Jon Greenwald, Caira Surgical - Software for Advanced Joint Replacement | LSI USA '24

Jon Greenwald  0:04  
My name is Jon Greenwald. I'm co founder and CEO of Caira surgical. And I've got to lead off with some distressing news. And that is that half of us in this room will at some point in our lives develop knee osteoarthritis. Now, there's a lot of treatments before joint replacement for that, for that condition. But the prevalence of joint replacement these are US statistics as it has been growing rapidly over the past several decades. And by 2030, we anticipate there'll be three and a half million joint knee replacement surgeries in the US alone. So over the years, there has been a lot of technology advancement to help surgeons optimize the outcomes in knee replacement. But another sort of alarming statistic is that only 70% of knees done in the United States utilize any sort of technology whatsoever. The majority of that is robotics and navigation. Why is that? Is because current technology impedes adoption, it puts up its own barriers, it gets in its own way to to increasing use. So what you have here on the screen is a state of the art navigation system. And whether your surgeon is using robotics or navigation, they rely on surgical tracking. And so most of what you see here is a surgical tracking system. In this instance, it's a navigation, but that consists of a couple of components. So the first is a user interface, which is often outside of the the sterile field. And the surgeon relies on a tech or a sales rep to operate that at their instruction. And then the other is opt the the primary mode of tracking right now is optical tracking fact that's almost all joint replacement utilizes optical tracking. So optical tracking requires the use of these fiducials. And the financials are held in place in the anatomy with by cortical pins. So in this case, you see there's two pins in the tibia, two pins in the femur by cortical means they go all the way through the cortices, there is a complication rate associated with these pins, everything from post, post operative pin site pain to infection, and also, although it's a low incidence under 2% fracture, and then you have an optical camera outside of the field. Now the problem here is that the optical camera has to maintain uninterrupted line of sight with the fiducials throughout the procedure. What does that mean? That means that an assistant has to move themselves away from the table. So there's a surgeon losing a pair of hands that they would otherwise rely on such that the optical tracking can have an uninterrupted line of sight on the fiducials. So other disadvantages with current tech and this is from navigation systems to robotics is there is there very high cost not just for capital equipment, but also on a per procedure basis. For the consumables, the disposables that are used in every case, they all add time to the operation, as I said, they increase infection risk as a result of the pins associated with the optical tracking and complication risks. And there's a high complexity to these with a large learning curve. And that is partly why they add time to the procedure. And lastly, they're obstructive, those pins get in the way, the team has to move around them, they're in place for the entire procedure. So we took a different approach. We looked at all of these pain points. And we thought how can we address these such that we lower the barriers to adoption of new technology in orthopedics. And the first our flagship technology is to use radar for surgical tracking instead of optical. We also have other technologies that we've developed. The first is a handheld scanner, which enables very rapid anatomic registration. So that cuts registration down dramatically. The time rather cuts it down dramatically. And then also we have surgical planning that helps the surgeon develop a plan for each specific patient. But our flagship technology, the radar utilizes a couple of elements. On the left there you can see what we call the constellation and it's just that it's a constellation of six radar around a user interface. And rather than those big fiducials that go outside of the standard incision require additional incisions and pins, we utilize radar beacons radar enables us to create a very small beacon that's held in place with a single three and a half millimeter diameter cancellous bone screw that's pretty small, so it fits within a standard incision. And unlike optical trackers, the beacons can be removed and replaced during the procedure. Why is that important? When when surgeons are advancing cutting tools, oftentimes they want to get those trackers out of the way. So here you see what the relationship between the the constellation and the surgical field and you can see that that that tack on the left or I guess on the left hand side of this, your right hand side of the screen doesn't have to move out of the way there's no line of sight problem. Radar enables a couple of things it enables proximity and redundancy, so proximity and that you can put a sterile drape as pictured here. Over the constellation, pull it in close to the sterile field, and redundancy in that the radars themselves are relatively inexpensive on an individual basis. So we have six of them on our in our constellation. And it's it is truly impossible to block all six simultaneously. So there's no line of sight problem with this. And here is the near production prototypes, constellation on the left, and on the right, you can see the beacons. Okay, so we cut costs by about 75%. When compared with robotic solutions. We remove a lot of time in with a fast landmark registration with our scanner. And we improve safety and reduce complications by eliminating by cortical pins and additional incisions. The learning curve is very quick that animation that you saw can be mastered by a surgeon really one procedure. And it's unobtrusive, we get rid of the line of sight problem. And the beacons are removable and are small. So we have a very large market. We are a platform technology. So our first product is a navigation system for total knee replacement. And we're a product pipeline includes hip, spine, and even shoulder. So growing at a worldwide basis were $13 billion Tam. And we also address a segment of the market that as we all know is growing very rapidly. And that's the ambulatory surgery or outpatient surgery centers. So by 2030, almost 70% of joints will move to outpatient settings. ASCs and outpatient settings have certain requirements, the reimbursement is typically lower, and they rely on case surgery throughput. So our system enables really fast room turnover. It also decreases the the time associated with using technology. So while we are building this technology