Greetings, and welcome to the Monogram Technologies First Quarter 2024 Business Update Conference Call. I'm Larry Hall, Director at MZ Group North America, representing Monogram Technologies as their external investor relations advisor. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. A press release detailing First Quarter 2024 financial results was issued on May 14th and is available in the investor relations section of the company's website. I will now turn the call over to Monogram Technologies' Chief Financial Officer, Noel Knape. Good afternoon, everyone. I'm looking forward to this conversation. Welcome to our Q1 2024 investor call. Would you please forward to the next slide? I'm gonna go over the forward-looking statements disclaimer, real quick for everyone. So this is a legal disclaimer. This presentation by Monogram Orthopedics, Inc., Monogram, may include forward-looking statements to the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram business plan results, or operations, products, or markets, or otherwise makes statements about future events. Such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as should, may, intends, anticipates, believes, estimates, projects, forecasts, expects, plans, goal, target, or proposes. Although Monogram believes that the expectations reflected in this presentation are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. Thank you for that. So this presentation is summarized here. It's gonna be a quick recap of the Q1 summary, financial data, the investment thesis, timeline review, and next steps. So here is the summary financial data of Q1 2024. Importantly, at the end of the quarter, our cash balance was as projected, about $2.1 million. That's a quarterly burn of about $3.6 million or $1.2 million per month. It's important to note that management was able to pay down the accounts payable balance by net of $1.1 million. This balance related to elevated balances from the activity in Q4 related to verification and validation activities. We expect that the monthly burn this will not be repeated in subsequent quarters, and the monthly burn will reduce to around $1 million a month. Important to note in our financials and our cost structure, we have 28 full-time employees, 22 of which are in engineering and six are administrative support, and an additional 26 engineering contractors, 12 of whom support the V&V efforts that I just mentioned. It's very important to note that 60% of our costs are labor, and so it's a highly variable cost structure. As the V&V activity winds down, we will be able to reduce that cost significantly, particularly on the contractor side. About 12 of the contractors support the V&V activities, and we should be able to reduce some of that cost outlay when those activities are done, and we anticipate that to be done most largely at the end of the first half of the year. It's an extremely highly variable cost structure, and we will manage it accordingly. It's important to note that we still have no debt, and we have no warrant obligations as overhangs. We expect to have sufficient access to cash through our 510(k) application and significant milestones as they occur. With that, I'll hand it over to Ben to give you an update about recent progress. Sure. Thanks, Noel. Appreciate that color, and thank you, everybody, for joining us today, and for those of you who are watching the recording. So I wanna start by just highlighting some of the key recent progress we've made and then walk through where we're headed. So, as we have communicated, we had our fourth formal pre-submission communication with the FDA. We put out a press release on that. Management was pretty excited about the feedback we received. The FDA reviewed substantial portions of our verification and validation testing plans, provided helpful feedback that we're integrating into those plans. We feel that our verification and validation plan is pretty pretty robust. The FDA also reviewed, as part of that process, our planned OUS clinical trial protocol, and we felt that they provided a very fair and constructive feedback to that. We feel like the FDA didn't. There were no kind of objections to the plan that was proposed, so we felt pretty good about that. We plan to share with the FDA our final clinical trial protocol when that's ready, at the appropriate time, but feeling very good about where we are with the FDA and their understanding of how our product works. It's been an extremely busy quarter, and this second quarter is also very busy. We're really pushing very hard through the verification and validation testing. We'll get into the weeds on that shortly, but there's a lot of activity happening. For example, as part of the verification effort, we need to bring in external surgeons to run fully end-to-end simulated surgeries on cadaveric specimens. We so far have completed nine of 15 surgeries successfully. We've also made very significant progress with our mVision navigation. We hope to share more, potentially demo more soon. mVision is our AI-enabled navigation technology that, when combined with robotics, really was the impetus for us to expand the name. We felt like Monogram Orthopedics was not really truly representative of the potential application opportunities for what we call kind of markerless or marker lite registration and tracking. We're very excited about the promise of that technology in other, potentially other areas. As Noel said, we're pretty aggressively resourced right now. Our burn is certainly elevated as we push through the verification and validation phase in anticipation of a submission for 510(k) approval. We've brought on a lot of experienced contractors to help us with execution of the various verification test protocols, and that certainly contributed significantly to the elevated burn. But again, that's pretty variable. And we have been recently supporting ongoing site visits and demos with tier one capital allocators. So that's also been taking a lot of effort and resources from the team. But overall, it's been very