Implantica AG (IMPASDB) Earnings Call Transcript & Summary

Welcome to the Implenica Q2 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.

Thank you. So my name is Peter Forsell, the CEO of the company. And I will try to guide you through today's Q2 presentation. So for those who has not heard this before, I'm a surgeon, and I'm also the inventor of the products we have in Implantica, and also the CEO and founder of the company. And this is the second journey. So the first journey was the gastric band, which I developed and also a business for 6 years that successfully was sold to J&J. And that's the funding, part of that has been used for this new Implantica venture. The really good news for today is, of course, that Implantica has got FDA approval for its product RefluxStop. And that's, of course, fantastic news because United States is the largest market for medical products overall. And it's also a country who is more positive to new technology and also willing to pay for new technology. And the good thing here is that we have 1 billion suffers whereof 78 million we have in the United States. So it's enormous amount of people who have this disease. It's larger than obesity basically. So I will come back to the FDA approval because I think today, we have quite many new listeners, so I will just give a little bit feedback of Implantica shortly, and then we come back to the FDA and what will happen next and so on. So here, you see the device, called RefluxStop. And today, we are operating at 60 centers in Europe, and we have done 1,800 procedures. And we introduced the device with a special instrument that we sell together that you see on the picture here. And existing surgical methods for acid reflux, it's also called GERD, gastroesophageal reflux disease. As always been focused on that sphincter between the stomach and esophagus is weak. It can't close properly, and therefore, we need to support its closing. And that Dr. did already 1956. He took the top part of the stomach, we stuck with the mouth and he wrapped it around, so you support the closing. There is another product called LINX. It's a magnetic band that will also do the same thing, try to support by, so to say, applying some kind of pressure or at least hindering expansion in this area here. The problem we have now is that this is people's food passage way. That means you get difficult to swallow, you can't get nothing up. We can't belch, you can't vomit. All the air you swallow with your saliva and food that normally regulates up, it's not going up anymore, and you get swallow and distended in your abdomen and people are quite unhappy with this surgery. So therefore, with RefluxStop, we realized these problems, so we have constructed the device that do not affect the food passageway at all. You have no problems with swallowing and other gas bloating and stuff like that. So what we realized is that sphincter is perfect. It's nothing wrong with the sphincter. It's all about the positioning of the sphincter. And the reason for that is that in the chest, you are breathing and you create then, of course, pressure in, pressure out. It's changing direction of the pressure all the time, if you are breathing in, if you are breathing out. And -- then you have your big muscle called diaphragm with device the chest from abdomen, which moves because you use it for breathing. And that means that the then have a whole passing through a hole in the diaphragm. So it can move freely. And these pressure variations then are leaking out through the opening here. And it's like you have a huge stone wall at the harbor, for example, to protect both from the waves and then you have an opening where they both go in and out and it's always very, very streaming in that opening. And that's exactly what we have here. So when the sphincter comes closer and closer to the diaphragm, you get more and more problems for the sphincter function and or property. So what we are doing, we are placing our device on the outside of the stomach wall, so we create a big package here. It's called the top part of the stomach. So we create a big bundle package here that acts like a mechanical stop towards the diaphragm. So this stands here is always kept. So basically, what we are doing, we are just restoring the body's normal anatomy. And then the body treat itself. We are not treating acid reflux. We just restore the anatomy and ensure that it maintains in that position. And when this sphincter all the way to the chest that you see on this picture here, then you call it hernia. And many of these reflux patients have a hernia, then is, of course, even worse than. And you can see the normal anatomy and when you place RefluxStop, is very, very similar. So why do we then need a RefluxStop? Yes, the answer is that we have drugs that try to limit the production of acid. The problem is that you try to change things inside the body with drugs, there is always side effects. And there is a reason why you have the acid in your stomach. The acid is there for killing bacteria and killing parasites and things that you eat with your food. There is always bacteria in you food of some kind. Now they just pass through when they come into this morning testing who normally is steroid and you get overgrowth of bacteria, it's called small intestine in your abdomen and so on. And the biggest problem is that: one, 40% are not treated. So it's only 60% was helped by these drugs. And second, it's lots of very, very serious side effects with these drugs. So if you take them long term, in this case, it was a study with 157,000 U.S. veterans. They were followed for 10 years and 7,000 die due to the PPI use. So it's a drug that never should have been approved. It's a terrible drug actually. And one thing that you didn't know from before was that this drug is stacking out a substance from your blood vessel, which means they get extra prone to get atherosclerosis. So when you are 40 years old, you have a 60 years old blood vessels, and that's why you have a lot of extra death of cardiovascular death. And that -- it's not like you -- "Oh, this patient died from heart attack. It was because he take PPI," that's not the first thing you think about. But now people understand that this is actually a complication by the drug. People get cancer from this disease. They get cancer likely from the drug, but it's very difficult to prove these things. You remember a long term, we take to prove that smoking was dangerous, although everybody understands smoking was dangerous. And it's the same here. We know that if we put down an endoscope, a gastroscope/endoscope