Implantica AG (8IM1.F) Q2 FY2025 Earnings Call Transcript & Summary

Good afternoon, everybody. My name is Peter Forsell, and it's, of course, the Q2 presentation we are doing today. So 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. And I also once developed adjustable gastric band and a very successful business around that and the funding that has generated in Implantica is coming from this gastric band business. So our main product, cornerstone product is RefluxStop, and that's targeting a treatment field of 1 billion sufferers, and that's enormous, absolutely enormous. And here you see the device mounted on the insertion tool, which you use for a keyhole surgery. You see the metal there to the left goes into a little keyhole in the abdominal wall and you introduce the device and place it in the right place. And we have come quite far with our clinical evidence. So this quarter, we actually have published our 5-year pivotal study results. And they are objectively absolutely extraordinary results. And you can read these articles yourself, but it clearly shows how superior your RefluxStop is in relation to existing treatments. And one of the reasons for that is that in the past, everybody has focused on that you should close the food passage way. So acid is not coming up from the stomach into esophagus and you have magnetic bands and you have a wrap of your stomach called Nissen Fundoplication to try to compress and close -- support the 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. And what we realized is how you treat the cause of acid reflux instead. And I will show you a little bit, this is very late research from United States largest user of the magnetic band. And he has published a very interesting article where they have used different sizes of the device. They are 13, 14, 15, 16 and 17 centimeters, you can see here. And then 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. And then 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. And then he looked when he has done several of those dilatations, how many patients still had what we call dysphagia that's swallowing difficulties. And 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. And then you can see here that when you get a larger, let's say, we take the number, second last and third last from the right here, you see that treatment is only 65% to 72%. That means only 2/3 of the patients are actually treated, which is quite low. And at the same time, you look at need for dilatation, you see 28% to 29%, which is nearly 1/3 of the patients need to do several quite burdensome esophageal dilatations. And at the same time, you can see that they still after this between 8% and 14% had persistent swallowing difficulties. So it's -- the conclusion here could be these methods doesn't work. You can't attack the sphincter and try to keep it closed. You get too much problems. So RefluxStop on the other hand, then treats the cause of acid reflux. And I know most of you know this since before, and I should be very short here in repeating. But 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. And 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. And this is leaking out through the opening here around the esophagus. And this is affecting the sphincter. So 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. So medical treatment, they are calling PPI. There are some other new treatments that claim have a better treatment effect, but they are all the same complications. And they failed PPI treatment about 59% of sufferers now and then. And 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. So it's a large group of patients. And PPI have really serious side effects and people do not understand how bad it is. And I need to say this again, a study from 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. So it's nearly 1 out of 20 over a 10-year period. And you can ask yourself, how could this be possible? How could this be so dangerous? And the answer is it's because these people have reached an older age and have been taking this for a very long time, and then it starts to be really dangerous to take these drugs. And here, you can see the 4 main reasons for death, it's cardiovascular disease, through the kidney disease. It's actually cancers could be #2 and kidney disease #3 here and infections and parasites. And I will try to explain a little bit about this because we get so many questions about this and about new better treatments and so on. And it's not a competitor for the RefluxStop device. So first of all, if you go for why do people die in cardiovascular disease, so extra death. We don't -- people die in cardiovascular disease. And no one would say, okay, it was my PPI who made 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 and is because PPI reduces nitric oxide in the blood vessel. It's a substance in the blood vessel who is reduced and that promotes vascular stiffening and plaque formation. And this is crucial, this substance to keep the blood vessel relaxed and preventing plaque buildup. So 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. And also very simple, when you have no acid in your stomach, you have no protection for infection and parasites anymore. 