Welcome everybody to Implantica's Q1 2026 report. I will as usual start with a little introduction that you have maybe heard a few times before, but I will try to do it as quick as possible.

My name is Peter Forsell. Sorry for the delay.

As I'm the founder of this company, and also surgeon, and the inventor of the products we have. I've invested lots of money in this company, and they are based on my previous business, was the gastric band business, was very successful and later sold to Johnson & Johnson.

Our main and cornerstone product is RefluxStop, and that's working in a treatment field of 1 billion sufferers. An enormous field, it's only obesity who can match this kind of levels of disease.

RefluxStop you see on the picture here with a nice tool that we supply to the hospital to place it. On the next slide, you see a closer picture how RefluxStop looks.

It's made in five pieces. Today, we have 50 hospitals who do the procedure in Europe, and we have done around 1,500 surgeries so far.

Existing treatment in the past has always been focusing on that it's the sphincter, the closing muscle between the stomach and esophagus, which is the problem. Therefore, everybody has tried to close that, either with a magnetic band, our main device competitor from LINX, or so-called fundoplication, where you wrap the stomach around to try to support the closing.

The problem now is that this is your food passageway, and therefore people get lots of problems. They can't swallow, and they get swallowing difficulties.

They can get nothing up, they can't belch and vomit, and you try and you get maybe lots of air down with your food, but nothing comes up, and you get bloated and distended, and people are quite unhappy with these kind of surgeries. We at Implantica instead find out that it's nothing wrong with the sphincter.

You don't need to affect the food passageway at all, and you can actually treat acid reflux much better than the other methods that try to compress. We are doing that based on the following theory: in the chest, you breathe.

That means pressure variation is coming and going. Every time you breathe, the pressure change direction.

You have a big muscle, the diaphragm, who divides the chest from abdomen, and there you have an opening for esophagus. Through that opening, pressure variation is leaking out.

It mean that this poor little sphincter here who should close is terrorized with constant pressure variations, and it can't handle it. Therefore, the closer the muscle gets to the diaphragm, the more reflux you get.

With RefluxStop, you restore the normal anatomical and physiological situation when you place the device on the outside of the stomach, and thereby you always have a nice 5 cm distance to the diaphragm, and simsalabim, all acid reflux disappears, in principle. If you get the sphincter all the way up into the chest, then you call it a hernia, that you see on the middle little picture here.

This hernia, that's has maybe two-thirds of those operated for acid reflux. People then take drugs, that's the main treatment for this disease.

However, 40% of the sufferers are not helped by the drugs. There is a reason why we have acid in the stomach.

It's to kill off all the bacteria or parasites and so on that you get with your food. When you don't have the acid barrier, then suddenly your bacteria come down to your small intestine, and the small intestine, who normally is sterile, suddenly get inflamed, red, swollen, and you get bloated.

This happens quite a lot of the people who takes PPI, a so-called SIBO it's called. These drugs, if they should come to the market today, would never be approved, because they are really, really dangerous.

In a huge study from United States with 157,000 US veterans, 1 out of 20 died in a period of 10 years PPI use. This is a really, really terrible drug.

48,000 people die from esophageal adenocarcinoma every year, 48,000 people just in Europe and United States, and it's not like breast cancer when they do anything to save a life, here they just let 48,000 people die. Completely unacceptable, that's why all these people need to be operated with RefluxStop.

Finally, before I start with the update, a little bit of our previous clinical outcomes. We have our pivotal study filed as an FDA PMA submission, and this data is fantastic, basically.

We have all patient took PPI medication before surgery, and one patient at 5 years, only one, and this patient likely didn't even take it for acid reflux. If you look at the objective measurement when you measure pH in lower esophagus over 24 hours, then you can see that it verifies this fantastic results.

The pH goes down to normal values in all patients. If you use the definition used by our competitor in the FDA trial, 100% of the patients have normalized pH, and you can see at 6 months and 5 years, it's the same.

It's stable over 5 years, this fantastic results, completely unmatched results. Here you can see the difference between a recently published meta-analysis literature review of the main competitor we have, the standard of care is this fundoplication method, and you can see that it's like night and day.

So 40% can't belch and vomit, no one who operated for RefluxStop had a problem to belch and vomit. 30% have swallowing difficulties, we had one patient who had temporary swallowing difficulties.

