Hello, welcome to the next session of Oppenheimer's 36th Annual Healthcare, MedTech and Services Conference. My name is Seamus Contorno. Next up, we have Harel Gadot, Co-founder and CEO of Microbot Medical for a presentation. Harel, I'll pop back at the end for some Q&A, I'll turn it over to you for now. Thank you, Seamus, thank you for inviting me to present at your conference. Good morning, good afternoon, everybody. I hope you and everybody else are safe and well those days. Microbot Medical, driving the future of intervention. We're going to skip the safe harbor statement. I'm sure all of we are familiar with it. The end of 2025 was a very exciting and pivotal time for the company. In September 2025, we got the FDA clearance for the approval of our LIBERTY Endovascular Robotic System for the peripheral interventional procedures. In November 2025, we commenced our limited market release, focusing on the U.S. with specific territories to launch the LIBERTY Endovascular Robotic System. Very shortly after, we already closed couple of accounts. Some of them you are probably familiar since we announced them publicly, some of them that are still in the making, we are already have presence at Emory University Hospital, as well as Tampa General Hospital. We will discuss a little bit later why are we so excited to have at least these two customers with us because they are reflecting a lot of the assessment we had before we launched the product. Before we even talk about the product itself, where we are commercially, we probably want to explore the market. There are many players that want to play in the robotic-assisted surgery. Everybody's talking about Intuitive Surgical. Everybody's talking about orthopedics with Stryker and Medtronic. Everybody wants to play there. If you look into the market of the general robotic-assisted surgery, regardless if it's orthopedic, soft tissue, if it's for hysterectomy, prostatectomy, or anything else, it's very crowded. Is there a blue ocean within this very crowded space? This is what's so unique about the market we're playing in, because if you take a very close look, you'll see that in the endovascular market, it's a completely blue ocean. Currently, other than Microbot Medical, there is only one other endovascular robotic system which is cleared, which is Stereotaxis, which is a very niche product, which we are not competing with. Basically, within the entire endovascular space, Microbot Medical is the only company that has a solution which has to do with robotic system. How big is the market? If we look about the U.S. endovascular market alone, we have about five to six annual procedures yearly, which splits between three spaces. The neurovascular, which includes, for example, stroke, which has about 200+ procedures a year. There are coronary blockage, for example, that has about 2.5 million to 3 million procedures a year annually in the U.S. There is the peripheral, everything that is not the heart or the brain, that has over 2 million procedures in the U.S. alone. After the soft tissue market, this is the largest market in the U.S. If you talk about the global market, we're talking somewhere between 12 million to 15 million procedures annually. The market is big. The market is large. More than this, it's an emerging market. People can wait for hernia repair. They don't need a robotic surgery for that, or people looking into telesurgery. People wait for hysterectomy, prostatectomy. When you talk about, for example, GI bleed in the peripheral, or in the future as we go into neurovascular stroke management, time is life. You need access anywhere you are around the world and even just across the U.S. As we said, there's about 6 million procedures, endovascular procedures in the U.S. alone. It's a very heavy lift on the health economy. Something that is really interesting about this market, it's performed by 15,000 physicians. You can see the split between the cardiologists, the radiologists, the vascular surgeons, 15,000, so it's a very focused market. If you talk, for example, prostatectomies, that we're of course not competing with, but just the urologist in the U.S., there is about 40,000 to 50,000. We have a very dedicated and focused call points. It's performed in about 8,000 facilities, a mix between hospitals, ASCs, and OBLs. If you go out and you ask the interventionalists if they believe that robotics will be part of their future, because something that it's really coming out is you have robotics in gynecology, urology, orthopedics, general surgery. You don't have it in endovascular. One of the questions people ask, maybe the physician don't want it. When you go out and you ask them, this is a study we have done with over 200 interventionalists, it's clear that about 75% of them expect to have robotic system within the next one to three years. There is a growing unmet needs, and it's not only the industry recognized it, but also the American Medical Association recognized that radiation safety and protection and ergonomic in the workplace are extremely important. When you talk about the endovascular space, this is a space where all the procedures are done under imaging. A lot of radiation exposure, a lot of physical strain on the user because of standing there for hours wearing a very heavy lead vest. There is a staff shortage. IR, for example, is ranked second in specialists facing