About 30 seconds. The best way to kind of get someone up to speed on this technology is through a live demo, but not having the ability to do that right now, we've just put together kind of the robot in action. I'll kind of talk over it, just to give you an idea of what we're doing. So this is the. It's a highly technical, advanced orthopedic robot with a sagittal saw attached to the robot. It's got seven joints as opposed to four that the Mako has. It enables quick registration, quick cutting, safe cutting along predefined paths. There's no change tool that increases the surgical time speed. It's extremely accurate. It enables the doctors to do pre-operative planning that enables them to do very specific cuts and very precise cuts. We think that our technology is going to revolutionize the total knee, total joint replacement market. It's going to be the next generation of surgical robotics. We're starting to get some market recognition. We were just awarded this award for the Medical Tech Outlook Highlights. We're very proud of that. It kind of validates that we're getting traction in the industry, and we look forward to greater events and announcements in the near future. I'm going to jump right into our investment thesis, okay, and that has to do with the market dynamics. Right now, the incumbent has a monopoly. The incumbent is Stryker with their Mako solution, and they basically own total knee replacements. They have more than 90% of the market share. They dominate the space, and they've been able to do that by developing a solution that has a very accurate, precision cut with a saw that does it extremely fast and efficiently in a relatively safe manner. I'll get into that in the next slide. Their robot and their ability to do these high-precision machine cuts has also led to their dominance of the cementless knees. As that kind of alludes to, it's a construct without cement, which has all kinds of clinical benefits, not the least of which is you don't have to use the cement, which takes 12-15 minutes to dry and introduces infection risk and is really just a pain to work with. They're leading that, and that's why they're leading the market. Again, the incumbent is a monopoly. We feel that we've taken the characteristics and the attributes of their system, and we've improved upon them. We've basically built a better mousetrap. We, as well, use CT scans to develop our pre-operative planning. We have fully automated cutting with Stryker. They use haptics, and I'll get into that in the next slide, which is hand-guided. So the surgeon actually guides the robot with just robot assisting. We have a seven-joint arm. Theirs is four. The more mobility allows us to get into tighter cut spaces, so we're able to do more cuts without having to do a tool change. Our boundaries that are really important for safety are driven by patient-specific anatomy. We use the CT scan to actually define the boundaries on the bone of the patient as opposed to Stryker, who uses the Mako product, which uses the implant as their boundaries. That can cause some problems and risk of soft tissue damage. And we have also enhanced the navigation in our next-generation system, and theirs is a legacy navigation system. In addition to those two points, we're looking at the market, and we just see it as an extremely attractive market to pursue. The large joint reconstruction market, which is basically shoulders and knees, is $22 billion and growing, and total orthopedics is $33 billion. The cementless robotic knees are going to double in the next three years. Again, we see the market going in that direction. The margins are high and accretive, and so there seems to be space there. It's a highly established market with four players dominating the space. They're all orthopedic companies with 75 years of existence, so they're not very nimble. They're not very R&D-driven. They're not robotic companies. So we see that there's an opportunity there. You know, as you know, demographically, there's some tailwinds. We're all getting older and larger with knee problems that need to be addressed, and it's not cyclical. You know, if you have a knee problem, if you know anybody with a knee problem, they're going to get addressed whether there's a bad economy or not. So that's, again, the market dynamics. There's a monopoly, and we are going to address that and become competition. This slide I won't get that heavily into, but it's kind of an investment opportunity explained in a picture. It's kind of hard to compare these because Stryker is a large conglomerate. Mako is just one piece of their overall puzzle. But when they bought Mako, they started to differentiate from the other orthopedic competitors in the space. And this slide is just kind of showing that graphically. That's what we're going after. We're going after that delta there. So this is getting into the weeds slide. So can anyone do this, and why is Mako so dominant? So Mako basically owns the hand-based cutting method, and that's called haptics. And I'll go to the next slide just to kind of define that. Haptics is when the surgeon actually holds the robot and moves the end effector around, right? So there's a haptic boundary. So there's a boundary that's defined by the