Implantica AG (IMPASDB) Q4 FY2025 Earnings Call Transcript & Summary

Welcome to the Implantica Q4 2025 Report Presentation. [Operator Instructions] Now I will hand the conference over to the speakers, CEO, Peter Forsell; CFO, Andreas Ohrnberg; and Chief Corporate Affairs Officer, Nicole Pehrsson. Please go ahead.

Thank you. My name is Peter Forsell, and welcome to Implantica's Q4 2025 Presentation. So for new listeners, I am a surgeon, inventor of RefluxStop, and have invested more than EUR 100 million in Implantica and also created a successful business with adjustable gastric band. Here, you see the RefluxStop introduction tool with the device at the end. And we have a little bit closer picture here, where you see how the device looks in real life. It's 2.5 centimeter in size. And currently, we have 50 hospitals performing this procedure in Europe, and we have done more than 1,500 procedures. And existing surgical treatment is plagued with high complication rates. It's actually 30% to 50% complication rate. And that's why this surgery has been heavily compressed compared to the huge market size we talk about here. So everybody in the past has believed you need to compress and support the closing of the sphincter between the stomach and the esophagus. However, it's nothing wrong with the sphincter. And when you do that, try to compress, you get swallowing difficulties, you can't belch, you can't vomit, you get so-called gas bloating because you can swallow your saliva, but nothing comes up. So with RefluxStop instead, we have showed that the sphincter is perfect. It's just a question of the anatomical and physiological region, how things are organized here. So what we realized is that in the chest, you have breathings. That means the pressure is coming-going; coming and going. And that is leaking out through the big diaphragm muscle that you have, that divides the chest from abdomen. And these pressure variations is affecting the sphincter, when that comes close to diaphragm. And diaphragm is a muscle that is used for breathing. So it moves up and down and that creates a hole for esophagus to pass through, and that is where the pressure variation leak out. You can compare to harbor with a big stone wall to protect both from the waves -- and in the opening, where the boats go in and out, it's always very streaming. So what we are doing, we are free dissecting and moving the sphincter down 5 centimeter below the diaphragm, so it's not affected so heavily by these pressure variations anymore, and we place our device on the outside of the stomach wall. And it's a little bit more sophisticated than that, it's actually 3 components of the anti-reflux barrier that we all correct. And that's why in reality, if you do this operation correctly, we don't know any single patient who is not treated. Why is it now so important to have a new treatment for acid reflux. First of all, the drugs only help 40% of the sufferers. You have drugs that diminish the acid in your stomach. However, the acid has a purpose. It kills off bacteria, it kills off parasites; you don't have the acid anymore, it comes back clearly into your small intestine, who normally is sterile region, and then you get inflammated, swollen -- this time the gas bloating, and it's not so fun to take these drugs. On top of that, they are really dangerous. These drugs should never have been approved if it was known what we know today. And it's a huge study from United States, they have followed 157,000 U.S. veterans, and one out of 20 died during 10 years of PPI use. So extra death due to PPI use of the medication, one out of 20 died. That's just an incredible figure. Really, really dangerous drug to take long-term. Also, we know that both, the drugs and the disease, together cause cancer. So it's 48,000 people only in Europe and United States who die from cancer in this region, esophageal adenocarcinoma. And that's absolutely unacceptable. And when they looked at these deaths here in Sweden, they found that all the people that died from esophageal adenocarcinoma, 38% took PPI. And it was increased number even if you didn't have this disease and took PPI for other reasons, you still had an increased PPI use in the deaths here. So not good for the patients. You can compare with breast cancer, you do anything to save lives, here just these people let go. It's not acceptable. So the clinical outcomes of this new treatment with RefluxStop has now reached more than 5 years of experience. So we have built a really heavy clinical evidence. And in our pivotal study that has been used for the filing PMA to FDA, we have all patients took drugs before surgery and only one single patient at 5 years was still taking drugs. And when you look at the objective measurement to measure pH in lower esophagus for over 24 hours, then you can see that everybody was normalized. And between 6 months and 5 years, it's more or less the same. It's stable for 5 years and everybody is very successfully treated. If you compare to standard of care who is Fundoplication, where you wrap the top part of the stomach around to compress the sphincter, you can see here in orange color, the complications; and in green, you see our study, the pivotal study. And you can then see that inability to belch, for example, 40% of the patients after 5 years can't vomit, can't belch. None had that problem in our study, as an example. And you see to the left, every single parameter you look at, our outcome is between 93% and 100% successful. You can read yourself because all the FDA data has now been published, they are published in Surgical Endoscopy, an American magazine for SAGES. And there you have 2 articles to read, one about food passageway-related events and one overall. And during this time, it's like we are building a castle of LEGO made for grown-ups and you have several thousands of pieces, and we build step, by step, by step. And when the castle finally is ready, then people will realize how beautiful it is. Here, you can see what we have achieved in terms of clinical evidence. We have 33 published or accepted manuscripts. It's absolutely incredible number of articles about RefluxStop. Center after, center after, center pop up with the results. And it's all very, very successful clinical evidence produced. Little bit further update. I guess you all are waiting for FDA approval, so are actually we. And I can then tell you that we have fulfilled the approval inspections from FDA. So when you reach the final stage of your PMA, FDA come out and do lots of inspections, they inspect the hospital sites, they inspect the production sites, inspect