All right. Good morning, everybody. Good morning, and thank you for joining us. I wanted to start off by introducing myself. My name is Pete Weiss. I am a physiologist at Banner University of Arizona Medical Center in Phoenix. Also been heavily involved with the Society for Cardiac Robotic Navigation. I'm sure that many of you are wondering, what is the SRN? So the Society for Cardiac Robotic Navigation is the international academic society for those interested in the use of robotics in electrophysiology. And this is an organization that's been up and running for about a decade now. We're about to have our eighth international symposium in Lisbon in October. And we very much appreciate the opportunity to combine forces with Heart Rhythm Society and HRX in particular, and really thank the organizers for having us here. I think I would like to start off by having each of our panelists introduce themselves, say a brief word about their interest in robotics, what led you to be here on this panel, and we'll take it from there. And again, from the audience, if anybody has any questions, feel free to use the Q&A system, and we'll be taking a peek at that as we go along. But I think it should be a pretty free-flowing conversation. Thank you. Want to go first, Ben? Sure, I'll start. Good morning, everybody. My name is Ben D'Souza. I'm the section chief of cardiac electrophysiology at University of Pennsylvania, Penn Presbyterian Medical Center in Philadelphia. I've been utilizing robotics in terms of ablation pretty much since I've been in attending for the last close to 10 years, I guess now. And it was one of those things that I adopted after my first year, but with actually very little exposure to it during my training, even though there was robotics and there was stereotaxis and the ability to do it. It was something that I decided to use more so that I was interested in kind of innovation and trying something new. And I think anytime you're an EP, you want to try something new and learn. So I started to adopt it, acknowledging full well that I trained at a center where we did all of our ablations manually. And I felt very confident that I could do everything I could manually, but really have learned as time's gone on that sort of using technology to your advantage can truly help revolutionize our field. And I think we're really only scratching the surface of what we can do, which is why I wanted to participate more in these types of conferences. And I'm very happy that both SCRN and HRX have sort of combined forces so that we can talk about how we can leverage all of the industry players that are sitting around us right now to really develop the best patient care possible. That's why we're all here. Great. So Dan Cooper, I am an electrophysiologist at Washington University in St. Louis. I am the program director for the EP fellowship program there. Joined faculty 2011 after doing all my training there. And, you know, Stereotaxis is a St. Louis company. We've been collaborating for decades and decades on the technology. My mentors, Bruce Lindsay and Mitch Faddis wrote the original clinical experience in Jack back in 2003. And so I was exposed early on to the technology and have been able to be a witness to the ups and downs of the robotic EP space. And I'm very passionate and excited about the future. As I always say, when I talk about robotics, there's no doubt in my mind that the future of EP, the future EP lab will undoubtedly have a substantial role of robotics in that lab. And, you know, the only thing that remains uncertain is kind of the timeline when it becomes one of those dominant forces. And so we're going to try to pull that timeline out of David today and see where things stand. And, you know, I'm excited to be here for this conversation. Looking forward to it. And I'm David Fischel, CEO of Stereotaxis. Joined Stereotaxis actually from the finance world where I was focused on investing in medical device companies that are trying to push the boundaries of medicine forward. So I'm very comfortable in the HRX-like environment. I'm delighted to be here as well. And really the big challenge for Stereotaxis has been over the last few years is how do you innovate? How do you push forward the technology that fundamentally was capable of doing things that are otherwise impossible and providing good clinical value but really wasn't designed in a way that could be broadly adopted and kind of to the full extent kind of taking advantage of robotic capabilities. And that's really been the focus. So happy to have you guys here. Yeah, thank you very much. And I think as you alluded to and you alluded to and I started off probably in 2008ish, something like this, there's really been a long history here. And I think in some ways this is sort of the elephant in the room. Okay, robotics has been here for a while. But why isn't it more broadly adopted? And David, you've been with the company for seven years or so now. So I'd love to hear from each of you why you think it has struggled so long. But also a little comment about one or two points you think might be the optimism for the future that really makes this feel like a tipping point. Yeah, I mean, I think, you know, like I said, we've kind of been there at WashU from the beginning and seen some of those ups and downs. And I think some of it, you know, stemmed from the fact that it came out at a time when probably we weren't quite ready for it. The original model generated a lot of excitement. But it had some downsides in terms of latency of movement of the catheter, the logistics of the magnets in the EP lab, getting the staff used to it, the cost of the system to hospitals provided a lot of obstacles. And then I think at a very critical time in the existence of the technology, we had the unfortunate circumstance where irrigated catheters came out and there was some lag time before the irrigated magnetic catheter was available. And so during that time, it allowed this window of a drop, you know, in interest, which maybe something we come back to later is we, again, are at an impasse with PFA really taking over the AFib ablation space, both Europe and here in the U.S., you know, what kind of threats does that pose to a technology like stereotaxis? And I think some great