Good afternoon everybody. My name is Peter Forsell and it's of course the Q2 presentation we are doing today. For new listeners which we seem to get quite a few lately I'm a surgeon. I'm the inventor of the device we will talk mostly about today. I also once developed an adjustable gastric band and a very successful business around that. The funding that has generated Implantica is coming from this gastric band business. Our main product cornerstone product is RefluxStop and that's targeting a treatment field of 1 billion sufferers. That's enormous absolutely enormous. Here you see the device mounted on the insertion tool which you use for a keyhole surgery. You see the metal that to the left goes into a little keyhole in the abdominal wall and you introduce the device and place it in the right place. We have come quite far with our clinical evidence. This quarter we actually have published our five-year pivotal study results. They are objectively absolutely extraordinary results. You can read these articles yourself but it clearly shows how superior RefluxStop is in relation to existing treatments. One of the reasons for that is that in the past everybody has focused on that you should close the food passageway so acid is not coming up from the stomach into the esophagus and you have magnetic bands and you have a wrap of your stomach called Nissen fundoplication to try to compress and close supported closing. The problem is that they didn't understand how it really works and you get swallowing problems. You can't belch and vomit and you get bloated in your abdomen. What we realized is how you treat the cause of acid reflux instead. I will show you a little bit. This is very late research from the United States' largest user of the magnetic band. He has published a very interesting article where they have used different sizes of the device. They are 13 14 15 16 and so on centimeters you can see here. They have measured the objective measurement the only really objective measurement to see if you are treated or not and that you measure pH in lower esophagus over 24 hours. You monitor it for 24 hours. He looked at how many got swallowing difficulties so they needed dilatation. You go down with an endoscope and you blow up a balloon and you try to make it larger because people have swallowing difficulties. He looked when he has done several of those dilatations how many patients still had what we call dysphagia that's also swallowing difficulties. He also noticed how many did I need to take away the band because it was impossible if it didn't work at all with the swallowing difficulties. You can see here that when you get a larger let's say we take the number the second last and third last from the right here you see that treatment is only 65% - 72%. That means only 2/3 of the patients are actually treated which is quite low. At the same time you look at need for dilatation you see it's 28% - 29% which is nearly 1/3 of the patients need to do several quite burdensome esophagus dilatations. At the same time you can see that they still after this between 8% and 14% had persistent swallowing difficulties. The conclusion here could be this method doesn't work. You can't attack the sphincter and try to keep it closed. You get too much problems. RefluxStop on the other hand then treats the cause of acid reflux. I know most of you know this since before and I should be very short here in repeating. The principle is that you restore the anatomic and physiological situation and you keep it there by placing the RefluxStop device on the outside of the stomach wall invaginated in the pouch and ensuring that the position of the sphincter maintains in relation to the diaphragm. The reason for this is that when you breathe you have pressure variation. You breathe in you breathe out and it comes and goes the pressure. This is leaking out through the opening here around the esophagus and this is affecting the sphincter. Just by keeping the sphincter far away you let the body treat itself. We don't treat acid reflux. We just restore a normal situation so the body treats itself. That's what makes this so fantastic and that's why we have so little side effects and so excellent treatment effect. Medical treatment they are calling PPI. There are some other new treatments they claim have a better treatment effect but they are all the same complications. They fail PPI treatment about 59% of sufferers now and then. If you measure the objective pH I talked about before where you saw that we had 2/3 only treated it's about 60% who is treated with PPI usage. It's a large group of patients. PPI has really serious side effects and people do not understand how bad it is. I need to say this again. A study from the United States from 2019 followed 157,000 U.S. veterans taking PPI for 10 years and more than 7,000 extra deaths due to PPI use. 7,000 people of 157,000 died extra due to PPI use. It's nearly 1 out of 20 over a 10-year period. You can ask yourself how could this be possible? How could this be so dangerous? The answer is it's because these people have reached an older age and have been taking this for a very long time. It starts to be really dangerous to take these drugs. Here you can see the four main reasons for deaths are cardiovascular disease kidney disease. It's actually cancer could be number two and kidney disease number three here and infections and parasites. I will try to explain a little bit about this because we get so many questions about this and about new better treatment and so on. It's not a competitor for the RefluxStop device. First of all if you go for why do people die in cardiovascular disease extra deaths. People die in cardiovascular disease and no one would say okay it was my PPI who made it get me my heart attack now. People don't understand that it's the PPI but it's actually the main cause of death