Hello and welcome everyone. Good afternoon. Welcome to Episurf's second ever Capital Markets Day. We're here at the Redeye Studio. I'm here with my colleagues, board members, and I would also like to say welcome to all investors and other stakeholders who are watching this live or in the room. We have a couple of hours ahead of us, and I think we will stick to this timetable reasonably well, which means that we will end up at about four o'clock this afternoon. If you have any questions throughout the afternoon, please send them to our email address at ir@episurf.com or use the function at the website at the redeye.se.
I will start and provide you with an update on our strategy and where we are at the moment, and the team that will help me during the afternoon is Professor Tim Spalding from Cleveland Clinic in London. Tim has been with Episurf for many years now, and in the last years he's been really focusing on the clinical studies of the Episealer device. Dr. Clemens Kösters from Greven in Germany is a friend of ours since his first surgery in 2016, and he will speak about the role of the Episealer implants in his clinic, and he has been helping many patients in the Nordrhein-Westfalen area in Germany, and I think you will find that presentation quite interesting. Katarina Flodström, you've met before. She's the COO of Episurf, and she's been with us since the start.
Since January, Steve Caswell is the head of sales in our non-US markets. He will provide you with an update on our strategy in his regions. Patrick Jamnik joined Episurf Medical a little bit more than a year ago, and he's running our US activities, and he has an interesting presentation focusing on the US strategy later on. First, Professor Leif Ryd. He's not in the room today. He's in Switzerland working at a cadaver lab on our product development efforts, and I'm glad for that prioritization. Leif, it's great working with Leif.
It's been a couple of great years together, and ever since he got this idea around 2017, he's been very dedicated to Episurf, and he still is, and we are all grateful for him taking the step and starting Episurf now more than 10 years ago. We will try to be as clear as possible during the afternoon. However, there are a few abbreviations and industry words, so this slide might pop up from time to time. I don't expect anyone to remember all of this, but we will nevertheless use this just for the sake of simplicity. Getting into it, we'll start with the slide I used more or less exactly 2 years ago at our first Capital Markets Day.
What's been leading up to the situation now in November 2022 is the intense focus on clinical studies and product development that we undertook during several years. At that point in time, we were also looking forward to a potential U.S. launch later in time, which was subject to the IDE clinical trial, our EPIC-Knee trial, that was going to lead up to a PMA approval. We're still committed to that trial, but it has proven a challenge to run it, especially as we started it during the pandemic. We were also conducting a regulatory review of several markets internationally, and the U.S. launch was planned a little bit later on at around 2024, 2025. If we look at what's actually changed since then, and I would like to highlight a couple of things.
On the clinical studies, we did see great two-year results two years ago. Today you will see the largest ever presentation on five-year data for the Episealer. We really added on to what we did two years ago. The IDE clinical trial I mentioned has been a challenge, still is, but we are still committed as I mentioned, but that also means that the timetable has been postponed a little bit for that particular product. However, we have been able to move the US launch earlier, so we're looking at the US launch already in early 2023, and that's due to the product expansion that we undertaken in the last years, and we really kickstarted this during COVID.
We had some ideas on the drawing table, but during the pandemic, and especially in 2020, we really started to make a reality out of our plans, and you will see the results of that today. The regulatory review has also led us to a great number of global commercial opportunities, and we're really now seeing that we can execute on a much more global agenda in our commercial activities outside of the US, as you will see today. Just a little bit of repetition. We're looking at the state of the knee, the knee degeneration, and the age of the patient, and now I'm focusing on our first product group, the Episealer Knee implants. They are intended for the middle-aged patient. They're often 35-65 years of age.
In the middle here, there is a big treatment gap, and we are aiming at, driving the creation of a new category in orthopedics, and we wanna be the market leader in this segment. We come after the early biological procedures but well before the knee replacement surgery. We're doing this on a global basis, targeting a great number of people. Just to give you an idea, in the Western world, about 8% of the population suffer from osteoarthritis in the knee, so we're talking about a big market out there. Early on, our customers and our surgeons have been using the Episealer implants predominantly in the sort of 40 to 50s maybe with a smaller single lesion in the knee.
Later on, we're now seeing that the surgeons are using the Episealer implants also for more complex cases, as you will see today. Again, just as a point of reference, about 2 million knee replacement surgeries are taking place in our target markets every year. This is a big problem. What are we really looking at in the treatment gap? This is a very typical patient, a 37-year-old guy. He has a failed microfracture procedure, a single lesion in the trochlea area, but it can also look like this, a 63-year-old patient with again a single lesion. The patient age-wise is probably a candidate for a knee replacement, but the lesion is the size of a coin, so a full knee replacement would be a significant overtreatment in this case.
It can also look like this, a 44-year-old with multiple lesions. In this case, the patient was treated with 2 Episealers. Look at this one, 55 years of age, a nice tibial plateau. That's the sort of lower part of the knee joint. Too young for a knee replacement and three isolated lesions in the knee treated with three Episealer implants. There are many like this. We see our patients all over the treatment gap, and we know that our customers, the orthopedic surgeons, they really appreciate the opportunity to be able to treat this patient with our solutions, which they didn't have before. Just a quick strategy recap. We've been working quite focused with this strategy for now for several years, and we have generated a significant amount of clinical data in support of our technology.
We've done this on a global basis, and just to give you a number, in the last 12 months, there has been Episealer surgeries in 20 countries, so there's really a foundation for growth in place. Reimbursement has been challenging for us as we are targeting several markets, not only in Europe, but also globally, and the systems are very fragmented between those markets. However, based on the strong key opinion leaders support we have and the data we have, we are now in a really good position to really work through the reimbursement systems, and we saw that in the U.K. most recently with the inclusion in the NICE guidelines.
On our efforts to always maintain a high standard on our technology platform, we're now been able to deliver new products, as you will see today, and we're very glad of that. What we said two years ago was that we were over the long term, targeting a 30% market share in all our markets with the 15% market shares three years after the US launch, and this was then based on the original Episealer implant technology. That's still in place, and as we get the approvals for additional products, I think you should look out for updates on this with respect to each individual product. Quickly on the data, we started off with the preclinical studies showing that this technology could work and be an alternative also in the clinical studies, which we later showed.
We saw some excellent results, and we are now really being able to compare with other modes of treatments for these patients. The technology platform has generated now much more than a one product company. We have a product portfolio being ready for launch in several countries globally, and we have done so at a small scale in many countries. I would remind everyone that the majority of our revenues are still in Germany, but we have been starting to do the first surgery with the first customers in a great number of countries, so there is great opportunities for scale on a global basis. Our customer, who is it really? It is the orthopedic surgeon. The orthopedic industry, just have a look at it.
It's a big market, $54 billion. The joint replacement is part of that, about 36% is the largest single segment. In that segment, the knee segment is the largest sub-segment. During the pandemic, the knee segment was the hardest hit part of all. It's been a couple of tough years, but I think we're coming out of this now in a good way. If you look at the geographies, the US market is the absolutely most important market for us as it is also the single largest market in the orthopedic industry by some margin. Looking at our products and our plans for the coming years, it's important to distinguish between those products.
What we started out was to create a new category of implants in the orthopedic industry by focusing on the focal lesions, the single lesions in the knee. The competition is probably lower as there aren't any really good options for these patients, and there has been attempts with standardized implants for these lesions. They don't really work, so there's not really much competition if you look at similar products. However, the clinical and regulatory barriers to enter that market is probably slightly higher. Same for the Episealer Talus. We won't focus too much on this today. This is our first implant system for ankle lesions, a really interesting market, a great technology, works very well in the cases we've done. Again, a really unique product and not much competition. However, again, clinical and regulatory barriers slightly higher.
Look into our new products, and then you would see that we're targeting the much larger osteoarthritis market. This is our first two-component implant system for the knee, the Episealer Patellofemoral System. As you will see that there's one component for the femoral bone and one for the inside of the patella. The competition is probably higher as this is a well-known concept, sort of implant to implant, and there are other products out there. We believe we will have a really strong offering to potential customers as we are the first truly individualized implant system for these kind of lesions.
On the other hand, the regulatory and clinical barriers, they are on the lower end, and we will be able to get market access in the US through a 510(k), in this context then in easier fashion than with the first product line, as we are going into an established market. Similarly for the greater toe, the Episealer MTP system, we're also targeting the larger osteoarthritis market where there is products today on the market, surgeons are using some of these mini implants for treating these lesions. There's not a clear winner in that market, and we believe we have again a really strong offering, and we can benefit from a 510(k) route to target the US market quite early on as we're going into an established market.
Our markets. Just quickly give you the big numbers. For the first, the Episealer Knee market for the focal lesions, that market is estimated to be worth about $1 billion. The Episealer Patellofemoral market, we know today that the revenues for patellofemoral implant systems in the US market amount to about $75 million. The market is underserved, as there are not too many products like that, and most of these patients, they receive a total knee replacement today. There is room for growth, and we can take a share of the existing market and also the great opportunity that exists as about 18% of all osteoarthritis patients with osteoarthritis in the knee, they have osteoarthritis in the patellofemoral joint. The opportunities are significant.
On the lower extremity side, the potential market for the Episealer MTP system is worth about $400 million in the US and a similar amount in our non-US markets. All in all, we're looking at a potential market of about $2 billion with room for growth. How are we going about targeting these markets? I will start to look and discuss this by looking at the quarterly customer acquisition rate. Essentially, how many surgeons are using our products every individual quarter. This slide is just to give you an idea of whether we've been growing or not. Pre-COVID, we definitely had some growth, but you should remember that surgeons were in the absence of clinical data, often trying out our products.
They did a case or two, and they wanted to follow up on their own patients before they really could start to use it more widely. Then the pandemic hit, so it's been a little bit up and down. Now in the last quarters, we're really seeing strong growth in our customer base. The individual volumes are still a little bit lower than what we would like. However, we are coming out of COVID. The backlogs of knee replacement patients are substantial out in Europe. Again, definitely an improvement, and the last three quarters are looking quite good. The average growth rate during just the last three quarters on customer base is 48%.
We will take a look at that number and see, okay, what could be driving growth in the years to come if we maintain the growth rate at 48%? We will map this out to our existing and future products and also our markets. First of all, the 48% growth, that's generated from our first product, the Episealer Knee and Episealer Talus products in the markets in Europe and some markets outside of Europe. The absolute majority is from the German market. Again, room for growth. If you look ahead in the next year with these products, we will be able to launch in Singapore, Malaysia, and also some additional markets in the Middle East and in Asia and even in Europe.
Over the long term, we are targeting a US launch for the Episealer Knee implant system. However, that's dependent on the success of the EPIC-Knee trial. If you move down to our new products, the Episealer Patellofemoral System, we will open the US market in 2023 for that product. The Episealer MTP system, the target is to access the US market in 2024. Over the slightly longer period of time, we will try and work hard towards launching these products in Europe, Middle East and in the Asian markets. We will, of course, bring this forward as much as possible, as there are great opportunities for these products also outside of the US.
We think there is room for growth in the coming years, and we think we have a strong foundation to work from with the Episealer Knee and Talus in our current markets. As you clearly see on this slide, we will open new markets every year now in the following years with both the existing and new products. I'm not going into any guidance or forecast, but we will make a calculation example just to see what this would generate. If we look at the 48% growth rate that we had now during the year of the customer base, and we are at about 100 orthopedic surgeons who are using our products now on an annual basis.
If you were growing this by 48% a year, you would end up somewhere between 500-1,000 customers. That's a wide interval, I know, but it gives you an idea of where we're heading and how we are thinking about this. The drivers for achieving this is, of course, what I just mentioned, the launch of new products in new markets globally. If we assume a run rate of what we are expecting in the first years of about 7-10 and then later on from 10-14 surgeries per year, at our current pricing, with that customer group, you will then end up with a commercial breakthrough and you see the revenue numbers in SEK million on this table on your right.
This is how we are thinking about the future, about the next years, and how we position our new products and new geographies in this context. Before I move on, I will just leave on a positive note. The first surgery we did in 2012 here in Stockholm, a 57-year-old individual, very active, a small lesion size of a coin in his knee, and he was suffering from severe pain. He was the first patient who ever got an Episealer implant, and at the five-year follow-up in 2017, he was doing really well. I will say thank you and just leave you with his testimonial now when he's coming up at the 10-year anniversary. Thank you very much.