down in your stomach and you have this disease, 10% to 20% have pre-cancer chances. If you do that in the normal population, it's 1% to 2%, and they are mainly the reflux patients we talk about. So it's clear you -- this disease plus this drug give you cancer. But what is what is difficult to separate. RefluxStop has now been tested for the first patient in is nearly 10 years away now more than 9 years since the first patient was operated. And we have presented for FDA our 5-year results. And I will just show you a little bit the results to. So everybody took drugs before surgery at 5 years 1 patient of drug and likely not for acid reflux because it was a patient with pain and a kidney disease. If you do the objective measurement, you put down -- put a capsule who said why was the pH over 24 hours from your lower esophagus, you see here that the results before surgery is much higher here, then it goes down nicely at 6 months and it's completely stable at 5 years. So the outcome is stable 4, 5 years here. And here, you see the results outcome from every single patient. And this, of course, many lines here in the line of zeros here. And if you use the same definition as it links use for their FDA trial in their SSD memorandum, then everybody was treated as an objectively treated patients. So if you then look in the literature, we found a huge literature review of which is from duplication, which is the standard of care I talked about before. And you can see the comparison and outcome here. So if you look at inability to vomit, 40% have is, we have 0%. 29% have severe swallowing difficulties. We had one patient who had temporary swallowing difficulty and so on. All these are a little bit like night and day, 52% as gas floating or it's not on this slide here. And I think we had around 4% or -- So it's like that in the outcome. And today, we have 38 articles. So we have done a really good job systematically doing everything we can, every surgeon who do this procedure is publishing the results, go to Congress, present. We have been going to United States for 4 years, lots of presentations. Every congress, we are there, we are presenting, and that's why we have convinced the surgical society and surgical surgeons in U.S. that this is a fantastic thing. You can read yourself. It's published in surgical endoscopy, both the food passageway related events and the total complication rate 2 articles, you can find in surgical endoscopy. We also have a fantastic study where 22 centers from Europe put together all the results. And it's 602 patients from -- it's 9 countries or 6 countries -- 9 or 6 countries, maybe 6 countries. And it's showing that it's a very, very safe device, much, much, much lower complication rates than standard of care. So finally, we come to the business update and the FDA approval. This is, of course, a really -- we have been working 4.5 years to get this approval. It's so much work, so much effort, so much test, so much things to do. I would say I can take my full -- if we had the paper system, I can take a full wall and a fully defines so huge is this project. It's hard to understand, but it's a very, very rigorous process. So FDA, they come and check all your data. They go to the hospitals, they look at every paper at the hospitals. They look at our quality system, they go to all your manufacturers to check that they do better tracking properly and so on. And this is a huge quality stamp. Someone, a company who can pass an FDA PMA like this, this is a core step. Implant is approved, and that is a fantastic milestone achievement. So we will have a kickoff in September when the American Society have their meeting in Washington. So we have already prepared. We have a huge room, and we will have a symposium and speeches and it's a big, big event. And we have a lots of key surgeons involved here. Some of them are here. So you are mainly European surgeons below when you have U.S. surgeons on top here. So this is the perfect opportunity to make the first step now in United States. Now we launch. And -- very exciting times. Here you see the previous meeting at the AEFS meeting, the same meeting. And here you see here, you actually see the slide of the pH measurement for RefluxStop. So this was a presentation for data RefluxStop, you see it's tons of surgeons here. And this was our symposium, and it was even more than 120 surgeons here. It's people are standing. It's enormous event, just to describe about the drug. We have the absolutely hottest topic in United States. It's like SMS is standing like it's really, really top, top, top for the moment. So we have more than 100 surgeons who has told us they are interested to start with RefluxStop. So we don't really need to do any sales work at this moment. It's all about selecting the key centers. We need to do this step by step. It's not like you run 1,000 centers in the same time. Because we need to ensure the quality. We need to train the surgeons. We need to take a legal agreement with every hospital. It's not -- in the United States, everything is legal. It's very, very serious. It's not like in a coffee break, you go to the hospital and one day later, you have a signed contract with a hospital. No, no, no. The hospital, they have legal committees, they have medical committees, they have ethical committees, all these need to be passed step by step and then you need to negotiate the agreement with every single hospital, and then you need to train the surgery. So we will have a fantastic outcome in the United States, but it will be step by step. You can't run around and take several hundreds at the same time. We will be a step-by-step, nicely, safe very seriously growth, long-term sustained growth, build on high quality. 