decisions were made and some bad decisions were made over the decades. And certainly over the last decade, when I've been heavily involved in the current iteration, the reason why I am incredibly optimistic is that I feel a different vibe in terms of the momentum. I feel like despite, you know, the magnetic solution from stereotaxis being a mature technology where we have, you know, very firm grasp of what the technology can do. I also feel you pair that experience and data behind it with incredible amounts of innovation going into it with new catheters, new magnets. And the next steps are really exciting. And it comes at a time when the, you know, the ground is very ripe for this. You know, the market forces are in such great support for surgical robotic solutions that the timing is perfect for this to really hit its inflection point. Yeah, so I mean, I agree with pretty much everything that Dr. Cooper had mentioned. It's sort of disappointing in some ways, right? And so while I appreciate David being up on the stage with us, I would prefer if there were other CEOs of robotic companies here. I'm sorry to say that, David, but competition is a good thing, right? We have a lot of banners up of very large players in the space, whether it be mapping systems or catheters or imaging systems. But we don't actually in robotics. And again, I'll echo the disappointment that we haven't gotten there yet, but I think that it's just an inflection point in terms of where we're going to get to, where robotics will be the future. It sort of has to in many ways. I mean, the field is very well versed as electrophysiology, getting a catheter to move to a very sensitive area of the heart. And look at, I mean, modern day hysterectomies, modern day gallbladder surgery, modern day cardiac surgery. I mean, Penn itself advertises that we can do robotic mitral, robotic this. And at the last SCRN conference, we had neurosurgeons talked about some of the really neat stuff that they're doing. And we're, unfortunately, at EP, we kind of brag about how great we are in terms of tech and how we're sort of advanced. This we're not. We really do need to continue to push. And I think that, yes, when the technology came out, as we were sort of joking earlier, we're still doing ablations currently with catheters that are 15 years old, which no one would currently do in manual ablation. Yeah. And David, I'll definitely let you address it. But I did want to kind of jump on and share our experience where, so Miriam Curie is the chief medical officer of Intuitive Surgical. She actually is now on the board of Stereotaxis. And she spoke at our last symposium of the SCRN and is really instructive to hear their journey. They started off 15 plus years ago as a cardiac surgical tool, unwieldy, long procedures. 25 years ago. 25 years ago. No clear evidence of benefit. And they were really, really struggling. Very poor traction. And then they were kind of almost bankrupt. And then some crazy guy in Europe decided he'd try for the prostate, right? And fast forward 15 years, they now have 90% market share in prostate surgery. And they're really dominant in all the soft tissue surgical fields. So I think the idea of what would be the killer application, we may not have discovered that. The other thing that was very clear from that is that while soft tissue robotics is very much in place, there is nothing in the transvascular procedures writ large. Not only electrophysiology, but interventional radiology, neuroradiology interventions. There's really a wide open playing field here. And I think that this is what also makes this very exciting. So with that in mind and sort of following on these guys, David, where are you in that whole? You guys each said it perfectly from different angles. I mean, stereotaxis is one of the most interesting business case studies probably that you could write a book about. Kind of both why it was not successful, what role it could play in the future, how kind of that all played out. I think that, you know, Dan, you mentioned perfectly why while the technology became viable and real and kind of capable of this distal tip control of interventional devices, it wasn't really able to get widespread adoption. I think about the timeline of stereotaxis probably in four stages. I think it's kind of helpful from a timeline perspective. The first stage being all those initial years in WashU, in the lab, you know, preclinical studies, trying to take this weird concept of using magnetic fields to do distal tip control, turning that into something real. And that kind of was from when it was a university project till, let's say, around 2003 where it actually got its first FDA approval and kind of the first day human clinical use. The second stage is this kind of, let's say, 2003 to 2010-ish time frame where there was great fanfare excitement around the robot, great adoption of the system itself over hundreds of systems were installed globally, but the vast majority of those were not being used. And that's the reputation that stereotaxis got of being a coat hanger and sitting there idle. And there's reasons for that. I think the two main reasons, one is the clunkiness and the latency, all the kind of things that made it just impractical. So, you know, we all take notes when we're in meetings. You're taking notes with a pen and paper. I come to you, tell you, use a laptop. You have a spell check and you can change the font and you can edit and you can send it and you can save it. It's better than taking notes on pen and paper. But then I give you a laptop and every time you try to move, it takes you three seconds to do anything. You're going to tell me, David, you might be right, but it's, you know, I'm going back to pen and paper. And that was kind of the environment there. The other thing was, and that's where a society like SCRN is fantastic. There wasn't the right understanding of best practices, neither on the company side nor on the physician side. How do you train in this new approach for navigation? And so just kind of, you had kind of pain in the learning process there. In around kind of 2010, 2011, and you guys live this, so you probably actually know it a little bit better than me, but the best practices kind of started to mature. There