It's sort of completely new world opens up for these patients. You can see to the left that different outcome you look at, the results are between 94% and 100%.

It's just absolutely astonishing result. You can read yourself.

It's published, all the FDA submission basically has been summarized in two articles published in Surgical Endoscopy, the 5-year data. There you can read yourself and enjoy.

Then, over to the business update. Sorry for a little introduction.

Let's start with FDA. We have really good news this quarter, and here at Implantica, we are jumping up and down of happiness actually because that we finally have made our FDA submission for the final answers to FDA, which is a big landmark.

It's hard to understand, but this is many, many, many years of hard work of all fronts, it's money, it's clinical, it's so much work behind this, it's hard to understand. Here a little bit map how we now are targeting if we now get the FDA approval.

We have already agreed with Canada that we will be approved. We have come far with Japan, and also Brazil we are working on.

We have a really good situation, and we can also expand to countries where we have actively not sold yet, Middle East for example, which is a good market. Everything looks quite promising for Implantica.

We have submitted now the final response. As you maybe know, FDA has reviewed all our three PMA modules.

We supply the PMA divided in three parts called modules. All three has been reviewed by FDA, they have provided feedback to us on all modules, and we have answered on their feedback on all modules.

We have also have what you call pre-approval inspections, when you come to the end point of this process, FDA comes out and they look at your manufacturing, they look at all the hospitals, they look at your facility, your quality system, and we have passed six of these pre-approval inspections, and all was successfully concluded as reported in the closing meetings. This looks a little bit promising now, and now it's in the hands of FDA.

According to FDA's guidelines for their work, they have up to 90 days to answer on this final response. This is also of course lots of work now to really start to do the perfect launch here in United States, because we need to prepare in advance.

We already had more than 100 surgeons who show interest to start with RefluxStop, and we target to start with the key center, 50 centers, and 20 surgeons has already been trained. As since before, we flow them over here to Europe, they saw two centers operations, and we have done cadaver treatment and they operate on cadaver in Chicago.

We are now preparing so we have maybe tenfold of European surgeons willing to fly over for the starting kick where we should train the key centers, and thereafter, we will then develop centers in United States who will do the training. For example, Professor Lipham, you see SS USC on the photo there, this is Professor Lipham, one of the most known and yeah, highest regarded surgeons in United States, and his center will be one of the training centers.

He has five surgeons doing this type of surgery, and they do 1,100 surgeries every year of reflux, as an example. We are also preparing, this you know since before as well, we are producing and have basically produced quite a lot already of 10,000 RefluxStop devices for this launch.

We really are prepared. We also have made a special tool for production inside United States, we are prepared for any rule change of any kind.

We also have a fantastic interest from the US surgeons. They are really, really eager to get this product on the US market.

Here is example, this is at SAGES. SAGES is the organizations who provide the guidelines, and they also have this magazine Surgical Endoscopy I showed you before.

This is a very, very prominent place to be. Here we had lots of presentations of RefluxStop.

They presented from Spain 56 patients, and we have also Dr. Secchi presented his 108 patients, and Professor Leeman presented robotic surgery, that's the new thing now that they do RefluxStop with robotic surgery.

It's a very good feeling, very good atmosphere, and our booth is, to say, completely full all the time with interest. Here you see another important meeting, this is DDW, also from 2026.

This is a place where you have more than 13,000 people coming. It's incredible.

It's both surgeons and medical doctors. There Dr.

Borbély presented his data. He is coming from Bern, from Inselspital, it's the largest university hospital in Switzerland, it's a highly regarded place, and he presented up to 7.25 years data, more than 7 years data, and it was incredible interest.

He has operated really, really severe sufferers, lots of severe sufferers. We had nearly 25% had precancerous changes in the group he operated, and really terrible disease.

55% had large hernia, and he even operated lung transplant patients. This is a new field for Implantica.

In United States, for example, you have 15 million people with severe lung disease, and they get really worse. If you do a lung transplant, for example, you can't have acid reflux destroying your lung, it doesn't work.

They lay down and sleep and the acid comes up and into the lung, and it's terrible. He has operated already 4% of his surgeries here was done on lung transplant patients, so that's another very, very interesting group.

Many medical doctors was highly interested in this. It's a few thousand, I think, of these transplants done every year in US only, but it's a big, big group of many, many such sufferers that could partly be affected by this.