great physician shortage. Every physician, for example, or a nurse, or a technologist who are exceeding the exposure to radiation cannot practice for two, three, sometimes a month at a time. There's an access to quality care. As an example, even here in the U.S., 20% of Americans live in rural areas, whereas only 10% of the doctors are practicing. If you live in New York City or Boston, in L.A. or Chicago, you're in a great place because you can access really great healthcare with experience. What if you're not? What if you are in a place where the physician doesn't have that experience, if you don't have the right tech to carry on those procedures? Those unmet needs are very obvious when it comes to the endovascular space. We see that this is a big market with unmet needs. The question people keep asking us is, why is there less than 1% adoption in endovascular robotic procedures? Why isn't it like Intuitive Surgical in the soft tissue? It's because of the barriers, and the barriers are multiple. One of the things that it's really interesting, we always think that the number one barrier is the expense of the capital equipment of a robotic system. Yes, it is a barrier, but it's not the number one when it comes to endovascular. As we discussed earlier, many of the procedures in endovasculars are urgent, and the extended set-up time to set up a robot, drape it, put up all the instruments on it, that takes sometimes 20-30 minutes, cannot be accepted in the endovascular space. When you have a patient with GI bleed, when you have a patient with stroke, you do not have 20 minutes to set up the robot. One of the barriers, the number one, is actually the extended set-up time of the robot. The second thing is the special training and the long learning curve. No physician that went through 10, 15 years of education, experience, performing procedures want to go back and go through this learning curve again. We spoke about the expense of the capital equipment, but there's another thing that comes with the capital equipment, which is a large footprint. The ORs, the operating room that accommodates, for example, Intuitive Surgical, they're big. You have a lot of real estate room in there. That's not the case when it comes to the angio suite, where the endovascular procedures are being performed. Not only that they are smaller, but they already have X-ray machines in them. You don't have a room to put what I call an F-150 truck, which is the size of the current robotic systems in other spaces. Of course, the capital expense. Nobody wants to pay $1 million-$2 million for capital equipment that you do not know how it fits into your workflow. On top of the capital equipment, for every procedures, you have to have a cumbersome and expensive disposables, and then you need to have dedicated infrastructure. In some hospitals, it sometimes costs more to build the infrastructure to accommodate for a robotic system than actually buying the robotic system. How do we do this? At Microbot Medical, we just changed the entire conversation, and this is our solution. We're not only competing within the endovascular space. Microbot Medical is creating a new robotic category, period. It is the only, it's the first and only fully disposable, single-use robotic system that is designed to allow access and adoption. There's two parts to it. One is the external benefit for the customers, for the healthcare system, for patients, physicians. It's single-use, disposable system that eliminates completely the expense of both the capital and the infrastructure. It is sterile, which means it's coming ready to use off the shelf. In our experience to date, both in our clinical studies, but also in the accounts we already sold the system commercially, it takes on an average less than two minutes to open the product and start the procedures. There is no capital investment, reduce the upfront cost, and the long-term risk for the hospital of buying something which they do not know how it fits into the workflow. Additionally, there is no service contract to annual service. With Microbot, which it's a product that fits literally in the palm of my hand, if something goes wrong, we'll ship you a new robot through FedEx the next day. We don't need to have a dedicated service team. It also goes for the strength and the internal benefits of the company. First of all, we have the first-mover advantage. We're not competing with the Intuitive of the world, with the Mako of the world. We're competing with the manual procedures and those all the unmet needs that we shared earlier. There is a predictable recurrence revenue from hospital. Think about the razors and razor blades, but without actually selling a razor, just a razor blade. We expect faster sales cycle for quicker acquisition, which we already proved with the first accounts that we sold to, the two that you already know, which is Emory and Tampa General, we do have additional accounts that you're not familiar with, but we will probably announce them shortly. The disposable components reduce our own, as the company operational expenses. Think about it. When you have a capital equipment, you need to invest millions of dollars just building your inventory before selling one product. You need to spend millions of dollars on warehouses, millions of dollars on parts. You need to have a dedicated service team. You need to have training