was the upgrade in software with Niobe ES, which made it more practical for day-to-day use. And so you started to actually see utilization growing. But by then the company had entered into a type of tailspin where hospitals had, there was this reputation out there that it was a coat hanger. It wasn't being used. So hospitals started to adopt it less. Like most young companies, the company was spending with expectation of significant growth. Suddenly, you know, sales are declining. It has to cut its staff. It has to dilute financing. Its stock prices drop. That's kind of a negative tailspin that is unhealthy. And unfortunately, during that time, then the company was not focused on continuous innovation. So you had kind of a stasis. And when you're working in an innovative field like EP, and when you're working with cutting edge technology, stasis is a killer. You need to constantly push forward and move forward. And stereotaxis, it's not all stereotaxis fault also. It also was stuck in certain structural agreements, right? With Biosense as the main kind of partner, which limited its ability to easily innovate. It was kind of stuck in historical agreements. And so what kind of, with that context of that history, what excited me about stereotaxis was exactly the story of Intuitive Surgical. 23 years ago, 2001, I think, our firm in Los Angeles, we visited Computer Motion at the time, right before their merger with Intuitive Surgical. If you remember, both Computer Motion and Intuitive in those years were struggling and nearly going out of business. We invest in, it was a big garage, but a garage shop at the time. Invest in the company, saw kind of the success of Intuitive then over those years. Kind of one of my first investments when joining the firm in 2008 was in Mako, which was the orthopedic robot. And kind of looked at stereotaxis, and we looked at the different potential mechanisms of action for how robotics can play a role in endovascular interventions. The magnetic mechanism was the most elegant in allowing things that were otherwise impossible. So that was kind of the intrigue. How do you take this technology that's out there, that's actually working in the real world, providing clinical value, and turn it into something that could be a platform that can do much, much more? The diagnosis of how to take this history and the technology and turn it into something that can actually do much greater good for the world, kind of the diagnosis of what was needed to do well was really predicated on four main thrusts that we've been working on for these last six, seven years. And each of you have actually been core parts of making this real. One was how do you make a robot broadly accessible? And so how do you take something that was a construction process and expensive and very complicated and meant that the vast majority of interested physicians never got a robot just because of that complexity? How do you make something broadly accessible, broadly affordable, so that anyone who wants a robot could have one in their lab? The second was how do you build the right family of EP interventional devices and integrations so that it's never going to be perfectly like this, though I would love if we could get there, but we're trying to go from a very black shade to a much whiter shade where you can pair the benefits of robotics broadly with different therapeutic and diagnostic technologies in the field. This is a highly innovative field with a lot of changes, a lot of different approaches. And so to be tied to only specific therapeutic approaches or one specific diagnostic, that just isn't right. It isn't right for physicians. You don't get your choices. And for patients, you don't get to pair the right technologies together for that patient. So how do you create kind of an open ecosystem around our robot in EP? The third was how do you make the robot multi-specialty? So how do you have the right tools so that the same robot can be used in multiple specialties? And the fourth is how do you add intelligence to the robot? And that's maybe with HRX, perhaps the most interesting is this kind of digitization of the operating room. How do you add a kind of information integration, automation, decision support, connectivity to the robot, kind of all these aspects of enhancing the robot beyond its mechanistic benefits to also its kind of cognitive benefits? Yeah, I think that's been one of the eye-opening things of walking into this room and looking at all the participants here and how much is going on in the innovation side and how much that integration of these innovations is really going to be key. And it really can't happen unless you have this open EP ecosystem. And I think also thinking about a platform for how to put all that together in an easy, usable workspace. So if I'm in the lab and I've got 10 different screens I have to look at from 10 different companies providing 10 different types of information, that's really not going to work. And I think optimizing the synergy of all that is key. And I think we also understand, and I'd love to hear your thoughts too, about in the end we still have to work with the big strategic partners, right? So how do we optimize that as well? So I think that even beyond the movement of a catheter from a robotic perspective, the data integration, the ability to bring in virtual reality, artificial reality, AI, there's a lot of big data involved, et cetera, et cetera. So imaging technologies, new mapping technologies, et cetera. So how do you foresee those all coming together? And what role can the robotic systems play there? Maybe I'll start and then you guys have actually played a role. Actually clinically you've done these integrations, you've used them, so it'd be great to get your feeling. I guess I have less of the clinical background, but got the awareness that yes, there is this huge amount of innovation. You cannot expect stereotaxis to be the innovator on every front and things, right? The beauty of a modern, sophisticated society is you have many smart people each pushing in their own way. And when you look at societies, when you look at technology ecosystems, generally open ecosystems are by far the most successful. They drive the most competition, the most innovation, they