Earnings call transcript: Implantica Q4 2024 sees mixed financial results

Implantica reported a mixed financial performance for Q4 2024, with a 30% year-over-year decrease in quarterly revenue to €442,000, while full-year net sales rose by 38% to €1.9 million. The company's stock, represented by Impact Develop (IMP), saw a slight decline of 1.09%, closing at $0.184. According to InvestingPro data, the stock is currently trading near its 52-week low, suggesting potential value opportunity for investors looking at the medical device sector. Despite a strong gross margin of 90%, the company faced an increased operating loss and complex reimbursement challenges in some markets.

Key Takeaways

• Q4 revenue decreased by 30% year-over-year.
• Full-year net sales increased by 38%.
• Operating loss rose by 17% for the full year.
• Expansion into over 40 hospitals in Europe.
• Preparing for US market entry with FDA approval progress.

Company Performance

Implantica's performance in Q4 2024 was mixed, with a significant decline in quarterly revenue but a notable increase in full-year net sales. The company's focus on its RefluxStop medical device and eHealth (NASDAQ:EHTH) platform underpins its growth strategy. Despite financial challenges, the company's expansion into new hospitals and progress in the FDA approval process highlight its potential for future growth.

Financial Highlights

• Q4 Revenue: €442,000 (30% decrease year-over-year)
• Full Year Net Sales: €1.9 million (38% increase)
• Q4 Gross Margin: 90% (down from 92% last year)
• Full Year Operating Loss: €25.5 million (17% increase)
• Cash Position: €64.6 million at year-end

Outlook & Guidance

Implantica is optimistic about receiving US FDA approval in the near term, which would facilitate its entry into the US market. The company is also exploring private pay surgery options and considering a potential capital raise to support its US expansion. Efforts to expand surgical centers and enhance clinical evidence continue to be a priority.

Executive Commentary

CEO Peter Forsell expressed confidence, stating, "RefluxStop is unstoppable," highlighting the company's innovative approach to treating acid reflux. CFO Andreas Orenberg added, "We expect the business to continue to grow," signaling optimism about future performance.

Risks and Challenges

• Continued operating losses pose financial challenges.
• Complex reimbursement processes in certain countries may hinder market expansion.
• Potential capital requirements for US market entry could strain resources.
• The competitive landscape in the medical device market remains challenging.

Q&A

During the earnings call, analysts inquired about the company's US market strategy, with executives noting no immediate plans for a large sales force. Questions also focused on reimbursement variability across countries, with Implantica highlighting the flexibility in Spain and Italy compared to the more complex processes in Germany.

Full transcript - Impact Develop (IMP) Q4 2024:

Conference Moderator: Welcome to the Emplantica q four twenty twenty four report presentation. For the first part of the presentation, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing 5 on their telephone keypad. Now I will hand the conference over to the speakers, CEO Peter Forsell and CFO Andreas Orenberg. Please go ahead.

Peter Forsell, CEO and Founder, Implantica: Thank you. This is Peter Forsell here. And we should talk about Q4 twenty twenty four investor presentation for Implantica. And I always have a slide about my background that I have actually done a successful journey with implants before and invested lots of money in this company. And the Implantica has something really fantastic in its pipeline.

And that is that we have developed an eHealth platform. And this platform then will allow to treat patients on distance. And you can control what happens inside the body because the focus of this system is from inside the body. And you can wireless recharge implants and connect the stimulation systems and so on. And to be able to treat people on distance means they don't need to go to hospital as much and it will be much more convenient for the patients.

And we also have a huge patent portfolio because we have gone through the whole body to see how could we now improve healthcare if we have this platform technology, both the wireless and this platform and the eHealth platform. And we actually have spent three years going through all these patents and evaluate them and selected not less than 40 products from 300 inventions. And this will be able to, you know, revolutionize healthcare basically. You will be able to treat better and you treat more efficiently, you will save costs for society. And I have a few examples only quickly here.