Also, this really severe sufferers created a big interest. He had operated from 6% of patients with no food transportation at all, they had aperistalsis, also no contraction at all in esophagus for food transportation, and it still worked out perfectly with RefluxStop.

All this opens up really large, huge new territories, and it was highly, highly regarded this presentation. What does this mean all this work that we are doing?

It actually means that we will have a much faster launch. To do all these articles, to present all this and being at all this Congresses, it's hard work, but at the end, this will generate a much faster launch.

If you look at US companies in a similar situation as us, you will see that they normally has one-year data. A US company, do a US trial of one year, and then they go to launch.

Then it takes them 4 years, because they need to develop data, they need to develop confidence in the market. People are not starting to operate like crazy something they don't know how it works long-term.

We already have the 5-year data, and that means that when we do our US launch, it will be dramatically faster. We talk about several years of quicker launch, because we have selected all these important data.

Clinical evidence and reimbursement update. Today, we have not less than 35 articles, also peer review, professional articles written about RefluxStop data.

Incredible work from our team. We have a really full team of eight people doing nothing else than supporting surgeons if they need any help in this respect.

It's really, really fantastic clinical evidence that we have created. One special article I wanted to emphasize, which is also press released this quarter, and this is that we presented 602 patients across 22 European centers.

Professor Schoppmann managed to get all these 22 centers to do hard work and present all their data, we can have up to 7 years follow-up from 22 European centers, and it's fantastic results. It's 98% have no kind of reoperation of any kind, and those who had problems were all satisfactory resolved.

This is really excellent. We talk about tenfold lower results than in standard of care.

Also, we are doing lots of work on health economics side, because today, it's nice to be the best treatment, but you should actually also be the most cost-effective. Society should save money by switching to RefluxStop, then you are in a really good situation, and that's actually what we have proven with all this research.

From the beginning, it's University of York, their health economic consortium, has done all this work and put together all the cost analysis for all the different treatments of acid reflux. The conclusion is that RefluxStop is highly, highly cost benefit, also we are much cheaper to do than any of the other fundoplication, LINX magnetic band, or medical treatment.

Although the medical treatment cost nothing, the complications is so high that it cost more than taking the cost for the RefluxStop procedure. We have now done this in United States as well, the same fantastic results, and that we hope should be published now to the launch.

We have also done it in Italy. Here you see some of the reference I just put together, some reference how we do this in country by country to show we are superior.

In Italy now, it's quite interesting, because here we have then have an article published to show that it's more cost-effective to operate with RefluxStop, that the society save money by operating with RefluxStop. That's of course incredible.

What is the result? The result is that we have more and more so-called tender wins.

In Italy, they specify that they want to do so and so many surgeries, and then you make offers how much that will cost with the different procedures and so on. You see here all these to the right here is tender wins.

Lately, we had a tender win of €1.2 million, for example, and this is like a snowball effect. Imagine you stand on the top of the mountain and it's really soft snow, warm, nice, and you start to roll down.

This is the effect that we will have here in Italy now. It will be more and more centers, more and more tender wins until we reach a really good reimbursement situation.

Also in Germany, our situation starts to become quite good. As we have already got our own OPS code, that means in this so-called DRG system that they have to specify all the different surgeries, we have a specific code for RefluxStop.

The problem is just that in the beginning, they don't give any money for that code. When they operate in Germany, they can't get a penny.

However, is an organization, a body, a health body in Germany who called InEK, and they look at all the costs, real-world cost for this operation, and then they will give money to this. To do that, we then need so-called InEK hospitals, and there is not so many and not so many operating reflux.

We have really tried very hard to convince people to start here with reflux surgery. We are very happy to say that we have another two centers now who have started, both in Leipzig and in Menden in Germany.

Have six InEK reporting hospitals, and we are targeting to do what InEK requests, around 200 surgeries this year now in Germany, we can get paid also in Germany, which will be fantastic, a country who do 12,000 procedures or so of this reflux surgery. Market expansion opportunities.

This you maybe also know, but it's quite interesting for us of course that J&J, also Johnson & Johnson, has withdrawn LINX, our main device competitor, the magnetic band, from all markets outside US March 31, 2026. That means it opens up a big gap all over Europe or the whole world where they have used LINX before, and they need something to fill that gap.

Our intention is to fill that gap, and hopefully later on also in United States. We also have new very, very interesting market aspects.