to take PPI and get old is because PPI reduces nitric oxide in the blood vessel. It's a substance in the blood vessel which is reduced and that promotes vascular stiffening and plaque formation. This is crucial this substance to keep the blood vessel relaxed and preventing plaque buildup. Although all these people who die from heart disease they don't understand it but it's still when you make a really serious study like they have made here you find out that this is really dangerous. Also very simple when you have no acid in your stomach you have no protection for infection and parasites anymore. You know the acid in your stomach has a function. It's intended to kill anything that you eat that is not good. It kills bacteria it kills parasites. That's why we survive. Suddenly we have this protection anymore. Actually the fourth case of death in this study with these 7,000 people who died was infection and parasites because you don't have this barrier this protection anymore. Often for these patients I think PPI users will know what I talk about. Often the small intestine got overgrown by bacteria which caused bloating and is quite annoying for the patient. It reduced quality of life. This bloating problem is quite people rank it very very high. People doesn't like this at all. It's called SIBO if you want to read in the literature. I should have maybe written this here. S-I-B-O. It's a symptom when the small intestine gets bacterial overgrowth because normally there is no bacteria in the small intestine. Yeah. How is it then with cancer? Cancer is the second cause of extra deaths among PPI users. The bad thing here is that the disease itself gives you cancer. When the stomach fluid is coming up and irritating esophagus you know it's like burning esophagus. It gets small ulcers gets red it gets swollen irritated. When you do that over and over again that's terrorizing your tissue. That's a master example of how you get cancer. We know that 10% - 15% of all people with acid reflux they actually have precancerous changes. It's called Barrett's esophagus if you want to read Barrett's esophagus. This is the precancerous status that up to 15% of all sufferers get. Out of these of course a certain number then gets fulminant cancer very dangerous cancer. Most people die. It's 48,000 people only in Europe in the United States alone that die from esophageal adenocarcinoma. You can compare this to breast cancer where they do anything take any cost to find the breast cancer. They have all these programs to find the cancers. Here 48,000 people are just let die. It's completely unacceptable. This must change. Now there is a treatment with RefluxStop who can do this who can treat people without all these side effects and treat people much much better than anything else before. That's why it's so important we get RefluxStop spread over the world. Be old and have been eating PPI the rest of your life. That's not to recommend. Implantica is not only about RefluxStop. It's also about our platform technologies. We have two platform technologies. You already know we have the eHealth platform which is actually designed however due to the U.S. launch and that we need the resources for the U.S. launch. We have this on a low burn rate for the moment but as quickly as we get going you know with RefluxStop on the U.S. market we will of course restart and launch more products on the market and launch this fantastic eHealth platform. The really fantastic thing with this is that you can monitor people's treatment at a distance and you can change treatment at a distance. You can monitor how people have it inside their body. Are they healthy? Is it problems? It's a revolution of healthcare when this will be launched. We have also many patents. We have more than 1,000 patent cases. We have filed 25,000 pages of patents to protect our eHealth platform. It's an absolutely enormous work. Society will save money. You know people doesn't need to run to the hospital all the time. You will find diseases earlier. You can control treatment more effectively and you can treat more diseases because you can do much more advanced diseases. This is sort of the future of healthcare. We have developed a completely new communication system and we are starting to develop our own chip. We see this technology with the eHealth platform the virus platform something that could probably be licensed worldwide if we want to pursue that route. Just some examples of products that could be classified as humanitarian product as the products that really will change people's lives. One example is people who have a plastic bag collecting their fecal matter. Maybe someone has taken away the large intestine for some reason a cancer or ulcerative colitis often young people can get. They collect 2 liters - 3 liters of fluid in that plastic bag and they have self-adhesive on the skin all the time. Skin gets red gets irritated. It's not fun and it's not fun to run to the beach either. We have a solution for that. Everything will be inside the body reservoir emptying function sphincter and they can empty through anus like a normal person. We have people who can't urinate. Maybe you have a spinal cord injury or an accident in sport or whatever and suddenly your legs are gone and you can't urinate anymore. That's not fun. You put in a catheter in your own bladder 5x per day to urinate. I can tell you if you succeed to put in a catheter in your own bladder once you have been very successful. It's really a burdensome life. We have a solution for that. We can now just have a remote control for these people to empty their bladder. That's why we have the vision to become the world leader in smart medical implants. A little bit business update finally. FDA I guess everybody's interested in FDA. We filed our application the third and last module June 23rd. Together with the