Thank you. My name is Peter Forsell, the CEO of the company.

I will try to guide you through today's Q2 presentation. For those who has not heard this before, I'm a surgeon and I'm also the inventor of the product we have in Implantica.

Also the CEO and founder of the company. This is the second journey.

The first journey was the gastric band, which I developed, and also a business for 6 years that successfully was sold to J&J. 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. That's, of course, fantastic news because United States is the largest market for medical products overall.

It's also a country who is more positive to new technology and also willing to pay for new technology. The good thing here is that we have 1 billion sufferers whereof 78 million we have in United States.

It's enormous amount of people who have this disease. It's larger than obesity basically.

I will come back to the FDA approval because I think today we have quite many new listeners, 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. Here you see the device called RefluxStop.

Today we are operating at 60 centers in Europe and we have done 1,800 procedures. We introduce the device with a special instrument that we sell together that you see on the picture here.

Existing surgical methods for acid reflux, it's also called GERD, gastroesophageal reflux disease, though 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.

That Dr. Nissen did already in 1956.

He took the top part of the stomach, which luckily the mountain, and he wrapped it around, you support the closing. There is another product called LINX.

It's a magnetic band that also do the same thing, try to support by, 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.

People are quite unhappy with this surgery. Therefore, with RefluxStop we realized these problems, we have constructed a device that do not affect the food passageway at all.

You have no problems with swallowing and other this gas bloating and stuff like that. What we realized is that the sphincter is perfect.

It's nothing wrong with the sphincter. It's all about the positioning of the sphincter.

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.

Then you have your big muscle called diaphragm who divides the chest from abdomen, which moves because you use it for breathing. That means that the esophagus then passing through a hole in the diaphragm, it can move freely.

These pressure variations then are leaking out through the opening here. It's like you have a huge stone wall at the harbor, for example, to protect the boat from the waves.

Then you have an opening where the boats go in and out, and it's always very, very streamy in that opening. That's exactly what you have here.

When the sphincter comes closer and closer to the diaphragm, you get more and more problems for the sphincter to function and work properly. What we are doing, we are placing our device on the outside of the stomach wall, we create a big package here.

It's called fundus, the top part of the stomach. We create a big fundal package here that acts like a mechanical stop towards the diaphragm.

This distance here is always kept. Basically, what we are doing, we are just restoring the body's normal anatomy, and then let the body treat itself.

We are not treating acid reflux. We just restore the anatomy and ensure that it maintains in that position.

When this little sphincter here goes all the way to the chest, like you see on this picture here, then you call it a hernia. Many of these reflux patients have a hernia.

Then it's, of course, even worse then. You can see the normal anatomy, and when you place RefluxStop, it's very, very similar.

Why do we then need RefluxStop? 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. 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 your food of some kind.

Now they just pass through and they come into the small intestine, who normally is sterile, and you get overgrowth of bacteria. It's called SIBO, swollen, distended in your abdomen and so on.

The biggest problem is that, one, 40% are not treated, it's only 60% who has helped by these drugs. Second, it's lots of very, very serious side effects with these drugs.

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. It's a drug that never should have been approved.

It's a terrible drug actually. One thing that you didn't know from before was that this drug is sucking out a substance from your blood vessel, which means that you get extra prone to get atherosclerosis.

When you are 40 years old, you have a 60-years-old blood vessels. That's why you have lots of extra death of cardiovascular death.

It's not like, "Oh, this patient died from heart attack. It was because he take PPI."

That's not the first thing you think about. 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 take to prove that smoking was dangerous, although everybody understand smoking was dangerous. It's the same here.

We know that if we put down an endoscope down in your stomach, and you have this disease, 10% to 20% have precancerous changes. If you do that in the normal population, it's 1% to 2%, and they are mainly the reflux patients we talk about.

It's clear this disease plus this drug give you cancer. What is difficult to separate.

RefluxStop then has now been tested the first patient in is nearly 10 years away. Now more than 9 years since the first patient was operated.

We have presented for FDA our 5-year results. I will just show you a bit the results FDA got.