One is people who has, for some reason, take away the large intestine, for example, and they have a plastic bag to collect the fecal matter. They don't need that anymore because we can now make storage and openclose emptying function, everything inside the body, and they just need a remote control instead. And this is around 1,000,000 people nearly every year who is operated with this. We also have people who can't urinate for some reason, maybe they are traffic accident or spinal cord injury or multiple sclerosis or something. And in this case, they put in a catheter in themselves every time they should urinate it.

Five times per day, at least, they need to put in a catheter in their own bladder. And that's quite a burdensome life. And instead, with our system, we can empty the bladder with the remote control without using catheters. Just as examples, and implanting actually have so many products and so big IP portfolio that we believe that we should become the world leader in smart med green plants. So we are not shy in our vision.

And the main product that we, of course, are focusing on right now is ReflexStop, especially since we are coming closer and closer to US launch. And before I start with the business update, just a quick recap how RefluxStop works. So existing surgical treatment today has all been focusing on that you need to compress your food passage. Well, you need to try to close by applying pressure. And that of course logically means you get swallowing difficulties, you can't belch and vomit, you get so called gas bloating, you get the standard swollen in your abdomen because you can press the gas down with your saliva and food, but it doesn't come up anymore.

So it's not so well liked surgeries. And implant has then completely new treatment principle. So you don't affect the food passageway at all. The only thing that was needed was to reposition and restructure the normal anatomy in this region. And suddenly the body itself treats acid reflux.

So by ensuring that this splinter, the lower esophagus splinter between the stomach and the esophagus, that that is clearly on distance far away from the opening in the diaphragm muscle, you know, who divides the chest from abdomen, people get treated by themselves. And the reason is that when you breathe, you get pressure variation. You can imagine in the chest breathing, the pressure comes and goes, comes and goes. And this is leaking out through this opening here in the diaphragm called the atos. And that is what affecting the muscle and create the reflux.

So very simple, very genius solution, and it also works exactly as intended. So here you see a little device to introduce it through keyhole surgery. You see the device in the end and a little deployment tool that is associated with it. And why is Novoacid Reflux so important? Yeah, the reason is, it's one billion people have acid reflux.

So one billion, it's enormous treatment field. It's larger than obesity. And it's dangerous to have this acid coming up in your lower esophagus over and over again because that's how you get cancer, to terrorize your tissue over and over again. You know, the acid is burning, causing small menial ulcers, red, irritated. And that's how you get cancer.

And it's forty eight thousand people die from this kind of type of cancer in the world every year today. It's enormous amount of lost lives and most of them are due to this disease. So let's come to the business update. Sorry. So we have really good news for today, actually.

So, you know, we are have filed for FDA approval to sell in United States in three modules. And we have now got the information that module one, that's closed from FDA side. So that that's good. And also we have received feedback from module two. So module one is sort of closed, although they should come and do a formal inspection of the production sites.

And module two, we got feedback who was very, very favorable. The people we have here who has experience of this kind of responses from FDA, they say this is absolute unique. Very, very light and pleasant response from FDA. So we believe FDA really wants this product on the market. So this is really, really good because this module too is the key module.

It's the, you know, 10 times more important than any other module because this is the clinical trial. And this is the basis for everything that you have a successful clinical trial that FDA accepts. So we nearly opened a champagne here actually. So it's absolutely this is a fantastic milestone actually. This is something really incredible because that increased the likelihood that we now will get the FDA approval substantially.

So we are now preparing the response. And because these remarks and questions for FDA are so light, we we talk about a few weeks to prepare this answer. We are also completing the module three, which is the last module to file, and that will also take a few weeks. So it could weeks to a few months, that's sort of the absolutely maximum this could take to to now file. And it hopefully will be in the very near term now we can file the last module.

And that's really, really great news. And why is now FDA so happy with our clinical module? Yeah. The the answer is that we had fantastic results. You have already heard this before, but I like to talk about this because this is so fantastic.

