Ladies and gentlemen, welcome to the Implantica Audiocast with Teleconference third quarter 2022. For the first part of this call, all participants will be in listen-only mode, and afterwards, there will be a question and answer session. Today, I'm pleased to present CEO Peter Forsell, CFO Andreas Öhrnberg, and VP IR and Operations Nicole Pehrsson. Dear speakers, please begin. Yeah. Good afternoon. My name is Peter Forsell, and I will start to give a little short overview of Implantica before we go into the updates. Implantica is all about bringing advanced technology into the body. Myself, you can see on slide three a beautiful picture. I'm a surgeon, and I have invested more than SEK 1 billion in Implantica. This is not the first journey. We once developed adjustable gastric band and had a very successful business with that, the whole gastric banding business peaked at 42% of the worldwide market share with this surgery, which is quite astonishing. Implantica has developed two platform technologies. We have one e-health platform where we will be able to control treatment at distance, monitor what happens inside the body and change treatment. We also have a wireless energizing platform where we can energize implant through intact skin which makes it possible to use an implant for a long time, not limited by the battery size. e-health will revolutionize healthcare. This I can more or less guarantee you. It will be possible to treat diseases that was not maybe possible before or treat them in a better way, and you will be able to save cost. Treatment will be closer to the patient. Patient will be more involved in what is going on. Our e-health platform treats from distance, and that's a fundamental breakthrough in the e-health market. The physician can monitor what happens inside the patient's body, how it's going with the disease, how it's going with the treatment. He can check and change treatment on distance. When this platform technology will be released, it will be a total breakthrough, and this will open up many doors for more advanced treatment and better treatment. We will be able to collect lots of data, of course, relating to that. As you all know, data builds value. It could be used for medical analysis, market analysis, and many, many other things. This is quite important in today's climate. Implantica has then based on their platform technologies gone through the whole body to look for suitable applications. We have been able to make nearly 2,000 patent cases, more than 300 inventions. We have been sitting two years to go through all these inventions and selected 40 what we believe really strong implant product candidates. That's the background. That's the platform for the future potential of Implantica. That's why we have a vision which is quite high. We should become the world leader in smart medical implants. We have the mission to provide implant solutions to millions of patients and save cost for society at the same time. Before I go on with the background, I thought it was quite suitable to mention that Implantica has been selected as the most innovative medtech company in Central Europe based on the Healthcare & Pharma Awards 2022. That's quite astonishing, and it endorses that we really are doing something special in this company. Our first product on the market is, of course, RefluxStop, which treats acid reflux. This product has all the attributes to become the new standard of care in a treatment area with 1 billion sufferers. That means that Implantica has here a multi-billion dollar opportunity in our hands. Here it's all about execution and doing the right things. Previous existing surgery for acid reflux basically all have been treating the symptoms. Focus has been to try to close the ring muscle between the stomach and esophagus to hinder fluid coming up. However, the problem is that this is people's food passageway. That means you get swallowing problems. You can't belch. You can't vomit. You often get gas bloating because you are able to maybe get something down, but nothing comes up, so you get distended and swollen because of all the air you swallow when you swallow your saliva, for example. Instead, RefluxStop treats the cause of acid reflux. What we find out is that it's not the muscle that close, the ring muscle or sphincter that close above the stomach to hinder acid coming up. This is not weak. This is just about the position. It needs to have the right original position. You need to restore the original physiological anatomy, and thereby you treat the disease by itself. The body treats the disease. The only thing we need to do is to restore the position and maintain it. That we do with our little device sitting on top of the stomach, invaginated and we pulse to reduce complication. That's a real breakthrough in this treatment area. Now we are all the way to slide 14, and here you can then see the results of this treatment compared to the main device competitor for Johnson & Johnson. In this case, we have the LINX FDA trial compared to the RefluxStop CE Mark trial. You can see that the results here, they are not small difference. This is like night and day. If you take the first column here, where you see that we measure pH in lower esophagus, and we do that over 24 hours, then you see that 42% of the LINX group failed that test. This is ten times more failures than in our study. At the same time, you can see that 68% had something called dysphagia, which is swallowing problems. That really tells you that it's impossible to compress the food passageway so much to avoid acid reflux because you can't swallow anymore. It's just not compatible. As the reflux is even more serious disease than people normally think, you can of course understand that you get acid coming up and it gives you big pain, but it could also cause cancer. If you have repeated acid reflux, it should clearly increase the risk of cancer. Forty-eight thousand people only in Europe and United States die from esophageal adenocarcinoma. Most of these cancers is believed to be caused by acid reflux. It's the drugs that you take to reduce this acid, they do not protect you from the cancer risk. When you look in the literature, it's very conflicting messages, and it's absolutely no proof that drugs at all affect this cancer risk and all these deaths. Let's then go to the business update here regarding RefluxStop. Here I show a little bit how you step-by-step are launching a