Implantica AG

Yeah, welcome everybody to Implantica's Q1 2036 report. And I will, as usual, start with a short little introduction that you have maybe heard a few times before, but I will try to do it as quick as possible. So I'm not so familiar. So my name is Peter Forssell, sorry for the delay. And as you know, I'm the founder of this company and also surgeon and the inventor of the products we have. And I've invested lots of money in this company, and they are based on my previous business. It was a gastric band business who was very successful and later sold to Johnson & Johnson. So our main and cornerstone product is reflux stop, and that's working in the treatment field of 1 billion sufferers. An enormous field. It's only obesity who can match these kind of levels of disease. So reflux stop you see on the picture here with a nice tool that we supplied to the hospital to place it. On the next slide you see a closer picture of how reflux stop looks. It's made in five pieces. Today we have 50 hospitals who do the procedure in Europe and we have done around 1,500 surgeries so far. And existing treatments in the past has always been focusing on that it's the swinter, the closing muscle between the stomach and the esophagus, which is the problem. And therefore, everybody has tried to close that, either with the magnetic band, our main device competitive from Lynx, or so-called fundoplication, where you wrap the stomach around to try to support the closing. The problem now is that this is your food passageway and therefore people get lots of problems. They can't swallow and they get swallowing difficulties. They can't get nothing up. They can't bench and vomit. And you try and you get maybe lots of air down with your food, but nothing comes up and you get bloated and distended and people are quite unhappy with this kind of surgeries. So we at Implantica instead find out that it's nothing wrong with the Swinter. You don't need to affect the food passageway at all. And you can actually treat acid reflux much better than the other metals that try to compress. And we are doing that based on the following theory. In the chest, you breathe. That means pressure variation is coming and going. Every time you breathe, the pressure changes direction. And you have a big muscle, the diaphragm, who divides the chest from abdomen. And there you have an opening for esophagus. And through that opening, pressure variations is leaking out. So that means that this poor little swinter here who should close is terrorized with constant pressure variations and it can't handle it. And therefore, the closer the muscle gets to the diaphragm, the more reflux you get. And with reflux stop, you restore the normal anatomical and physiological situation. And you place the device on the outside of the stomach. And thereby, you always have a nice five centimeter distance to the diaphragm. And simsalabim all as the reflux disappears in principle. And if you get this... the sphincter all the way up into the chest, then you call it the hernia. That you see on the middle of the picture here. And this hernia, that has maybe two-thirds of those operated for acid reflux. So people then take drugs. That's the main treatment for this disease. However, 40% of the sufferers are not helped by the drugs. And there is a reason why we have acid in the stomach. It's to kill off all the bacteria or parasites and so on that you get with your food. And when you don't have the acid barrier, Then suddenly your bacteria come down to your small intestine, and the small intestine, who normally is sterile, suddenly get inflamated, red, swollen, and you get bloated. And this happens quite a lot of the people who take PPI. It's called SIBO, it's called. And these drugs, if they should come to the market today, would never be approved because they are really, really dangerous. In a huge study from the United States with 157,000 US veterans, one out of 20 died in a period of 10 years BPI use. So this is a really, really terrible drug. 48,000 people die from esophageal adenocarcinoma every year. 48,000 people just in Europe and United States. And it's not like breast cancer when they do anything to save a life. Here they just let 48,000 people die. Completely unacceptable. That's why all these people need to be operated with reflux stopper. And... Finally, before I start with the update, a little bit of our previous clinical outcomes. So we have our pivotal study filed as an FDA PMA submission. And this data is fantastic, basically. We have one old patient took PPI medication before surgery and one patient at five years, only one. And this patient likely didn't even take it for acid reflux. And if you look at the objective measurement, when you measure pH in Dover is over 24 hours, then you can see that it verifies these fantastic results. So the pH goes down to normal values in all patients. If you use the definition used by our competitor in the FDA trial, 100% of the patients have normalized pH. And you can see at six months and five years, it's the same. It's stable over five years, these fantastic results, completely unmatched results. And here you can see the difference between a recently published meta-analysis literature review of the main competitor we have. The standard of care is this fundoplication method. And you can see that it's like night and day. So 40% can't bench and vomit. No one who operated for reflux had a problem to bench and vomit. 