as a standalone navigation system, we're also looking to integrate with surgical robots. As I said in the beginning, any robot utilizes a surgical requires a surgical tracking system. So we're looking to replace optical tracking, with radar tracking on surgical robots in orthopedics. Nonetheless, we're building a company that is durable, we're obviously seeking collaboration with the big strategics. But whether or not that happens, the company is being built to go to market on our on our own. So we are already talking to 23 surgeons at 13 joint centers around the country. We are in discussions with key strategics as well. But this is what our limited clinical release looks like end of 20 for early 25. and compare it to other technologies we really have a lot of advantages benefits. So I'll draw your attention to the first two the cost the second line, so our constellation will install for 75,000. Compared to other systems, it's a dramatic reduction in cost of capital equipment, that lowers the barrier to entry right away. And then we're also able to price our disposables lower. A lot of that is because the radar technology that we utilize some of its organic to Kira, but we are building on a lot of automotive radar advancements over the past decade. So the parts that we utilize the components that we utilize in our electronics are all manufactured at scale. Thus we can keep our cogs down and, and price ourselves lower on a per surgery basis in the rest of the market. Increased efficiency with the workflow dramatically simplified. And we are also open platform so as a navigation system, it can be used with any implant system from any manufacturer. This is our timeline. So we are looking to be clinical in the first half of next year. We've raised $6 million to date. And we have a robust supply chain in place already quality system in place. And we're raising now a Series A for 10 million down the road in after our the launch of our navigation system. We are also expanding our AI planning surgical planning tool. Fast landmark registration will be introduced thereafter. And then also of course, robotic integration and other applications hip spine shoulder, we have a very broad IP moat. We have five patents granted already on the radar system. And on the fast landmark registration. We have eight and review and six and development all of our granted patents have PCT protection outside of the United States as well. So we've been very active in protecting the space. There's also a lot of know how associated with radar for surgery. We are the first company to utilize radar in a medical application, and also the first company in any field aerospace defense automotive to achieve a submillimetre accurate radar tracking system. And that's largely because in those other fields that just isn't an application, they're more concerned in measuring accuracy and feet and inches rather than sub millimeter. So we are a 510 K regulatory pathway with multiple predicates Well, radar itself is novel. Surgical tracking does have a series of predicates and in fact our CTO worked on and obtained the 510 K for the predicate that we intend to cite

Another unique feature of our system is that we have an ESG or a reprocessing lifecycle. In other words, rather than having disposable consumables, as most, most of these robotic competitive robotic and navigation systems do, we intend to ask hospitals to return them to us. And then we are setting we designed the beacons in such a way that we can reprocess them. In other words, they come in, we clean them, and extract the electronics, put them through a quality assurance process, and then put them back into the manufacturing cycle. So in this way, this is not just, you know, it's not just reducing our environmental footprint, but it also has a tangible impact to our cogs. We put together a super team. I've been in orthopedics about 25 years, several, eight years with j&j. Several startups including ortho sensor which we exited to Stryker. My co founder is north of high volume orthopedic surgeon at NYU. Our CFO was spent 10 years on Wall Street doing some a lot of big healthcare deals. Gordon, our CTO who's earlier in the presentation, he and I worked together at ortho sensor, he has spent 25 plus years of his career developing surgical navigation systems. And then our software engineering team is very strong, Sarah and Wendell, with deep imaging backgrounds and Safa is a radar hardware engineer, she comes from the automotive industry, as you can imagine, there's not a whole lot of radar talent within medtech. So we also have a network of fantastic partners both on the development and clinical side. Our key radar advisors, they're in the middle of the slide. They were both 2020 23 and 24, presidents of the IEEE radar section and ran their radar meeting. So we've got some very high powered support on the radar side. And then also some legacy of other companies. We have Stefan Kreutzer on the top was involved in makers engine and Dr. Believe us, they were both involved in makers IDE, so a lot of experience bringing new technologies into the or and to market. And then lower left, you see Jonathan or lower right rather see Jonathan Truesdale. He was early on in Mako and also was chief legal counsel at ortho sensor. So again, we are looking to partner with strategics. We are of course, we do have an exit strategy. And that is to exit to a large strategic, but nonetheless, we're building a durable company that is self sustainable. And as we build out our product line, we anticipate being 40 plus million dollar company by 2028. We are raising now as I said a Series A for 10 million. The use of proceeds for that is for r&d to support our continued pipeline development, and then also sales and marketing to support the limited clinical release operations, building all the inventory, etc to support that clinical release. And they continued IP development and regulatory approval. Now in this space, there has been a lot of m&a over the last several years, I know we've had a slowdown of last 12 to 12 some odd months but in the space, there's a lot of activity whereby strategics are acquiring technologies that are either standalone technologies or make existing technologies better in other words, improve a robotic system and then also provide a pathway into that ASC segment of that outpatient segment. Kyra fits into every single one of those categories. So lastly, we have an extremely experienced team, a great IP mode, very large market. We've got great partners both on the clinical and product development side. We address many of the pain points associated with technology adoption. And we decrease costs which is one of the big pain points that everybody dislikes. Thank you very much