Impel Pharmaceuticals Inc.

Thank you. So my name is Peter Forssell, 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 product we have in implant. and also the CEO and founder of the company. And this is the second journey. So the first journey was Stochastic Band, which I developed, and also a business for six years that successfully was sold to J&J. And that's the funding. Part of that has been used for this new Implantica venture. Oh, the really good news for today is, of course, that Implante has got FDA approval for its product, Reflux Stop. And that's, of course, fantastic news because the 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 sufferers, where of 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 Reflux Stop. 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. Dr. Nissen has always been focused on that the sphincter between the stomach and esophagus is weak. It can't close properly, and therefore we need to support its closing. And that Dr. Nissen did already in 1956. He took the top part of the stomach, we stuck it in the mountain, and he wrapped it around so you support the closing. There is another product called Lynx. It's a magnetic band that 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 passageway. That means you get difficult to swallow. You can't get nothing up. You can't belch. You can't vomit. All the air you swallow with your saliva and food that normally just regulates up is not going up anymore. And you get swollen distended in your abdomen. And people are quite unhappy with this surgery. So therefore, we realized these problems. So we have constructed a 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 this winter is perfect. There's nothing wrong with this winter. It's all about the positioning of this winter. 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 who divides the chest from abdomen which moves because you use it for breathing and that means that the esophagus then have a hole or 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, you know, at the harbor, for example, to protect the boat from the waves. And then you have an opening where the boats go in and out. And it's always very, very streamy in that opening. And that's exactly what we have here. So when this filter comes closer and closer, to the diaphragm, you get more and more problems for the sphincter to function and work properly. 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 fundus, the top part of the stomach. So we create a big fundal package here that acts like a mechanical stop towards the diaphragm. So this This stance 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 as a reflux. We just restore the anatomy and ensure that it maintains in that position. And when this little swinter here goes all the way to the chest, like you see on this picture here, then you call it a hernia. And many of these reflux patients have a hernia. Then it's, of course, even worse. And you can see the normal anatomy, and when you place reflux up, it's very, very similar. So why do we then need reflux though? Yeah, 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. Thank you very much. And the biggest problem is that one, 40% are not treated. So it's only 60% who has 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 US veterans. They were followed for 10 years and 7,000 died 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 sucking out the substance from your blood vessel, which means that you 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 lots of extra deaths of cardiovascular deaths. 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 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 how long time it took 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-cancerous changes. If you do that in the normal population, it's one to two percent. 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. Reflux stop then has now been tested for the first patient in is nearly 10 years away. More than nine years since the first patient was operated. And we have presented for FDA our five-year results. And I will just show you a little bit the results FDA got. So everybody took drugs before surgery. At five years, one patient took 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, you put a little capsule who send wirelessly 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 six months. It's completely stable at five years. So the outcome is stable for five years here. And here you see the results outcome from every single patient. and this was many lines here and a line of zeros here. And if you use the same definition as the links used for their FDA trial in their SSED memorandum, then everybody was treated, objectively treated patients. So if you then look in the literature, and we found a huge literature review of Nissen fundoplication, which is the standard of care RAP I talked about before, and you can see the comparison in outcome here. So if you look at inability to belch and vomit, 40% had this. We have 0%. 29% have severe swallowing difficulties. We had one patient who had temporary swallowing difficulties. and so on. All these are a little bit like night and day. 52% has gas bloating, although it's not on this slide here. And I think we had around 4%, 4.6%. And so it's like night and day, 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, is present. We have been going to United States for four years, lots of presentation. Every Congress we are there, we are presenting. and that's why we have convinced the surgical society and surgical surgeons in the US 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 complications. There are two 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, is it nine countries or six countries? Nine or six countries, maybe six 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 four and a half years to get this approval. It's so much work, so much effort, so much tests, so much things to do. I would say I can take my full, if we had a paper system, I can take a full wall and I have full files. 