30% have swallowing difficulties. We had one patient who has temporary swallowing difficulties. It's sort of Completely new world opens up for these patients. And you can see to the left that different outcome you look at, the results are between 94 and 100%. It's just absolutely astonishing result. You can read yourself. It's published, the FDA, all the FDA submission basically has been summarized in two articles published in surgical endoscopy, the five-year data. There you can read yourself and enjoy. Then over to the business update. Sorry for a little introduction. So let's start with FDA. We have really good news this quarter. And here at Implantica, we are jumping up and down of happiness, actually, because that we finally have made our FDA submission for the final answer to FDA, which is a big landmark. And it's hard to understand, but this is many, many, many years of hard work of all fronts. You know, it's money it's clinical it's it's so much work behind this it's hard to understand and here a little bit map how we now are targeting if we now get the fda approval We have already agreed with Canada that we will be approved. We have come far with Japan and also Brazil we are working on. And we have a really good situation. And we can also expand to countries where we have actively not sold yet. Middle East, for example, which is a good market. And everything looks quite promising for Implantica. So we have submitted now the final response. As you maybe know, FDA has reviewed all our three PMA modules. We supply the PMA divided in three parts called modules. And all three has been reviewed by FDA. They have provided feedback to us on all modules and we have answered on their feedback on all modules. And we have also have what you call pre-approval inspections. So when you come to the end point of this process, FDA comes out and they look at your manufacturing, they look at all the hospitals, they look at your facility, your quality system. And we have passed six of these pre-approval inspections and all was successfully concluded as reported in the closing meetings. So this looks a little bit promising now, and now it's in the hands of FDA and according to FDA's guidelines for their work, they have up to 90 days to answer on this final response. This is also, of course, lots of work now to really start to do the perfect launch here in the United States because we need to prepare in advance. And we already had more than 100 surgeons who show interest to start with reflux op. And we target to start with the key center, 50 centers. And 20 surgeons has already been trained. As you know, since before we flew them over here to Europe, they saw two centers operations and we have done cadaver treatment. And they operate the cadaver in Chicago. So we are now preparing. So we have maybe tenfold of European surgeons willing to fly over for the starting kick where we should train the key centers. And thereafter, we will then develop centers in the United States who will do the training. So for example, Professor Lippam, you see he says USC on the photo there. This is Professor Lippam, one of the most known and famous highest regarded surgeons in the United States and his center will be one of the training centers. He has five surgeons doing this type of surgery and they do 1,100 surgeries every year of reflux. As an example, So we are also preparing, as you know since before as well, we are producing and have basically produced quite a lot already of 10,000 reflux stop devices for this launch. So we really are prepared. We also have made a special tool for production inside United States. So we are prepared for any rule change of any kind. We also have a fantastic interest from the U.S. surgeons. They are really, really eager to get this product on the U.S. market. And here is an example. This is at Sages. Sages is the organization to provide the guidelines. And they also have this magazine here. surgical endoscopy I showed you before. So this is a very, very prominent place to be. And here we had lots of presentations of reflux stop. So they presented from Spain, 56 patients. And we have also Dr. Seter presented his 108 patients. And Professor Lehman presented robotic surgery. You know, that's the new thing now that they do reflux stop with robotic surgery. And it's a very good feeling, very good atmosphere, and our booth is completely full all the time with interest. Here you see another important meeting. This is DDW, also from 2026. This is the place where you have more than 30,000 people coming. It's incredible. It's both surgeons and medical doctors. And there, Dr. Borbely presented his data. He is coming from Bern, from Inselspitalis, the largest university hospital in Switzerland. So it's a highly regarded place. And he presented up to 7.25 years data. So more than seven years data. And it was... incredible interest. And he has operated really, really severe sufferers, lots of severe sufferers. Nearly 25% had pre-cancerous changes in the group he operated, and really terrible disease. 55% had large hernia, and he even operated lung transplant patients. So This is a new field for implantica. So in the United States, for example, you have 15 million people with severe lung disease and they get really worse. So if you do a lung transplant, for example, you can't have acid reflux destroying your lung. It doesn't work. You know, they lay down and sleep and the acid comes up and into the lung and it's terrible. So he has operated already. 4% of his surgeries here was done on lung transplant patients. So that's another very, very interesting group. And many medical doctors was highly interested in this. It's a few thousand, I think, of these transplants done every year in the US only. But it's a big, big group of many, many such sufferers that could possibly be affected by this. And also these really severe sufferers created a big interest. So he had operated for almost 6% of patients with no food transportation at all. They had aparystalsis, so no contraction at all in esophagus for food transportation. And it still worked out perfectly with reflux. So all this opens up really large, huge, new territories. And it was highly, highly regarded, these presentations. Yeah, so what does this mean, all this work that we are doing? It actually means that we will have a much faster load. So to do all these articles, to present all this, being at all these congresses, it's hard work, but at the end, This will generate a much faster launch. So if you look at U.S. companies in a similar situation as us, you will see that they normally has one year data. They do a U.S. company, do a U.S. trial of one year, and then they go to launch. And then it takes them four years because they need to develop data. They need to develop confidence in the market. People are not starting to operate like crazy, something they don't know how it works long term. And we already have the five year data. And that means that when we do our US launch, it will be dramatically faster. We talk about several years of quicker launch because we have selected all these important data. Clinical evidence and reimbursement update. So today we have not less than 35 articles, peer review, professional articles written about reflux of data. Incredible work from our team. We have a really