Chris Sturm, Facet Dynamics, Inc. - Unilateral Lumbar Facet Replacement Device | LSI USA '24

Chris Sturm  0:03  
I'm very excited to be here today. This is the first time that I've presented this device to anybody. And the problem is that for the last seven years, there's really been no change. We've been using performing lumbar fusion procedures to provide stability after decompression. The problem is that leaves the spine in a completely opposite state, it's not moving, it's supposed to move. Each one of those discs are called a motion segment. So fusion, which has been the case for the last seven years has its problems. The market space in this situation is huge, projected to be about 18 million in 2030. Our device represents a very simple and pure solution. It is a lumbar Fustat replacement device akin to an artificial hip or knee joint replacement device. To this process, we have utilized consultants to get us to where we are, and we're basically in effect ready to do an ID study moving forward. So I'm a practicing neurosurgeon, and it's very common if somebody will show up with mono radicular pain, meaning pain from a nerve being compressed, secondary to the first set joint being too big. In order to decompress that nerve, I have to remove the first set. If I do that it stabilizes a segment, meaning I have to infuse that patient, leaving that patient with the antithesis of what's supposed to occur at that motion segment. That changes the biomechanics as how the spine handles load, and curate undo load transfer to the levels both above and below a few segment creating something called adjacent segment disease. Meaning you can then chase your tail you did a fusion at what level now you're having to do a fusion and not level and so on. That's why artificial lumbar discs were developed to try to address this problem. The problem is is that is contraindicated if there's the set degenerative disease there in terms of implanting that device, and we feel that our device represents a very simple solution. The market again, as I said, is huge one point or something 11 point 4 billion in 2021, projected to be 18 billion in 2030. This is speaking to a population where the degenerative process occurs in everybody, it's inescapable, there's no pill that you're going to take that's going to stop this. So it's an ever evolving ever enlarging patient population that our device speaks to. Basically, in the in the past, the approach to creating a preset replacement device has been one in which it's an artificially designed contraption, if you will to reproduce all the vectors of movement in the spine. What we're looking at is a lumbar spine specific device, where the primary vector of motion is flexion and extension. The Fustat joints not that complicated is two bones talking to each other with lubrication in between and a capsule that is reproduced in cervical, thoracic and lumbar. The only thing that changes is the articulation angle. That's what drives the function of the cassette and in the lumbar region, the primary vector movement is flexion and extension. Our device seeks to reproduce that anatomy. So by reproducing the anatomical structure of the facade joint, the attempt is then to reproduce that function. The key is the articulation angle, as I said, and our device which is enclosed to represent the or reproduce the set capsule is designed to be lumbar spinal level specific. So those angles then change at the different levels. It's made out of chromium, cobalt and ultra high molecular weight polyethylene the same materials that are used in today's artificial hip and knee joints. The same materials that are already FDA approved for multiple cycles of movement to the life of the device. Surgeons basically want devices that are conceptually appropriate, they're easy to implant and they work. We deal with anatomy everyday. I'm a practicing neurosurgeon. That's how our brains work. This is a anatomic set replacement, previous iterations designed to try to move in all the different vectors. But frankly, in the lumbar region that's not required 91% of the movement is flexion and extension. There's been a new device that breached the market and for set arthroplasty very recently. It's called Tops by Premier spine in Israel. It is is a bilateral device. They did all the hard work for us. They establish the CPT billing codes and pre certification. The hospital facility costs and the surgeon reimbursement. The problem is we have a much better device. Our device is unilateral, that allows the surgeon to be customized in terms of their delivery of care. If you have a bilateral device you have to remove everything was ours, you only remove the part that's messed up leaving a normal structures there so that our device in effect works in concert with the spine. It's not a spinal takeover. implantation is very simple. It's the same as today's lumbar fusion procedures. The only difference is instead of putting a 5.5 millimeter rod to the pedicle screws, you place our device but it's exactly the same fashion using exactly the same polyaxial pedicle screws that are used today's and today's fusions. Where we're at now we have for US patents was another pendant we have international European patent was another pending we have an Australian patent, and we have a Canadian patent pending. We have strategic partnerships with precision spine, who will be providing us with the pedicle screws through testing and the ID study. We had the opportunity to meet with the FDA who defined our regulatory pathway. But that also successfully introduced the concept of a unilateral facade replacement versus a bilateral facade replacement is easy to implant. It's easy to revise, it's straightforward. It doesn't require any surgeon trainer and it's perfectly suited for mis as well as ambulatory surgical care center. We have utilized a team of very high level consultants to get us to where we are. We have Janice Hogan with regard to regulatory affairs canobie Martin with regard to oral patents, we have a strategic partnership as a separate precision spine, empirical technologies are going to be doing our IDE study, medical device development did all of our counter varix testing which we just recently performed. And in that study that categoric study that we recently performed tops did the same thing. So this is this, this is a bilateral device that's already in the market. flexion extension most important. When tops did their study, they were able to reproduce 55% of lumbar flexion extension, we produced it 93% We assessed the forces of the screw at the pedicle bone interface, which is critical because if there's a lot of force there and degradation, things gonna break down. We were 40% less than tops. In terms of the investments, we're looking to raise 15 million, we have to go through an ID protocol or an ID pathway PMA pathway based upon our FDA meaning if we were to be received that 15 million we anticipate that we will enter market in March of 2028. There are however exit points when we complete our ID when the FDA comes in checks us out halfway through that ID as well as when we complete but our our valuation along this process that slope is going to be incredibly steep. This is the epitome of disruptive technology, we are talking an $18 billion market. We are speaking to 85% of that market, artificial on our desk only 15% Because of the set problems. So this is is choose. We are looking again to raise the 59 in effect at the very bottom. But the the slope of that valuation curve stands to earn a tremendous amount of money. And we would love to talk to anybody who is interested in our project. Thank you