Okay. Thank you for joining us for our 38th Annual ROTH Conference. I'm Kyle Bauser, Senior Research Analyst with ROTH, covering the medical device sector. I'm excited to be joined by Harel Gadot, CEO and President and Chairman of Microbot Medical. Thank you for taking the time.
Kyle, thank you for having us.
Maybe for anyone listening in that's new to the Microbot story, Harel, can you briefly walk through the history of the company and how it came to be publicly traded as MBOT?
Yes, absolutely. First thing we need to look back on when we thought about Microbot as a company. Two guidelines led the path for me and the team later on as we look into why endovascular. The first thing was that robotics is the future of healthcare. That was 2011.
No question. Yeah.
I think now 15 years later, I don't think anybody will disagree with that assessment.
Yeah.
The second thing was, I think a little bit easier, is really believing that the trend that we have seen since the early '70s, '60s, that surgery becomes less and less invasive will continue.
For example, we started with laparotomy, open surgery. We move into laparoscopy. We moved into robotic-assisted surgery. People spoke about NOTES, natural orifice transluminal surgery. When I looked into this and I searched, I felt as we going to move from surgery to interventional, and interventional was the endovascular space, basically. Interventional radiology, interventional cardiology, neurovascular. That was the guiding light in a way for why Microbot, why the endovascular. If you go through the slides that I put together, for example, and of course we have great news. As you know, we got the FDA clearance, and we already secured couple of our early customers. When you look into the market, did the market agree that robotics is going to grow? When you really understand robotics, you understand that this is a very crowded space.
As we understood that we want to go after endovascular, that we want to go after robotics, we ask ourself why? Why endovascular? Is that a blue ocean? That's what we really found out, that if you look into the soft tissue, you look into orthopedics, you look into spine surgery, they're very crowded. In the endovascular, you really have one competitor in the U.S., and that's a very niche product. Other than this, nobody's there. The question was, is it not big enough market? That question can be easily answered. There's about 5 million-6 million procedures in the U.S. between the three spaces of neurovascular, coronary, and peripheral. That answer our question, are we in the right space in terms of size? The next question was, are there any unmet needs?
One of the things that we understand is that unlike, for example, prostatectomy, hysterectomy, hernia repair, many of the procedures in endovascular are life-saving. We're talking about stroke, we're talking about chronic total occlusion, cancer bleeding, and so on. You can see this is a very big market. The third question was maybe people or physician don't want it. Every research you look at, people in the endovascular space believe robotics will be part of their future. The last question was, maybe there's just not an unmet need. Otherwise, why do you have a big market, clear unmet needs, and there's no robotics? When you look into what we did with Microbot, we try to answer basically the unmet needs that we saw already in 2011.
One was the radiation exposure and the ergonomic risk for not only the user, meaning the physician, but the entire staff. The second thing is that you have staff shortage, and it's just growing. For example, why do you need two physician to be in the room at the same time, and access to quality and everything else. The number one was actually the setup time. People think it's the $1 million-$2 million robotic expense. No, it's not. It's actually the setup time. Because again, in hernia repair, in prostatectomy, you have 20, 30 minutes to drape the robot, to clean the robot, to get the room ready. When you have a patient on the table with bleeding, with stroke, with a heart attack, you don't have the time.
Right.
We had to get rid of the capital equipment. That was the number one thing that we have done. The second thing is, of course, to fit into the existing infrastructure in the endo suite, which is a much smaller room than the OR, and of course, get rid of the capital expense, make it very easy for adoption. That's how we started, as we went through the development phase and understanding what it will take, we understood that developing robotics, and especially taking them to market eventually, will require a lot of capital support. That's when you ask me the path to us becoming public is understanding what do we need in order to go to market.
We felt as the exposure and the support with our, I believe, a very unique story, an attractive story, will be well accepted in the public market to support us growing as a company, which I'm very pleased to see that over the last 12-18 months, when we start hitting meaningful milestones like getting the FDA clearance, getting our first customers, the market appreciate it, and we get that support.
Yeah. Appreciate that. Obviously you mentioned the massive milestone for the company, which was getting clearance of the LIBERTY system in September. Can you dig in a little bit more on the technology, kind of tell us what it is, and why it would be preferred to doing some of these peripheral procedures manually?