When you operate obese people, in United States, it's nearly 300,000 people who is operated for obesity. Out of those, 160,000 or so are done with gastric sleeve, that means you suture your stomach like a prolongation of your esophagus, it becomes a long tube.

Since you all now know that when everything glides up, you get reflux, it's of course very easy that everything glides up if you have a long tube only, you have nothing to stop it from gliding up. That's also what happens here.

After one year, more than 50% of the gastric sleeve obesity surgery operated patients have surgically induced acid reflux. That means we have 80,000 people who need treatment.

That's perfect for RefluxStop. It's actually so many, and probably will increase after two, three years, that it could be discussed if not all gastric sleeve patients should have a RefluxStop.

That's say, all 160,000 would benefit to get RefluxStop together with the gastric sleeve surgery. That's a very, very interesting aspect.

You can see here a little bit here we have put together, in relation to the market share of the obesity surgery, you can see that it could be quite many surgeries if you are successful in this field. I will come later with some more nice information relating to that.

Here you see a little bit some further developments then how we are planning to step-by-step launch a so-called RefluxStop 2 and 3 and expand also to this obesity market. We are doing another randomized trial.

We have already agreed with Inselspital here in Switzerland and some other key centers that we should compare this gastric sleeve with and without RefluxStop. It's called RESHAPE, a very nice name for someone who lose weight.

This is a very, very interesting study that we are not so far away to launch, and that will be very, very interesting expansion of the market. Finance update.

Andreas.

Many thanks, Peter. Good afternoon, or good morning.

I'll walk through our financial performance for the first quarter of 2026. Net sales for the quarter amounted to €857,000, representing an increase of 15% compared to Q1 2025.

Implantica continues to selectively commercialize RefluxStop through partnering with leading key opinion leaders in Europe while preparing for broader commercialization driven by a US market approval and expanded European reimbursement coverage. As Peter outlined, the company is making solid progress towards both achieving a US approval and European reimbursement.

The business consistently delivers best-in-class gross margins. Adjusted gross margin for the quarter came in at 93%, remaining at a very high level despite normal quarterly variance.

First-quarter operating loss amounted to €3.9 million, representing an 8% year-on-year improvement. This despite an 8% increase in R&D expenses compared to last year, mainly driven by post-market study costs.

The higher R&D spending was more than offset by a 12% reduction in general and admin expenses as a result of disciplined cost management. Turning to cash flow.

Operating cash outflow amounted to €3.7 million for the quarter, an 19% improvement compared to Q1 2025. At the end of March, the company held cash and cash equivalents of €45.5 million, providing a solid financial position.

Let me also highlight that the capital structure remains debt-free. Turning briefly to our shareholder base.

We continue to benefit from the support of a committed high-quality investor group, including our founder and CEO and principal shareholder, Peter. We value the continued long-term support as we relentlessly work to ensure that GERD sufferers worldwide gain access to the best available treatment at scale.

Back to you, Peter.

Thank you. Before we start with questions, I of course need to tell you that Implantica is actually much more than RefluxStop.

Although RefluxStop has the potential and attributes to build an enormous business, we have something that is actually even much, much larger than that, and that's our platform technologies and pipeline products. We have created an e-health platform and an wireless energizing platform so we can actually build extremely advanced medical implants, so-called super-smart medical implants.

We can control these implants remotely. That's absolutely fantastic.

It's long, long work behind this. It's actually so advanced that we believe if we want, we could license this platform technologies to yeah, the whole implant world basically, if you want.

We can also discuss if it's more advanced to use it for our own products, because we have a huge pipeline. As we went through the whole body, and we looked at every single treatment field, how could we improve health care with our platform technologies.

It showed up that more advanced technology, it was possible to improve nearly everything. It's fantastic.

We have more than 300 inventions, and we've been sitting doing market analysis, product analysis, production analysis, and we have selected 40 of these 300 inventions that we believe are really strong implant products. The e-health platform, we have filed 25,000 pages of patents.

You can imagine how many pages this is, just to cover and protect our e-health platform. Sorry.

It's a bit hard to grasp how huge this could be, but it really is something very special. It's need of course lots of execution and lots of funding.

Our first priority is of course RefluxStop, our second priority is RefluxStop, and our third priority is RefluxStop. Don't worry, we will bring RefluxStop to a successful launch.

