Implantica AG ($IMPASDB)

Welcome to the Implantica Q1 2026 report presentation. [Operator Instructions]. Now I will hand the conference over to the speakers, CEO, Peter Forsell; CFO, Andreas Öhrnberg; and Chief Corporate Affairs Officer, Nicole Pehrsson. Please go ahead.

Yes. Welcome, everybody, to Implantica's Q1 2026 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 my name is Peter Forsell. 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 have invested lots of money in this company, and they are based on my previous business of [ telecast band ] business, who was very successful and made this [indiscernible]. So our main cornerstone product is [indiscernible] and that's working in a treatment fee of 1 billion sufferers. An enormous field, it's only obesity who can match these kind of levels of disease. So RefluxStop, you see on the picture here with a nice tool that we supply to the hospitals to place it. On the next slide, you see you close the picture how RefluxStop looks. It's made in [indiscernible] 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 [ winter ]. The closing mass between the stomach and the [indiscernible] problem. And therefore, everybody has tried to close that either with the magnetic band, our main device competitor from [indiscernible] or so-called for implication of [indiscernible] the stomach round to try to support the closing. The problem now is that this is your food passage way. And therefore, people get lots of problems. They can't swallow to get following difficulties. They can't get nothing up. They can't [indiscernible] and you try and you get maybe lots of [ ad ] down with your food, but nothing comes up and you get bloated and you stand it and people are quite unhappy with these kind of surgeries. So we have implanted and [indiscernible] find out that it's nothing wrong with the [indiscernible]. You don't need to affect the full passageway at all, and you can actually treat [indiscernible] 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 change direction. And you have a big master diaphragm who divides the chest from abdomen and there you have an opening for esophagus. And through that opening, pressure variations is peaking out. So this means that this poor little [indiscernible] who should close is terrorized with constant pressure variations, and it can't handle it. And therefore, the closer the matter gets to the diaphragm, the more reflex you get. And with RefluxStop, you restore the normal anatomical physiological situation and you place device outside of the [ stomach ]. And thereby, you always have a 5-centimeter distance to the diaphragm and [indiscernible] all as a reflex disappears in principal. And if you get this [indiscernible], all the way up into the chest, then you call it a hernia, that's just in the middle of the picture here. And this hernia that has maybe 2/3 of those operated for us. So people then take drugs as 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 is 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 our small intestine and the small intestine, who normally is sterile, [indiscernible] they get [ inflammated ], red, swollen and you get bloated. And this happens quite a lot of the people who take [ PPI ] is called [ CBC ]. And these drugs, if they should come to the market today would never be approved because they are really, really dangereous. A huge study from the United States with 157,000 U.S. restaurants, 1 out of 20 died in a period of 10 years [indiscernible]. So this is a really, really terrible [indiscernible]. 48,000 people die from [indiscernible] carcinoma every year, 48,000 people just in Europe and United States. I mean it's not like breast cancer when they do anything to save a life. Here, they just let 48,000 people die. Completely unacceptable and that's why all these people need to be operative. And finally, before I start with update a little bit our previous clinical outcome. So we have our pivotal study filed as an FDA PMA submission this data. is fantastic basically. We have one -- all patients took PPI medication before surgery and 1 patient at 5 years, only one. And these patients likely didn't even take it for acid reflux. And if you look at the objective measurements, when you measure PH in [indiscernible] over 24 hours, then you can see that it verifies these fantastic results. So the [ PS ] 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 [indiscernible] and you can see at 6 months and 5 years, it's the same. It's stable over 5 years, these fantastic results, completely unmatched results. And here, you can see the difference between a recently published [ methanolysis ] literature review of the main competitor we have is the standard of care is this [ fund ] application method. And you can see that it's like night and day. So 40% conversion [indiscernible], no one who operates for reflux had a problem to [indiscernible]. 30% have swallowing difficulties. We had 1 patient who had temporary swallowing difficulties. It's sort of a 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 results. You can read yourself. It's published. The FDA, all the FDA submission basically has been summarized in 2 articles published in surgical endoscopy, the 5-year data. There you can read yourself and enjoy. Then over to the business update. Sorry for little bit 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 time last, which is a big landmark. And it's hard to understand, but this is many, many, many years of hard work of all fronts. It's money, it's clinical, it's so much work behind this. It's hard to understand. And here a little map how we now are targeting if we now get the FDA approval. We have already agreed with Canada that 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 implant. So we have submitted now the final response. As you maybe know, FDA has reviewed all our 3 PMA modules. We supply the PMA divided in 3 parts called modules. And all 3 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 inspection. So when you come to the endpoint 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 6 of these pre-approval inspections and all was successfully concluded as reported in the closing. So this looks a little bit promising now. And now it's in the hands of FDA and according to FDA's guidelines for the work they have up to 90 days to answer on this time in 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 that showing interest to start with RefluxStop and we target to start with the key center, 50 centers and 20 surgeons has already been trained. As you know since before, we flow them over here to Europe. They [indiscernible], operations, and we have a cadaver treatment and the operator [indiscernible]. So we are now preparing to -- 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 United States who will do the trading. So for example, Professor [indiscernible], you see [ USC ] on default there. This is Professor [ Lihaman ], one of the most known and highest regarded surgeons in the United States and his center will be one of the trading centers. He has 5 surgeons doing this type of surgery, and they do 1,100 surgeries every year of reflux. As an example, so we are also preparing the [indiscernible] before as well. We have -- we are producing and have basically produced quite a lot already of 10,000 RefluxStop devices for this launch. 