Implantica, our quality system, how we have acted as a sponsor of this study, and so on. So all these 6 inspections you see here has been finalized without any major findings and the result has been given in a meeting after each of these in a successful manner for Implantica. So as you know, we have made a modular PMA. That means we have filed in 3 different modules. And all modules have been reviewed by FDA. FDA has provided feedback to Implantica of these; 2 of the 3 modules, we have also answered on the feedback, which from our perspective means they are closed. Of course, FDA may have another opinion. And regarding module 3, FDA required some additional tests. And we got the information in writing how long time this test should take at the test lab. But of course, they didn't fulfill their promises, and we have been a little bit of delay. However, this in the long run is very marginal, and we are very, very close now to finalize and also get our FDA approval in the near term. We are preparing for the U.S. launch, of course, now pending FDA approval. And we have done lots of work preparing a very extensive plan, and we have made efforts that you could make so far. You're not allowed to start the business and visit hospitals for business, but the scientific part, we are allowed. And there, we have done a big effort, we have been at all the congresses and all the important meetings in the United States. And 20 surgeons have already been flown over to Europe. They have seen the procedure at 2 different hospitals, and they have operated a cadaver in United States. And we are targeting the first initial launch, 25 to 50 centers. And the key here is the training part. We have also made a production tool, so we can produce products in the United States. We have a new tool where you put silicon in one end and out comes products, and we can make many, many products in a short period of time. And this allows us to produce these 10,000 products we are doing right now. So for the launch, we expect to do a really splash in the market. That's our target for this launch. And the good thing here is that it already exists -- existing codes that we are targeting. So both the surgeons and the hospitals will get paid with high likelihood based on these existing codes. And for the product, we are targeting something called Medicare transitional pass-through payments, which is a program where you get paid for 3 years, meanwhile, you finalize your permanent code for the implant. Also to explain a little bit more about the market for RefluxStop, we have 2 markets. So one is the existing market. In U.S., it's like 30,000 procedures done every year, and that's where you have most of the medical treatment, the surgeries and so on today. However, this is only half of the sufferers. The other half of the sufferers is those with very severe disease, very long-term disease where they have developed a damaged esophagus. So the food transportation is damaged because the nerve ends and the muscles have been got this acid over, and over and over again. So these patients, you can't operate. Imagine that you have a very weak food transportation and then you put the sphincter and try to close the sphincter down, it doesn't work. They have no power enough to get the food down. So it's only RefluxStop works for these patients. And because they are all the severe, really bad, long-term sufferers, the need for surgeries may be 10x larger. So instead of 30,000, here, we have a need of 300,000 and still a very compressed market we talk about here. So as an endorsement for this, NHS, who runs all the public health care in U.K., they have an organization called NICE who create guidelines and evaluate new treatment. And they, for 9 months, have looked into RefluxStop and their conclusion was, we recommend RefluxStop for use for IEM subjects in the public health care in U.K. And that's a fantastic reinforcement endorsement maybe. And that means that this is something really real here. If you then look at our main device competitor and suddenly, they are withdrawing from the whole market outside U.S. So from end of March, this product will no longer exist except in U.S. And in U.S., this product, MSA it's called LINX, it's a trademark from J&J and Torax Medical. They develop the business very, very quickly up to, let's say, 350 hospitals. However, you also need good results, and that has not come, sorry to say. So they have failed in the outcome, and that's why they have like 10% of the sales left only in the United States today. And also these links, they could not be used for IEM sufferers, they cannot be used for large hernia sufferers like RefluxStop. So RefluxStop has like 10x larger market size than LINX, approximately. So if we then look at the U.S. market, this is now play with figures. You have to take it. This is not any prognostic figure or anything, it's just the play with figures. But in United States, 22.9% has acid reflux, that's 78 million people. And if we just look at those who is not treated by drugs, it's 31 million people, 40% of the sufferers. This represents a potential market size of USD 290 billion. And if we just play with the figures and say, okay, 1%, we take 1% of this market for surgeries, that becomes around 300,000 surgeries, 330,000 maybe surgeries. And this is approximately the message you get when you talk to U.S. surgeons, what is now realistic if it suddenly pops up a method that actually works for treating acid reflux, then it's approximately the figure you get if you talk to 10 surgeons. So I wanted to show you this figure because that's a product that could be used for some similarities with our product. This is actually a product from Inspire Medical. And this is a device which is used for snoring. It's a surgical procedure with a little stimulator for snoring. And when they come out to the market, they had 1 year of clinical evidence. They do 1 year study in U.S., they get the FDA approval. But they had a completely new market. They need to build a new market. No one wants to start to use something without first having more evidence, long-term evidence to show. And it took them 4 years to do around 1,000 cases and create this clinical evidence, the 5-year evidence that people want to see. After that, they took off and they reached in their peak $8 billion valuation. You see it just continuing to increase, a very nice success story here. This is a little bit similarity to our IEM group because this group has no surgery today, no treatment today, and we are building a new group of patients for treatment. The difference between Inspire Medical and us is that