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 your quality system. They go to all your manufacturers to check that they do by refracting properly and so on. and this is a huge quality stamp. You know, someone, a company who can pass an FDA PMA like this, this is a quality stamp. Implantica is approved and that is a fantastic milestone achievement. So we will have a kickoff. In September, when the American Forgot Society have their meeting in Washington. So we have already prepared. So we have a huge room and we will have a symposium and speeches. And it's a big, big event. And we have lots of key surgeons involved here. Some of them are here. So you are mainly European surgeons below and you have US surgeons on top here. So This is the perfect opportunity to make the first step now in the United States. Now we launch. Very exciting times. Here you see the previous meeting. at the AFS meeting. The same meeting. And here you see, here you actually see the slide of the pH measurement for reflux stop. So this was a presentation for data of reflux stop. And you see it's tons of surgeons here. And this was our symposium. And it was even more than the 120 surgeons here. People were standing. It's an enormous event. Just... to describe about reflux. We are the absolutely hottest topic in the United States. It's like SMS is standing like, you know, hagel. It's really, really top, top, top for the moment. So we have more than 100 surgeons who have told us they are interested to start with reflux topics. 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 2,000 centers in the same time because we need to ensure the quality. We need to train the surgeons. We need to make a legal agreement with every hospital. 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 the hospital. No, 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 surgeon. So we will have a fantastic outcome in the United States, but it will be step by step. You can't, you know, run around and take several hundreds at the same time. It 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 surgeries here. They have the cadaver surgeries in Chicago. So 20, we have already reasonable trade. And here you see a little bit this process. So, you know, the hospital, they have certain process when they start with new technology. So first you have a sort of 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 than to start to sell something. So if we are generous when we do the training, we can start training in a couple of months or a few months. That's approximately the timeframe 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 the U.S. Then, of course, we will be training centers in the U.S. So we are targeting 10 training centers in the 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 well. So that, of course, opens up a new market for us. Good things also that we have made cost-benefit analysis in the 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 and more people to employ. We already have nine people in the US, but we are now targeting to make a quite heavy expansion. And we have several of those coming from leagues, really competent people who know 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 this clinical evidence? Yeah, the answer is that if you come like a normal standard US company, you do your PMA in US, 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 five-year data. That's a completely different animal. People know that this product really works long term. And therefore, when you come with five-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 the United States. We 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 the United States as well so we can produce in the U.S., and we are sort of prepared for a splash in the market. That's what we really target here. The good thing with Reflex Stop is that our market is approximately 10 times larger than the existing surgical market. And now you wonder how could that be the case that your market is 10 times 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 nerve ends, it damaged the muscles. So you have very weak food transportation. It's difficult to swallow. and 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 try to show here. You have two halves. This half is the one who is operated today. The other half is those who has no treatment today. They are completely without treatment. And this half... They are all the severe sufferers, all the long-term sufferers. In this group here, you have 10 times higher surgical need because they are all the really terrible patients. And that's the one who get damaged in the esophagus by the acid because they have so much acid coming up. They have it so 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 damages over us. It doesn't matter for us. And NHS is the public hospitals organization in UK 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 nine months to analyze reflux salt. And their conclusion was, yes, we think you should let them operate for these patients here in the UK. 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. You have a good treatment. Please go ahead. And because this is 10 times larger market than this, it's super fine for the moment. So this is, of course, fantastic when we now go to the 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 to obesity surgery, who had the market before the injections came, you know, 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. One out of five Americans 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 drugs is terrible complications. So 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 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, very realistic for this huge shipping 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 gives you a potential. Update for Europe. 