Implantica AG

This is Peter Forssell speaking, and I will try to give you a little bit update of what is going on in Implantica.

Let's see here.

So I will start with a little company overview. It's for the new listeners, and it may be a little bit boring for those who have heard this before, but I will go quickly through. So myself, I'm a surgeon, and I'm also inventor of most of the devices we have in Implantica. And this is the second business journey. We also developed a business with the Adjustable Gastric Band, where we took 28% of the obesity market outside US. and implantica has a very interesting developed e-health platform and this is a platform where you'll be able to treat people from distance and the focus will be from inside the body so we will have very nice miniaturized technology where you can control and replace different bodily functions of different kinds and everything could be controlled from the hospitals and you can change the treatment from distance. And that's the absolutely key here, which then will enable us to replace and do many nice things in the body. So we have been sitting three years and gone through how could we now improve health care. And here you see 40 selected products that we believe we can do and improve and make health care better going forward. And this will save lots of cost for society and as well as it will be making more advanced treatments for the patients. I have one example, people who have a stoma bag, they have a plastic bag, collected fecal matter because they maybe have taken away their large intestine for some reason, some disease, ulcerous colitis or cancer or other things. And it's not so nice. You have two to three liter floating substance coming out in this bag and you need to change it. It's self-adhesive on the skin all the time, makes it... red, irritated. It's very burdensome. And this is the product we get most requests from patients every day. Basically, we have requests about this product. And in this case, we are then replacing this stoma bag and we are collecting the intestine down to anus and we can create a reservoir, open and close function and people could get more to more normal life that's the intention with this product we also have product for example now for people who can't urinate they may be paraplegic had an accident of some kind or multiple sclerosis disease and They put in a catheter. Every time they should urinate, they put in a catheter in their own bladder, let's say five times per day. And that's quite burdensome life. We have a solution for that. So you can instead urinate with the remote control. This is just examples to show you that Implantica has a fantastic portfolio going forward. However, it's needed lots of resources for that, and we need to get going with reflux stop to be able to continue with all these different nice products. But we have a very shy vision in this company. We should become the world leader of smart medical implants. And actually, we have the products, we have the patents, we have the competence. It's just about execution and funding. And it's interesting, fascinating journey, I can promise you. Just a few words about Triflagstop before we go over to the business update. So existing treatment for people who has acid coming up from their stomach into esophagus. The stomach has a special inner layer that you can tolerate the acid, but not the esophagus. And therefore you burn esophagus, you get small mini ulcers and it's very painful, burdensome disease. And though the normal surgical treatment so far has been focusing on that you should close, support the closing of the sphincter here between the stomach and esophagus. And the reason that people believe this was weak this winter. However, this is your food passageway. And that means if you try to compress here, you get swallowing problems. You can't get anything up. You can't belch or vomit and you get all the gas you swallow with your saliva and so on. It's accumulated and you get swollen and distended and so on. And people are not so happy with this type of surgery. So we instead find out that there's nothing wrong with this winter. This winter is perfect. It's all about how you create the correct anatomy in this region. So you need to restore the position, original position, and keep it in that position. And you restore something called angle of hiss. That's the angle between the esophagus and the stomach. And our device is then sitting on the outside of the stomach to enable that you... get the normal functional anatomy again. And basically we treat all the three components of the anti-reflux barrier with this device. And here you see how it looks, the instrument and the little device with two and a half centimeter large at the end here. And this works astonishingly well, as you will see from this presentation here. And why is it now so important to treat this disease? The answer is you get cancer. So 48,000 people die from esophageal adenocarcinoma. And according to the literature, most of them is coming from acid reflux. And you can compare to breast cancer. They do anything to find a breast cancer. They do all these mammographies and programs and anything. Here 48,000 people just die and no one is doing anything. It's a disastrous situation and we believe we have the treatment that could in the long run change this. It's 20% of the population we talk about. It's 17% of the population in Europe and 20% in the United States. They have acid reflux. And if I took a gastroscope and endoscope and I just put down in the stomach of anyone who has this disease, I will find that 10 to 20% has pre-cancerous changes. That's