we already have 5-year data. We have a massive clinical evidence and 5-year data, which means that we will start and much faster get to this stage here than they did. Here, you see the 2025 AFS meeting. Actually, this was in September, not the last quarter, but I can't avoid to show this because the interest was so incredible. We talk about hundreds of surgeons. They looked here at our 5-year data, they worked at our symposium to the left, and the interest was enormous. We are absolutely hottest topic among surgeons in this treatment field in United States. Here, you see a very respected center in Florence in Italy who operates with robotic surgery, and it's more and more centers who try to use, and successfully use RefluxStop with robotic surgery. So if we then look at Europe and other countries, we, of course, have our 50 centers approximately in Europe, but we still have not any full reimbursement. We are still struggling, but we are coming closer and closer, and I will show you that very soon here how we are in different markets, so you get a bit updated. Regarding Canada, they have said, if you get the U.S. approval, we accept that for approval in Canada. Also in Japan, it's high likelihood that they will accept the U.S. approval. So we are preparing, we have all of the network surgeons, we have been at the meetings down there. So we are prepared to get going also in Japan. And the nice thing with Japan is that when you get approved, you also get reimbursed. That is, of course, a very nice feature. So if we then look at reimbursement, what is happening in Europe? Why don't we sell tens of thousands of units instead of what we are doing today? And the answer comes here. So first of all, if you take Italy and Spain, they have so-called budget systems. That means that every year, you need to apply, I want to do RefluxStop, I want to do this and this. The first year they say, okay, you can do 10 RefluxStop. Next year, they say, okay, you do 30 RefluxStop, and so on, and so on. You negotiate and you increase step by step in the budget system. In December this year, we actually had 2 tender wins for 2 centers for over EUR 1.2 million for RefluxStop surgeries. So we are getting there step by step. Also in Spain, we have these wins, tender wins. And we are not so far away from -- in a few years' time, it will increase more and more and more basically. If we look in U.K., as you already heard, they have endorsed NICE for NHS public hospitals that RefluxStop is used, which of course, is a fantastic step when we now should also get paid. There is already an existing code that gives us part paid, but we are trying now to get fully paid here in U.K. as well and to increase the market. And that also looks quite promising. In Germany, again, a completely different system. We already have achieved our own OPS Code. So we have a code in the system to operate RefluxStop, and that's fantastic, big achievement. However, we didn't apply any money to that code. So we are getting the same pay as from the application procedure, although we also need to pay for the implant. So in this case, they instead have a system, the so-called InEK hospitals. That's hospitals, a small, selected group of hospitals that report cost, every cost for a procedure is reported and based on that cost, you then finally will get your pay to your code. And the problem we have had is that it has been very few InEK hospitals that all do this type of surgery. They don't do anti-reflux surgery. And finally, we have now managed so we have 7 hospitals, InEK reporting hospitals. So we need around 200 surgeries in a year, from these hospitals to finally get us registered and also get paid. And that's what we are targeting now. So we will file actually both this year and next year, but we don't expect approval until after the next year's filing, which is this month, next month, I think, yes, next month. So on top of that, we have the cost effectiveness, which we have presented at ISPOR, which show that also in United States, societies save money by operating with RefluxStop. It's more cost effective than taking drugs, it's more cost effective than do for duplication, than doing links and that's because there is so few complications and the treatment effect is better. Just to remind new listeners, Implantica is not only about RefluxStop. That's, of course, the highest priority and a blockbuster potential product. However, we also have 2 platform technologies that we have developed an eHealth platform and a wireless energizing platform. And these platforms are actually so unique. So we think we have the potential to license this to all implant manufacturers, these platforms. So we are step-by-step coming forward, and this will save lots of cost for society, and you will be able to do much more advanced treatment and you can do treatment on distance. This will actually be a complete revolution of health care. It will be like AI coming to your computer. This is a new world for health care. We have done not less than 25,000 pages of patent on this platform technology. You can imagine 25,000 pages of patents. It's an incredible effort, and this is something that is enormous. It's just that for the moment, it's RefluxStop and RefluxStop. But this will come in a later stage. Two pipeline products repeated for those who listen to me often, but I just want to take those before we go to the finance part. So people have the stoma bag. They are maybe taken away the large intestine for some reason, and they collect the fecal matter in a plastic bag. The business just for the plastic bags is $3 billion. It's an enormous business just for plastic bags. Here, we get the most e-mails from patients. And they don't need this plastic bag anymore because we have reservoir, emptying function, open-close, everything designed. And when I was a young surgeon, we actually started with this type of experimental surgery. So I have a big experience of that part. We have another very humanitarian product that probably can go into the humanitarian program in United States, if we are lucky. And that's UriRestore, and that's for people who can't urinate. It's 1.7% of the U.S. population who can't urinate. And that's because either they have spinal cord injury or multiple sclerosis disease or some other reasons. They put in a catheter in their own bladder 5 times per day. And I can tell you, if you manage to put a catheter in your own bladder once, you have done a real achievement. They don't need this anymore. They need a remote control, an Implantica's device. Thereby, I will give the word to Andreas to talk about the finance update.