No, absolutely. The product itself, it is completely disposable. People always ask me: What does it mean it's completely disposable or single-use? The number one thing that comes with a single-use device, that it comes sterile off the shelf, which means you don't have setup time. You open the robot, and it's ready to go. From our experience, both in the clinical study that we have done as well as in the first few accounts that we just acquired and start working with the device, it usually takes the technologist less than two minutes to open the robot, get both the wires and the catheter integrated into the robot, and by the time the physician is in the room to start a procedure, then they're ready to go. We're basically not only developing a robot for endovascular.
I truly believe that we are establishing a whole new category in surgical robotics. Because think about it, we are the first and only disposable robotic system everywhere, and that change everything. For example, you look at all these barriers. You talk about the extended setup time. We get rid of the special training and the learning curve. We get rid of the large footprint. You don't need a large infrastructure, big capital equipment. You go in the interventional suite. It's already a small room, and you have an X-ray machine there. You don't have the place for this big capital machine and all. The expense, of course, make it much easier for the hospital. Nobody want to commit to $1 million-$2 million without knowing how it fits into your workflow, and of course, nobody wants very complex disposable.
You want to make it simple, you don't want to invest additional money in dedicated infrastructure. What we did with Microbot is basically getting rid of all of them, that's the solution that we have. The solution we have is a robotic system that it's single use. As you can see right here, a physician sitting in the control room in a chair, no lead vest, doing the procedure remotely. If I will ask anybody listening to this call or to this talk, if you had a surgery, will you do the 7:00 A.M. or the 4:00 P.M.? 99.9 of us will say 7:00 A.M. Why is that? You want your physician as fresh as possible. Allowing the physician to sit down, not wearing a lead vest, getting the procedure done without the radiation concern will allow the physician to potentially better treat the patients.
That's what it's all about, right? It's patient outcome. Going through all the barriers that we eliminated from a single use to no capital equipment, we are also agnostic to the instruments. I think one of the failures, as you asked me in the past, for companies who try to go into peripheral, which I am familiar with one company, the rest of the companies started to go with usually cardiovascular. They try to have their own instruments, meaning wires and guide wires. I think it's a big mistake because the brand loyalty users have to the instruments they have, wires and catheters, is very strong. Now you're not only taking it away from their hand because now the robot is doing it, now you're telling them to use something they don't have experience with. I think that's led to one failure in the past.
Other failures, again, were the expense of the capital equipment, the number one failure was the setup time. Nobody wants to change their workflow to integrate a robotic system, what we've seen with LIBERTY, it fits perfectly into their workflow.
To your point on being device agnostic, do you think at some point in the future, maybe once you've got scale and more adoption, it would make sense to have your own wires and catheters or no?
Absolutely. I think it's a great point. Today, when you look into LIBERTY or basically every robotic system out there in endovascular that are trying to be, you're looking into a product. It's a robot that need to use other things off the shelf. I think as we can show and prove to physicians and hospitals that using the robot, regardless of your instruments, you get the same results across the board, then the brand loyalty will go away. Then you can turn from a product to a procedure that can eventually you can have the robot with the instruments already integrated into them, and when you open it, you can carry an entire procedure because this is going to be your instrument of choice for a robotic procedure. If you still want to do it manually, feel free.
Use whatever you want to use, but we need to optimize the robotic procedures, and the way to do this is that eventually have the optimal instruments to go with it. I absolutely believe that based on the experience we have to date, that in the future, Microbot will have the opportunity to also play not only in the robotic product, but a complete robotic procedure that will include instruments to go along the robot.
Maximize the revenue per procedure at that point.
Absolutely.
Yeah.
Create additional brand loyalty. It will allow you to work with more departments in the hospital at that point. I think the future is very bright to where we can go.
Yeah
we can add to the robot.
Related to that, maybe we can talk about the market opportunity. You touched on that earlier. The LIBERTY has applications that would make sense in neuro and cardio, but right now you're focusing on the peripheral space. Maybe you can just kind of size that up and help us think about when some of those other opportunities might hit as well.
When you look into an invasive procedure, you basically use the same instruments to gain access to the target, just different sizes.
Yeah.