At five years, as of five years of the treatment, one single patient still took medication. This is an absolutely incredible results. It's unheard of such results. And this is giving a little bit indication why likely FDA wants this product to the market as soon as possible because this means something for the patients. And you can see here a comparison at five years.

So it has recently published a huge literature review of our main competitors of the same, NISTEN for duplication, who is regarded as the standard of care in all the guidelines. And there, it has been huge compiling of all the different articles and all the randomized articles has been used. And when you compare to that platform of results for Nissan (OTC:NSANY), you can see here the green lower staples here, they are sort of reflux stop. And it's basically night and day. It's absolutely outstanding results.

So the likelihood that reflux stop will conquer the world and become the new standard of care is quite high. And that's very, very promising, of course. So we are already starting The US market entry preparation, of course. And it's many, many things, you know, to think about here with the business development. We need to do the right marketing, and we need to build up some kind of customer service organization.

It's many, many, many things that need to be done to prepare for US launch, and that's what we are doing right now. And as we have done already a usability trial in US, maybe you're aware of that we had 20 surgeons who was trained on cadavers and operating two reflux stop cases each. And yeah, it's it's, we had a good way here. So we have already these centers that we trained in the Qatar, where they all want to start to do this procedure. And then we have 10 to 20 more who has told us afterwards during the congresses and meetings and so on that they want to start.

So we have a fantastic start here in In US to make a really good launch. And you can see a bit how it went for our main device competitor. That's, as you know, the treatment is not so optimal because it compressed the food passageway. But they still managed to get 400 hospitals in US and more than 50,000 implants. And now it has sort of declined because now they see new better treatments.

But still, it tells you a little bit the potential of The US market. And what we are focusing on right now is three main topics. First of all, we need now to show the cost benefit analysis. Those who have followed us, you know that we have made very advanced cost benefit analysis in many countries today. We've gone all over the world, so to say, to try to analyze the cost benefit of RefluxStop.

And now we are building a new model for The US market, and this is very important for the payers. So with this is in construction an article about this. Also, of course, we need to find out what is the payers, so those insurance companies and so on, who pays for the procedure or meets their requirement. So this is ongoing. We have started with the 20 key payers.

And also selection of hospitals, you know, which hospital should we now select in the initial start here. And this cost benefit analysis, you know, we have the leading surgeon in US basically, professor John Lipam. He is involved in this and he will be the master for this article. So it will be very very important article. And that's very far away in this process as well.

Also, the payers, you know, it's actually in US, you have more than thousand payers, but there is maybe 20 who is the key, maybe 10 who is the key payers who pay for for the surgeries and so on. And normally in US, you can get them to accept that instead of doing their links to reflux stop, that's okay, and you get the same pay. That's why The US market is much easier to target than the European market. In Europe, it's like black and white. Do you get paid or not?

Could you do surgeries or not? Here, it's more a floating process, which I will show you. So we are already starting to talk to the hospitals. We, of course, are not allowed to make any agreement with the hospitals until we have the approval, but we can prepare all the ground because this is an admin process that normally could take quite some time. It could take half a year to get the hospital fully onboarded and trained and everything.

So we by starting this process already now, we hope we should get a quicker, you know, launch when we actually get there. And here is just an example which shows this is a company called Axionix. There is actually many, many examples on The US market, what happens when you get a good, well working medical device on the market. Here you can see they get FDA approval 2018, and here can you see how the revenue expands. And it's 2023, I think they had a value of 3,600,000,000.0, something like that.

And there is other example with even higher valuations and faster and some somewhat slower. But it's just to give you a feeling that The US market is clearly superior when it comes to developing growth. So if we talk about our three pillar strategy, once again, with the superior cost effectiveness, superior clinical data and market expansion, I can show a little bit what we have done here during 2024, because we are now at the fourth quarter. Could be nice to summarize. And you can see here that we have made 36 conference abstracts to leading conferences.

We have 28 presentations, either oral or poster presentation, in leading conferences. We have 22 submitted manuscripts of articles, whereas 17 has been published. We have 11 additional manuscripts already because it's more and more data. You know, more and more surgeons do reflux to open. More and more data pops up.