Jag mår jättebra. Jag har full aktivitet. Jag jobbar fortfarande trots att jag är pensionär så jobbar jag 20 procent. Men aktivitetsmässigt så lever jag ett normalt liv. Jag åker rullskidor nu på sommaren och powerwalkar och gymmar och mår bra, helt enkelt.
Thank you for letting me speak and present these results to you. My name is Tim Spalding. I've been involved with Episurf really since early on, and undertaking this surgery. This is partly in Coventry, and then also down at the Cleveland Clinic London, where I'm now based as well. So the focus here is really on the clinical outcomes, and that's what I've been invited to present to you. You've heard that there is this treatment gap between the biological solutions at one end of the spectrum, and then the knee replacement at the other end of the spectrum. That leaves a large number of people who are in trouble with the knee, and we need this treatment option for those patients.
We know the Episealer then has these various options to treat from different sizes and different locations to cover specific lesions on the joint surface. I want to focus on the results that we've undertaken, and this is essentially a study cohort that we've had two year results published, and then now we have updated 5-year results. We have some larger cohort of patients from those surgeons who have been treating patients over the last five years or so, giving more data on the specific outcomes that we can expect. We'll just discuss at the end the reasons for success and maybe the indications where it's gone to now. There have been several publications over the years, the initial preclinical work and then the clinical results that have come out.
The focus here I want to talk about is this patient-specific multicenter study. That's 80 patients in a consecutive series from the surgeons that you can see on the right-hand side of the slide there. Those surgeons have put their patients into this study where we keep the comprehensive data and then can analyze that and look at the results. This paper took the 80 patients, and it's a prospective 24-month outcome study you can see here on that left. It takes the right size defects where biological repair is no longer indicated, but it's a single lesion. Patients that may have had two lesions treated are not included in this. The tibia has got to be good, and the alignment has to be good as well.
We kept the focus data on them pre-op, three, six, 12, 24 months post-op. The KOOS score, which is a specific score that collects questions about your patient outcome, and the visual analog score. These are the two main scores that we're using. That cohort then from 80 gets to 75. Two had revisions, so we don't have the outcome scores because this is mainly looking at the patient-reported outcomes scores. One declined to stay in the study, and two had incomplete data, so we couldn't include those. This wants to be the comprehensive data on the study cohort. Now, you can see then, 59% female, mean age 48, young 27-69. BMI, body mass index, at 28. We need to be careful about that in considering the indications.
Sixty-five percent have had previous treatment, and I think this is important because it reflects on the outcomes, who gets good results. Previous microfracture, failed cartilage repair treatments. Ten on the trochlear, the front part of the knee, and then the rest on the main weight-bearing part. Twenty-five were twin implants, and forty were the solo single implants. That's sixty-five on the condyles. The key results then, this is the different KOOS domains. Now, the knee outcome orthopedic arthritis score is then breaks it down into different domains by pain, symptoms, activity of daily living, then sport score, and quality of life. Over time then, there's different bars here from pre-op, 3 months, 12 months, and 24 months. We see the improvement in those scores, the different domains of the overall functional score improving over time.
This gives us that improvement and gives us a good overview of that recovery matched by the visual analog score, which we want to decrease. We want the KOOS to increase, but the visual analog score for pain, in other words, what pain have you got, to decrease pre-op, 3 months, 6 months, 12 months. That's maintained, showing a slight drop at the 24 months in that group. We've further taken that data and then tried to break it down by the implant type on the side, and the visual analog score by implant type on this right-hand side. This is trying to look at what the difference is, but we've only got a small number of patients here, and at this stage, they don't look to be different.
They may appear the green is a bit higher, which is the trochlea, but it's not a statistically significant difference. It's important that if we can try and understand which patients are doing well and which ones are not doing so well. This was analysis by whether they've had previous cartilage treatment, because that's very important to know if we can help those that have had previous surgery where it has failed. Now, it may appear at the moment that primary cases and prior cartilage surgery, but the range is so big, this does not reach any statistical significance, but it still seems good in those patients that have had previous cartilage repair.
This is something, as the results go on, we need to be looking for. Additionally, in this group, we've had one that got an infection, had to be revised, the implant was removed outside of that 24-month window, and two had arthroscopy for treating ongoing pain, to help them, and one deep vein thrombosis. That is the 2-year results, consecutive series of where we have the 2-year results. Now we've extended out to 5 years in that same group, and we have the first 50 patients who are reaching this 5-year point. At the moment, we have the patient-reported data in 37. Seven we're still trying to collect and chase. One, the same one, withdrew consent, didn't want to stay in the study, and then we've now got four revisions and one had infection, as you heard in the last bit, that's been removed.
That's four revisions out of this group. Now extending that, KOOS score, again, a slightly different way of expressing it. We've got the same domains at the bottom, pain, symptoms, activities of daily living. Then the blue line pre-op and going up afterwards to the 24 months and the 60-month, five-year point. The scores, that functional scores reported by the patient, seem to be maintained out to this time. 3 months getting there, and then the rest it seems to stay the same. This is very reassuring to see those results at that point. This is a similar way of reflecting it. The pain scores going up and staying constant. Activities of daily living. We want a high score on the KOOS. Then the other way of looking at KOOS is to put the scores together as a total score.
The way that's done is you take four of the domains. We actually take out the activities of daily living because that's got such a large number of questions, it rather drowns out the other changes. We have the mean of four of the domains, and then we can see the scores going up from pre-op and staying good out to 60 months. That's a good reflection of the outcomes and maintained over this time. That's also then reflective of the visual analog score for pain. When they get pain, that has come down and stayed down. Now, the subgroup analysis. Again, we're trying to look at whether something makes a difference.
Interestingly, the points from this is the twin implant, which is the larger one in orange, seems to show slightly better scores over the time for that KOOS-4, the aggregate score, compared to the solo. The worry is that if a lesion is too big, then it may not do so well with the implant. The second part on the right here is whether the trochlear or the end of the bone, the trochlear being the front of the bone where the kneecap articulates, whether that is worse or better. It seems on this early data that the trochlear is doing very well compared to the condyle. That's the message from this.
Next, analysis was by defect size, with the dotted blue line being the small lesions, and then orange moderate, and the purple bigger lesions. Again, the message from this is that the larger lesions are doing as well, if not better almost, than the smaller lesions, which is very reassuring because the worry is that too big an implant will do badly. That's gonna be reflected on this graph. Just visually looking at it, the small lesions seem to improve from bottom to top here. The medium-sized lesions improve and the larger lesions maybe improve as well, if not more. There's nine patients in this larger area group. It's the messages that large lesions seem to do well as small lesions.
Now the third bit of this results bit is looking at the overall results from this group. We've taken our surgeons and focused on the first lot of patients that were done. Meanwhile, we've continued doing operations, so now we've got from those six surgeon centers, we've got 186 who have got a minimum 12 months follow-up. This is rolled on, keeping data on other patients. You can see female and male numbers. Mean age, 48. Location, mostly on the medial femoral condyle, the main weight-bearing part, the lateral femoral condyle, the main, again, the weight-bearing part on the outer side of the knee. 17 trochlear and multiple lesions. This is creeping in, whereas before we take it out, where two lesions had been treated. We've now got 10 patients who had multiple lesions.
The implants in range again here. Solo, in fact now more twins, that's the larger implant. Then on the trochlear, they're all solo implants. Then multiple is in the 10 patients. It seemed more twins. The results on the right-hand side, the aggregated, that KOOS-4 again for 186, recognizing that only 45 are out to this 60-month time. We see the improvement in that KOOS score is maintained. This is very similar to the focused cohort that we had where we've got the 37 out to the time point. Putting it in a similar way, going out to 12 months and then beyond, we're seeing the scores improved and maintained over time for the different domains, pain, symptoms, ADL, sport, and quality of life again.
Similar to the focus group, in the general mix, in other words, and the visual analog score of pain coming down as well, maintained over time. This is nice to see that reflected in other patients. This analysis again by lesion. If I just put the other graph up that we had before. Slightly confusing because on the left-hand side, we're looking condyles versus trochlear in the overall group of these 186 compared to then bottom right here, condyles, trochlear in our focus group. Look like the trochlear is doing different, doing better. In this wider group, maybe not so clear it's doing better, but it's certainly not worse. Generally, the trochlear, the patellofemoral joint, the front of the knee, has a reputation of doing worse for some cartilage repair lesions.
On the right-hand slide, the right-hand side, the condyle, the smaller against the larger, they seem equal on the bigger group, but might have appeared better on the larger when we had the focus group. It's reflecting similar things, just diluted down a bit. The KOOS-4 by the size of that treated area, again, reflected they're all improving. Now, there's very few patients we've followed up to the 60 months, so this drop-down here from the smaller lesions is probably not reflecting true difference because there's only small numbers at this point. We mentioned that 10 patients had multiple implants, and the results from those that had 2 implants, therefore, you're covering two areas in the knee and not just the one area, seem as good as those patients that just had the single implants.
It's only 10, but it's not a flat line where those have not improved at all. That's another message from this. Multiple implants, when you see two areas, three areas, then they can be treated. Let's put all these results together then and try and work out what we've said then. We've taken that select cohort, 75 implants at two years, and shown this low failure rate, two at that point. They've had good clinical improvement. We're measuring that on the patient-reported outcomes. As a surgeon, we're happy that this design is accurate and the depth is easy to achieve. You can put it exactly where it wants to be, and that damage reporting and the instrumentation allows us to do that.
Taking the first 50 out of five years, the failure rate is still low, and that is low, 8%, four out of the 50 failed at that point. That is good. There's a variety of the implants and includes the early cases in that series. In the wider group of all those surgeons, again, that improvement seems consistent and maintained over time, and there doesn't seem to be a clear difference between one lesion being better than another or the trochlear or the twin or the solo. All the implants, provided we do it accurately, seem to be consistent in the results. Some of the failures, we analyze that in our knee discussion and work out, well, is there some factor that will lead more often lead to failure or something? That, of course, is the ongoing work.
We think some of the early cases, there was some poor matching for the implant and so less accurate, and that might be an excuse for the failure. Then in other cases, we've extended the indication and really stretched doing it for a larger lesion, and that's what we wanna know. If you do it for a bigger lesion, is it still good? Essentially, we know this works when the indications are good, but what we've then gotta work on is can we push the limit, and can this work on the borderline cases and still get the good results that last, buying time for the patient? Let me finish with some little examples, right. Here's a guy. He's got the damage marking we'd see. We send the MRI scan off. We see that damage marking.
It can be covered by this twin implant. Great. It covers all of that area, leaving that bit not quite so covered. Happy. At two years, delighted with the result, responded well. He can do bowls, 18 holes of golf. That's bowls, kneeling down, 18 holes of golf, getting in and out of the bunkers, of course. He's back to work, outdoor work, and he feels like he can run, so he's loving it, and these are the happy situations that we get. This patient, this is a way of presenting the results. You can see the implant has covered the defect and the individual scores for pain on that one, symptoms, activities of daily living. This is the improvement for that individual patient on the results. He's a happy patient as well.
What he is, he's 43. He's an outdoor active farmer, three-four years history of pain and big problems with his collapsed area on his joint, with pain on walking and has to flick his leg out straight, so he doesn't take weight on the bent knee. It avoids taking that load on the painful area. Getting some imagery here that we've got this. The MRI scans, you can see this damaged area. We can then fill that and cover that with the mini metal implant to then take away that pain on walking from this damaged bone marrow area. Operation pictures, warning. There is the damaged area, knee open on the medial inner side, right? Then using the 3D printed guide, accurately placing in exactly covered position.
It's amazingly stable when that's in place. Then ream it, do the dummy in there to check that the height is right and exactly seat it or go in a bit further. Then taking the guide off, then finally putting on the implant to cover that damaged area. On the surgeon side, it really is very accurate to do that. Now this is the latest thing. We contacted him recently. He says, "I'm feeling 100% better than before surgery. Occasional ache from time to time, but no obvious things that make it sore." He's moved to France for some reason. He's happy. All right, why do we get these good results?
I think the indication is important, and we focus on that, and the size of the defect doesn't seem to matter. We've got to cover it properly, and the implant's got to be good, and it's got to be even. And then we'll get the good results. If we leave it a bit uncovered, that's the worry area for extending the indications. Getting the indication right is important. It is for these patients with specific lesions, the surrounding cartilage is good, and they've got pain localized to those damaged areas that gives us the results. They need to have tried conservative treatment, non-operative treatment before, and that they're happy to accept the surgical route, having tried other things before.