implants that limits the mobility of the robot, but the surgeon is actually moving the robot around and doing the cuts within the confines of that boundary. It requires surgeon skill to do it, and there's a possibility of cutting soft tissue. The hands are not free. You have to hold the retractors, and you may require assistance from an assistant to support. Our system, conversely, is we aim to own autonomous cutting, and active autonomous cutting is where the robot does the cuts itself. So the surgeon doesn't do the cuts. And I like to describe that. Think about it in terms of like an automated CNC shop. You would not have an operator go in, and when you design, put in the cut patterns for a CNC lathe to do cuts. You wouldn't have an operator actually get on the lathe machine itself and do the cuts. You would have the CNC machine do it itself. Right now, with Mako's solution, the surgeon is actually doing the cuts, albeit assisted with a robot. Our solution is to have the robot do the whole cut. So you're eliminating that operator. The surgeon is no longer required to do the cuts. So how does that work? So we have the CT scan. We develop a plan for this, a pre-operative plan for the surgery. The cut paths are determined by the surgeon. The surgeon looks at the anatomy of each patient and says, you know, this guy's a little knock-kneed. This person's a little bow-legged. You need to have different angles to the cuts. So I'm going to adjust it this way, and I'm going to adjust it that way. And this is the optimal cut for an individual person, for this client, customer-specific anatomy. And then he puts that into the plan, into the robot, in the pre-operative plan, and the robot actually does the cuts. So the surgeon is hands-free. It's a foot pedal. The foot pedal drives the robot. It drives it forward. It makes it stop. It puts it in reverse. It increases the speed. But the robot itself is actually doing all of the cuts. So you're kind of. It's easy to learn, and you're taking the required skill of actually doing the cuts away from the procedure, and you're enabling the robot to actually take over that kind of repetitive, mundane task that the robot's really designed to do, and the surgeon can focus on the pre-operative planning and how the laxity values are actually working out and make adjustments as needed, so again, our aim is to let Mako have the haptics. We're going to do the autonomous cutting. Mako has over 1,000 patents around haptics, and that's why they're able to protect their market, and nobody else is able to kind of play in that space, and our plan is to do the same with autonomous active cutting. We have patents, 23-plus patents around this, and they really kind of protect our IP portfolio, protects our ability to own this space for around active cutting with a sagittal saw attached to a robot. If anybody does that, they're going to infringe on our IP. So that's basically our thesis there. And I want to point out about everybody else in this space. And I won't get into each individual orthopedic robot company, but this one is really illustrative of our view that everything else is marketing. What's in this lower left picture here is the Zimmer ROSA, right? So you can see you have the robot that's there, and the robot's actually just holding a jig. The surgeon has the saw in his hands. The saw is going through the jig. All the robot is doing there is putting a boundary on where you can go with the saw blade. The robot's not actually doing the cutting. Are you actually getting the benefits of a robot with this kind of a system? Our view is no. You can't get the precision that you need. You can't get the precision that you need to do the cementless knees. We think that the market is recognizing this. We think that this is why Mako is the only solution out there that is so popular with surgeons and patients. We think that we're going to disrupt the market by being the only competition. This is just another slide to reiterate the difference between haptic and active. This is available for you to take on our website to download so you have this information going forward. This is an example of our IP, and it seems kind of simple and generalized, and it kind of is, but a simple generalized patent is a very strong patent, and this has to do with cut ordering, so think about it with a sagittal saw. You have the constraint of the bone, so you can only put the saw in certain areas before you have to, you're constrained by putting the saw through that area in space. So you have to follow certain cut paths in order to not cross that boundary, one, but you need to evacuate the space next to the cut path that you're doing in order to get the saw into that area. So you have to do one cut first in order to do the second cut second and the third cut third, and that sequencing, we've patented. So again, with that and combined with others around the saw and the hardware and the software associated with it and in combination, we think we have a very significant IP moat and that anyone trying to do robot cuts with a saw attached to a robot will infringe on our IP. And that's very important. We see some major disruption catalysts in the near horizon. Press-fit knees will become the standard