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. organs, they are really, really eager to get this product on the U.S. market. And here is an example, this is at [ Sage ]. [ Sage ] is the organization to provide the guidelines, and they also have this magazine surgical endoscopy, I showed you before. So this is a very, very prominent place to be. And here, we have lots of presentations of RefluxStop for the [ present ] across Spain, [indiscernible] patients. And we have also Dr. [ Cash ] presented his 108 patients, [indiscernible] presented robotic surgery. That's the new thing now that they do RefluxStop with robotic surgery. And it's a very good feeling, very good atmosphere and our boost is completely full all the time with interest. Here you see another important meeting. This is DDW also on 2026. This is a place where you have more than 13,000 people coming. It's incredible. It's both surgeons and medical doctors. And there, Dr. [ Barber ] presented his data. He is coming from Burn from [indiscernible], largest university hospital in Switzerland. So it's a highly regarded place and he presented up to 7.25 years data, more than 7 years data, and it was incredible interest. And he has operated really, really severe suffers, lots of severe suffers had nearly 25% had pre account there changes in the [indiscernible] operated and really terrible disease, 55% at large hernia. I even operated long [indiscernible] non patients. So this is a new field for implant. So in 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 lungs. It doesn't work. They lay down on sleep and [indiscernible] comes up an into the lung and it's terrible. So he has operated already 4% of the 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 tenants done every year in U.S. only, but it's a big, big group of many, many such sufferers that were partly 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 have up [indiscernible]. So no contraction at the [indiscernible] for food transportation, and it still worked out perfectly with RefluxStop. So all this opens up really large, huge, new territories and it was highly, highly regarded this presentation. Yes. So what does this mean all these work that we are doing? It actually means that we will have a much faster launch. So to do all these articles to present all these -- I mean, being at all these progresses, 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 have 1-year data. They do a U.S. company, they have a U.S. trial of 1 year and then they go to launch. And then it takes them 4 years because they need to develop, data they need to develop, confidence in the market -- people are not starting to operate like [indiscernible] is something they don't know how it works on term. And we already have the 5-year data, and that means that when we do our U.S. launch, it will be dramatically faster. If 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 had in 35 articles as a peer review, professional articles written about RefluxStop data. Incredible work from our team, we have a really full team of 8 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 as a press release this quarter, and this is that we presented 602 patients across 22 European centers and Professor [ Shoppa ] managed to get all these 2 centers through hard work and present all their data, so we can have up to 7 years follow-up from 22 European centers and its fantastic results. So it's 98% have no kind of reoperation of any kind, and those who had problems were all satisfactory resolved. 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 RefluxStop, then you are in a really good situation, and that's actually what we have proven with all this research. So from the beginning, as you know, University of York, their health economic [ Consultum ] 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 RefluxStop is highly, highly cost benefit. As we are much cheaper to do than any of the other [ fund ] application, links, magnetic ban or medical treatment. Although the medical treatment case nothing, the complications is so high that it costs more than taking the cost for the RefluxStop procedure. And we have now done this in the United States as well, the same fantastic results and that we hope to 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 country by country to show we are superior. And in Italy now is quite interesting because here, we have then have an article published to show that it's more cost effective to operative RefluxStop. The society save money by operating with RefluxStop. And that's, of course, incredible. And what is the result? The result is that we have more and more so-called tender wins. So in Italy, you -- they specify that they want to do so on, 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 reasons. So lately, we had a tender win of EUR 1.2 million, for example, and this is like a snowball effect. I imagine you stand on the top of the amount, then it really soft now, 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 [indiscernible] 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 the support [ DRG ] system that they have specify or the different surgeries, we have a specific code for RefluxStop. The problem is just that in the beginning, they don't give any money for that code. So when they operate in Germany, the can't get a penny. However, it's an organization about the health body in Germany, we called [indiscernible]. 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 to call in hospitals. And there is not so many and not so many operating reflux. We 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 2 centers now we started, both in life [indiscernible] in Germany. We now have 6 in reporting hospitals, and we are targeting to do what [indiscernible] requests around 200 surgeries this year now in Germany. So we can get paid also in Germany, which will be fantastic, a country who do 12,000 procedures or so of this refrac surgery. Market expansion opportunity. So this view maybe also know, but it's quite interesting for us, of course, that J&J, Johnson and Johnson as withdrawn LINX, our main device competitor, the magnetic band from all markets outside U.S., March 31, 2026. That means it opens up a big gap all over Europe or the whole world, where they have used LINX 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 the 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 suit your [indiscernible] like a prolongation of your esophagus, it becomes a long tube. And since you all now know that when everything lines up, you get reflux, of course, very easy that everything [ ties ] up if you have a long ton, you have nothing to stop with from lagging up. And that's also what happened here. So after 1 year, more than 50% of the gastric sleeve or [indiscernible] operated patients have surgically induced acid reflux. That means we have 80,000 people who need treatment. That's perfect for RefluxStop. It's actually so many and probably will increase after 2, 3 years, that it could be discussed if not all gastric patients should have a RefluxStop, let's say, all 160,000 would benefit to get RefluxStop together with the gastric [indiscernible] surgery. And that's a very, very interesting aspect. And you can see here a little bit here, we have put together in relation to the market share of the [ VCP ] surgery, you can see that it could be quite many surgeries if you are 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 development than how we are planning to step-by-step launch a RefluxStop 2 and 3 and expand also to this obesity market. And we are doing another randomized trial. So we have already agreed with [indiscernible] here in Switzerland and some other key centers that we should compare this gastric [indiscernible] with and without RefluxStop. 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.