I think the ability to accurately map out the area and have an implant that exactly covers that point is ideal. To be able to play with it on the screen on the damage marking and to plan and know and then even go back to the company and say, "Actually, can I have one a bit smaller? I don't think you need a twin here." That's the advantage of it, and we can play with that damage marking to be happy that it's covering the defect. That's a key factor to this. Getting that final design and the actual positioning of the guide it's gonna sit we have that printed out. It's on the wall in the operating room so we can exactly see where it's gotta go and it fits so well.
You ream in the right place to put that implant, exactly covering the damaged area, taking away that pressure on the bone. We focus on the indications, and recently I've put these together as this sort of 10 key points to exactly make the indications right. This is our in zone. This is the right times to be doing this. The focal lesion, the correct area of damage on the other part of the joint to make sure there's not damage on the corresponding surface and that the alignment is good. We don't like smoking, 'cause that slows down healing, and the ideal weight. Essentially, these are the sort of defined indications that we want to get the best results for this.
I appreciate this is a rush through of different stages of the results, but we've really focused on understanding those results, and then that leads to the correct indications and allowing to continue doing it. I hope that's given you the information. I'm very happy to take some questions on that.
Thank you, Mr. Spalding, for that presentation, and I welcome you to the Q&A session. I'm gonna start off by asking you to elaborate on the patient-doctor dynamics and how patients react to the possibility of getting an Episealer implant versus the traditional treatment methods.
Yeah, that's good because I think we have a pathway with patients to assess them, MRI scan, understanding exactly the nature of their symptoms, and then go down like a pathway of treatment. Or it's almost like explaining an option, a ladder of treatment for things that can be done. If it's a meniscus tear, then that's arthroscopy. If it's damage on the joint surface, then we have traditionally less options to treat that. From the MRI scan, initially diagnosing that area as a source of pain, and then trying the physiotherapy, and maybe some injections in the knee first before then broaching the subject of the partial resurfacing. That's how it works.
The patient is, as we know, in the so-called treatment gap. Could you elaborate on what the perfect candidate looks like for Episealer, and what criteria must be met for the best clinical outcome?
Ideally, it's the 40- to 45-year-old up to 65 who's got pain on activity in the specific compartments. It could be the front of the knee, it could be the inner medial side on walking, who wants to be active still, getting some limitation. The sport-wise afterwards, running, we can allow running. It's not the main intention. Whether they should run or not is different, but we can allow that. They wanna be keen. Alignment should be good, so not particularly too bow-legged, 'cause that means they're taking more weight on it. Their weight reasonably under control, not high BMI. That's your ideal patient who's tried other things and then motivated for the recovery.
You have used Episealer many, many times, but generally speaking, what does the interest and curiosity look like among knee surgeons when it comes to new products? What are the key obstacles to getting a new product like Episealer to become a more standardized treatment method?
The surgeon wants to know results and wants to know the case profile of someone who needs it, who is an ideal indication, as you just asked. Once that then fits, so much of the time previously, we've just said, "Well, look, there's. You've had this. There's nothing much more we can do. You just need to look after your knee until it's time for knee replacement." Once we know there is this option and that it's available, and then you've got the published series, and we're gonna finish publishing the five-year results, then a surgeon has something to look at. You see a case profile, and you see the published results. It becomes an option and available, and it fills another little gap of patients.
It's got this excellent narrow indication, which is so good for when we see the patients who then need it. That's the main obstacles is that data and then getting it out there.
There is long-term data now on five years. How do you-
Yeah
Expect the even longer-term data to look like, let's say in 9-10 years?
What we've seen from results of another type of mini metal implant, the HemiCAP, UniCAP, is that those that survived, there were failures early on, but those that survived that have the good results, then it tends to last once it's there. In that sense, at the 10-year point, we would anticipate the results should still be good. What we're not seeing is big erosion on the other side of the joint from the metal sort of nail in your shoe, as it were. It doesn't seem to be appearing. Once you've sealed that area and covered the damaged area, we're not seeing this progression of the damage. I would foresee that the results stay good.
There's gonna be a few failures, but you marry that against the idea we've bought time for people that's got them from their 45 to 60, or 65, and then maybe the rest of the knee is beginning to wear a bit more, then you can convert to a knee replacement very easily. You've bought quality of life, which is a very valid outcome measure.
Sure. In your career, you have clearly seen many different orthopedic parts, products coming and going, and Episurf seems to be very diligent in collecting clinical data. In your experience with the data available, is the product being positioned for a wider commercialization?
Yes. That knowledge of the outcome, this focused group, is very influential in that, in being able to position that. It's in everyone's practice, you've got a number of patients where this is suitable for. Many surgeons don't really know about this, or there's, they just dismiss it because they don't know the detail. In that sense, we are very much meeting other surgeons. We run the meetings, and that's great. The education part matches the data collection, 'cause then you've got something to say. We've got the technique, we've got the focused results, and then that leads to the indication, and then you've got experience of people slightly pushing the limit and expanding that. Yes, that's how it expands out there to Phil, and for the many surgeons that don't yet know about this.
You're also on Episurf's advisory board. I'm wondering if you can tell us what attracted you to this role, and in your opinion, what key steps the company needs to take in order to establish itself as a challenging player in this field?
Yeah. I've been interested in cartilage repair a long time. I used to be Navy initially, and we had access to growing cartilage in the lab to be able to treat this as the Genzyme technique, and then different other cartilage repairs. That's been a drive all along. Then this new technology sprung up, and it became very appealing. The role on the medical advisory board is literally to advise, and they sometimes don't listen to us on the board, and that's fine. We give that information, get the data, answering almost the questions you're answering now, giving that advice to do that. It's been they've been, to me, nicely responsive. I'm not just saying that.
It is actually, 'cause we can give advice with the key surgeons that are involved, to direct and to how to get this product out there. Plus keeping the results, because if it's not good, then we would say it's not good and wouldn't be involved. That's how it works. From my point of view, it's been a good journey.
A final question. In your opinion, what are the key competitive threats that could hinder Episealer from becoming a more widely implemented implant?
The other products, right? The HemiCAP, UniCAP, which is a much more off-the-shelf item, not customized to the patient, the early series showed some not so good results on it. Therefore, we've been able to show in our results, hopefully this seems to be better. There's not a head-to-head trial, and the indications for getting this right is what we've then focused on. In that sense, at the moment, this is a neater thing because you can exactly position it. I can't emphasize more the equipment, the guide to put it in. That 3D printed guide is a key part to the success here. That makes it doable for surgeons to do, and that's an important part. The BioPoly, which is a polyethylene implant.
Again, that's good, and I think that probably is a threat. The trouble is there, they've got no results on that yet. There's one paper. I know they're writing up some other results in a small series. They've been pushing down to lower age groups. I think that's an interesting product, but very few results on it, and that's why it's not really taken off. The other forms of cartilage repair are all still for the biological group. New ways of trying to grow articular surface. They just don't do well when we're over this 45. The biological solutions are not so good, so those are less competitive. Osteochondral allografts, the donor fresh, viable cartilage, again, results over 45, less good. They still work, but less good.
Those other competitors are not really there for this 45-60-year-old focused focal lesion.
Thank you very much, Mr. Spalding, for the presentation and the participation in this Q&A session.
Well, thank you very much for letting me do this.
Hello, everyone. My name's Patrick Jamnik, and I head Episurf's US business and commercial activities, and I will be here to speak to you a little bit about what we have going on in the United States and why we're so excited about the future. A little bit of background about myself, first of all. I have nearly 18 years of med tech experience. Almost all of that is orthopedic-related. A bit of a mix between both large companies, Stryker, Zimmer Biomet, some names you may be familiar with, and smaller sort of emerging startup type of companies.
I've helped commercialize businesses in different therapeutic areas on a number of different geographic locations across the world, and I think most relevant to this conversation, I was part of the initial team at a UK-based company called Stanmore Implants, where we took the technology that was designed in Europe and had been used successfully in Europe for a number of years and sort of brought that company to the United States and helped sort of get things off of the ground in the US. I wanna talk a little bit about some of the things that we are seeing on the ground from surgeons, first of all, and why we're so excited about the marketplace moving forward.
First of all, we think we are in a category that is sort of gaining customer attention to a level that has not been seen before. This idea of the middle-aged patient is frankly just one, not one that has been discussed all that much in orthopedic circles. There tends to have been conversations around sports medicine patients in their twenties and thirties and joint replacement patients in their sixties and seventies. This idea of the middle-aged patient is something that is gaining traction at medical meetings. You're seeing things like panels of orthopedic surgeons that are being comprised of a mixture of sports medicine surgeons and joint replacement surgeons.
We've never seen these types of things before, where people from sort of different ends of the spectrum are coming together to realize that the way that they have been treating patients in their forties and fifties is, you know, maybe needs a little bit more attention. Additionally, we're hearing more and more increased conversation around the need to delay joint replacement surgery. Joint replacement surgery is a wonderful operation with terrific outcomes that has helped millions and millions of people across over the years. However, if done too early, it presents a lot of problems for both patients and surgeons later on in their lives.
If someone has their joints replaced when they're 50 years old, it's very likely they're going to need some sort of revision or redo procedure when that patient is in their late 70s or in their 80s, and by the time they come back for that revision procedure, their bone quality is much worse. They have a lot of other medical comorbidities. It's much more expensive. There's a higher risk of infection. Those are the surgeries, these revision joint replacements resurgeries, those are the ones that surgeons really want to avoid altogether, and by postponing the initial joint replacement surgery, you can hopefully remove the need for revision surgery later on in patients' lives.
In addition to all of this discussion around how do we treat middle-aged patients, there's a growing consensus among surgeons that there are no really good options, and all different previous options, some of which Professor Spalding just sort of referred to a couple of minutes ago, they have either been designed for patients that are younger, sports medicine type of patients in their thirties and forties or even younger, or joint replacement implants that have been designed for patients later on in life. The patients in the middle, they have always been sort of just left with either being faced with some sort of undertreatment or overtreatment, and that is really where all of the different products that we're creating at Episurf, you know, sort of, sort of come together.
One of the things that really attracted me to come to the company, when I came last year, was some of these trends that I see throughout the orthopedic market and specifically in the United States, these trends of personalization, patients wanting to be treated as individuals with a solution geared specifically toward them. There's a big move in the U.S. of surgeons wanting to do as many procedures as possible in what's called the ASC or the ambulatory surgery center. Everything that Episurf makes, due to its personalized nature, is perfect for ambulatory surgery centers. We have no inventory, we don't need to take up valuable shelf space at these facilities.
All of our procedures are minimally invasive enough that they can all be done on an outpatient basis, so we have no issues whatsoever operating within these ASC types of settings. Clinical data emphasis. Mr. Spalding just referenced a lot of this, but regulators around the world are demanding more and more clinical data as we go on, and that is one of the sort of fundamental pillars at Episurf. It's not just a sort of nice-to-have. Many companies sort of do a minimum viable data possible type of idea, and Episurf has not taken that approach along the way, and therefore, we're able to kind of marry the both the kind of what might seem as a paradox, these concepts of introducing something new but also backing it up by evidence at the same time.
We're doing that better than anyone that I've ever seen. On top of that, we have this sort of software platform as well, and this is something you see more and more when you go to medical meetings, is how can we use software to make better hardware, essentially? We're doing that on a per-patient level, not just on a broader spectrum, but down to the individual patient level. This idea of marrying software and hardware platforms is a trend we see in orthopedics and one that we sort of fit within very, very perfectly. As we go to talk about some of the products that we're hoping to introduce through the 510K pathway in the next 18 months here, the first of which Paul mentioned earlier is this patellofemoral replacement.
Just a brief refresher. We're talking about a two-bone solution here, a metal implant on the, in the trochlea or in the center of the patient's femur paired with a customized patella on the patient's kneecap. A bit of background as to how we intend to go to market with this type of product. In contrast to many European countries, there's no real national United States distributor that Episurf or any other company could go out and just hire where you sign one distributor and you have coast-to-coast coverage. Distribution networks are built on a much more local level, and that's exactly what we intend to do. You can see only even the largest multi-billion dollar companies out there, names you're very familiar with, only those companies even use a combination of their own sales employees and these distributors.
Everyone else, aside from the largest companies in the world, they all build these third-party distribution networks, and we intend to do the exact same thing. Now, once we get to these distributors, though, they're just like surgeons. You need to pique their interest in the product. You need to capture their attention. They have other product lines that you can sell. We're going to be able to do that really, really nicely with our software platform. We intend to be able to sort of capture their attention with our software solutions. These are very catchy. No one's doing this, taking these sort of images, these what people are used to seeing medical images, X-rays and MRIs. No one's taking these types of things, though, and producing them in such an aesthetically appealing way as we are. These are very attention-grabbing.