full team of eight people doing nothing else than supporting surgeons if they need any help in this respect. So it's really, really fantastic clinical evidence that we have created. And one special article I wanted to emphasize, which is also press release this quarter, and this is that we presented 602 patients across 22 European centers and Professor Schopman managed to get all these 22 centers to do hard work and present all their data so we can have up to seven years follow-up from 22 European centers and it's fantastic results. So it's 98% have no kind of re-operation of any kind and those who had problems were all satisfactory result. So this is really excellent. We talk about tenfold lower results than in standard of care. Also, we are doing lots of work on health economic side because today it's nice to be the best treatment, but you should actually also be the most cost effective. Society should save money by switching to reflux stop. then you are in a really good situation. And that's actually what we have proven with all this research. So from the beginning, you know, University of York, their health economic consortium has done all this work and put together all the cost analysis for all the different treatments of acid reflux. And the conclusion is that reflux soap is highly, highly cost-benefit. We are much cheaper to do than any of the other fund application, links, magnetic band, or medical treatment. Although the medical treatment costs nothing, The complications is so high that it costs more than taking the cost for the reflux stop procedure. And we have now done this in the United States as well. The same fantastic results and that we hope should be published after the launch. And we have also done it in Italy. Here you see some of the reference I just put together, some reference how we do this in country by country to show we are superior. And in Italy now, it's quite interesting because here we have then have an article published to show that it's more cost-effective to operate the reflux stop, that the society save money by operating with reflux stop. And that's of course incredible. And what is the result? The result is that we have more and more so-called tender winds. So in Italy, you know, you, you, They specify that they want to do so and so many surgeries and then you make offers. How much that will cost with the different procedures and so on. And you see here, all this to the right here is tender winds. So lately we had a tender wind of 1.2 million euro, for example. And this is like a snowball effect. Imagine you stand on the top of the mountain and it's really soft snow, warm, nice, and you start to roll down. This is the effect that we will have here in Italy now. It will be more and more centers, more and more tender winds until we reach a really good reimbursement situation. Also in Germany, our situation starts to become quite good. As you know, we have already got our own OPS code. That means in this whole DRG system that they have to specify all the different surgeries, we have a specific code for reflux stop. The problem is just that in the beginning, they don't give any money for that code. So when they operate in Germany, they don't get a penny. However, it's an organization, a health body in Germany called INEC. And they look at all the costs. real-world cost for this operation, and then they will give money to this. And to do that, we then need so-called INIC hospitals. And there is not so many and not so many operating reflux. So you have really tried very hard to convince people to start here with reflux surgery. And we are very happy to say that we have another two centers now. We started both in Leipzig and in Menden in Germany. So we now have six ENIC reporting hospitals, and we are targeting to do what ENIC requests, around 200 surgeries this year now in Germany, so we can get paid also in Germany, which would be fantastic, a country who do 12,000 procedures or so of this reflux surgery. Market expansion opportunities. So... This you maybe also know, but it's quite interesting for us, of course, that J&J, as we draw on links, our main device competitor, the magnetic band from all markets outside US, March 31, 2026. That means it opens up a big gap all over Europe or the whole world where they have used links before and they need something to fill that gap. And our intention is to fill that gap and hopefully later on also in United States. And we also have new, very, very interesting market aspects. So when you operate obese people, so in United States, it's nearly 300,000 people who is operated for obesity. And out of those, 160,000 or so are done with gastric sleeve. That means you suture your stomach like a prolongation of your esophagus, so it becomes a long tube. And since you all now know that when everything lights up, you get reflux, It's of course very easy that everything lights up if you have a long tube only. You have nothing to stop it from lighting up. And that's also what happens here. So after one year, more than 50% of the gastric sleeve obesity surgery operated patients have surgically induced acid reflux. That means we have 80,000 people who need treatment. that's perfect for reflux stop. It's actually so many and probably will increase after two, three years that it could be discussed if not all gastric sleeve patients should have a reflux stop. Let's say all 160,000 would benefit to get reflux stop together with the gastric sleeve surgery. And that's a very, very interesting aspect. And you can see here a little bit here we have put together, you know, in relation to the market share of the VCT surgery, you can see that it could be quite many surgeries if you're successful in this field. And I will come later with some more nice information relating to that. So here you see a little bit some further developments than how we are planning to step by step launch a sort of reflux of two and three and expand also to this obesity market. And we are doing another randomized trial. So we have already agreed with Inset Spital here in Switzerland and some other key centers that we should compare this gastric sleeve with and without reflux stop. It's called ReShape, a very nice name for someone who lose weight. So this is a very, very interesting study that we are not so far away to launch, and that will be very, very interesting expansion of the market.