20 surgeons already trained. They have been traveling to Europe and they have seen lots of different service here. They have the cadaver surgeries in Chicago. So [ 20 ], we have already the reasonable trade. And here, you see a little bit of this process. So the hospital, they have a certain process when they start with new technology. So first, you have a sort of a hospital sign off of the technology, then you have the Ethics Committee sign off and then you have activation of the center. So it will take some time. It will go quicker to start to train then to start to sell something. So if we are generous when we do the training, we can start training Yes, in a couple of months or a few months, that's approximately the time frame we have here to get going. But of course, very exciting times and -- we will then, together with the European Forgot Society meeting, we will bring lots of American people over and also see surgeries here in U.S. Then of course, we will be training centers in the U.S. So we are targeting training centers in U.S. who should receive extra effort of training. So our main device competitor, which is this magnetic band I talked about, they have already decided to withdraw from all markets outside U.S. And I would not be surprised if they also will withdraw from the U.S. market in the near term as we well. So that, of course, opens up a new market for us. Good things also that we have made cost benefit analysis in United States, and we have concluded that we are much more cost-effective than any other treatment. And that is very important that you both have the best treatment, but you also are the most cost-effective alternative that people love when you are most cost-effective as well. We, of course, have lined up people to -- more people to employ. We already have 9 people in the U.S., but we are now targeting, of course, to make quite heavy expansion. And we have several of those coming from leagues, really competent people who knows this treatment, field and so on. So we have had many interviews and we have many more to come. And why is it now so important to have all these clinical evidence? The answer is that if you come like a normal standard U.S. company, you do your PMA in U.S., you come out with one year data. And people doesn't accept that to start to make a new treatment and operate like crazy. They do it very carefully. They want to know that data works long term. It's the 5-year data. That's a completely different animal. People know that this product really works long term. And therefore, when you come with 5-year data and make a launch, it's a completely different launch. It goes much faster, much quicker than you would expect a normal U.S. company to do their launch in United States. We are -- have produced and are producing in total 13,000 products to be prepared for the launch in the U.S. market. We have done a special tool for United States as well, so we can produce in U.S. And we are sort of prepared for a splash in the market, that's what we really target here. And the good thing, the RefluxStop is that our market is approximately 10x larger than the existing surgical market. And now you wonder how could that be the case that your market is 10x larger and the answer is the following. Half of the patients today, they are not operated because they have so much swallowing difficulties, so it doesn't work. You can imagine that you have this sphincter here. And then you try to operate with the old techniques where you try to compress and close. And then you come with your esophagus has been damaged by the acid -- the acid damaged the it damaged the muscles. So you have very weak food transportation. It's difficult to swallow, then you come with this weak food transportation and then you try to close down here. That doesn't work. Impossible. So therefore, half of all sufferers, they are not treated. And that's what we tried to show here. You have two halves. This half is the one who is operated today. the other half is those who are no treatment today. They were completely without treatment. And this half, they are all the severe sufferers, all the long-term suffers. In this loop here, you have 10x higher surgical need because they are all the really terrible patients, and that's the one who get damaged that is esophagus by the acid. Because they have so much acid coming up, they have it long term. And that's why we have a much, much larger market because we don't close down. We can operate these people with severe swallowing difficulties and damage esophagus. It doesn't matter for us. And NHS is the public hospitals organization in U.K. and they have an organization called NICE. This is the most respected organization in the world to analyze new technology and do that for NHS. They spent 9 months to analyze RefluxStop. And their conclusion was, yes, we think you should let them operate for these patients here in the U.K. So we are approved in the public NHS hospital to operate this half. They didn't even give us this half because at that time, we didn't have so much data like we have today, but they gave us this half and say, okay, they have no treatment. We have a good treatment, please go ahead. And because this is 10x larger market than this, it's super fine for the moment. So this is, of course, fantastic when we now go to United States. And as you can see, it's 30,000 procedures only done in the United States today, but we see our market as 300,000. And that you can compare it to obesity surgery, who had the market before the injections came, it was 300,000, today is 200,000 or maybe even less. So -- but it's the same magnitude. It's the same magnitude of treatment fee. One out of five Americas have acid reflux, one out of five. Here, you see a little bit summarizing this. So if we just look at those who is not treated by the drugs, forget now that this disease give you cancer, forget that the drug is terrible complications. We just say the drugs are fine, 60% take drugs. We still have 40% to operate. And if we do that, we have 31 million people, and if we then take 0.1% of that, we have EUR 250 million revenue calculated for some kind of estimated first imaginary initial price in U.S. of the product. So 1% market, which is quite realistic, 300,000 surgeries, better realistic for this huge treatment field, then you have $2.5 billion in revenue. this is sort of long-term goals, of course, it's not a coffee break here we talk about. And you never know in life, but it just give you a potential. Update for Europe, 6% growth this quarter, quite nice. Total revenue for the first half, EUR 1.6 million. Some real good hospital centers. We have started in different countries, of course, including one big group -- U.S. group actually, we spread all over the world called Ander Chain Madrid. Here is some examples how we have made this cost benefit analysis. I talked about in the United States. We have made them in country after country after country. Of course, a huge work, but very well spent time and money. And here is one example. It was published an article in Italy. They said that you save money by operating with RefluxStop. It's not only that you have the best treatment, you also save money by [indiscernible] So the total, we have now $2.3 million secured in public health care funding in Italy. This is just the beginning, and this is how it works in the budget system. You step by step by step, you get more and more real business, so to say. We have, in Germany, a very good