66% growth this quarter, quite nice. Total revenue for the first half, 1.6 million. Some really good hospital centers we have started in different countries, of course, including one big U.S. group actually who is spread all over the world called Andersen in 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 in an article in Italy. They said that you save money by operating with Reflex Stop. It's not only that you have the best treatment, you also save money by operating with Reflex Stop. And what happens then? Tender win, tender win, tender win, tender win. So the total we have now 2.3 million secured in public healthcare 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, a specific code just for the reflux spot procedure. The problem we experienced is that there is a healthcare body in Germany called INEC, 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 INEC reporting hospitals. So it's a smaller group of hospitals in Germany who report every cost they have for every procedure and they get paid for that as in from INEC to do that. and they had no big reflux surgery center in that group. They didn't do reflux surgery. So we had to start from scratch and educate and train and convince people to start with reflux surgery. So now we finally have seven of these ENIC reporting hospitals who perform reflux top surgery. So now we can get going to do the surgeries that Inek Need, so they can finally say, yes, we see the cost of your procedure is this. Okay, you get reimbursed for this. 12,000 procedures in Germany, so that would be fantastic, of course. UK, I already explained for you how we are into the NHS hospitals. Okay. Spain is a nice example of what happens when you have a healthcare system who listen to the surgeons. So if you take the Swedish healthcare 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 healthcare system is going the elevator down to the basement because no new treatment gets 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 then the surgeon says, I want to use Reflex Stop. They say, OK, you can do that. But this budget this year, you can only do one per month. And then they do that. They do 12 per first year. The next year, they can maybe get 36, for example. And that's how it works in the budget 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, we take the U.S. approval right away. You get approved. We have many other regions like Japan or Australia who actually take seriously with 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 obesity today, they do something called gastric sleeve, which means that they cut away a big portion of the stomach, put it in the trash, so the stomach gets like a proliferation of esophagus, like a tube. You have a long, long tube of esophagus in the stomach, and because you know that you get reflux because the sphincter glides up, Of course, it glides up and everything is lost a long tube. There's nothing to stop it from gliding up at all anymore. So 68% long-term get acid reflux, surgically induced acid reflux. And already after one year, 40 to 50% of these patients have acid reflux. So we are starting directly now after the summer, a combination of reflux stop and gastric sleeve. So it will be a European study here with four 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 e-health platform. And these... is extremely advanced. It's a decade of development and it's We have 25,000 pages of patents for this ER 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 can change the treatment remotely. The doctor could be in his hospital, the patient in his home, and you can change the treatment. And we have then gone through the whole body to say, how could we now improve healthcare with these technologies? And we ended up with 300 inventions, 300. And we have then gone through 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 reflex stop 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 lots of money and it's lots of execution, but still... In the future, long-term, Implantica may be someone who is really attractive to own chairs in. 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 ulcerative colitis or some other disease, cancer or whatever, and they collect the fecal matter in a plastic bag outside the abdominal wall. And it's, of course, not like you are running on the beach, super happy with this plastic bag with your stuff in. However, The business for plastic bags is $3.9 billion. So only these plastic bags have a business of $3.9 billion. and we can solve that. They need our device and a remote control. When I was a young surgeon, we made experimental surgery with this. We sutured the small intestine down to the anus, those who had the sphincter left, and we tried to do a little rest of our bedding and suture together, but this didn't work because in the small intestine, you have two, three liters of fluid because all the fluid is sucked up in the large intestine. And it's like you have the worst diarrhea you can imagine, and no swinter could handle it. And the reservoir made it just stand there full and just overflowing. It was nothing to empty. All this is sold now. We can make a reservoir. We can empty the reservoir on command. We have a swinter who is artificial, so we can handle it open and close. And people don't need any swinter. They can take away their wholly inflamed large intestine with the swinter and everything. and they fix it anyhow and they don't need this plastic bag anymore. Another example, people can't urinate. 1.7% of the US population can't urinate. They have a spinal cord injury, multiple sclerosis disease. They put in a catheter in their own bladder five times per day. Every time they urinate, they put in a catheter. If you manage to put in a catheter in your own bladder once, you have done an achievement. It's not fun. They don't need this anymore. They need our device and the remote 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 of 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 €717,000, up 66% compared with the second quarter of 2025. Growth was mainly driven by accelerating reflux stop 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 4.2 million euro that represented 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 3.9 million euro, broadly unchanged from the second quarter of 2025. At the end of June, we held €41.7 million in cash and cash equivalents and no interest-bearing bet. 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 reflux stop available to GERD patients at scale in the US and worldwide. With that, let me hand it back to you, Peter.

