Vicarious Surgical Inc. (RBOT)
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TD Cowen 44th Annual Health Care Conference

Mar 5, 2024

Operator

We're going to continue with our next presentation from Vicarious Surgical, and here to present is Founder and CEO Adam Sachs.

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

Hey, hey. Thanks, guys. So let's dive right into it. So yeah, I'm Adam, Founding CEO of Vicarious Surgical. I'm gonna keep this pretty high level, but obviously there's not a huge room here, so please feel free to interrupt, ask questions, and happy to take questions at the end. So, to dive right in, this is an incredible market and an incredible opportunity. There are about 45 million procedures addressable with soft tissue surgical robotics in the abdomen alone worldwide, and of those, only about 4% are actually addressed with robotics today. That leaves, you know, that leaves 96% of those 45 million as an opportunity. And within that, about one in three have a meaningful complication. There is an incredible opportunity both from a financial side and from an ethical side. So, of course, let's dive right into what we're doing.

We've designed a system with our hospital and surgeon partners that is uniquely able to address the needs of patients, surgeons, and hospital systems. The entire system is inserted through a single 1.8 cm incision, and once it's inside, it has a dexterity and range of motion that is unlike any system that exists today, with shoulders, elbows, and wrists rather than just wrists, all coming from our decoupled actuator technology. And all of this is built with a level of force and position sensing that enables automated procedural protections, automated patient protection, that it goes well beyond anything that exists in surgery today. The technology that we invented that enables all of this is something called decoupled actuators. We came up with a type of decoupled actuators.

Over the last 10 years that we've been working on this full time, about seven of that was really just getting this technology to work. The concept here is that in existing surgical robots, there is something called coupled motion, and that what that means is that each joint in the robotic arm, in the instruments, is connected to each other joint. And that's because the cables that control the joints, the distal joints toward the tip, go through the proximal joints around pulleys. So when you move one of these proximal joints, the cables change length, and therefore it imparts a force on the proximal joints when you try to control the distal joints. We've figured out a way to remove all of that.

So instead of, with existing surgical robots, having this exponential buildup of force on control cables, we've removed that and are able to have more than just a wrist on the end of a stick. We're actually able to have wrists, elbows, and shoulders all inside of the abdominal cavity, and we can do all of that through one really small incision. Our system goes entirely in through one 18-mm, 1.8-cm incision, and that's incredibly important because incision size is everything in surgery. So if you go beyond about two cm, you end up needing to use a scalpel to cut through the layers of the abdominal wall. But if you can stay below about, you know, 1.8, 1.9 cm, not a coincidence that we designed our system to be exactly 1.8, you're able to go between the fibers of the abdominal wall.

You make a scalpel incision in the skin and then separate the muscle fibers with a blunt tool called an obturator. The analogy I like to use for this is if you think about, like, a crocheted blanket. If you try to stick your finger through a crocheted blanket and then remove your finger, you'll be able to see where your finger went through, but if you, you know, massage it a little bit, that will just go away and the blanket will go back to how it was.

If you want to put your fist through a crocheted blanket, you're going to need to take a pair of scissors or a knife, cut the fibers of the blanket, and then when you close it back up, even if you sew it back together, it will never be the same, and it will be much more likely to fail at that point. In fact, with just a 2.5-cm incision, 10% of abdominal walls fail within three years, and with a 10-cm open incision, 20% fail within three years. So it is incredibly important to stay below about two cm. So our system, because of those decoupled actuators, the way it goes in, it's able to essentially pop up and move out of the way, and then has a camera system that is much larger and much more capable than any other system.

And on top of the visualization, we're able to provide true unrestricted workspace through this single incision. So if you look at the way all the way over on the right, I kind of wish I could go point at it, but I'm going to lose the microphone, you end up triangulating with conventional surgical robotics to a single point in the abdomen. What this means, because the motion actually pivots about the abdominal wall, it means that the entire motion profile of those surgical robots depends on where the surgeon puts the incision. So if they're too close together, you get both collisions inside and outside the abdominal wall, sorry, abdominal cavity. If you put them too far apart, you don't get good triangulation and good ability to operate at your surgical site.

