Microbot Medical Inc. (MBOT) Earnings Call Transcript & Summary

Give us another minute before we start, we want to make sure that everybody has time to join us. Thank you. Again, we will be starting shortly. And again, we appreciate your interest, joining us this morning. And if you have any questions, there's a feature on the Zoom to ask a question. And if you have a question, please submit, and we will address as many questions as we can during the allotted time. Thank you. Harel and the team Israel. We are 3 minutes past the short time. We should begin. We have, I believe, it's over 100 people joining currently. And we'll test everybody's volume to make sure.

Michael, can you hear me? It's Harel. Good morning. And can you see the screen?

Good morning, Harel, yes, we can hear you. We can see your screen, and we can see the team in Israel as well. So we can be begin.

Excellent. Well, thank you, Michael. Before we start, I think the most important thing is to wish all of you and your families are well and I have trust and hope that all of you and your families are keeping safe during these unprecedented times. So I appreciate all of you joining the call. Before we will start, I would like to introduce the people on the call. For those of you that I did not have the pleasure to meet either in person or online, my name is Harel Gadot. I am the founder and CEO of Microbot Medical. Together with me today, we have Dr. Eyal Morag. I don't know if you can see him on the screen. Eyal, if you can raise your hand. That's the guy with afro, as you can tell. Dr. Eyal Morag joined us about 3 months ago, as the Chief Medical Officer, one of the leading interventional radiologist globally. We're very fortunate to have him join our growing team. On the right-hand side, you see Simon Sharon, our Chief Technology Officer. And in the back, you will see Eran Cohen, who's our Senior Director of Business Development. They will join me today and answer and address any questions that you may have moving forward. So again, thank you for joining us. But before we will start, I'm going to ask Michael to take you through the safe harbor statement.

Thank you, Harel, and I want to thank everyone for joining us this morning for Microbot Medical's virtual meeting. On today's webinar for Microbot Medical are Harel Gadot, CEO, President and Chairman; additionally, Dr. Eyal Morag; Chief Medical Officer; Simon Sharon, Chief Technology Officer; and Eran Cohen, Senior Director of Business Development, will be available for Q&A session, as Harel just indicated. Today's webinar is live over the Internet and available on the company's website. Before turning the call over to Harel, I would like to make the following remarks concerning forward-looking statements. All statements in this webinar other than historical facts are forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to risks and uncertainties and other factors that may affect Microbot Medical's business, financial condition and other operating results, which include, but are not limited to the risk factors and other qualifications contained in the company's Form 10-K that was filed with the Securities and Exchange Commission as well as other documents filed with the SEC. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. Microbot Medical expresses or disclaims any intent or obligation to update these forward-looking statements except as otherwise may be required by applicable law. Finally, after management makes the prepared remarks, we will conduct a question-and-answer session. With that, I'll turn the webinar to Harel to share the company's view on the surgical robotic market, the result of the feasibility animal study as well as other recent achievements. Harel, please go ahead.