feedback so answers from the feedback from Module 2 which was of minor character we also filed together with that. That means that five weeks from now if FDA keeps their timeline we can't guarantee that but if they keep their timeline in five weeks we will have the answer from the last module and we will probably have a very very good idea how quickly we can get our FDA approval. That's of course very very interesting. There is also a 100-day meeting when FDA will tell us more or less what they think about this and that's just a week later basically because that's 100 days after they accepted the filing of the Module 3. We have already booked with FDA inspections scheduled for October on Implantica's premises. Everything here looks very promising of course pending FDA approval. We are also preparing for U.S. launch of course and production ramp up. We have actually ordered 10,000 devices for the moment and we are building a new production tool a multi-cavity tool for the U.S. market. We started two years ago. It has taken 1.5 years just to produce this tool. Also you know we're setting up now the new manufacturing in U.S. It's final testing in U.S. remains but this of course is quite positive right now when you have all these discussions about custom fees and so on. I have a little video here which I think the team behind me here should try to show you. There you can see that with such a tool we can do many products. It's fully automatic and silicone in and then it says butcher butcher basically and out comes finished products. It's really to prepare us for a possible success in the U.S. market. What are we doing more for the U.S. launch? We have set up a complete strategy how we should do this launch and we have looked at all the other companies basically how they have done it what they have done good or bad and we have a really good strategy. For the moment we have more than 100 surgeons who want to start with RefluxStop after U.S. approval. We are starting with the first 50 centers that are under selection right now. As you know U.S. has a much more favorable payment system than Europe. In Europe they believe you should be able to run your business for five years before you get any income because they don't pay for anything new. In United States they understand that new technology must be favored. The good thing in the U.S. is that it already exists reimbursement procedure codes with good payment amounts for both hospitals and surgeons. That means if we start to operate today hospitals and surgeons can just start operating. They will earn exactly as much money as they earn now or even more. That's really the good thing. For the implant itself there is a code which is good. We can use the implant. We can use this code. However payments are undefined. That's the process that will take a year maybe to get most of the insurance companies to accept our payment. That's a process. That's why we are working on supplying a complete package to the insurance companies how they save money. We know that we have superior cost effectiveness also in the United States. It's an analysis based on the University of York's Health Economic Consortium's model who they have developed and that has been used for the U.S. market. Also in the U.S. we provide superior cost effectiveness which is very very important for these insurance companies. Of course the fantastic results we now have the five-year results and lots of articles. This is an important part. Of course we are targeting the main hubs and we will of course start with maybe 20 and then go to the 50 that we talked about. We have around 600 accounts that previously used the magnetic band. That's the ultimate goal to replace so to say an older method with this in these 600 hospitals. We think we have all the attributes now to really be the new standard of care for treatment of acid reflux. The five-year results really support that. We have made a press release where you can have links so you can see these articles. It's one article just focusing on food passageway-related aspects you know swallowing difficulties you can't belch and vomit and pain at swallowing and so on. Then it's the more overall outcome how you are treated with low pH quality of life is any taking PPI and so on. This is a very interesting reading. Basically you can say these results are completely unmatched. It's like night and day basically. You know swallowing difficulty goes from zero or one patient to 30% or 28.9%. Able to belch and vomit 40% can't do that in standard of care. We have 0% for example. It's completely like night and day. Here you can see some of the results. It's actually here I see it's missing a little percentage but it's 97.9% do not take PPI. We have one single patient who took PPI at five years. That could be compared to every patient taking it before surgery and only one patient taking PPI at five years follow-up. 97.9% have no swallowing difficulties. We had no device-related adverse event over the entire study. No complication that was directly related to the device over the whole study. No device location erosion or no re-herniation at five years defined by X-rays. It's objective contrast wall of XC at five years. All the devices are in place and there is no re-herniation. 