Peter Weiland Presents NGMedical at LSI Europe '23

Transcription

Peter Weiland  0:05  
Thank you very much. Good morning, ladies and gentlemen, for having me here. Let me talk I'm happy to present to you how we can improve patient outcome by keeping motion in spine. So we're talking about motional, preservation in spine. Let me start with the cervical part of the motion preservation. I guess every one of you knows anyone who has back problems, or has back problems. I think it hits all of you. I know personally, what is degenerative disc disease? What do we treat degenerative disc disease is Theodosia healthy, this healthy spine. And what you see here is a nice degeneration, very nice described, and we have about 40% of adults suffer of this generation. How are they treated today? Majority of people are treated today with a fusion. And we see here, I'm sorry. Here on the left side, this is the standard fusion cage, what is it, Mike, it just fuses the level. So you can't you can't move anymore. And we reduce actually we have an overload on the neighbor levels. So what we tend to do is actually what we try to do, we keep motion, keep motion on the left and the segment. So overdeveloped is actually move see, it's a cervical artificial disc prothesis. What you see here on the left on the right side, in the implant holder, which is delivered to the surgical field, here an example how it's implanted. Now, what's unique with musi is actually that we are able to really replace physiological motion motion entirely. So it's not only the motion as a joint, it's also actual shock absorption is restriction to motion. So it's not a totally open free motion. It supports the body motion, and it's the only TDR available in the market with FDA manufactured end plates. So the titanium and plates are manufactured relatively, it has a defined neutral zone. So if you move your head, you know that you have a free zone for motion. And then if you turn it further, it stopped any prevents motion. So that's what's built in here. So we protect anatomical structures and help the patient to really move physiologically. The implant holder is complete a resolution. This is why you see intraoperatively exactly what you see here. So it's a perfect application for the for the for the surgeon to implant it. And it has a unique anatomic design so it's easier to implant it's fast to implant so it's really outside the future in cervical degenerative disc disease treatment. Why do we stand today? It's commercial. We did the first cases just in time for COVID. So we all know we went through the pandemic, everyone was hit by it. We did the first case in January 20, which was, what four weeks before COVID to Germany, so perfect timing. But nevertheless, we did meanwhile, we actually surpassed in August of 1000 implantations, we'll see this. It's approved in entire Europe, its approval. We do have additional approvals in like Nam, Taiwan, we just waiting actually for Mexico, which should be approved in a couple of days now. And we are in the middle actually of the PMA trial for the US approval, which obviously is the most important market worldwide. We should complete patient enrollment in q1 next year. And then we all know it's a two year follow up time we can change two years, it's two years. So we do our best to complete patient enrollment. We are in contact with the FDA, we had a pre submission web nice discussion with the FDA and a very good response. So I think we have very good track what will be musi and obviously it's IP protected, that's for sure. Let's go to a lumber because it's not only it's we're not a one technology company like most companies presenting here, we define ourselves as motion preservation experts. That's what we do. So we don't only work on the on the cervical spine we also work in the lumbar spine and all the products we which keeps you moving, I called move. So let's see for cervical P for lumbar. What does this product do? Let me explain a little bit what a choice in this disease means in the lumbar spine stainable general treatment and lumbar spine is a fusion in one level, what you see here is pedicle screws and cage and then what you see here is an overload after six month, eight month you have fusion so you don't move anymore in the segment and you have very strong points or upon the works here you have a very strong overload in the adjacent segments. So what does this happen? The cause and the patient has very often that you fuse one level and the next level will degenerate a lot faster because you have an overload there. So what do we do what what do we try to prevent your move p is a Pedic screw by system. I hope this you can see I can And see, this is an example of the applications, we have two standard Pedic screws for fusion. So you have one level of fusion and then you implant move p on top of this one, which is called topping off. So you have a smooth transition from the fuse level to the next level. And to keep motion in this level, and we have a nice publication on the system, which really proves that exactly the physiological motion that we intended to achieve is achieved, but not 100%, this wouldn't work that just wouldn't make sense, will reduce motion to 80%. So it works, you probably would say like an internal price. It supports the human structure. But it reduces motion a little bit. Where do we stand, or what's what's the use piece here? Important is very important, that's absolutely unique. It's the whole motion is built in the head of the screw, exactly what motion happens on the spine. And if you imagine you do a flexion and extension motion, the implant is implanted postural Lee. So the distance between the two vertebral bodies changes. So if you will see the screws here and you're matching, you do a fraction, then the distance between this group and this group just gets larger. If you're if you go backward, if you do an extension, it gets shorter. And what's in what's very interesting is the force you need for flexion. And extension is totally different in the body, you need less force for flexion for a longer distance of motion. And you need a very high force. If you extend back, you we all know we can learn, we can bend forward to lift a case of beer, for example, for the germs, or you can move backwards, but you can move forward very deeply, but backwards just a little bit. And this is built the system completely. So the system is designed in a way that if you do an extension, it allows very limited reduction of the length of the rod will the high force or high load. If you bend forward, the rod gets longer with a lower load. So it's completely adapted to the field office philosophy. And the motion is always in the hands. So it's exactly where it should be. A little describe description of how it works, what makes it easier, I think for everyone in the room. This is the green lines here just symbolize move move P instruction. So this is the move P screw. And this would be a standard pedicle screw. And you can move this level completely normal physiologically with just a limited motion. Because the Rottier gets longer and shorter and likes all the motion in there. Where do we stand? This is not clinical yet we plan to get to get clinical in q1, latest q2 next year. We do plan and we are in preparation for a combined clinical trials for Europe and the FDA. So we are in contact with the German health ministry and we're in contact with the FDA under pre submission. So we do all to put together and get this done. Several IPs Grand Tour. And very interesting. So what is the market potential is interesting for your market potential cervical is pretty interesting. It's a huge market, you probably wouldn't be wouldn't expect this. The same for lumbar, which is a little bit more difficult because there is no really comparable device on the market. Yes, there are some devices which are called dynamic devices, but they're not really comparable. We are commercial business that we started in two in 2020. And meanwhile, obviously we all have discovered phase, we are pretty much on track and we already surpassed 2020. So we and the good I would say speed coming up protections pretty interesting, because it's a very interesting market and we especially will the FDA approval be expecting 26 where we can we can really gain speed. The team very short, very family driven business. Obviously the best in the middle. What you see here is just an overview on deals happened so at the very high valuation market very interesting market is driven by strategics. And what we're looking for at the moment is we raising 10 million. So if you're interested to push forward PMA trials, commercial commercialization and support us, we are very open and happy to talk to you. So thank you very much