busy. We're working a lot. There's been a lot of weekends that the team's been putting in and late nights, so really, really proud of, of how hard the team's working. The next thing I want to jump into is just a recap on the investment thesis of Monogram. I feel like this is a little bit misunderstood, and I want to make sure we really highlight what it is we're doing and why we think it's important. So in really simple terms, the largest robotics player in our market, in our view, has a monopoly. So if you look at Stryker's market share for robotic joint replacements, they have 89% of those. And then if you look at their share of the cementless knee market, they have 75% of those. In any other industry, if you were to talk about a company with 89% or 75% market share, you would call that a monopoly, and we would not disagree. Basically, they account for the majority of cementless and robotic procedures in our market. Now, I think where a lot of people fail to realize why that is, is they don't appreciate the significant IP advantage that Mako has established. So, they own essentially robotic cutting with what's called haptics. Now, haptics is essentially haptic control, so that's control with impedance or admittance, where external forces are applied to the arm. So in Mako's case, a surgeon is actually pushing on the end effector to move it around within a virtual no-fly zone. That technology and that patent portfolio is broad, extensive, and we think extremely well protected, and we think that's a huge reason why Mako has 89% of the market, and I feel like this is really not well understood, and I want to try and highlight that today. So of 1,352 patents assigned to Mako, this is kind of approximate, about 600 of those include a haptic claim. So haptics does not mean just something vibrating, it's far more than that, and we feel like this is really not well understood. If you look at any of the competitors on the market today, basically, none of them are of significance, are doing really robot cutting. Even those that do claim to do robot cutting in practical use, surgeons are still kind of using limited portions of those systems. So there's a picture there, for example, of the largest player in knees, which is, Zimmer, that you can see that they have a robotic jig. So that would be a robot holding a jig that constrains a saw, wherein the surgeon manually completes the cut. There's other systems on the market that have, let's say, a rotary tool, but, we think the efficiency of making all six total knee cuts with, such tools is, challenging. So when you really just to recap, Mako has a very, very solid market position. They essentially own haptics, and there are serious problems with every other kind of system on the market. So, for example, most of the, other, of the other systems don't use a CT scan, so it's not a patient-specific surgery. Some systems, some embodiments don't have any safety boundaries. Some systems use a rotary tool, which has issues with thermal necrosis and requires irrigation. There's potential accuracy issues in the sagittal plane when you're cutting with a manual saw. So there's serious limitations. Monogram looked at this, and we saw an opportunity, and what was the opportunity we saw was there's an opportunity for a robot to come in and cut, but to cut actively or autonomously. So this is a completely different paradigm. Now, there are companies that have tried to do this in the past, but they have relied primarily on rotary cutting tools. The problem with rotary cutting tools is that they are not sufficiently efficient to resect bone, as far as we've seen and in the research we've conducted. The most efficient way to execute six planar cuts in a knee is with a robotic saw. Actively cutting or autonomously cutting with a rotary saw is a non-trivial challenge that we believe we have solved. The Monogram system works by a robot that's autonomously executing the cuts, and the surgeon is controlling the arm with a foot pedal. It's a completely different paradigm. What we think the advantages of the system are may include, and this is not substantiated by clinical claims, but it's really how we design the system, is we're looking to minimize surgeon fatigue. We're looking to eliminate user skill. We're looking for a faster learning curve. We're looking for a robot with more dexterity, so no tool changes during cutting. We have patient-specific bone boundaries at the resection level for enhanced safety. We believe that accuracy is less encumbered when you don't have significant forces being applied to the robot arm. We believe robots are inherently accurate if they're well programmed. We believe that this morphology is more scalable to other clinical applications. We're planning to execute a one robot for the operating room business model, and we do not believe that haptics is the perfect embodiment for other applications outside of knees. In some senses, we've started with what we believe is the most difficult application for our robot, which is knees, where you require extreme efficiency, and it's very difficult to compete with a haptic system. The idea is to demonstrate that we can do it in the most difficult clinical application, and therefore, we believe it's scalable to other applications. If you think about it from the perspective of a large strategic, our goal is to not require cannibalization of an existing product. So we want to enhance what would be an existing product in knees, but have something scalable to other applications. Now, we think the benefit of being early, and again, we can't speak, maybe somebody has this under the radar, we don't know about it, but we believe that we have a significant first mover advantage. The benefit of being first to market is that it allows you to encounter problems that are almost impossible to foresee until you start executing the solution. So we believe that we now have a very compelling patent strategy. As one of the first robot companies to demonstrate autonomous cutting with a saw, with high efficiency, without