We think they'll be able to capture distributors' attention, and ultimately we think distributors will be able to capture surgeon attention with them. We can use our software platform to grab the attention and capture distributors. Once we have their attention, we can capitalize on some of the unique product attributes that we think will make this a very compelling and, frankly, a very fun thing for a lot of people to sell out in the market. It's a bone and soft tissue conserving solution. Because we are replacing just the damaged section of a patient's joint, we are burning as few bridges as possible. This concept of burning bridges is something you'll hear oftentimes surgeons speak of. We're burning as few bridges as possible. We are sort of maximally conservative. By conservative, I mean preservation of existing bony and soft tissue structures.
Because of that, surgeons can feel confident that if they need to revise an Episealer device down the road, and we're talking 15, 20 years down the road, all of the other surgical options that they would like to be available, they're still all out there on the table for them. We haven't removed anything out of their sort of bag of tricks that they can offer to the patients. Because of this also, we've got rapid rehabilitation. Our product patients can be up moving right away. Some of these other more biologically centered alternatives, patients need to be on crutches for a considerable amount of time. These are people who are in the prime of their working years. It's a major hindrance on them to be unable to fully weight bear on their joints right away.
On top of that, we're going to be able to position the patellofemoral product as an extension of the very clinically successful Episealer knee implant. You saw Mr. Spalding in the previous presentation reference the trochlea implant and how well those trochlea implants are doing long term. The trochlea implant of the already in use product portfolio in Europe, that trochlea implant is the basis for our patellofemoral implant. There's very, very little re-engineering or anything that was done. When we started our product development activities, we took our existing trochlear implant and then are marrying it with a customized patella product. We were going to be able to sort of piggyback or springboard off of the clinically successful Episealer knee portfolio. If we look at the size of the market, this is a very important chart here on the lower right-hand side.
Just as a reminder, patients can get arthritis in their knee in one of three locations or two of three locations or three of three locations. Your knee is actually three separate smaller joints. When someone gets a total knee replacement, they are replacing all three sections or compartments of their knee. However, if you look at the chart down below on the bottom line, that's only 17% of where arthritis actually exists in patients' knees. Many times when people are receiving a total knee replacement, they are receiving technically some form of an over-treatment. They are having healthy sections of their knee removed, sort of getting caught up or swept up in with the damaged sections that need to be addressed.
The highlighted part of this table shows that 18%, so almost one in five patients that present into orthopedic clinics with osteoarthritis of their knee, almost one out of five of them have it contained or isolated to the patellofemoral compartment. Yet not anywhere close to one out of five knee implants that goes in as a patellofemoral replacement. There are historical reasons due to sort of what we consider faulty implant designs in the past that result in this type of market existing where this is in a market where we can take an existing share of a sort of a pie that's already created, but we also think that there's plenty of room to expand the overall pie as well over time. I mentioned some of these existing industry trends that exist. On the right-hand column, this product that we are ready to launch in the U.S.
Within a couple of months, this fits perfectly within all of these types of trends. It's personalized. It can be used in the ASC setting. It leverages off of existing clinical data, and yet it marries this software and hardware sort of combination that I've mentioned in the past. There's a broad group of available customers that we will be able to speak about this product with. This pie chart here shows a breakdown among orthopedic surgeons and where they go to do a fellowship or where they go and do one year of additional subspecialty training at the end of their residency. The two largest sections of the chart, sports medicine and adult reconstruction. Adult reconstruction is another term for joint replacement. Sports medicine and adult reconstruction, those two combined, that's almost 50% of the market or almost 50% of the available surgeons, the existing U.S. surgeons.
That's our target market. If you throw on probably another 10% that do no subspecialty training, most of those surgeons probably deal with these types of problems as well. We're talking at a minimum half of the roughly 30,000 U.S. orthopedic surgeons are surgeons that we will be able to speak to about this product and they will see patients with this type of condition. How are we going to sell this or what do we think are some of the reasons that could be compelling to a surgeon? One is that we're dealing with in the patellofemoral joint a location of high anatomic variance. If everyone in the audience here or everyone listening from home, there are different spots on your own skeletal system where from person to person, they're very, very similar. Then there are other spots of your skeletal system where there's high variance.
They're very different. Everyone in the audience here has a very different patellofemoral joint from the person sitting next to them. Where there are different high variance skeletal locations, that's where Episurf's personalized solutions really come to shine. The higher the difference is from person to person on their anatomic structures, the more that our personalized solutions really come to the forefront. On top of that, in the U.S., as there are in many countries around the world, there's a very high arthroplasty burden. There's more and more people need the procedure. There's a huge sort of population gap that is aging into these years that are prime arthroplasty years. As a result of that, more and more surgeons that have typically kind of a sports medicine background, they're looking to sort of inch into the joint replacement world.
We provide a very nice sort of on-ramp for those surgeons because this patellofemoral product, this is a partial knee replacement, but it sort of marries the mindset of a sports medicine surgeon. Those surgeons have been trained for many, many years thinking about bony conservation, bony preservation, soft tissue preservation. We can take some of these sort of sports medicine types of concepts that they are comfortable and familiar with and provide them with a partial knee replacement type of solution. It's a very, very sort of nice on-ramp to aid their movement or their slow march into the joint replacement world.
On top of that, one of the major reasons that these patellofemoral products, in our opinion, have never seen as much uptick or as much commercial traction as compared to the magnitude of the clinical problem is that surgeons are always a little bit hesitant when they replace, if they go to replace one of the three sections of the knee, they're always a little bit worried that there is damage that they can't see or understand in some of the other sections of the knee. If they go in to replace one and leave the other two untreated, the patient's going to be back really quickly with a problem in another spot of their knee. Our software solution, though, is something that will help aid them in their own patient selection efforts.
We think that this is a real sort of value added to the surgeons that we can help assist them in their patient selection efforts. Because our software, if there is a problem in another location within the knee, our software is going to be able to tell them that ahead of time. Even if we may say, thank you for considering us, but however, you know, our patellofemoral product would fit nicely in this area, but there's other areas of the knee that you may need to consider, that's going to be a real, we're aiding the surgeon in their own sort of clinical activities that they would do normally. That's something that they will really appreciate and come to, I think, really value from us as sort of a partner in their practice of helping their patients.
We also have this product as we're thinking about it. It is something that 10 or 15 years ago, the way to sell implants was just let's go make as sort of as cool of technology as we have as possible. Let's go run to the surgeons and get them very excited about it and hope that they'll put it in. That's still important, but it's not as, it's an activity that needs to be done today in addition to addressing other areas within the entire sort of value ecosystem. Addressing the hospital system's needs, addressing the patient's needs, frankly, and addressing the surgeon's needs. We have a product that we think is really well situated to address this sort of multi-headed customer and satisfy a lot of the needs of the surgeons, the patients, and the healthcare systems along the way.
The patellofemoral product will be our first product out to the market, again, via the 510(k) pathway. We hope to have that available within a couple of months here. Roughly 12 months or so after that time, we'll move on to introducing the toe product or the MTP market to the U.S. The toe market or the MTP market in the U.S., this is a big problem and is an everyday sort of problem for foot and ankle surgeons. Hallux rigidus, that's this condition, arthritis of the first toe. This is an everyday problem for foot and ankle surgeons. The U.S. population is about 330 million people. Roughly one third of those are above the age of 50. Roughly 2.5% of those, so one out of 25 of those, suffers from hallux rigidus. There are almost three million people in the U.S.
Today walking around with this problem. We're having conversations right now with a number of prominent surgeons who think that the approach that we're taking and the personalized way that we are able to address the joint will really shine some light on really kind of breaking through some real innovation here. As we think about this, I want to just bring up the sort of contrast a little bit, the difference between foot and ankle surgeons and knee surgeons. The foot and ankle market historically has really moved a lot more dynamically than the knee market in the, in the past.
There are numerous examples of things that have happened within just the past five or 10 years of new products that can come out in the foot and ankle space and new products that can come out to address this same clinical indication and have seen widespread adoption very, very quickly. I think it really speaks to the magnitude of the problem and the limitations of some of the existing technologies that surgeons will sort of move en masse to a much greater degree in the foot and ankle space than they historically have in the knee space. What you're seeing here is a video from the NBC National News. So this is one of the main three broadcast networks in the US.
It's not easy to get any kind of story related to orthopedic implants to be covered on the national news. It does go to show the promise that a lot of these products and solving this problem of hallux rigidus has on this patient population. What we see here is sort of a chart of a product that was introduced a couple of years ago, and within 24 months was taking double-digit market shares very quickly. Again, the foot and ankle surgeons historically, at least for this specific problem, have shown how they are much more comfortable and much more willing to move en masse to help their patients to adopt a new technology.
Now, this particular product didn't exactly sort of work out, and there's a number of more sort of complicated reasons why. But again, we think we're playing in the right space, and we have the right solution to address this. In sum, what I'll sort of leave everyone with is that I think we have a company profile that is really consistent with a lot of the major orthopedic trends that are happening out there. We have personalized solutions. We're ASC-friendly, we're data-rich, and we're digital. We have a surgeon group that is vocalizing on their own, really, frankly, independent from us yet in the U.S. A surgeon group who is vocalizing on their own, a lot of the major problems that we're intending to solve.
Within the next 18 months, both via the 510(k) regulatory pathway, we have a couple of new products that both target unmet needs and underserved patient populations. They both treat high-variance skeletal locations. They both offer a lot of opportunities to both take share and grow the overall market at the same time. They both have established reimbursement structures in place and established sort of markets already in place, and they're both well-suited to address the multi-headed customer. Thank you, everyone.
Okay. Hello, everybody. My name is Clemens Kösters. I'm an orthopedic surgeon from Germany. I'm working in Greven. It's a small town near to the university town of Münster in West Germany. I'm an Episealer user since 2016, or right, since then I used the Episealer implants. First of all, thank you very much, Episurf, for the kind invitation to this big event and to let me have a presentation on my results and on my treatment with the Episealer implant for multiple lesions. I would like to start, that's what I already said. Why should we implant two or three patient-specific implants in one knee? Why shouldn't we go for total knee, and that's it? We have many middle-aged patients, or sometimes we say best age patients.
Yeah. Patients in the age of 40-60, and they are healthy, they are doing a lot of sports, and they have high demands on their free time. When they have pain in the knee and they can't do their sports anymore, they have a big problem, and they want to have a change. On the other hand, many of these patients don't want to have a total knee because a total knee is not always working fine, as we know, and all the patients are well-informed in these days via internet and so they know that not every total knee is working really, really fine.
They are too young for a total knee, because if we implant a total knee with the age of 40, many of these patients need two or three revisions in their whole life. What we also could do is a biologic cartilage repair, as you can see in this image here below. That's the AMIC technique where you drill holes in the bone, and via the blood clot, there is regrowing new cartilage. But this is a problem because in the middle-aged patients, these techniques don't work as fine as in, for example, young like 20 years old patients. This is one reason why the Episealer implant was developed.
Here you can see a damage report of a knee that has not only one area of cartilage defects but two, one in the so-called patellofemoral joint. This is here where the patella is gliding on the medial part of the knee. There we did an Episealer implant for two areas. Here you can see the drill guide that allows a very exact implantation. Here the implant of the trochlea prior implantation and after implantation. This is the X-ray after the operation. Looks very fine. Now how do I decide which patient is suitable for this technique for two or three implants? Again, middle-aged or let's say best age patients, no malalignment.
That's important because malalignment, we all know, leads to severe osteoarthritis, so we shouldn't do this in patients with a varus or valgus malalignment. The patients shouldn't be obese, and the range of motion of the knee should be also okay. Then in my daily practice, I nearly do in every patient an arthroscopy to see if the tibial cartilage is really fine because this is very important. The cartilage should be fine on the tibial part. An exception for me is the retropatellar cartilage, so the cartilage of the patella. That shouldn't be fine in my opinion. It could be damaged. In the tibial part where you walk on these areas should be fine, and the meniscus should be intact. That's what I want to check.
I think we could reach results like we know for the single Episealer implants. You maybe already heard the results of this two-year results study that we did on a cohort of 80 patients, and that was really impressive, how good the results were. My question was, can we reach these results also for two or three Episealer implantations? In Greven, we already operated many of these patients, and we included the first 32 patient in this prospective study. There were 23 patients with two implants and nine patients with three implants. You see a mean age of 53 years and a mean body mass index of 27.