Many thanks, Peter. I will walk you through our financial performance for the fourth quarter of 2025. Net sales for the fourth quarter amounted to EUR 530,000, representing an increase of 20% compared to the same period last year. As discussed on earlier calls, Implantica is currently solely commercializing its lead product, RefluxStop, to selected European key opinion leaders. As Peter has discussed, U.S. market approval and European reimbursement coverage represent the key milestones to unlock the vast RefluxStop revenue opportunity. The business consistently achieves exceptional gross margins. Adjusted gross margin for the fourth quarter amounted to 92%, up from 90% in the same period last year. Operating loss for the fourth quarter amounted to EUR 7.4 million, representing an increase of 3% compared to the same period last year. R&D expenses increased by 12% year-on-year, driven by FDA inspections and data collection. During the fourth quarter, EUR 1.3 million of capitalized development costs were impaired. This non-cash expense reflects a realignment of the product portfolio. For the full year, operating loss decreased to EUR 20.5 million, representing an improvement of 19% compared to the prior year. Let's turn to cash. Operating cash outflow amounted to EUR 4.9 million for the quarter, 2% lower than the same period last year. For the full year, operating cash outflow decreased by 27% to EUR 16.6 million, underpinned by disciplined cost management. At the end of December 2025, we held EUR 48.9 million of cash and short-term investments. The short-term investments are simple fixed deposits with a leading A+ rated Swiss bank. There is no interest-bearing debt in our capital structure. Let me sum up this slide by saying we have a solid financial position. Moving to the next slide. In addition to management, including our Founder and principal shareholder, Dr. Peter Forsell, our shareholders base is primarily composed of high-quality Swedish and Swiss institutions. We value the continued trust and long-term support we're receiving to ensure that GERD sufferers globally are getting access to the best available treatment at scale. Let me hand it back to you, Peter.