Michael, thank you again. So welcome again, everybody, for joining this call. Very excited to be here. Some questions we had is why do we have this call. So we have this call because of last week, we participated in a virtual meeting at Needham, the investment bank. And we could not accommodate all the meeting requests we had. Following the conference, we could not accommodate all the requests for meeting with us offline. We have to work somehow. So we decided to get everybody in one place, take you through the presentation that we showed at Needham, answer as many questions as we can and be as transparent as possible to our shareholders and investors. So where are we playing? Let's start with the macro environment. For those of you who are not familiar with it, we are playing in what we call the MIS, the minimally invasive surgery, which is the fastest-growing healthcare segment, expected to be over $50 billion. And very interesting that even through pandemics or other issues like the 2019 -- 2008 financial crisis, it's still expected to grow by 20% CAGR and continue growing this through 2025. One of the reasons that I'm extremely excited about the space of robotics is the fact that we don't need to educate the market anymore. If you talk about 10 years ago, it was a question about, is this marketing unique? Is this really the future? But now if you look at it, in the past, it was mainly in orthopedics, mainly implants replacement or hip replacement, joint replacement and cardiovascular. Today, if you look into robotics, you see it everywhere. You see it in spine, you see it in cardiology, you see it in interventional radiology. You see it in urology, gynecology, you see it everywhere else. The adoption is there. The question is, how do we increase adoption and how do we make the devices becoming smaller, automated and more precise. And that is the holy grail on how we're getting to adoption. And one of the barrier for adoption is the capital equipment. It's not only the price and the cost of the capital equipment, but the fact that you need to have dedicated room, dedicated staff to have capital equipment. That's before you even paid another cent for the disposables. And this is how we're going to make this market bigger with bigger adoption. Two weeks ago, the Society of Robotic Surgery came up with their analysis. And one of the interesting things that we saw is although there was over 19 million procedure in 2019, you can see that the addressable market that remains available is still around 95%, taking us back to adoption is not there. And we look, again, what are the barriers for adoptions. Mostly it's the cost associated with the fact that we have major capital equipment, the fact that you need to have dedicated room, dedicated staff. How can we change that? And if you look at one of the interesting outcomes, and that's exactly where Microbot is playing, is the growth of the market anticipated in the endoluminal surgery, which take us to believe that Microbot Medical is in the right market at the right time with the right product. But moreover, we cannot ignore the fact that COVID-19 created challenges to the healthcare, but also accelerated many areas in healthcare. One of them is the remote healthcare or the telehealth as many of people call them. If in the past, cross contamination was mostly to the patient, how do we prevent the patients from getting sicker when they get to the hospital. During the COVID-19, that discussion actually changed. It changed the fact that cross contamination, it's, of course, still for the patient but it's becoming more and more relevant for the surgical staff and not necessarily just the physician. It's the physicians, the nurses, the technicians. How can they stay away from patients in order to allow them to perform their duty? And if you look at both of our products, both our LIBERTY device and the Self-Cleaning Shunt, both of them were designed to be remote controlled and monitored. So we're not only playing in the fastest-growing segment of the minimally invasive and robotics, but we already integrated into our devices, what the market sees now through the COVID-19 of the acceleration of telehealth. And if you need any more convincing that this is the hottest market, just look at what happened the last roughly 12 months with the big corporations trying to actually take a leading position into the robotic space. Medtronic, Intuitive, Stryker, Johnson -- J&J, of course, with the acquisition of Auris. And why are they doing this? They're not doing this just because they think it's going to be there. They know it's going to be there. And it's going to leverage the robotics as an anchor devices to actually allow other devices grow as well. So if you talk about for example the acquisition of Mazor Robotics, or Mazor Robotics as we call them in Israel, it's not necessarily just the robot, but it's the fact that the robot will have an implants. And then, of course, the outcomes for patients and assistance to the physicians. But this is the market. The market it's already there. And we're not creating anything new at Microbot Medical. Let's face it. We are creating a new technology, very attractive, but [ in terms of the ] market, this is just a natural evolution of surgery. 40 years ago, to do a simple appendectomy, you used to open a patient, 5, 10 centimeter to do a simple procedure. About 30 years ago, people moved into laparoscopy 3 small incisions. And in today's environment, people are talking about robotic-assisted surgery, still highly dependent on physicians, capital equipment, dedicated room, but the future is really about the small robotics, for example, Microbot Medical, a disposable robot that will integrate what's available in the OR to allow physicians to perform their procedure in more efficient and effective way while allowing them to do it remotely, to avoid radiation, to avoid strain, physical strain and eventually to also avoid the fact that they need dedicated room and dedicated staff. And opportunities in the endoluminal surgeries are endless. So you have some robots that are dedicated, some do bronchoscopy. Some will do just neurovascular. But what we're looking at with LIBERTY is the ability for literally the same system to leverage that system and play within the peripheral, the cardiovascular and the neurosurgical space. Before we go into the LIBERTY and take you through our latest development with the LIBERTY system, I want to take you through the key milestones that the company achieved in 2020. We cannot ignore the fact that cash is extremely important, especially at this time of COVID-19. We don't know how long it's going to last, and we need to meet very important milestones as we go into the next 24 months. We're very fortunate that at the end of last year, beginning of 2020, we strengthened our balance sheet. Right now, we have around roughly $28 million in cash in the bank that assuming we can meet all of our milestones, that should last us for the next 24 to 30 months. As we always disclose, the company will continue exploring additional collaborations, additional acquisitions of products that will enhance our capabilities. I want to remind many of you that about 2 years ago, we acquired a technology from a company called CardioSert. Back then, we did not reveal yet LIBERTY. Once we revealed LIBERTY, then the community really understood the acquisition of CardioSert back about 2 years ago, and we will continue exploring these opportunities. But assuming that our milestones that we will present you are met, our cash on hand should last us for the next 24 to 30 months. Being the first comes with a lot of opportunities, one of them is strengthening our IP portfolio. We already have 38 global patents that are issued and allowed. We have 19 pending patent applications, and we're growing our patent portfolio in trademarks every day. One of the milestones we always shared with investors and shareholders is that we will meet with the FDA by the end of this year. That meeting took place. Unfortunately, and I know there's some question around the Self-Cleaning Shunt, we are still in very close discussion and advanced discussion with the FDA. And in order not to jeopardize the progress we have done with the FDA, we will not get into details regarding our discussion with the FDA or the status of the Self-Cleaning Shunt as we're going through the process with the FDA. In January this year, during the JPMorgan conference, we unveiled the first-ever fully disposable robotic system, a completely game changer, no more capital equipment, no more need for heavy expenses on OpEx. We continue to strengthen our leadership team. The addition of Dr. Eyal Morag, our Chief Medical Officer as well as an in-house IP and regulatory person to continue creating barriers for sustainable competitive advantage to creating barriers through the global patents that we have already and continue to establish. And as we're looking into both the peripheral, the cardiovascular as well as the neurovascular space, we created additional key opinion leaders to add to our scientific advisory board, people like or physicians like Dr. Ajay Wakhloo, Dr. Ziv Neeman and so on as well as strengthening our Board of Directors, the latest addition of Mr. Tal Wenderow. For those of you who don't know Mr. Wenderow he was the founder of Corindus. Corindus what I may say, it's the old generation of LIBERTY, big capital equipment, but playing in the same space of the endoluminal robotic surgery. So Tal will add a lot of experience and knowledge into that space as well as Aileen Stockburger. Aileen Stockburger used to run the new business development for J&J Medical. A lot of experience in transactions, from acquisition, mergers, collaborations, and she can add a lot of value to our Board as we continue looking into these opportunities. As we go into LIBERTY, I'm going to let these videos tell you. [Presentation]

Harel, there's no volume on the -- there it goes. [Presentation]

Michael, can everybody hear me well?