team, clinical team to be at every procedure. We do not have any of this. All those line items in our budget, in our expenses do not exist. All this money, all those expenses are shifted into focus, into sales, marketing, and clinical support. It's a big benefit for the company as well, allowing us to support our adoption and customers. We're a very differentiated robotic system. We're the only single-use, full disposable robotic system. It empowers physician to precisely steer guide wires and catheters. It's a small footprint that integrate into an existing procedure workflow. There is no additional infrastructure required. It's a simple and intuitive setup. We're saying under five minutes, but from our experience, it's probably less than two minutes. A very short learning curve. We have a council ready that after a few cases, the physician just picked up the robot and did the procedures on their own without us being in the room. They don't need us in the room anymore after they went through the training and asked for me to be there as long as they need to be. It's compatible with off-the-shelf guide wires and catheters. We are universal. We do not want to change the behavior of the trusted instruments, the wires, the catheters and so on that the physicians are already used to. We are agnostic to what they want to use. Our initial target is the peripheral vascular, about 2.3 million procedures in the U.S. alone, about 6,000 physicians in the U.S. A very large market on one hand, but also very focused market for us in terms of the call points. We proved many of those claims that we have. In our clinical study, in our pivotal clinical study, we achieved 100% robotic navigation success in every case. We showed 92% relative reduction in radiation exposure. We had no adverse events, and probably as important is the satisfaction on both the physician and the staff from using the LIBERTY Robotic System. Because if we go back and talk about what's the number one barrier, it's the setup time. If the physician and/or the technicians would not been happy with the setup time, we will not have 100% satisfaction. Our first-mover advantage is very clear. We are very different in everything out there, either on the market or companies that are trying to come to the market. Nobody, to our knowledge, is developing a fully disposable robotic system that requires no capital equipment. This is just a very high level. This is some companies that we always hear in the market, from Robocath to Corindus to Nanoflex Robotics. First of all, we're the only one that is FDA approved to be commercialized in the U.S., we're the only one that has no capital equipment, no maintenance, and no infrastructure, removing all the barriers that needed for not only adoption, but a quick adoptions by customers. There is attractive reimbursement. We're working in a space, the peripheral, that reimbursement for many of the procedures we are targeting starts at around $16,000 and up. Procedures like embolization, prostate, liver, uterus, talking about cancer treatment, Y90 mapping, that starts at around $45,000. The reimbursement is very attractive that we believe with our benefits that we bring, allow the hospital to find a place within an existing reimbursement for the procedure to add our robotic system. We have a very unique business model. There is no capital investment, as we've discussed earlier. There is no maintenance expense. There is no custom infrastructure. From us as a company, there is a continuous consumable revenue. We are not relying on services that will come once in a while. We're not requiring a one-time capital acquisition as part of our business model. In terms of our commercialization timeline, you see all the activities that we have executed during 2025, leading to a Q4 2025, which was in mid-November when we started our limited market release. Our limited market release is going very well, and as such, we are on target to commence our full market release during the Society of Interventional Radiology, which will take place in mid-April this year. We started with four territories as part of our limited market release. As preparation for our full market release, we are already hired and training our additional four territories, leading to the full market release in mid-April. The go-to market strategy is also very clear and very focused. In the U.S., we're planning to go with a direct sales team, supplemented strategically with distribution channels as needed. We are increasing our manufacturing and build inventory levels to meet anticipated demands. We are building another line of manufacturing overseas, and we are actually in the process of establishing a line either here in the U.S. or close to the U.S. to allow us to support the increase in demand that we anticipate. As mentioned earlier, our limited market release is progressing extremely well, and it will follow by a full market release in early 2026, in April 2026. We're not only focusing. The main key is focus on sales commercialization in the U.S. At the same time, we're also building for comprehensive growth. As a company, when we mention comprehensive growth, what it means is we're not only looking into new markets, we're also looking into new spaces and usability. For example, in terms of the active R&D pipeline is how do we develop the next generation LIBERTY and the robotic system that