finance update andreas many thanks peter good afternoon or good morning i'll walk through our financial performance for the first quarter of 2026. net sales for the quarter amounted to 857 000 euros representing an increase of 15% compared to Q1 2025. Implantka continues to selectively commercialize Reflux Stop through partnering with leading key opinion leaders in Europe, while preparing for broader commercialization driven by a US market approval and expanded European reimbursement coverage. As Peter outlined, The company is making solid progress towards both achieving a US approval and European reimbursement. The business consistently delivers best-in-class gross margins. Adjusted gross margin for the quarter came in at 93%, remaining at a very high level despite normal quarterly variance. First quarter operating loss amounted to 3.9 million euro, representing an 8% year-on-year improvement. This despite an 8% increase in R&D expenses compared to last year, mainly driven by post-market study costs. The higher R&D spending was more than offset by a 12% reduction in general and admin expenses as a result of disciplined cost management. Turning to cash flow. Operating cash outflow amounted to 3.7 million for the quarter, a 19% improvement compared to Q1 2025. At the end of March, the company held cash and cash equivalents of €45.5 million, providing a solid financial possession. Let me also highlight that the capital structure remains debt-free. Turning briefly to our shareholder base. We continue to benefit from the support of a committed high-quality investor group, including our founder and CEO and principal shareholder, Peter. We value the continued long-term support as we relentlessly work to ensure that GERD sufferers worldwide gain access to the best available treatment at scale. Back to you, Peter.