Everybody took drugs before surgery. At 5 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 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 6 months, it's completely stable at 5 years. The outcome is stable for 5 years here.

Here you see the outcome from every single patient. This of course many lines here and a line of zeros here.

If you use the same definition as LINX used for their FDA trial in their SSED memorandum, then everybody is treated, objectively treated patients. If you then look in the literature, and we found a huge literature review of Nissen fundoplication, which is the standard of care wrap I talked about before, and you can see the comparison in outcome here.

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%.

It's like night and day the outcome. Today we have 38 articles.

We have done a really good job systematically doing everything we can. Every surgeon who do this procedure is publishing the results, go to congresses, 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 surgeons in 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 complication rate, two articles you can find in Surgical Endoscopy.

We also have a fantastic study where 22 centers from Europe put together all their results. It's 602 patients from is it nine countries or six countries, nine or six countries, maybe six countries.

It's showing that it's a very, very safe device, much, much, much lower complication rates than standard of care. Finally we come to the business update and FDA approval.

This is, of course, we have been working 4.5 years to get this approval. It's so much work, so much effort, so much tests, so much things to do.

I would say if we had a paper system, I can take a full wall and I full it with files. Huge is this project.

It's hard to understand, but it's a very, very rigorous process. 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 manufacturing properly, and so on.

This is a huge quality stamp. 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. We will have a kickoff in September when the American Foregut Society have their meeting in Washington.

We have already prepared, we have a huge room and we will have a symposium and speeches and it's a big, big event. We have lots of key surgeons involved here.

Some of them are here, you have mainly the European surgeons below and you have US surgeons on top here. This is the perfect opportunity to make the first step now in United States.

Now we launch. Very exciting times.

Here you see the previous meeting at the AFS meeting the same meeting. Here you actually see the slide of the pH measurement for RefluxStop.

This was a presentation for data of RefluxStop and you see it's tons of surgeons here. This was our symposium, and it was even more than 120 surgeons here.

People were standing. It's enormous event just to describe about RefluxStop.

We are the absolutely hottest topic in United States. It's like SMS is standing like hagel.

It's really really top top top for the moment. We have more than 100 surgeons who has told us they are interested to start with RefluxStop.

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 to 1,000 centers in the same time because we need to ensure the quality.

We need to train the surgeons. We need to make an legal agreement with every hospital.

It's not, in 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.

We will have a fantastic outcome in United States, but it will be step-by-step. You can't run around and take several hundreds at the same time.

We will do it step-by-step, nicely, safe, very seriously growth, long-term sustain 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 done cadaver surgeries in Chicago.

So 20 we have already reasonably trained. Here you see a little bit this process.

The hospital they have certain process when they start with new technology. 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.

It will take some time. It will go quicker to start to train than to start to sell something.

If we are generous when we do the training, we can start training, yeah, in a couple or months or a few months. That's approximately the time frame we have here to get going.

Of course, very exciting times. We will then together with the European Foregut Society meeting, we will bring lots of American people over and also see surgeries here in US.

Then, of course, we will be training centers in US. We are targeting 10 training centers in US who should receive extra effort of training.

Our main device competitor, which is this magnetic band I talked about, they have already decided to withdraw from all markets outside US, and I would not be surprised if they also will withdraw from the US market in the near term as well. That's 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. 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 more people to employ.

We already have nine people in US, but we are now target of course to make quite heavy expansion. We have several of those coming from LINX really competent people who knows this treatment field and so on.

We have had many interviews and we have many more to come. Why is it now so important to have all these clinical evidence?

The answer is that if you come like a normal standard US company, you do your PMA in US, you come out with 1-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 your 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 US company to do their launch in United States.

We have produced and are producing in total 13,000 products to be prepared for the launch in the US market. We have done a special tool for United States as well, we can produce in US.

We are sort of prepared for a splash in the market. That's what we really target here.

The good thing with RefluxStop is that our market is approximately 10 times larger than the existing surgical market. Now you wonder, how could that be the case that your market is 10 times larger?

