Monogram Orthopaedics, Inc. (NASDAQ:MGRM) Q4 2023 Earnings Call Transcript

Monogram Orthopaedics, Inc. (NASDAQ:MGRM) Q4 2023 Earnings Call Transcript March 21, 2024

Monogram Orthopaedics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Benjamin Sexson: Okay, great. Thanks Greg. Well, good afternoon, everybody. We really appreciate you joining us today for this Update Call. I want to try and lay a couple of ground rules from the start. We’re going to be really collaborative on this. You’re going to be able to chat with us. There’s a chat on the right-hand side of your screen, and we will be looking at that and doing our best not to — it’s going to be a free speech platform, so please keep it respectful. Please no bad language, nothing obvious — obviously kind of unconstructive. But as a management team, we really want to be as open and available as we possibly can and give everybody an update on how everything is doing and go from there. So, we’re going to start out with a — and I should introduce the team.

So, on the left, I don’t know if it’s in the same order for our viewers, but my name is Ben Sexson, I’m the CEO of Monogram Orthopaedics. Directly below me on the left there is Noel, maybe Noel you can wave to the audience, Noel Knape, our CFO. We have our CTO, Kamran Shamaei below him; and then Dr. Unis, our Founder, who is still a practicing orthopedic surgeon, and we got him out of the operating room for this call. So, with that, I’m going to turn it over to Noel to just mention some of the disclaimers about forward-looking statements and then we’ll jump into the call.

An orthopedic surgeon performing a surgery while using ankle plating systems.

Noel Knape: Thanks Ben. Good afternoon everybody. Just some little housekeeping here. I want to go over the forward-looking statements disclaimer with you before we get started in this presentation, we’re really excited to give. As a legal disclaimer, this presentation by Monogram Orthopaedics, Monogram may include forward-looking statements. To the extent that information presented in this presentation discussed as financial projections, information or expectations about Monogram’s business plans, results of operations, products or markets or otherwise, make statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words as they should, may, intends, anticipates, believes, estimates, projects, forecasts, expects, plans, goal, target, and 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. So, no one has a crystal ball.

Benjamin Sexson: Terrific. Thanks Noel. Appreciate it. So, the presentation is going to cover these five topics. We’re going to start with a quick financial summary. We’re going to get into a detailed regulatory strategy review, give you some market analysis and just an overview of where we are. We’ll have, hopefully, Dr. Unis to kind of speak from a surgeon’s perspective on our product. And then from there, we’re going to open it up to a Q&A. And if you have questions, please type them in the right, and we will be doing our best to get to kind of the majority of those. So, with that, Noel, why don’t you kick it off?

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Q&A Session

Noel Knape: Okay. Just some key points about where we are financially speaking. As our 10-K reflected as of the end of the year, we had $13.5 million in cash. As you’re all aware, we had it raised earlier in the year and we’ve marshaled that cash well through the year, keeping our burn at a minimum. We had an account receivable from that first robot sale at the end of the year of $365,000 and no issues with that. Our operating cash flow for the year is $13.5 million. So, as you can kind of do the math, it’s a burn of about $1.1 million.

Benjamin Sexson: Hey Noel, just really quick. I’m seeing some comments that people can’t hear and can’t see. Can somebody in the chat just confirm that you can see the summary financial data slide and that you can hear Noel?

Noel Knape: Yes, can you hear me? I–

Benjamin Sexson: Okay. Good. So, keeping Noel.

Noel Knape: Okay. Sorry about that. Okay. So, some people maybe have some issues, I apologize for that. But anyway, so our monthly burn has been about $1.1 million, and it’s been running a little hot with the verification and validation phase that we’ve been going through. We expect that to come down a bit going into the new year. Some select information to give you a little color behind that is we now have 28 full-time employees. We’re very product focused. We have 22 in engineering and just 6 in the administrative function. So, we’re very, very much focused on the product development. We have 26 engineering contractors, 12 specifically supporting the V&V process. Like I said, as that winds up at the end of the first half of the year or shortly thereafter, we’ll be able to cut back on that a little bit.

And that’s denoted in this highly variable cost structure. That’s what we’re kind of referring to, we’ll be able to dial back on that a bit. We have no debt, and that’s a big comment for a start-up such as ourselves to not having leverage debt to get cash flow to be able to support our operations and development of our product is a big accomplishment. And as we communicated a little while ago, we were able to finalize the one outstanding warrant that we had. And that holder actually was an early strategic investor, and they converted their warrant for $1.25 million in cash. So that’s kind of indicative of their confidence in our forward progress, they’re willing to put in more cash. So, we took that as a very good sign. We have no other warrant overhang outstanding, so we have a very, very clean balance sheet.

We’re very proud of that. And importantly, I’ll let Ben get into the regulatory roadmap, but we expect to have sufficient access to cash to get us through the 510(k) approval process. So, that’s — I mean those are the main points that–

Benjamin Sexson: Just to say, I think what we said, Noel, it’s not through the approval through the submission is what we said. So, we’re comfortable with the submission. Certainly think that from there, we would move forward from there. Okay, perfect. Sounds good. So, I’m going to dive into the regulatory strategy. And for those of you who are unfamiliar with some of the vernacular, we’re going to explain all of it, but if you are, just bear with us. So, I’m going to kind of go through the details of this to help bring people up to speed on where we are and what we’re doing. So, Monogram’s Surgical Robot, we’ve called it mBôs and it’s a Class II risk device. And Class II risk devices are eligible for what’s called a 510(k) submission.

A 510(k) submission, for all intents and purposes, it’s just FDA submission for clearance of a device. To legally sell our device in the United States, it has to be approved — or not approved, the FDA’s preferred vernacular is cleared for sale in the U.S. and that involves taking a product through a very intense, what’s called, verification and validation testing process. So, there’s a whole development that has to take place and to kind of not more focus on all of the details, but the device has to be very thoroughly tested. And that testing depending on your equivalents to other cleared predicates may or may not require clinical data. So, the way the 510(k) submission works, which is the FDA submission for approval, you find predicates that you think are kind of reflective of the technology and application has the same intended use as your device and it’s similar in function in operation.

And then you show the FDA through a formal communication process, how your system works and then they evaluate whether or not you’re equivalent or operate similarly to the other devices that you’re comparing to. And then they look at the safety features and profile of your device and how that compares to the predicate device. And where they especially scrutinized are anywhere where there’s a technical difference between the predicate that you’re claiming equivalence to and your device, that’s where the heightened level of kind of scrutiny goes, those differences need to enhance safety and efficacy, and it can be sometimes difficult to prove to the FDA through non-life patient testing that that’s the case. So, there’s — typically speaking, the FDA is looking to first establish technical equivalents and then they’re evaluating the differences and trying to determine whether or not those differences are at risk that basically can’t be proven to be safe without clinical data.