drive down cost. Those are good societies, good environments are the ones where you have the freedom of competition and that openness. And so we built an API that allowed our robot to communicate relatively openly with a different diagnostic, different other kind of imaging and mapping technologies. We're grateful that we have kind of some both innovative smaller companies and last year we had kind of the big announcement was obviously with Abbott being able to integrate with Insight and so that was kind of, that starts to build out this ecosystem where you have integration and our key goal was again just generally you want to use the robot and you want to be able to pair it with the diagnostic information that Insight X gives you or that another mapping system gives you, fantastic. If you want to try it with the innovative work that Vector or ADAS 3D is doing, fantastic. And if you look at what Intuitive has done, to some extent a robot plays, because of what it is, it plays at the end of the day this kind of hub in a hospital, in a room, in an operating room where you do, you're putting the physician in a cockpit, you're trying to present all the procedural information, all the patient information to them in the most intuitive fashion and so it has to play that role of kind of the hub where you want to aggregate all the information, present it in the right way and allow the physicians to use then the robot and the information that they have out of it in the best way possible to do a procedure. So the catheter movement at the end by the robotic system is just the final actuation of all of that, right? So there's been so much focus on the robot, but it's all that goes into it. Go ahead, guys. Yeah, I would say that the lack of integration of all of these moving parts, I mean, I can't tell you how many times I spent in an EP lab trying to troubleshoot why this thing isn't working with this thing instead of being able to actually do patient care. And so I think the pivot beyond, and the answer to the question is that we needed people like ourselves who are KOLs for many of these companies going in and say, I'm not happy that I can't use this technology with this technology. And I think that most companies have acknowledged they can't do all of it. There's not one EP lab where there's one company that has every single piece of that puzzle. Because the technology keeps changing, you know, we mentioned PFA, we mentioned new mapping catheters, new in everything. As it keeps changing, if we can't use and work nicely in the sandbox together, it's not going to work. And I think that was part of the problem is that we essentially had some other companies that said, well, we don't want to work together. And because that didn't happen, we weren't able to push the field forward. And so I think now we're starting to move in that direction, and we're starting to find that we're having people talk to each other that traditionally did not talk to each other from a company standpoint. But when you have physicians saying, well, I'm going to stop using your company if you don't have the ability to work with other companies so that we can do better for what we're doing. Because it's an extremely complicated process. Doing an ablation is not just a robotic system. That's only very one small piece of the puzzle, to be honest. And there's so many things from the beginning to the end in terms of our ability to care for these patients. And so I think it gets overwhelming because of the amount of new technology that we have in our field and how it keeps changing every year as something different. I'm not doing the procedure the same almost now from like a couple monthly basis, let alone yearly basis. So as Dave Cowens told me years ago, Ben, if you're not comfortable with change, you are going to be a dinosaur in this field very quickly. And I think anyone who wants to partner with us in electrophysiology has to be comfortable with change, has to be comfortable knowing that it's not going to be the same. And as long as you keep adapting to the changes that occur, we'll do well. And I think we've done a good job of that recently. And I want to just continue to echo that. But yeah, I go to other companies and I beat them up if you're not working with us to be able to get us to this result. And that's the way that we affect change. Yeah, I think that integration piece is incredibly vital to future EP, robotic EP, because the robot is a master at catheter navigation. There's no doubt. We have 150,000 cases now, 500 plus publications. That's undoubtedly an incredible way to move a catheter around safely and effectively. I think that is without debate in my mind. But the integration piece is what's going to be the exciting next steps. If the robot can be the centerpiece of this future digital interface with everything else, image integration, AI, machine learning to essentially collect this complex data, tell us the areas of most likely arrhythmia origin, integrate an automation piece, which takes us there and essentially just needs the human oversight to deliver the energy, and then integrating it with new energies, again, the integration with PFA, the integration with the next step in ablation technology. All of that is vital to realizing our vision in the years to come. I kind of create a fantasy procedure of the future, and I think this is where it's so exciting that the pieces are coming together. This concept, for instance, and knowing that atrial fibrillation is such a key part of the marketplace, and as well-adapted as this has been in particular ablations, that's still key. But if you, for a minute, imagine what it would look like to have a patient come in to an inventory surgical center, have a single radial artery access with a retrograde aortic pulmonary vein isolation performed in an automated fashion, with that automation based upon three-dimensional mapping in real time, along with integration of imaging that comes from some of our partners, with targeting of the important sites within that anatomy by our ad partners, with aid in the navigation through augmented reality, you put all these pieces together, and all of a sudden, we have human error-free, efficient, highly effective, highly safe, and these pieces are all present in