With our system, it can go flip in any direction, even reach straight up and work on the ceiling of the abdomen or all the way back at the incision site. This is one of my favorite videos. Someday we'll bother to reshoot it less blurry. But, what you can see here is our system is actually able to suture even all the way back toward the incision site, and to the surgeon, it feels as if they're working straightforward with high-resolution video right in front of them. This is completely different than any surgical system that exists today, and it lets the surgeon be free from that incision to simply operate. Then on top of that, we've built out sensing and visualization unlike anything else. Our system has force and position sensors at every joint inside of the body.

Again, because it goes in and moves out of the way, each of the arms and the camera is able to use that full 1.8-cm incision site and therefore has far more real estate, plus our camera actually has a liquid cooling system built in so that we're able to run a lot more electrical power as well. When we do all of that, we end up with a system that knows where it is inside the body, how much force it's exerting, and with multispectral imaging that can operate in the background as well as 3D mapping of the abdominal cavity, our system is also able to know what tissue it's interacting with. All of this gives the system the capability to actually understand what the surgeon is doing during the procedure.

Then finally, and actually the surgeon's favorite feature out of all, our system is able to clean its own lenses on the camera. We like to call this blinking. It kind of rolls its eyes back into its head and wipes them against what's essentially just a windshield wiper on the back of the camera. And this alleviates a huge pain point.

On top of all of that, because our system no longer has four gigantic robotic arms, outside of the abdomen that then triangulate to produce small motions inside the abdomen, our system is able to have a much more attractive cost model with a cost of goods of the capital that is far lower than today's systems, as well as with instruments and accessories that are fully disposable and therefore much easier for hospital systems to use, particularly important at a time when bottlenecks for many hospitals for their ability to do surgical procedures is actually central processing, the ability to reprocess equipment, and train and retain staff to do so.

So all of this is building out to a future where we're able to not only support excellent surgical procedures with a system that's less invasive, offers unrestricted dexterity and access, has incredible sensing and visualization, and is adding attractive value. All of that lets us get into the hospital, into the OR, and quite literally into the patient. But with the sensing that we have, we can also move toward automated patient protection, which allows us to reduce errors and accidents, create more efficient procedures, and actually move to automate simple surgical tasks. To use an example of what this really could look like, one of the most common and devastating injuries during a hysterectomy, which will be one of our early procedures, is accidentally injuring the urinary anatomy, most often the ureters that go between the kidneys and the bladder.

With specific dyes, you're actually able to highlight the ureters, but existing camera technologies can only let the surgeon see where they are, where the ureters are, when they flip into a different visualization mode to visualize the ureters. Our system can map where they are in 3D throughout the entire procedure, plus additional modes of fluorescence to map other anatomy like nerves or blood vessels. And with that, at a high frame rate, we can track where the critical structures are in 3D and warn the surgeon if they're approaching them or about to injure them. All of this is built into our system from the very beginning, even if we, for some of these, will require additional clinical data to be able to enable them and turn them on. So all of this was built together into our, what we called our Beta 2 system.

Excuse me, I rearranged the slides. Let's jump to pathway to commercialization. So we have these incredible hospital partnerships that we have built out over the last couple of years that we are incredibly proud of. This includes hospital systems like HCA Healthcare, UPMC, and Pittsburgh CREATES, University Hospitals, and most recently Intermountain Health. Together, these represent over 250 hospitals. In the case of HCA, they are also a major investor in our company and have been incredible partners through product development and will be through verification and validation, clinical evaluation, and training once we're on market.

This is all to address a market that is, is again, absolutely colossal, starting with a single indication of ventral hernia repair, enabling us to get to market with the lowest risk and easiest clinical path possible, and then moving out to other hernia repair, gynecology, gallbladder procedures, and GI procedures after that. Today we are, we've gone through our Beta 2 system, tested it with our hospital system partners, received incredible feedback, and have spent the last year and a half, replicating that, rearchitecting the system from Beta 2 to create all that functionality that surgeons and hospitals loved into our Version 1.0 system. Version 1.0 system is designed, you know, to, to be our first product on the market. We are integrating it right now.

We'll be doing our first cadaveric procedures this spring, remediating any issues over the summer and fall into the clinic in 2025, and then filing for De Novo after that. We have an incredible team that I'm also really proud of, Bill, who's here, as well as we've recently had Randy Clark join. Randy comes from Flex and Olympus, where he held president roles at each of those organizations, and rounding it out with a number of other executives, including John and Michael Pratt. Our board is also an experienced board with financial experience, medical experience, and significant device development experience. So with that, I'm not sure where the video went, but I guess I'll take questions instead. Any questions at all? Yeah?