fixation, we believe that that's going to help us build an IP portfolio or a patent portfolio that will, in a sense, allow us to claim active or autonomous. Our goal is to own active or autonomous. In the same way Mako owns haptics, we want to own active robotics. That's really what our vision is, to be the first active saw cutting robot and establish a broad patent portfolio around that. We think that that's a pretty compelling value proposition, given how well Mako has done, claiming 89% of the market, with basically the only robot cutting system on the market. So again, just to highlight the opportunity, you can just see, now, obviously, Stryker is a much larger company than Smith+Nephew or Zimmer Biomet as shown. But really what we're trying to show here is, and I believe we also have an Enovis on there. What we're trying to show is, yes, even though Stryker is a well-diversified portfolio, since acquiring Mako, their knee business has really thrived, and we believe this presents a really significant opportunity. You have one company that's really consolidated a market and has a monopoly. That value creation needs to be shared, or, we believe is, is, should be, at least competed with. So a lot of times we hear as a criticism, "Oh, well, you're just doing Mako." That's the biggest compliment in the world to us. Mako is 89% of the market. If we're competing in a way and comparable to them, look at the value that that's created for the Stryker brand. You know, does that, would that not be accretive to somebody else? That's really how we're thinking about it. And then, if you think about other clinical applications, we think just objectively, that an active autonomous robot scales better than, a haptic system with 4 joints versus 7 joints, and we can get into other details on that. So with that, I really want to talk about what, as a management team, is front and center for us to execute over the coming months. So there's really a couple of big things. The first is we need to complete 60601 certification. The second is we need to complete the 60601 is a big part of this, but all the verification and validation testing. Then we need to submit the 510(k) for FDA clearance. Then we wanna demonstrate mVision integrated into a robotic pipeline. We also then anticipate our first live inpatient surgeries and then hopefully 510(k) clearance. What we've said publicly is that we expect verification and validation testing to be largely complete by the end of this quarter, and we anticipate a 510(k) submission in the second half of this year. So that's what we've said publicly. Just to give you a little more detail on what we're talking about when we say IEC 60601. So really consists of two major things. So we're, it's 60601-1-2. So the electro EMC testing is basically largely complete. So we expect to have our final test report this week, but we have passed. This was, for any of you who know, this testing, was extremely difficult, a ton of effort, and I'm incredibly proud of our hardworking team for getting there. And now we're in the same vein, aggressively pushing IEC 60601 testing. It's approximately 40% complete, and this is the critical path to our 510(k) submission. So getting the certification, all this testing done, is the most important thing for us to submit a very robust application to the FDA. It's not a requirement by the FDA, but it certainly makes for a very strong application. and the robot is getting put through a lot of rough handling. I just wanna take a video of a test, share it with everybody to give people a sense of sort of what the robot's getting put through. So this is a test that was run on foot pedal, and they literally connected it to a fire hose, which you can see kind of the pressures coming out of this thing, and they sprayed it at our foot pedal. And, you know, the foot pedal can't have any leakage, it needs to be fully functional after this testing. And this kind of hopefully gives folks a flavor of what we're dealing with and kind of the level of rigor. So any of you who have any familiarity with IEC 60601, it's really is a bear, and it's by far kind of the lion's share of the focus for a lot of our team is just pushing through that. In terms of internal testing, so we have a lot of verification and validation test protocols. So these are things like system accuracy, registration, validations, all kinds of—every little kind of minutiae of the system has to be thoroughly tested, both on the software and the hardware side. The electromechanical testing is about 63% complete, and the software cycle three, this is really the final version of the software that we anticipate is the cycle three testing is about to kick off, and that testing is gonna take about four weeks. But really, a lot of this is really coming together. And, just to kind of highlight, the verification, validation, to give folks a sample of what that looks like. So, you know, what that looks like is bringing in surgeons, running simulated surgeries on cadavers, and then, it's a pretty, pretty gruesome process. I don't want to share pictures, but then what we do after the surgery is complete, we literally remove the bone from the specimen, put it into a chemical bath, and then laser scan and compare the planned cuts versus the actual cuts. And, right now we're very, very happy with the accuracy of our system, with the specimens that have been tested so far. So we're looking at sub-millimeter accuracy. And that's not a statistically significant sample size yet, but we're aggressively getting there. So again, it's just a ton of testing that we're going through. And again, you know, folks sometimes really don't appreciate the difference between a medical device and a prototype. I mean, Monogram had a prototype five years ago. It's a really big difference between a product that's been through all of this testing, all of these validations, all of this verification testing, and a prototype. It's not. It's a very heavy lift. So with that, just kind of jumping into the capitalization plan. So a couple of things