this room, okay? This is not imaginary anymore. The key is how do we begin to put all this together? That's something that SCRN has obviously done great over the last few years, and maybe HRX actually could be a great partner in this effort, almost. If you remember, it's exactly about five years ago at HRS where we presented the Open Mapping API and came out with this hashtag, Open EP, with the idea of how do you push a field that is very siloed and where technologies are very kind of in their own gated walls and closed, how do you push things towards a more open environment? SCRN did fantastic, and you personally and your colleagues did fantastic in kind of explaining why that's valuable to some of the other companies in the field, and I think kind of Abbott always had an interest in open environments, but they also actually kind of leveraged this idea of an Open Mapping API, created their own LiveSync, which was also kind of an API that kind of could standardize communication with the outside world, so it was kind of fantastic to see a larger company take that step. I think that if we do get generally, if you look at certain areas of medicine, for example, in the diabetes space, that was the best example always in my mind, the FDA and the societies largely pushed and kind of encouraged in a strong way industry to create APIs so that pumps and CGMs could communicate together in standardized ways and to make that much, much easier. Integration isn't necessarily always easy because you have to maintain compatibility with different versions. I mean, there's technical, when you're trying to build complex devices that have to be extremely safe, we're talking about patients that are relying on these devices, it isn't super easy necessarily to build integrations between many different systems, but when you create kind of standard protocols, and that does make it much, much easier, and it allows you to kind of to scale integrations, and so in that field of medicine, it actually has worked beautifully to the benefit of patients, and you have even the initial things of closed loop systems where CGMs are guiding the pumps in how to titrate their delivery of insulin. I think that EP, if you want to see what would be successful for many of the smaller companies here in terms of being allowed, able to benefit from all the data that's in the lab and being able to benefit from the pairing of data from this system with that system, probably having a master open mapping, or an open API, open EP API, that would probably be kind of the most impactful thing for medicine in terms of information sharing and allowing us to benefit from the data, and that could be something, I know SCRN has promoted and pushed it as a society, it could be something that HRX would be kind of ideal to try to get behind. I will say from talking to patients about convincing them to have this procedure done and come up to me in Philadelphia, sort of the top two things when I mention it to them, the use of AI and use of AI mapping systems that have integrated hundreds of thousands of data points to help tailor the procedure to that specific patient, and robotics. When patients hear about robotics, I will honestly say that they are like, oh, that's really interesting that you're using something that is modern technology, and I think as we continue to integrate those things, the patients are going to drive the market, too. They learn about this stuff. They're very savvy. They're coming to me directly talking about PFA. I didn't even know that they knew what that was. They're talking to me about these new technologies sometimes before I even know about them, and so I think that the way of the world now is that people can research much more than they have before, so I think it's incumbent upon us to be able to do that as well. Yeah. That's an excellent point. I think if we return to the intuitive surgical example in the context of, like, patient-driving, you know, demand of these technologies, you know, recall that timeline. So 1997, the first da Vinci robot-guided procedure was done for minimally invasive surgery, and more than a decade goes by, 15 years later, and only 1% to 2% of all surgeries are done with a robot, and then they found that killer application, right? They found radical prostatectomy, and very quickly, in a matter of years, it went from no use to essentially 90-plus percent use. Why? Was it better? Were the long-term outcomes improved by using the robot for radical prostatectomy? Absolutely not. The data actually says long-term outcomes are equivalent in terms of urologic and sexual health function in the years after radical prostatectomy, whether you use a da Vinci or do it old-school manual. But what is the difference? The incisions are smaller, the pain is less, there's some less UTIs early on, maybe some less bladder neck contractions that require some early care, and those are the things that the patient cares about, you know. They want the small incisions. They want less pain, especially when we're dealing with an area like that, where there's a lot of fear about going into that surgery, and the patients demanded it, and now hospitals have absolutely no qualms about dropping 1, 1.5 million on a da Vinci robot or two or three or four in their hospital system, because the patients are demanding it, and if they don't offer it, they're going to go elsewhere. And so, yeah, that brings us back to something like this, you know, where do we find that killer application? Because we're in that middle ground kind of when Intuitive was in that less than 5% usage. How do we take that next step? How do we find that killer application? I'd love to hear what everyone thinks might be that killer application, and maybe it's not an EP application. We just talked about it being a PVC machine. I wish that was the common sentiment, because that's when I love to use it. PVC, you know, complex navigation of catheters integrated with some type of noninvasive imaging to show us where to go, throw in automation as things develop. That's a very exciting thing for me, but the market for PVC ablation is not a huge one like AFib or something else. You know, what other killer applications do you think will be on the horizon? And that allows me to bring in maybe a