Thank you. So before we start with questions, I of course need to tell you that Implantica is actually much more than reflux stop. Although reflux stop has the potential and attributes to build an enormous business, we have something that is actually even much, much larger than that. And that's our platform technologies and pipeline products. So we have created an e-help platform and an energizing virus energizing platform so we can actually build extremely advanced medical implants called super smart medical implants. And we can control these implants remotely. That's absolutely fantastic. It's long, long work behind this. And it's actually so advanced that we believe if we want, we could license this platform technologies to the whole implant world, basically, if you want. We can also discuss if it's more advanced to use it for our own products. because we have a huge pipeline. As you know, we went through the whole body and we looked at every single treatment field. How could we improve healthcare with our platform technologies? And it showed up that more advanced technology, it was possible to improve nearly everything. It's fantastic. And we have more than 300 inventions And we've been sitting doing market analysis, product analysis, production analysis, and we have selected 40 of these 300 inventions that we believe are really strong implant products. And the e-health platform, we have filed 25,000 pages of patents. You can imagine how many pages this is just to cover and protect our e-health platform. Sorry. So it's a bit hard to grasp how huge this could be, but it really is something very special. But it needs, of course, lots of execution and lots of funding. And our first priority is, of course, reflux stop. Our second priority is reflux stop. And our third priority is reflux stop. So don't worry. We will bring reflux stop to a successful launch. Just another product, because we talked about obesity and we discussed how we can use reflux stop in the obesity world. And then I wanted to tell you also that we actually have a fantastic product to treat obesity. And as you know, today you have these injections, even drugs sometimes, but mainly injections that is quite good at treating obesity. You can lose 10%, 15% or so of your weight loss. But of course, if you have 50, 60, 70 overweight, then it's a bit too much for these drugs. And what is worse is that as soon as you stop this drug, you gain your weight again. It's incredible. I worked with these obese patients in the past and It's hard to believe, you know, you can have a patient who lost weight from 160 to 70 kilo with a gastric band and we take out the gastric band and three years later they are 155 kilo. And you just don't understand it. But that's the case. These people, they are bound to take this injection for the rest of their life. And how looks the complication when you take it for the rest of your life? And that's why obesity surgery will always feel a very important part. And this product is working exactly like the normal body's way of feeling full. Then you eat, you fill the stomach, you stretch the stomach wall, and then you have receptors to send a signal to the brain, stop eating, you are full. Otherwise, you will blow your stomach if you don't have these receptors. We use these receptors by stretching the stomach wall and tricking the stomach that it's full. Very simple and geniusly did we mention. Also, this is the part we get most interested from patients. This is people who have taken away the large intestine, for example. Maybe they have an ulcerous colitis inflammation or they have a cancer or something. And they collect the fecal matter outside the abdominal wall here in a plastic bag. And the business just for plastic bags is $3.9 billion. Imagine, $4 billion for plastic bags. They don't need this anymore. We have reservoir, open, closed, remote control is all you need. And you can have a normal life, everything connected to us. So that was a little bit this. Now we think we should move over to questions. And I think I put my little camera off here to try to, we need to read and communicate a bit here so we get the right answer to your questions. And thank you very much for listening. Otherwise.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Philip Weyberg from Pareto Securities. Please go ahead.