will allow us to go deep into an existing space? In the peripheral, for example, are there additional procedures that we need to add some features to allow us to go and acquire more procedures within the peripheral, can we also go wide? When are we going to enter the cardiovascular space and the neurovascular space? We have ongoing developments into the future. Tele-intervention, many people call it tele-surgery, and autonomous robotics programs are already in the progress. We have collaboration with both, Corewell Health when it comes to the tele-intervention, and collaboration with Emory University when it comes to the autonomous. We're building a direct sales team, as I mentioned earlier. We started with four regions here in the U.S. We already hire additional four going into the full market release, and by the second half of this year, we will grow into at least 12 territories in the U.S. Expanding into new markets, we already start the process of understanding and building the strategy for ex-U.S., specifically Europe, Middle East, and Asia, which are big markets. Pursue CE Mark. We're going to supplement the FDA clearance with a CE Mark. Today, it's called an MDR process outside the U.S., specifically in Europe, which is already in a process and an ongoing. We're also looking into markets that will accept FDA cleared devices without the need for an MDR. Markets like Singapore, markets like the U.K., Switzerland. There are markets that look more and more into FDA-approved devices. How are we going to go about it financially? First of all, we have a very capital-efficient operating model. As discussed earlier, we don't have the upfront expenses of capital expenses, warehouses, service people. This frees capitals to invest, and our financial statement as of the end of last year, we have about $80 million in cash on our balance sheet that will allow us to execute our commercial activities as planned. From a protection perspective, we're continuously investing in our patents portfolio. We have already 20 patents that are issued worldwide, and about 52 patents that are pending across the globe. Strategically, we're looking into the markets that we're either commercializing currently, for example, the U.S., and markets that are coming in the pipeline. That's where we're focusing most of our efforts when it comes to the IP. A very strong and experienced management team. Many of us come from corporate, J&J, Boston Scientific, Medtronic, and a lot of experience running a very early, nimble-stage company. As you can see, we have a very strong commercial leadership here in the U.S. with the addition of capabilities to understand the strategy and how to access ex-U.S., where the main key for us is focus. Focus on the U.S. while we're looking into understanding the ex-U.S. market to build the infrastructure. Seeing all of this, what are the reasons to believe? First of all, we do have FDA cleared. We obtain it not only in 2025, but actually on time, as we predicted and expected. We secured U.S.-based logistic partner to support commercialization. We're already shipping products to existing customers. We completed the recruitment and onboarding of the commercial leadership team, not only phase one of the limited market release, but we just completed and training, as we speak, the second phase leading to the full market release. Our limited market release is commenced and advancing as planned. We already have initial customers, Emory University, Tampa General. What's really interesting about Tampa General, we started with the vascular surgeons, and now the interventional radiologists are using the product as well. We see that we are actually reaching the call points that we expected, mostly the interventional radiologists and the vascular surgeons. We have a very strong balance sheet, $80 million available to drive commercialization activities, and the full market release is on target for mid-April this year. In about 30 days from now, you should all expect us to start our full market release. Thank you for your time. I appreciate the invitation, Seamus, and I'm turning it back to you. Thank you, Harel, for the nice presentation. Obviously, you guys, it's been an exciting, I'll say, 6 months since approval, and I know it's only building up to a crescendo as we get to April here when you're going to do that full commercial release. I guess to start, physicians have been doing procedures. It went from vascular to the interventional radiologist. Within the reimbursement slide, I know you noted a few different categories. I guess, what's been the breakdown of procedures that physicians have been doing so far? Has it lent, so to speak, to more vascular? Has it lent to more interventional radiology? Just wondering that split of the commercial cases you've seen so far. That's a great question. As we expected, we expect about 90%, even more of the procedure will be under the interventional radiologist, at least for now. Most of the procedures are embolization, for example, which is growing. There's a big market that is a new market for pain management called GAE, genicular artery embolization. Those procedures we've seen a physician executing. Obviously, prostate embolization, which is for a big market, which is the BPH, a very, very torturous navigation, this is probably the number one procedure that we've seen to date, but also uterus. The