instead of 1 to 2% if I do within the normal population. So this is not to play with this disease. Finally, business update. So far we have done more than 1000 surgeries in Europe. We have more than 35 hospitals and it's going very well for Implantica, actually extremely well. And we have submitted our second module in our PMA to FDA. to get approval for selling also in US. This is the most important of the three modules we are supplying because it includes all the clinical trial, all the effort we have done, all the results of all the hospitals doing these thousand surgeries, everything, all the complications, everything is submitted to FDA. And I will give you a little short recap of the five year clinical results, which is the one who has been submitted to FDA. And you can see here that everybody took drugs before surgery. There is a drug called PPI who reduce the acid in your stomach. The problem with this drug is it has nasty complications long term. So it's not pleasant to take this drug for the rest of your life. And if you compare Before and after surgery, you can see we had one patient out of 50 who took PPI after surgery. At four year follow up, we had 44 patients left. We had two people died from COVID, one disabled with long COVID, bed bound and so on. But anyhow, one single patient needing to take drugs, that's an absolutely extraordinary result. There is no literature, no treatment whatsoever who even come close to this type of treatment. And here you can see when we compare to standard of care, this is five year results and there is published a very, very comprehensive literature review of standard of care, missing from duplication. And it's from Karolinska Institute. It's very, very seriously done. They have looked at all the randomized articles, the high quality articles. They found 63 randomized articles. And here you see the results of that. And then you see in comparison our five year results. So this is like an indirect comparison, which is not super accepted, you know, when you do research and so on. But in this case, because it's such an extensive literature review, you can see this as the platform for this treatment Nissen here. And you can see this is like night and day. It's a sort of no comparison in outcome here. And you see like 40% have difficulties, belch and vomit, for example, or 29% has swallowing difficulties after the other, the Nissenfront application, for example. And if you compare to our main device competitor, this is now Links, a device who is on the market since a long time, since 2012. It's a magnetic band that you place around the esophagus. And here you can see how we compare their FDA trial with our CMR trial at one year. because this is the most serious research done on Lynx is their FDA trial because that's rigorously controlled and so on. And you can see it's again like night and day. If you compare the pH, so you measure pH in lower esophagus over 24 hours, which is the most objective measurement we have for this disease, you see that 36% still fail this test with our competitor. And you see that 68% had swallowing difficulties called dysphagia. So again, we are presenting a revolution in the treatment of acid reflux. We are then starting to do some market entry preparation in United States because we hope that it will not be too far away until we can enter the US market. And here you see a little bit, we have already have a great interest from surgeons. You know, we go to exhibitions, we have had a cadaver training in US, so we had 10, 20 centers and we have already a fantastic interest in United States. We have more or less done all our marketing we need to do to select 20, 30 leading centers in US to start directly after launch, which is also fantastic. And we have actually decided to develop United States in six region. We are preparing for how we should do this. If we now get the FDA approval, you need to be very careful what you say here, because FDA really don't want us to talk about any commercial activities before we actually are approved. But here you can see the comparison. I have Great Britain and Germany here as sizes just to compare how huge you actually, the market is here in United States. and we have also very heavily investigated how our medical devices have succeeded in united states how they have done it how it has gone for them and if you take our main device competitor they have so far sold 50 000 devices of their device we have another device here it's inspired it's a device for snoring it's like a little mini pacemaker you put in so you stimulate so you don't store anymore And here you can see how they are developed. It took quite some time. They were a small company. It took some time, but they have expanded like crazy. They have today a market value of 8 billion US. So it's really going well for them, even if it took some time in this case. Here I have another example. This is Ionix, another device. And here you see the expansion went much faster. And we have, of course, studied very carefully how they have done their market launch. And you see that they sold 400 million within two years. third year. And they have today a market value of 3.6 billion in the United States. This is examples of success stories. And I'm not telling you, of course, that we will become such a success story. That's beyond my right to do. But I'm just showing you how it could go if you're successful in the United States. We are also doing lots of other activities in the United States. Here you see the American Foregold Society. Foregold stands for this region where you have reflux. And it's a meeting with like six, seven hundred thousand