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 EUR 857,000, representing an increase of 15% compared to Q1 2025. Implantica continues to selectively commercialize RefluxStop to partnering with leading key opinion leaders in Europe, while preparing for broader commercialization driven by a U.S. market approval and expanded European reimbursement coverage. As Peter outlined, the company is making solid progress towards both achieving a U.S. 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 EUR 3.9 million, 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 EUR 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 position. 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 suffers 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 RefluxStop or the RefluxStop has the potential and had to use 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 eHealth platform and an energizing virus energizing platform. So we can actually build extremely advanced medical implants, so 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 -- yes, 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 feel, how could we improve health care with our platform technologies and it showed us 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 practices production analysis and we have selected 40 of these 300 inventions that we believe are really strong in from products. And the eHealth platform, we have filed 25,000 pages of patterns. You can imagine how many pages is it. Just to cover and protect our retail platform -- sorry. So -- it's a little bit hard to grasp how huge this could be, but it really is something very special, but it means, of course, lots of execution and lots of funding. And our first priority is, of course, RefluxStop. Our second priority RefluxStop and our third priority is RefluxStop. So don't worry, we will bring RefluxStop to a successful launch. Just another product because we talked about obesity, and we discussed how we can use RefluxStop 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 be very close. But of course, if you have 50, 60, 70-kilowatt overweight, then it's a bit too much for these drugs. And what is worth is that as soon as you stop this drug, you gain your weight again. It's incredible. I work with so many obese patients in the past. And it's hard to believe. 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 3 years later, they are 155-kilo and you just want to understand it, but that's the case. These people, they are bound to take this injection for the rest of their life and how look the complication when you take them for the rest of your life. And that's why obese [indiscernible] will always feel an important part. And this product is working exactly like the normal bodies way of feeling full. You eat, you fill the stomach, you stretch the stomach [indiscernible] and then you have receptors who sell a signature vein. Stop eating, you are full. Otherwise, you will know your stomach if you don't have these receptors. We use these receptors by stressing the stomach wall and tricking the stomach that is full, very simple [indiscernible] we mentioned. Also, this is the product we get most interested for patients. This is people who have taken away the large intestine, for example, maybe they have a lot [ colitis ] inflammation or they have cancer or something and they collect the fecal matter outside the abdominal wall here in the plastic bag. And the business, just for plastic bags is $3.9 billion. Imagine that a $4 billion for plastic bags. They don't need this anymore. We have reservoir open close, remote control is all you need, and you can have a normal life, everything connected to [ anus ]. 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.