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. But suddenly, we have this -- not this protection anymore. And 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. And 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 it's quite annoying for the patient. It reduced quality of life. And this bloating problem is quite -- people rank it very, very high. People doesn't like this at all. And 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. Yes. So how is it then the cancer? Yes, cancer is the second cause of extra death among PPI users. And the bad thing here is that the disease itself gives you cancer. So when the stomach fluid is coming up and irritating esophagus, it's like burning esophagus. It gets small ulcers, get red, it gets swollen, irritated. When you do that over and over again, that's paralyzing your tissue, that's a master example how you get cancer. And we know that 10% to 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. And this is the precancerous status that up to 15% of all sufferers get. And then out of these, of course, a certain number then get pulmonary cancer, very dangerous cancer, most people die. And it's 48,000 people only in Europe and United States alone that die from esophageal adenocarcinoma. And you can compare this to breast cancer where they do anything, take any cost to find a breast cancer. They have all these programs to find the cancers. Here, 48,000 people is just let's die. It's completely unacceptable. It's -- this must change, and 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. So be old and having 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 2 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 that on a low burn rate for the moment. But as long quickly as we get going 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. And really fantastic with this is that you can monitor people's treatment on distance and you can change treatment of distance. You can monitor how people have it inside their body. Are they healthy? Is It problems? It's a revolution of health care when this will be launched. And 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. And society will save money. 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 health care. And we have developed a completely new communication system, and we are starting to develop our own chip. And we see this technology with the ER platform, the wireless platform, something that could probably be licensed worldwide if we want to pursue that route. Just some examples of products that sort of could be classified as humanitarian products, as the products that really will change people's life. And one example is people who has a plastic bag collecting their fecal matter. Maybe someone has taken away the large intestine for some reason, a cancer or ulcerous colitis often young people can get. And they collect 2 to 3 liters of fluid in that plastic bag and they have self adhesive on the skin all the time. Skin gets red, get irritated. It's not fun and it's not fun to run to the beach either. And 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 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 5 times 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 burdensome life. We have a solution for that. We can now just have a remote control for these people to enter 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 is interested in FDA. We filed our application, the third and last module June 23. And together with the feedback, so answers from the feedback from module 2, which was a minor character, we also filed together with that. That means that 5 weeks from now, if FDA hit the time line, we can't guarantee that. But if they hit their time line in 5 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. And 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. So we have already booked with FDA inspections scheduled for October on Implantica's premises. So everything here looks very promising, of course, pending FDA approval. And 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 new production tool, multi-cavity tool for the U.S. market. This started 2 years ago. It has taken 1.5 years just to produce this tool. And also 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 this discussion about custom fees and so on. So I have a little video here, which I think the team behind me here should try to show you. [Presentation]