Okay. I have made a little summary slide here, which I thought could be on view. Meanwhile, we see if we have any questions.

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

I've got some questions today. I'll try to take them one by one. So perhaps I'll start with the FDA process here. So I would like to just get a better sense of the current status here. So where exactly you are at the moment? So have you done the testing yet and submitted it again, or is that still underway, so to say?

So the testing parts were delayed due to third party, nothing we can do. And the testing is now ongoing, and we expect it in the very near term to be finished.

So after that is done, you will compile that data basically and send it back to the FDA, and that's where the clock starts. Is that accurate or...

That's accurate. And FDA has their own time-line, we cannot affect that, so to say. But on the other hand, we know that FDA has already reviewed all our 3 modules, and they have presented feedback and got answer then on all the feedback. So of course, they have a more streamlined process than they would have had if they had the whole PMA in hand.

Yes. Good. But then it sounds like a delay of just a few months based on the -- like compared to prior communication. Would you say that's accurate as well or...

That's accurate, yes.

Then perhaps I'll follow-up with -- you talked about it during the presentation, I also wrote in the report that you had 20 U.S. surgeons that have completed hands-on training, some observational procedures at the European centers and cadaver-based surgical training in the U.S. So does this refer to the cadaver training you did some time ago, or was this now also done in Q4?

No, this is referred to earlier training.

Earlier training. Okay. But you're not allowed to do any such activities now before the approval in the U.S., for instance?

No. We can only do basically activities related to the scientific world. So by presenting our data of all the different congresses and meetings in U.S. and European surgeons flying over, and talking, and presenting and also U.S. surgeons, that is increased awareness. So we have more than 100 surgeons who has lined up, so to say, and want to start here. So we are well prepared in the sales process, but it's not called sales, it's called scientific awareness.

Yes. And then just a question on the production of the 10,000 units. We talked about it in a couple of reports now. So I'm just curious how far you've come. I've looked at the inventories in the balance sheet and seen it increase somewhat during the year. So I was wondering if that's an effect of this increased production.

So the tool, of course, is not something cheap. That's something so you can produce very quickly a large amount of quantities of products. And this has been produced, finished, validated in Europe, finished. So everything is controlled that the production is correct with this tool. And then it's moved to U.S., and then you need to do another line of, so to say, validation in the machine that we use in U.S., and then we are ready to produce in U.S. But we are already now producing these units in Europe, so to say. So we will send them over to U.S.

Okay. So these 10,000 units, those will be produced in Europe now prior to the launch. And how far have you gone with that?

They will be produced prior to the launch, yes.

How many have you done so far?

That was a difficult question. I can't say you exactly, but maybe it can take 6 weeks to produce these units, something like that. I can't say exactly.

Okay. And then maybe just a few questions on Europe here also. So you had the tenders that you won in Italy now. So I was just curious if you could share any more details around that. So how many years it is for and if you have gotten the price that you want and the one that we always talked about for RefluxStop device.