question from the audience, actually, because it kind of comes on the tail, and I think it's geared more towards eventual automation as well. So the question is, you know, what in more detail would it take from a mapping system and from catheter perspective, and I think the robotic system perspective, to actually bring along robotic catheter movement in that sort of way? You know, really right now, and same thing with DaVinci, honestly, this is robotic-assisted work, okay? We're still driving the robot ourselves, right? So, you know, take that next leap forward, you know, what would it really take as far as those systems to bring about automation? And how important is automation? Is catheter assist, I mean, is robotic assist enough, or is automation the actual goal? Yeah, it's a good question. Just to comment on, you know, what Dan said, I think it's really interesting you talk about DaVinci, and you talk about the clear safety improvement, or maybe not necessarily like the rubber, where we've proven a very clear safety improvement with robotic versus manual immobilization for EP, but still has not necessarily translated into more adoption. And if you talk to patients about it, obviously they would want the safer version, but we don't. We don't necessarily do that. I just think it's interesting in terms of a correlate. So, you know, in terms of automation, to answer your question, I think that pulmonary vein isolation is by far the most, at least in my opinion, automatedly easy procedure, right? We're kind of drawing circles. I turn my brain off a lot of times when we're doing PVI, because it's really just moving the catheter to the next spot kind of thing. So from my mind, combining that with something like pulse field ablation and combining that with, you know, continuous feedback from the system, to me, would be a very easy concept. I think we have some version of it, but it's not perfect yet, and I think that we can certainly drive that. I also think that some EPs are concerned that we may be out of a job if we let the robots take over, right? Like the Terminator. Don't worry. It's way too far in the future. You don't have to worry about that. I agree. But I think that a lot of folks, you know, it's sort of a similar correlate that people are concerned with all of these new AI mapping algorithms that we have that tell us where to go for something. We think we're smarter than everyone else, and we want to make sure that we are the only person that can tell you where to go to ablate the arrhythmia. Your computer cannot tell me better than I can do it. I think that, unfortunately, that bravado is the same reason that people think that their hands are better than a robot. So, you know, I think my hands should be framed and put in the Smithsonian later. But later, I can still say that the robotic catheter can do it as good or better than me. I had, you know, we were doing multiple cases. We were talking about PVCs. I had two PVC cases two days ago, and my partner was using the robotics lab, so I was nice and played nice and sandboxed and did it manually. I mean, we got it, but it was a struggle. I mean, those are areas of the heart that were very difficult to get to, and that's Someone who's been doing this for years with, you know, I'm very biased in terms of very good training, still difficult. I mean, I think that there's humility in our field in which there are certain parts of the heart that are just difficult to get to. There are certain parts that are just not easy to do safely, and then robotics clearly has been proven to be safer and more effective in those patients. But in answer to your question, I think that automation has a role, certainly. I don't think it has to be complete, but I think it could be helpful in terms of a massive amount of volume of patients that, you know, we're talking about AFib, where it's just going to continue to skyrocket, and we have to get these patients in quicker, do the procedures faster, safer. You mentioned ASCs, not doing them in hospitals, all of this, you know, the field is evolving to the point where we have to do more cases effectively, safely, and get them out of the hospital or not even in the hospital at all. That's where I think robotics could also be, you know, very much a player. Yeah, I think in general, we're, you know, for whatever reason, our, you know, as EPs, we're kind of glutton for punishment. We take pride in these long procedures and, you know, going after eight different VTs in a single case. Someone yesterday said that, you know, doctors get tired, AI does not get tired, right? And I can imagine how, you know, how important over the course of a challenging case, you know, something that doesn't have the human flaws of fatigue and, you know, something like, you know, automation and AI where you essentially can be guided to an arrhythmia location, the appropriate, you know, ablation application can be planned by something without human flaws would be very attractive with human oversight. And so, yeah, I think it's very important, you know, like David said, if you're not innovating and taking those next steps while we're trying to do what we do well at the core level of the robotics, I think you're missing great opportunities. So, yeah, the future in years, not decades, needs to include automation, needs to include automatic arrhythmia detection and guidance in order for this to be an application that can be applied everywhere across skill levels, across the planet, no matter where you are, this, you know, could improve care. And David, how are we going to do that if I have to buy a $2 million system, have a million dollar lab build with MRI safe walls, et cetera, et cetera? Is that what we're stuck with going forward or what's next? So, I definitely want to give a little bit of context on the automation topic. And on the thing of just accessibility of a robot, you're correct. I think that the price point of a robot has been set to some extent by the DaVinci system and by the other robots out there that are widely, widely adopted. And the cost of generally running a sophisticated EP lab or a sophisticated operating room is relatively high where the robot itself, that's not the barrier to adoption. I think the barrier is the complexity of gaining a