We can hear you and we can hear the volume, we can hear the audio and the video. [Presentation]

For those of you who didn't have the pleasure of seeing the device in real life, it really fits within the palm of your hand. Now I'm a 6'1" so I may have a bigger hand, but it still fits well within most people hand. This is how small it is. So when we're talking about really changing the game, we're talking about the first company that don't have capital equipment. Just think about it. Think about the fact that if you want to have a stroke management procedure -- I don't know how many of you have heard the phrase, time is brain. But today, to set up a robot to have a procedure, probably going to take you about 45 minutes. Can you imagine patients coming to the ER or the ICU, and they are in dire straits to have a procedure to resolve a stroke, and now they wait 45 minutes just to set up the robot. That will never fly. Here is another issue with adoption. But with LIBERTY, it takes about 2 to 5 minutes. You just take it off the shelf, you open it, you put it on the patient and you're ready to go on with the procedure. That's just one example how eliminating capital equipment allow robotics to get more adoption in the market. Another value proposition is the remote operations. Everybody is talking about, of course, prevention of radiation. Today, physicians are staying day in and day out within the patients and getting tons of radiation. Part of the radiation to them and their patients, it's also the fact why they need to wear a very heavy lead vest. That heavy lead vest may not seem heavy for people who work like once in a lifetime, but if you work every day for hours and hours and hours, many of these physicians have physical strain, so we are actually extending their capabilities. And as we move forward, we also have the one & done capabilities that is done through the acquisition, as I mentioned earlier, of the technology we acquired 2 years ago from a company called CardioSert, and that's the integration within LIBERTY. We have done multiple labs, multiple tests, latest one, specifically, is an animal lab that we have done on the peripheral and neuro procedures. The main objective was to evaluate the safety measures, but also to confirm usability of the system with the leading key opinion leaders. So in order to do that, we brought 2 key opinion leaders, one a peripheral physician and one neurovascular physician that have never used the system in a lab setting. They saw the system in our office, but they have never used it. It was extremely important for us to give them the device for the first time and see how easy it is for them to adopt. One of the heavy lifts for corporations in any company in order to get adoption is the expense they have on professional education. What we're trying to do with LIBERTY is actually eliminate those costs associated with professional education. If we can mimic what they do manually through the use of LIBERTY, we can eliminate the learning gap and the professional education expense as related to understanding those procedures. And again, if you look at the items on the slides, on the right side, the photos on the right side, you can see Dr. Neeman is doing the procedure remotely, sitting on a chair, doesn't have to sit there with a vest -- lead vest on top of him. And as you can appreciate the size of the device on the bottom right-hand photo about the size of the palm of your hand. This is a short video about the procedure we had with animal. You have the remote control on the right-hand side. The one thing you don't see here is the mounting device that we have. In order to do it in the animal lab, we use something off the shelf. And you can see Dr. Ziv Neeman doing the procedure remotely outside the room while the robot is performing the procedure inside the room autonomously. As you can see right here, remotely Dr. Neeman is able to guide a microwire. Many people refer to it as a guidewire, all the way to the target. Now on top of that, as you can see, they are running a micro catheter. One of the most amazing thing about our system is the relevance between the 2 wires. And now coil was pushed over the micro catheter and deployed in order to create what they call embolization. As I mentioned earlier, one of the features that are so unique about our system is the fact that you're on multiple devices in parallel, but still you can control each device in order to make sure that they stay in place. Many times, you see a physician putting a guidewire in as they run the microcatheter, the guidewire jumps out and they need to restart the procedure, not in our case. And here's a happy team after the procedure. We performed 4 procedures. Two procedures were done in the peripheral and 2 procedures were done in the external carotids and the neuro procedures, both of them were successfully achieved. The most important thing from our perspective, there are 0 intraoperative adverse effect on the pig, the patient in that case. And it was performed flawlessly during the animal study. The feedback we had from the physician was that it took him about 5 minutes to really feel extremely comfortable with our system and perform the procedure remotely, to their satisfaction, which you can take it lightly. Many physicians rely heavily on what they call their tactile feel. And to take it away from them and still allow them to feel extremely comfortable performing the procedure and really feel comfortable within 5 minutes. It means that we were able to achieve the usability aspect of that specific study. On top of that, the fact that the safety profile was there, and 4 procedures were completed successfully, we concluded this animal study was completed to our extreme satisfaction, and we're moving forward to the next step. Dr. Morag, since you're there with the other physicians, would you like to add anything to that study?