So there, you can see that with such a tool, we can do many products. It's fully automatic and silicon in, and then it says, butcha, butcha, basically, and outcomes finished products. And it's really to prepare us for a possible success in the U.S. market. So 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. So for the moment, we have more than 100 surgeons who want to start with RefluxStop after U.S. approval. And we are starting with the first 50 centers that is under selection right now. And as you know, U.S. has a much more favorable payment system than in Europe. In Europe, they believe you should be able to run your business for 5 years before you get any income because we don't pay for anything new. But in United States, they understand that new technology must be favored. So the good thing in the United States 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, hospital and surgeon can just start operating, they will earn exactly as much money as they earn now or even more. So 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, payment is undefined. And that's the process that then will take a year maybe to get most of the insurance companies to accept our payment. And that's a process and that's why we are working on supplying a complete package to the insurance companies, how they save money. Because we know that we have superior cost effectiveness also in United States. So it's 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. And also in U.S., we provide superior cost effectiveness, which is very, very important for these insurance companies. And of course, the fantastic results. We now have the 5-year results and lots of articles. So 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. But we have around 600 accounts that previously used the magnetic band and of course, that's the ultimate goal to replace, so to say, an older method with this in these 600 hospitals. So we think we have all the attributes now to really be the new standard of care for treatment of acid reflux. And the 5-year results really support that. So 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, swallowing difficulties, you can't mention vomit and pain at swallowing and so on. And then it's the more overall outcome, how you are treated with low pH, quality of life, is any taking PPI and so on. That's -- so this is a very interesting reading. And basically, you can say these results are completely unmatched. It's like night and day basically. Swallowing difficulty goes from 0 or 1 patient to 30% or 28.9% and able to belch and vomit, 40% can't do that in standard of care, and we have 0%, for example. So it's completely like night and day. And here, you can see some of the results. So it's actually -- here I see is missing a little percentage, but it's 97.9% do not take PPI. We have one single patient who took PPI at 5 years. That could be compared to every patient taking it before surgery and only one patient taking PPI at 5 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 device over the whole study. No device location erosion, no reherniation at 5 years, defined by x-ray. So it's objective contrast swallow x-ray at 5 years. All the devices are in place, and there is no reherniation. 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 30% are not at all treated and then you have another 30% as swallowing difficulties, and it's just not matchable. Here, you can see a little bit the difference. This is standard of care and Nissen Fundoplication, and you see the green staples down there. They are quite different between the orange ones. And our clinical evidence is expanding with snowball effect. It's so many articles, poster presentations, oral presentations and manuscripts. We are publishing more and more and more and more article about RefluxStop, center of the center pop up and present the results. And the good thing is it all is the same. All is fantastic. So it's not only we in our study. No, it's all these different centers from all these different countries. They have the same results. And we are doing lots now of expanded trials. We are doing -- the registry is already ongoing. We have now just got green light with the starting of the RCT versus Nissen. And 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, they have not operated this quarter. They just accumulated patients to be able to quickly do the trial when we kick off. So this is very exciting. It will be also a registry in U.S., of course, and we will do a 200-patient study there when we get approved. So the randomized trial is led by Professor Schoppmann in AKH in Vienna. It's Europe's largest university hospital. So this is a very, very exciting study. So around -- I don't know these figures. They are always too low because we always forget to change them. But here is 1,300 products and 45 hospitals. I think it's a little bit more than that. And I wanted to give you one example of a good expansion of the market for RefluxStop surgery. And this is Spain. So this quarter, we added another 3 centers. And I think we wrote in the report that we had 19 new centers, but actually 2 of them has only said they will start, but we have not operated yet. So it was a mistake. So it's 17 centers. But still, we launched 2023. So in 2 years' time, we have 17 plus 2 ones to start in Spain. And then you can ask yourself, that's quite an astonishing achievement. I mean, if every country would have been -- have 17 hospitals, it would be very many hospitals. And then the question is, why just Spain? And the answer is that Spain has a health care system that it was in the past. They prioritize providing the best treatment. The surgeons has 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. But it's still -- they look at the patients, they 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, and that's an absolutely terrible situation. But 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 are not really -- have not been reimbursed. But as you know, the situation is easing a bit now. We have NICE, the big organization who give guidelines to NHA, the public hospitals in U.K., they have been given recommendations that the hospital should use RefluxStop. And that's for around 50% of the patient, those who has ineffective esophageal motility. So 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 health care system, so we could get fully paid. And then, of course, the business will expand enormously also in Europe. So 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 recommended now to use this in NHS hospitals. Everybody was very enthusiastic. And of course, it was discussed about training and so on. And we have also expanded to other territories, our work and Canada has agreed to accept the U.S. filing data. So 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. And also Japan, we have established all the necessary contact relations, how it should be done, surgeons established. So 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. And this is basically around 11% of the world market. So that's a very important market. Yes. So overall, we view RefluxStop as unstoppable. And we had a bit shaky start, as you know, with COVID and FDA wanted us to provide 5-year data instead of 3 years and so on. But now it looks really, really promising for Implantica. And then we should go over to the capital market and finances. And 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% in 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 the increased production capacity as announced earlier this week with the 2 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 selected pruning of the pipeline product patent portfolio and nonrecurring 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. And 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. So I think we then should try to go to some questions.