I want to reiterate here. You know, one is that, you know, we are still an early-stage company. We're not in the market yet, but we're obviously trying to get close, and fundraising is certainly milestone-driven, and it's also driven by kind of de-risking events, right? So, continued bulletproofing and de-risking of the system are critical, right? You guys saw a flavor of the IEC 60601 testing that we have to do. These large capital allocators in the space are not ignorant. They understand how difficult it is to take a product through all of this testing and through all the remediations and bulletproof. And so a lot of times you really do need to do the heavy lifting and continue to move the ball forward, and that's exactly what we're trying to do. We closed the quarter, what we said publicly, is with $10.1 million in cash. We believe we have the capital we need to submit a 510(k), which is, in our opinion, a very significant milestone. And we have done significant on-site visits and demos for various people who allocate capital in medtech. Now, we believe that we are starting to build value in terms of the product that's being created, but obviously, it takes time, effort, and we are sensitive to kind of the timing of critical milestones versus the money that comes in. And it's not easy, but again, we're not... We believe we have some very significant catalysts coming up. So we're going to continue to communicate our value proposition of our system, which is really, we aim to be the first autonomous, active cutting, saw-based robot on the market. And, you know, Mako kind of demonstrated what happens when you build a solid IP portfolio around a very kind of effective way of doing a surgery, and we plan to try and do the same thing that they've done in haptics with active. And, you know, monopolistic markets a lot of times create opportunity, so we're going to try and do all we can to have a compelling product. One thing I do want to say is, you know, for a startup, it's important to have options. One of the things that's still, I would say, kind of an intangible asset is we have a lot of a very significant investor base that's been with us for a long time, that really understands the story. And we see opportunities to potentially open up access to additional investment opportunities that could be accretive in advance of some of the critical milestones we have planned. So we're gonna be sharing more in the future about how we plan to raise capital, but we're considering a small bridge potentially from our community and kind of as a potential way to give back before we have what we anticipate could be some pretty significant updates. But well, stay tuned for that. We just don't wanna be in a position where we are only beholden to institutional capital, especially as we have access to this intangible asset, and especially as we have some pretty significant milestones on the horizon. So, basically we're taking a parallel path to fundraising, and it really is a balance between raising kind of absolutely what you need to, and trying to anticipate what's gonna happen with the economy and also what we have in terms of critical milestones. So, not always easy to juggle that, but we're doing our best to kind of manage that. We think we're in a good spot for the next milestones. This is just kind of highlighting that. So when you look at 510(k) approval in our space, we think that it's generally very accretive. We think the market generally rewards companies that have taken technologies through all of this testing, through all of this development, and especially if the product market fit is solid. So with a market cap today of, you know, a little over $60 million, we think that there's certainly the potential for this to be an interesting opportunity if we can continue to execute our goals. And with that, just to recap the investment thesis. So our vision broadly is to advance medicine through technology adoption. So in orthopedics, we're starting with knees. And, you know, Mako owns robotic cutting with haptics. Monogram wants to own robotic cutting autonomously or active. We wanna be the first robot company to do that with a saw. We think that a first mover advantage in autonomous robotics is gonna help us establish very significant patent protections that would make it potentially difficult for another player to do the same thing. We believe that active robotics have a lot of potential benefits. Again, we have not yet conducted a clinical trial to substantiate this, but it's just our design objectives. So, for example, we think active robotics could enable more personalized surgery, 3D printed custom implants, for example. We believe that they may offer enhanced patient safety, reduced learning curves. We believe that it could be more scalable to other clinical applications, drive increased efficiencies, potentially over time, even decrease surgical time. And that kind of lends into mVision Navigation, which is our next-gen navigation solution, which we're hoping to demonstrate as well as a catalyst. And we believe we have some pretty significant catalysts coming up, not the least of which is our planned 510(k) submission. Then, just for anybody who has any questions, you guys met Chris Tyson, who runs our investor relations for Monogram. We really wanna make sure that folks have somebody they can contact. Please reach out to Chris if you have any follow-up questions, but I do wanna give everybody here an opportunity to ask questions and engage with management, and hopefully, to the best of our abilities, we'll be able to answer that. Okay, so if you wanna-- if you want to write a question, just on the right-hand side, there is a comment, and we will do our best to answer as many of these as we can. So Tom Kerr asks, "Can you provide more color on why and how the FDA can or needs to rely on an OUS clinical trial to help make a decision? What is the length of the OUS trial?" So the OUS trial is more of a belt and suspenders, Tom. So right now, we don't believe that our 510(k) submission will require