Harel, I just wanted to stress the fact that there were 2 main points that made this device very attractive to both of these physicians, the user interface, as you mentioned, the 2 key points here was the fact that the operation was done remotely without any issues sitting outside of the cath lab. And the other item that you already mentioned was the really very intuitive operation, fast adoption of the console and control. And the second point was the ratio of standardization of the procedure, the fact that you can accurate -- extremely accurately deliver a catheter and wire to a specific target and actually release a coil for treatment in a very stable condition.

Thank you. So what are steps moving forward? Right now, we are in the process of continue evaluating our device until what we believe to get to what we call a design freeze, sometimes during next year, probably during Q2 or Q3 next year. The design freeze, for those of you who are not aware what it is, it means that this is a device that will be submitted for the FDA for approval. This is the device that from that moment on, we're going to go through the formal VNV, validation and verification studies. You can make changes to that design freeze model, but it has to be very controlled, and it has to be reported. The design freeze is the last stage before we're getting into the submission phase to the FDA. We are leveraging what we call a 510(k) procedure. This is our assumption. We're working with a leading regulatory agency, and we believe that we are going to be under the category of the 510(k). Now 510(k) in some instances will not require first-in-human or any clinical studies. But this is why as we're going into Q4 next year, it's either going to be a pre-submission with the FDA to really understand, do we need to have clinical studies as part of our official clearance from the FDA or our animal studies are -- will suffice. Regardless, as a company before we launch a product, we would like to see enough procedures performed in human in order for us to feel comfortable to launch it to the market. Under these assumptions, we are planning to assume clinical trials that will start in Q1 2020. And one of the beautiful thing about our device is that the follow-up that we assume will not be as long as implants for example. Therefore, we believe that we are positioned for an FDA submission sometimes during the second half of 2022. And if all goes according to our plan, we should have the 510(k) clearance during Q4 2022 or Q1 '23, that should have already enough clinical data generated in human to allow us to launch the product. This product is what we call an open system. This product will allow us to take any guidewire, any microcatheter, which is on the market and will allow us to complete the procedures. In parallel, we are integrating the CardioSert, as you saw -- the CardioSert technology, which we frame it as the one & done technology, due to the fact that one of the major challenges in the procedure is the constant exchange of tools, guidewires and microcatheters. We believe that as we move forward and integrate what we call the customized system of the one & done system, we will be able to reduce dramatically the usage of multiple disposables, such as the guidewire and microcatheters. As I mentioned earlier, and as all of you know, there is another device in our portfolio that has been under development for the last 5 to 6 years, it's called the Self-Cleaning Shunt. The Self-Cleaning Shunt right now, it's in discussion with the FDA under a process called EFS, early feasibility study. We can share with you that we've been to the FDA multiple time, the last one was just a couple of months ago, which was a pre-submission for -- specifically for the early feasibility study due to the fact that we are in an active process with the FDA, and we expect to know from the FDA final directions and decision by the end of this year. We are not in liberty to discuss any status of the Self-Cleaning Shunt on this call. Just to remind you what it is, the Self-Cleaning Shunt, it's actually a little robot less than 1 millimeter, that fits within a shunt that's supposed to solve the problem of occlusion into a hydrocephalus and normal pressure hydrocephalus patients, which is a condition that happen mostly with kids and the elderly population, where there's an accumulation of the CSF fluid in the brain that does not dissolve on its own. And today procedure is to put a shunt in place. However those shunts get occluded, about 50% of them get occluded within 2 years. As we look into the Self-Cleaning Shunt, assuming we get alignment with the FDA regarding the EFS, this is the milestone moving forward. So as you can see, we feel very comfortable that within the next 24 to 30 months, we will have 2 devices, one of them already in commercialization phase. The other one should be either in an IDE phase or at least within the process of getting into the approvals. We mentioned earlier the robust IP platform. We're going to continue investing in our platform, either through internal developments, external acquisitions, collaboration and so on. And one of the strengths of the company, if not the strength of the company, obviously, I'm biased toward the technology, I believe that both of our devices are extremely unique. I believe that we're creating a big differentiator in the market. But it's really about the people. And I know that many of you know, at least Professor Moshe Shoham, who is the founder of Mazor Robotics that was sold to Medtronic recently -- well not recently, about over a year ago, probably one of the top thought leader when it comes to surgical robotics. My job is just try to complement his capabilities together with Yossi Bornstein and the people that run the daily operations are Simon Sharon, the Chief Technology Officer; Dr. Eyal Morag, the Chief Medical Officer; and we also have the CFO in our office in Israel, taking care of our budgets, making sure that we not only meet development milestones, but we also meet budget milestones. All in all, we have about 12 people working in the company, most of them based in Israel, where our major operations are. So to summarize this presentation, I want to make sure that I leave around 20 to 15 minutes for questions, which is more important than me presenting and talking too much. We are addressing a multibillion high-growth underserved market. Anybody heard about a blue ocean. Here it is. It's right there in front of you. We are developing -- we're pretty much the only one, who at this stage we're developing microinvasive medical robotic technology. As you can see, we're not developing just one product. We're developing a multigenerational product pipeline. Our expectation is not to have just one product. And here it is. If you just look at LIBERTY, I had multiple meetings with couple of shareholders who told us how were you able to hide LIBERTY from us for about 2 years. And my answer was, we didn't. If you really look at our statement, when we acquired a technology from CardioSert, we told people we will play in that space. We're not going to tell you exactly what we're going to do because we're not going to disclose it to our competition. But this is the beautiful thing about what we're doing. Even with LIBERTY, the third device is an open system. We can leverage any guidewire or microcatheter on the market. But as we move forward, we're going to customize it and we're going to integrate some of our additional technologies. We continue creating significant IP to continue developing sustainable, competitive advantage. We have proven leadership team led by Professor Moshe Shoham, the founder of Mazor Robotics. And our cash position is extremely strong. As I mentioned, with our current cash position, meeting the milestone we expect, granted the fact that we're still looking into additional transactions to add additional value to the company. This cash position should last us for the next 24 to 30 months and allow us to reach a meaningful milestone as we move forward into commercialization. With that in mind, I would like to thank all of you for your time. And Michael, I'm opening this for any questions that anybody want to ask.

