stop here.

Thank you. Thank you, Sarowar. 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 U.S. clinical and commercial activities at Medaxis.

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 going to talk about here is how you take this medical data and also, to a degree, the training is a runway to the reimbursement and commercial success. I just want to clarify that you've seen Sarowar's presentation just then, we're basically, as you mentioned, 2 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 Sarowar 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 pretty much heard it from every presentation so far. We need the data for the reimbursement. We also needed 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 4 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 of 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. Society is a key instant payer decisions. As we move into America, you're going to 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. And 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'd go into the hospital, they'd try a couple of cases, and 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 products 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 ongoing. But 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 ethical 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 all the data that needs to be collected to show the product is working safely and efficacious. 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 versus Nissen fundoplication. This is the -- as you've seen this morning -- or sorry, earlier this afternoon, -- you've seen this procedure 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 study we are 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 Dr. Lehmann's 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 trials. And these will be of varied 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 date, track the product, track RefluxStop, its performance in the market, somewhat similar to what we do with the registry here in Europe. And so that we are proposing, we'll do a 200-patient single-arm study in the U.S. to show the product is working as advertised. So nextly, that is the study side. And what I'd like to quickly show you now is how we're bringing surgical excellence to the table. I mean, getting the -- getting surgeons to perform to the highest standard requires training. This is a somewhat different procedure. The Forssell's 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 a standard. And then that is how -- once we have that as a standard, that is how we expand out to all the other surgeons and train to a method. And that method is called OSATS and that OSATS method is a method of standardizing a structured training and it breaks the surgery down into bite-size pieces. And you actually assess according to standards of each of those bite-size pieces. It's a well-accepted and peer-reviewed method of training and 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 trade and assess according to the standardized surgical OSATS method -- training method. And then once they meet 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 of more training, they will become a hospitation 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 the 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 have now -- we are now seeing data flow in from a number of different sources. So we have our CMAP 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 Jörg Zehetner from Hirslanden in Bern. And we have seen multiyear data from these clinical experiences in these 4 areas -- 4 surgeons, and we're seeing consistent performance. So we're very confident beyond confidence now in the clinical performance of RefluxStop. In fact, if I take 2 of the key measures. One is the GERD-HRQL 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 CE study, the scores drop and are maintained low for 4 years. This is this top level -- this is top left graph here. It goes down, the GERD-HRQL scores go down. They stay down for 4 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 3 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? Yes. And here is Dr. Borbély, here is his 2 years data stays down after 2 years, consistent performance across center. 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 of 2 years. And then finally, 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, these 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've got all these studies planned now, including these 2 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 Arduini. 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.

So thank you. We are moving now from the global perspective to a local perspective at country level, and we are moving to Italy. Health is everyone writes protected by Italian constitution and that is fundamental for the country for in Italy. Patients 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 the national reimbursement classification code that is DRG, and it is more or less common in the biggest country in Europe. And the reimbursement, most by amount is fixed for any surgery and cover all the hospital costs. But now if you look on the patient side, all the patients with GERD you learn in this afternoon, that stay in this part with the medication, in Italy, we have more than 7 people -- 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 moved to the surgeons and ask for a definitive solution, the surgeons is looking for the criteria for inclusion or exclusion. And in Italy, we have 3 main surgical options. The gold standard is Nissen fundoplication, plus we have LINX from this 15 years and 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, surgeon are -- has the freedom to choose the best option for the patient. And they negotiate internal to the hospital to push for 1 procedure or another. So when we talk about the efficacy and the side effect of the therapy, they are very interesting in the side effect because they scrub out the dysphagia permanently. So we start this year to sell in Italy, and they get a great acceptance by Italian [ QS ] due to the low rate side effect and the maximum efficacy. So far, we have 4 centers started and the 15 patients implanted in these 4 centers has excellent results. They stopped completely the PPI use. They have no reflux episode and no side effects -- in -- within 6 months. More centers are targeted during this year, and we will double the center by the end of this year. The excellent result on cost saving will allow to scale more rapidly also next year and onward. So the first 6 month, 4 centers started. We doubled 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 did 7,600 procedure and 99.9% is Nissen fundoplication. But if we 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'll give you an example what happened in hospital in the South. It is a National Center of Research Gastroenterology Hospital is close to Bari, in Puglia and this is de Bellis Hospital. We start in May, we support them with 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. Well, the hospital helped to open a dedicated ambulatory for RefluxStop patient -- for reflux patient in general, may focus on RefluxStop after then thousands of patients starting calling the hospital. So now that hospital, we started in May. During the last -- the summer, the hospital open an ambulatory, every Monday morning, 1 physician, 2 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 resolution. If we are able to show directive to the patient, 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 of center is showing the enormous potential of RefluxStop in Italy and Italy is definitely an interesting market for RefluxStop. Thank you.