So, the company has not been just kind of going at this alone. We are working with the preeminent of a CRO, whether they’re basically regulatory consultants that run clinical trials and provide consulting. We have retained a firm called Mikra [ph] to help us with the strategy of this submission and to evaluate our technology, evaluate all the predicates on the market, evaluate the technical equivalents, and determine whether or not the device would need a clinical trial with our submission. So, we did this in July 2022, we got a formal report from them and their conclusion was that we were equivalent to the predicates and they did not see a need for clinical testing. So, that’s really kind of been management’s opinion as well that we think we have enhanced the safety of our device versus predicates.

I don’t want to go too far into the weeds on that, but typically, then what happens is you submit, let’s call it, for all intents and purposes, a device description. You explained to the FDA what your device does, how it works, all of the details of the device. And the FDA, as you can imagine, with receiving a piece of paperwork that’s many tens, if not more than, I don’t know how many pages it was, probably 50 to 100 pages describing your product. That’s a lot of information for them to digest. So, you then engage in this process of going back and forth on how the device works, how it functions, there’s questions — just really high-level questions about what the product does, right? So, to-date, we have had three formal FDA pre-submission communications, and we have a fourth plant in April.

And really what this back and forth has been intended to do is just help the FDA, first of all, just understand how our product works, which, as you can imagine, is a pretty involved process. This a very complex piece of equipment. It’s not just kind of a quick here’s how it works, then they understand everything there is to understand about it. So, there’s a learning curve and process that has to happen. And you start to present to them various aspects of your verification and validation plan, how you intend to test the system. You show them the technical equivalence claims that you’re making. You show them how the safety compares to your predicate. And there’s a back-and-forth communication. So, what’s been established so far with the FDA is that our system has the same intended use as the predicate and our predicate has basically been accepted.

We have — I would say, it’s a 510(k) submission that’s been pretty well-established. Management never got a formal written yes or no from the FDA, it still haven’t regarding clinical data. The FDA is typically very reluctant to give you in writing a yes or no answer before you do a 510(k) submission. So, it’s a pretty subjective process where management has to — and the team have to try and deduce from clues and kind of, in some instances, somewhat vague responses what the best course of action is. The FDA has not overtly said, you need to run a clinical trial, they’ve just given us areas of how we were concerned about this and then we respond to their concerns and there’s this back and forth and it’s very difficult to know exactly where the FDA — how they feel about your device.

They really do try and hold back from giving you a firm opinion until they absolutely have to, which is once you submit. So, there’s a lot of strategy that goes into this. So, I just want to kind of lay the groundwork to help people understand. The goal of our next April meeting is — our assessment, I’ll just give you management’s assessment. At this point, management’s assessment is that the risk of the FDA after we submit with our current, let’s call it, our Gen 1 system, the risk of the FDA asking for a clinical data request after we submit, in our opinion, it’s still too high with what we’re calling our active embodiment. Now, it’s not because the FDA has said you need to run a clinical trial. This is a subjective assessment that, as a management team, we try and weigh the risks to benefits.

So, the goal of our next meeting is to specifically obtain feedback related to our verification test plan as well as a clinical trial protocol that we put together that would involve running a clinical trial on a target population outside of the U.S. Now, we’ll get into kind of why we’re thinking about doing that in a moment. But right now, we’re kind of getting to the point where I would say, if we were to do everything perfectly in terms of the verification test plan, it would be largely derisked in terms of knowing what the FDA wants to see in our 510(k) submission. We brought in a very long way. The FDA understands our product, they would understand the verification and testing plans and all the ways that we’re going to test the system and including the clinical trial test protocol that would have the number of patients, the endpoints, the follow-up time, all of that detail.

So, that’s really where we’re going to have a very clear understanding of what it will take to submit a fully derisked 510(k), assuming the active version of the device. Now, obviously, as you start to go back and forth with the FDA, the reason of a clinical study is of so much significance is because Monogram is an oligopoly, right? The orthopedic market is highly consolidated. The top four players account for 75% of the market, and the top robotics player has almost 90% market share in orthopedic robotics and had 75% market share in press-fit implants. It’s not easy for new market entrants to come into oligopolies. It’s — there’s scarcity of capital and these large companies understand this. So, getting funding for a clinical trial, which can have a significant cost, now it’s not an astronomical cost, but it’s a significant cost.

But to give you some framework for that, our CRO estimates that the cost to run the clinical trial would be somewhere in the order of $30,000 to $40,000 per surgery that we would need to run on the order of 90 to 100 surgeries with three to six months of follow-up depending. So that would give you some scale. It’s not so much even the cost of running the clinical trial itself and paying for those surgeries, the big challenge is the number of sites that the FDA would request. So, if you, let’s say, had a three-site trial, you need to have inventory for three sites. And the biggest challenge that we have in our industry is the lead-times to procure implants is significant. This is why we exist. We want to have a just-in-time 3D-printed implant model.

But in the world we live in now with generic implants, the lead-times are very significant. They can be in excess of eight months, they can even be up to a year. If you imagine for a small company, you have to have the working capital to fund all of that implant inventory, you need to have robot inventory. And it’s — and then you have to obviously fund the operations, while the clinical trial is running. So, it becomes not an astronomical cost, but a significant cost in a market that is an oligopoly, where there’s a general let’s call it, adversity to new market entrants and where funding can be expensive. So, that’s a long way of saying we don’t want to do a clinical trial if we don’t have to. And so as we started to get a feeling that we may need to do a clinical trial without certainty, it’s still a gray area, we could still submit a 510(k) and say we think we have good arguments, but we don’t think that’s prudent.

We have been working on making some technical differences to our system that we think could significantly enhance the safety profile and equivalents to systems that are on the market already. So, we have kind of — we’re putting a package around what our, let’s call it, our active system is. We’re going to know exactly what the FDA wants to see. And then in parallel, we’re going to have another version of the product that we are working on and very likely going to be the one we submit for approval, that we think is — really does not meet the threshold of a clinical trial, and they will say that, that’s our opinion. Maybe the FDA would see it another way, but we’ve had enough meetings with them where we think we understand where their concerns lie and which I’ll get into what their concerns are largely and they — I don’t want to characterize everything they’ve said, maybe there’s other concerns that we haven’t identified, but these are the ones that we think are relevant.

And so I’m going to jump into that next. So, where do we think the main problem lies with the FDA’s, sort of, concerns about our product and the technical equivalent to the current state-of-the-art. You think it mostly relates to what they characterize as active versus semi-active. So, on the left there, you can see two semi-active systems, Mako, which is owned by Stryker and Velys, which is owned by J&J. And what you’ll notice is that the surgeon is holding the saw that is mounted to the robot arm. And the surgeon is responsible for moving the saw during cutting. With the Monogram system, the movement of the saw doesn’t depend on force applied by the user directly to the cutting tool. So, that’s more of an active embodiment. This is really what the FDA has concerns with.