Thank you, Harel. So with regard to the Q&A, we have received a number of Q&A or questions over the last few days. So from that list, in addition to the Qs that are coming in through the Zoom feature, we will aggregate and just give us a moment here as we get some of these questions. But in the meantime, I will ask Harel a list of questions that have come in via e-mail over the last few days. Harel and to the team, what was or what is the purpose of the feasibility animal study?

So as we mentioned earlier, you can hold feasibility study, but -- animal study -- the animal studies we form right now is to lead us to the design freeze. So we need to understand multiple things. When you do a study, the number one thing you want to understand is the safety and efficacy of the device. If you don't have a safe device, you don't have a device. So the number one is -- and we will continue doing multiple animal studies until the design freeze and until we get to the FDA. So the first one is the safety. Second one is how efficacy -- efficacious of the devices. But most importantly, in that specific study was the fact that we gave it for the first time to 2 physicians in 2 different spaces, the peripheral and the neurovascular, and we gave the device for the first time and say, here, use it. If it will take them hours to understand how to work with it, we're doing something wrong. So it was really important for us to understand, if you use it for the first time as a physician, how long does it take you to feel comfortable with it? And when you use it and you feel comfortable with it, our -- the safety profile is still there. So that was the major endpoint of the study. On top of that, every time you give a device to somebody, they'll learn something new. And they see something new. And when they learn something and see something new, guess what we learn and we see something new. And we have the time to integrate every feedback they have into our final device, leading to our design freeze, which we expect to happen during Q2 or Q3 next year. So that's part of why we may call these studies feasibility study, but really, there are all around animal studies that we will need to perform, leading to our FDA submission eventually. And it's going to include safety, efficacy as well as usability feedback and additional features that some of them we may integrate into our current device, some of them we may integrate into our future devices.

Thank you, Harel. I just want to answer some questions that have come in. The presentation is on the website with the videos. If you have any questions, please contact us. We'll be happy to send you the presentation. Additionally, as Harel mentioned earlier, a specific question about the Self-Cleaning Shunt, will not be addressed on this call, per Harel's earlier comments regarding the FDA. We'll take a next question. Harel, do you expect human trials will follow the completion of the animal trial?

Absolutely. And as I mentioned during the presentation, the question is when. It's not if. Absolutely. The right thing to do is to test your device once you've proven it in animal studies, and you feel comfortable that it's stable through the VNV studies. It's tested in a simple size of clinical studies. So it's not a question of if. Yes, we will. The question is when. If part of the 510(k), the FDA will not require us to have first-in-human or clinical studies. And the answer is, no, we're not going to do it before our submission for clearance. But regardless if it's going to happen before or after or it's going to be post-clearance study, we will perform clinical studies in human before we launch the product because this is a very responsible thing to do from the company perspective. Now keep in mind, a study for our device is very different than a study for example when you put an implant. When you put an implant, it's the recruitment of the patient that takes a lot of time, but especially the follow-up on the study. With our device, recruitment, you have so many procedures in peripheral. And especially when -- focusing on peripheral is the first step. You have enough patients pull in order to get your recruitment but most importantly, your follow-up on your study should not be as lengthy as you have when using an implant. Our initial estimate is roughly around 30 days follow-up, rented out, we still need to confirm with the FDA. So the study will take place, Michael, regardless if it's going to be as part of the submission to the FDA for clearance or the post clearance study leading to our commercial activities.

Thank you, Harel. Question that did come in through the feature here. Beyond the Self-Cleaning Shunt and beyond the LIBERTY Robotic system, what other projects or R&D efforts are being contemplated with regards to other products, other markets? And in what geographies, what markets will you focus the LIBERTY robotic system first?

