All right, we're going to get started here. Welcome to the afternoon session at the Piper Sandler Healthcare Conference. My name is Adam Maeder. I'm one of the med tech analysts here at Piper. Very pleased to introduce the management team from Vicarious Surgical. With us, we have Stephen From, the CEO of the company. Stephen, thanks so much for joining us.
Thank you, Adam, for having me.
Of course. You had a press release, I believe it was today.
Yeah.
Everything's kind of blending together this week. But, you know, you reduced the cash burn guidance for FY 2025. I think it was by $5 million to $45 million for full year 2025. Do I have that correct?
Correct.
And then you also had some operational. I think you're going to give some additional details on kind of the operational work you're doing before year-end. I think that's what you also messaged in the.
Correct. Correct. And I want to give guidance for 2026 before year-end as well.
Okay. Okay. And maybe just to start on the 2025 cash burn outlook, you know, bridges from the $50 million to the $45 million, like, where were you able to kind of trim the fat, so to speak?
Yeah. So it's interesting. So, you know, a company at our stage and our size, we have a really high, I could almost say, ludicrous burn rate. You know, the guidance for 2025 was $50 million. So, you know, one of the first things, it wasn't just me, actually, my CFO's here as well, and she's new to the company. She joined a few months before me. We were really going through all of the line items to understand where we could save some money. And there were some obvious places. But also, you know, we did let some people go as well. And I can talk a little bit more about what we're trying to do when we restructure, what we're trying to accomplish here, and how that's going to help us not just reduce burn, but also keep us on our timeline to get the design freeze.
Okay. Fantastic. In the operational reset, and, and kind of giving an update there, and I think you said before year-end.
Yes.
Just maybe what should we expect to hear from that update? How will you communicate it? Will it be 8-K'd, press release? And I guess the same question would go for the FY 2026 guidance.
Yeah. So it's interesting. We're still trying to figure that out. In fact, we have a call tomorrow with our PR firm. But the way I'm thinking about it right now is I'd like to put out a CEO letter, which is really focused on the restructuring and talking about how we're doing that, what I'm trying to accomplish. And then I'm thinking a separate press release, which would go into more on the guidance for 2026 and how, you know, what are the details on that. My first thought was to combine them, but I'm thinking that maybe I'll do those as two separate press releases.
Okay.
But close together.
Yeah. Okay. Fantastic. Well, we'll definitely keep our eyes peeled for those in the next couple of weeks, you know, and I guess just kind of like a bigger picture question for you, Stephen, is, you know, I think you've been the CEO for maybe four months.
About four months. Yeah, almost.
Maybe just, you know, reflect on your time at the company. You know, what are some of the learnings? What are some of the opportunities? What have been some of the challenges, and kind of how do you intend to put your fingerprints on the business?
Adam, there's a lot to unpack there. It has only been about four months. The company's been around for about 10 years. You know, I'll step back a little bit. What got me excited? Why did I join? I'm not an expert in robotics. I'm not even an engineer. I've been doing this for a long time, and I understand how to evaluate the asset. I spent a lot of time really trying to understand what do we have here. Do we have, are we trying to develop something that anybody should care about? It's really important that we start there because what we're doing, miniaturizing robot, this is a new class of robot for doing surgical procedures. We're miniaturizing the robot so that the whole thing can fit inside the patient.
It's going to fundamentally change soft tissue surgery. And that's, that's what we're trying to accomplish here. And so one of the things that I was looking for, does it differentiate itself enough from the existing platforms, the da Vinci, the Hugo, OTTAVA, so that we can actually go where they can't? It's a really hard sell to people to say that we're going to displace the da Vinci. Intuitive has been doing it for 20 years. They have deep relationships. But so I really wanted to understand why, why are there still so many open surgery procedures in the soft tissue space? And can we go after that market instead? Because then we don't have any competition. And that's what led me to saying, yeah, this looks like something that's worthwhile digging into and trying to fix. So I started with that premise, okay?
I know there's a lot to talk about there. Then I got involved here, and it was more watching them in action. The first thing I had them do was put a brand new project plan in place and just watch the chaos. Now I know where to start and how to fix. That's what we've been doing. Been digging at every piece of it. It's a, you know, it's a fairly large company. There was about 130 people when I joined. It's now less than that. The idea was, is there's a lot, I mean, we're in Boston, and it's expensive in Boston.