Yeah, so I think it's time for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Alexander Perman from Securilon Capital AB. Please go ahead.

First of all, congratulations to the Empire 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 roadmap from Implantica? For example, a five-year financial 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 US launch the 9th of September in the afternoon in Stockholm, which will be sent live and also recorded for and others 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 I think it's rather clear that the US 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. 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 the US. It's a step-by-step approach. We need to do this very seriously. We need to go over there and travel around with the European surgeons for a couple of months and train center after center after center. and that we cannot risk in the United States to do poor surgeries. It should be perfect everything. That's how Implantica 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 danger because you get complications. We need to do this very seriously. But of course, it's very exciting times.

Yeah, okay, thanks.

The next question comes from Philip Weiberg from Pareto Securities. Please go ahead.

Hi, good afternoon. First of all, a big congratulations to the FDA approval. I've got a few questions today that... Yeah, my questions today mainly relate to, you know, the strategy now and what to expect going forward. And I understand you will disclose more on the capital market state there. But, you know, first of all, just... What are the exact next steps? When do you expect the first 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 hospital, even if we decide that we would give the training surgery, so the 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 eager, really super competent people, surgeons in US, they can maybe push this forward quicker. or, you know, it depends on the hospital, but it could take two months. It could take three months. It could maybe go faster as well, depending how the surgeon is connected with its hospital. Could probably even take 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 Lippham, for example, who sits at University of Southern California, maybe the most respected surgeon in this field in the United States, a heavily promoter of our device. I would say he do 1,100 surgeries at that center. So it's not that the training need to take forever, so to say. Everything is bigger, larger in the United States, so to say. 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-Baker trial. So we will file for two different trials and we will make a legal agreement with the hospital. And that's again, you know, a legal agreement with the hospital in U.S. It could go quickly, but it could also take forever. You know, there is examples that they can negotiate for nine months. So it depends on have interested the surgeon of course is to get this through and how he tries to push it a bit the hospital and that you come with fair deals and so on but a 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 the We have a situation where there 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, not paid yet. So it will be very different to launch in the US. More exciting for the investors.

Okay, great. Thanks very much. The second one will then be on reimbursement and payment. So maybe you'll share more at the Capital Markets Day around when you expect to see the first reimbursed cases, but is it possible to share today? And then the second point to that question is also what potential do you see for self-pay before you've actually secured reimbursement? I suppose there are a 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.

In general, would you say that there is potential for self-pay even before there is some kind of reimbursement?

There is no need for self-pay because we have existing codes that we could use. So, but we will explain more. So it's known it should not be any need for anyone to pay the self-pay for this. They have such system in US as well that the patient could 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 on the CMV then. I got another question on Europol. So previously talked about, you know, 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 US 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, Canada had ordered to say they are okay with the US approvals. We just need to file 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. Thank you. It will be a new, I would say Implantica go from collecting clinical evidence to execution. Now it's the commercialization phase. It's an inflection point for Implantica where we go from the basic work to build a The basement, the ground for the house, all the pipes, all the things prepared so we can put the house there. 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 the 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.

Okay, thank you very much. Next one.

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. Lipman make the first U.S. reflux stop surgery, and how many proctor centers are you planning to start in the first year?

Yes, our target is to let Dr. Lipa do the first surgery because he has, you know, he helped us and me with good advice. So we hope that will be the case. And what was the other one?

How many proctor centers?

Yeah, how many proctor centers? Yeah, so up to 10 proctor centers. We will start with a little bit less, maybe four centers maybe, and then we will increase to maybe 10 proctor centers. Centers where other surgeons can go and see the procedure and understand how to do it.

And how many centers do you think you will start during the first 12 months in total?

That's, you know, a more detailed question that I think we will cover a bit more around the Capital Markets Day. But of course, you start with the really large centers, the really prominent, the really key surgeons. So you have, you know, five, ten centers which do really, they do lots of surgeries and they are very respected and Those you start with in the United States and then you expand from there. And I mean, you can take a snoring device like Inspire Medical Cell, for example. Today, they have 1400 hospitals. and you don't make 1,400 hospitals in a coffee break, so to say. You have to do them step by step, but there's many examples in the US of this expansion go relatively surprisingly quickly. But of course, it's easier when you come with this five-year date, as I said before, if you come with One-year data, you have to prepare and collect your data before it really takes off. We have nothing really who stops us from this, from taking off. But it's a physical, everybody understand that you cannot train all these hospitals at the same time. It's a step-by-step process.