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

Peter, 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 handed in your response, so 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 100-day meeting. And is it a decision on approval? Or what kind of risks remaining can you see now?

I mean FDA has gone through all our modules and they have provided written feedback and then we had this meeting, and we discussed the later all the feedback that was remaining with FDA to find out exactly what they wanted, and we have 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 because we have 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 what we know so far that we can see as being any problem here. Good side, everything is under control.

Yes. Okay. Good. Then just around the launch also. So -- so it seems like if the FDA uses their 90 days or the 92 days that you've previously sent out in the press release, it looks like August 20 around there is the deadline. So just curious if you -- 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 cost yet. So I was just curious around that and what the plans are going forward now.

So we must say that we are not in charge of FDA. And you know FDA have had a bit tough timing here with the new bond there is, yes, things happening in U.S. 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 reasonable 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. [indiscernible]. But you're right that if FDA follows the time plan they have on their own home page, I should say, then we have these days. So you are absolutely right. That's the formal maximum time. 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, ramping costs for some new --

We are, of course, doing lots of work for this U.S. launch and in United States, the only thing you can do is a call 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 tenders you want to start. But we don't -- 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 learned up some people. We would need, of course, to employ more people in U.S. salespeople as well. And a lot of hard work is done the same as with the health economics in U.S. and the whole business plan, how we should do this. We have a really good situation, we believe, to do a real splash in the U.S. market. That's why we are producing so many products. And this we can do because we have -- you saw a 92% gross margin. In reality, we have 98% gross margin, but we gave away some products for studies. So it's like a drug, basically this.

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

It looks like this in the United States that you need to have an agreement with every hospital. This, you have to expect take 3 months. Maybe some of the key centers here are really eager to get this done other 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 3-month start-up period in U.S. because of all the contracts. And during this period, in U.S., they have 2 weeks termination time is not like in Europe, they have 3 months to it. It's normally quite short time lines which means that you're relatively quick. If you have a live people up and you have an agreement and so on, you can get going with your costs. So we don't need to take costs extra in advance if you don't want.

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 or -- 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 basis. 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 the net profit is not so high. But this is a way to get the business rolling until we get reimbursement. Now it's starting to come. You see in Spain, in Italy. Also now we are now to do in the public hospital in NHS in U.K. you see in Germany, we are not so far away from something to get money collected to our code. So already starting to take shape. It is a long, hard work. And it was, of course, interfered by the COVID, [indiscernible], but we are getting there, 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 forward. That's -- but when you sort of look at our sales figures, the expansion will be dramatically higher, of course, if we get paid. It would be enough to get reimbursed in Germany, and you will see the completely different figures. It's 12,000 surgeries done in Germany, for example, with the current poor surgeries that exists. I mean this is potentially 50,000 surgeries. So it's -- it takes time. It has taken time, but we are coming closer and closer that all the hard work bear fruit.

Yes. Okay. So the Q1 numbers, do they reflect at all any sort of the real money, as you said? Or is it mainly study money still?

No, I think the increase is because this -- to sell in the study format cost us money. And we have hold down a little bit. So the expansion you see, that's mainly the real the real money, so to say, the real sales of products that is expanding. And you see that in Italy, for example, you saw it's quite a lot of different tender wins. And also in Spain, the same, it's -- we were step-by-step getting that.