There are a lot of companies outside of Boston and other countries, and countries that don't cost as much, that have really talented engineers that know a lot about robotics, know a lot about mechanical, electrical engineering, that could do some of this work for us at a cheaper cost. We don't have to do it all in-house, so we spent a couple of weeks with the executive team really understanding what is the type of skill set and talent that we need to keep internally so that we control our special sauce, which at the end of the day, it's the miniaturized robots and the camera, all right? The capital equipment, the surgeon console, and the patient cart. Yeah, they're tailored to us, but they're not really our special sauce. They're not really what differentiates us from the other platforms out there.
So now that we identify all of those people that are instrumental in actually helping us finish the development and continue on with development after our first platform gets commercialized, then we can start thinking about what we do to outsource. And even when I think about outsourcing, I kind of have. I call it the three-pillar approach. And I'm going to go into that in my CEO letter. And I don't know how much detail I want to go into right now. But there's a lot of different things that we're looking at, including internally with the core team, the people that are really, you know, instrumental here, making sure that we know that they have the correct direction and focus so that we can get more output per person. I know that sounds strange.
It's not a factory, and we're developing something that's really high-tech, and nobody's done this before. But there hasn't been a lot of focus at the company. One of the first things that I noticed, and I've noticed this throughout my career, even when we did acquisitions of other early-stage companies when I was CEO of this other public company, most of the opportunities occurred because a lot of CEOs of smaller companies actually don't know how to filter and focus, and that was what was going on here. The prior CEO had difficulty focusing. He had difficulty making decisions, and so it causes confusion in the company, right? What are we doing? Are we trying to get into clinic this year? We don't have the full system developed yet, so are we taking a version of that system into the clinic?
You know, and then you change your mind and say, well, no, we should. There was a lot of that going on. So I had to put, you know, that's the first, you know, thumbprint that I'm putting on the company is that discipline. And, you know, the funny thing is, though, there's a lot of muscle memory there. They've been doing this for 10 years. So to move that ship isn't going to happen overnight, but it's happening. We're seeing some really good progress.
Fantastic. Really good color there. You know, maybe just, I think you just touched on it, but I think one of the changes that you've made since you've come on board is shifting the focus to making sure you have a production-ready system.
Correct.
Just maybe remind the audience and me where we stand today and how you're thinking about most your timelines for a production-equivalent system. Is that.
Yeah.
For end 2026? Is that correct?
Correct. Yeah, so just so we're on the same page, the production-equivalent system means that all the features at the specifications that we want to commercialize, so that's our internal definition. I know that's industry definition, but when I joined, they had multiple definitions of what that system was going to look like. You know, they were calling it different things as well, PDV1, PDV2. And so we were going through all of the requirements right now. We've just gone through all the user requirements for finishing up the specification of the requirements right now for the full system. We're going through everything again so that we all understand what it is we're trying to finalize for design freeze, and we're calling that the production-equivalent system. And so we close out phase II. And we're still on target for hitting that for the end of next year.
So once we do that, the thing is, we're doing all the integration, and we're always updating the integration and upgrading it. The idea is to get to that before the end of next year and then do the pressure testing, do some informal, continue to do informal V&V, continue to pressure test it, go into animals, continue to do a lot more cadaver work, and then do design freeze. I want to make sure that we don't have any meltdowns when we do our regulatory V&V. We don't have any meltdowns when we go into the clinic. I want to make sure that once we've got the full development of the system done, that we have time to do some real pressure testing on it. Yes, that makes sense.
Yep. No, that's really good color. And I, I guess kind of lends itself. I don't know if you're going to bless us or not, but first in human in 2027.
That's the idea. Yeah. So, you know, the regulatory V&V is, you know, I mean, it's pretty straightforward. You know, we've done our pre-submission meetings with the FDA. We know exactly what's required from a preclinical, non-clinical point of view. We even the clinical trial that's been blessed. So we know, you know, we know what has to be done, right? You know, GLP studies take a certain amount of time. So we can, you know, you can kind of add up, here's what we need to do, and here's how long it'll take. And then you got to file your application to go into the clinic. So I'm hoping that we can do all of the regulatory V&V in around six months, file. And hopefully, there aren't any big hiccups when we file, right?