product. You need, of course, to find the key opinion leaders to train them and have them to start the message. It's like you find 100 very important KOLs, and they go out like 100 messiahs for this treatment. Of course, you need to make patient aware of this, and patient satisfaction is of course key for the whole process. We need to then, of course, have the doctors, the medical doctors, general practitioners. They need to be informed so they can send the patients. Because current surgery has declined a lot dramatically because the results are so poor. Now they need to know that suddenly this is something that is much better, and they need to start send patient for surgery again. Finally, we need to get sufficient reimbursement. We need to get all the healthcare systems and insurance companies in different countries. They need to pay for our device. That's sort of the key for any great business expansion. You see here to the right, the little rocket here that shows you what happens when in the key market will have the reimbursement. There is still place in this little rocket here to join this journey. We can say that it's three pillars that define the strategy to now establish RefluxStop as the new standard of care for acid reflux treatment. The first thing is, of course, we need to have superior health economics. Our device need to be more cost-effective to give better value for money than existing treatments. In this respect, we have then get very, very far because we started very early with York Health Economics Consortium, has made a very advanced model for healthcare, health economic analysis of RefluxStop. They have actually compared RefluxStop with the standard of care fundoplication, with magnetic augmentation, and with drug therapy medical PPI treatment. They found when they analyze something called incremental cost-effectiveness ratios, ICERs is the definition here. This is the standard how you value new treatment. They find basically that we are superior to all these other treatment options. We are a better treatment option compared to the other therapies based on quality of life outcomes. That's of course fantastic results, and that will mean a lot because this will be considered by governmental bodies and insurance companies going forward when we should achieve this reimbursement process. We presented these fantastic results here at the biggest congress for payers. Healthcare payer organizations like different countries, some countries, it's insurance companies, in other countries, it's more government-controlled healthcare. All these payers, they basically go to this big congress ISPOR. It's several thousand attendees at such a congress. We have then presented two abstracts, one on the cost-effectiveness and one on the budget impact, which is minimal with our device. It's what is happening now going forward and is already ongoing is that this model that University of York now has developed, we will apply that model to many countries. Now this was for UK, and we are now updating with current values for different countries. This is of course mainly the same. It's just some, what does the therapy cost in different countries, which vary a little bit, for example, and so on. We are repeating that, so there will be, you know, cost-effectiveness analysis, for example, for Sweden and budget analysis. They like very much in Italy and Spain, and so on. This is an ongoing work. We have employed a new employee who is super competent in these exercises, and we will present for country by country how our device is a way to increase cost benefit in the treatment. The next of the pillars here is the clinical evidence generation. We need to show clinical data that we are better than the competition. Sorry. I've been a little bit ill lately. Here you see a little picture how RefluxStop was presented at the European Foregut Society. The question is, what is then foregut? Foregut is basically the organs comprising the twelve-finger intestine, the stomach, and esophagus. That's what it's all about. Mainly you can say that this is the surgeons who do reflux surgery. That's the dominating area of this Foregut Society. In Inselspital, the largest university hospital in Switzerland, they gave a presentation on RefluxStop, and their overall conclusion comparing their data with our fantastic SEAMOCK study was that the outcomes were similar, and they said, "We believe we can show here that also in the real-world hospital setting, these really excellent results could be repeated." This is the most maybe important meeting for these type of surgeons. Here I show you a little bit of the other presentations we have made during Q3 and Q4, just for you to understand that it's lots of activities ongoing. Here is lots of congresses, and this is different surgeons and professors who is presenting their results and all of them have really, really good results with RefluxStop. Here you can see a little bit what type of congresses we have attended. This is between July and today. You can see we have been at 15 different congresses. A couple of them in U.K., one in U.S., three in Germany, two in Sweden, and so on and so on. We are really increasing our activity level to spread the news. Now it is something that really works for this poor patient category here. Solid evidence generation, you know, that will support the market access as in this second pillar we talk about here. It's many surgeons right now who is writing articles about their results, and it will pop up a number of articles already this year and at the beginning of next year. We are also launching, as maybe you're aware, our registry study, so we have six centers of excellence from three countries. That is the minimum target and starting point for this study. On margas, we are quite far in discussions with Ersta Hospital to join this study as one important center. We are also developing this multinational randomized controlled center, where we will be basically select which patient should have RefluxStop or which should have standard of care by lottery, basically. We are working closely with both the payer authorities to get feedback on study design outcomes to really meet what they need to approve the product and be reimbursed to really pay for the product in real-life practice. It's a multitude of publications ongoing here. It's already one published in the U.S., RefluxStop therapy, a new minimally invasive technology in anti-reflux