So I see 2 parts of this question. The first part is I can tell you on whoever asked that, but then I will have to kill you. So I think that everybody can respect the fact that we will not share not on this call and not publicly what is in our bag of surprises moving forward. I know that a lot of investors were pleasantly surprised when we came out with LIBERTY, although we told them it wasn't a surprise. Your second question, I believe, was more of a market, geographical markets. And that's very interesting. It's very interesting because I can tell you where the market is going to be today, and then COVID-19 may change everything else moving forward. The capabilities of our device -- devices, regardless if it's a Self-Cleaning Shunt or the LIBERTY, but let's focus on LIBERTY because of your questions, the capabilities of the telesurgery or telehealth will allow us -- and the fact that we don't have heavy-lift expense on capital equipment will allow us to get into more of the developing markets, not only developed markets, but obviously, you need to get the first adoptions in the leading markets, mainly the U.S., North America, Europe. And then as we look into the developing markets, we're going to see the value of not having capital equipment, the value of being able -- let me rephrase that, it's not just the capital equipment. As many of you know, I used to work for Johnson & Johnson. One of the things I saw at J&J is the fact that in the developing markets, many times, the budget wasn't the issue. It was the surgical skills. And that's one of the lessons learned that we implement into the LIBERTY. It's the fact that we're eliminating the barrier of the capital expense, but potentially, we can also mitigate, to the point, maybe even eliminate the gap in the surgical skills because can you imagine if somebody in mid-Brazil or mid-India now needs to do a procedure, but they don't feel as comfortable, they have somebody from Sloan Kettering from Israel, from anybody else around the world log into their system and help them go through the procedure through a remote control procedure. So big markets first, developed markets. But at the same time, we are exploring how we're going to get into the developing markets through our value proposition of remote controlled telesurgery as well as no capital equipment expense.

Thank you, Harel. Just some more questions. I will read a question here that came in. Why would the FDA give clearance to the LIBERTY Robotic System without any indication of human trial results?

First of all, I never said they will. But what I did say is that we believe that we're going to be under a 510(k) process. And 510(k) process sometimes does not require to have clinical studies. It's what they call substantial equivalence. We believe that we have substantial equivalence on how our system performed. It's very different in the fact that it doesn't have capital equipment, completely agree with this one. And again, we cannot sit here and guarantee that we're not going to have clinical studies or not. The FDA under 510(k), sometimes if you have substantial equivalents will not require clinical studies. I cannot sit here and tell you what the FDA will tell us. What I can tell you is from a company perspective, regardless of how our 510(k) process is going to look like with clinical studies, without clinical studies, we are planning to have a clinical study in order to do the right thing before we launch the product up in the open market.

Great. Some more questions about LIBERTY. You may have already addressed this, Harel, but question just came in. What was your rationale or the company's rationale for the feasibility study?

I think we answered that before. So I'm not sure if you want me to go again. So I'll just answer that again very quickly. The rationale is, number one, you always want to test your safety and the efficacy of your device. As we're developing the product, leading to our what we call the design freeze if -- I hope I don't have to remind people what the design freeze is assuming people remember what the design freeze is, it's pretty much the freeze of the design that will be submitted to the FDA for approval. As we go through this, we need to continuously challenging our system to get to the safety profile and the efficacy you want to see. And on top of that, we want to make sure that we give it in the hands of physicians in different skills with different experience in order to see how they react to our system, how easy it is for them to adopt the system. We want to get to the point where not only you do not expense on capital equipment, but you don't need to have expense on professional education. The fact that we had 2 physicians that held our device and within less than 5 minutes were able to perform 4 procedures of coiling 2 neuro procedures and 2 peripherals. And the feedback was, not only it was so simple and so intuitive but it actually solved them problems that it just can't solve it the other way. For example, the relationship between the microcatheter and the guidewire. We will continue doing these studies. We can call it feasibility study, we can call it animal study. It really doesn't matter. The endpoints is always going to be the same. We're going to check our safety, our efficacy and our usability, leading to our design freeze, leading to our studies for FDA clearance.

Right. And it was worth repeating. We received a couple of questions. Can you...

Maybe you want me to repeat it in Hebrew? No. I'm just kidding.

We haven't received that request. Yes. But we did receive the request in terms of how many procedures have been performed?

Four procedures. And that's specific procedure. And I know that some people asked us how many pigs. So first of all, people ask me what animal. So yes, I'm sorry, it was a non kosher animal. So my apology for that. It was a pig. And it's not about how many pigs. It does make no sense to do one procedure in a pig and then kill the pig and bring another one in. In Israel, they don't consume so much bacon that it's worthwhile to kill so many pigs. So it's really about leveraging the animal to do multiple procedures. So it's really a question about how many procedures were done. In that studies, we have 4 procedures done, as I mentioned. All 4 of them were embolizations and 2 of them were in the external carotids and 2 of them were in the peripheral. Dr. Morag, would you like to add anything else on this study, anything that I missed?

No. We performed 2 types of -- in general 2 categories of procedures, as you mentioned, one was a peripheral vasculature. We catharize the arteries supplying the liver and kidneys. And then in the neurovascular area, we selectively catharized the external carotid artery for embolization.

Thank you. We did get a question here. You mentioned disposable. How much of the LIBERTY will be -- able to be recycled?

All of it. So all of it is recycled. Recycled, you mean?

Recycled, correct.

So there's a big difference between the disposable and recycle. Okay? We are looking to have as much as possible to be recycled, meaning not be sterilized. So not people can use, but we don't -- we want to eliminate as much waste as we can. But you have to remember, you may throw up this little robo that you see and the remote control and you may dispose off that, but if you're using a capital equipment, it doesn't mean that you don't have any disposables. Just to, for example, to drape your Mazor Robotics, their device or Corindus just the drapes that you have for these devices are pretty much more than the entire LIBERTY device that you see right here. That comes sterile, you open it, you put it on the patient. So our goal is to minimize waste as much as possible compared to our competition and compared to what we can develop with our device.