100% of the patients could belch and vomit. Gas bloating eliminated in 95.7% of the patients which is a very serious problem for the patients. The quality of life improved median 90%. No or minimal regurgitation 95.7%. pH value reduced by more than 90%. It's just absolutely incredible results compared to what I showed you before when you know 30% are not at all treated and then you have another 30% have swallowing difficulties and it's just not matchable. Here you can see a little bit of the difference. This is standard of care Nissen fundoplication and you see the green staples down there. They are quite different between the orange ones. Our clinical evidence is expanding with the snowball effect. It's so many articles poster presentations oral presentations and manuscripts. We are publishing more and more and more and more articles about RefluxStop center after center pop up and present their results. The good thing is that all is the same. All is fantastic. It's not only we in our study. No it's all these different centers from all these different countries. They have the same result. We are doing lots now of expanded trials. The registry is already ongoing. We have now just got green light with the starting of the RCT versus Nissen. That's also why you saw that the revenue went down a bit this quarter. That's because all the key top surgeons more than 10 surgeons have not operated this quarter. They just accumulated patients to be able to quickly do the trial when we kick off. This is very exciting. It will be also a registry in the U.S. of course and we will do a 200-patient study there when we get approved. The randomized trial is led by Professor Schoppmann in AKH in Vienna. It's Europe's largest university hospital. This is a very very exciting study. Around one I don't know these figures. They are always too low because we always forget to change them. Here is a 1,300 products and 45 hospitals. I think it's a little bit more than that. I wanted to give you one example of a good expansion of the market for RefluxStop surgery. This is Spain. This quarter we added another three centers. I think we wrote in the report that we had 19 new centers but actually two of them have only said they will start but we have not operated yet. It was a mistake. It's 17 centers. Still we launched 2023. In two years' time we have 17 + 2 want to start in Spain. You can ask yourself that that's quite an astonishing achievement. I mean if every country would have been 17 hospitals it would be very many hospitals. The question is why just Spain? The answer is that Spain has a healthcare system that it was in the past. They prioritize providing the best treatment. The surgeons have to say what treatment should be used in the hospitals. If the surgeons say this treatment is much better than anything else I need this treatment they get this treatment. They maybe don't get enormous quantities in the beginning because it's a budget system so you need to approve more patients every year. Still they look at the patients take care of the patients. In other hospitals and in other countries for example like Sweden they don't care at all if the patient gets the best treatment or not. It's only about administrative incompetent medical incompetent people deciding based on cost. That's only cost who drives the treatment. That's an absolutely terrible situation. We are very very far very very far now to get this running and get reimbursement. The reason why we have so many hospitals and so many countries in Europe operating but doesn't have a huge turnover is basically because no one pays for the device. We have not really been reimbursed. As you know the situation is easing a bit now. We have NICE the big organization who gives guidelines to NHS the public hospitals in the U. K. They have been given recommendations that the hospitals should use RefluxStop. That's for around 50% of the patients those who have ineffective esophageal motility. That is starting to open up and we are preparing now to try to convince Germany and France and all the different countries that we now need to be in the public healthcare system so we could get fully paid. Of course the business will expand enormously also in Europe. We had our first U.K. national user meeting. It was 21 surgeons and it was of course heavily discussed the positive news that they are recommending now to use this in NHS hospitals. Everybody was very enthusiastic and of course it was discussed about training and so on. We have also expanded to other territories our work and Canada has agreed to accept the U.S. filing data. That means as soon as now FDA gets through which we hopefully should be in the near term now then Canada will come as well. Also Japan we have established all the necessary contact relations how it should be done surgeons established. Even here we have a very good hope that the U.S. approval together with the European will be enough to also get to the Japanese market. This is basically around 11% of the world market. That's a very important market. Overall we view RefluxStop as unstoppable. We had a bit of a shaky start as you know with COVID and FDA wanted us to provide five-year data instead of three years and so on. Now it looks really really promising for Implantica. We should go over to the capital market and finances. I give hereby the word to our CFO Andreas Öhrnberg. Many thanks Peter. I will take you through the financial review starting with revenues. We reported net sales of EUR 433,000 for the quarter a decrease of 22% compared to the same period last year. The decrease is driven by the deliberate choice of having clinics focusing on enrolling patients into the randomized clinical study that Peter referred to that is commencing in the near term. As also previously noted by Peter we are at this stage only marketing our lead product RefluxStop for which we selectively partner with key opinion leaders in Europe. Looking at the gross margin we continue to deliver best-in-class gross margins. Adjusted gross margin for the quarter amounted to 90% compared to 91% the same period last year. Given the subscale nature of our business period-to-period gross margin variability is expected and we will continue to see that in future periods. The industry-leading gross margins combined with increased production capacity as announced earlier this week with the two new multi-cavity production tools provide a solid foundation for substantial operating leverage as