Mark Novotny Presents Spinal Stabilization Technologies at LSI USA ‘23

Transcriptions

Hello, everyone. Good afternoon. My name is Mark Novotny. I'm the president of Spinal Stabilization Technologies day, that was a very nice presentation. I hope you're successful because I think I need that. So let's get that thing to market. Well, I can't see as good as I thought I was going to. But just to ask a quick question, before I start, can I just see a show of hands of who in the audience has heard of lumbar nucleus replacement? Of course, we have some hardcore orthopedic good. Okay. So this has been a real heart project. And we've been working on it for a long time. And we've spent a lot of money on this. And I'm going to present where we are to you today. And we have experts, obviously, in the room. So I'm available after if you want to talk about this a little bit. So it's had an amazing history, this category of innovation. A lot of people use the term it's or the phrase, it's the Holy Grail if someone can actually solve this problem. In fact, as I've been presenting here, over the last few days, I've heard this 10 times at least Oh, the Grail, the Holy Grail, you think you have it, it's a graveyard of failure. I hear that every day for the last nine years. And there were numerous attempts over decades and millions and millions of dollars spent on the problem of lumbar nucleus replacement. Really, it comes down to they come out. So lots of innovators and lots of surgeons attempted to put lots of different devices in the lumbar disc for dark disc disease and back pain, severe back pain. And expulsion has been the problem that's kept the sector, the segment or the device category, from actually getting to market. And the entire spine sector, which I also live everyday believes it may not be able to be done. So what I want to do is at least if some of you walk out of here today saying SST may have it on, that's going to be a win for us. That's my goal. So just quickly, not to oversimplify this, but on the left side, this is a functional spinal unit or an FSU or it's an area of the spine that all these structures work together. In the middle of the left image is a disc. And then it's surrounded by two vertebral bodies, and there's nerve roots and musculature, etc. It's a very complex joint that has a lot of force and a lot of motion applied to it throughout your life. And it breaks down. That's degenerative disc disease. On the right side is a expansion of the disc graphic that shows the two primary parts of the of the disk itself, which is the outer band, which would be like the sidewall of a car tire, it's layered. And it's very, very tough. And there's multiple concentric rings that make up the outer band or the annulus. And in the middle is the nucleus. Now, the nucleus is also an extremely complex structure. And it's very tough, but essentially, it's a hydrated piece of tissue that is incompressible, and it works in conjunction with the annulus and each share about 15% 50% of the load. That's how to think about this. It's an oversimplification, but that's essentially what's happening here. So I come from cardiology, interventional cardiology, and interventional radiology. So what I'm about to show you looks like an interventional procedure. And there's a set of catheters and balloons etc. And a delivery system that's very easy to use. And that's highlighted here by this picture of the percutaneous delivery system, which is a series of membranes and balloons that are all organized together and then loaded into a six millimeter catheter, that after the nucleus is removed, this is advanced in unsheath and then filled and cured inside to on the bottom is the perkiness cured. It's essentially a replacement for the nucleus, it's the Think of it maybe as the new inner tube inside the tire. Just quickly, each implant is custom based on the patient's nucleus. And based on the geometry that results from the surgeon removing the nucleus, so they surgeon, the surgeon access the disk, either laterally or anteriorly or through the back, which is not something we've innovated or developed. This is common spine surgery access. And they remove the nucleus with a set of instruments or tools that they are used to using so we don't do a lot of work around that. But that's a key part of our physician training. And it's custom so when the balloon is put inside, it's filled from outside with a film material that is very similar to what's inside had over breast implant. And then it cures into a specific stiffness or hardness that is known to be similar to the biomechanics of an annulus and a nucleus. And there's a lot of work people in this room that have done decades on that. And so that's widely published and known. And that's what we've been able to design our technology to. Let's see if this plays I don't think this is going to play that's a video. But essentially, this is a something our independent core lab does on all patients that we treat at 30 days, and then at one year, and if this were working, it would show the disk going back and forth. The perky disk is the white new nucleus in the middle, you can't image the annulus so easily, so you can't see it. But it's secured inside to by the outer margin of the of the annulus of the disk. So this is not coming out. This is a typical group of patients, I just selected a random group, some 30 Day follow up data, some 90 Day follow up on the top as an MRI, the black discoid structure inside the middle of the disk is the perky disk. That's what it looks like it follow up. So you can image it at different time points, watch what it's doing, see how it's performing. That's a very important feature of this technology. And on the bottom in the X ray, you can see the perky disc, it's petricola pedicle in the center. And on the left and right the little glowing dots are marker beads that are very common in balloon technology these days. Okay, so here's the data, we've treated 30 patients. And our clinical trial is really ramping up. We're going to be at the end of April around six patients three to eight patients a month in our clinical trial program. But their data, I don't see it really changing that much since we've followed our patients out to two years. And it all comes down to picking the right patient where percutaneous will work with any surgical procedure, you have to identify a certain population. And in our case, it's huge. And we do a lot of work about six months of work getting the patients ready for this procedure. And that is the whole key to a really great outcome with nucleus replacement. And the yellow line is back pain or back visual analogue store score. The green line is leg pain. And the blue line is the Oswestry disability index, or the ODI, and these are all FDA style endpoints for a trial of this nature. And you can see that we took very high pain scores and very high disability scores. In fact, all of our patients in these trials were disabled, and either not working or working with heavy restrictions. And I'll show you some of that data in a minute. And so they've had this great response in pain and disability. So we're really excited that we're helping out a lot of people that have a really tough disease state. On the right is pain medications. And we follow our patients at 30 days, 60 days, 90 days, six months, one year, two years. So we have a ton of data on what's happening. And green is no medication, blue is over the counter and red is opioids. And you can see one of the really cool findings is all of our patients are off opioids at 24 months. And in fact, all of them were off at 12 months, except one was on over the counter pain medication. And so no expulsions yet. And I don't think we're going to have them because there's no channel for the device to leave the disk. So the problem that's hurt the sector, I think we may have cracked it. So keep an eye on it. We're going to start putting our data out and publishing it etc. Reduces back pain, leg pain maintains the range of motion. It's not fusion and the patients get back to work. So it's for degenerative disc disease, nine hospitals enrolling if anyone wants to see a case, if you're interested. You see one case and I think you'll be you'll be pretty much on your way to being convinced. We've raised 40,000,009 years of development, but I think it's probably here to stay. Now finally, and we're preparing for our FDA trial. We're far along in the negotiation. And we're raising 40 million now for the FDA trial. I've got a little bit more than half covered. And if you're interested, there's my cell phone. Easy to find me because I'm on this damn crutch. So I'm around. Thank you very much.