ATRO Medical | Jan Hunik, CEO

Jan Hunik  0:02  

Good morning, everybody. My name is Jan Hunik. I'm the CEO of ATRO Medical, we are the meniscus prosthesis company, we try to solve chronic knee pain. Just to introduce a little bit on why the meniscus is so important. And what happens when you lost your meniscus function.

The meniscus is really your shock absorber in your knee and helps to also to distribute the mechanical forces of the knee, but also guide you with flexion and extension of your knee. And everybody is familiar with sports trauma, or your own sport fields or you hurt your knee. In many cases, you have a ligament injury, but also a meniscus injury as you can see on the bottom. And what happens then is that meniscus tissue is being removed, and your shock sort of function of that of that meniscus disappeared, or you get localized high mechanical forces on the cartilage in your knee. And it leads to accelerated wear of your knee joint. And this is how it looks like if you see an X ray. On the right side you see a healthy knee, and on the left or sorry, on the left side, you see the healthy knee on the right side you see a knee where the meniscus function is basically minimized, or you see what we call joint space narrowing. This patient will probably are in pain or soon be having chronic knee pain and knee pain. chronic knee pain is really a debilitating disease for a lot of people, I suppose you are a teacher or a policeman or you are standing in front of a classroom or even military service people. For them, this is really a life threatening event. So how does that look like if you look at the timeframe on how this disease develops trauma and the loss is something really associated with sports when you're relatively young. Material meniscus meniscus material can easily be removed without scopic procedure. And you can go back to your normal life again. In principle, cartilage and meniscus doesn't contain any nerve pain, so you don't feel pain. Bone has a lot of nerve pain. So as soon as the disease progresses, that pain start to appear. And then you get a period where people are developing that pain. And they will have lengthy discussions with an orthopedic surgeon because there is not really a solution for it. What they do is pain medication, physical supplementation, anti inflammatory and injections, braces, whatever. But it doesn't work. Finally, so let's wait and see until you come to joint replacement, which is not something that you would like to see before you're 65. So this period can take quite a long period of time. Now this, our solution comes in place here, we have made a trampoline meniscus prosthesis, it has an anatomical shape. So it really mimics what the meniscus looks like. It's a polymer. It's a permanent polymer. So we don't think scaffold will work in this case we make versus full polymer meniscus, highly durable, minimal invasive surgery to to to, to apply it. And that restores the function indications are if you have persistent pain and history of meniscus damage, filled conservative treatment, ligaments intact and neutral alignment of your knee or limited cartilage damage, you can be eligible for this procedure. This is how it looks like. And this is what we try to to achieve. We want to reduce of course the time that you are in pain, but also push out the total knee replacement to an age of 65 and 70. And it's probably life lasting as a device. So this is our mission to improve the day life those patients provide them with a real meniscus prosthesis that works. Do that be minimally invasive surgery. It's also easy to learn by the way for orthepedic surgeons we have experienced with that reduce, reduce the chronic knee pain to show restore the day to day mobility. We don't think they can go into active sports yet and save that native knee joint. It's really a large market opportunity. I mean there is no there is no comparable device that can do this at this stage available in the US. But if you look at it, I mean there are 2 million people who receive an otoscope procedure each year and EU and US a 50% of that procedures meniscus material is being removed. That's a huge group of people and outdoor literature. We think that 40% of those group is being eligible for our trampoline meniscus prosthesis. It makes sense if you link take about a reasonable market price over A billion dollar, euro dollar opportunity, a little bit about the competitive environment because if it's not there, you can imagine that people are working on it. The two are in the middle of very experimental University spinouts.

You can see active implants our new surface with a new Surface device, they have taken a different direction. They have they are not anatomical shapes, and they also are not fixed on the tibial plateau. They are in clinical studies just like we are, they had CE mark in Europe in 2008, but not a lot of market traction. And they have done a large US study and are waiting the verdict of the FDA on their on our final device. But we think with the anatomical shape and the fixation, that we are much better positioned to help those patients. Now, where are we basically are based in the Netherlands and started in 2017. We did our first immense study in 2019. With a lot of interesting learnings, which we implemented in our in our revised design. We are ISO certified, we have the FDA breakthrough designation. We're Medtech innovate finalist. And we obtain a large grant for the development of this product. So what is our plans? However, where do we want to go? This now 2022. In three weeks from now, we will start our second clinical study and have the first patients in the OR at the beginning of April. It takes about six to 12 months before we can really see where the study is going and if these patients are really performing well. And we want to use that time to prepare prepare for the follow up studies and accelerate our our program by collecting a larger CDB investment to start a study in Europe and start to study in the US and aim for an CE mark in Europe as soon as possible. The FDA and in the US and de novo classification will take longer we think the 2027 is realistic. Skip this one, this is the takeaways. So what we tried to do is really solve a large unmet need with a simple procedure and prove proven but biomaterial by making this anatomical as possible. We also and fix it where nativeness was fixed. It's also very recognizable about orthopedic surgeons and they really give them a solution for their patients. Your IP portfolio is we own that. And in COVID period, what we tried to do is implement all the learnings of our first immense study in our improved design. We obtained our FDA breakthrough designation. And we spent a lot of time on preparing ourselves for the follow up studies in the EU and US. So what are we looking for, we're looking for 12 million investment and and this year or the beginning of 2023. And we think we can obtain commercialization in the EU as of 2025. This our team we are more than way over 225 years of medical device development and under our belt and we are very experienced supervisory board is a very European way of organizing ourselves, Supervisory Board are investment people with commercial and also medical device experience. And I want to thank you for your attention and the opportunity to present at this conference. Thank you very much