Thank you, Andrea. And our last speaker today is Simon Freedman. He's the Business and Therapy Development Director for U.K. 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. So I'm very aware that I'm speaker. I'm between you and the drinks. So there's not always a good position to be in. So, let's start with the NHS. The NHS is the largest single payer health care system in the world. The budget of the NHS is GBP 130 billion a year. So it really is really important, but not just important in the U.K., it's actually important globally as well, and I'll come on to talk about a couple bit there in the moment. And the NHS is funny -- that -- I think the British people loved 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. And part of the NHS is NICE. And NICE is the body that evaluates new technologies, new drugs and so on. And Peter already showed the slide that NICE is already making an assessment of the Forsell RefluxStop procedure. And that's -- why is that important? Obviously, that's important for the U.K., 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. There's lots of steps. The first thing we have to do is to meet with NICE and establish how we were going to do our submission for RefluxStop. That's been done. Then we have 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. We now -- they've now started the review process, and we have submitted with our medical access support and Sarowar 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 and to give their advice. So I'm not sure exactly how long that's going to take. I'd imagine it will 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 2 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 2 active centers. And 1 of the patients from the U.K. was treated in the center at Manchester very successfully, nice to hear. And we -- so 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 would allow insured patients to also get access to RefluxStop. And so -- we have 2, as I said, existing centers. In fact, we have 2 centers that are approved, since Jonathan Elizabeth and Nuffield, they 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 brand. 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 -- or the actually, sorry, the King's Garden now. So yes, that's a real privilege, but I think the top floors rooms are they're the most expensive, obviously, because they have the best view. So that's the private market. And then in the NHS, 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 or that's about half of the anti-reflux surgeries, but of course, in the long term, it's the NHS, where the big prize is because the NHS treats 90% of the patients in the U.K. So we started with some 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 we have a whole 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. If you're going to speak to the gastroenterologists and ask them about 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 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 that 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. They can't really have a fundoplication. They can't really have the LINX. And I -- 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 want to 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 a positive guidance because we can treat patients who don't apparently have good options. So that's the first phase. And we've kind of -- 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 post-op -- post-op problems. And in fact, the NHS surgeon who did 4 cases in 1 day said to me, I went to see him the next day. And he said, he said the lack of post-op dysphagia was striking. In virtually every patient who has anti-reflux surgery will get some difficulty swallowing. It's a normal and expected postoperative state for the patient. And he said 3 of the 4 patients was like they didn't have an operation. Their reflux was gone. They had no side effects whatsoever. You said it was absolutely astonishing. And I think that's the reason why people are so enthusiastic about this product. And it actually, it's not just the surgeons, it's the gastroenterologists as well because the gastroenterologists have these patients with dysmotility. They don't know what to do with them. They don't know where to send them. 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 lack of post-op dysphagia is a big competitive advantage, and that will allow us to gain share of the existing market and 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 want to 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 going to go in the long term. So I look forward to coming back at some point in the future and talking about how we're going 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. I don't know if we have the microphone. Okay. Thank you.

Maybe Dr. Freedman touched upon it. When it comes to randomized clinical trials, I mean, there are non-PPI responders. Maybe I'm ignorant about what the company has achieved. But why not make a study with these PPI nonresponders and they being their own control.

Yes Absolutely. But it's, of course, even better if we can prove that we are better in all patients.

Yes, 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 largest comparative study between [ an reflux surgery and PPI use. ] And if you want to 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 [ an refract ]traditional and reflux surgery in 25 plus 25 plus 25 patients, small study still accepted and published in New England Journal of Medicine, showing superiority of [ an reflux ] surgery but more importantly, no significant effect of adjusting the dose or adding the motility stimulating drugs or whatever, 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 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.