the business matures. Let us turn to EBIT. Our operating loss decreased by 23% to EUR 4.5 million down from EUR 5.9 million the same period last year. The lower operating loss was driven by a 54% reduction in R&D spend compared to the same period last year. This reflecting selective pruning of the pipeline product patent portfolio and non-recurring FDA preparation costs in the comparable period. Let us look at the balance sheet. We have a solid financial position. End of June we held EUR 56 million cash and short-term investments. What we recognize as short-term investments on the balance sheet are plain fixed-term deposits with a leading Swiss bank hence no direct exposure to financial market risk. Over the quarter the total net cash outflow amounted to EUR 3.9 million the same level as the operating cash flow for the period. We do not carry any interest bearing debt on the balance sheet. Looking at our shareholder structure in addition to our CEO and main shareholder Dr. Peter Forsell and other senior leaders that you see here on the list our investor base is dominated by Swedish and Swiss high-quality institutions. We are grateful for the trust and support we are receiving to ensure that GERD sufferers globally are getting access to the best available treatment at scale. Back to you Peter. Okay thank you very much. I think we then should try to go to some questions. If you wish to ask a question please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question please dial pound key six on your telephone keypad. The next question comes from Filip Wiberg from Pareto Securities. Please go ahead. Hi can you hear me well? Absolutely. Great great. I've got a few questions. Firstly on the FDA progress that you've made here with Module 3 now submitted the feedback you talked about that you're expecting in five weeks are you expecting like sort of questions that you had on Module 2 also now in five weeks and then there will be some time for you to respond to those? We of course don't know what the FDA will answer but we will of course know if it's a positive feedback so to say. I mean like in Module 2 it was some questions but they were not really of any important character. We can already immediately see that we are past so to say. Normally when you have Module 3 you are absolutely correct that formally FDA has another three months to answer our answers so to say. Because this is the end of the road now and the next step is the approval normally they ramp up the things quicker. This is all in. Okay got it. You also submitted your response to those Module 2 questions. Are those going to be reviewed at the same time and then they'll come up during this meeting in five weeks as well? How is Module 2 handled now going forward? No no it's coming at the same time. If we are lucky of course Module 2 will be closed. If we are unlucky there is some small topic left that they will want to know something or. Okay. Still reasonable to have an approval by year end or perhaps early next year then? Yeah you can say that we will have inspections during October. I would say there is a Thanksgiving in U.S. an important holiday. I would say earliest before that could be realistic. Okay thanks for that. On the RCT that you're starting up now you've had all these pre-startup meetings at least. What is the status here? When is the first operation expected to take place? I guess the first operations will happen anytime. We have sort of got the last EC we made an update of the protocol and some changes and we got the final decision from the Ethics Committee that this is just information in nature. We don't need to have any more approval or anything. We can just get going. It's a little bit up to the holidays of the surgeons but I could foresee surgery starting very soon now. As you know the surgeons have some sort of the [crosstalk]. Yeah the surgeons have all collected patients for this. We have you know more than 10 surgeons and they have not been operating their patients now because they have collected them to quickly do this randomized trial. It's lots of patients lined up for this RCT. That's the reason why we have a reduced revenue this quarter. That's because the patients are not operated. They are waiting now to go into the study. Okay. Is it possible to give some sort of details around the timeline for this? How quickly do you expect all the procedures to take place and then you know readouts and all of that? Could you give a timeline for that? Yeah so it's 100 patients per group formally. That's 200 patients. If something is operated completely off label so to say those patients are excluded. There's a review of videos within three days after surgery. Anything that is completely stupid that's taken off. A few more than the 200 so maybe 220 patients we may need. With 10 centers this could go very quickly. It's of course depending how quickly the surgeons could operate but it's not a long long period now. Okay what is your best guess on that? Is it a half year or is it one year? I mean it's not unrealistic in one year. It's already half a year but it could of course also take one year. Okay thanks. Lastly on the NICE recommendation here you got the positive recommendation for these patients with IEM. Is it possible to just share some more details around that? Why only those and what would NICE require to expand to the full population? NICE only accepts published articles in their review. We didn't have our five-year results published. We have a fantastic study coming up now with 602 patients safety data for example that will be published from 22 centers in Europe. Excellent results. None of this was published. FDA NICE came with a compromise and said we approve you for these IEM patients. They are called IOM in the U.K. because they spell esophagus with O-E in esophagus. That's the reason why it's two names. The