a clinical trial for approval. We believe that our equivalence to the predicate device is that we're substantially equivalent. We believe that our solution addresses the concerns that have been raised by the FDA over the past two years and four formal pre-submission communications. But we wanna run a clinical trial in parallel to our submission for two reasons. The first reason is, you know, once we hopefully get FDA clearance, which we hope we can get on a reasonably quick timeframe, if the submission is well received, we wanna have data to actually market with. So we would go to a surgeon and say, they might ask for clinical data, well, we would have it, we would have the live patient data to market the solution with. And in addition to just the safety of our system, we're really looking at it, some additional features in capturing additional data. So we're gonna be looking at surgical time, learning curve, the accuracy of the system. So, not just the accuracy of making bone cuts, but the accuracy of the planned stress laxity to the postoperative stress laxity. So we would have data that would be actual clinical, real-world data that we could share, and that our sales force could use to help communicate the value proposition. But then the other potential benefit is, if for whatever reason, the FDA was unconvinced, we think this is a low probability. We've had a lot of very smart people assess the application. But let's say the FDA said, "We really, really wanna see clinical data with the submission," well, we would have clinical data ready to go, in parallel to that as a backup plan. So it kills two birds with one stone. The benefit of doing it OUS is it's substantially cheaper, so like on the order of more than 10 times cheaper. And the partner that we will be running the trial with uses the same implant, a cemented version of our implant that we licensed, so we wouldn't need a bunch of implant inventory. It's a very, very high volume institution, so we think we could enroll patients and get through the study very quickly. The study is actually pretty small in scope, so it's less than 100 patients, and the FDA has reviewed this protocol. And 3 months of follow-up with 4 critical endpoints, which are kind of 4 critical safety factors. So that's really kind of the idea there, and our goal is to try and have that data as soon as possible. I would say the blocker there is the IEC 60601, so that's a globally recognized certification that we think will greatly enhance the time to approval of the clinical study. So we think it's the smart approach is to get that in hand and then go for the study. Okay, just wanna make sure I tackled it because I was answering this question. This is from Kapil. OUS trials practice system or semi-active. If for semi-active, then what is the approval path for the active system? So, Kapil, that's a really good question. We are gonna do semi-active OUS, and that's because for two reasons. But basically, I articulated both of those reasons, but just to recap, we, we wanna have post-marketing data, and we wanna have an approval really completely de-risked as much as possible. The plan for active would be to subsequently run OUS for the active version. So the institution we're working with is very receptive, wants to work, wants to partner, wants to collaborate. The market we're looking at is extremely large, and so we envision having a long-term relationship with this this institution. We plan on for example, collaborating with mVision, which is our next-gen navigation solution. So we're not really seeing it as one and done. We plan on having a clinical sort of pipeline as part of our R&D process. So we're gonna be running trials continuously. The partner we're working with, we can do it very efficiently, and a lot cheaper than here in the U.S. So we think it's actually a great relationship, and if the FDA is accommodative to the data, which they really certainly seem to be, we think it's a real win. So this is kind of tied to the same thing. So Sal is asking about the first sale last year and first revenue. What does this distributor intend to do with the first robot, and can we sell more? So you know, the country that we're looking at has a very large population, and we think that there's a great and bright future for robotics. The partner that we have been talking to is actually a different partner than we sold the first system to. And we think the partner we're now working with is kind of a better relationship for us long term. And they do a lot of the surgeons that their KOLs are actually highly recognized and publishing. So the plan is really to go through the process and the approvals and all of that with them, which is what we're working through, and the clinical trial is part of that. So I should have mentioned the third benefit of doing the clinical trial is that it's going to facilitate approval in the country, which we think is a very attractive market. Let's kind of keep going. So James Bull says the ROSA Robotic Surgical Inc. has been getting increased exposure lately. Any comments as to how Monogram competes? So just to kind of go back, so ROSA is the robot that is owned by Zimmer. You can see here, it's shown on the right, so it's a robotic jig. You know, what's difficult is all we know is what we hear from surgeons that are users and kind of having our ear to the ground. The Zimmer implant is an incredible implant. We've talked to one of our surgeon KOLs who loves the ROSA system, and so you're right, it's you know, they're a great company and a great brand. And so we think that any player in the space is formidable. They have been looking at different applications for the robot. I know that it started out really with helping treat epilepsy, and there's applications in shoulder now. You know, fundamentally, though, we think that the opportunity is in robotic cutting. We think that's partly what was demonstrated by MAKO, which is really the only robot cutting system on the market. So MAKO owns robotic cutting. Nobody else is really with a robot arm