Hi, Tim. I've got a few questions today, but I think I'll take them one by one as usual. So first, just on the FDA process here, as you've I handed in your responses. I was just curious around what you see as the possible remaining scenarios. What's your feeling given the latest feedback that you got after the 100-day meeting? Is it a decision on approval or what kind of risks remaining can you see now?

I mean, you know, FDA has gone through all our modules and they have provided written feedback. And then we had this meeting and we discussed all the feedback that was remaining with FDA to find out exactly what they wanted. And we had a very nice dialogue with FDA. I must say, very, very positive dialogue. And it worked nicely. And we have then fulfilled everything they asked for. And this included some complicated tests that we have done. And that's why it has been delayed. We had to do more testing. And that's all part of what has been filed now. So I don't know. It's, of course, completely in FDA's hands. But there is nothing that we know so far that we can see as being any problem here.

Okay, good. From our side, everything is under control. Yeah. Okay, good. Then just around the launch also. So it seems like if the FDA uses their 90 days or the 92 days that you previously sent out in a press release, it looks like August 20th around there is the deadline. So just curious if there has been any additional launch preparations this quarter. just looking at the OPEX numbers, it doesn't seem like you've ramped any costs yet. So I was just curious on that and what the plans are going forward now.

So we must say, you know, that We are not in charge of FDAs, you know, and you know, FDA have had a bit tough timing here with the new boss and there is, yeah, things happening in US and we could not promise anything in the hands of FDA. It's completely now up to FDA. The only thing we can say that the things that is left is not enormous, so to say. It's a package of things that... it's very much under control. It's not a big effort left for them, I think. But we have to wait and see. We don't know, simply. That's the answer. But you're right that if FDA follows the time plan they have on their own homepage, let's say, then we have these days. So you are absolutely right. That's the formal maximum time period. FDA could of course decide to do this earlier, and it could be that they are delayed for reasons we don't know.

Okay, but then on the cost side, you know, ramping costs for... Yeah, you know, we are of course doing

lots of work for this u.s launch and in united states the only thing you can do is so-called scientific work we can show our fantastic data we can visit all the congresses we can talk with all the surgeons and of course if you go to congress and it's many many european surgeons presenting fantastic data you create interest and you get more and more centers who want to start But at the moment, we don't need more centers, so to say. We have enough for a fantastic launch already. Then, of course, we are looking for key people. We already have lined up some people. We would need, of course, to employ more people in the US, salespeople as well. And lots of hard work is done, the same as with health economics in the US. and the whole business plan, how we should do this. We have a really good situation, we believe, to do a really splash in the US market. That's why we are producing so many products. And this we can do because we have, you know, you saw 93% gross margin. In reality, we have 98% gross margin, but we gave away some products for... you know, your studies. So it's like a drug, basically this.

Okay. It really sounds like most of the increase is going to come after an approval. So quite limited before that. Would you say that's correct?

Well, it works like this in the United States that you need to have an agreement with every hospital. this you have to expect take three months maybe you know some of the key centers here are really eager to get this done very very quickly because they really want this and they want to be one of the leading ones but normally you can expect that you have a three-month startup period in us because of all the contracts And during this period, you know, in the US, they have two weeks termination time. It's not like in Europe, you know, they have three months to quit. It's normally quite short timelines, which means that you're relatively quick. If you have lined people up and you are in agreement and so on, you can get going with your costs. So we don't need to take costs extra, you know, in advance if we don't want to.

Okay, great. That answers the question. Then I was just wondering about the quarterly sales that you had now. So it seems like a record quarter. So I was wondering if you could comment on the factors driving it, like if there were any particular countries or activities, and if it was any revenue from the recent Italy tender, for instance.