Well, one moment. Harel, you just mentioned competition. Are you aware of any other company or any other academic institution that is working on something similar? But I will join that with another question that came in. In terms of your IP -- in terms of these barriers, what kind of competitive advantage do you have? How long will it take somebody to replicate what you have, if they can indeed even replicate it?

So there's a couple of phases to your questions. So let me try to answer that. The number one is to sit here and say we don't have competition, it's irresponsible, okay? There are competition and there are always going to be competition. Competition can be something we are aware of and competition will be something we're not aware of. So competition, we're not aware of, we can always understand through IPs and people that still don't have IPs that we can see in a public domain, they're pretty much 5 years behind us. And 5 years is a long way to establish, as I mentioned, sustainable competitive advantage through pricing, through clinical experience, reduction and so on. We are not aware of anything similar to this that it's being developed commercially. We are not aware of anything that it's similar to this that is being developed through universities or academia, something that is completely disposable. It doesn't mean that there's not something that somebody's trying to develop that does not mimic what we do, but trying to replace it completely. For example, if somebody trying to develop a guidewire or microcatheter that they can push manually. But again, you're going back to pushing manually. So people are trying to develop smaller systems. Are the smaller systems going to turn into a completely disposable? Can they meet the cost of good manufactured that we're trying to meet? It's a question. We don't know that. We haven't seen anything like this. Regarding our IP, again, I can tell you, I will have to shoot you. I'm not going to get into what are differences in our IPs. This is highly confidential. So I highly recommend for people really interested is to just go online into the USPTO and look into our patents, and they can see our patent. And patents that they cannot see there, I'm sure that people on this call will appreciate why we're not going to share what they are and how differentiated they are from our competition -- potential competition today, and mostly moving into the future.

Terrific. Thank you, Harel. This is a question, perhaps for Dr. Morag. What type of staffing is required in the cath Lab when using the LIBERTY Robotic System?

Yes. So this is a processing evolution, that basically, there will be a staff member that will be in charge of inserting the catheter initially, which is a nonrobotic action. And then the rest of the robotic control will be done from outside by physician. So it will be -- as far as the nursing staff is not any different than what it is right now. There'll still be nursing to check [ in there ].

Great. And again, another question for Dr. Morag. In terms of the physical strain, as somebody who has done procedures, a questioner wants to know what impact does that physical strain have on your career and on your practice.

Well, that's an excellent question. We -- I think a high percentage of the interventional radiologist, the people who perform catheterization in the lab. I think over 90% suffer from back pain, ruptured discs, muscle pain and aches. It's a very significant strain. We have days where we wear the lead jacket for about 10 hours from neck down to below the knee level. So the strain is indeed a factor. On a personal level, I ruptured disc twice doing catheterizations. And it's amazing, in the last 30 years, despite the technologies, the lead jacket has not really changed much. We still wear it, and it's still heavy.

And is that physical -- I'm sorry, Harel, it was a follow-up question. Is that physical toll responsible for the skills gap for less interventional radiologists entering this field?

I'm not aware of any decrease in number of applicants related to lead wearings. I think physicians [ go ] this year because it's -- the impact is amazing and a satisfaction of a good procedure is something that you cannot truly imagine. So the lead is not a hindering factor for the professional, in general. But I just -- as far as I want to just share with you the experience with these 2 physicians in a cath lab, when they stepped outside and were able to sit in a chair and in front of the screen and not standing there with the lead jacket, they were extremely pleased and happy. So the impact is significant as far as doing it remotely.

So Michael, I'm willing to offer anybody on this call if they're willing to sign that they're going for 1 week -- wear a lead vest for 1 week without taking it off, the company will send them a lead vest, and -- but they have to agree to just wear it for 1 week. Not take it off. We will send them one and they can appreciate it.

Very good. Everybody...

We'll send them for Christmas.

Right. We could put a Microbot logo on it. Harel, Tal Wenderow recently joined your Board. What is the significance of that? And what do you expect his contribution to be on your Board?