So already this year, we have certain abstracts and and so on, several presentations. So it's a really hard work to build the platform from where you can make a very fast expansion of this business. So here is one. It was Professor Lipam I talked about before. He hold a nice speech about RefluxStop at this big, huge conference they had in Ohio here.

Hawaii, yeah, Hawaii. Yeah, sorry. So we also have our clinical trials, you know, to really be able to really do this in a quicker way, we have realized we need to have randomized trials. So we have two randomized trials, and they are more or less ready to start now. We have seven ethics approval in the different countries, protocols, okay, and so on.

So it's, sorry, seven submissions and four approvals. Yeah. And we have 12 sites we are working with. So we will, hopefully, we can even start end of this quarter and maybe more realistic in the beginning of next quarter with these trials. And that, of course, will also be a milestone for for us.

We have also lots of real world data popping up. And and actually, the real world data is more or less as fantastic as our clinical trial. It's not that our clinical trial stand out and and the real world data is poor. No. It's fantastic.

So here you see one study from Germany. It's a totally independent regional hospital, not even a university. They operated 79 patients in Germany. And their results is even better than us. So they had also here, PPI use, you know, it was ninety four point nine percent took PPI before surgery and two point five percent after surgery.

So that's approximately in line with our data. And then they had the questionnaire you asked people how they are treated, ten, fifteen questions. Then you find that the median improvement was 100% and mean improvement 92. That's absolutely astonishing. Imagine you have 15 questions and you have score zero to five, which means you can get 75 points.

And to have % improvement on all 15 questions, the patients need to answer zero. And to have a median value of %, more than half of the patients need to answer 15 questions zero if they have any symptoms or any problems. That's an absolutely astonishing result. It's just a dream result basically. And if we then continue on the economic aspect, we have done some further economic analysis.

So we even have done now in Sweden, you know, to show that we have better cost effectiveness. In Sweden, we'd refluxed Optum in any other treatment. And we also have made it in Italy, also successfully published. And the Italian paper even was selected as the top tier 5% in this East border, the main congress for these topics for payers and the healthcare providers. So we are working effortlessly.

And finally, then, market expansion. Of course, the biggest effort with market expansion is The US part. If you can see that we have done more than 2,000 surgeries, quite a bit more. And we have quite a bit more than 40 hospitals in Europe by now. And we had 50 new hospitals this year.

And as you know, we can have many more hospitals. We can have much more revenue, but we are not taking all hospitals. We are ensuring quality. When you should go to FDA and US, they look at all the data worldwide. We need to control that we only have top class hospitals, centers of excellence that do perfect surgery.

That's why we select the key ones, we train them carefully. So our revenue figures, you don't need to care about. Just be concerned that we now get The US approval, and and you will see how it will develop going forward. So here we have some hospital in Spain. I think this is three centers in Spain.

La Paz University is one of the largest hospital in Spain and also worldwide very famous hospital actually. And we have some more hospital here in in Germany, in Italy, in UK. So we are this is just for the last quarter some hospitals. We're also lacking lots lots of media and and social media attacks, And we have lots of ongoing things everywhere, you know, different activities. I can give you one example here is about the patient here, Philip Perkins, who got the reflux stop and he was interviewed in Radio Yaki, for example.

And I don't know if it has, like, yeah, 800,000 listeners or something like that. And, Chelsea Westmister, it's one of these NHS hospitals. So that's one of the public hospitals in in UK. And they even made their own press release, and and fantastic press release made by them. We are not involved, so to say.

And they, in their own press release, says RefluxUp coming as a revolution, says doctor Gomez. So it's not only we who believe in this. It's many, many others. And we basically see that we have reached the status now. That reflux stop is unstoppable.

This is like a little snowball in warm snow in the mountain, and we are rolling down. So we are very, very optimistic for the moment in the Implantica team, and we are very much looking forward for The U. S. Launch if we now can finalize the rest of the topics. Yeah, then we come to capital market and finances.