[Operator Instructions] The next question comes from Filip Wiberg from Pareto Securities.

Can you hear me well?

Absolutely.

Great. So I've got a few questions. Firstly, on the FDA progress that you've made here. So with Module 3 now submitted, so the feedback you talked about that you're expecting in 5 weeks, are you expecting like sort of questions that you had on Module 2 also now in 5 weeks and then there will be some time for you to respond to those?

So we, of course, don't know what 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 have passed, so to say. And normally, when you have Module 3, you are absolutely correct that formally FDA have another 3 months to answer our answer, so to say. But because this is the end of the route now and the next step is the approval. So normally, they ramp up the things quicker. So this is all...

Okay. Got it. Yes. And you also submitted your response to those Module 2 questions. So are those going to be reviewed at the same time and then they'll come up during this meeting in 5 weeks as well? Or how is Module 2 handled now going forward?

No, no, it's coming at the same time. And if we are lucky, of course, Module 2 will be closed or if we are unlucky, there is some small topic left that they want to know something of.

Yes. Okay. So still reasonable to have an approval by year-end or perhaps early next year then?

Yes. I mean, you can say that we will have inspections during October. So I would say I mean, there is Thanksgiving in U.S., an important holiday. And I would say earliest before that could be realistic.

Okay. Okay. And then just on the RCT that you're starting up now. So you've had all these pre-start-up meetings at least. But what is the status here? When is the first operation expected to take place?

I guess the first operations will happen any time. 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 nature. We don't need to have any more approval or anything. We can just get going. So it's a little bit about to the holidays of the surgeons, but I could foresee surgery starting very soon now.

Can you give some sort of...

The surgeons has all collected patients for this. So we have more than 10 surgeons, and they have not been operating their patients now because they have collected them to quickly do this randomized trial. So it's lots of patients lined up for this RCT. And 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.

Yes. Okay. And is it possible to give some sort of details around the time line for this? How quickly do you expect all the procedures have taken place and then readouts and all of that? Could you give a time line for that?

Yes. So it's 100 patients per group formally. So that's 200 patients. Then if something is operated completely off label, so to say, then those patients is excluded. So there's a review of videos within 3 days after surgery. So anything that is completely stupid, that's taken off. So a few more than the 200, so maybe 220 patients we may need. And with 10 centers, yes, 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. And what is your best guess on that? Is it half year or is it 1 year or...

I mean it's not unrealistic in 1 year. It's already half a year, but it could, of course, also take 1 year. Yes.

Okay. And then just lastly on the NICE recommendation here. So you got the positive recommendation for these patients with IEM. So 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?

So NICE only accepts published articles in their review. So we didn't have our 5-year results published. We didn't have -- 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 and none of this was published. But then FDA -- and FDA and NICE came with a compromise and said, we approved you for these IEM patients. And they are called IOM in U.K. because they spell esophagus with O-E in esophagus. That's the reason why it's 2 names. And the problem is that when acid is coming up in lower esophagus, the nerves and muscles, everything gets a bit destroyed. And suddenly, the transportation of food get worse and worse. So that's generally the worst sufferers. When we talk about IEM sufferers, but of course, those who has it from the beginning, but many achieve it by having the disease for a long time. And 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. This, of course, gets really terrible if you then have a stop down. It has no power to open this -- stop the stenosis you have there. So this is not recommended to operate with existing technique. This is just a group of patients who stays untreated with terrible symptoms, long-term sufferer. It's the worst. And those patients, they gave to us because they realized, of course, that our treatment is much better than anything else, but they formally need to have a little bit more documentation before we get all the 100%. So this is around 50% of the patients, 40% to 50% of the patients.

Yes. All right. Okay. So it's just about documentation. Yes. Lastly, just what's 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. And there is a few lined up. But as you know, they need to be trained. And it's a little process for every -- we can't -- 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...

Yes. I mean I guess we will now -- when the summer is over, we will start training more hospitals, and then they will do their first surgeries with a proctor and they will send videos so we can control that they do it the right way. And in 3 months' time, they will probably be up and running.

There are no more callers at this time. So I hand the conference back to the speakers for any written questions and closing comments.