problem is that when acid is coming up in lower esophagus the nerves and muscles everything gets a bit destroyed. Suddenly the transportation of food gets worse and worse. That's generally the worst sufferers. When we talk about IEM sufferers of course those who have it from the beginning but many achieve it by having the disease for a long time. These patients if you operate with existing technique that means you are encircling down on esophagus at the sphincter level. That means this weak transportation of food that is not transporting food down as well anymore gets really terrible if you then have a stop down. It has no power to open this stop this stenosis you have there. This is not recommended to operate with existing technique. This is just a group of patients who stay untreated with terrible symptoms long-term sufferers. It's the worst. Those patients they gave to us because they realized of course that our treatment is much better than anything else. They formally need to have a little bit more documentation before we get all the 100%. This is around 50% of the patients 40%- 50% of the patients. All right. Okay so it's just about documentation. Lastly just what was the next step now in the U. K.? Do you expect some type of commercial acceleration or when could that happen? Of course we expect that more of the public hospitals also the NHS hospitals will now join to operate. That's clear. There are a few lined up but as you know they need to be trained. It's a little process for every. We We can't you know we need to keep up the quality of everything we do. Okay so a bit of time maybe start of next year we could see some sort of extra revenue from the U.K. or. Yeah I mean I guess we will now when the summer is over we will start training more hospitals. They will do their first surgeries with the Proctor and they will send videos so we can control that they do it the right way. In three months' time they will probably be up and running. You know that's the magnitude. Great thanks. That was all for me. Thank you. There are no more callers at this time. I hand the conference back to the speakers for any written questions and closing comments. I have a few questions down here written questions. I can quickly try to answer them. One question sorts on PCABs and the potential on PPI-resistant patients. Can they negatively impact the market size for RefluxStop? First of all 1 billion sufferers that's more than enough for everybody. No one needs to feel that they don't have a nice market in this treatment field. It's enormous basically. Second the problem with PPI is more treatment effect and that's sort of not the biggest problem. The biggest problem is the complications. The complication profile of the new and the old treatment is basically the same what I have seen in studies so far. As I told you a little bit in this presentation if you don't have any stomach acid that's not to play with. People die because they get infections and parasites and you get overgrowth in your small intestine you get SIBO you get bloated swollen in your abdomen people are unhappy. As I told you during this presentation 7,000 out of 150,000 extra deaths for 10 years of PPI use when you are older. It was U.S. veterans. You can maybe take PPI when you're young fine. You take it some years that's probably okay. To take it lifelong and be old with PPIs that's not recommended. I think to be honest in the long run we will see less of these drugs. In my opinion they will be faded out rather than increasing because now it exists a definite surgical method that actually works long term. Why should you risk all these side effects? I see no reason for that. What requirements are placed on surgeons in order to operate with RefluxStop? Do they need a special foregut surgeon to do it or can a general surgeon do it? Any surgeon general surgeon could do it. It's just that they need to train a little bit. That's like in every whatever you do in life you need to train on that specific area. It's a certain training needed and the key we had a study actually published when they noticed how long time it takes to train. I think the conclusion was that it was was it nine maybe seven? I think it was nine surgeries or it was seven eight or nine I don't remember fully now to take to feel that you're comfortable with the procedure. Then it could take maybe before you are really super specialists you know that you improve the operating time all the time maybe up to 30 cases. After that you are so fully trained that you can't improve your operating time anymore. Yes 6,000 surgeons in U.S. could do this. How does it look when it comes to money if FDA approves? Can you live on the income only from surgeons or do you have to emission or take a loan from bank? I mean we have as you can see then we had EUR 56 million and we are spending I think we were spending EUR 1.3 million per month. We still have a quite long runway. Of course it will be some extra costs for FDA. It's a strategic decision. We have enough money. It could also be an even improved U.S. launch by some small money more. That's not fully decided yet. We are just preparing everything for the launch right now. What are your thoughts on patients that have been diagnosed of having a weak LES but no hiatal hernia or wrong angle of His? Are they misaligned misdiagnosed or do you think they exist? I mean since our device which doesn't compress the food passageway at all I can say we have 100% treatment effect. That means those who have a weak LES are very very few if they at all exist. It's more the question about restoring the angle of His to restore the angle the position. That's the important part. What people who have this problem should do is just to measure the acid in the lower esophagus to see over 24 hours if they have acid reflux or not. Do you see need to increase your cash offer? That