You use a wire, a catheter or microcatheter, and a sheath or a base catheter. When we went after the market initially, we went after the roughly two and a half million procedures in peripheral. That's the approval we got. If you want to map the two and a half million procedures, people ask us sometimes, "What's going to be your beachhead? What's going to be your winning application? Why? Why one?
Physicians are using the 0.014 to 0.018 guide wires, 2 to 3 French microcatheters, and 4 to 6 French base catheter for multiple procedures, from different embolizations, from prostate to uterus fibroids, for example, to Y90, to Y90 mapping, to BTKs, Below-the-Knee occlusions. Why limit it? You are solving the same problem. As we go into the peripheral, I always tell people our pipeline, as we call it, the MGPP, the multi-generation product portfolio, is to go deep and go wide. Go deep, it means to enhance the efficiency within the peripheral. How can we allow more procedures, less time, less instruments, to really show not only the clinical benefit but also the economical benefit? That's part of the developments that we're doing.
Go wide, it means how do we take the base of what we have today, leverage the 510(k) approval that we have, of course, it will require additional clinicals and probably additional regulatory submission, and then go after the cardiovascular procedures and go after the neurovascular procedures. It's the same thing. It's how do you gain access to the target by navigating wires and catheters. It will require additional developments, accommodation for different sizes, potentially accommodation for not just the navigation to the target, but the introduction of the treatment itself, a stent, a balloon. All of this we're working on to achieve, and I expect to have a very robust pipeline coming over the next couple of years.
That's great. Maybe you can talk about the latest wins. You're in the limited market release now, ahead of the SIR conference next month. Maybe you can talk about Emory and Tampa and also the next steps to scaling the organization as you transition into full market release.
Absolutely. We received the FDA clearance in September last year, we started the limited market release in November with a very clear endpoint in mind, is to really prove to us that it will be not only safe but efficient in the hands of everybody. For us as a company, how do we validate certain assumptions from price, for sales cycle, for example. All those things we're able to prove during the limited market release. For example, our assumption was there is no capital equipment. Instead of spending 9, 12, 18 months of a purchasing process going through an extensive value analysis committee-
Yeah
Can it be shortened? Can it be bought by the operational expense of the department? When it's got to a VAC, it will be a simple or shorter VAC with no capital. So far, yes, publicly, we announced two accounts, and we'll speak about what the difference between account and a hospital in a second, but we have more that we will announce shortly. In all of them, the process to buy the robotic systems, and they bought multiple of them, took somewhere between 14 days, I believe, at Emory, all the way. This is one of the areas where okay, we know the process. For us, an account, for example, is Emory.
Emory as an account has seven hospitals.
Same thing with Tampa General. Same thing in the future when we go to accounts that have a healthcare system. For example, at Emory, they already have two hospitals using it. Yes, it's one account, but it's two hospitals. Sometimes if the market hear that we have six or seven accounts, it may be 15, 20 hospitals. That's one thing that we really like to see, that the adoption is growing from the one hospital that bought it to the entire system eventually. This is for us going deep. The feedback been phenomenal. We are on track for the full market release, which we expect in April this year. We basically closed almost every account that we targeted for this period. Either closed them, sorry, or are in the process of buying it. Hopefully, we'll have some great news coming soon.
Other things that we learned through the way is that the way we manage a territory, it's the right way. We started the limited market release with four area sales managers or sales people, and we already hired additional five area sales managers in advance to SIR next month. As we go to the full market release, we should have nine territories active. As we go through Q3, we expect to have four to five additional territories, which we always aim to have between 12 and 14 territories by the time we get to the end of 2026. Part of it is how do we go deep, meaning once we get into account, how do we ensure more hospitals are using it, more users?
How do we go wide, is once we got adoption in one account, how do we move on then to a new account? Those are things that we learn as we went along, who are the salespeople and who are the support team. For example, a field marketing person that works not only internally in the hospital, but also work with the hospital to potentially tell the world, AKA patients, there is a procedure using a robot. You should look at it when you decide which hospital you want to go after.
Got it. Maybe can you talk about the IP around LIBERTY and how that looks?