Maybe I can speak loudly. How does the payment system work in the U.S. when you were to be approved in the U.S. by the FDA. How does the reimbursement system work there?

I Amit?

I think Amit maybe is the best...

Yeah I mean no sure. So I think it's a great question. But it's different from Europe...

If I can start there. It's a lot more streamlined 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 we get a decision from one payer, it really multiplies very quickly. So that is a huge advantage. You will see, as I was -- kind of one of the point I was making is everything we are doing in Europe is going to 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. And coverage policy basically means every payer in the U.S. 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, you've got to start from all or step by step by step. So our whole strategy here is get as ready as you can be. The trials we are speaking, we are really expediting. We haven't talked about timelines, but those trials are going to be highly expedited. We already have thought through how we're going to put it in the right place and the right time. So hopefully, that is a plug-and-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 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 that 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 a 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 going to pay for it. It's getting rejected 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 going to be very quick to uptake. It still takes time. You've still got to do the basic work, but we are not talking years, we're talking months to get in the system.

Any other questions?

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 lose weight, I have had GERD myself and that was the solution for me, was to lose some weight. And I was just wondering, I mean, will this -- will the -- 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...

Maybe I can Answer that. I did my doctorate in biochemistry, focusing on metabolism. I've got a very strong feeling that these weight loss drugs are going to 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 going to 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 magic pill to solve all obesity. I really do feel like they'll bounce back. Last, please.

I mean, since we believe that... Is it on... ? Since we believe that this is a lifestyle 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 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 reduce weight in women. You can probably, probably squeeze the data hard. To see a significant effect, whereas a randomized contort clinical trial weight reduction up to 10% short term doesn't affect symptomatology at all. You lock it. It could well be a fatty women. Unfortunately. So we don't have the evidence to say weight reduction is fundamentally important. It's good probably for general risks and for health reasons. So please reduce weight originally. But you cannot introduce this as a selection criteria when in the clinical trial. I'm sorry to say.

[ Now that NHS ] because it seems like it's miracle drugs. And...

Yeah. That's fine, but it's good to renew weight for cardiovascular things. Diabetes. But don't think that it cures your reflux disease.

Okay. And just one more question here on the... So I was wondering, might there be some payers that might 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 are 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 the device, it might be some movement over time that it -- you never know. We're a few years into this now, but who knows in 10 years, if it will last. And I was wondering if some payers perhaps think like this that they want to see more -- a few more years, 5 more years, I don't know?

I can honestly say that you are wrong in both comments here. So first of all, those companies 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, all your product is not good enough, then you can struggle forever. 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 then the last one, now my brain. What was your second point? Yes, redos. Oh yes, sorry. This is, of course included. All the complications are included in the health care analysis. So you compare the total cost, all the side effects the PPI, all the side effects with the links, if you need to do [indiscernible] dilatation of the 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 model in then, I mean because it's a guess and...

No, this is based on the 3-year results...

I understand your concern. The interesting part is payers worldwide, they have to take a decision, right? Today. So it -- what is the standard practice that 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 these 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 1 or 2 variables. So all complications are included, that is possible. And RefluxStop cost effectiveness is actually driven by only 2 things: one, the higher quality of life and two is very low side effects. That's the 2 strong variable what made RefluxStop cost-effective and economically lucrative. Does that answer your question?

And can I just add one more point there. I think one question -- one aspect of your question was also payers. What do they think? How do they look at something like this early stage because we are 5-year old, not 15-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 -- they are innovation pathway. Some of the programs I mentioned, their 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. And -- but 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 going to look at this 3 years after they approved the first time, 6 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 going to let us treat 100,000. They're going to let us treat 5,000, 20,000, 30,000 and every time they reevaluate. So it's just as a process on an ongoing basis. Thanks

Okay. No other questions?

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, front edge, and we know how to do this. And I think that's really an important message of this meeting here today. And of course, when you have 40 products in your pipeline and you have [ EL ] platforms that will revolutionize health care, 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. And we will create, and we will build these systems, even if it goes step by step. And 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 the 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. Yes. Otherwise, we thank you very, very much for coming. And I think we have some...

Yes... Refreshments. Thank you very much, everyone.

And you can ask questions here to all the team, to the Board members, to me, Nicole, and at the same time here, you can take something to drink and yes. Okay. Thank you.

Thank you.