Speaker 3

Kind of standard indications might be looked at.

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

Yeah.

Speaker 3

Lung resection.

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

Actually, lung resection is super interesting. It's not kind of on our official list yet because it's much more experimental. But there are—so let's start with the real answer. The real answer is, you know, hernia repair is in the beginning. It's both low risk and an absolutely colossal market, as well as it's mostly open surgery today. We also, frankly, are fortunate to have some of the biggest name brand KOLs working directly with us. So we feel like that the pathway is just going to be beautiful for a launch in hernia. After that, there is both general surgery indications. That'll be things like cholecystectomy. It's the bread and butter of what a lot of general surgeons do. And even if the economics are not incredible, they're still decent, and we can make it work.

And we'll allow, you know, general surgeons to be able to do a higher percentage of their procedures with our system, and then, colorectal procedures as well. And then also moving into gynecology pretty quickly. So hysterectomy is probably one of the best markets for us. There's a variety of reasons for that, but if you think about the shape of a uterus in the pelvis, the actual hysterectomy requires dissection all the way around the uterus and then suturing in the vaginal cuff. And both of those, you know, our system, because it can turn around as it works, allows a gynecologist to do a much easier dissection there. Whereas today they're operating with, you know, straight sticks or wristed robotics, but with straight sticks.

As they're working on the lateral sides of the uterus, they have to both avoid the critical structures like the ureters and dissect with very little visualization. Then I'd say back to lung, which is one of the things that I'm particularly excited about. I mean, just think about how cool it would be to be able to do an abdominal incision because we have such an ability to enter at one spot, traverse, and then operate in a different spot with a ton of flexibility. You could even enter in a little waistline incision, go through the abdominal cavity, through the diaphragm, neither of which cause pain, and do like a wedge resection, a lobectomy, without any thoracic incisions.

It's incredibly important because thoracic incisions, first of all, crack the ribs a decent percentage of the time, especially when you have a stick wiggling around. And second, they hurt every time you breathe for the next month.

Speaker 3

There have been some changes for competitors who are developing robotic systems for the U.S. market recently in terms of their development timelines and some of their thoughts about the process. Can you just share whether that influences you in any way and just remind us of just your regulatory submissions?

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

Yeah, I'd say definitely has had an influence on us. You know, those who have followed closely have seen that, you know, we have certainly not been immune to having some of those adjustments and frankly been impacted by some of the regulatory changes. We have actually gone back and forth on what the regulatory process should look like for this and have finally just settled on what is essentially the ceiling of what the process could be because it's the lowest risk pathway for us to just collect all of the data that the FDA is looking for. In our case, that looks like about a 30-patient clinical trial. If the data look good, could be up to about 50 or 60 patients with just okay data.

Overall, you know, we're approaching it with a very, very one step at a time philosophy, frankly, given cost to capital today. It makes a lot more sense to take things one step at a time and be as efficient as we possibly can.

Speaker 3

The decoupling idea, what does that say to haptic feedback? Are you still providing haptic feedback with your system?

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

So, it's got haptic feedback, is one of the most interesting things. So haptic feedback, I think, in this market is, in my opinion, an amazing example of something that every customer asks for and no customer wants. If you actually provide haptic feedback, and so we sense force at every joint, and that is the hard part of haptic feedback. And actually, our surgeon console is fully capable of the thing that you hold onto. Is actually in itself its own robot. We can provide that haptic feedback back to the surgeon. We've tried this out. It works. It is the coolest thing in the world for about five minutes, and then you start getting tired. And you really wish that you didn't have to physically exert yourself anymore to do surgery.

So it's sort of going back to what surgeons actually didn't like about manual surgery and preferred about robotics, which is the fact that they don't have to physically exert themselves. But there is a place where haptic feedback is incredibly valuable, and it's if you're exerting too much force. So the reason we put force sensors throughout our system is so that we can start to warn surgeons if they're exerting too much force given the particular task or the particular tissue that they're manipulating. And that, in our opinion, is what surgeons really wanted when they say they want haptic feedback. Does that make sense?

Speaker 3

What do you offer?

Adam Sachs
Co-Founder and CEO, Vicarious Surgical

We offer, I'd say, the benefits of haptics without actually giving the literal haptic feedback to the surgeons. Any other questions? Cool. Well, thank you guys for the time. I appreciate it.

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