Now, I will say — I’m going to jump into this now, we had very good reasons for designing the system this way. We actually think that our embodiment potentially enhances the safety profile of our device. So, for example, with both hands-free, the surgeon who is the most experienced and trained user of the device and the most trained person in the operating room now has two free hands to hold retractors and protect soft tissue. So, we think that’s a pretty significant enhancement. You don’t have any surgeon fatigue because the surgeon isn’t holding a trigger and trying to wrestle a robot. They’re focusing entirely on where the blade is cutting. And there’s a lot of other things we can get into. But be it as it may, that’s kind of the perspective that we are working with.

The reason we designed an active system really was some of those things I already said, we believe that it would minimize the learning curve, we believe that eliminates a lot of the surgeons skill required with cutting, surgeon fatigue. Our goal is really to enable complex bone preparation, so milling for patient-specific implants, minimize the disruption to the workflow. We also don’t think that it’s a perfect safety feature for devices that have virtual boundaries for the user to be pushing into a virtual boundary. A lot of times, those virtual boundaries are protecting soft tissues, and we don’t think it’s kind of a perfect system to be pushing into a boundary that is protecting soft tissue. And really, our goal generally is to have a robotic system that is multi-application and we believe that a more active paradigm is more scalable for that.

So, that’s some of the design motivation. With that said, there’s limitations to an active design that we’ll get into. But I’m not going to get into the weeds on that. This is highly proprietary, and we’re just not going to talk about how we’re changing our system. But we basically believe that we can modify our robot to basically be closer to the predicates that we’re claiming substantial equivalents too. So, we think the devices in the market that were more similar to are Mako and Velys. Velys did not have to do a clinical trial, and they claim substantial equivalents to Omni, which is another system on the market. We think we have pretty strong equivalents arguments. So, for example, if you just look at the Velys 510(k), they describe their system as a motorized instrument controlled by the system automatically positioning the reception plane within the planned plane.

For the bone resection, maintains alignment through dynamic compensation. So, to make a long story short, we believe that we have some very, very strong equivalent arguments with that system. It is foot-pedal-operated for movement of the arm between reception planes, and we can — we’ll leave it at that. So, there’s — the company has decided that the technical differences of concern relating to active versus system-active can be addressed with some technical tweaks and that’s what we’re going to be doing. And we believe that these changes will mitigate the risk of the clinical data request. So, we think that’s really positive news. We announced that in the 10-K, and I’m going to get into a little more detail on that. But before I do, I just want to talk about potentially some benefits because there is certainly ways that these technical improvements potentially improve the system.

So, specifically, one of the barriers to utilization of robots is the time it takes for the robot to actually do the cutting. So, we believe that our changes could enhance the fee rates of the system, and we’ve proven that to be the case in kind of our testing. Dr. Unis was here actually last week for a lab, and he can speak more to that. But there are some improvements. So, I don’t want folks to think that we’re just purely modifying the system so we don’t have to do a 510(k) — not a 510(k) clinical trial. There are actually ways that we think this will make our device even more attractive to surgeons. So, I just want to kind of help explain where we are. Now, this is — might be a little bit tedious, but I think it’s really important. So, Monogram is kind of where — not that it’s a little bit small in production, should have made a little bigger, but Monogram’s kind of — it says Monogram is here and it’s circled design verification phase.

So, we are in the thick of the design verification phase. So, there’s approximately 60 hardware and system test protocols that we’re working through and then another over 100 software test protocols we’re working through. And these are all tests to basically prove that the system is safe. The goal is to be largely complete, I say largely, and that’s bolded complete with the verification and validation, what we said is in the first half of this year. So, we’re pushing very aggressively on that. We’re making very good headway. Is it possible for it to that time line to slip? Yes, certainly. And I’ll get into what would make it slip. The biggest risk really is that we’re a pretty small team and working very hard. And most of this is in our control, but there are some of it that’s not, I’ll get into that.

And then we are in parallel preparing the 510(k). So, our quality and regulatory team is working very hard to have kind of everything ready, so that once we finish the verification and validation testing, we would be able to submit that to the FDA as quickly as possible. So, our target that we’ve said publicly is for a submission in the second half of 2024. And what we’ve said is we believe we have the capital on hand for that submission. And the reason I corrected Noel is the — right now the time for the FDA to respond is on the order of between five and six months, that’s kind of their turnaround time for clearance or approval or rejection of a 510(k). So, that’s variable. The FDA — that’s out of our hands if the FDA took longer, obviously, we would need to account for that if they took shorter, that’s great.

But this gives you some idea of kind of where we are. So, we — the biggest risk, and I’ll just kind of talk to the verification and validation. So, this is what we have to do before we consume at 510(k), I’m just going to get into some of the big ones. The biggest risk is — and we have Kamran on the phone who’s had many kind of sleepless nights over this is what’s called ISO 6601. So, this is a kind of an industry gold standard for safety. It’s a third-party that basically is kind of certifying the safety of your device. It’s not a requirement for the FDA, but it’s a very, very, very strong and good, nice to have, and we think that it greatly enhances our 510(k) submission to have this. The biggest, most risky part of this that we’ve already passed was radiated and conductive emissions.

So, we pushed very hard through that. The team — I can’t say you had many sleepless nights getting through that, but the pace at which we cleared that was phenomenal and so we’re halfway through that. And we expect that that’s going to be done. And the next piece of it, we have more confidence in. We’ve been able to derisk the remaining piece with internal testing. The radiated and conducted emissions is very hard to simulate in house, but the remaining tests we’ve already tested, we’re pretty confident our system is good. There’s a huge amount of paperwork involved, but we are pushing really hard on that. But that is a risk if that — that’s a third-party and a steady or slow, there’s not much we can do about it. But we do think we’re on track there.

We’re pushing them very hard. The other thing is just kind of resource constraints. We have a lean team. We’ve been running it very lean, and that’s always a risk if you have key people get sick that hurts us, but I think we’re in a good spot. We — human factors, which is part of the verification requires a minimum of 15 patient surgeons. Surgeons are very busy. We have identified the surgeons for the most part that we’re going to be working with, and we’re getting them booked in on aggressive schedules, but it’s tough. Surgeons have very busy schedules and sometimes things don’t work out. We think we have plenty of cushion there, but I do want to flag it as a risk. And then again, this is what we’ve said. These aren’t guarantees. We think we have a pretty good shot at it and we’re pushing to do it as aggressively as possible.

And of course, we think that it’s a very meaningful milestone for the company to submit a 510(k) with what we think are very, very strong equivalence arguments and what we think is a very, very attractive safety profile to the FDA. So, to — we’re not just going in with risk of that. We want to mitigate risk every possible way. So, what we’re doing in parallel, as I said, is we are preparing to launch a clinical trial outside of the U.S. This is well underway. So, we expect, hopefully, we can make some more announcements in the near future about this. But we are currently targeting about — we need to do just to make the statistics work out about 88 surgeries at three sites, and we have — we’re looking for a 25% safety event rate reduction.