Here you see two images of patients with these multiple lesions. This was the aggregated KOOS score. That's the score that shows you the results for a functional outcome of the patient, what can they do, but also pain. Here we can see a very low amount in the preoperative questionnaire, and then after 24 months, we have a very good result. This is again shown the KOOS score, but in the subdomains like pain, activities of daily living, sports. Also here you can see after a 24-month, a really nice result. Here you see this again, little bit different, but also here nice results. Then very important, pain is the most important thing for these patients.
They have pain, and they can't do sports, so they want to have no pain. Here you can see that, if you see the preoperative pain, it's more than six. That's really severe pain. After 24 and already after 12 months, you have a really nice reduction of this pain. Here you can see single and multiple implants in one graph. We can see that the two or three implants are not that worse than the single implants. That's what you also can see in the subdomains of the KOOS and also for the pain.
If you see on the two implants versus one implant, you even can see that the pain was reduced even more in the two implants. Okay, let's say it's not a study with thousands and thousands of patients. It's a small number, okay? It's until now a short follow-up and single center data. In the end, I think it's showing good results, and it's we could be very hopeful that it's also with more patients the same. Now I would like to present you a case of a 43-year-old lady. She's a professional fitness coach, and she had an ACL reconstruction 15 years ago.
She came to me with consistent pain under full weight bearing, when she was doing her sports courses, leading her sports courses. One of the first things she told me was, "I don't want a total knee. What can you provide me?" That was good. We did our diagnostics. We always need these standing X-rays to see if we have a malalignment. She has no malalignment. Here you can see that, the medial and lateral part was not osteoarthritic in this left knee. Here you can see the MRIs of this lady, and you see, areas with, cartilage defect is in both condyles. If you see it from the lateral view, you can see here cartilage defect is in also, a bone edema here in these areas.
Maybe if you see such MRIs, I think 90% of my colleagues would go for a total knee because they say in all three compartments of the knee, there are severe cartilage defects, so we just implant the total knee. The patient, again, is 43 years old, very sportive, and she doesn't want a total knee. I told her, "Okay, let's have a look what we can do," and there's this new technique from Sweden. Now we did this Episurf MRI, and we had a look on the damage report. When you see this, you may be a little bit concerned because you see red areas where there's no cartilage. The thing was that on the tibial part, there was most parts of the cartilage were fine.
Only in this damage report, you can see one small area in the lateral tibial condyle where you are a little bit afraid about more than grade two cartilage defects, and that would be a contraindication. I decided to do an arthroscopy, and here you can see the video about it. This is the medial part of the knee, and you see cartilage defects in the femur, but the tibial part was fine, and also the meniscus was fine. This is lateral view. Here you can see that the tibial cartilage was not that damaged, as we have seen it in the damage report.
Maybe sometimes in these cases, here you can see the femoral lesion, we should go for an arthroscopy and to be sure that it's possible to implant such implants. Here again, this is the femoral part on the lateral part of the knee. You can see that here down the tibial cartilage is not that bad as we expected from the damage report. I decided. Here you can see the trochlea with quite big lesions. In the end, we talked and we decided to do an Episealer because what are our options in the end for these patients? You could try a biological repair, but she said, "I cannot do 6 weeks of partial weight bearing because I have to work.
I earn my money with my sports courses, and I have to to do these courses." These options are not suitable for this patient. Again, she doesn't want a total knee. You can implant very nice total knees like this, custom-made total knee from Symbios in Switzerland. Very nice. I like it. But in the end, I think it's for her not suitable. If you see here, the treatment options in this slide for the young patient, there's no problem to do a biological repair with good results. But for the old patients, we can do a unio total. If old is 40 years, I feel very old because I'm 46 now.
In my opinion, the middle-aged patients, they have a chance to get this Episealer in this area between the old and the young patients. Also, we have a chance to implant Episealer implants in patients that maybe have tibial good cartilage or fine cartilage. We could avoid a total knee in rare cases also if we have two or three parts of the knee with severe cartilage defects. Okay. She said, "I said it sometimes. I don't want the total knee." Okay. We implanted these three nice implants. Here you can see the intraoperative image, very nice and patient-specific implants. That's the postoperative view. This is 20 months after the operation. Here you can see the standing X-rays, 20 months on the right side after surgery.
There was no narrowing of the medial joint space that would be a sign for osteoarthritis, and she was fine. That's the video 2 weeks ago. I've seen her in my outpatient unit, and she was really happy because she was already doing her spinning courses and other courses that she was giving in her private practice. She was very happy with this. I think such a function is really good, a really impressive result. I don't know if we could reach this with a total knee. On the other hand, if these implants maybe fail in 10 or 15 years, it's not a problem to implant a total knee. Okay. We have opportunities with these mini metal implants, but maybe also risks.
Now I would like to present you a borderline case maybe. It's also a quite young guy. I know him personally, and he had this arthritis in the medial part, medial osteoarthritis. I wanted to do an osteotomy because he has a varus knee. Then I did an arthroscopy, and I've seen cartilage defects also here in this lateral femoral condyle, but the tibial part was fine. He had this varus, as you can see here. It's the left knee. That was the image from the arthroscopy. Here you can see the cartilage defects on the medial part and in the trochlea.
The lateral part was the tibia was fine, the meniscus was fine, and there was only this focal lesion in the femur. We did an MRI, Episurf MRI, and we have seen these lesions. The medial part is the osteoarthritis, and here the other red areas are the fourth-grade cartilage defects. We plan these implants, and we did an implantation. This was the arthroscopy when we did the second operation, and the second operation was an osteotomy to correct the malalignment. Here you can see a very nice implanted Episealer in the trochlea, and now you see it here on the lateral part. Again, here you can see it, very nice. You see overgrown cartilage at the rim of the implant, and now we go further.
This was then after HTO, we did a varus correction of the knee, and here you see the standing X-rays with the straight leg and corrected deformity. This guy is doing fine, maybe in future we could use this technique for more patients, not only for single small cartilage defects, but maybe we could extend these indications a little bit, and maybe it could be combined with more digital procedures, maybe with a robot and all the things that are going on. Let me summarize. We have good clinical short-term results for two and three Episealer implants. I think we have to compare it with the total knee results in this patient group.
Malalignment, meniscal, cartilage defects are a contraindication, so in my daily practice, I do an arthroscopy prior decision-making to be sure that the tibial cartilage is fine and the menisci are fine. Sometimes you have patients that could get an osteotomy in combination with an Episealer. If you think about what is the value of a Episealer implant, in my opinion, it's in between these two things. We have the biological repair for young patients, total knee for old patients, and for the best age patients, we have the Episealer as one more open option in your toolbox. Maybe it's a little bit too much, but maybe it's the missing brick in the wall. Thank you very much. That's my presentation, and now I would be happy to answer some questions. Thank you very much.
Thank you, Dr. Kösters, for that presentation, and welcome to the Q&A session. I'm gonna start off by just asking you to go back to where you discussed in the presentation, namely how you first got in contact with Episurf and why you decided to try the Episealer implant.
My first contact was funny because I had a presentation on periprosthetic fractures on the Danish National Congress of Orthopedic and Trauma Surgery. There was an Episurf presentation, and there was a guy from Episurf. We talked about it, and it was good because I had several patients with these problems. That was the first contact. I think half a year after this, we did the first case.
Good. You're also an early adopter of Episealer. Can you say what your peers at your clinic said about the Episealer implant, and are they also using it?
Let's say I'm head of department, so my colleagues have to use it. No, but yeah, my colleagues like it, and everyone is impressed how good are the results. Also, if we see the patient in our outpatient unit because every patient comes later to a control, and we include every patient in our study, so we want to collect data. My colleagues, my residents, and my consultants, they also use it or use it together with me, and so they are already convinced.
Good. We know about the typical Episealer patient already, but can you try to elaborate a bit on the typical Episealer Knee surgeon, or at least what type of surgeon is more likely to use the Episealer implant than the traditional methods?
Yeah, that's a nice question. In my opinion, the younger guys, maybe also the middle-aged surgeons like to use this technique more because it's a progressive technique. It's if you're a little bit more old school, maybe you go for total knee in these cases, or also if you have cartilage defects, maybe you try again and again biological healings that will not work at the end. In my opinion, you have to be open-minded, you have to be progressive in your therapy, maybe also a little bit, you have to be kind of a researcher. Maybe you're not a researcher, but maybe it's easier for people who were trained at university where you know about new techniques, where you have more contact to new developments.
I think you have to be very open-minded for new techniques, and that's one thing maybe that is different to other surgeons. I don't know.
Good. Do you use Episealer for especially complex cases, or do you use it more widely across the treatment gap patients? Can you elaborate a bit on the typical concerns that patients may have for using this relatively new device?
Let's start with the concerns of the patients. They don't have many concerns. They are really convinced about it when I explain it. The thing is that sometimes you have to stop them a little bit or to get downsized their expectations because they hear about custom-made implant only made for you. It's the newest thing, digitalization and all these things. They're very interested, and they think it's really high tech, and it is high tech, but that gives the patients very high expectations. You have to tell them, "Okay, but you have cartilage defects, and it's not.
After the surgery, it will be better, but maybe you have some small pain also after the operation. Sometimes the expectations are a little bit too high, in my opinion.
Mm-hmm.
That's important that you have to downsize this a little bit for the patients. The first question. Sorry, what was it again?
If you use Episealer for specifically more complex cases or more widely?
Yes. Yes, I do. As you have seen, I sometimes combine it with osteotomies, and so I do two or three implants that I think not many surgeons who use the Episealer do. Maybe I'm a little bit progressive in this, but I have good experiences with it, and the patients are really fine. I go on this way, and I think it's okay.
Mm-hmm. In your personal opinion, what should Episurf Medical do in order to get knee surgeons to start and keep using Episealer?
Yeah. You have to be present at the orthopedic congresses in different countries. There it's important that surgeons like me present their data and present cases and everything. Then in the end, we have to publish our data that we collect. We have to publish our results. If the results are going on like this, I think it's not a problem to make it more public or more common to use it. But in every technique, every new technique, it's difficult to convince some colleagues that this could be a new way for our patients.
In your view, what competing methods or innovations are the largest threats to Episurf? What could make you consider using a different method or a product?
You mean other techniques that could be an alternative to Episealer or? Yeah. In Europe, it's difficult. In the States, maybe you have the possibility to do allograft osteochondral transplantations. That seems to be also a good option. In Europe, we don't get these fresh frozen implants. I don't see many possibilities, alternatives, in this technique because other small implants, they are not patient-specific, and they are not that exact in the operative technique. I wouldn't go for other implants.
Mm-hmm. My final question, Dr. Kösters, it's a relatively speculative one, but what do you think Episurf's position could look like in five-10 years?
In my opinion, in five to 10 years, it will be more known in our daily practice. I think many more colleagues will know that we have this possibility for maybe failed cartilage surgery to use the Episealer. It will not be like a uni or total knee that you do more and more cases. It will be more common to use in next five or 10 years. I'm really sure.
Thank you very much, Dr. Kösters, for the presentation and the Q&A session.
Thank you very much.
Hello, everyone. Welcome back after the break. We're fully refreshed here in Stockholm. My name is Stephen Caswell. I'm Head of Sales for all markets outside the U.S. Just one brief slide about me before we dive into something more interesting. I joined Episurf Medical in January. Prior to that, I had 11 years as a chartered physiotherapist in both NHS and private settings. I then spent seven years at Stryker in joint replacement business in various roles from sales management, Mako Robotics, and then latterly as Director of Strategic Capabilities. I was originally attracted to Episurf Medical's 3D MRI capability. I believe that's a world-leading capability and something that we can make more of in the future. I genuinely believe that this implant platform will play an increasing role in the early surgical management of these patients moving forward.
I personally would like to consider the impact that this technology could make when partnered with a robotic platform, although that's not a corporate strategy as of today. You've heard today from Patrick already that this patient segment, this gap patient, is getting increasing amount of tension in the U.S. That's very similar globally. We're seeing a number of multiple podium presentations in large markets, new markets, and existing markets. We've had presentations in Israel, Australia, Germany, recently at DKOU, Dr. Kösters's presenting cases, but also Tobias Jung presenting cases in Berlin. We've also had presentations in India, at IASCON Conference, over 1,000 surgeons seeing the European experience of the Episealer technology. Then in breakouts in ESSKA Conference in Paris, both our Talus and our Knee symposiums were very well attended.