I give the word to Andreas.

Andreas Orenberg, CFO, Implantica: Thanks, Peter. Good afternoon or good morning. Activity levels continue to increase over the fourth quarter. Compared to the same period last year, we saw the number of surgeries increasing, but revenues decreased by 30% to €442,000, explained by an increase in free devices for studies. Full year net sales increased by 38% to €1,900,000.

We expect the business to continue to grow. There will be volatility due to order patterns, free devices per studies as well as seasonality. However, to unlock the substantial revenue opportunity, we will require U. S. Marked approval or broad European reimbursement.

The business continues to deliver exceptional gross margins. Adjusted Q4 gross margins amounted to 90%, a decrease from 92% in the same period last year. The lower gross margin is explained by expiring inventory. Full year gross margin decreased to 92% down from 94%. Gross margin fluctuations are expected due to the subscale nature of the operations.

At scale, the exceptional gross margins will provide operating leverage, enabling high profitability and free cash flow generation. The Q4 operating loss amounted to €7,200,000, which is 3% higher compared to the same period last year. Full year operating loss increased to EUR 25,500,000.0, a 17% increase, explained by a fourth quarter impairment of intangible assets, which is a non cash expense driven by a realignment of the product pipeline strategy and R and D expenses expanding year on year driven by minimal capitalization of R and D compared to earlier periods. As R and D activities in 2024 was driven by strengthening the reflux stock offering, which is not capitalized, including FDA submission preparations, usability study and other data collection. Non reflux stock R and D has been further scaled down over the year.

General and admin expenses have also been managed down over the period. Let us turn to the next slide. We have a solid financial position. End of twenty twenty four, we held 64,600,000.0 Euro in cash and cash equivalents. Over 2024, we had a net cash outflow of 22,700,000.0 Euro.

We don't carry any interest bearing debt on our books. Let us turn to the investor slide. In addition to management colleagues, including our founder and main shareholder, Doctor. Peter Frosell, Our investor base is dominated by Swedish and Swiss high quality institutions. We are very grateful for the trust and support our investors provide to address a huge unmet patient need.

Let me hand it back to you, Peter.

Peter Forsell, CEO and Founder, Implantica: Yeah. I maybe can add that, of course, we this year has had lots of extraordinary costs. For example, the FDA process is very expensive, so you can calculate maybe 4,000,000 of extraordinary cost just for your understanding. Yeah. So then I think we have reached the questions and answers section.

And we will see here what If

Conference Moderator: you wish to ask a question, please dial key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial key 6 on your telephone keypad. The next question comes from Chien Shun Li from Pareto Securities. Please go ahead.

Chien Shun Li, Analyst, Pareto Securities: Hi, good afternoon and congrats with the progress. Just have a few quick questions. So regarding The U. S. Commercial preparation activities, do you have an estimate of how much how many sales force do you need and in order to achieve a strong sales uptake?

Thanks.

Peter Forsell, CEO and Founder, Implantica: So for the start up in U. S, we don't need people to sell anything because we have these up to 40 hospitals already lined up. So what we need is training, going there to be there to check the surgeries and so on. And that we develop in regions we are plan region basically. And we have a European surgeon who is working in Frankfurt today, who is targeted to somewhere near get a nice package for him.

So he can then train surgeons and they can go to this hospital and and be teach and so on. So we we are preparing different matters so this should be efficient and I don't think it would be a large expensive organization for the moment. It will be reasonable. But of course, we need to do some activities here to get to a fast expansion in U. S.

That's clear.

Chien Shun Li, Analyst, Pareto Securities: Okay. Thank you. And regarding the European reimbursement, could you provide a little bit more flavor on maybe which country is so far the most advanced? Because I understand you are trying in from multiple channels putting the effort, but it's not a so straightforward process. But if you can provide some details on the progress, that would be great.

Thank you.