using a saw in the way that MAKO is doing it, and we plan to be the second player in the market to do that. And the way we're gonna do that is actively instead of haptically, which is an extremely challenging engineering problem. So we think we have a pretty compelling value proposition. You know, one of the things that's a problem for any manual system that relies on a jig is, we think that certainly the accuracy in the coronal plane tends to be okay, but in the sagittal plane, we think that it's challenging for manual-based instruments. And if you think about just where the market might be going, which is more safety, more accuracy, ease of use, scalability, all of those factors, we think that we continue to believe in robot-based cutting. Okay, any other questions here? Oh, there's a question from James about NVIDIA. I think, anything that's been publicly said there is what we're going to say at this time. Let's see here. Does a successful OUS clinical trial pave the way for approval in the EU or other regions? So, we think an FDA approval is by far the kind of most, that's kind of the gold standard for getting into other markets. And, so not FDA approval, FDA clearance. And, having clinical data can't hurt, right? So, the more real-world data you have, the stronger the application, certainly. But again, there's kind of multiple layers to having an OUS clinical strategy. It really is... Monogram wants to be at the forefront of technology, and it's really important to have real-world data. So, for example, the mVision navigation solution uses a machine learning-based pipeline to auto-segment critical structures. And we can do that in cadavers all day long, but we want to have data of live patients, where we want to be training our models when there's blood and when there's other things happening in the operating room, in different lighting conditions, so on, so forth. And so those are the kinds of things that are really imperative to an ongoing clinical relationship. And the partner we're working with, we think is going to allow us to do that in a very scalable, efficient way at low cost. I mean, much lower cost. So, the cost to run a clinical trial in the U.S. far exceeds what it will cost us to run it outside the U.S. So maybe time for a couple more questions. We, you know, we really appreciate everybody's time. If you do have questions, please, please type them into the chat on the right. So I'll give you guys maybe 20 more seconds. Yeah, so, it, you know, it's been a very busy time here. Hopefully, that gives you some idea of what we've been working on. Oh, sure. So... Nope. Thanks. Thanks, Steven. So just a discussion about anything ongoing with tier one relationships. So thanks for the question, Chris. You know, again, we, we think that the investment thesis that I laid out is potentially starting to be more and more recognized as time goes on and as Mako continues to do incredibly well. Mako has some very distinct things about it. It's the only saw-based cutting robot on the market. It uses a CT scan, so it's a personalized surgery, and surgeon adoption is really tremendous, and surgeon utilization is tremendous. So when you look at the utilization of their system, you know, 60% plus, Stryker procedures are robotic, and they have 75% of the press-fit knee market. So maybe I want to spend a little bit of time just understanding that. So if you think about hips, I think, the utilization of press-fit hips today is more than 95%, and over a ten-year period, it went from about 40% to 95% utilization of press-fit hips. Let's look at knees. The utilization of press-fit knees today is about 15%, and Stryker has 75% of that. Now, imagine if that 15% does something similar to what happened in hips and goes to 95%. So I do think that large companies are starting to realize that there's a synergy between robotics and press-fit implants. The benefits of press-fit implants are really twofold. One is surgical time. You don't have to wait for the cement to cure, which takes about 12-15 minutes. And then for younger active patients, press-fit implants, the bones constantly remodeling over time. You're not relying on bone cement for fixation. So there seems to be significant clinical benefit too from press-fit implants. So Stryker has 89% utilization of robotics and 75% of the press-fit knee market, which is only 15% of knees today. But what if that goes to 95% of knees today? Do the other companies in this market have compelling robot utilization and a compelling answer to compete with Stryker? I think that's the fundamental question people need to ask, and we think that we have a compelling robot that works very well with press-fit implants. Hopefully, that helped answer that, Chris. Sure. So Michael's asking us to please define haptic, and that comes down to really this slide here. So the Mako system, which is shown on the left, the user grabs an end effector that has a handle on it at the end of the robot and moves the robot around, and the user's force is what's really moving the robot arm. So in robotics, this is called haptic control. So generally speaking, it's either impedance control or admittance control. And the Mako portfolios or patent portfolios cover more than just this, but in essence, this is really what it's about. So with the Mako robot, the user is moving the robot around along a plane, unconstrained until they reach boundaries, virtual boundaries that seem to be tied to the implants. So that's haptics. So if you want to have the user move the robot around, you're really at risk of stepping on Stryker's toes, in our opinion. And the FDA, the benefit of this is that it's very efficient at cutting. Human beings are very smart, and we do a lot of dynamic compensation without even knowing it. And a human being, it really allows a user to cut as they would with a manual instrument, very efficiently, but safely within boundaries. Now, we will say that we think the boundaries could be enhanced, and that's what we've tried to do with our version of the system, but, that's really what