doctors from the United States at this meeting. And here you see some people listening to the reflux stop session here. And we have a fantastic, it's incredible interest from the US audience. And that's, of course, pretending on these fantastic results, because it's not only these results from the sea study now have been made available for the public. It's also lots of different centers from Europe are presenting the result one after another. And this create they have the same fantastic results, basically every center. And that's why the US, they are eagerly, eagerly waiting for this product. Here you can see our user meeting, the third global annual reflux of user meeting. And here you can see it's more than 100 surgeons are spending one day extra for us. They come and spend one day, they get full day of training all the different centers present the results there is lots of discussion interaction and of course a nice dinner and this day they spend here with us just because they are so eagerly interested in this device we also have wc on this on the slide before oh sorry on this slide you see here also to the right we have developed a new very advanced training program and this is professor seten who is presenting a bit the locums bottom suture we are making here in this end i just wanted to show you how we then have developed a really advanced training program so we are really prepared for training all these surgeons. So this will be an online system and lots of videos and other interesting stuff for the surgeons. So I talked about the other clinical data, and that's also what is making it so fantastic with ReflexDop that it's not only the very controlled CE or FDA study, it's also all the other centers who present. And we are then visiting all the big congresses and the different surgeons are presenting their results. And we have so far this year, 75 conference abstracts presented at these congresses. We have more than 15 published manuscripts. So and lots of things in the pipeline. It's like a snowball effect. You put a little snowball, you know, on top of the mountain and it's warm weather. That's the little bit the effect we have here with all the research, all the articles coming up for this product. And it's all fantastic results. We have published our four year results, of course. The five year is so far only supplied to FDA, but it's presented at the Congresses. So if you're interested, you can go in and read about the four year results in endoscopic endosurgery. This has been published and it's lots of very, very high renowned art or magazines you know repetition high repetition sorry for my english it it's very highly regarded magazines so you have swiss medical weekly for example that where dr nissen published his results 1956 could you imagine this magazine has been since 1956 And it's very regarded magazine. Nature, the same, the scientific reports have very high ranked article and so on. So it's lots of stuff coming up, all from independent hospitals, centers who present their own result, independent from implantica. We also have our studies ongoing, so we are doing our randomized trials. We have a Pan-European Registry study we are doing, and we have 80 committees supplied and approved in many, many different countries now. And it's all, we are step by step, so to say, working in one direction to prove this is by far the best you can get. So the randomized trial between Nissen and reflux stop will of course be very, very interesting because if we can in a randomized trial could prove that we are the better treatment, that's of course will open many doors for payers and reimbursement and so on. So this is Professor Schopman in Vienna who is doing this study. He's the central hospital. And then it's of course many other hospitals joining. So if we then look at cost effectiveness, but today's world economy is also very important. Also here we have been extremely successful. So we have made individual analysis of the cost benefit in all these different countries. You see the map here and we have published it and that got published in highly respected magazines as well. So we have proven now that we save so much re-operation and so much complications, so it's worthwhile to invest in a reflux stop treatment. That's basically what you can say. It's even more cost-effective than drugs, although the drugs cost very little money because it's so much side effects with the drugs. And that's, of course, very, very important. Then we talk about... the market expansion. I will give you some example how fantastic the interest for this product is. So we started one and a half year ago in Italy and we invited people to come to a user meeting and take one day off and only spend it with us. And 21 surgeons came to this meeting. We have in Spain 23 surgeons from 17 hospitals, one and a half year after launch. And they spent two days with us, Friday and Saturday. And Saturday it was live surgeries going on and they could see the operation live. Incredible. So it's absolutely incredible interest for this new treatment. Also, as I showed you last time, we have made really some nice marketing campaigns in the UK and Italy. Here is an example from Spain, Madrid. And it's one out of five person have this disease. Imagine one out of five. So when you manage like this to get press and radio and magazines and all these things writing about this, it's so many patients who contacts the hospitals. It's just incredible. So it's, you can imagine one out of five have this disease. So, The conclusion of all this is that reflux stop is unstoppable. And I will then give the world word to Andreas, our CFO.