So, as you know, we have built our business on a study format, basically. So that's why we have these fantastic data and so many data and so many surgeons publishing data. That's because we have done it in a way that we provided the study format. And that means it costs us something. And, you know, the net profit is not so high. But this is a way to get the business rolling until we get the reimbursement. Now it's starting to come, you see, in Spain, in Italy. Also now we are allowed to do in Europe. the public hospital in nhs in uk you see in germany we are not so far away from suddenly get money correct to our code so all is starting to take shape you know it is a long hard work and it was of course interfered by the kovitz stuff you know but we are getting there and and we are now coming closer and closer And it will be more and more real money, so to say, and less and less study format. But when you sort of look at our sales figures, the expansion will be dramatically higher, of course, if we get paid. It wouldn't be enough to get... reimbursed in Germany and you will see so completely different figures. It's 12,000 surgeries done in Germany, for example, with the current poor surgeries that exist. I mean, this is potentially 50,000 surgeries. So it's takes time it has taken time but we are coming closer and closer that all the hard work bear fruit yeah okay so so the q1 numbers do they reflect at all any sort of the the real money as you said or is it mainly study money still no i think the increase is you know with Because this, to sell in a study format, cost us money. And we have hold down a little bit, you know. So the expansion you see, that's mainly the real money, so to say. The real sales of products that is expanding, you know. And you see that in Italy, for example. You saw it's quite a lot of different tender winds. And also in Spain, the same. We are step by step getting there.

Okay, very good. It sounds then that you're expecting this to be some kind of new baseline and perhaps an acceleration for the remainder of the year. Or what are your expectations there? If we focus solely on Europe here and not on the U.S.? ?

I think it will be a constant expansion going forward. Yeah, it should be.

Okay, good. And then just last question from me was on the ENIC hospitals in Germany. So you talked about that you need 200 surgeries or that you're aiming to do 200 surgeries this year. I suppose then you'll submit those cases. And I was just wondering what's the current status, like how many have you done? When is the best case scenario for when you could get it reimbursed? Is it from the beginning of 28 or what do you see there?

I mean, this is a good question. You know, we have actually filed to INEC also now. We have an application already in with INEC that they should approve it based on the surgeries we have done. And we don't know the outcome of that, but there is a certain likelihood that it will be no this year and that we don't need to come back the next year. But, you know, all these other organizations it's very difficult for us to promise anything or say anything really it's not sort of in our hands but i mean we are not so far away from from finally getting reimbursement in germany if we put it this way okay i'll take that um all for me thanks a lot thank you

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.

Thank you. So we have several questions from investors. The first one being, now that the submission is out of the way, what are the next go-to market steps for the U.S.?

Yeah, I mean... If you should launch in a new country like the United States, there are of course many parallel things that happen. The problem is that the FDA is quite strict on that we can't establish the relation with the centers, we can't make agreements with the centers. We need to follow their rules. And that means what we can focus on is the scientific side. We can have three presentations from European surgeons in fantastic data. We have a booth as a huge Congress with 13,000 people. And we meet lots of surgeons who want to start and we talk to them. But everything is in this framework of scientific work. We could not run to the hospital with salespeople that FDA doesn't allow. Of course, we are then doing lots of other things. We are talking to people who really know how to do this. And as you know, we have a team who has brought 10 products to the market in the United States before. So we are in a relatively good situation. We do all the groundwork. We prepare people to employ. We interview people. It's, you know, many aspects in relation to payers and to, you know, how you get coded. It's many, many aspects that is hard to answer in a short question like this. But you can be sure that we are doing everything we can that we should do a read splash in the market when we finally get approved.

Shouldn't you partner with one of the largest med tech companies in the US to accelerate the launch?

so because we know our customers you know if you sell something let's say you sell a cd player you have no clue who is your customer and you need to do lots of marketing and you don't know how to find your client that the person who should buy your cd player but we know these centers we know here we have like say it's thousand centers And we know who we should target and we know who is the key ones and we know who we should start with. And it's so much easier. So it's better to keep the business in our hands and take the big value increase that we hope will come from this in our own hands.

If Refill Stop receives FDA approval this year, what would need to go right for the company to reach 10,000 annual procedures in the U.S.? And what do you see as the biggest obstacles to achieving that?