Peter Forsell, CEO and Founder, Implantica: Yeah. So the problem we have there is that every country is different. And if I take, for example, Spain and Italy, where we today have 22 hospitals just in Spain and Italy, there it's like a budget system. The hospital apply, could I please operate surgery reflex stop? And then they get, okay, you get paid for surgery reflex stop.

The next year they can ask, could I get paid for 50 reflex stop? And so on now. And more or less all these hospital are now applying because we have several hospitals as you know who has got paid for their device in Italy and Spain. So now it's all these hospitals is applying to get paid and more and more get paid and this will expand over the coming years. So I'd say maybe it takes three years to have a full coverage here with with lots of hospitals getting paid.

But it's a process. It gets more and more If you take a country like Germany, that it's the total opposite. There you have something called DRG, that's to say, you have a certain surgery has a certain number. This number gives you a certain amount of money. You get nothing else.

If you are not part of that system, you are lost, so to say. There is no extra money. Nothing to say. No, no, I want this or this in a budget system. No.

You need to be in that DRG with a certain amount of money. We have then in Germany managed to get our own DRG. We have our number, we have everything registered, we say fantastic, but we just don't get paid enough. So it's too small amount we get paid. So in this process, we are done working.

It's something in Germany called eDeck Hospitals. That means it's hospitals who do economic calculation. They send all the costs for everything, for the procedure, everything to eNeck so they can do their calculation what you actually should be paid. And currently, we are the problem with this is that the Enoch Hospital is not so many and very few of them actually are doing reflux surgery in a good way. You know, we also need centers to do this kind of surgery.

So for the moment, we are starting up in a few weeks our fourth center of the e neck type. They need to operate a certain amount so you then can file into e neck and say, oh, look at the figures. We need more pay for our number. But we have the number, we are in the lease system and everything. So it's just a matter a matter of time.

In The UK, for example, NICE is currently doing an evaluation of our device to decide how we should be paid. And basically, it's not a reimbursement decision. It's a medical recommendations decision, but that will follow with the payment, so to say. And there, we have NICE is just evaluating if they are willing to postpone. We have applied that they should postpone the decision a bit because we have five hospitals supplying data, safety data.

574 patients, and that's It's tough work, but most of the work is done. We are coming closer and closer to finally get paid. But you know, when you look at our revenue, as I said before, you can't judge this company over revenue. We decide how much revenue we want. We have prioritized quality, not revenue.

So the convincing the surgical society that we have the best treatment, that's already done. We we did this. We don't need that. We we just need someone who pays for the device. Then it will be someone

Chien Shun Li, Analyst, Pareto Securities: Okay. Perfect. Perfect. Thanks for taking my questions.

Peter Forsell, CEO and Founder, Implantica: Thank you. Thank you.

Conference Moderator: As a reminder, if you wish to ask a question, please dial 5 on your telephone keypad.

Peter Forsell, CEO and Founder, Implantica: Yeah. So then There

Conference Moderator: are no phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

Peter Forsell, CEO and Founder, Implantica: Okay. So here I have many questions. So has FDA visit to production for it has been scheduled yet? Do you have an indication when it might be? We don't have an indication.

Our specialists, who is expert on how FDA works, believe it could be maybe noon. It's we can't save. But it seems like FDA is is favorable to us and our device. Then it's a question, when is FDA approval coming for Implantica? And and the straight answer is, it's not in our hands.

It's it's totally depends on how quickly FDA acts, if they quickly come and do their inspections and yeah. We we we don't know. The only thing we can say is that the first two modules, I guess, there will be nothing really to to discuss because those will be solved. So the only module we have left is the testing module, you know, when we do all these biocomapability. Yeah.

It's, I can't also in relation to FDA, I can't really say any timing here, but we hope it will not be so long. It likely will be in a shorter time period. What is the timeline to get resetting? That's the same question. Yeah.

Swedish healthcare system is that someone has taken the Swedish And they have cut down the resources for the health care over and over and over and over and over again. So in Sweden, you can't get the best health care anymore. It's administrative people who decides what healthcare you should get. It's not it's a disaster, basically. It's, there is no resources for anything.