situation. We have our own code. So a specific code just for the RefluxStop procedure. The problem we experienced is that there is a health care body in Germany called and they should decide how much money you should get, and that's based on real cost. And the real cost is calculated for so-called reporting hospitals it's a smaller group of hospitals in Germany to report every cost they have for every procedure, and they get paid for that, I think, from I to do that. And they have no big reflux surgery center in that group because they didn't do reflux surgery. So we have to start from scratch and educate and train and convince people to start with reflux surgery. So now we finally have 7 of these InEK reporting hospitals who perform RefluxStop surgery. So now we can get going to do the surgery is that need, so they can finally say, yes, we see the cost of your procedure is this. Okay, you get reimbursed for this. 10,000 procedures in Germany, so that would be fantastic, of course. U.K., I already explained for you how we are into the hospitals. Spain is a nice example of what happens when you have a health care system who listened to the surgeons. So if you take the Swedish health care system, it's the admin people who decides. They don't care if the surgeon wants to do a new treatment. They just look at cost. And that means that the Swedish health care system is going the elevated down to the basement because no new treatment get approved. No one pays for anything because they just try to save cost. In Spain, it's completely different. They don't have lots of money in Spain or big budgets and so on. But when the surgeon says, "I want to use RefluxStop." They say, "Okay, you can do that. But this badge this year, you can only do one per month." And then they do that. They do 12 per 1st year. And next year, they can maybe give 36, for example. And that's how it works in the burger system. You need to go step by step by step. But you see we have 20 centers in Spain because they listen to the surgeons and patients. And this is just showing you what potential we have in our treatment. U.S. approval opens up many doors Canada, for example, say, yes, okay, we want to be -- if you take the U.S. approval right away, you get approved. We have many other regions like Japan, Australia, who take seriously to be the U.S. And now we can start to operate in Middle East that we didn't do before. South America and so on and so on. So it opens up much more markets here now that we have been taking calmly before. We also have a new treatment area, and that's obesity, where those who operate for best today, they do something called Gastric Sleeve which means that they cut away a big portion of stomach, put in the trash. So the same gets like a esophagus, like a tube. So you have a long, long tube now esophagus and stomach. And because you know that you get the reflux because the sphincter glides up. Of course, it glides up, but everything is as a long tube. There's nothing to stop it from climbing up at all anymore. So 68% long term get acid reflux, surgically induced acid reflux. And already after 1 year, 40% to 50% of these patients have acid reflux. So we are starting directly now after the summer, a combination of reflux open gastric So will be a European study here with 4 centers to test this. Finally, then before we start with questions, as you know, we have two fantastic platform technologies. So we have a wireless energizing platform and an eHealth platform. And these are extremely advanced. It's a decade of development. And it's -- we have 25,000 pages of patents for this eHealth platform. And this allows you to -- we can control people's health from inside the body, and we can look at it from distance. We can have super smart implants, ultra smart implants and we could change the treatment remotely. The doctor can be is hospital patient be on and you can change the treatment. And we have then gone through the whole body to say, how could we now improve health care with these technologies. And we ended up with 300 inventions, 300. And we have then control them all with market analysis, product analysis, production analysis. And we have ended up with 40 what we believe, completely viable, really good, long-term, really perfect implant products. And out of these, I can tell you, we have around 10 RefluxStop caliber products. So we have something in the background that could create a new Medtronic. It's the same number of products like Medtronic. It's just not done in the coffee break and it's not our priority right now, and it costs also money and it's a lot of execution. But still, in the future, long term, Implantica may be someone who is really attractive to own charging. And I will just give you shortly two examples of what you can do. In this case, it's people who has taken away the large intestine they may have to or some other disease, cancer or whatever, and they collect the fecal matter in a plastic bag outside abdominal wall. And it's, of course, not like we are running on the beach, super happy with this plastic bag with your staff in. However, the business for plastic bags is $3.9 billion. So all these plastic bags have a business of $3.9 billion, and we can solve that. Do they need our device and a remote control. When I was a young surgeon, we made experimented surgery with this. This future is small intestine down to the anus, those who had a sphincter left, and we try to do a little and suture together, but this didn't work because it is small intestine, you have 2, 3 liters of fluid because all the fluid is stacked up in the large intestine is like you have the worst area, you can imagine, and no sphincter could handle it. And the rest are made just stand there full and just overflowing was nothing we emptied. All this is sold now. We have -- we can make a reservoir. We can enter the reservoir or command. We have a sphincter who is artificial so we can handle it open and close. And people don't need any sphincter. They can take away the wholly inflammated intestine -- large intestine with this sphincter and everything, and we fix it anyhow, and they don't need the anymore. Another example, people can't ordinate 1.7% of the U.S. population can ordinate. They have a spinal cord injury, multiple disease. They put in a catheter in their own bladder 5 times per day, every time we send ordinate the catheter. This -- if you manage to put in a catheter in your own bladder ones, you have done an achievement. It's not fun. They don't need this anymore. They need our device and they're about control. Finance update, I give the word to Andreas, our CFO.