Yeah, that's of course a very good question. You know, we are a bit careful with this with coming with prognosis as a listed company and we need to do that very, very carefully. So I think I will not give you today any such answers, but there is a reason why we produce 10,000 products to have as a starting point. when we launch. And that maybe will tell you that we at least don't think we will do, you know, 10 or 100 products. We hope that we should be able to do a really good launch here. But I cannot at the moment share our business plan with you here. I'm sorry, but I'm sure it will be absolutely good enough, this launch.

How long from FDA approval to actual sales increase in the US? I imagine it will take some time with insurance compensation.

Yeah, so absolutely it will take some time. But the main delay is the three months to do the contract with the hospital and the training of the surgeons. So the training of the surgeons, you could not take easy in the United States. We only need 100% successful surgeries. We cannot allow someone who is not trained enough to do this procedure. And therefore, we will start with around 10 European surgeons who travels over and they see different centers and we train them. Then we will do online work. So today, a lot of surgeries in the United States are done with robotic surgery and they have really advanced top of the line streaming, online streaming. So they could be guided by surgeons online. online to ensure that they really do the right stuff. And then we would build up training centers in the United States. So we already have around five centers lined up. And I told you earlier about Professor Lippham, who is one of the leading surgeons in the US. He has a team of five surgeons doing this CAPO surgery. And there we will build up one of the training centers as an example. And because they do, let's say, 1,100 surgeries in one year, to do like 20 surgeries to be well-trained, that goes very quickly for them. You know, it's not like it takes a long, long time. And thereby we can then establish these training centers. And then it will expand, you know, It's like, it's a very expansive process, of course, because it will be more and more training centers and more and more centers. But the focus initially is 50 centers, the key centers. to really establish this. So it's of course many more aspects. So one key aspect in the United States is to do direct consumer marketing. So in Europe, for example, you cannot do an advertisement or TV and say, hey, come and operate with reflux, that doesn't work. But in the United States, you're allowed to do lots of social media marketing, and if you own TV, for example, to get people aware of that it now actually exists, a completely new, much better treatment for reflux. So they will go to all the... So the hospitals and say, hey, I heard about the reflux stop. I want the reflux stop. And this way you create the pressure on the whole system and it will then be more and more and expanding. So this is a key part. of a launch in US is to do the direct to consumer marketing. So it will be a little bit team doing social media, for example. You need a big effort here to really reach out to all the people. Very exciting. And yeah, you will see. It will be very, very exciting process.

How long after FDA approval do you expect first surgeries to be performed in Canada and Japan?

Oh, that was a really good question again. So in Canada, I think it's around three months from the file, who is the normal time, but then how long time the team needs to have everything prepared after you have the U.S. approval, that I can't say. But it's not years of waiting. It's a shorter time period. In Japan, it's a little bit longer, and there it depends how... if they want us to do any trial in Japan or not. So sometimes because we have long-term data, we have US approval, they accept this data like they did in US now with European data. And the likelihood is probably quite high that they will do that, but we don't know. It's not in our hands. But the good thing is in Japan is that when you finally get approval, you also are reimbursed. So they pay you directly correlated to reimbursement. You get paid. That's, of course, a very, very interesting market. So Japan is around 11% of the world market, so it's an important market, of course.

Okay, last question. There have been some rumors in forums about an upcoming sale of the company. Can you confirm this? Would partnerships or mergers be possible in a future scale-up provided favorable and compatible opportunities emerge?

As you know, I already sold my company once, the obesity company to Yay and Yay, and I got lots of money for that. But this time we should build something special. This is not, this is just false remorse. It's nothing behind that. Yeah, I think it was many questions, but it was many much the same questions. You know, it was repeated over and over again about the FDA, of course. And we are as excited as you. It's fantastic, finally. So just open the champagne and hope for the best. And we thank you very much for listening, taking all your time. And sorry if I talk too much about things you already know, but I just try to cover also the new listeners. Once again, thank you and have a fantastic evening. Bye-bye.