Just another product, because we talked about obesity, and we discussed how we can use RefluxStop in the obesity world, and then I wanted to tell you also that we actually have a fantastic product to treat obesity. As you know today, you have these injections, even drugs sometimes, but mainly injections that is quite good that treat obesity.

You can lose 10%, 15% or so in weight loss, but of course if you have 50, 60, 70 kg overweight, then it's a bit too much for these drugs. What is worst is that as soon as you stop this drug, you gain your weight again.

It's incredible. I worked with these obese patients in the past, and it's hard to believe, you can have a patient who lost weight from 160 to 70 kg with a gastric band, and we take out the gastric band, and 3 years later, they are 155 kg.

You just don't understand it, but that's the case. These people, they are bound to take this injection for the rest of their life.

How looks the complication when you take them for the rest of your life? That's why obesity surgery will always feel an very important part.

This product is working exactly like the normal body's way of feeling full. When you eat, you fill the stomach, you stretch the stomach wall, and then you have receptors who send a signal to the brain, "Stop eating, you are full," otherwise you would blow your stomach if you don't have these receptors.

We use these receptors by stretching the stomach wall and tricking the stomach that it's full. Very simple and ingenious little invention.

Also, this is the product we get most interest from patients. This is people who have taken away the large intestine, for example.

Maybe they have an ulcerous colitis inflammation, or they had a cancer or something, and they collect the fecal matter outside the abdominal wall here in a plastic bag. The business just for plastic bags is $3.9 billion.

Imagine, also $4 billion for plastic bags. They don't need this anymore.

We have reservoir, open-close, remote control is all you need, and you can have a normal life, everything connected to anus. That was a little bit this.

Now, I think we should move over to questions. I think I put my little camera off here we need to read and communicate a bit here so we get the right answers to your questions.

Thank you very much for listening, otherwise. 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.

Hi, team. I've got a few questions today, but I think I'll take them one by one as usual.

First just on the FDA process here. You've handed in your responses, I was just curious around what you see as the possible remaining scenarios, what's your feeling given the latest feedback that you've got after the 100-day meeting and is it a decision on approval or what kind of risks remaining can you see now?

FDA has gone through all our modules, and they have provided written feedback, and then we had this meeting and we discussed all the feedback that was remaining with FDA to find out exactly what they wanted, and we had a very nice dialogue with FDA, I must say very, very positive dialogue. It worked nicely, and we have then fulfilled everything they ask for, and this included some complicated tests that we have done, and that's why it has been delayed because we had to do more testing.

That's all part of what has been filed now. I don't know.

It's of course completely in FDA's hands, but there is nothing what we know so far that we can see as being any problem here.

Good. Thanks.

From our side, we think everything is under control,

yeah. Good.

Then just around the launch also. It seems like if the FDA uses the 90 days or the 92 days that you previously sent out in a press release, it looks like August 20th or around there is the deadline.

Just curious if there has been any additional launch preparations this quarter, just looking at the OpEx numbers. It doesn't seem like you've ramped any costs yet, it's just curious around that, and what the plans are going forward now.

We must say that we are not in charge of FDA's, and FDA have had a bit tough timing here with the new boss, and there is, yeah, things happening in US, and we could not promise anything in the hands of FDA. It's completely now up to FDA.

The only thing we can say that the things that is left is not enormous, to say. It's a package of things, it's very much under control.

It's not a big effort left for them, I think. We have to wait and see.

We don't know, simply. That's the answer.

You are right that if FDA follows the time plan they have on their own home page, to say, then we have these days. You are absolutely right.

That's the formal maximum time. FDA could of course decide to do this earlier, and it could be that they are delayed for reasons we don't know.

Okay. Then on the cost side, ramping cost for the

US launch? Ramp-up cost.

We are of course doing lots of work for this US launch, and in United States, the only thing you can do is so-called scientific work. We can show our fantastic data, we can visit all the Congresses, we can talk with all the surgeons, and of course if you go to a Congress and it's many, many European surgeons presenting fantastic data, you create interest and you get more and more centers who want to start.

At the moment we don't need more centers, to say. We have enough for the fantastic launch already.

Then of course we are looking for key people. We already have lined up some people.

We would need of course to employ more people in US, sales people as well, and lots of hard work is done the same as with health economics in US and the whole business plan how we should do this. We have a really good situation we believe to do a really splash in the US market, that's why we are producing so many products.