surgery. One European article from Hirslanden has already been submitted, and there is a multitude of other papers ongoing. As you're aware, we had a meeting with the 10 key opinion leaders here in Europe, and we have made a consensus paper regarding the standardization of RefluxStop surgical technique. This is now for the final review phase, to be later and soon to be published. If we then go to the third pillar in our strategy is, of course, the market expansion. Market expansion could, of course, be that you expand in markets with existing regulatory approval. I'm not so good at telling you the slide number, but now I'm at slide 30 here. For example, in U.K., we have got Spire Manchester Hospital to begin operating with RefluxStop. The good thing here is that Spire Healthcare Group is the second largest provider of private healthcare in the U.K., and they have a network of 39 hospitals and eight clinics across U.K. That will going forward, be a very powerful partner for us. We are also expanding in Spain, where we have the first hospital in Spain now wanting to start and buy, and therefore we need to go through the so-called bidding process, because in Spain, it's all about bidding. Even if you are the only one who can supply the treatment, you need to have the bidding process. That's ongoing. We have a rather large interest also in Italy. It's actually a large number of hospitals in Italy is interested to start with RefluxStop. We have the most maybe important center in Europe. The former boss of the European Foregut Society is working with us, and we have started to negotiate the terms with the hospital, so we can start with RefluxStop. Of course, another step here is now to increase not only the market within the approved territories, but also get regulatory approval in additional markets. Of course, then United States is, of course, the key place. We are working right now on Canada, who probably will be the first market where we can enter, and the process has started in Japan. Of course, our PMA application in United States, where you maybe are aware of that, they approved that they use our European data, which is, of course, fantastic news. We are preparing now a final little pre-submission to receive additional input from FDA on the last open issues before we file the final PMA application. United States will, of course, be extremely important market for us. That could not be underestimated, the U.S. market, basically. We are very much looking forward to that. We also attended in the U.S. market, slide 32 here, the American Foregut Society conference. We had a doctor from Hirslanden, Professor Zehetner, who presented his excellent results. As you know, we are cooperating with Professor Lipham from University of Southern California, who is maybe the main anti-reflux surgery person in the U.S. He has supported us to help us with his FDA results, and then he is part of that. He says that he has never seen such important marketing effect as we have achieved with RefluxStop. He says he has patient coming to him and want to have RefluxStop surgery, although it's far away from U.S. yet. It's really going very well, and the news are spreading both through social media, on the congresses. Also, we have articles published in U.S. We will continue to work on payer and marketing, and we will attend maybe another four congresses next year. In the other markets, this is just a summary of what we are targeting right now. We, of course, are working our key markets here, like, you know, the whole DACH region and U.K. Sweden, Norway, we have Norwegian center who is now going to start, as well as hope for the Swedish centers. It's improving step by step now. The really big weak situation we have after COVID, when it was a big waiting time and no one could really do anything else than just trying to do cancers who has been waiting and so on. That's starting to be a little bit lighter. It looks promising going forward. Then we are expanding, of course, to France as well. We will do the RCT. Important centers will be working with us in France. So far, we have five centers who want to join the RCT in France. As we see it, RefluxStop is unstoppable. This is just a question of how long time it will take, but we have all bold attributes to become a really important player here. We have the capital market and finance section, and I wanted to give the word to our CEO, Andreas Öhrnberg. Thank you very much, Peter. Good afternoon or good morning also on my side. I have the pleasure of sharing a brief financial update. Let us turn to slide 36. Figures in this slide are expressed in EUR thousands. I will comment on the upper graphs exhibiting our Q3 performance. We recorded net sales of SEK 195 thousand for Q3 2022, an increase of 135% compared to Q3 2021. As a reminder, we are currently solely marketing our lead product, RefluxStop, and still only selectively engaging with key opinion leaders and their clinics as part of our market access strategy. Our business development colleagues are very happy that after a long and challenging COVID period, now fully being back on the road, engaging surgeons at conferences and at their clinics. As Peter mentioned, the level of interest that we see from the KOL, from the KOLs is very significant, and we expect these key KOLs to be the base for building the commercial success. Moving to gross margin. The gross margin levels that our lead product, RefluxStop, has delivered quarter after quarter are highly attractive. Adjusted gross margin for the quarter amounted to 94%, three percentage points lower than Q3 2021. Period-on-period volatility is expected considering the current subscale volumes. The combination of exceptional gross margins and no limitation to scaling RefluxStop production underpins the opportunity to generate long-term future profitable growth and free cash flows. EBIT. Our quarterly operating loss expanded to SEK 4.6 million, up from SEK 3.9 million Q3 2021. The year-on-year OpEx increase reflects the transformation we have gone through over the last 12 months, where the company has been focusing on capability building in the areas of commercial development as well as quality and regulatory. We see these capabilities as key for successfully scaling the business. Investing in R&D, both our pipeline products and the eHealth platform, as reflected in OpEx and CapEx spend, remain a key priority. Let us turn to slide 37. We are fortunate to have a