We have identified the endpoints we’re looking for. They will largely relate to atherogenic injury. We’re pushing for a six-week follow-up, which is pretty aggressive. We’ve already identified the sites, we’ve already identified the CRO, we’ve identified the PIs, identified the distributors. So, this would be at a significantly reduced cost to what it would cost for us to run a clinical trial in the United States. So, the plan is if we submit the 510(k), which we think is a very, very strong 510(k) with very good equivalence arguments, but if the FDA were to come back to us and say that they had an unfavorable view of our submission and would like to see clinical data, our plan is to have it very well, far along in parallel kind of as a belt-and-suspenders where we could just say, okay, well, here it is.

And in April, we hope to fully derisk the FDA’s view on the clinical data submission. So, I hope that makes sense. We’re really trying to have optionality. And if the FDA were to approve the 510(k), it’s still fine because, first of all, the cost to run this trial is not very significant. I mean certainly, there’s cost there, but it’s much less costly than in the U.S. And then we could use that data for post-marketing post-launch marketing in the United States, and we could look for other endpoints like learning curve, accuracy of our system, surgical time, and so forth. And then we would have the added benefit of being able to launch OUS in what we think is a very attractive market. So, it’s kind of a win-win and killing two birds with one stone.

So, I just kind of want to give folks a little bit of a view of how we’re thinking about just the market generally. And Doug, this is where I’ll tee you up in a second here, but when we started, this is like very simply what we saw the market opportunity is. If you just look at the market dynamics today, there is one company that has 89% market share in orthopedic robotics for knees and 75% market share in press-fit needs. Now, in anybody’s definition of a monopoly, this is what a monopoly looks like. And our investment thesis was — is very simple. We think that not all — certainly, Stryker is a well-diversified business, but we think that Mako has added billions of dollars of value to Stryker. It’s reflected in how the stock has performed.

It’s reflected in the market performance of Mako versus everyone else. And so we think there’s a very simply an opportunity for a compelling robotic system. And we really are thinking about it in a very similar terms. That’s what we see as the opportunity. We think there’s an obvious market. It’s a very high-margin market. And we think that our investment thesis going in was that this would be valuable to somebody. Could we be wrong? And could this be a complete not valuable? Certainly. But we’re not — I don’t think that’s where we as a management team are today. I think we have a very compelling product. We think it’s competitive with the current state-of-the-art. We think that it enhances on the current state-of-the-art. And we certainly think that with future upgrades that Doug will get into like the mVision navigation, Kamran can describe as well, it will be hopefully a pretty significant improvement over time.

So, I’m just going to play this video, Doug, it’s like a two-second video here. And I want you to try and explain this because I think it really is — sets the stage for how early this market opportunity is and how significant it could be. We want to play this video. [Video Presentation]

Benjamin Sexson: I’m going to press pause here. This is from a — it’s on our site when we released an update on mVision navigation, we had a Q&A, and this is Dr. Adler describing basically why robotic adoption has been slow. And this is a big part of investment thesis. So, I’ll play and then, Doug, maybe you can comment on it.

Doug Unis: Sure. [Video Presentation]

Benjamin Sexson: So, Doug, what does that mean? I want to make sure folks understand that.

Doug Unis: Yes, I want to be careful to stay out of the weeds, so Ben, just pull me out if I go in too deep. But we’ve been doing knee replacements for 50 years with mechanical instruments, basically, that look like the kind of instruments you would use to build a chair. They’re really just jigs and saw guides and that kind of thing. And largely because — and you can imagine, that’s fairly crude. You can’t make a cut that’s 3 degrees or 2.5 degree, you can kind of cut it right angles. You can see that and judge that with manual instruments. But you can’t really make these little fine-tuned cuts. And so partially because of the constraint of the way we’ve done knees for the last few decades, every knee gets put in essentially straight so that what we call mechanically aligned knee.

So, that — and the problem with that is that very, very few people actually have their knees lined up that way. And so about 20% of knee replacement patients don’t love their knees. And so a few years ago, probably about 12-ish years ago now, there was a move to align people’s knees more the way that their individual anatomy is because we’re aligned in all kinds of different ways. Some people [Indiscernible] knee, some people are a little bit bowlegged, and there’s been more and more research looking at kind of the spread of how people are aligned. The problem — one of the problems with giving people back their kind of the way that their knee should be aligned is that to do that with manual instruments is hard. And most surgeons can’t really do it.

And so — and there’s a very strong movement in this direction to kind of get people to kind of align their knees — we call it personalized alignment. And so there’s a huge opportunity for technology to make it more possible to get there, to get to those targets. The current technology platforms that are out there, they really weren’t designed for that. They were designed to do a better job of kind of giving everybody that straight knee and they do that. But the problem is that it hasn’t — giving everybody that perfectly straight knee and hitting that target every time, it hasn’t actually really moved the needle on how well people do after a knee replacement. Even with robotic knees done with the kind of traditional alignment, the same 20% of people are still not super happy with their knees.

But if you use the right robot to kind of give people back their own anatomy, all of a sudden, there’s data coming out saying that they actually do much, much better. And you have 95% plus very, very happy with their knees. So, we think that there’s — we’re designing a system that really is looking at where the puck is going, as Ben likes to say, and that is at personalized alignment. So, we’re designing into it the ability to resurface the joint to restore their patient’s anatomy. It’s one of the reasons we think having a CAT scan is important because you’re trying to resurface their knee. And without that CAT scan, there are a lot of systems out there that are imageless that don’t use a CAT scan and we think a CAT scan is important as we move more toward personalized alignment.

So, — anything else you want to say about that, Ben?

Benjamin Sexson: I think you nailed it, Doug. I’m seeing a couple of questions that relate to — are we basically downgrading our product to appeal in the FDA, I would say, definitively no, right? In anything in life, in any engineering or there’s trade-offs, right? So, the benefits of a fully active system, we think I articulated those, there’s also benefits to the current state-of-the-art. And so what we envision is a system that can do both. So, we want a system that could be active when it needs to be active and its most efficient to be active. And we want a system that has other modalities when it suits the surgeon for the other modalities to be working. We do not believe everything we do at Monogram is for basically the benefit of the patient. If we didn’t believe that we had a compelling product, I don’t think we would be here. I mean, Doug, you used it on this weekend. Do you think it’s — without saying too much, do you think it’s a downgrade?