of care. We've seen this before in hips in the 1990s. Only 40% of hips used press-fit hips. That's hips without cement as a binder. In the course of 10 years, that increased to 92%. It just became the standard of care. Our view is that the same thing is going to happen with knees. The cement knees are inherently problematic. It's 12 to 15 minutes of additional surgical time for the cement to cure. That introduces time risk for infections, and eventually, it degrades and it's not good for the body. It needs to be replaced, so we're going to move towards cementless, and second, robotics will become the standard of care. In order to do cementless knee, which are press-fit knees, you have to imagine it. Instead of having the binder that is the cement, you're just pressing the implant with a porous surface onto the knee, and the fixation of the two is so tight that the implant grows into the bone without the need for the cement. Our view is that robotics are going to, one, they're fundamental. You have to have that kind of precision cut in order to do it. And so robotics, which are only 12% of the total knee market today, are going to continue to grow and expand as new surgeons come on. And they're going to enable the further use of cementless knees as the standard of care. We have anecdotal information that fellows and fellowship programs, orthopedic fellowship programs right now, 70% plus of the new fellows are being trained on Mako. So they're very, you know, the young surgeons are very attuned to technology. They like to use robots, and they're using Mako. On the other end of that funnel, we're having natural attrition through retirement and people just getting out of the practice. So fast forward a few years, you know, Mako's going to be even more dominant. All the surgeons are going to be using, or a majority of the surgeons are going to be using robots. It's going to be majority Mako. What are the other orthopedic knee companies going to do? I mean, they're going to need something. And what we're trying to be is we're that something that they're going to need. This is just a quick visual of our competitive summary. Like I said, Stryker is dominating the market, and they do it with a fast sagittal cutting and advanced imaging. They've really defined the space and are market dominant. But their technology is kind of old. It was developed in the 1990s. They've been in a monopoly position for a long time. They haven't been forced through competition to improve their product. They're somewhat complacent. You see this in monopoly spaces in all kinds of industries. This is the same. We're just applying modern cutting-edge technology to improve the mousetrap. So that was the lowdown on the technology and our service offering. Now I'm going to talk a little bit about where we are as a company and our timeline to market and all those kinds of things. We're approaching a critical inflection point. We submitted the 510(k) earlier this year. We received an additional information request that was expected. It's a medical technology company, and they usually have questions for these kinds of complex solutions. The questions that we received are very addressable. They're along the lines of, they call it deficiencies. One was, we don't see enough high BMI cadavers in your population. Do some more with more high BMI cadavers. The surgeons that did the external validation are all self-identified as expert robot users. We need you to have some novice robot users. So do some more surgeons with people who haven't really used robots before. Some of our tests for accuracy and whatnot, they didn't like their methodology, so they wanted to do additional tests, so again, we think all of these are addressable. We have 180 days to address them. That's our intent. We will address those, and in the meantime, we announced earlier this year that we are going to do clinical trials in India with Shalby Hospitals. Shalby Hospitals is the largest orthopedic hospital in India. They do 16,000 knees a year. They're going to be our strategic partner with our clinical trials. We've been in communication with the FDA. Like I said, we submitted the 510(k). They accepted our predicate. They accepted that it is a 510(k). We've communicated our intention to do a clinical trial. Not that it's required for their clearance, but we're going to do it anyway. And they accepted that the India population is fit for purpose and the scope of our trial. And the scope of our trial is 100 patients over a three-month follow-up in three sites. So we have the surgeons. We have the hospitals. We have the patients. We expect to get that going in the first half of Q of next year. And we think when we do that, we will have further de-risked this opportunity. And when we get clearance, obviously, it'll be that much further de-risked. And we see these as massively accretive events in our timeline. Along the same time, strategics are starting to feel the pain. They're going to feel it more and more. The literature coming out from Mako is that we have better patient outcomes. Surgeons want to use the Mako. Like I said about the fellowships, they're all going towards Mako. None of these other guys have a solution. We're positioning ourselves to