You should be saved. Save money. Save money is what only thing that counts. That you have a new better treatment that costs something if it's more economic in the long run. Cost.

But they only look at the cost now, and it's admin people who decides. So Sweden is a bit programmatic country for the moment in terms of health. Would an FDA approval, which seems to be very likely now, which I agree, affect the European market and acceptance in of reflux stock. I mean, of course, every step you can take, I think, affects a bit. So if we get US approval or or we get nice to say yes, for example, and so on, on.

Everything will will affect a little bit, so it goes a little bit faster. But we are quite far. So it's it's not that it will take forever now, I hope, to to get this. Then is someone who asked if we should do a broader program for privately funded operations. I think that's a very good idea.

Absolutely, we could probably do quite a lot of surgeries with private pay also. So I think that's a good idea. We're using the Yeah, then it's the question of NICE. And this I have basically answered. Then there's another question of FDA's visit.

Would you prefer partnership in US when launching reflux stop? We actually don't think we need that because we already have made good sales already, so to say. Would you consider selling someone has asked if you would consider selling reflux top and instead focus on all the other excellent products. I mean, we have many fantastic products, and incredible many products actually. But I think ReflexDock will generate so much funds because it has such a high gross margin.

You know, it will be quite a lot of profit when we finally get going. So I think that could be a really good cash cow to have and you should make all these other different products. Very good slides in today's presentation where we download the slides. Oh, that's a good question. I can't answer that one.

Will you be able to keep gross margin this high? Or what is the long term rate? I mean, it's all depending how you, let's say you start a new hospital and they need to train first and so on. Maybe you give them three devices for free. That's, of course, then affects the total gross margin a bit.

But because our product is so inexpensive, it doesn't matter so much for the company. But we have not done that because it affects the reimbursement process and it's not so good. But it's always a possibility that you make it a little bit smoother. But it's we will have a very high gross margin anyhow. Time now for module three, are you expecting if they finish in three months?

Yeah. I think of there is something called hundred day meeting. So I think FDA will make this three months review of module three. And then so totally after one hundred days, we will have a meeting with FDA. And that meeting, they will basically, I guess, tell us that we will be approved or yeah.

So the it's it's we are coming forward more and more, of course, now. Nice. I think I've answered. What do you expect to charge for device in US? Yeah, I mean, in US, the price will be higher.

That's part of the investigation we are doing right now. We are discussing with the surgeons, the payers and so on. And I will come back to that, but it normally the price is higher in US. What is the longer the device has been in place in the patient? Yeah, since December 2016.

So that's eight years. That's a very long time, and it still works. I want to do surgery in Sweden or Norway. Who can I contact? In Norway, we have a couple of hospitals.

I don't have the details on my hand. And the person who asked this question could maybe send an email to Nicole, and we can answer where you can operate in Norway. In Sweden, it's difficult. They have done three surgeries in Sofia, not Sofia Hemet.

Conference Moderator: What? Karolinska.

Peter Forsell, CEO and Founder, Implantica: Yeah. Karolinska. No, no, no. Not Sofia Hemet. You're right.

Karolinska Huikusen in Iesta actually. Iesta Huikus. They have done three surgeries. But then due to economical reasons, although the surgeon wanted nothing more than to do this, they have stopped. So I don't know the situation there right now.

Yeah. Long question here. Someone is asking about potential capital raise. And that's, of course, this is nothing we have decided anything about. But of course, we have looked into how other US how other companies have made a US launch.

And we see that those who have invested a bit more, of course, have been a little bit more successful. So it's a balance, you know, what is the best outcome here. And it could be that you raise some money for a faster US launch that could not be excluded. Yeah, I think I have now answered all the questions. And sorry for taking some time, but I need to read in between here.

And I thank you very much for listening. And I hope I've given you a positive feeling of the future for reflux stop because at least I have a very positive feeling right now. Thank you, and have a good day.

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