Doug Unis: No, because what we’ve done is we’ve kept the safety features. We’ve kept the kind of the pluses of the active system. We’ve kept all those safety features. The hand-guided a bit of it just allows you to go faster, which is ultimately a premium. And as Ben was saying, we — there are some things that you want to be active. For example, our ultimate vision for the company is — and the reason it’s called Monogram is that we ultimately think that pairing a robot with custom 3D-printed implants is where things are going. And custom milling for example, where you swap a saw out for essentially a drem [ph] or a bur, for custom milling, we think active is a much better way to go for that part of it. So, we want to keep the active fit for that type of thing. But for cutting with saw, hand guiding definitely helps

Benjamin Sexson: Yes. If hand guiding is the way we go. Is semi-active, just kind of broader. We have a different embodiment that we think enhances the equivalent, but we think we ultimately will have a more robust product. And just kind of to recap the critical design features of our product and this is why we’re here. So, when you look at the current kind of state-of-the-art, right, every system basically follows these workflows. And maybe, Kamran, you can talk a little bit about the — our novel navigation that you’ve developed?

Kamran Shamaei: Specifically about the — next Gen or the current one?

Benjamin Sexson: mVision.

Kamran Shamaei: Okay. Yes. So, one of the major steps in joint replacement is basically called registration. Registration is a process that allows the robot to know where the patient’s anatomy are that means where the bones are, you name it. So, currently, the — all the robots in the market, they use a technology called optical tracking. And what that means is that we place a series of markers on the bone or the anatomy that we want to track. And then we run some algorithms to register the bone. We basically tell the bone where the bone is and then from that point on we track those markers on the bone and then that’s how we know where the anatomy of the patient, all the bones and all the different tissues are during the procedure.

This part of the workflow takes time. There is — we need time to expose the bone. We need to mount those markers on the bone, and then we need to register those — the patient anatomy to their markers and so on and so forth. And these procedures entire, all these parts of the workflow could take around 15 minutes with installation of the markers all the way through the actual data collection and registration. It could go between 15 to 20 minutes depending on the system. So, the technology that we have developed here and we’re now productizing it, basically removes that step. And in a matter of a couple of seconds, we basically register and start tracking the bone. And so what that means is that 15 minutes-ish of the procedure — 15 to 20 minutes of the — I mean based on the data you see here is more than that.

But I’m just being harshens or so. That step is basically entirely removed. What that means is that 15 minutes of OR time, which is very expensive, is removed. In addition to that, all the consumables and all the navigation instruments that we need to do the current tracking and registration, they are also removed. That is, again, a major cost-saving per procedure, but also for OUS market, that is basically a game-changer, not only in the U.S., but even more so for OUS because consumables tend to be way more expensive when the currency is exchanged. Yes, so we’re very excited about that.

Benjamin Sexson: Perfect. Thanks Kamran. So, kind of just really recap the design features. So, we’re innovating on the surgical approach and registration that’s not going to be in our Gen 1, but it’s going to be, the mBôs is going to be upgradable to mVision. And the idea here would be, as Kamran said, no point-based registration and hopefully very streamlined navigation. We have — we think enhance certainly over some of the state-of-the-art solutions with, we think, improved joint balancing have been a huge focus on for the company. We think this is a major benefit of being a CT-based system is joint balancing and specifically as you get to more patient-specific techniques, our system accounts for things like tibial rollback and some of the really the biomechanics, which is not a trivial thing.

And then the bone preparation, we think we have a very high efficiency mode of removing bone. And — but we have enhanced safety and — our mVision we have a cleared mPress implant line that’s ready to go. So, we have state-of-the-art cement-less implants that are already approved. And then as we are successful, our plan is to scale to other applications. Our plan is to scale to patient optimized 3D-printed implants that will happen in series. So, what we’ve said is we’re starting with the mPress implant line. The tibial component will be replaced with a novel tibia component that Doug has been spearheading the design of and then we would look for further optimizations from there. And then finally, launching OUS, we think, is also a pretty attractive I’m not sure.

I think that might have been a running [ph] bullet. So, I’m going to — basically, we believe that the solution we have, as Kamran said, makes sense OUS as well from a consumables perspective. Just in terms of kind of how we’re thinking about what the company — just looking at comparable company analysis for predicates — or not predicates with comparable companies in the space that got approval. There’s not a lot here. It’s a very consolidated market. There really haven’t been a lot of good comps. I think we could argue why Monogram is different than any of these, why we think that the value of Monogram in these metrics may not fully reflect the value of kind of what we’re doing here and how disruptive what we’re doing could be. But this gives you some idea of where a company like Monogram could be post-approval, but certainly not a forecast or make your own determinations of what you think Monogram could be worth.

But these are the metrics that bankers and so forth generally look at. And now I just want to recap our investment thesis. So, our vision is to commercialize an orthopedic robot that advance the standard-of-care in orthopedic robotics, while addressing the economic obstacles of orthopedic robotics today. So, when you look at robots on the market today, we don’t see any robot on the market today that increases throughput, so increases surgical time — decreases surgical time and we see every robot on the market today, basically requires incremental consumables. So, you’re adding cost, you’re adding time, and then the clinical benefit for any system that doesn’t really do personalized surgery very well is sort of, I would say, kind of marginal at best.

You can probably do a mechanical knee replacement with manual instruments more accurately than you can with the robot. So, the value proposition of robotics really hasn’t been fully realized. And our vision is to create a robot that solves economic problems and clinical problems. So, how do we solve the economic problems? We’re going to try and make a robot that’s faster. How are we going to do that? We’re going to use technology like mVision, where we get rid of point-based registration and hopefully get rid of all of the setup placing larger rates. We have very, very efficient cutting. And then we’re going to have a system that doesn’t — hopefully doesn’t require any consumables in the navigation. So, if you imagine kind of getting rid of the incremental consumables.

And then you think about a system that can scale to other clinical opportunities because it is such an incredible piece of hardware, right? This is a seven-joint robot arm, it has a lot of dexterity. We can nil hip cavities in prototype versions of our design in simulated surgeries. We can — if you think about minimally-invasive surgery, having a system that could be active when it makes sense to be active or semi-active. It really — what we’re envisioning is one robot for the operating room, training, servicing, sales, all synergistic, basically a Trojan horse that if you get it into a hospital, now your spine group has something to sell. Now, your knee group has something to sell. Now, your hip group has something to sell, your shoulder team.

That’s really the vision of the company. And then over time, we have very compelling personalized implant designs, and we plan to upgrade the mPress implant line to more and more enhanced implants that we think will address the — basically the working capital burden. I think that said, we want to close with this slide. First off, I want to say something because there are people that post online and I just want to tell you, as a management team, we do read those comments. So, if you want to communicate with us, we do see where people are frustrated and what they’re saying. And I want to say a couple of things right out of the gate. We’re not happy about where the stock is at. It doesn’t make us feel good. We are competitive. We believe we have something compelling and that’s not something that makes us happy to see.