This we can do because we have, now you saw 93% gross margin. In reality, we have 98% gross margin, but we gave away some products to studies.

It's like a drug, basically, this.

Okay. It really sounds like most of the increase is going to come after an approval, quite limited before that.

Would you say that's correct?

It works like this in United States that you need to have an agreement with every hospital. This you have to expect take 3 months.

Maybe some of the key centers here are really eager to get this done very, very quickly because they really want this, and they want to be one of the leading ones. Normally you can expect that you have a 3 months start-up period in US because of all the contracts.

During this period, in US, they have 2 weeks termination time. It's not like in Europe, they have 3 months to quit.

It's normally quite short timelines, which means that you're relatively quick if you have lined people up and you are in agreement and so on, you can get going with your costs, we don't need to take costs extra in advance if we don't want.

Great. That answers the question.

Then I was just wondering about the quarterly sales that you had now. Seems like a record quarter, I was wondering if you could comment on the factors driving it, like if there were any particular countries or activities, and if it was any revenue from the recent Italy tender, for instance?

As we have built our business on a study format basically. That's why we have these fantastic data, and so many data, and so many surgeons publishing data.

That's because we have done it in a way that we provided a study format, and that means it cost us something, and the net profit is not so high. This is a way to get the business rolling until we get reimbursement.

Now it's starting to come, you see in Spain, in Italy, also now we are allowed to do in the public hospital in NHS in UK, you see in Germany, we are not so far away from suddenly get money connected to our code. All is starting to take shape, it is a long, hard work, and it was of course interfered by the COVID stuff, but we are getting there, and we are now coming closer and closer, and it will be more and more real money, to say, and less and less study format.

When you sort of look at our sales figures, the expansion would be dramatically higher of course if we get paid. It would be enough to get reimbursed in Germany, and you will see completely different figures.

It's 12,000 surgeries done in Germany, for example, with the current poor surgeries that exist. This is potentially 50,000 surgeries.

It takes time, it has taken time, but we are coming closer and closer that all the hard work bear fruit.

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

No, I think the increase is because this to sell in a study format cost us money. We have hold down a little bit.

The expansion you see, that's mainly the real money, to say, the real sales of products that is expanding. You see that in Italy, for example, you saw it's quite a lot of different tender wins, and also in Spain the same, we are step-by-step getting there.

Very good. It sounds then that you're expecting this to be some kind of new baseline and perhaps an acceleration for the remainder of the year, or what are your expectations there, if we focus solely on Europe here and nothing on the US?

I think it will be a constant expansion going forward, yeah. Should be.

Good. Then just last question from me was on the InEK hospitals in Germany.

You talked about that you need 200 surgeries, or that you're aiming to do 200 surgeries this year. Suppose then you'll submit those cases, and so just wondering what's the current status, how many have you done, and when is the best-case scenario when you could get it reimbursed, is it from the beginning of '28 or what do you see there?

This is good question. We have actually filed to InEK also now.

We have an application already in with InEK that they should approve it based on the surgeries we have done. We don't know the outcome of that, but there is a certain likelihood that it will be no this year, and that we then need to come back the next year.

All these other organizations, is very difficult for us to promise anything or say anything. It's not sort of in our hands.

We are not so far away from finally getting reimbursement in Germany, if we put it this way,

yeah. I'll take that.

All for me. Thanks a lot.

Thank you.

Thank you. We have several questions from investors, the first one being: now that the submission is out of the way, what are the next go-to-market steps for the US?

If you should launch in a new country like United States is of course many parallel things that happens. The problem a little bit is that FDA is quite strict on that we can't establish the relation with the centers, we can't make agreement with the centers, and we need to follow their rules.

That means what we can focus on is, to say, the scientific side. We can have three presentations from European surgeons with fantastic data.

We have a booth as a huge Congress with 13,000 people, and we meet lots of surgeons who want to start, and we talk to them, but everything is in this framework of scientific work. We could not run to the hospital with salespeople, that FDA doesn't allow.

Of course, we are then doing lots of other things. We are talking with people who really know how to do this, and as we have a team who has brought 10 products to the market in United States before, we are in a relatively good situation.

We do all the groundwork, we prepare people to employ, we interview people, it's many aspects in relation to payers and to how you get coded, and it's many, many aspects that is hard to answer in a short question like this. You can be sure that we're doing everything we can that we should do a real splash in the market when we finally get approved.