Thank you very much, Peter. I'll walk through the financial highlights for the second quarter 2026, with a focus on revenues, margins, operating costs and our balance sheet position. Overall, we are pleased with the continued commercial progress during the quarter. Net sales came in at EUR 717,000, up 66% compared with the second quarter 2025. Growth was mainly driven by accelerating RefluxStop adoption in the Italian and the Spanish markets. Turning to profitability. Our gross margin remained best-in-class. This underpins the attractive economics of our business model as we scale the business. Adjusted gross margin amounted to 94% in the quarter compared with 90% in the same period last year. So even at this early stage of commercialization, we continue to see very attractive margins. On operating expenses, the operating loss for the quarter amounted to EUR 4.2 million that represents a 7% improvement year-on-year. This improvement was achieved despite a 6% increase in R&D expenses mainly related to the finalization of the FDA application. That increase was more than offset by lower general admin expenses, which demonstrates that we continue to manage costs in a very disciplined manner. Let me turn to the next slide to look at cash flow and balance sheet. Operating cash outflow for the quarter amounted to EUR 3.9 million, broadly unchanged from the second quarter of 2025. At the end of June, we held EUR 41.7 million in cash and cash equivalents and no interest-bearing debt. Finally, on our shareholder base on the next page. We continue to benefit from the support of long-term institutional investors. We greatly value the continued support as we focus on making RefluxStop available to cure patients at scale in the U.S. and worldwide. With that, let me hand back to you, Peter.