The answer is the following. Half of the patients today, they are not operated because they have so much swallowing difficulties, 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. Then you come with your esophagus who has been damaged by the acid.

The acid damaged the nerve ends, it damaged the muscles, you have very weak food transportation. It 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.

Therefore, half of all sufferers they are not treated. 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.

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.

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 damaged esophagus, doesn't matter for us.

NHS is the public hospital 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 9 months to analyze RefluxStop, and their conclusion was, "Yes, we think you should let them operate for these patients here in UK." 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. They gave us this half and say, "Okay, they have no treatment.

You have a good treatment. Please go ahead."

Because this is 10 times larger market than this, it's super fine for the moment. This is, of course, fantastic when we now go to United States.

As you can see, it's 30,000 procedures only done in United States today, but we see our market as 300,000. That you can compare to obesity surgery who had the market before the injections came, it was 300,000, today is 200,000 or maybe even less.

It's the same magnitude, it's the same magnitude of treatment field. One out of five Americans have acid reflux, one out of five.

Here you see a little bit summarizing this. If we just look at those who's not treated by the drugs, forget now that this disease give you cancer, forget that the drugs is terrible complication zone, we just say the drugs are fine, 60% take drugs, we still have 40% to operate.

If we do that, we have 31 million people. If we then take 0.1% of that, we have a $250 million revenue calculated for some kind of estimated first imaginary initial price in US of the product.

So 1% market, which is quite realistic, 300,000 surgeries, very 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 the coffee break here we talk about. You never know in life, but it's just give 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 US group actually who is spread all over the world called Anderson in Madrid. Here is some examples how we have made this cost-benefit analysis I talked about in United States.

We have made them in country after country after country. Of course, a huge work, but very well spent time and money.

Here is one example. It was published an article in Italy that said that you save money by operating with RefluxStop.

It's not only that you have the best treatment, you also save money by operating with RefluxStop. What happens then?

Tender win, tender win, tender win, tender win. 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. Step-by-step by step you get more and more real business, to say.

We have in Germany a very good situation. We have our own code, a specific code just for the RefluxStop procedure.

The problem we experienced is that there is a healthcare body in Germany called InEK, and they should decide how much money you should get, and that's based on real cost. The real cost is calculated from so-called InEK reporting hospitals.

It's a smaller group of hospitals in Germany who report every cost they have for every procedure, and they get paid for that I think from InEK to do that. They had no big reflux surgery center in that group.

They didn't do reflux surgery. We had to start from scratch and educate and train and convince people to start with reflux surgery.

Now we finally have seven of these InEK reporting hospitals who perform RefluxStop surgery. Now we can get going to do the surgeries that InEK need, they can finally say, "Yes, we see the cost of your procedure is this.

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. Spain is a nice example what happens when you have a healthcare system who listen to the surgeons.

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. That means that the Swedish healthcare system is going the elevator 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 the 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 budget this year you can only do one per month."

Then they do that. They do 12 per first year, next year they can maybe get 36, for example.

That's how it works in the budget system. You need to go step-by-step by step.

You see, we have 20 centers in Spain because they listen to the surgeons and patients. This is just showing you what potential we have in our treatment.

US approval opens up many doors. Canada, for example, say, "Yes, okay, we take the US approval right away.

You get approved." We have many other regions like Japan, Australia who really take seriously with the US.

Now we can start to operate in Middle East that we didn't do before, Southern America, and so on and so on. 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 operates for obese today, they do something called gastric sleeve, which means that they cut away a big portion of your stomach, put in the trash, the stomach gets like a prolongation of esophagus like a tube. You have a long, long tube now, esophagus and the stomach.

Because you know that you get reflux because the sphincter glides up. Of course it glides up and everything is lost a long tube.

It'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 1 year 40% to 50% of these patients have acid reflux.

We are starting directly now after the summer a combination of RefluxStop and gastric sleeve. We be a European study here with four centers to test this.

Finally, then before we start with questions, as we have two fantastic platform technologies. We have a wireless energizing platform and an e-health platform.

This is extremely advanced. It's a decade of development.

We have 25,000 pages of patents for this e-health platform, and 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, patient in his home, and you can change the treatment. 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.