So we only sell RefluxStop to full price. We do not give any kind of discount. It has happened in some exceptional situation that we have given products for free for studies. And that's why you see the gross margin is 92%. Actually, the gross margin is 98%. So our device is cheaper to produce than a drug basically. In Italy now, it was 2 centers, and I think it is a 2-year program for these 2 centers. It is like open the door, so to say. It will follow more and more of these and more and more centers are fine. That's how it works in the budget system. You need sort of to get accepted and take the first steps. And this we have done now both in Italy and Spain, we have won quite a bit of tenders. This is a process that will take a couple of years. You get every year more centers, more products per center. As you heard during the presentation, it's extremely different in different countries. So I selected Italy, Spain as one who is the budget system. I selected Germany, which is completely based on this InEK reporting hospitals who report all the cost of a procedure and in U.K., where they have this evaluation by NICE. So completely different system for every country, basically.

Okay. But have I understood it correctly then? So you're expecting revenue from Italy here quite soon with this tender and it goes on for basically 2 years out in time?

Yes. And we have today quite many centers in Italy and Spain, many centers, and they have done not so many because they are not allowed to, but maybe 10 procedures or something like that, but quite many centers. I don't know exactly how many centers we have in Italy and Spain, but it's many.

That's a very good answer. And then just perhaps in the U.K. as well, I was wondering after this NICE recommendation, if you have been able to onboard any new hospitals since then and if you're expecting any sales ramp here in '26 or if you have to wait for that full reimbursement that you talked about during their presentation?

There is more and more centers coming on board in terms of NHS hospitals. But all this process is a bit slow. It's lots of administration, people involved and you make agreements that takes many months and it's not like it's popping up like this and suddenly you have another 20 hospitals operating. It's a process, so to say. You need to take it step by step. But it's clear that having recommendation that should be used in NHS hospitals, that's, of course, very, very powerful. And that will create a change, of course.

Yes. And then my last question is just on LINX here. There have now been a few months since they announced they will withdraw from the European market. So I guess they're still on the market and will withdraw in the spring, as I understand it. But have you seen any changes so far in terms of the market dynamics or if you've got like even higher interest for RefluxStop from surgeons that have used LINX in the past, for instance?

Absolutely, from many different areas. So for example, LINX was targeted to do a study that G-BA, the big health care organization, governmental in Germany, they have got 4 million to do a study, and now they can't do this study, for example. And there's many centers who do LINX, who contact us, because they realize that after end of March, it will be more products. So that's, of course, very positive for us. But still, most of our surgeries is done in a study format so far in Europe, and it's starting to take off step by step. But it could be a process, I would say, over a couple of years more before we really can get going in a good way in Europe. Then, of course, it's much different in the United States where you saw we had the 2 codes already. So to produce these 10,000 products cost us EUR 1 million, which is not so much. And we are in a much, much better situation in U.S. And you can see that from the few -- I showed you one example from another product in U.S. The U.S. market is very different. They sort of give priority to new technology and they take care of new technology in a completely different way. So to start in Europe or to start in the United States is like night and day. And that's why it's so fantastic to get going in the United States as we hope in the near term. Then, of course, Europe will also come. And I think they could add on in a fantastic way, but that's because we have done all this groundwork for all these years. But it's more complicated in Europe and basically you expect a company to run a business for 5 years without getting paid, before you come into the normal health care system, which is only Johnson & Johnson and Medtronic can afford. It's sort of a non-functioning system basically. It kills off all new technology, all new treatment. So yes, it's different.

[Operator Instructions] There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments. I will address the questions. We have many repeat questions, so I'll try to condense them. One question is, do you expect to maintain such a high gross margin percentage in the U.S.? Or do you foresee price pressure there?

So in U.S., we target a little price premium compared to the European market because you have a little bit more legal cost, but we will follow the same principle, we hope to try to keep the gross margin up. So we have no intention to start to sell with lots of discount if it's not during any special circumstance and that is not affecting the price at the end. Because at the end, we need to keep our price.

You mentioned the price of approximately $8,000 for RefluxStop in the U.S. Is that still the target?

I mean, I think our target price is $8,800, but that's completely undefined. We need to be adapted depending on the situation.

Can you describe the status and plans regarding information activities towards insurance companies in the U.S., in order to build knowledge about RefluxStop?