You've heard Paul explain that we're going into a period of global expansion and commercial focus. You've probably heard that before. What I'd like to explain to you today is what that really means for where Episurf Medical are now. The reality is we have done 1,300 cases globally. This is a really strong base to then move on and take the next step into growth. We have established various global partnerships and announced a number of market firsts. First Talus cases, first knee cases, first product registrations. These are all very positive steps. The reality is, many of these contracts have been set up between 2019 and 2021, and the onboarding has been significantly impacted by the COVID pandemic. Challenges getting the right partners in these markets is not unusual. We'll continue to assess our position with partners globally.
We do have some fantastic partners, but we'll continue to stay close to that as we move forward. We have a direct and an indirect model that is absolutely normal for our stage in market development. We are investing in resource for both, and both models have a very clear focus and incentives aligned with our commercial strategy. This year, we are carrying vacancies on our sales teams, so we are yet to feel the full benefits of investment in both our direct and indirect model. The reality is, although we have a solid base, a good number of cases done, we are still getting started in many countries. What does getting started really mean for Episurf in new markets? The reality is we are building or rebuilding trust in the procedure of focal resurfacing. Focal resurfacing itself is not a new concept.
First-generation implants have gone before us. You've heard Mr. Spalding mention this earlier, and they have had high failure rates reported in significant large international registries. For example, the Australian National Joint Registry, which is a well-respected registry globally. You can see here first-generation failure rates. Right out to five years and six years, you're talking of revision rates around 25%-30%, significant revision rates. You've heard Mr. Spalding present to you our data around an 8% revision rate at five years, which he clearly says is a low revision rate in this category. You can also see how we compare to other treatments, other treatment options for this patient group. We're very happy with our revision rates and how the implant is performing. Focal resurfacing itself, combined with advanced technologies, is actually a very good idea.
I'd like to just cover briefly some of the differentiators in the market as to why we know we're doing so well. Firstly, indication. You've heard indication mentioned a number of times today of how this is so important. All of our customers get a significant amount of data about the patient, about the lesion, the size of the lesion, the location of the lesion, and whether a small implant is actually suitable for their treatment. Moving on, we're talking about personalization of the implant. All implants, the articulating surface is matched to an MRI. Also, the depth of the implant is varied depending on the involvement of subchondral bone. Of course, the size and location of the implant is varied per patient. The instrumentation, you've heard from Mr. Spalding and also Dr.
Dr. Kösters, this is how important this instrumentation is to provide a really stable bony preparation bed for the implant itself. 3D printed instrumentation based on the MRI scan. Then moving on to the implant itself, a step in the right direction towards a monoblock implant seems to be making a difference to the results. Also, the benefit of having a HA, hydroxyapatite coating around the body of the implant seems to be making a significant difference, allowing the cartilage to grow into the implant to seal the joint surface. Once we've been getting started in these new markets, we really get surgeons to accept that the advanced implant platform and personalized resurfacing is a safe and effective procedure. We then see them starting to think about what the implant looks like in an expanded treatment algorithm.
You've heard the term expanded treatment algorithm a couple of times today. What does that really mean? Many markets that we enter have already got an established arthroplasty pathway. That means that the first implant a patient is often offered will probably be a uni knee that you see in the middle of the screen in front of you, and some patients will be a total knee that will be the first implant that's offered to them. There's an increase in interest in the market of delaying the total knee replacement as being the index procedure, moving that procedure as far to the right as possible. We know that delaying this procedure by five years can prevent 17% of revisions. That's the procedure you see on the right-hand side. Revisions are very costly, not only for the health system, but also for the patient.
There's increased risk of infection and often don't do quite so well from a functional recovery perspective. It's really important that we start to get this wider algorithm accepted. When you think about all the treatments that the patient may be subjected to prior to the uni, they're often kept in the community, managed conservatively with physiotherapy, injections, bracing. They may be referred in for biological procedures, depending on their age or healing capacity. And almost certainly, many patients will be subjected to a microfracture procedure, and we're seeing many failed microfracture procedures being sent in to Episurf to provide an Episealer device. We really have to change mindsets to try and delay TK intervention and drive this acceptance of an expanded treatment algorithm. We have a really solid option in this pre-uni space.
You've heard low revision rates, good patient-reported outcome measures, maintained function, whether that be activities of daily living, return to sport, and certainly quality-of-life measures are returning. Importantly, we're preserving healthy cartilage on both the femur and also the tibia. Because we don't have to resect, we don't have to make an incision, a cut across the tibia, we can preserve the meniscus, which helps the knee feel more normal for the patient for longer. It's really important that once we get this gradual clinical acceptance, that we start to see an increase in implant run rate. Surgeons often like to get started by sending us some scans to test the system, see how they read the damage marking reports. They might often wait for a perfectly round, ideal indication on the medial femoral condyle.
They then naturally want to wait and see how their first patient does. We know after having implanted implants for over 10 years, you heard from our first patient earlier, they do very well. Surgeons only then will start to widen their indications. For us, that then means an increase in implant run rate, which is why Paul has such a focus in his reports on customer acquisition rate. It's essential for us to be adding customers at a really high rate every quarter. I'm really pleased that the team have grasped that, and they're really trying to add customers at a faster rate. Let's look at our more established markets. For example, Germany, where we've been selling the implant since 2016. We were certainly on a good growth trajectory prior to the pandemic. Yes, there was some turbulence from a quarter-by-quarter basis.
You can see that the pandemic certainly lost a little bit of momentum for us. The pleasing thing is we are seeing a good recovery. We will recover back to pre-pandemic status very soon. Also we've lost a little bit of that turbulence on a quarter-by-quarter basis, starting to build on momentum on a quarter-by-quarter basis, which is a real positive step forward. We have no doubt that we can mimic that growth rate in other markets. If we zoom back out for a moment, we can look at our direct structure overall. There is no doubt that this year the team are going through a little bit of a culture change. We have some great people that really have accountability to grow their business. They grow their knee business, to grow their ankle business, and also to add customers at a faster rate.
We have a team of 11 sales representatives, which is a good number for a company of our size. We're carrying vacancies in the GSA region, in Nordics, and also in our indirect channel management. Looking after our distributors and agents across the globe. We've also increased resources in our indirect channel management team this year. We previously only had 1 person looking after all markets outside the U.S., all indirect markets outside the U.S. We now have three, 4four including me, so much more resource focused on driving the business forward in these markets. We have had some changes in our main markets, such as Germany, U.K., and Nordics. I'll mention those a little bit more in a moment. All of the team are focused on the need to drive a reimbursement strategy in each market and have a really good focus on moving those forward.
You've heard already from Dr. Kösters that there is this demand for using the device in more end-stage focal lesions, really truly in the pre-uni space. Also, very interesting to see the traction of multiple implant cases. Not only Dr. Kösters, multiple customers in multiple markets requesting us to present them to them multiple cases. I've mentioned we've made some changes in the UK, Germany, and Nordics, and I'll summarize those briefly now. In the UK, we did have two direct salespeople who are now working on our indirect channel team to really help drive a better onboarding process in multiple markets. They know the product well, and they can certainly accelerate that process.
We also had a smaller distributor in the Midlands that we unfortunately had to terminate, and now we have a national distributor, full coverage across the whole of the UK, and they have good experience of selling personalized devices. I have no hesitation to say that we're well-placed in the UK to take the next step and grow. In Germany, we had a split north and south, including Switzerland. We now have just one region. We've brought Austria into that direct model, and we have one strong sales leader leading a team of five sales representatives. We are still carrying one vacancy. In the Nordics, we're recruiting a business development director for a refreshed approach to the Nordics. The team are very clear that we have to drive and focus on our sales execution. They know that we're expecting to see aggressive growth in the knee platform.
They know that we want to see growth and support to gather further clinical data on the Talus, the ankle product. They also know that we expect to increase our customer base at an accelerated rate. Of course, we'll add additional markets, and we'll mention that in a moment or two, but they also will take responsibility at growing their own customer base much more quickly. You'll hear all the things that they can leverage, the patient-specific messaging that's very much on trend, superior clinical results that Mr. Spalding presented to you. We have a wide network of global KOLs that will help with peer-to-peer selling, which you've heard is so important. A fantastic software capability to leverage. We'll have knee- and ankle-focused marketing strategies that the team can execute upon. We'll also have a direct-to-patient marketing campaigns in those markets that are ready for that.
For example, Germany and the UK. A couple of slides on just some focused markets prior to a summary slide. I won't cover all markets. That might take us a little while. Our European partners that we expect to support much more closely. If we take a look at Italy first, our Italian partners have had a really good start. Started our business off in the northern parts of Italy. Good traction with our Talus product, but they do know that we expect more traction in other parts of Italy, but also more growth traction with our knee products. They have a good plan to execute on that over the next coming months, and I have no doubt that our Italian partners are well-placed to deliver on growth in both platforms. Spain and Portugal, again, big markets.
We've already got started with first initial cases, and we will support our partners in those markets to accelerate the growth in those markets. We're also open to recruiting a Spanish and Portuguese business development manager in this region, and we're very happy to start those recruitment processes soon. Same again in France. We've got started, and we're ready to take the next step. We're just discussing what resources we need in the French market to drive that growth a little bit faster. There are some reimbursement challenges in France, but that might change in the first one or two quarters next year. There are some changes there. Poland, we're seeing some green shoots of growth in both the TALUS and the knee platform.
We do have study sites in Poland, and we're already speaking to additional sales agents in Poland to help us drive further growth in that market. I'd already mentioned the UK, and I believe we are now well-placed in the UK to take the next step, certainly with NICE guidelines being published. It all adds to our momentum in this market. We have a strong pipeline, particularly in the south. India, one of the fastest-growing healthcare markets globally. It's great to be present and done a first knee case in India. We also have first Talus cases in the pipeline, so our ankle product in the pipeline, and we've built a relationship with two very experienced business consultants in India to help us build a scale plan in various regions in India. I'm excited to be present in that market.
The Middle East, we just signed our first distribution agreement in the Middle East last week. A couple more regulatory steps, and then we can actively sell in this region, and the team will be onboarding those distributors now. Australia, we'd already mentioned we expect Australia to be a cautious market because of the performance of first-generation implants. This is still an important global market that we'd like to be present in. We've had first in-person meetings, recently had a presentation at the Australian Knee Society meeting, and we again have invested in senior business consultant based in Sydney to help us penetrate this market. In fact, I'm out in Sydney and Melbourne next week to further those opportunities. We still have other big markets on the horizon. Pål Ryfors has mentioned South America previously.
This still is on the plan, and our regulatory team will soon turn their attention to these markets. We do want to go to South America, but we want to do so with Brazil first. Clearly, scale of market being one of the drivers. We know Chile has got lower barriers to entry, but the ANVISA application will be prioritized. Also, if we were to invest in a Portuguese-speaking business manager, that will help us in this region also. We just finalized a distribution agreement in Taiwan only this week, with registration processes starting for the knee soon. Turkey and the Balkan regions, I'll be spending more time in those markets over the coming months, really to assess whether the ASP that we're after is suitable for those markets.
Canada remains on the list, but we have more work to do on our QMS system in 2023 prior to being able to do the registrations in Canada. China and Japan, clearly huge opportunity markets still remain on our opportunity list, but we do need to continue to explore the data that's required in those markets. In summary, I hope you see that we have solid foundations in place to go on and take the next step and accelerate growth further. In our direct markets, they are going through a period of transition, but they have a very clear plan focused on sales execution. Those markets where we are more established, we need to be confident and be more aggressive to take market share in these markets. Some markets are ready for more direct-to-patient communication along a private healthcare provider.
Our indirect markets will remain key, and we'll allocate resources as appropriate. We need to ensure we have great partners in each market who are motivated to sell the product. In many markets, though, as I've explained, we are still just getting started driving acceptance of those expanded algorithms. We've talked to you about category creation and how change in existing treatment algorithms does take time. On the whole, we are getting good market acceptance on the need for Episealer. We do have many significant markets still to enter in the short and midterm. In the 510(k) products that you've already heard from Patrick earlier, and you'll get more detail from Katarina in a moment, there is a huge opportunity in some of our existing markets for these products. They're in established OA markets with a reimbursement pathway.
By the time we get our hands on these products, we will have a robust commercial model in place, and most importantly, we'll have brand equity with a wider group of surgeons. Thank you for your time. I'm gonna now pass over to my colleague, Katarina.