haptics is. And nobody else... It's really they've created an incredible impenetrable fortress around this technology, and we think that's why the other companies are struggling. And for active or autonomous, which is where the robot is autonomously executing a cut path, so it's not really reliant on the user to move it around, it's removing autonomously, there's been no robot company that's been able to cut efficiently. Most of the robot companies that have tried to cut autonomously have used a rotary tool, which is not efficient, has a lot of problems. And so the surgical times with rotary tools are just too high. So if it takes you 15 minutes plus to resect bone, you're never going to be competitive with Mako. So from the ground, we said this, we need to have a active saw-based system. Now, the problem with autonomously cutting with a saw is that it's incredibly challenging for a number of reasons. One is there is a lot of vibration into the arm. The second is that you have to have a sequence of cuts. So a sagittal saw can only cut on a vector moving kind of on a specific vector, it can't side cut, which makes it incredibly challenging. So you have to create cut paths that are generalizable to any anatomy, and it's not trivial, and we think we have some very, very clever ways of doing it, and we think that it would be very difficult to do it without stepping on our patents, which we think have the potential to be extremely broad. So hopefully that helps answer it, Michael. So David's asking, you know, "Why do we think the stock is valued and selling so low, and what do you think will happen?" I think fundamentally, David, the problem we have is that we don't have enough institutional ownership, so we're mostly kind of retail-driven. And I think that the value proposition requires a little bit of digging to really understand. You know, we're talking about haptic, haptic robotics, active robotics, autonomous, and I think a lot of people just think that, well, everybody has a robot, and all robots are the same, and they don't dig a layer deeper to see, well, not all robots are the same when one of them has 89% of the market and 75% of press-fit knees. And the arguments that, well, Stryker has a first-mover advantage are really null and void when you look at utilization of their system, which is over 60%, and I don't know any other robot company that has that level of utilization, right? So, they've done something right, and I think that, a lot of retail investors don't really fully understand that. I think that, you know, again, to get institutional capital interested, it takes time, it takes milestones, it takes moving the ball forward, and that's really what we're focused on, is trying to do everything we can to continue to de-risk the opportunity. We believe the value proposition is going to become more and more and more obvious over time as Stryker continues to do what they're doing, which is demonstrating that robotic cutting with a saw efficiently is what surgeons want and is what drives utilization, and press-fitting is what surgeons want. And that's really, we think, our investment thesis, is that there isn't a good answer to what Mako is doing, and we think we have a reasonably good answer for that. You know, it's obviously, I think it's... A lot of people also appreciate that it's a very difficult market to raise capital in. Orthopedics doesn't have a lot of, you know, startup activity, and the cost to distribute is high, and so forth. So I think there's just a lot of people who remain skeptical and don't fully understand our investment thesis, which is why we're really trying hard to explain it. It is a little bit technical, but again, you know, David, we're focused on the long term, and ultimately, what we're focused on is patients and trying to enhance patient outcomes, and trying to bring technology to a market that we think will help drive utilization. So our goal is to have a robot that is as safe as possible, as accurate as possible, that automates the procedure, that... You know, one of the things we don't really get into is, you know, surgeons don't do the surgery the same way. We're bringing in different surgeons to do our verification labs, and they all want to plan the knee differently. Well, what is the best way to plan a knee? There has to be a better way. Some ways have to be better than other ways, and these are areas of opportunity where we think that technology is going to help us answer critical questions that are gonna make patients' lives better. So fundamentally, that's the, that's the value add that we're focused on. We're focused on how to make products that'll make patient outcomes better, and we're gonna let the rest take care of itself. That's really, that's really what we're doing. And if we are able to drive patient outcomes and build something that is gonna be helpful for humanity, I'm optimistic that that will be rewarded. And if we aren't able to build something that's valuable, then, you know, we'll continue to be penalized. I really do believe in what we're doing. I believe that it's going to be a very, very accurate, safe system. And I've never been more excited about what the product can do and more optimistic about the product. Let's see if we can get, you know, get to a point where we can get this into more surgeon hands. But yeah, again, it's tough. Markets are tough, David. So David's asking, you know, "What's the general timeline for the FDA approval?" So the most recent timeline we've seen, I think... Noel, correct me if I'm wrong. I think we actually put it into, I recently pulled that data. It's about 5, 5-ish, 5.5 months, something like that, I think is the average time, I want to say. Yes, that's correct. So, you know, we think that's a good target to plan and, you know, we're pushing to get through the verification and validation testing as quick as we can, and then have all those test reports done. And in parallel, we're working on the 510(k), and so, we want to be in a position to submit as aggressively and in as timely a manner