be that solution. In terms of our short-term financial goals right now, we really have two goals. One, I'll back up a little bit and say that we recently had a financial raise. We were looking to raise $10 million. We oversubscribed. We increased it to $12.5 million. We ended up raising $13 million. So we have a strong balance sheet. What we're looking to do now is to solidify that even further. We're looking for up to $10 million in funds, and we're looking mainly, like I said, just to have a strong powder position with our balance sheet and to be in a good negotiating position for discussions with potential acquirers or whatever the next step may be. We just want to have a strong balance sheet. So that's really what we're looking for. The development work's done, so there'll be no drain on development work. Our run rates, let me go to the next slide. Here, our cash burn's about $1.2 million. At the end of June, we had $7. We added $13. You can do the math to see where we are. We're in a good cash position. We will see ourselves through our next accretive events with the cash that we have. Just at the end of that time period, we want to have cash in the bank and be in a strong negotiating position. So we're being fiduciarily responsible and proactive in getting our balance sheet in order. Kind of select information. We're a tight engineering shop. We have 28 full-time employees, 22 are engineering. We have 26 engineering contractors. So it's a highly variable cost structure. We can turn it on and off at will. Our clinical trial is included in that $1.2 million burn. It's only estimated to be about $1 million. It's a very capital-efficient program there. We have no debt, no traditional debt. We've got minimal short-term warrant obligations that are associated with our recent raise. If you're interested, we can walk through that. It's not onerous. And like I said, we expect to have cash through these next accretive events. Management team, Doug Unis, practicing orthopedic surgeon at Mount Sinai in New York. Ben Sexson was in management for Pro-Dex, which is our key supplier of the saw and the end effector. Doug convinced him to come on board as the CEO. Cameron is a PhD from Yale who's driving our robotics effort, knows more than most people would ever dream to know. Mohammed is in the Bay Area, is a very seasoned software developer that oversees the sprints and keeps us very agile in the development of our technology, and I'm a CPA, MBA, CFO, so we only have three minutes left, so I went over a little bit. I apologize for that. If anybody has questions, I'm happy to ask. Yes? What are your goals to be acquired? Do you have any intentions of being acquired? Well, ideally, in an ideal world, we would very much entertain being acquired, but we are preparing ourselves to go out commercially on our own. We have about 20 surgeons who've worked with us, who've expressed interest in using our product, so we will be very surgical in our approach. You go to maybe three sites in the U.S. with these surgeons and deploy our robots and go from there, so if it happens. But ideally, we'd like to be acquired. Because that's only, yeah, the short-term timeline sounds like you won't be able to build anything if you do get to those stages until like 2026. We won't go commercial until after FDA, so that won't be until 2026, correct. Do you have any interest in acquiring? We've had discussions with several potential acquirers over recent time. But it's not in the position to talk about that right now. But there is interest, and there's certainly market knowledge of our availability. Yeah. One of your slides said that 12% of your equipment are currently robotic. Right. 78%, is that manual? That's the second question. Is that manual creating surgical errors in a material way? That kind of soft tissue damage. Is that what you're trying to focus on? Yes. Yes. To your first point, yes. The 12% are robotic now. The other remaining percentage is manual. And with manual, imagine it's kind of barbaric, and there's no boundaries, no soft tissue limitations, no constraints on cuts. It's really, really complicated to get a precision, precise, accurate cut manually. Everyone does just mechanical alignment because they don't have enough information to do the preoperative planning to do more patient-specific alignment. So everybody gets the same knee. So right now, 20% of manual knees have bad outcomes. And that's what we're trying to address. Robotics in general is trying to address that, but we think we have the answer. Yeah. Were you involved in some NVIDIA program that really popped your stock earlier this year? Did you discuss it? We're no longer involved in that program. We were involved in another program. That program was more focused on startup companies that had not gone public. We had gone public. So we switched over to the other program. From our view, there was no. That was a completely unexpected pop in the stock related to that PR. And it's really kind of driven by the algorithms in the market associated with the name NVIDIA. So, all right, I'm being run off the stage. So thank you very much for your attention. I appreciate it. Have a wonderful day.
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