Hello, everyone. I am Katarina Flodström, Chief Operating Officer at Episurf Medical. I have a background in research within materials chemistry, and I have a long history at Episurf Medical. I'm managing our engineering team with the engineers covering both our daily production work and our R&D activities. I have a great interest in our technical details and the regulatory work. Today, I will focus on our novel devices, the products we are currently working on, and the processes to get those onto the market. I will start with the Patellofemoral System. You have heard quite a lot about it already today. It's the extension of the Episealer Knee portfolio, where we are now adding an additional implant. We have an implant system with two implants, metal implant on the femoral side of the knee joint and a polymeric implant opposing.
This is then indicated for patients with wear on both sides of the patellofemoral joint, so osteoarthritis. We have then identified this possibility to go the so-called 510(k) route for the US market, and I will go more into those details in a while. The technical details we have here, I mean, it's the same as for our new technology with these three fundamentals. We have our imaging technology, MRI-based, and we do the 3D modeling and the design based on our proprietary software. After that, we do the individualized design of surgical instruments to assist with the surgery so that we get a perfect surgical result. Then of course, we have the implants, the individualized, truly individualized, and this is the first-ever product with two truly individualized implants for the resurfacing of the patellofemoral joint.
We have great hopes that this will be successful because there are so many synergies with our existing knee products, and we have all the know-how after 10 years of development of the patient-specific implants and instruments. Also, the clinical data that you have heard about today is highly relevant also for this system. There are also some additional features. We have the broader indications here with the opposing components. It's a two-component system, and we also have the possibility with that to focus more on getting a stable joint. With two implants, you have the possibility to remodel the joint if needed, if the patient has a need for better stability.
The 510(k) word has been mentioned a few times, and that means that there is already a device on the market that we can use as a predicate device and show that we are similar to. That means also that the concept that we now have here with a cobalt chromium implant that is articulating towards a polyethylene implant, that is something that is already available on the market, so the materials are well-proven. We think that this will be a great complement to our Episealer Knee implants the day they are approved for the US market as well. Here we have some details on the regulatory pathways for FDA approval and how to reach the US market, basically. I will not go into the details, but you can see here basically that you have a pathway depending on the risk class.
The FDA makes an assessment of the risk class of your device, and if you are considered as high risk class, then you need to go the so-called PMA route. That is what we are doing with our Episealer Knee implants, and you need solid clinical data from a clinical study when you do your PMA submission. But for the Episealer Patellofemoral System, we can do the 510(k) route, and that means that we can show equivalence to an already cleared device and hopefully have a smoother way to the market. Here are some more details on this 510(k) route. This is really what we have spent our time on the last year.
The 510(k) submission for this device is done, and we have got feedback from the FDA, and we've been working with the FDA to set up then a strategy to close any questions that they have. For the Patellofemoral System, we are now in the final stage of this 510(k) process. Meanwhile, we are working with the FDA to get this product clear. We are of course also in parallel working on our internal production processes, and we are setting everything up so that we are prepared for a market launch. While this product is now in the final stage, we have another product that is in the beginning of its 510(k) journey, and that is our toe implant that we refer to as the Episealer MTP.
This has already also been mentioned today, but here you get some more details on where we are in this project. For this implant, we have not done our 510(k) submission yet. We have done a pre-submission. That means that we have started our interaction with the FDA to have hopefully a very smooth 510(k) process once we file the 510(k). Our plan is to do that during the first half of next year. This MTP implant is then the big toe implant. It's a metal implant for the metatarsal head of the big toe, and it is intended to treat osteoarthritis, also referred to as hallux rigidus. When you have that, you have a stiff toe, so you have very bad range of motion, and you also have a lot of pain.
We truly think that our personalized implant will be perfect to treat this pathology. It will be a truly individualized MTP implant and we will initially then go for the US market with this. We have had very interesting discussions and good feedback with the foot surgeons that are involved in the development of this device, and we do hope that we can bring this implant to other markets as well in the future. We have kind of a recipe how we do this individualized design because the different devices that we develop and produce, they have this personalized feature in common. Our recipe is that you take our know-how. We have then more than 10 years experience of how we set up processes to manage the design and the production of these devices.
Of course, you need good software. We have developed proprietary software that we use for this AI-based automatic segmentation of the medical images to get our 3-D models, and that's really the basis for our design. In this software, we also do damage assessment and the 3-D modeling and the visualizations. In addition to this software, we also have other software solutions on how to make efficient design. Our R&D team is not only developing the devices, implants, and instruments, but we also have a great focus on software. Of course, you need a supply chain that can manage on-demand production with reasonable lead times, and you need the regulatory approvals that we have touched upon already.
I just want to stress there that what we're doing with the regulatory processes is really we are creating this new segment, so the authorities are not really used to the discussions regarding individualized design. This is very exciting, the progress we're doing there. Of course you need IP so that you can really handle your competitors and have a competitive product. This is something Episurf has really prioritized, and we are proud over our patent portfolio. On the regulatory side, I will touch upon then also this PMA process that we will need to take with our Episealer Knee implants. This is again for the U.S. market where we want our Episealer Knee implants approved one day. To go the PMA route, you need to have a clinical study, which is very robust, a randomized controlled study.
As Paul mentioned earlier, we have our challenges as this study was started right under the pandemic. It is ongoing, and it is very exciting. It's highly prioritized in our daily work. We finally start to see some activity, especially in the U.S. This is a U.S.-European collaboration. But it's also now great that I have a colleague in the U.S. who can help them with a close interaction with our U.S. investigators. I will conclude with, yes, stressing again that we have three very exciting projects ongoing with a focus on getting devices onto initially then the U.S. market. I'm very happy to see how our technology is getting adapted for additional joints as well as for additional markets. Thank you very much.
Thank you, Mr. Spalding, Dr. Kösters, Patrick, Katarina, Steve, thank you very much for your excellent presentations. I will provide you with a short summary of today, just a few slides before we move into the Q&A. First of all, what I hope we have been able to communicate today is that this company is now in a different stage, where we're entering into a very interesting phase with not only focus on the clinical and regulatory aspects of the business, but also we're entering into excellent commercial opportunities within the five-year window. If you look a little bit longer into the future beyond the five-year window, we're focusing on commercial activities in hopefully all of our target markets.
We're targeting thousands and thousands of orthopedic surgeons, and we are going to address them with the truly individualized technology that is state-of-the-art in the orthopedic industry. The strategy in summary also looks like this. We are focusing on the commercialization of the Episealer Knee and Episealer Talus implants in Europe and certain other markets, especially then in Asia and the Middle East. The Episealer Knee implant for the US market, the patient recruitment activities in the EPIC-Knee Trial, they're ongoing, and we're targeting a PMA, but it's been delayed slightly as compared to our original timetable. On the other hand, we are hoping to achieve the FDA clearance for the Episealer Patellofemoral System now within a matter of weeks and maybe a few months.
Following that, we will commercialize this product on the US market, and the timetable for the Episealer MTP system is about one year after that. Hopefully we have that on the market sometime early 2024. This is an interesting commercial journey we're about to initiate at a higher pace than what we've seen before and in more countries with more products. Our funding is strong. We are funded well into 2025 with our current cash position, and we have worked hard with our investors to get their support in the last years, and I'm proud to show this list of the largest shareholders in the company. The management team has also invested, and personally, I am invested in Episurf, and I truly believe in the future of this company.
The team on the board level is I would like to say a really great team. We have some of them here today, and we're grateful for the support from our chairman and the rest of the board now for many, many years. We are all aligned about our strategy in the next years. As a summary from me, this is really about category creation in orthopedics with our unique individualized Episealer technology that we're now also bringing into more established markets, and that combination is really attractive. Our R&D efforts and the input from our customers have now led us to a position where we can expand our product portfolio into additional joints, broadening the target markets for us.
We have not fewer than three processes ongoing, targeting the US market with the biggest milestone in the near future being the 510(k) clearance for the Episealer Patellofemoral System very soon. In our current markets, we have done well over 1,300 surgeries, and you've seen the clinical results today. We've done surgeries in 20 countries in the last 12 months, so the foundation from which we are growing is very strong. As Steve showed you, we have a very diligent focus on both the direct markets and our indirect markets. Most importantly, we are also aligned with the major orthopedic trends, so we are trusted by our customers, the orthopedic surgeons. Thank you very much.
Thank you very much, Episurf Medical, for that presentation, or presentations, I should say. We have a relatively lengthy Q&A session, so feel free to elaborate on the answers. I'm gonna focus mostly on commercialization, but I'm gonna start off by asking you, Paul. We've heard a lot about the product, the market, clinical validation, and so on. Can you just give a brief background on who you are and your professional journey to Episurf Medical and maybe even your passion working in this field?
Yeah, yes, of course. I started in the banking business, so I've been a banker for many years. Although that was fun, this is much more interesting, so I'll focus on that. I ended up at Episurf Medical as a CFO in December 2015 and became the interim CEO a little bit more than a year after that. I always felt that this company, this really works, and this will require some patience, some funding, of course, and some strategy execution. The product is really badly needed, and it really works well. I felt that this has a bright future and this is a good thing for society.
We can create an excellent business out of this, and that's sort of the cornerstones of my passion for this. It's been a great journey so far, and I think the next five years there, they will be even more fun, so simple as that.
We're gonna stay on that theme just for one more question before I broaden my questions. You are introducing a pretty new product to a customer base that is essentially very conservative, orthopedic or knee surgeons. In order to do that, you have to have a very excellent team. Can you just elaborate a bit more on the people behind Episurf and why these people are the right people?
Yeah, sure. I mean, you have to be quite knowledgeable about what we're doing if you're going to work at Episurf Medical, needless to say, the people are very knowledgeable. I remember saying, standing at this very stage, a little bit more than two years ago at Capital Markets Day that in the next years, we will have to hire people that are better than ourselves. I said, especially in my case, and we've added and broadened the team with Steve and Patrick in the next years, following that statement. I would say they all have a great passion for what we're doing. Steve and Patrick doesn't leave Stryker because this is a cozy small company in Stockholm. Absolutely not.
We're very serious about bringing this to the global markets, and I think I can speak for them when I say that they're truly passionate about that. If you look at, for example, the engineering team in Stockholm, there are a couple of people that have been with us now for many years. You build a knowledge, and they all know, and I think I dare say they all feel what I am feeling and what Patrick and Steve are feeling about the potential opportunities for this product. All in all, a strong knowledge combined with this passion you're mentioning about this, I think that's the key. That's characteristic for many people at Episurf Medical.
You are a commercial phase company, but looking back historically, your sales have been quite lacking, honestly. At the same time you have some ambitious financial targets. Can you just elaborate on what those targets are and maybe give some color in regard to your confidence in those targets?
Sure. I mean, first of all, there are some companies with smaller implants and maybe products for similar patient group that we're doing, and they started maybe even a year before us or two years before us, and they are at similar volumes as we are in terms of revenues. It takes time to bring something like this to the market. I'm the first to say that I would love to see higher actual numbers, I mean, already now. At the same time, we've gotta understand that in many respects, we are where we should be.
Then the speed of that commercialization as we go into additional markets, additional products, we will find more of these users are willing to adapt this quite early on. We also go into the established markets. I think, without giving any guidance, I think things will go faster. When you look at the potential, we have looked at how many Episealers can a surgeon do per year, what kind of pricing can we have, what does the literature and academic science say about the prevalence of a specific indication, and then we come up with these numbers. I think we haven't changed that much for many years. You can always twist and turn and round it off here or there, but overall, this is a big market. We know that.
If you look at someone like Clemens Kösters, for example, he's way above the average run rate that we are talking about. There are both rooms for upsides and, you know, maybe slightly on the downside. It's not an exact science because we have to create the total addressable market, but we are very confident that we are much more right than wrong there.
I mean, it surely seems that there is a clinical advantage of using Episealer, but you still have to be able to reach those centers and those surgeons. Do you think that you will be able to do so solely on your own, you know, on your own, using your own salespeople and distributors? Or are you prone to maybe branching out to a partnership?
Yeah, I will answer that question. We've said before that we. That's an option for us. I've also said before that we have been talking to the industry over the years. We've learned the hard way, so to say, that we were early on, and the feedback has always been, get some more data and come closer to the US market. I think we have delivered on that. During the pandemic, we have been keeping the industry updated. We met with many of them, but it's been over Teams. It's not really the same thing.
If you look at a partnership for us, what I would say is that we won't go into anything without making a good deal for the Episurf team and the Episurf shareholders because we don't wanna tie ourself to one partner without getting some kind of reassurance in return. For now, the strategy is to go with the channels you've seen us present today. I wouldn't exclude anything in terms of potential partnerships, and it can be very attractive, and if it is, we would go for it.