as we can. So let's see here. So let's have this be kind of... let's second to last question. So I want to maybe we go for an hour. Okay, there we go. Thanks for the compliment. So Carmel said he would trust us. Honestly, Carmel, you know, my mom has two knee replacements and a hip replacement, and my dad needs a knee replacement, and I want a system that I would trust and that I would be comfortable doing on my own family. So we have made painstaking efforts to have a system that performs at the highest level, and I'm incredibly proud of that. Okay, "Can you provide a little more color on the next steps that need to happen before you submit the application in the coming weeks?" So, that's really all of this stuff here. So, we need to get through this IEC 60601, so we're through the EMC portion. We need to get through the basic safety and essential performance, which is about 40% of the way through. When I show this video of the fire hose, you know, being shot at our system, I mean, this is the kind of stuff that we're dealing with. And it's just working very, very hard to get through all of that. And there's a massive amount of paperwork that goes through it, too, and they go through the FMEAs and all of the components, and it's just a huge amount of work. So there's that piece of it, but we're aggressively resourced. And then there's the internal sort of verification and validation testing. So this is all of the test protocols of looking at every detail of the system. You know, what is the system latency? How can you prove that it follows exactly within the cut paths? How can you prove the system accuracy? What is the end-to-end system accuracy? What is the accuracy of the arm? What is the accuracy of your registration? What is your accuracy of your segmentation? All of these details, and then all of the software to make sure that there aren't critical bugs, to make sure that it can't be hacked. There's a ton of things. So what I'm saying here is we are 63% on the way through our electromechanical tests. There's not any real concern about the test protocols. So, like, the big one that would have been a risk, right, is system accuracy. So let's say we were doing a simulated cadaveric surgery and our accuracy was 3 millimeters, we would have problems. But right now, our accuracy is, basically, less than or equal to 1 millimeter. So we're very, very accurate so far. Now, this is not statistically significant, but what we're seeing is looking extremely promising, that we're gonna get through all of this and that there's not a lot of high risk to our verification. So we're not biting our nails whether or not the system is gonna pass, our internal testing. We've tested it very, very, very robustly. The big critical path... So when I say critical path, the thing that's gonna slow down our 510(k) submission, if anything, would be the IEC 60601, which is a little bit out of our hands. We're reliant on a third party to test our system, and, you know, it just takes, it takes time, but we're pushing as hard as we can. Hopefully, that's that. But, before we can submit the application in the coming weeks. So, you know, we never said that. What we, what we said is, that we expect the V&V to be largely complete by the end of this quarter, and then, we plan to submit the 510(k) in the second half of the year. But I certainly like your enthusiasm, Kyle. The team is being very aggressive about working hard. So Kapil's asking about the timeline for custom implants, and, I love this question, so I'm actually. I have this, I have our, mPress implant. It's my paperwork here on my desk. So, so the plan is going to be, we're launching with mPress, which is already cleared. So it's a press-fit total knee that has a clinical track record in the cemented version, and so we really like the articulation, inserts, locking mechanisms, all of that, and we have a very attractive supply agreement. So that's our gen one knee. And then the plan is to swap out the tibial component with a 3D-printed, customized tibial component that we think has some significant clinical benefits. It's... We've been working with the University of Nebraska on the development of that. We've shown that it has improved initial stability over the current state-of-the-art total knee. And we think it's gonna be easier to revise. A hypothesis we have is that it's more peripherally loading, which we think could be really positive. We haven't provided a timeline for that. We're really focused on getting the system cleared and getting adoption of the robot, which we think is a very significant opportunity. And then once people are comfortable with our robot and our implants, we're gonna start swapping components out of those with the press-fit 3D-printed custom implants. So starting with the tibial component of the total knee, and then going from there. So, let's see here. I think that's, I think that's pretty good. What do you think, Noel? Seem to answer everybody's questions? I think, I think so. I think it's important to reiterate the milestones that are forthcoming- Sure ... and to keep everybody, you know, aware of that, and keep their ears open for those activities, because those are important for our continued evolution. Yeah. These are, these are really, you know, big things that, you know, companies recognize, right? So, large strategics appreciate how hard it is to get IEC 60601 certification, how hard it is to submit a high-quality 510(k), and all of these things are just big milestones, and we're continuing to push hard, as forward as hard as we can. So perfect. Well, thanks, everybody, for your time. We appreciate it. We will look forward to updating you next quarter and hopefully, you know, going back to some demos like we've done in the past, to give folks a flavor of what mVision can do. That, I think, a sort of underappreciated hidden gem in our portfolio. But stay tuned for more news, and thank you so much for your support and your continued support. We'll be updating you next quarter. Have a great one. Thank you, everybody. Thank you.