system. And that's where the newest robot that we just got CMARC for, hopefully we'll have FDA by the end of the year, kind of allows you to see a type of environment where you can get a robot into a traditional cath lab without any construction, without any changes. Yeah. Would you like to just describe that a little bit more? I'm not sure that the folks in the audience are as aware of that. Sure. So up until now, establishing a robotic EP lab with our technology has required shielding of the walls for magnetic shielding, reinforcement of the floor, special power requirements. There's just a process to make a lab ready to accommodate our robot. We have been working very hard, as I mentioned, kind of one of the four pillars of our innovation effort has been how do you make robotics broadly accessible? So we just announced three weeks ago, roughly three weeks ago, I think, a CEMARC receipt for a new robot we call Genesis X, going after the HRX brand. And that system does not require reinforcement of the floor, does not require shielding. It has built in magnetic shielding into the system, so you don't need to, what normally gets constructed in the walls is within the system itself, uses normal power outlets. So the same thing that you would use to power this, can power the full robot, and has a cabinet that fits under the table. So just generally, you're making it something that you can envision in the near term. Next year, you know, after FDA approval and with the catheter approved, coming in on the weekend, installing it in a typical cath lab, if in two years from then, the hospital doesn't want the robot anymore, taking it out without any lasting impact on the lab. And that starts to kind of take you away from this construction world to more a placement world. And how's the work integrating with different x-ray systems, different mapping systems, potentially moving outside the EP realm, is gonna be more flexible than we've seen in the past? Because I think that lack of flexibility has been. That's exactly, the goal is flexibility, right? And kind of ease of access, and you wanna try it, right? Allowing lease models, other types of models, because when you don't have to go through years long planning, architects, contractors, permitting process that allows you to just, it gives a lot more freedom of use, right? Maybe on the automation side, maybe a little bit of context would be helpful. There's about now 9,000 da Vinci systems in the world, right, treating almost, I think, two million patients a year. There's several thousand, I don't know, probably 3,000, 4,000 orthopedic robots out there in the world being used clinically, right? So it's order, literally almost couple orders of, couple orders of magnitude more than what we have in EP. If you look at all of the usage of robots, even in these fields, with all of the widespread adoption, robots are adopted for their mechanistic benefits, precision, stability, safety, right? The same reasons you use it, reach of the catheter, but in those fields, that kind of really precision, stability, safety, those are the mechanistic benefits, the physician benefit of being seated, kind of in a more comforting environment, a more comfortable environment that allows them to focus on the procedure. Those are kind of the reasons it gets adopted. If you look out over the next, and that's 20 years now of adoption with amazing, amazing overall kind of penetration in some of the markets. If you look out over the next 20 years, and I'm kind of putting it in that framework because I think you do have to look in relatively longer frameworks, in a decade-like framework, probably the big, big thrust is going to be this concept of not just the mechanistic benefits, but how do you add cognitive benefits to the robot? And when we think about that, we do think automation is one of those, but I think about four real kind of tangible things that we can push forward to add a cognitive value to the robot, and we're not alone in this, right? Intuitive Surgical is doing very, very similar things. Striker with the Mako system is doing very, very similar things. The four that kind of we have in mind are information integration. So how do we take as much information on that specific patient and present it to the physician intraoperatively in a way that allows you to make the right decisions for that patient? And that includes integrations with mapping systems like Insight, integrations with preoperative imaging systems with some of these AI systems, kind of how do you take all that information, how do you register it to each other, present it to the physician in the right way, and allow then kind of the right decision-making intraoperatively? A second big thing is, let's call it kind of a big data. How do you take all the data that's collected from thousands and thousands of procedures over time and glean insights out of that? That's a particularly tough thing because collecting data is easy, and many companies here talked about collecting data. The question is how do you gain insights out of data that are correct insights and not just, right, you can glean a lot of information out of data, but oftentimes cleaning data in the correct way and using it to actually gain real insights that are correct insights is difficult. But we do collect thousands and thousands of patients' worth of data by now, procedures' worth of data, not patient data, procedure data, that kind of does hold the promise to allow certain insights. The third one is automation, which kind of we discussed, and I think that on the automation side specifically, our focus has been on three thrusts because we have automation currently in our systems. Like you have automation of cars, you as practitioners are very, very good drivers, and so to make automation work as reliably, as rapidly as you can do personally is very tough, and that's the reason why even though we've had automation talked about in cars for over a decade now, practically I don't use automation, right? I have a Tesla, I don't use it, I drive myself, right? And so the things that kind of we've been working on to make automation much more reliable and rapid are focused on three main efforts. One was making the robot very responsive. When you have a slower robot that has