very solid balance sheet. End of September, we held SEK 118.4 million of cash and short-term investments. Short-term investments relate to term deposits with a tier-one Swiss bank. Hence, we are not exposed to financial market risk, and we do not carry any interest-bearing debt on our books. Let us turn to slide 38. In addition to our founder and main shareholder, Dr. Peter Forsell, our investor base is dominated by Swedish and Swiss high-quality institutions. We are grateful for the trust and support we receive from our investors to scale the business to address the huge unmet patient need. With that, I would like to hand it back to you, Peter. Thank you very much. Yeah. I think it's time to hear if anyone has any questions. Thank you. Ladies and gentlemen, if you have any questions for the speakers, please press zero one on your telephone keypad. We have a question from Christian Lee from Pareto Securities. Please go ahead. Thank you and good afternoon. Thank you for taking my questions. I have a couple of ones. The first question, could you please give us an update on the status of the PMA application, if you have encountered new situations making the application more complex and when you expect to submit it? You know, United States and FDA, they have a little bit different approach than they have in Europe. If you have a device, medical implant in Europe, and you, for example, tell the surgeons that you can use a suture here to put it together, or you can use a little bit gel to make it easier to introduce it into the body, that's not part of the approval. The gel has its own approval process. The suture has its own approval process. In United States, they say our product is a system. Our product should include the gel, it should include the suturing and so on. Which means that all the tests and biocompatibility tests and all these things you have done in the past for Europe, they now have to be repeated with a little bit of gel on the device, with the suture on the device and so on. That is what we have been doing to prepare for this PMA application. We have been advised by our big advisors, Hogan Lovells, that it is a little bit safer if we do another small pre-submission to clear any outstanding issues, to clear that we are doing exactly the right thing, what FDA expect from us. Especially since we got so favorable treatment from FDA, it's better to get things off the table that could cause any delay going forward. That's what we are doing right now. We are in the process now of filing that, and that will take an additional 3 months before we get our answer on that request. We will not be able to file this year for any PMA, but our target is to file during the first half next year our PMA applications for approval. The normal waiting time for FDA handling time is 10-12 months. However, that's then depending that everything goes, you know, is as planned and that nothing pops up. Nothing in this area is 100%. It's just about likelihood. It looks quite promising that we then will be able to get our approval, let's say first half 2024, if everything goes smoothly and if no new obstacles occur. Yeah. Thank you for clarifying the time schedule. My second question is regarding your expansion strategy. Your current business strategy is to focus on markets where you have existing regulatory approvals. Given that you're close to submit the PMA application, how will you approach the U.S. market? Are you planning to be more proactive in the U.S. by building a sales organization there, or will you wait for the approval first? We have already, of course, as I said, started with the whole marketing machine in U.S. We will do our best to get patients and surgeons. They should all be prepared and longing for RefluxStop to enter the U.S. market. That's our key, and that we are working very hard for, and we have been extremely successful as well. Of course, in terms of sales, we need to have a match so we can get a nice sales organization when we finally get ready to sell. There is two options for that. One is, of course, the organic growth. The good thing with U.S. employees is that they normally have very short termination time. They normally have, like, two weeks. You can then agree with salespeople and people you want to employ that they are sort of on the standby, and then you press the button. Then you see when you finally you get there. It's also a possibility to acquire a company with a sales organization that maybe then doesn't make any loss. Then you can be even earlier, and you can prepare in advance for such a purchase, basically. We are working on both these aspects to see what we can possibly achieve. Okay, thank you very much. My last question. You recently presented a health economic study for RefluxStop, showing superior cost-effectiveness, compared with the existing treatments. I was wondering if it would be possible to refer to the study when discussing reimbursement levels in the U.S. Absolutely. I mean, this is sort of key. As I said, this is number one on the three pillars I outlined to really get a successful reimbursement here. This will be repeated. You know, the York Health Economics Consortium here, they have put together this very, very advanced, very complicated model for doing this work, you know. This is based on sort of standard of health economic analysis that they have used. We can then use the same platform, and we can just adapt and introduce the cost for different countries. You know, different countries have bit different cost levels and so on. What we are talking now is to do the same model for many different countries. It's two different models. It's sort of one for the cost benefit and one is for budget impact. This will play a very important role for getting the approval for the payers to pay. This is one of the most important factors we have. That we have these fantastic results, that's incredible, basically. Yeah. That's great. Thank you very much. Thank you. Ladies and gentlemen, just a reminder, in order to ask a question, please press zero one on your telephone keypad. Thank you. Ladies and gentlemen, if you wish to ask a question to our speakers, please press zero one on your telephone keypad. There are no further questions. Dear speakers, back to you. Thank you very much. Now, we would like very much to say thank you to all who has listened to us and who follow us and we really appreciate your support. Have a really good day. Thank you.