In your financial targets, you mentioned the 15% markets targets from 2 years after launch. Are you looking into some sort of automation in the manufacturing, or how will you be able to cope with such high numbers in production with a patient-specific implant?
Yeah. I will invite my colleagues to answer any incoming questions, but I'll take this one as well and say we have the game plan has always been to start pre-production in-house at about maybe 1,500 implants a year. That could be soon. That could be in a few years' time. That's where it's beneficial to us. There are specific parts in the actual manufacturing chain that would significantly improve our gross margins. We would focus on that. Parts like the sterilization coating might come later as it is more technically advanced. On the software side, I'm sure Katarina can add a little bit that we are all already doing quite a lot.
Yes. I think we have taken big steps forward the last years with the software we have and the processes we have. I think we are prepared for higher volumes.
Is that mainly feedback that you've gotten from your customers that has implemented those changes?
Sorry, the customers?
Customer feedback. How do you work with customer feedback in terms of delivery and the manufacturing?
When it comes to the manufacturing, I would say there is not much customer feedback. They kind of accept what we deliver. Of course, we have an ISO system, and we are constantly collecting feedback, complaints, any deviations or whatever feedback they may have. We are collecting that, and we are analyzing and acting on that to improve our processes, definitely.
In the product development phase, customer feedback is crucial, of course.
Yeah. Yes. Yes.
That's at the heart of what we do.
Yes.
You talked about the PMA or the intended PMA process. Can you explain that? Because you had had some lack in patient recruitment, and you made some changes in the protocol. How can you just elaborate a bit on those changes that you made in the protocol some time back?
Yeah. This is not the first time. I mean, it's natural in these clinical studies that you do fine-tuning of the inclusion, exclusion criteria for the clinical study. We have done this again now after again interviewing all our especially the U.S. investigators, spoken to them to see, learn what challenges they see and if there is something they think we can adjust to facilitate. We have, of course, discussed internally and together with our regulatory consultants on what could be doable to do. We did a submission now in September to the FDA, and we have got it approved. Now we are in the stage of starting all the ethics applications that we need for the updated clinical protocol.
There will be an effect soon, hopefully, that they can start enrolling under this new clinical protocol, which will then be slightly broader indications. We will allow more, for example, when it comes to what previous treatments the patient has gone through, we will be a little bit more aggressive on that, for example.
You seem then relatively confident still in the timeline for a U.S. launch of Episealer.
If you look at the first 510(k) products, I would say a high degree of certainty. I think the EPIC-Knee trial is delayed, but we're looking into about 2026 ±, and it's hard to say exactly when, but around that time should definitely be possible. Mm-hmm.
You just gonna stay in the US for some more. Can you elaborate on the pricing for all three products and its reimbursement statuses?
Sure. Let's sort of bracket those in two separate groups. For the two products which we spoke about as it pertains to the U.S. mostly today, the patellofemoral product and the MTP product. One of the benefits or one of the numerous benefits of these sort of 510(k) type of products is you're going into existing markets. There's existing pricing. There's existing reimbursement. You're going in and your sort of sales tactics are much less category creation types of tactics, and they're much more sort of share gaining tactics. It's much more sort of features and benefits types of selling interactions. That's a long way of saying the pricing exists. We're aware of the pricing. We're comfortable of the pricing. It fits very well within our own financial models.
We should have no real issues whatsoever when it comes to both pricing and reimbursement. These are existing, you know, these are existing markets. We're just offering another product into existing markets.
Is that the same for Episealer?
The Episealer itself will be a little bit different. You do these high-powered level one type clinical trials like an IDE trial. Everyone thinks of them as trials to get past the FDA, and that is certainly sort of the headline reason that you do these trials. One of the other reasons that you do these trials is you walk away with you own the data and payers want to see that same type of data. Sort of a secondary function of those trials is then you can work within the medical societies to go then eventually get your own codes adapted that are implant and procedure specific.
You can't go do that without your own insurance providers, Medicare, and the commercial insurance providers. They all want to see these level one types of studies. On the literal day of the approval, there may not be the fully, you know, sort of baked-in reimbursement structure in place. However, we will own then most of the data and can begin immediately sort of working within the appropriate surgeon medical societies to go ultimately get our own codes created.
With the MTP and the patellofemoral product, they are taking the 510(k) route. Have you had to make any development compromises on those products to
Uh, well-
Yes
Yes, some compromises, I would say, yes. Not too severe. I mean, we still believe that we will have a great product. However, I mean, it's not that easy to get through the FDA. You cannot get through with anything you need to adjust. To make sure you really fulfill what FDA sees as that you are substantially equivalent.
If I could just ask or get technical on a word here. Compromise doesn't always necessarily mean, though, worse. I mean, it might mean a slight deviation from the existing European product, but some of those you know, some of those differences might be very sort of differences of opinion rather than differences in kind. While there have been a couple of differences that might have to be changed, there's no one walks away thinking that the product is any worse. It's just slightly different than the existing European product.
Okay. Once you're in the US, I mean, how do you make sure that you will not face the same slow sales ramp-up that you've had so far in the EU? Because that's an entirely different market than you have been active in for some years now.
I think one of the, it comes back to this established versus creating markets. When you show the standalone Episealer device to many surgeons, you know, they'll first ask, well, they won't literally ask, "What is this?" They start to ask questions very quickly where you can tell they're, they are trying to understand from the company how this fits in their existing, you know, which of their current patients that this sort of fits within.
With the patellofemoral product and the toe product, as soon as you show that to a surgeon, they will not think, "Well, what is this?" or, "How do I use this?" or, "For which patients is this intended for?" They will immediately know, and again, the conversation becomes much more feature and benefits related than it becomes like patient selection, indications types of conversations. Those are just, frankly, faster conversations that you have. Those are back and forth types of things versus these, "Well, I'd like to talk to three separate people who have used it and followed it up." The conversations, they sort of get down to business really quick about, you know, "Okay, I see this. How is this better for me?" Then you're sort of off.
We don't have to or won't have to explain to them how this fits into their sort of current treatment paradigm.
Those surgeons, are they? They're not the ones who actually carry out the knee surgeries, are they? I mean, is there a synergy with those surgeons who are using the MTP and the patellofemoral, obviously patellofemoral, but also MTP joint once you launch Episealer?
There's no synergy really between the patellofemoral and the toe users, but there's complete synergy between the standalone knee device and the patellofemoral users.
Yeah. You launch there with that product. That product is essentially you're starting to raise awareness once you launch with Episealer.
That's right.
Yeah. In the EU, you have inclusion in UK NICE guidelines. I'm just wondering if you could elaborate on how the opportunities would look like in the UK without NICE guidelines and what other markets you expect to follow suit.
Yeah. I'm happy to take that. I mean, the UK NICE guidelines, it's a definite vote of confidence. It really helps existing users. It gives them some reassurance that they're doing the right things, but it's not necessarily a home run, you know? We still need to work with payers. You know, we need to work with our clinical teams to really build the business case for Episealer even in those markets. Other markets do still look to the UK. What are the UK doing from an evidence-based perspective? They still look to those NICE guidelines. I'd say it's definitely a step in the right direction. It's building on our evidence base. It's building on our story about it being a successful procedure, and it'll certainly help with private insurance reimbursement.
I'm not suggesting that that's just, you know, done and dusted. We've still got some work to do there.
Have you been able to practically notice some extra increase in interest after the UK NICE guidelines?
Yeah. I mentioned earlier in the south part of the UK, we're certainly seeing an increase in pipeline, increase in scan submissions, which is positive. Definitely within the NHS setting, there's this reassurance that having UK NICE guidelines, it's often requested by trusts and NHS trusts to really have that as a just to reassure the trust that they're doing the right things. Yeah, definitely.
In the EU, we have the MDR, the Medical Device Regulation. How are you positioned for that change?
We have our CE certificate for the knee implant and the patella implant, valid until May 2024. Under the MDD, we still have our old certificates. And therefore, we have not yet gone through the MDR transition. We have a plan together with our notified body, so we have planned this for next year, so there will be a lot of attention to this next year and do the submission and go through the process, and also for the quality assurance system, of course.
I'm gonna soon leave the commercialization questions, but just a final one. With these financial targets in the back of my head and the future that I expect could lay in front of you, how do you think that the organization will change from here?
I mean, it's twofold. Obviously we have a plan for our different cases we're working towards. What's important in the sales organization is that we succeed with the independent distributors, both in the US and in non-US markets. That there's obviously both, you know, pros and cons with either direct or indirect models. In the indirect model, we haven't really seen success yet. As we do that, we can obviously gain a lot of efficiencies in our cost base, if you look at our P&L. The investments we will have to make in the organization in Sweden, if you like, is especially within the engineering team that's working on the damage marking report.
I foresee some kind of subgroup, potentially not in Sweden, that's working exclusively on the damage assessment. That would be a highly specialized unit, with a high degree of efficiency. Then that team will definitely grow, but we have quite good forecast for how we will handle that to ensure a good gross margin in the coming years.
Okay
That's how we're thinking about it.
Just moving on to clinical documentation for a bit. We all know that without clinical documentation, you're not gonna make it in med tech. I mean, are you so far happy with the clinical documentation process that you have? Or are there any missteps along the way that you can look back on and say, "Well, we should have done this instead"?
No, I mean, we tend to look forward. The EPIC-Knee trial, I mean, you would have loved to start that earlier. Professor Leif Ryd and I, Leif, we've discussed it many times. What one has to remember when you think about that, backtracking decisions like that, is that in the beginning, Episurf didn't know that this worked. Starting the EPIC-Knee trial, let's say four or five years earlier, would have come with a much bigger clinical risk in the eyes of investors and the then management, et cetera.
I can clearly understand that they really wanted to see that this works and it's well-received by surgeons in Europe before you go into such an enormous undertaking that the PMA trial is. With that said, of course, we would have loved to start it earlier. I think on the other clinical trials in Europe, I think we've done a massive amount of efforts at a very limited cost base, and we have been quite efficient in our clinical work. Especially, I mean, we've been supporting clinical trials and giving grants, et cetera, but the big trials that you see in Europe being published now, they are investigator-initiated, and they're not ours, so to say.
We've been fortunate to have good relationship with people who wanna use this and who wanna try this, and that's been very beneficial from a financial perspective. You know, we look forward, but there are things to say, of course.
Apart from the EPIC-Knee trial, is there any other particular clinical data or that you look forward to the most? I mean, you have medium-term data, for example, but are you? I mean, long-term data must be the next big thing for you, is it?
Yeah, I'll answer that one, and my colleagues can definitely add to this. If you look at the milestones in the short term, it's the publication of the five-year results that we've seen being presented today. That is the absolutely most important milestone in the coming months for us, and we're talking about months.
Of course, we have the TALOS data coming in. We start getting two-year data for TALOS, which will be very exciting and important.
Professor Spalding said earlier, these first generation implants failed, they failed early. He's not really expecting any major deviations from the performance that we're having already. Of course it's reassuring when you do have longer-term data.
Yeah. Yeah, I can imagine knee surgeons really wanting the long-term data before, yeah, implementing it more broadly. Health economic data as well, very important. How are you progressing on that point?
It's been resubmitted a few months ago now. I know we have talked about this for quite some time. All we can say, we hope to have it published now. I've said that before, so I understand that the credibility low in this, in this particular question. That's the best. To the best of my knowledge, it should be published quite soon, and it'll hopefully show some good results.
Before I ask my final question for the day, is there anything that you would like to just clarify or elaborate on in my previous questions? No? Okay. Okay, so my final question before we wrap this event up, it's a pretty basic one. In the coming 12 months, what is the key priorities and focus areas?
We tend to look at this in two regions, it's US and non-US markets. As I've shown on one of my slides today, how we're thinking about the growth in the coming years. We need to see continuous growth in the customer base and then the activity level in Europe and the Asian and Middle East markets. That's absolutely a priority. Secondly, in the US, the 510(k) clearance for the Episealer PFJ in a matter of weeks or months, it's one of our biggest milestones ever, and the subsequent commercialization of that product in the US. I think those two are the key activities for us in the next 12 months.
Just around the corner from 12 months, we add the MTP product as well.
Perfect. Thank you very much, and I look forward to your next Capital Markets Day. Hopefully we'll see some more exciting things presented.
Thank you very much.
Thank you.
Thank you, Oscar. Thanks.