I think it's major. I think the fact that we are approached by him that he understood what we're doing and he can really see how we are solving issues that are in the market already. I can tell you that I heard it from multiple physicians and other people that were -- that had preferred Corindus is the fact that physicians sometimes walk into the room and they want to do a procedure with the robot, but the room is taken, somebody else is doing another procedure, and they cannot use it because the robot is attached to the bed and they're stuck. Just one example of how LIBERTY solve the problem that Corindus don't have -- cannot overcome. So his understanding of the market, his understanding of the gaps in the market. He's been through this process for almost 20 years, starting when he founded Corindus. All these experience, it's very similar to when people asked us why are we doing feasibility studies. It's because getting into a room physician who have 20 years of experience, and they're using our system and they can challenge our system and tell us I know from what I'm doing, you can do this better or that better and we integrate it. Same thing when Tal can look and tell us, well, the market may think about XYZ. I think it's major for us the fact that we have somebody with that experience joining our Board and helping us understand how to position the development of the product and the company moving forward is very valuable. And it's not just him, it's also Aileen Stockburger who joined us most recently. Now it's the fact that we keep looking into how to enhance our capabilities. As I mentioned, the acquisition of the technology from CardioSert was just one of them. But having somebody with that experience of creating those transactions and understanding how to build those transactions. And I'm not going to talk about partnerships, not partnerships, I'm really talking about adding value to our current development and our future pipeline. This is where you want to have people like Aileen Stockburger on your Board, Tal on your Board, let's not forget everybody else. We have Martin Madden who used to be VP R&D at J&J; Laxmin, who you used to be the worldwide President for Codman. So we have people with such vast experience that will allow us to position our development and the company as we grow. And that's what -- those are the changes what we're continuously implementing. We're continuously being proactive to our development. I've seen too many companies being reactive. So we always look to a point to be proactive. How can we add more assets from IP to people on the Board, to the management team to take us to the next step. Eventually, our objective is to be in commercialization phase, and we want to be set for success in commercialization. We don't want to be just set for commercialization. So all the activities you see today are gearing toward when we're going to be in the market.

Very good. I just want to also address the question with regards to the Self-Cleaning Shunt that we're continuing to receive, Harel, has expressed earlier because of the FDA discussions, we will not be addressing it. I do want to correct somebody out there. The results of Wayne State had been disclosed previously in the company's filings, and we will not discuss the timing or expectation updates for the Washington U study.

Michael, I don't mind addressing this again, just so people understand again.

Well, okay. Certainly.

Our objective is not to make people happy on this call. Our objective is to make the company successful. And being successful, it means that when we're going through a very close discussion with the FDA, we just met with the FDA virtually, unfortunately, but virtually about 2 or 3 months ago about the Self-Cleaning Shunt. And we're making great progress with them under what we -- under what the FDA established as an EFS, early feasibility study. And we know where we are, we know what the answer is they're still looking for, what we need to from them. It's irresponsible to disclose it right now before we feel extremely comfortable that we are fully aligned with the FDA. Once we're fully aligned with the FDA and people who's been on calls with this company before, we work with full transparency. You like it or you don't like it, you're going to hear it. But right now, the right thing to do is to let the company complete its process with the FDA, which we expect to finish by the end of this month -- by the end of this year, sorry. And once we have this, you will get all the answers that you want around the Self-Cleaning Shunt.

Terrific. There's a question here, Harel, in terms of what process are in place for the LIBERTY robotic system in terms of the protection for the patient. But I think it bears repeating, and you might want to say in terms of the COVID and the infectious pathogens, how LIBERTY will address that in the future?

Oh, it's very simple. It's the fact that -- and then Dr. Morag can actually tell you about multiple hospitals in Israel that the entire departments were shut down because the entire surgical staff were quarantined right for COVID-19. So just the fact Dr. Morag, I believe we spoke about in the past, right?

Yes.

So just the fact that -- and I'm going back again to what I explained earlier on, in the past, when we spoke about, or anybody, the market spoke about cross contamination, it was mainly the patient. How do we prevent patients from coming to the hospital and getting sicker because of cross contamination. But COVID-19 brought something else to the table. It's how do we protect the surgical staff. And the surgical staff, it's not just the physicians, it's the nurses and the technicians. It helps nobody when you don't have staff to actually treat patients. The fact that you don't have to be in the room with the patient, performing the procedure, will create that separation that potentially will allow to reduce the risk for cross contamination, both for the patient and for the surgical staff.

Great. A question that did come in earlier. And I'll ask now because it's a part of this. What is the technology? And maybe too technical, we may have to address it offline. But what is the technology that communicates the robot with the actual system itself. Obviously, it's over WiFi or Internet. But what are the safeguards from that purpose? Or from that...

We have multiple things. Some of them are actually covered with either Corindus IPs or IPs we're working on. So again, I will kindly decline to answer that question.

Fair enough, fair enough. It may have been too technical anyway. Harel, in terms of the questions that we have, I think you have addressed -- again, we've received over 20 questions from here and probably another 2 dozen that came online. It seems like you have addressed all of these questions. Is there anything that you want to add in summary?

Again, I think the only thing I want to add right now is to wish everybody health, to keep everybody safe. We're going to continue working as a company to meet our milestones because it's going to add tremendous value to patients. That's the number one thing, and patients, not just in the U.S., but globally, and then everybody who's -- and then I think we all have more appreciation to this -- people who are helping those patients. So that's the number one thing I want to tell everybody. It's -- we're going to continue to focus on delivering results as we've done to date. We have our milestones, very clear. We share them with you. But as we're going through this, the only thing I really want us to focus on is our health and people's health and families health. I mean I believe this is the most important thing for anybody on this call and anybody else.

Great. Thank you, Harel. I just want to add that Harel will be presenting at the Wainwright -- excuse me, at the H.C. Wainwright Global Investment Conference, presenting at 4:00 p.m. on Tuesday, September 15. The presentation will be webcast, and details will follow. We appreciate your interest, and thank you for joining us today.

Thank you Michael. Thank you, everybody. Good health. Bye-bye.

Bye-bye.