Yes. So I think it's time for questions.

[Operator Instructions] The next question comes from Alexander Kerman from Security Long Capital AB.

First of all, congratulations to the entire Implantica team and all the long-term shareholders on this very important approval. My question is when can we expect to see a more detailed financial road map from Implantica? For example, our 5-year plan with clear financial targets and milestones. Is this something that you are currently working on? And if so, when might we be able to get access to such a plan?

To answer your question, we already have that plan. What we will disclose to the investors is a bit more unclear. However, we will have a Capital Market Day and focused, of course, on the U.S. launch. The 9th of September in the afternoon in Stockholm, which will be sent live and also recorded for other who can't join at that time point. So yes, we will disclose much more information to our investors during this afternoon. We, of course, need to balance to not set the expectations too high. But it's -- I think it's rather clear that the U.S. market is quite different from the European market. It's much more prioritizing new technology and willing to pay for new technology and -- also, the market is larger. It's more obese people, and it's more reflux. So I think investors will not be unhappy going forward, but you can't expect that it's a coffee break before you have a fantastic revenue in U.S., it's a step-by-step approach. We need to do this very seriously. We need to go over there and traveled around with the European surgeons for a couple of months and train center after center of the center. And that we cannot risk in the United States to do core surgeries. It should be perfect everything. That's how plant has worked now. We have step by step by step, build all our clinical evidence, everything methodically, and we will continue with the same approach. We will not have centers who can risk that the whole thing is put in the age because you get complications. We need to do this very seriously. But of course, it's a very exciting time.

The next question comes from Filip Wiberg from Pareto Securities.

First of all, big congratulations to the FDA approval. I've got a few questions today that -- Yes. My question is to mainly related to the strategy now and what we expect going forward. And I understand you will disclose more on the Capital Markets Day there. But first of all, just -- what are the exact next steps? When do you expect the first like training operations to take place? And when do you expect the first sort of real operations that are not part of training to take place?