Yes. So what we have done is to prepare the dossier to present this for the insurance companies and of course, we have quite fantastic presentation with all these clinical evidence we have built with all these more than 30 articles. Yes, we are in a good shape. We have cost benefit analysis that show it's more cost benefit and save money basically to operating with RefluxStop. So we have a good situation, but we are not allowed to start the actual process until we have FDA approval.

Do you plan to set up a production facility in the U.S., or via a CMO? Is this in process?

We are producing in U.S., yes.

Are you looking also at the Middle East and North Africa region and Latin America, I assume then via partners, outsourcing or licensing.

So of course, for example, Middle East is a very good market that is not so dependent on reimbursement. So that, of course, will be a good market for us. For the moment, we are focusing on the FDA approval, and we are not doing anything else until we have that.

What is the commercial structure or organization plan for the U.S. by partners or your own setup?

Our own setup.

How much will LINX withdrawal in Europe boost revenue and uptake in Europe?

I guess it will be very valuable for us, but please remember that because it's not reimbursed fully yet, it will not take off in a fantastic way in Europe. It will be a process over a couple of years.

You've shared in your presentation that the other procedures had around 30% to 50% of complication rates. Could you share this figure for RefluxStop as well?

Yes. So if I compare 40% rate for not able to belch and vomit after 5 years, in the RefluxStop group, it was 0% who to go belch and vomit. If you take swallowing difficulties, it was 28.9% in the fundoplication group. And in the NICE group, we had 2.3%, one patient. What else should we take? We have gas bloating, I think, it's 52% who has gas bloating in the fundoplication group. And I think we had the magnitude of 4.3% or something in the RefluxStop group. Yes, that was I remember spontaneously, but there is, of course, many more data.

How can robotic surgeries help you scale the business?

So in United States, nearly 60% of all surgeries today is done with robotic surgery. So it's, of course, very, very important that RefluxStop fits so well for robotic surgery. So we are developing parallel operating instructions for this type of surgery. So this is a new development, and we are joining.

Some questions on InEK. How are you going to reach the 200 surgeries necessary -- of the InEK cost reporting surgeries? And what will happen once you reach that number of 200?

So as I said, we have 7 InEK reporting hospitals, and we have been negotiating with them that they together try to do these surgeries. So everybody has agreed to focus really a lot on this and we're also performing a little registry study for this group. And we are really trying and people have actually committed to this. So we hope we really should reach our goal, of course, without any guarantees, but that's our target.

When do you plan to relaunch the RCT with Dr. Schoppmann?

Yes. So our idea is to launch when we have the FDA approval because our advisers told us we should not fool around with any study before we have FDA approval. And that's the advice we are following.

So we just have, I would say, a final kind of question a couple of people have touched on is. How do you intend to monetize RefluxStop in Europe, which you've addressed through the reimbursement, but maybe you can...

Yes. I mean Europe will be nearly as good as U.S. if we just come into the health care systems and we get paid for the device, so surgeons can operate. That's what it's all about. It's not about the technology. We are clearly a superior treatment, and it's just sad for the patients that they need to wait. In some countries like Sweden, it's only administrative people today who decides which treatment should be given, which is very sad. And it's all about costs. It doesn't matter if your treatments are good or bad, cost is the first priority. And that's really, really sad if you compare to 1980s when I was a young surgeon. And Sweden was the best health care in Europe. It was fantastic. So for me as a surgeon, I think, this influence from only administrative people, that's not good for the patients.

A final question here. Any comments on Japan and Canada?

Yes. I think I answered that, but I can repeat it. So Canada has committed to approve us when we come with the U.S. approval. In Japan, it's high likelihood that they will approve us when we come with the U.S. approval, but it's not as clear and there's no commitment made. And all the FDA data need to be prepared in a format that is -- every of these organizations, they have a specific requirement for the format when you file. And that's what we are doing right now. We are preparing and organizing all the information we have in our FDA submission to also be able to file in Japan, which is actually 11% of the world market for devices like us. Okay. I think that was all the questions. We tried to answer them all in the best possible way. Yes, we thank you very much for listening. Sorry, it took some time, but we appreciate the time you spent, and good luck. Have a nice evening.