Jon Greenwald Presents Caira Surgical at LSI Europe '23

Transcription

Jon Greenwald  0:05  
Okay, so I'm Jon Greenwald. I'm the co founder and CEO of Caira Surgical. And we are looking to invent the future of orthopedic surgery. So, I've been in med tech, orthopedics more specifically for about 25 years. And there's a couple of things I could share with you. The first is that half of us in this audience are going to at some point in our lifetimes develop knee osteoarthritis. And for women, there's a 50%, higher likelihood of, of, of knee osteoarthritis than for men. So in the US, there's a, the knee replacements have been growing significantly to six and a half percent compound annual growth rate. So here in 2023, there's over a million total knee replacements done in the United States. And by 2030, that number is expected to grow to three and a half million. So this is a very frequently performed procedure. So over the course of time, there have been incredible technology advancements around orthopedics and around joint replacement specifically, most of those are aimed at helping a surgeon reproducibly create precise bone cuts, which dictates the position of the implant, which to a very large extent dictates the outcome of that surgery. So in spite of the years of evolution around this technology, surprisingly, only 15% of knee replacement surgeries in the United States utilize any type of advanced technology, and for the most part that's either robotic system assistance or navigation. Why is that? Largely because technologies that exist today impedes adoption, it sets up adoption barriers in its own way. So if you look at the screen now, you can see a contemporary surgical navigation system and it's made up of several components. The first is a unit user interface which sits outside of the sterile field, oftentimes, the surgeon is asking for the rep to sort of advance the screens, or a dedicated technician to do so as well. The second are these fiducials. So the predominant tracking technology in orthopedics is optical tracking. There's also electromagnetic tracking, but the vast majority of tracking is utilized. Utilizing a a 15 year old technology called optical tracking optical tracking requires the use of these fiducials that are held into the bone with bicortical pins. So this is a total knee replacement. And in this instance, there's an extended incision more often, there are additional incisions outside the surgeons primary incision, and then the bicortical pin penetrates the bone because these fiducials need to be rigidly fixed to the bone. On the top of the screen, you'll see a camera that is tracking the fiducials in space that fiducials are attached to anatomy as you've seen, and also to instruments. But this camera records an uninterrupted line of sight throughout the procedure. So some of the drawbacks of this, it's expensive half a million to 1.2 installation costs with up to $1,000 per procedure cost. All of these systems add time to the procedure. They're invasive, again with the by cortical pins and the need to use fiducials. And that's whether you're navigating using a robot, you always need to be tracking anatomy and instruments. And they're complex. So there's a big learning curve. And that contributes to the added time in the OR. And then lastly, they're obstructive. So as you can imagine, you have the surgical team sort of reaching over these fiducials in the space. And then also, because the camera requires constant line of sight, you have to clear the surgical team from one side of the table to give that camera its line of sight. So we took a different approach, we leveraged a new technology in the space radar to do the surgical tracking piece. So our system is composed of two elements. The first is a constellation which you'll see on the left, the constellation each one of these black tiles is an individual radar. So we have six radar around this constellation around this user interface, and it can be draped and pulled into the sterile field. Sterile drape does not interfere with the radar signal. And the second element are the beacons. And those are those sort of those banana shaped instruments in the tray that you see there. So this is how the beacons are attached to the bone. You'll notice there's no incisions outside of the main incision. This is a relatively standard incision for total knee replacement. So it's a single 25 millimeter by 3.5 millimeter can't sell this bone screw that holds the beacon in place. The beacons can be removed during the procedure be to be unobtrusive. I think that's important when you're advancing a cutting instrument the surgeon is doing it by hand or there's a robotic arm advancing and cutting end effector. And so this is what a surgical scene looks like with the our radar navigation system. You can see the constellation positioned there out of the field. But it is sterile events the next picture but you'll notice the surgical team doesn't have to remove it doesn't have to move from their usual positions. This is a cadaver lab so you can see what a that's really production. And level constellation, it's got the sterile drape over it, the surgeon can operate it, pull it in close to the sterile field as needed. And of course, you see two people standing on either side of the table, because we've obviated the need for the optical camera. So, our system, Radar, we're standing on the shoulders of a lot of radar development in automotive over the last 10 to 15 years. So we're able to source consumer components that are manufactured at consumer scale. So we are able to provide a 75% less expensive option. That cost is a huge barrier to entry for these common systems available today. We have a landmark registration technology as well as the radar tracking that enables us to do very quick landmark registration in about 90 seconds, which is dramatically less than landmark registration in orthopedic surgery today, there's no additional incisions or the bicortical pins. It's a simple system, as you saw in the last animation, so learning curve is very quick. And it's unobtrusive, there's no line of sight issues. The beacons can be removed to advanced cutting instruments and get out of the way. So we have a very large market. We are our first product is a navigation system for total knee replacement. We we have a roadmap that takes us into hip and spine. So in the United States alone in those three areas, it's a $3 billion addressable market. And then if we look to international markets where we where we anticipate moving within 2025, it then opens it up to a $13 billion market. This is a US phenomenon but CMS allowed reimbursement of knee replacement and hip replacement in outpatient settings. As a result, a lot of total joint surgery is migrating to outpatient setting, specifically ambulatory surgery centers, so that by 2030, almost 70% of orthopedic procedures will be done in outpatient surgeries. This is relevant to us because ASC is an outpatient surgery centers often, in fact, they do have a lower rate of reimbursement the United States, so they're very cost sensitive. They also have smaller staffs typically. So a system that is very streamline that doesn't require a lot of OR turnover or instrument sterilization is very helpful to these environments. So we have a purpose built system. We have had great feedback from surgeons and also the strategics. We do have a limited clinical release planned in the second half of 2024. This is a very targeted limited clinical release. It represents major joint centers, some of the big IDNs as well. And we have had interactions with 23 surgeons at 13 centers around the country. And incidentally, these are all centers into which I or my colleagues have sold orthopedic technology in the past. You can see there along the top line, the big price differential, both installation and the post surgery cost and the third line down, we add a lot of efficiency to the system. And frankly, we I think out compete with all existing technologies, whether it be navigated or robotic, available today. Our roadmap takes us through a 510K in the first half of next year. And then image lists total knee replacement navigation system launch in the second half of next year. And then we're looking towards hip and spine and 2025 as well as OUS markets. Lastly, in 2024. On the bottom, you can see robotic integration. This is a pilot we've already started setting up. But the goal here is not just to have a standalone surgical navigation system, but also to integrate radar tracking with surgical robots. We have a broad IP remote we have four granted patents. Basically we've ring fenced submillimetre accurate radar tracking, and our fast landmark registration. We have a series of patents already in review and more in development, regulatory pathways of 510K, our CTO, worked on the predicate device that we're going to cite with the Medtronic system. And then lastly, we have a I'm rushing here to get through, but we have a an ESG program whereby our instruments go into a hospital. We ask that the hospital decontaminate them not sterilized, but just decontaminate them and then return them to us, whereby we then can reuse them. This actually has a tangible impact of cutting our cost of goods dramatically. Without Standing Team. My co founder is an orthopedic surgeon at New York University. A set of really world class partners in both robotics, semiconductor and PCB development. And then we projected path to revenue so that by 2027, we're 40 million plus company, just a knee, hip and spine. So we are raising 10 million open to all conversations here. Welcome. And then just lastly, in the last two years alone, there's been over $2 billion of acquisitions in this space with a 12.1 multiple revenue. So this is a very attractive space. This is a technology that fits very nicely with what the strategics did at present. Thank you very much.