I’ll say to that as well, none of us as a management team have sold a single share. I haven’t sold a single share. Noel hasn’t sold a single share. Kamran hasn’t sold a single share. In fact, Kamran, I think you bought not too long ago — you participated in the IPO, I believe. Doug hasn’t sold a single share. So, we’re all in this. We’re not selling. And this is kind of an interesting just sort of anecdote, but if you go back and look, Mako Surgical, their stock was down 75% six months before Stryker bought them for $1.6 billion. And when you think about how much value that technology has added to the Stryker portfolio, I mean, it’s pretty remarkable. So, our comment to people who are panicked is sometimes the market is right. It certainly is in the short-term, a voting machine on sentiment, but we’re here for the long-term.

We’re not selling. And we believe in what we’re doing, and we’re here to stick it out and do everything we can to bring this technology to market. And if the stock goes down to $0.01 or if it goes to $10, we’re here for the long-term. Ultimately, this is about technology. We’re trying to do something in the orthopedic market, right? This isn’t oligopoly. We think that there’s been a scarcity of innovation in the space. We feel like it’s to the detriment of patients and we’re actually trying to do something and make a clinical difference and that’s what drives us. What doesn’t drive us is the stock price going up there and down every day. What drives us is — how do we make a technology solution that is going to enhance patient lives. That’s the fundamental motivator behind our company.

Everybody who’s here has the same passion for patients. And so that’s really how we’re thinking about it going forward. And with that, I want to open the floor for questions. And I have seen a number of impressions — questions here that we kind of maybe want to tap into. I’ll put them onto the screen. I know folks have been asking a lot of questions here. So, you see here.

A – Benjamin Sexson: Let’s put one from Greg. So, Greg says, I worry about the lack of capital to move it to the end. It just doesn’t seem like you’ll have enough to complete the program. So, Greg, what you have to understand is when you’re a start-up company and somebody says, never, the team you’re looking at here is we’re not quitters. That’s — you’re looking at some of the — we are very, very, very, very dedicated, okay? I worked at Monogram for two years without making money. And if I have to do that again, I will. If I have — and this is not going to die. It may die, it may fail. We may run out of money fine, but I refuse to let this thing die. If it does, it’s going to be a massive disappointment to — I know, to me personally, to the team, it’s going to be devastating.

I know Doug, I know Doug had to sacrifice a lot. We may run out of money. There may be people who don’t believe in this and don’t want to fund it and want to see us fail. And the only way this would die in my opinion is if this isn’t actually a good idea. If the products we’re developing does not help improve patient outcomes, if it’s not a good product, if the market doesn’t want this product, then it should die. But as long as we believe that this is actually going to make a clinical difference, as long as we believe we actually have something. I think the team — I think we’re going to refuse as much as we can to quit. I’m not saying that we can’t fail. We have a going concern from the other — I think that actually got cleared. But even if we did have one, there’s a lot of risk here.

We might fail. It’s not a guarantee of success. But what I can guarantee is that we really want to see this be successful, and our motivation is more than just to make money. We care about this technology. I don’t know if I speak for everyone else Doug, if I speak for you, we’re not okay just seeing this all way, I think there’s a market need that we are trying to address. So–

Doug Unis: Yes–

Benjamin Sexson: And thinking of capital, we do have the capital, we think, to submit the 510(k), right? And that is a major catalyst, right? So, once you have a product that’s submitted for clearance, then that really does change the game in our opinion. So, yes, Doug, go for it.

Doug Unis: Yes. I think, look, you look at the market and you look at the slide that Ben showed before where Mako still has essentially the monopoly on the robotic market, despite the fact that one of those robots on the list actually came out before Mako and has essentially nothing. So, what happened was Stryker came and bought Mako, it’s been extremely successful at driving sales of implants for them. And so there was a just desperate drive in the market to get a robot in the market and it was kind of cynical. It was like, we’ll just get a robot out there and surgeons will use it because the robot’s a robot. And that turns out not to be true, like surgeons know what helps them in the operating room. They know what helps patients.

And they have largely rejected these other robots that were kind of brought on to the market. And we’re looking at that. I mean, I’m a surgeon. Like I know what helps me in the operating room. I know what my colleagues are talking about and what helps them. And so we’re really, really sensitive about not just putting another robot on the market and thinking that surgeons will see it as equal to everything else that’s out there. That’s just not the case. So, we are working on a product that is really going to, as Ben said, drive better patient outcomes, but also be a product that a surgeon wants in their hands. It’s a product that actually lowers their blood pressure, makes their day go easier and faster. And that ultimately is how these things get adopted and have staying power.

So–

Benjamin Sexson: Thanks Doug. Yes. So, again, there’s risk. Capital is tight, but we think we have a plan to execute and we’re focused on execution and doing all we can. So, Kamran, this one is for you, will the software be upgradable to add an AI element when AI technology matures to more. So, maybe you can talk about AI and–

Kamran Shamaei: Sure. Yes. So, our software already has AI components integrated in its pipeline, we extensively use them. And that’s one of the benefits of our system where we don’t need like an individual to sit back there and just generate whatever data the robot needs to operate in the OR. We already have those. But yes, our software is, I could say, not only software, but also our hardware is designed from the ground up to be upgradable and to be modular and to support multi-application. Just imagine how many years we have spent developing this robot to the level of maturity that it has right now. Now, imagine if we wanted to develop another robot for, let’s say, spine. Then we had to go back to like the first step and spend like we can spend around like five, six years, four years, how many years to get to where we are right now and develop a spine procedure.

But our system is not like that. Our system is already upgraded. In a matter of months, we can convert this for a different application, integrate AI modules in it and so on and so forth. Like the mVision ambition that I mentioned, that’s very much AI-driven and our engineers here already run it on our system for their proof-of-concept, for the prototyping, and all the other for the current version that we have in-house. So, the answer is yes. It’s already — it already has AI elements and is fully integratable and the software is fully much [Indiscernible]. So, any component that currently — any module that is currently potentially not AI-driven if — or when we have the AI base version of that, we can easily replace it.

Doug Unis: There are so many places in our pipeline and in our technology where AI can be plugged in. Kamran just touched on some of the technical stuff. But even on the clinical side, while I was talking earlier about just aligning knees and figuring out if everybody doesn’t get a straight knee anymore, like what’s the right target. And there’s a lot of discussion about that, like what — where should you put an individual’s knee if not like in this straight line that we’ve always done. An AI can really be used in that sense to figure out like to drive where do we — looking at a particular patient, where do we — what’s the right target for that patient? I think the — it’s a very rich environment for using AI in that sense and something that will get better as we do more cases, and as the technology matures, as we get more CAT scans, more imaging, more surgical data, et cetera. Really exciting opportunity.