So I have a few questions then here, written questions. I can quickly try to answer them. So one question sorts on PCABs and the potential of PPI-resistant patients. Can they negatively impact the market size for RefluxStop? So 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 than that's sort of not the biggest problem. The biggest problem is the complications. And the complication pre-file of the new and the old treatment is basically the same what I have seen in studies so far. And as I told you a little bit about in this presentation, you don't have any stomach acid, that's not to play with. People die because they get infections and parasites and you get lower growth in your small intestine, you get SIBO, you get bloated, swollen in your abdomen, people are unhappy. And 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. So it was U.S. veterans. So you can maybe take PPI when you are young, fine, you take this some years, that's probably okay. But to take it lifelong and be old with PPIs, that's not recommended. So it's really -- I think, to be honest, in the long run, we will see less of these drugs. And 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? I mean any surgeon, general surgeon could do it. It's just that they need to train a little bit. That's like in everything. I mean, whatever you do in life, you need to train on that specific area. So 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. And I think the conclusion was that it was -- was it 9, maybe 7 -- I think it was 9 surgeries or was 7, 8 or 9, I don't remember full enough to take to feel that you're comfortable with the procedure. And then it would take maybe if we are really super specialists that you improve the operating time all the time, maybe up to 30 cases. And after that, you are so fully trained that you can't improve your operating time anymore. So 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 for surgeons? Or do you have to [ emission ] or take a loan from bank? I mean we have -- as you could see, then we had EUR 56 million, and we are spending -- I think we were spending EUR 1.3 million per month. So we still have a quite long runway. And 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 who doesn't compress the food passage at all, I can say we have 100% treatment effect. So that means those who have a weak LES are very, very few if they at all exist. And it's more the question about to restore the angle of His, to restore the angle, the position, that's the important part. And what people who have this problem should do is just to measure the acid in the lower esophagus to see over 24 hours, do they have acid reflux or not? Do you see need to increase your cash offer, that I think I already answered. Do you think Model 3 can be approved at once? I would guess the 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? So when you do the RCT, you actually define the number of patients in advance. So you do your statistical calculation and see how many patients do I need to prove, statistically prove that we are better. And that's the number of patients we have selected. That's the 200 patients. And that we have to stick with, so to say. And when it will be ready, yes, so 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 year results, a few months thereafter. But then because I'm not -- I can't see exactly what will happen. Sorry, my screen disappeared here. So if it takes longer to operate, of course, that will prolong a bit. If it should take up to 1 year to operate, then it's 1.5 years because we need to follow them for 6 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. But as I said, we still have EUR 56 million. Is it necessary to have completed randomized controlled trial pre broader acceptance in the U.S.? No, it's not. Our 5-year results is fantastic, and it's so many centers now popping up with results. Yes, 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, we -- there is an option to change list, absolutely. The stock have been rallying, are you following it? The answer is not all the time, but sometimes. And I noticed I look at the 1 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. And then it goes down a bit and up a bit. But overall, I have a feeling that the share price may due to the FDA, yes, we never know. Are you going to file for CPT codes specifically in the U.S. or no need for that? I think I answered that, that there is already codes for the procedure, it codes for the surgeons, and it is a code for the product. It's just the amount is not defined for the product. So this was a question of who are going to file for CPT code 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 approval those outside the current approval process? Everything you do with the FDA, you need to always file for FDA for any change of production you do. But that's a quicker process. How does the NICE accommodation impact reimbursement [indiscernible] NHS? Do NHS need to decide on anything? How long can we expect to wait? So currently, there is a specific implant code who gives some of the payment for the device in U.S. So we are maybe paid off price or a little bit less with the existing codes. Then, of course, based on the recommendation, it is forecasted that we should try to get an own code at some point. Will the new -- so how -- will the new product will be approved by FDA, too? Yes. Of course, it needs to be. How are developments in -- we are producing 10,000 products with the existing tools. So we will have 10,000 products for the coming, let's say, 2 years or whatever we can be optimistic about. That's what we are preparing for the U.S. launch, 10,000 products. Then after that, it will be produced in U.S. How are developments in the U.K., that I really think I answered. With the planned U.S. expansion, is management consider raising additional debt? That's the same about question. What do you think about, no that I answered. Any other competitor done in RCT? No has done an RCT like we are doing here. This is unique, and that's because you need so many patients. So if you have just a little bit better results, you need like 1,000 patients, 700 patients to show that you are significantly and prove you are better, you need much better results than your competitor and that 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? Yes. So this I can answer actually because we have now put together the results of 22 centers, 602 patients. And we had 4 cases. I don't know what that is in percentage, but it's a very low amount, 4 cases of 602, and they are all due to that the surgeon have suture the pouch too tight. So if you imagine you put the device on 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. And this happens in one case, 4 surgeons, 4 out of 22 surgeons had this problem with 1 patient each. And after improved training, this has disappeared. I think that's -- I think I have answered all of them now. And there were many questions, of course, similar about NICE and similar about funding. So 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., and it will be very high likelihood 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. Then I think thank you very much. Sorry, it took a long time, but it's 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.