You built up inventory for an accelerated splash-style US launch. and also talk about a step-by-step rollout. Can you help us understand how those two fit together?

I think they fit very well together. I mean, it works like this in the United States that it's a commercial system and they also have private insurances, for example. These private insurances, they are affected by procedures done. So the more procedures that comes in and they apply for, the more likely is that they will accept and pay for that product. So it's quite important to have this bit splash in the market, but that doesn't mean that it go in the coffee break to have the center started. You have a little bit lag phase, as I said before, to train the surgeon to do the legal agreement. So it's not that your revenues doesn't start day one. It's a few months delay, of course, before you can have this process going. But when you finally get it going, there should be no limitations to make a splash in the market.

What is the capital requirements for a proper launch in the U.S.?

So, I mean, Implantica today spends like 15 million and we have 42 million. So with today's spending, it's not so far away from three years. But of course, when you start to spend in U.S., it costs you more. and then you can calculate yourself. So if you spend 50% more because you do the US launch, then you have two years before you should try to get your income, so to say. And I would say a US launch over two years cost 15 million or more, approximately. But you can spend any amount. There is examples. We have studied every company, basically, who have made this and see what it costs. And the maximum someone has spent on the US launch is 100 million. So everything is possible. But in our case, we think there will be more modest amounts, of course. And there is of course, How you get going with your revenue, so everything is a balance between real revenue and the cost. But we will present a bit more detailed plan in the nines, but we are very positive right now. We are walking on clouds, basically, here in Atlantica right now.

So you outlined a large potential total addressable market in the U.S. with reflux stop. As your solution is superior, is it likely that you will capture most of the surgery market over time? Are there any other competitors coming up with similar solutions?

There is no other product with similar solutions because we have a very broad Patent and we have the surgical method patented and so on. So I think we have operational patents to 2044 or 43. So I think it will be difficult for someone who comes with any competing products. Of course, I could not sit here and say we should take the whole market here. That's not really how it works, but I can say that with my previous gastric band business, we managed in six years to take 28% of all obesity surgery outside US. So it's sort of realistic to take a high part of a treatment field like this. If you just have the best treatment and it's cost-effective, like in our case, you have all the attributes to do this. But for me to sit and tell you that this will happen, that's just too much. You have to judge yourself, but the potential is really there for sure.

How can robotic surgery and AI help you expand faster in the US and globally?

Very good question. I'm sure we can use AI and support this process and we are actually looking into this. So this is a very good question.

Do you launch activities for approval in other markets immediately?

Yes, we have a team who will just launch new countries and do all that. You know, it's a heavy paperwork that needs to be done for every country. So we have a team and they will continue. We have made a plan. We have a detailed plan, which countries we do first, step by step, country by country. and the team will just work on these applications. So it will be for sure more and more countries.

And is that also in the Middle East? Is there market opportunity in the Middle East?

It's probably a very good market opportunity in the Middle East. I think it's a really good market opportunity in the Middle East actually. But we just decided to take it a bit more calm because FDA requires every complication to be reported to them worldwide. And it's difficult, you know, if you have market too far away. So we decided to start with the European market and get our FDA approval and then we could expand. And we would, of course, expand to the Middle East. And for sure, it's a good market.

And we have a repeating question. Do you have enough capital to fully fund the launch and how will that affect your launch?

I mean, the only thing I can say is what I already said. We have 42 million cash and we spend 15. That's not so far away from three years with the current setting. And then you should know that there's been quite a lot of extra costs for FDA. So actually, I would say our cost is lower. But then we have to add the US launch to that. And it's a balance. Every company like this, it's a balance how much you spend and how you want to do things. And this is detailed planning, which we already have done. But it's too much for me to tell like this. The only thing I can say, it looks very promising. Okay, I think then there's many questions that are very similar. So we have got many questions, but of course everybody wants to know, okay, when do you now have 100 million revenue? That would be good to know. But I think we change phase now and we hope we will not make our investors unhappy. We are really targeting to now enter a new phase and it's very, very exciting. So I thank you very much for this long time and for listening and for your support and good luck everybody and have a nice afternoon evening.