Benjamin Sexson: Yes, this is an interesting one from Stuart [Indiscernible] but he says there are people who want to see it fail. They have deep pockets and then they pick up the IP in a fire sale. I — Stuart, I know I’m an optimist. I know Doug is an optimist, I know Kamran is too, I know — we really believe in trying to — we believe that the standard-of-care in orthopedics that if you look at the market, right, and this is true of any oligopoly. What happens with oligopolies, it can happen is you can really have two things that I think are not positive. One is you really basically have no new market entrants, right? It’s very difficult for new market entrants. And you can start to have, in our view, over time a complacency where the — these incentives to actually try and change things and make things better and try and really push the ball, the economic incentives start to not be there anymore, right?

Is it really — is there really an economic incentive to take away the barriers to entry for new players, right? We actually had just-in-time implants. Is that really what’s best for incumbent players that already have billions and billions of dollars to fund the working capital? So, that’s true. But on the other hand, what we care about and why we’re doing this as patients. So, we fundamentally believe that. And there may be many people who think what motivates us is we’re just trying to get rich or we’re just trying to whatever. And I can tell you right now that, that is not the motivation of this company. The motivation of this company is to try and advance the standard-of-care for patients. That’s really why we’re here, what we’re trying to do.

And failure to me would be we fail to develop a product that does that. And every decision we’ve made from an engineering perspective has been to try and make things more accurate, make things faster, make things easier to use, drive utilization of robotics. We believe that the utilization of robotics will help patients. And I’m going to stick my neck out one level further. Every robot company that we’re aware of on the market has tried to be target-agnostic. So, robot companies have basically tried to say, okay, surgeon, do whatever you want to do. If you want to do a mechanical knee, do a mechanical knee. If you want to do a personalized knee, do a personalized knee. We’re just here selling an instrument. That’s not the view we’re taking.

We actually believe that clinically speaking, we have very strong biases about what a knee replacement should be like. And our goal is to try and drive the science there to prove it. Now, I’m not saying we’re right, but I think that it’s imperative that technology companies in medicine actually try and figure out what the best way to treat a patient is and don’t just sort of keep doing the status quo. And I think that’s part of what frustrates people about Monogram is that we are biased — now certainly, our tools, somebody can take our tool and do a mechanical knee because that’s what they want to do. But we will be researching. We will be trying to change how people think about knee replacements and we will be trying to help answer the question of what is the best target, because ultimately, why we’re doing this is not just to make a tool that cuts bone, but we want to have a tool that actually helps drive patient outcomes.

So, does that mean that somebody is going to try and kill us? Sure. But I do believe that if the mission is there and genuine and strong enough, can somebody squash it? Sure. But we’re highly motivated to try and do this for the right reasons, and we’ll see what happens. And hopefully, that prevails because I do think that these companies that we’re competing against, I think they do care about patients. I just think it’s sometimes being so large, it can be difficult. But I do think that, that exists in the orthopedic space, where I do believe there’s a lot of people with integrity, where that’s what they want. And I think that a company that cares about that, I do believe that it actually does resonate. So, that helps how we’re thinking about it.

Kamran Shamaei: I just wanted to add, Ben, if I may?

Benjamin Sexson: Yes, of course, go for it.

Kamran Shamaei: So, I want to talk on the behalf of the engineering team, which is right now pretty much other than a couple of people, most of the company. We are very lean. I can tell you and Denis, my witness, we worked around the clock. We worked every night, and we wake up at 7 A.M. back to work. And that’s not the thing that we do one day or two day, that’s basically for life ever since we joined Monogram. We don’t work like this out of fear. We work like that because we love what we’re doing and we love what we are developing. And — the example I always give a person from — the example I always give is Alexander the Great, when he started, the person — kings were laughing at me and see who wrote the history, right? I just limit to that.

Benjamin Sexson: That was good. No, it’s deep. We’re getting sentimental on this video. Yes. So, here’s just another question for Mark. How do you plan to raise money in the coming months before you go to market, right? So, this is an interesting question. As many of you know, we’re crowdfunded. We’ve been crowdfunded all along. I do think there have been opportunities for our crowdfunded investors to get out at accretive prices. Now, I certainly would have hoped that it would have been higher for longer and whoever wanted to get out and make money, could have. Whoever invested in our crowdfunding and is still with us, unfortunately, you’re here for the long time, the long haul. Sometimes there’s an expression like you started to make money, but now you’re here for the tech.

Now, it’s become a long-term opportunity, right, with the prices where they are. When we have gone out to institutional investors, they really have wanted to see things that we couldn’t actually answer. So, we didn’t know how many patients the FDA was going to require for a clinical trial because we hadn’t submitted a clinical trial protocol. And we hadn’t submitted a clinical trial protocol because the FDA hadn’t definitively — and they still haven’t told us whether we need to do a clinical trial. So, why would we submit a clinical trial protocol to them if we don’t need to do a clinical trial and bias the whole discussion, right? So, there are some things that have taken time that have been difficult for us to fund raise around, right? Because if you don’t know what the budget is to do something, it’s hard to get it funded.

But now a lot of these things are getting derisked, right? So, we talked about the discussion we’re having with the FDA in April. That’s going to be a massively derisking thing where we now have clear answers for all of that. We’re planning to submit our 510(k). That is a huge milestone. That has been a massive, massive amount of work. There are — hopefully, we’re going to get a clinical trial approved outside of the U.S. That’s a very significant milestone. So, now I think we’re getting in an improved position where we can tell the story and hopefully, we can find investors that believe in the opportunity just as much as we do and resonate with the mission of the company, which is to try and improve patient outcomes, that’s really why we’re here.

We have, and I’m just going to float this, there has been some discussion of should we even look at going back to — one of the things that’s really interesting, and it’s been a problem for us, but it’s a problem that I love and hate. So, one of the problems we have right now is our stock doesn’t have a lot of volume, and that’s because we don’t have a very large float. And the reason we don’t have a very large float is because a lot of our investors, in fact, the majority of our investors, — and I haven’t pulled this like as of the kind of recent price action. But a lot of our investors invested because they actually want Monogram to succeed, because they care about the technology, and they were really just almost like a GoFundMe. They weren’t concerned about the returns on the stock.

They were concerned about this technology getting to market. Our average investor was 65 years old and actually cared about the technology. And any time we do any kind of communication, we’re inundated with e-mails from people who actually care about the technology. So, we have an audience that cares about the technology and is interested in more than just kind of maximizing to the very less penny returns. And as a management team, we have been thinking about, okay, well, maybe there’s an opportunity to — at these levels, give access to people who care about the technology kind of one more opportunity with hopefully a lot of accretive milestones. We’re going to talk about that more that’s in discussion, but just something to have in your minds as we continue moving forward.

So, I want to make sure that we keep getting to questions folks have. So, — okay, here we go. He’s going to why so much engineering, now I thought the product was submitted to FDA and kind of frozen until approval. So, Mark, we have not yet submitted to the FDA. In fact, the engineering on this product is largely done and has been for a long time, Kamran can speak to that. Right now, it’s just going through all of the testing that’s required for the submission. So, you have to prove to the FDA that your product is safe and effective. And that is not a trivial process. We’re making a lot of headway and we plan for that to be largely complete in the coming months. So, all of the engineering or the predominant engineering is on the mVision navigation, which is our novel navigation technology.