I think I really answered. Do you think Model 3 can be approved at once? I would guess FDA will have some comments but normally as I said because it's the third module they ramp up our answer quite quickly normally. Regarding the RCT comparing RefluxStop it usually takes some time to conclude the RCT. When are the readout dates expected? Would it be ethical to continue the trial if early indication shows the superiority of the RS procedure? When you do the RCT you actually define the number of patients in advance. You do your statistical calculation and see how many patients do I need to statistically prove that we are better. That's the number of patients we have selected. That's the 200 patients. We have to stick with so to say. When it will be ready the answer is that it depends. If it takes half a year to operate half a year to follow them then we will have half a year results a few months thereafter. I can't see exactly what will happen. If it takes longer to operate of course that will prolong a bit. If it should take up to one year to operate then it's one- and- a- half year because we need to follow them for six months and then a couple of months to conclude the data. Basically that's the principle. Would you consider securing funding to accelerate the launch? It is an option if you want to do a really smash in the market. As I said we still have EUR 56 million. Is it necessary to have completed randomized controlled trial pre-regime broader acceptance in the U.S.? No it's not. Our five-year results are fantastic and it's so many centers now popping up with results. The same question about capital a popular question. What is the current FDA approval status? I think I have answered that. When FDA approval is done is it possible to change list to a small cap? Absolutely. There is an option to change list. Absolutely. The stock has been rallying. Are you following it? The answer is not all the time but sometimes. I noticed I looked at the one month so it looked relatively good. I mean it's like everything price goes up and then always someone wants to take some return and sell. Then it goes down a bit and up a bit. Overall I have a feeling that the share price may due to the FDA. We never know. Are you going to file for CPT codes in the U.S. or no need for that? I think I answered that that there are already codes for the procedure codes for the surgeons and there is a code for the product. It's just the amount is not defined for the product. This was a question of if you are going to file for CPT codes specific to RefluxStop in the U.S. was the question on that one. Can the new production tool facilities delay the FDA approval in any way? No not. Will FDA approve those outside the current approval process? Everything you do with FDA you know you need to always file for FDA for any change of production you do. That's a quicker process. How does the NICE recommendation impact reimbursement say for RefluxStop in NHS? Do NHS need to decide on anything? How long can we expect to wait? Currently there is a specific implant code which gives some of the payment for the device in U.S. We are maybe paid half price or a little bit less with existing codes. Of course based on the recommendation it is forecasted that we should try to get an own code at some point. Will the new product be approved by FDA too? Yes of course it needs to be. How are developments in the latest? We are producing 10,000 products with the existing tools. We will have 10,000 products for the coming let's say two years or whatever we can be optimistic about. That's what we are preparing for the U.S. launch. 10,000 products. After that it will be produced in U.S. How are developments in the U.K.? I really think I answered. Will the planned U.S. expansion is management considered raising additional? That's the same about the question. What do you think about? No that I answered. Have you had any other competitor done an RCT? No one has done an RCT like we are doing here. This is unique and that's because you need so many patients. If you have just a little bit better results you need like 1,000 patients 700 patients to show that you are significantly improved you are better. You need much better results than your competitor. We feel we have a good chance to succeed with. There have been some cases of device migration in the past. Could you provide any commentary on the factors contributing to this and whether there are opportunities to enhance surgical training to mitigate it? This I can answer actually because we have now put together the results of 22 centers 602 patients. We had four cases. I don't know what that is in percentage but it's a very low amount. Four cases of 602 and they are all due to that a surgeon had sutured the pouch too tight. If you imagine you put the device on the outside of the stomach and you should close around it if you then do it so tight so this device is pressing on the stomach wall so it distorts the blood supply then you can get this migration. This happens in one case per four surgeons. 4 out of 22 surgeons had this problem with one patient each. After improved training this has disappeared. I think I have answered all of them now. There were many questions of course similar about NICE and similar about funding. What you could say is that if there will be a funding it will be a positive funding. It will be a funding for an explosive launch in U.S. It will be a very high likelihood to improve also the value of the company. It's not any negative financing is not happening. If it's a positive one but it's not decided yet. I thank you very much. Sorry it took so long but there are so many questions here. It's very many questions actually but it's many questions about the same topic. I wish you a really nice afternoon and evening and thank you for listening for this long message here. Thank you. Bye-bye.