embolization market, that's big market we see, which is mostly with the IRs. The second market that we see is the cancer, which is the Y90 mapping, and the Y90, which is the delivery of substance to treat liver cancer. That's the second bucket of procedures. The third bucket that we've seen, which is growing, is CTO. It's Chronic Total Occlusion that we see the vascular physicians are looking into this more and more. Got it. Interesting. Obviously, you got to see how it plays out as we get to a more commercial launch. I guess, what are the things that you've learned from this limited market release at this point? You're taking that and saying, "All right, we need to do this differently, that differently," for the full commercial launch next month. I guess, can you give us a little bit more about what you exactly have planned at SIR? Can you give a little bit more on the commercial launch? Yes. I'm glad to share that what we learned is that we can actually check the box for every assumption we had going into the limited market release. For example, being able to sell the product without capital prevent will shorten the sales cycle. We already have multiple, not just Tampa General and Emory, which are public. We have additional customers that we will announce shortly, that all of them bought the robot within probably 60 to 90 days, I will say, since we approached them officially. That's one example, for example, we learned. The other one is the assumption of which procedures most people utilize it for. Our assumption was embolizations and the cancer treatment, like Y90, that has been the case. The ease of use, the setup time, the acceptance into the Angio Suite, all of these things have been proven right now for us, and that's why we feel very comfortable to move to the next stage of the full market release. To your questions, what do we expect at SIR? We really expect for people to, and I'm going to steal the tagline from our marketing team, test drive LIBERTY. It's like driving the future of intervention. It's really about put your hands on the robot. If you can see this, what's on the screen right now, you see the Xbox-like remote control, and it's extremely intuitive. When we have a physician that hold this in their hand, he or she, and they start just playing with it, they see not only how easy it is, but the precision and the benefit it will bring them, even when they use it in a model. So our whole idea is at SIR is get your hand on something that not only is very unique, but from a physician perspective, as well as the hospital eventually, it solves a lot of their unmet needs. Because people saying sometimes, "Will the hospital buy a robot to reduce radiation exposure?" Well, let's understand, A, what radiation exposure means. It's not only means risk for the physician and the staff, it also means lack of efficiency to the hospital, because hospital already have shortage of staff. Now if a user need to sit on the bench for 30 days, that's lack of efficiency. So our answer is yes. Get your hand on it. We have a booth over there. We are pivotal study. Manuscript was just accepted into a peer-reviewed JVIR. So those are the things we're going to share at SIR that will take us from an early adopters to the next stage of people that saying, "You already have users. Your clinical study or a manuscript of it is already in a peer-reviewed." We believe that will give a lot of confidence to the market to go from just the early adopters into the second phase of people that saying, "Now I see some facts and I want to move into adopting your robotic system. Got it. Appreciate all that info. One last one as we're coming up on time. I think you said four territories currently, 12 by end of year. I don't want to get ahead of myself and put you ahead of your skis so to speak. What kind of cadence should we think, obviously, through the year as well as going into 2027? How should that be? Is it a gradual pickup? Is it a backend weighted or hockey stick kind of approach? It's probably more like this year is going to be more of weighted, like staggered, very phased in. As we mentioned, we started with four for the first four months. We're moving into eight for the next four months, especially as we go into the full market release, then four additional ones as we go to the end of the year. That will be more phased. We should expect like a hockey stick because it's not only hiring people, it's more. It's hiring and training them, and after training them is when they're out on the market is ensured that we can support it from an operational perspective, that we have the right inventory, that we have the right clinical support when and if needed. All these activities are happening in parallel, and this is just the U.S. Keep in mind, as we go into 2027, that's when we expect to start leveraging the FDA clearance outside the U.S., then potentially, if we get the MDR, understand how do we approach countries that accept MDR and/or FDA outside the U.S. Gradual in 2026, as we discussed, probably a hockey stick supported by operational activities going into 2027 and on. Got it. Well, thank you for taking the time to come and present. Thank you to everyone on the call. Very exciting what's to come, so to speak. They're going to have to be watching this. Thank you again, and everyone have a wonderful day.
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