Yes. Very unique technology. One of the areas that you have to protect its IP and know-how. We have roughly, don't quote me on this one, we have a lot happening as we speak. We have about 20 patents that are granted globally, we have additional 50 to 55 patents that are in different stages of approval. They're covering everything from methods to design to anything else around the robotic system, and we're going to keep growing it as we look into different capabilities of the robot, different spaces that we're going to use the robot, as we look into having the robot as part of a procedure. There's a lot of activities happening around our IP.
Great. Any plans to commercialize outside of the U.S.?
It's a great point. The point we're driving to the team is the word focus. We have to focus on flawless execution in the U.S. The limited market release gave us a lot of confidence that we're on the right track, that we can move to the full market release. In parallel, we just recently added to our team a person that leads our ex-U.S., specifically Europe, Middle East, and Asia activities, where it's not executing sales yet. It's really understanding the strategy. The plan is going to be phased. Number one, focus on the U.S., execute, create clinical data, create adoption, create a group of key opinion leaders that can send the message out.
The second is countries outside the U.S. that accept FDA clearance, Singapore, Switzerland, Dubai, Israel with the AMAR approval, to see how can we leverage the FDA approval to go to these countries. Most likely in this region of EMEA, we're going to use distributors. We're not going to have a direct sales force as we have in the U.S. The third phase is we are in the process of getting MDR approval. We are hoping and aiming to get it by the end of this year. The third phase is to get the MDR approval in the first quarter of 2027 to start marketing and doing sales in the rest of EMEA.
That again, we will use most likely distributors with support from company personnel, like professional education, sales training that will come from the company, but the sales itself will leverage the knowhow and the core capabilities that distributors already have in their respective markets.
Great. That makes sense. Maybe just reimbursement for those new to the story. It's kind of a unique situation where you're selling into the hospital, there's existing DRG codes that you can utilize that LIBERTY does eat into that reimbursement for those procedures, but there's enough margin, and if they're helping to drive efficiencies, there's a payback. Maybe you can just describe that dynamic for reimbursement.
Unfortunately, to my knowledge, to our knowledge, there is not even one robotic company that has a specific reimbursement code. Whatever you use, Intuitive Surgical, Mazor, Mako, whatever it is.
Yeah
You're eating into the margins of the procedures. The question is twofold. Number one, is there enough meat on the bone that you can add something, and then do you add value, or does the hospital care about it? The number one thing is, yes, the reimbursement in the peripheral procedures starts with the base of embolization at $16,000.
It's very well reimbursed. When you talk about Y90, it will start around $45,000, and it will go north. That's answered the first question, there is enough meat on the bone to allow for a robotic system like LIBERTY to be there. The second question is, does it add value that a hospital care about it? Obviously, the physician care about their health, about being able to do more procedures. The American Medical Association, SIR, Society of Interventional Radiology, and CIRSE, which are the two main governing bodies for interventional radiology, over the last two, three months came out with their directive for 2026, and all of their guidelines are focused around radiation exposure, elimination, and physical strain. Now it's not the company pushing it. Now it's actually in the face of the healthcare system. We need to solve it.
The only way to solve it is through robotics or remote procedures. That will be the first one. The second thing is, can the robot reduce the time of the procedure? Can they allow for more procedures? We are in a very early stage, but we'd already seen some procedures where the physician very amazed how much time it saved. For the long run, we are going to collect the data and hopefully show that it's not just the obvious thing that we can do, which is reduce radiation exposure and reduce the physical strain, but can we, A, reduce the time? Second thing is, can we reduce the number of instruments that you use in the procedure? Another thing that LIBERTY already shows efficiency with is a single operator procedure.
In most procedures today, when you see the staff in the angio suite, you have one physician putting the instrument, the wire, the catheters in, and a physician holding the instrument right next to it. What's so unique about LIBERTY is the robot is holding your instruments. We already show efficiency by letting one physician or a technologist go and do some other stuff. From our perspective, we don't think the reimbursement is a barrier for entry. We don't see it as a growth preventer. Obviously, if we can either show the efficiency, not just the safety, and if we can get eventually a reimbursement code, that will eventually drive more adoption.
Right
moving forward.
Really interesting, congrats on the success. You've obviously got a really exciting year upcoming. Thank you for taking the time, and we've run out of time, so we'll leave it there.
Well, thank you for your time. Thank you for having us.
Of course.