Lali Sekhon, SpinePoint - Interbody Devices for Spine Surgery | LSI USA '24

Lali Sekhon  0:04  
SpinePoint is what I'm going to talk about now. It's a medical device company developing next generation spinal implants. There's a single owner, we've seed funded to $2 million. And we are pre revenue. What I'm going to present it to differentiated product families and it's nine potential products. For spine surgery. I'm a neurosurgeon. So I've been intimately involved in directing these products, we have three patents published, one is pending. And two of the products have already been prototyped. One will get a 510 K in the middle of this year as well. We've assembled a team together, and I'm the neurosurgeon founder, but we have seasoned executives involved in health care. And amongst that group, we have 150 years of combined clinical and executive leadership. If you look at the spine market, it has significant revenue potential and has growth, the orthopedic market in the US is about $50 billion. I'm going to talk about the nuts and bolts that spine surgeons use, and they are cages and screws. So in the US, which is about 60% of the world market cages are about a $2 billion market, and that's in the cervical spine, the lumbar spine as well. The average caged cage to produce is about $200. And this can be sold for about $3,000. So significant markup on cages, pedicle screws, again, it's a cool product response surgeons. And that's a $3 billion market. And the pedicle screws, again, a construct is two screws, sorry, four screws, two rods, and four set screws. And that's about $200. And again, the markup there is to 3000 or $6,000. So there's a huge market for markup for spinal implants. If we look at that market again, looking back in the last five years and projecting 10 years ahead, it's about a $9 billion mark. It's growing about 3% per year. Interesting thing about the spine market is 75% of the market is five companies. And these companies are not organically developing anymore, most of it is by acquisition of smaller companies. And our ultimate goal would be acquisition as well. So let's look at the products. What I want to present to you is fairly innovative pedicle screws, nothing like the screws that are on the market now. And a group of antibody cages, the top left one is the one that will get 510 K, mid 2024. We'll start with the cage. So most implants that are used in the spine are the stiffness of titanium. And you can see that on the bottom there. Bone is much less stiff. And if you can match closer to the stiffness of bond, then you're much likely to get problems and I'll show you what those problems are in a minute. And our implants are significantly less than the stiffness of bone, and significantly less than the stiffness of titanium. So what's wrong with cages and screws as they are now if you look at that top right diagram, there's a cage that's been placed. So when a surgeon takes out a desk, you're placing interbody cage into that space and that's a very common procedure. One of the challenges that happens is something called subsidence. Subsidence is where the cage sinks into the bone above and below. It's relatively common and stiffness is one of the causes of subsidence. If you have a less stiff stiff device, you will get less subsidence. The device that I'll show you is the lowest stiffness device that will be available on the market. Less subsidence means less clinical complications, less surgeries. The second issue that we get with spine surgery is we have a successful surgery as you can see on the bottom right, and over time the adjacent levels were out and this adjacent level degeneration is a common problem. spine surgeons face patients end up getting more surgeries. The cause is multifactorial, but stiffness is one of them. And if you can reduce the stiffness of the implants down to native born, you'll affect adjacent segment disease and all of this means less surgery for patients and spine surgeries becoming less common, more common, not less common as our population ages. This is the endoskeleton of the cage in a plastic mock up, and it's got a Z shape and in cushions, it load shares, it reduces the impact on the adjacent discs. And again, it may improve patient outcomes. So we started with the design on the left hand and that design because it moves and it's micro motion would need a PMA. So we went through eight different iterations and arrived at the design on the right hand side. And we've done all the preliminary FDA testing and we submit in about two months. There's a cavity which can take whatever biologic as well. So there's looks and smells like every cage that's on the market. However it cushions and that micro motion is what reduces the stiffness in this cage and that reduces subsidence reduces adjacent segment disease. So if we look just at the cage, this is the lowest stiffness cage that will be available on the market. And it's the geometry of the Z shape, which gives it that reduced stiffness. And that's patented, we have two patents protecting it and one pending. It's prototyped. It's tested, the design is frozen, we've done all the instrumentations for it. So for this particular design, we're on the homestretch in terms of getting FDA approval, and then looking at a commercialization. Now that same technology with the Z shape, can then be adapted to seven following products. And those seven products can be used from the front of the spine, the back of the spine, the side of the spine, cervical or lumbar, it's the same intellectual property, but it's just been adapted to the other areas. So one of our key things that we want to be moving at is finished the prototyping of these devices, and then bring them to market. Let's look at the screw. So most of us know what screws are. And everyone has put a screw into a wall and has spine surgeons, we use screws to hold things together whilst the bone grows across. Typically, we place anywhere between four and 20 screws into a patient. If you look on those figures there, the top left one is the degenerative case, there's a scoliosis, one with about 20 screws in there. The bottom one is a trauma car surgery. The problem is that despite efforts to improve bone quality our patients, we get screws pulling out and on the right hand side, you can see the screws are pulled out from the patient. And one of the screws pull out. Usually that's a poor clinical outcome and more surgeries. So all the screws on the market look basically the same. There's a pedicle screws from the top five competitors, they all have differences only in their screw thread, and only in their head. But otherwise, they're the same. So I sat down and decided how do you make a screw go around a corner? And how do you capture that bone in green there to improve pull out and as you know, you can't make a screw go around the corner. But we managed to do that. And that's the intellectual property. On the left side, you can see a standard screw on the right side, you can see the bear claw, which is their proprietary screw. We know the more you triangulate screws, the better the pullout, so the more we can get the screw to the center, the more likely we were to reduce pull out. Our original design was this one, it's a two piece, surgeons are pretty used to using something called a lengthy probe to insert screws. And so it's close to what surgeons already do. And then they thread that outer sleeve over the nail. We evolved over time. And this is our final design here. The distal part has much more of an interference fit to again, reduce screw pull out and improve that bone screw interface. We've done initial testing with the construct for screws to rods. Top left is a standard set of screws. That's a forced displacement curve on the bottom is our device. And there's a three to four times difference in the skripal out when we compare those two as well. So there's a significant difference between these two devices. So the spine point screws like nothing else that's out there in terms of pedicle screw fixation, the patent is protected, the IP is unique. It has game changing go out strength, its navigation and robotic ready. And it can be adapted to any screw head or any thread. So it allows for licensing opportunities with the bigger companies. So in summary, we're $2 million in and our target market is that $9 billion spine surgery implant market. There's two separate products and they're both unique. There's interbody cages. And there's a family of these devices with first one coming online this year, and another seven devices to follow. Then we have that modular pedicle screw technology which has significantly different pullout characteristics this standard technologies. Two of the products are tested prototyped ready for FDA submission, the IP is protected. The gross margins are very good shouldn't be profitable at the end of year two on our pro forma. We have the team assembled to do this. And we're looking for series a funding primarily to finish the products and to commercialize it. Thank you very much for your time.