Look, we're going to file the IDE, but we may file, you know, to go into the clinic in other countries as well. So if we do have a few hiccups in the U.S., hopefully we have less hiccups in other countries so that we can get to our FCU in 2027.
Really helpful. You talked a little bit about the technology, and that's really kind of what attracted you to the opportunity, the role. You know, I, I've always thought the technology at the company has been really interesting. So I guess, you know, from your vantage point, maybe just describe the single-port technology, you know, why you're so bullish about the tech.
Yeah.
How it compares to the other single-robot da Vinci SP, whether it's, you know, the size of the port, the, you know, degrees of freedom, things like that. We'd just love to kind of hear it from your vantage point.
Yeah. All those things. Yeah. So the cool thing about this is the whole premise of this being able to miniaturize the robot and even have the camera system we have. It all starts with a decoupled actuator system. So our motors are outside. They're not in the arms. We have cables that actually move the little joints, you know, the miniaturized joints. Whereas a lot of our competitors, they don't do that. They don't have decoupled actuators. They have their motors inside the robotic arm. So that gives us that ability to have the miniaturized robotic arms that fit in, like they fit right inside the body, inside the abdomen. They have full seven degrees. The human arm has seven degrees of freedom.
Ours have, in fact, they say, I'm told they have nine degrees of freedom, although the human arm only has seven degrees of freedom. But we have additional ones. You'll even see on our website at some point it says 13 degrees, but it doesn't really matter. We can stick both arms plus the eyes right into the abdomen, and you can maneuver upside down, front ways. It has full access to all quadrants to do everything that you want in there, which differentiates us from everybody else. The other thing that's really important, so not just the fact that we've miniaturized it and we have full access inside the abdomen, but it's how easy it is to use, to learn how to use. So we've been doing a lot of work since I joined.
One of the most important, so we're starting with ventral hernia, and I believe we'll get to that. But one of the most important end effectors or tools that you want to use on your instrument is our needle driver, right, for suturing. That's one of the most important things. So we spend a lot of our time, we have our own OR in our facility, and we do synthetic cadavers and cadavers. And we spend a lot of time really focusing on, can we get that suturing done in a specific amount of time? And so the cadence of us doing this work since I joined has been a lot more frequent. So we've been making sure there's OR work going on almost weekly. And a lot of times we'll bring in surgeons from some of these networks that we have collaborations with.
And the idea here is once we got it to a certain point, can we bring a naive surgeon in? And usually they're younger surgeons. And we did that just recently. And so we brought a guy in that's never seen our system live. He's seen it on our website, put him through our simulator, and within the same day, he was able to do a full IPOM surgery in a synthetic cadaver. So it's really important to understand a lot of the white space TAM that exists today is due to the limitations, but the limitations aren't just the rigidity of the robotic arms that exist on the current platforms. It's also how difficult it is. You have to relearn how to do surgery, right? The haptic feedback isn't the same when you're doing a surgery through a robot.
It's a lot more difficult for some of these younger surgeons and some of the older general surgeons to fully appreciate how to use the da Vinci or the other competitors. We're trying to also overcome that. That white space doesn't exist just because of the rigidity. There are other issues as well, even getting access to the system. Sometimes when you want access to the system because you're not as good, you're not going to get the time. It's going to be the more senior surgeons. We want, we're leveling the playing field for all surgeons so that they can, they can work with our system just as well as a more senior surgeon could. That gets more patients using minimally invasive surgery versus the open. That's the premise.
Really helpful. Let's talk about the indication kind of roadmap. So ventral hernia is the first target you're pursuing. You know, Stephen, you've also talked about being disciplined and focused.
Mm-hmm.
And so I guess the question is, can you at this juncture kind of afford to go after other indications while you're pursuing hernia? So we'd just love kind of your reaction to that. Like, how do you think about the roadmap and layering on, you know, a second and a third indication?