I think there’s been a lot of confusion and part of it is when we say 510(k), and I do see there’s some people who think we have been misleading about the timing of the clinical trial and so forth. We have never been misleading about the timing of the clinical trial. We’ve always said that we are discussing with the FDA. We are trying to determine whether or not clinical data would be needed and there was a lot of uncertainty around that. And in fact, we talk to regulatory consultants who still think — well, at this point, management has a strong feeling that we — it would be smart to have a clinical study with this embodiment. But it’s never a definitive. The FDA doesn’t give you definitive answers and the time it takes to get to a point of granular discussions is very time-consuming because every time you submit to the FDA for a response, it’s 60 days for them to get back to you.

So, you’re talking about a pretty tedious process. But–

Kamran Shamaei: If I can add Ben.

Benjamin Sexson: Yes. Sure.

Kamran Shamaei: Yes. So, if the question is why did engineer team is a big, I would say, the engineer team is actually relatively small compared to all the competitors that I’m aware of. We are actually order — at least one order of magnitude smaller in terms of size. But if the question was, why do we do so much engineering work because it really takes so much engineering work to get the surgical system of this scale to the market. And per Ben’s point, yes, no, we have not submitted to 510(k) through FDA yet.

Benjamin Sexson: Yes. So, we got a question here about analyst coverage, investor roadshows, strategic investors. So, we recently presented at the Canaccord Conference. A lot of it is kind of what I said, right, is institutional investors are not as inclined to take risk, right? They want to know what the budget is, what the milestones clearly are, what the timelines clearly are and so forth, right? So, we’re now getting to the point of having that very clearly defined for us. And we think that that’s going to be helpful for them. Now, what’s frustrating is the stock really kind of going down and becoming less attractive for fundraising. And so — we are not interested in diluting our shareholders. We really want folks who have been with the story with us a long time to thrive.

So, it’s a really delicate balance of trying to move the ball forward as far as you can, but obviously, derisking those milestones. So, what we have said is we think we’re in a good spot to get through the verification and validation. We think we’re in a good spot to submit 510(k). We think those are pretty accretive milestones, and then discussions are ongoing. Now, when it comes to the analyst coverage, that’s something that is difficult to control. We have talked to numerous investment banks, and we have retained investment banks. We did not like the deal flow so far that we were seeing, but hopefully, that improves as we kind of continue to move the ball forward. And generally speaking, initiating a relationship with an investment bank and working with them is helpful to analyst coverage.

So, the two are largely tied together. Okay. So, we got maybe — we’ll do five or 10 more minutes here. Any other questions for the team? Okay. This is a good one. So, I think this relates to the clinical trial, but it’s helpful to just talk about overseas. So, the — there’s a lot of synergy to the OUS clinical trial that we’re running. I — what we’ve said is we’ve identified the CRO. We’ve identified the distributor. We’ve identified the PIs. We know we will be using the — basically the mPress implant, cemented version of that. So, we think that we will be — require less inventory and that it will be kind of a lot more efficient to run a clinical trial OUS. So, for strategic reasons, it’s not helpful for us to say more. The Indian — when we talk about patients, right, there’s obviously a huge need in the United States, but Kamran and I had the opportunity to be in an operating room outside of the U.S., not too long ago.

And what I can tell you is that there is a very serious need for technology in certain markets outside the U.S. And I think this could do a lot of good for humanity to have products that basically make surgeons better at their jobs out there. So, we’re getting some comments about more regular updates. And we’ve tried to have a balance of making well-informed updates. It’s — there’s a lot of factors that we hope people can be aware of, right? We are an early-stage company, and we want to be careful about how much we say when we say it and so forth. So, it’s a little bit of a balance. But just because we haven’t been communicating as frequently does not mean we are not working extremely hard, and we’re working very, very hard and the team is highly dedicated.

We are going to try and make more of a regular cadence of providing updates now that we’re kind of closer to basically some of these big milestones that we’ve described. Ankush Sethi [ph] says, India is a huge market, Yes, we agree, it is a huge market. What’s the population of India right now, how many billions, Kamran do you know?

Kamran Shamaei: 1 billion to 1.5 billion.

Benjamin Sexson: There’s a lot of people who need knee replacements.

Kamran Shamaei: Yes. But I think for India, not only population, but level of sophistication of the surgeons over there and the healthcare familiarity with new technologies, with English, there are a lot of benefits to working with India for sure.

Benjamin Sexson: Yes. What’s nice about India too is the population is receptive to technology. They’re not scared of robotics. Yes. Yes, it’s Ankush says, you can do studies there, too. Yes, we think India is a pretty mature market for clinical studies. Okay. Somebody is asking — so Greg is saying, so can you tell us what the foreign sale is being? So, again in — pretty much — I mean, if there’s a market in the world where you don’t need to go through a regulatory process, please tell us. If you’re from somewhere where Monogram could just go and sell robots that are unapproved, we would like to know about it. But typically speaking, there’s a regulatory process where to legally market your devices and it doesn’t matter where, it has to go through the proper channels, right?

So, what we have said is we have hired a CRO. We have found a distributor. We have found PIs, we have found sites, and we plan to hopefully initiate a clinical trial outside the U.S. So, the — hopefully that’s helpful context.

Benjamin Sexson: Okay. So, maybe we get one or two more last questions. Anybody have any other questions for the management team? Hopefully, this was helpful. We appreciate everybody’s time. I don’t think a lot of public companies have this level of engagement, but we felt like it was really important to give our investors a chance to talk to us. One thing I’ve always said this, right, is thank you for your support. We really, really appreciate it. If your investment in Monogram is causing you stress, your oversized. Use proper risk management. This is part of a diversified portfolio, but I don’t want anybody aping into this and going all in, right? That’s not what this presentation is about. We want people to be conservative, cautious.

If you want to be supportive of the technology, we appreciate it. But don’t put your life’s savings into Monogram, please do not do that. Just support us with whatever you have. And even if you have nothing, you follow the story, share Monogram’s technology, keep folks updated on what we’re up to. So, I do see people who seem very distressed, you probably overpositioned if you’re distressed by your investment in Monogram. Great. We really appreciate everybody. Thank you so much for sticking with us, and we hope to do this with a more regular cadence. I’d say we got a lot of folks who stuck with us the whole thing, so that’s great. We really appreciate your support and we hope to speak again with you soon. So, thanks, everybody. Really appreciate it.

Thanks so much. You follow the story, share Monogram’s technology, key folks updated on what we’re up to. So, I do see people who seem very distressed, you’re probably overpositioned if you’re distressed by your investment in Monogram.