Shouldn't you partner with one of the largest medtech companies in the US to accelerate the launch?

Because we know our customers, if you sell something, let's say you sell a CD player, you have no clue who is your customer, and you need to do lots of marketing, and you don't know how to find or try that the person should buy your CD player. We know these centers, we know here we have say it's 1,000 centers, and we know who we should target, and we know who is the key ones, and we know how we should start with, and it's so much easier.

It's better to keep the business in our hands and take the big value increase that we hope will come from this in our own hands.

If RefluxStop receives FDA approval this year, what would need to go right for the company to reach 10,000 annual procedures in the US? What do you see as the biggest obstacles to achieving that?

That's of course a very good question. We are a bit careful with coming with prognosis as a listed company, and we need to do that very, very carefully.

I think I will not give you today any such answers, but there is a reason why we produce 10,000 products to have as a starting point when we launch. That maybe will tell you that we at least don't think we will do 10 or 100 products, we hope that we should be able to do a really good launch here.

I could not at the moment share our business plan with you here. I'm sorry, but I'm sure it will be absolutely good enough this launch.

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

Absolutely it will take some time, but the main delay is the 3 months to do the contract with the hospital and the training of the surgeons. The training of the surgeons you could not take easy in United States.

We only need 100% successful surgeries, we could not allow someone who is not trained enough to do this procedure. Therefore, we will start with around 10 European surgeons who travels over, and they see different centers and we train them.

Then we will do online work. Today, a lot of surgeries in United States is done with robotic surgery, and they have really advanced top-of-the-line streaming, online streaming.

They could be guided by surgeons online to ensure that they really do the right stuff. Then we will build up training centers in United States, we already have around five centers lined up, and I told you all about Professor Lipham who is one of the leading surgeons in US, he has a team of five surgeons doing this type of surgery, and there we will build up one of the training centers as an example.

Because they do, let's say, 1,100 surgeries in 1 year, to do 20 surgeries to be well-trained, that goes very quickly for them. It's not like it takes a long, long time, and thereby we can then establish these training centers.

It's a very expansive process of course, because it will be more and more training centers and more and more centers. The focus initially is 50 centers, the key centers to really establish this.

It's of course many more aspects. One key aspect in United States is to do direct-to-consumer marketing.

In Europe for example, you cannot do an advertisement or TV and say, "Hey, come and operate with RefluxStop." That doesn't work.

In United States, you're allowed to do lots of social media marketing and, if you want, TV, for example, to get people aware of that it now actually exists a completely new, much better treatment for reflux. They will go to all the hospitals and say, "Hey, I heard about RefluxStop.

I want a RefluxStop." This way you create a pressure on the whole system, and it will then be more and more and expanding.

This is a key part of a launch in US is to do direct-to-consumer marketing. It will be a little bit team doing social media, for example.

You need a big effort here to really reach out to all the people. Very exciting, and yeah, you will see it will be very, very exciting process.

Next.

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

that was a really good question again. In Canada, I think it's around 3 months from we file, who is the normal time.

Then how long time the team needs to have everything prepared after you have the US approval, that I can't say, but it's not years of waiting, it's shorter time period. In Japan, it's a little bit longer, and there it depends if they want us to do any trial in Japan or not.

Sometimes because we have long-term data, we have US approval, they accept these data like they did in US now with European data, and the likelihood is probably quite high that they will do that, but we don't know, it's not in our hands. The good thing is in Japan is that when you finally get the approval, you also are reimbursed, they pay you directly correlated to reimbursement, you get paid.

That's of course a very, very interesting market. Japan is around 11% of the world market, it's an important market of course.

Last question. There have been some rumors in forums about an upcoming sale of the company.

Can you confirm this? Would partnerships or mergers be possible in a future scale-up, provided favorable and compatible opportunities emerge?

As I already sold my company once, the obesity company to J&J, and got lots of money for that, but this time we should build something special. This is just false rumors, it's nothing behind that.

I think it was many questions, but it was very much the same questions. It was repeated over and over again about FDA of course, and we are as excited as you, it's fantastic finally.

Just open the champagne and hope for the best, huh? We thank you very much for listening, thank you for all your time, and sorry if I talk too much about things you already know, but I just tried to cover also the new listeners.

Once again, thank you, and have a fantastic evening. Bye-bye.