Yeah. No, it's a good point, so the indications are going to be dictated by the instruments that we have, and right now we're just developing the three instruments that are required to be able to do the ventral hernia. Within ventral hernia, even there, there's two different main types, you know, IPOM and rTAPP. IPOM is the easier one, so we're actually starting with that. Although our clinical trial is to do both, the idea is what instruments do we want next, which will allow us to go into other indications? There's a lot more room within hernia itself. We're starting with ventral because that demonstrates the power of our platform.
You know, I don't know how well, you know, ventral hernia, but it's difficult with the rigid systems that exist today, whether it be laparoscopy or whether it be the da Vinci, to actually try to triangulate and go up to the ceiling of the abdomen when the patient's laying on their back on the patient bed, right? We don't have that problem. We go in through a single incision, 18 mm right now, through that trocar. That whole robot is now in your abdomen, and it can maneuver all around, and it can go back up. You know, I call it the Michelangelo, not the da Vinci. It can go up and paint on the ceiling and do the ventral hernia. So it's going to, it's really powerful to be able to, it's what's really exciting for me because I'm new to this. Again, I'm not an engineer.
I'm not a surgeon. Watching these surgeons, especially the younger ones, come in and do this, and they can, it's like you see their eyeballs open up, and it's exciting to them to be able to play with the platform that can actually do the suturing up on the ceiling of the abdomen, and so where we can go next is just inguinal hernias. We'll go to all the hernias because it's the same tools. Then we'll start looking at other tools, and we're starting to think about those. Once we go to design freeze and we get through the V&V, my engineers can be retooled to do or repositioned to do other tools, and so that's what we'll start thinking about so that we can, you know, we want to go into the gynecology space as well, hysterectomies and so forth.
We're going to need additional tools for that. I got all these smart, you know, engineers there. Once we get to design freeze, I can start getting them to do other things, even increasing, like what we're doing. We're not. We're setting ourselves up with our platform so that we can, once we're ready to go into AI, we can run. We're not going to have AI on this first version, but for AI, you need a lot of data, okay? We're putting 28 sensors on each arm. Okay? That's 52 sensors. Even now, while we're doing these ORs with the cadavers, we're collecting a lot of data. That data is going to help us run towards AI once we're ready to do that.
And so that's one of the things I want to focus on once we do get the design freeze so that we can very quickly, after we get this thing approved, start thinking about AI. And we're a long way away from even just getting that to the Tesla level where the robot's doing everything and we're just kind of behind the steering wheel making sure there's no problems. We're going to take baby steps with the AI. And the first thing is really to identify the geography, you know, so that we don't hit certain things that you don't want to hit, arteries and so forth. That's the first, without having to use dyes. So that's kind of our thinking logically of how we would roadmap the tissue and help the surgeon with our first step into AI.
Fantastic. Very good color. You know, maybe I can ask a question about kind of site of care and the commercial strategy. And I know we're a couple of years away from market, but, you know, as you think about your technology, hospitals versus ambulatory surgery center.
Yeah.
You know, how do you think about the application in those sites of care? Will you target robotic centers of excellence? Do you go to folks that don't have a soft tissue robot? Just kind of what do you think that strategy will look like?
So look, I think we have them coming to us right now because they see what we're doing and their surgeons want to play. And that's why we do these collaborations because it gives us access to help validate what we're trying to accomplish. Or even with workflow within the OR suite, we use them for that as well. And they're coming to us because they see that this platform will help them expand further into minimally invasive and get away from the open surgery. They want to get away from open surgery, the hospitals. They want to be able to actually market that they have something that their competitors don't. And I think, you know, we're going to have to walk before we can run.
And if we don't have a partner helping us distribute or commercialize, and we have to do it on our own, yeah, we're going to be looking for the lowest hanging fruit. Right now there's some large hospital systems that we collaborate with, and they're the first ones that want to have our system in their hospitals. And that'll be pretty straightforward. How we actually do that financially at the beginning, I'm not sure. We got to figure that out, right? What the cost, the pricing, all of that. And I do have a bit of time to figure that out. But I mean, that data is out there. We know what the data is and what it looks like and where do our COGS need to be. We know what gross margins look like. So we know what our target needs to look like.