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. Out of these, I can tell you, we have around 10 RefluxStop-caliber products.

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 cost lots of money and it's lots of execution. Still, in the future long-term, Implantica may be someone who is really attractive to own shares in.

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 abdominal wall. 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. Only these plastic bags have a business of $3.9 billion.

We can solve that. Today need our device and a remote control.

When I was a young surgeon, we made experimental surgery for this. We sutured the small intestine down to the anus, those who had the sphincter left, and we tried to do a little reservoir bending and sutured together, but this didn't work because in the small intestine you have 2 to 3 liters of fluid because all the fluid is sucked up in the large intestine.

It's like you have had the worst diarrhea you can imagine, and no sphincter could handle it, and the reservoir made it just stand there full and just overflowing, was nothing to empty it. All this is solved now.

We can make a reservoir, we can empty the reservoir on command, we have a sphincter who is artificial so we can handle open and close, and people don't need any sphincter, they can take away the whole inflamed intestine or large intestine with sphincter and everything, and we fix it anyhow, and they don't need this plastic bag anymore. Another example, people who can't urinate, 1.7% of the US population can't urinate.

They have a spinal cord injury, multiple sclerosis, they put in a catheter in their own bladder five times per day. Every time they should 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 a remote control.

Finance update, I give the word to Andreas, our CFO.

Thank you very much, Peter. I will walk through the financial highlights for the second quarter 2026 with a focus on revenues, margins, operating cost, 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 2025.

Growth was mainly driven by accelerating RefluxStop adoption in the Italian and the Spanish markets. Turning to profitability, our gross margin remain 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.

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, 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 cost 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, 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 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 GERD patients at scale in the US and worldwide. With that, let me hand it back to you, Peter.

I think it's time for questions.

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 roadmap from Implantica?

For example, a 5-year financial plan with clear financial targets and milestones. Is this something that you is 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 focus, of course, on the US 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. 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. 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 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 European surgeons for a couple of months and train center after center after center.

We cannot risk in 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 built all our clinical evidence, everything methodically.

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. Of course, it's a very exciting times.

Okay. Thanks.

Hi. Good afternoon.

Big congratulations to the FDA approval. My questions today mainly relate to the strategy now and what to expect going forward.

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 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. We need to pass the committee approval in each hospitals even if we decide that we will give the product for free, to say, for the training surgeries.

It will still require an approval process in the hospital. It's a committee who need to evaluate and give their approval.

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 it depends on the hospital. It could take 2 months, it could take 3 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, to say.

It's difficult to say exactly. Let's say in a couple of months, few months, we will start with training surgeries.

That's a realistic target. Then, of course, it depends on the center.

These centers, yeah, take Professor Lipham, for example, who sits at University of Southern California, maybe the most respected surgeon in this field in United States, a heavily promoter of our device. I would say he do 1,100 surgeries at that center.

It's not that the training need to take forever, to say. They have everything is bigger, larger in United States, to say.

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, we will file for two different trials and we will make the legal agreement with the hospital.

That's again a legal agreement with the hospital in US, it could go quickly, but it could also take forever. There is examples that they can negotiate for 9 months.

It depends of how interested the surgeon, of course, is to get this through, and how he tries to push a little bit the hospital, and that you come with fair deals and so on. A legal process also takes a little bit of time, to say.

Therefore, it's a little bit of lagging where we train, but we can use this legal phase, to say, part of that will then be used for training. Then, of course, then we have a situation where it should be no limitation for the hospital or surgeons to operate.

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. It will be very different to launch in US, more exciting for the investors.

Great. Thanks very much.

Second one would then be on reimbursement and payment. 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?

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.

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

For some patients at least.

There is no need for self-pay because we have existing codes that we could use. We will explain more.

It should not be any need for anyone to pay 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.

Let's get back to that on the CMD then. I got another question on Europe also.

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. 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 have a little team who will work full time to try to expand the territory, they will take country after country and do the application. Of course, as I said, Canada had already say they are okay with the US approval, we just need to file and get the approval from them.