Okay. Very good. It sounds then that your like 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 only on Europe here and not on the U.S.

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

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

I mean, this is a good question. We have actually filed to [indiscernible] also now. We have an application already [indiscernible] that they should approve it based on the surgeries we have one. And we don't know the outcome of that, but there is a certain likelihood that it will be now this year and that we then need to come back to next year. But all these other organizations, it's very difficult for us to promise anything or say anything. This is not sort of in our hands. But I mean, we are not so far away from finally get reimbursement in Germany, if we put it this way.

[Operator Instructions]. 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.?

Yes. I mean, if you should launch in a new country like United States is, of course, many parallel things that happens. So the problem with it is that FDA is quite strict on that we can't established a relation with the centers. We can't make agreement with centers, and we need to follow their rules. And that means what we can focus on is -- so the scientific side, we can have 3 presentations from European surgeons in plastic data. We have a boost as a huge congress with 13,000 people and we need lots of surgeons who want to start and we talk to them and -- 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 people who really know how to do this. And as you know, we have the team has brought 10 products to the market in United States before. So we are in a relatively good situation. And we do all the groundwork we prepare people to employ, we interview people. It's many aspects in relation to payers to 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 real in the market and we find it gets approved.

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

So because we know our customers, 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 or client that the partner should buy your CD player. But we know these centers. We know -- here we have like say, it's 1,000 centers and we know who we should target. We know who is the key ones, and we know who we should start with, 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 RefluxStop received 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?

Yes. That's, of course, a very good question. We are a bit careful with this with coming with prognosis as a listed company, and we need to do that very, very carefully. But 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 launched. And that maybe will tell you that we at least don't think we will do 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. That's -- I'm sorry, but I'm sure it will be absolutely good enough in this launch.

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

Yes. So absolutely, it will take some time. But the main delay is the 3 months to do the contract with the hospital and the training of the surgeons. So the training of the surgeons, you cannot 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 and then we will do online work. So today, a lot of surgeries in the United States is done with robotic surgery, and they have really advanced top of the line streaming online streaming. So they could be guided by surgeons online to ensure that they really do the right stuff. And then we would build up training centers in United States. So we already have around [indiscernible] and I told you [indiscernible] about Professor [ Liam ], who is one of the leading surgeons in the U.S., just a team of 5 surgeons doing this capital surgery. From there, we will build up one of the tailing centers as an example. And because they do, let's say, 1,100 surgeries in 1 year to do like 2030 is to be well trained that goes very quickly for them. It's not like it takes a long, long time. And thereby, we can then establish these training centers. And then it will expand. It's like we say it's a very expensive 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 really establish this. So it's, of course, many more aspects. So one key aspect in United States is to do direct-to-consumer marketing. So in Europe, for example, you cannot do an advertisement or TV and say, "Hey, come and operate RefluxStop." That doesn't work. But in the United States, you're allowed to do lots of social media marketing and if you want, TV, for example, to get people aware of that it now actually exceeds the completely new, much better treatment for reflux. So they will go to all the hospitals and say, "Hey, I heard about RefluxStop, I want the RefluxStop." 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 our launch in U.S. is due to 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 yes, you will see, it will be a very, very exciting process.

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

Oh, that was a really good question again. So in Canada, I think it's around 3 months from we file, who is the normal time, but then how long time the team needs to have everything prepared after we have the U.S. approval that I can't say. But it's not years or anything, it's a shorter time period. In Japan, it's a little bit longer, and then 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 U.S. approval. They accept this data like they did in U.S. now with European data. And the likelihood is probably quite high that they will do that, but it's not -- 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. And that's, of course, a [indiscernible] 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 and forums about an upcoming sale of the company. Can you confirm this? Would partnerships or mergers be possible in the future scale up, provide favorable and compatible opportunities emerge?

As you know, I already sold my company on the obesity company to J&J, and I got lots of money for that. But this time, we should build something special. This is not -- this is just -- also is nothing behind that. Yes. I think this was many questions, but it was many much the same question. 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 hopefully best. And we thank you very much for listening. Thank you all your time and sorry if I talk about too much about things you already know, but I just started to cover also the new business. Once again, thank you, and have a fantastic evening. Bye-bye. Goodbye.