Sure. That's helpful. I'm jumping around a little bit here, but I actually wanted to go back to an earlier part of the discussion, outsourcing. And I guess maybe you're still kind of thinking through exactly how you'll utilize outsourcing, in which parts of the system and whether it comes from which geographies. But I think this is a relatively new topic. You might have talked about it on the earnings call too, but just any more color you can give us in terms of kind of like the role that it's going to play in terms of how you develop the robot going forward. Is this like a temporary situation, you know, that you'll kind of use to get across the goal line and then you'll bring things back in-house? Just how are you thinking about kind of the production?
Yeah, so it really is for flexibility, right? So I can lower my permanent fixed cost by reducing the number of headcount we have, but I still need that ability to be flexible on headcount, and outsourcing allows me to do that. I can get a partnership with some of these. So one of the first ones we're working on for outsourcing is software. We have a huge software team, different types of software, right? GUI, embedded, all of the different pieces that you need to run the robot. And a lot of them are core, but not all of them are.
I need that flexibility where I can, not flexibility just for scaling up and scaling down, but the partnership that we're putting in place right now just for software as an example is allowing us to do that scale up, scale down, but also to change out different skill sets, right? I may need more embedded or I may need more testing. I may need different skill sets at different times depending on where we are in the development process. But we'll always have that main core that drives everything. Working on the high value things that need to be done with the system, the integration part, especially the safety, all of that. But it's more they allow me that flexibility without having to always go out and hire a new permanent headcount.
That's what's really going to help us reduce our burden, especially if I can get that flexible headcount in a country which is less expensive, like Eastern Europe or India.
That's helpful. You know, I guess I wanted to ask another kind of bigger picture question. You know, clearly like there's a lot of work going on behind the scenes at headquarters that the street is not really privy to. I think the last time investors, analysts saw the system was December 2022, so how do we kind of help us kind of better understand how we should monitor your progress? Do you have, you know, and I guess as we look ahead to 2026, do you have anything planned at this time to show the system?
Yeah. We do. And it's a good question. So just a couple of weeks ago, we launched our communication plan externally using social media. LinkedIn's our main one, but we use the other social medias as well. And so what we're trying to do there is the full transparency. I say full transparency with parentheses. But the thing is what I want, like what really was interesting to me is when I talked to our current investors when I joined, how many of them didn't realize what we do, what we're really doing? What is it we've been doing for the last 10 years and where's all the money gone? So I thought we really need to have some messages out there and transparency on what goes on when you develop a platform, what are the different stages.
You know, it took us four and a half years to actually do the miniaturization of the robotic arms. We had nine different prototypes. And, you know, that never got communicated. So I want to communicate everything about what we're doing, including these little milestones that we're hitting, you know, and you know, we're planning on doing a small animal lab in a couple of weeks. And I want to be able to report back how well that went. It's got nothing to do with regulatory V&V, but part of our testing. We haven't been in an animal in over five years, and that was with a really early stage prototype. So now that we've gotten our needle driver, our suturing working at a really strong pace, we've got to test it. And that type of thing needs to be communicated.
What's more important is I want to make sure when we communicate that people understand if I'm going into the animal lab, if you do go into an animal lab, most people will think, well, you're probably working your way towards the clinic next month or next couple of months. That's not what we're doing. I want to make sure everybody understands where we are in the development process with the features and the specification. We're doing this as part of our ongoing testing. We want to make sure that there is no meltdown when we go into an alive environment, even if it's working in a cadaver. You need to do that. You can't have a design freeze without doing that kind of testing. Okay? We are going to be very open. I'll do more press releases about that.
I can do a press release every week. If it's meaningful, I'll do one. But where you can get the less meaningful stuff will be LinkedIn and our social media. And it'll also educate you on what we've been doing for the last 10 years and what it is we're trying to do to get to design freeze. Okay?
Fantastic, so it sounds like more visibility into the progress, into the system technology in 2026.
Yeah, definitely. Definitely. Yes.
Fantastic. That's a perfect place to stop, but we certainly covered a lot of ground and want to say thanks again, Stephen, for joining us.
I was happy to be here. Thank you, Adam. I appreciate it.
Thanks.