Good questions, of course. So we need to pass the committee approval in each hospitals. Even if we decide that we would give the training surgery procedure. We give the product for free, so to say, for the training surgeries, it will still require an approval process in the hospital. So it's a committee who need to evaluate and give their approval. And this could take -- I would say, if we talk about people who is really, really a really super competent people, surgeons in U.S. they can maybe push this forward quicker? Or it depends on the hospital, but it could take 2 months, it could take 3 months. It could maybe go faster as well, depending how the serum is connected with its hospital. I could probably even take a longer time, you don't know, so to say. It's difficult to say exactly. But let's say, in a couple of months, few months, we will start with training surgeries. That's a realistic target. And then, of course, it depends on the center. These centers take Professor Liam, for example, who sits at University of Southern California, maybe the most respected surgeon in this field in the United States, we have heavily promoted our device. I would say, he do 1,100 surgeries at that center. So it's not that the training needs to take forever, so to say. It's -- they have -- everything is bigger, larger in United States, so to say. It's -- and meanwhile, we do all this, we will do the full legal approval, and that's together with the study that FDA requires you have a post-market trial. So we will file for two different trials, and we will be a legal agreement with the hospital. And that's, again, a legal agreement with a hospital in U.S., it could go quickly, but it could also take forever. There is examples that they can negotiate for 9 months. So it depends of how interested the surgeon, of course, is to get this through and how we try to push a little bit the hospital and that you come with fair deals and so on. But legal process also takes a little bit of time. So therefore, it's a little bit of lagging where we train, but we can use this legal phase, so to say, part of that will then be used for training. And then, of course, then we have a situation where it should be no limitation for the hospital surgeons to operate. And that's, of course, completely different compared to the European situation, where they don't get paid in -- still in most instances don't pay yet. So it will be very different to launch in U.S. more exciting for the investors.

Okay. Okay. Great. Second one would then be on reimbursement and payment -- payments. So maybe we'll share more at the Capital Markets Day around went back to see the first reimbursement cases. But is it possible to share today? And then the second, like point to that question is also what potential do you see for self-pay before you've actually secured reimbursement? I suppose there are certain number of patients with kind of severe complications that might be willing to pay out of pocket for this treatment even before it can get reimbursed?

We don't see any problems for the surgeons and hospitals to operate. we don't see any economical limitation for that to happen, but we will explain more for you during the Capital Markets Day.

Okay. But would you -- like in general, would you say that there is potential for self-pay even before there is some kind of reimbursement for...

There is no -- self-pay because we have existing codes that we could use. So -- but we will explain more -- so it's -- it should not be any need for anyone to pay -- self pay for this. But to have such a system in U.S. as well that the patient would pay part of the procedure, but we don't see that as necessary in this case.

Okay. Let's get back to that on the CMB then. I got another question on Europe also. So you've previously talked about -- you've only focused on the best centers in Europe and the rest of the world to avoid complications during the FDA process. So how does this approval change that strategy? Will the focus be purely on the U.S. now? Or are you also planning to ramp activities outside?

No. We are planning -- we have a little team who will work full time to try to expand the territory. So they will take country after country and do the application. And of course, as I said, cannot have order to say they are okay with the U.S. approvals we and get the approval from them. And then we have come quite far with Japan, and that we have relatively good likelihood also because we have so long-term data, that we can get approval with existing studies, so to say. And you have a market like Middle East that we have not targeted at all because we -- as you know, we gave priority to FDA. And so there is quite a bit of market. Of course, initially now except the team who've been working with approval process in the different countries. I would guess the U.S. will follow most of our attention now because we want to get going as fast as possible here, of course. And -- yes, it's -- it would be a new -- I would say, Implantica go from collective clinical evidence to execution. Now it's the commercialization phase, it takes. We are -- it's an inflection point for Implantica where we go from the basic work to build the basement, the ground for the house, all the pipes, all the things prepared, so we can put a house there. That's -- we have done all this groundwork, all these methodical work step by step by step. But now we enter an execution phase. And that will happen both in United States, but it also will come in Europe maybe a little bit delayed in Europe still, but it's another for investors more attractive phase.

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.

Thank you. Okay. We have a few questions that have come through while you've been speaking, Peter. First of all, focus on U.S., will Dr. Lipton make the first U.S. RefluxStop surgery and how many proctor centers are planning to start in the first year?

Yes. Our target is to let Dr. Lipton do the first surgery because yes, he helped us and me with good advice. So we hope that would be the case. And what was the other one?