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, to say. You have a market like Middle East that we have not targeted at all because we, as give priority to FDA.

There is quite a bit of markets. Of course, initially now, except the team who will be working with approval process in the different countries, I would guess the US will swallow most of our attention because we want to get going as fast as possible here, of course, and yeah, I would say Implantica go from collecting clinical evidence to execution.

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. We have done all this groundwork, all these methodical work, step-by-step by step, but now we enter an execution phase.

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.

Okay. Thank you very much.

Next one

Thank you. We have a few questions that have come through while you've been speaking, Peter.

Focus on US: will Dr. Lipham make the first US RefluxStop surgery, and how many proctor centers are you planning to start in the first year?

Yes, our target is to let Dr. Lipham do the first surgery because he has helped us and me with good advice.

We hope that will be the case. What was the other one?

How many proctor centers?

How many proctor centers. 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 yeah, understand how to do it.

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

That's a more detailed question that I think we will cover a bit more around the Capital Markets Day. Of course, you start with the really large centers, the really prominent, the really key surgeons.

You have 5, 10 centers they do lots of surgeries and they are very respected. Those you start with in United States, and then you expand from there.

You can take a snoring device like Inspire Medical sell, for example. Today they have 1,400 hospitals, and you don't make 1,400 hospital in a coffee break, to say.

You have to do them step-by-step. There's many examples in the US how this expansion go relatively surprisingly quickly.

Of course, it's easier when you come with this 5-year data, as I said before. If you come with 1-year data, you have to prepare and collect your data before this really takes off.

We have nothing really who stops us from taking off, but everyone understand that you cannot train all these hospital at the same time. It's step-by-step process.

You've 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. It works like this in 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. The more procedures that comes in and they apply for, the more likely is that they will accept and pay for that product.

It's quite important to have this little bit splash in the market, but that doesn't mean that it go in a coffee break to have the center started. You have a little bit lag phase, as I said before, to train the surgeons, to do the legal agreement.

It's not that your revenue doesn't start day one. It's a few months delay, of course, before you can have this process going.

When you finally get it going, there should be no limitations to make a splash in the market.

What is the capital requirement for a proper launch in the US?

Implantica today spends 15 million and we have 42 million. With today's spending, it's not so far away from 3 years.

Of course, when you start to spend in US, it cost you more, huh? Then you can calculate yourself.

If you spend 50% more because you do the US launch, then you have 2 years before you should try to get your income, to say. I would say a US launch over 2 years cost 15 million or more, several approximately.

You can spend any amount. There is examples, we have studied every company basically who have made this and see what it cost.

The maximum someone has spent on a US launch is 100 billion, everything is possible. In our case, I think there will be more modest amounts, of course.

Then is of course how you get going with your revenue, everything is a balance between real revenue and the cost. We will present a little bit more detailed plan the 9th, but we are very positive right now.

We are walking on clouds basically here in Implantica right now.

You outline a large potential total addressable market in the US with RefluxStop, and 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. I think we have operation patents to 2044 or 43.

I think it will be difficult for someone who come 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. I can say that with my previous gastric band business, we managed in 6 years to take 28% of all obesity surgery outside US.

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 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.

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 it's a heavy paperwork that need to be done for every country. 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 and then so it will be for sure more and more countries, huh?

Is that also in the Middle East? Is there a market opportunity in the Middle East?

It's probably very good market opportunity in the Middle East. I think it's a really good market opportunity in the Middle East actually.

We just decided to take it a bit more calm because FDA requires every complication to be reported to them worldwide. It's difficult if you have market too far away.

We decided to start with the European market and get our FDA approval, and then we could expand. We would of course expand to Middle East, and I'm for sure it's a good market.

We have a repeating question: do you have enough capital to fully fund the launch, and how will that affect your launch with

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 3 years with the current setting.

Then you should know that has been quite a lot of extra cost for FDA, actually I would say our cost is lower. 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. 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. I think then it's many questions who is very similar.

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.

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.

I thank you very much for this long time and for listening and for your support. Good luck, everybody, and have a nice afternoon, evening.