latency, it just means that obviously it's like trying to redirect the steering wheel, but with a second latency, you're never going to have great automation. So that kind of I think we've overall done very well with the Genesis, Genesis X robot in kind of cutting latency down to where it's real time. And the second big thrust has been the interventional device itself has to be a very well-navigated interventional device. All of our experience in EP to date has been with the first generation ablation catheter. I mean, it is, I think you mentioned in the beginning, it is absurd that all of our experience to date is with a catheter that is now 18 years old. It was the first generation robotically steered catheter. The fact that the clinical data is so good and that you're still using it and able to use it well for patients is a testament to the magnetic mechanism of action, but it is absurd. And I think our new catheter that is awaiting approval smooths out the behavior of the catheter in different approaches. It gives you consistent forces irrespective of how you approach tissue in a way that allows automation to be much better. And then the most interesting, toughest part to make automation real is how do you move from an algorithmic approach to automation to a machine learning approach from automation? There's much more we can discuss there, but that's kind of, it relies, you have to think about how do you store data, how do you allow access pinging of data, and then how do you kind of score approaches and how do you then allow a machine learning to kind of take that database, the scoring mechanism, and kind of learn from itself to actually kind of build greater, better automation capabilities. Yeah, it occurs to me the conversation keeps circling back to this concept of integration of data sources from everywhere. And one of the audience members actually brings up an interesting concept that I hadn't really thought too much about, which is this idea of how do we really move forward this open EP ecosystem, you know, they mentioned Open Sandbox, but that open EP ecosystem. Should we actually look or expect there to be some overarching or outside organizations that might help drive this forward in the field at large? Organizations like the Medical Device Innovation Consortium, or even, frankly, the FDA, right? To say that if we're going to approve new devices, new tools, that they should actually have some sort of basis in an open platform that can work with each other. So, you know, or does it have to keep going organically, which is sort of what's happening now, where, again, we have several to break strategics, their immediate, you know, missions and finances, point towards a more closed ecosystem, right? And so, you know, how do we combat that, and do you think there's a role for some large organizations in driving that forward? Yeah, I mean, I think that would be a wonderful concept, right, you go around this room right now and you can see each company has something very unique to patient care, that provides something really wonderful that we can use for each of our patients, but it is impossible, currently, to integrate all of those things into one system. And so that, to me, is, as I had said before, disappointing. We need to be able to do that, and we've tried to do it organically, we've tried to go, in each one of us, as an individual physician, or even as an individual society, gone and said, we really need you to work with you so that we can actually do this properly, because if you do integrate all of these things together, you'll have a wonderful outcome, and, you know, a safe procedure, a quicker procedure, a better procedure, but we still haven't got there yet, and we're still really operating in silos, and that's a big part of medicine, to be honest, and a lot of medicine is siloed in every way that we practice from the very beginning, and it's very frustrating, to be honest. But the concept of having some sort of governing body say, no, in order for you to get FDA approval for your system, or for your technology, it has to be able to integrate with XYZ to some discretion, is, I think, fascinating, and would be wonderful, and, of course, I'm sure that folks at HRX or HRS, SCRN, would support it, because it's for the betterment of our patients. But you had said there's a lot of conflicting forces, right, there's finances involved with all these companies, and making sure that you sell what you need to sell, and, you know, continue to keep the lights on, so to speak, and so I think these are all mitigating forces, but I think the more voices that are standing up on platforms like this saying it's important is part of the picture. Yeah, I think it's tough. I think, you know, right now, my gut feeling is it's gonna be a big challenge to have that be the state that takes us to the next level. I think, unfortunately, it's gonna be the competition, and until the major players turn their eyes towards robotics, and whether it be through internal development or acquisition, you know, really drives everything forward, it's gonna be a challenge. You know, for a company like Stereotaxis, they've done an amazing job at keeping an open ecosystem, wanting to integrate with Abbott, with Volta Medical, you know, with Vivo, you know, all of those things are the elements that are gonna, you know, be part of the ultimate successful product, but I worry that the market forces are not pushing towards this multi-company integration at this time. I think it's gonna be a little bit of a slog, you know, for the next, you know, five-plus years, and, you know, hopefully, you know, we reach that inflection point where everyone's driven. They have to, you know, invest and focus on it, and hopefully it creates an environment where that integration is in everyone's interest, but right now it doesn't feel that way. You know, it's interesting, too. I think people think about the robotic system, and they think about the robot, right, and Catherine Movement, but, you know, an interesting part of the company, and, again, I do wish there were other companies who were doing this as well, is actually, you know, what was the Odyssey system and is now the Synchronicity Sync system. There's a whole nother part of the company that's entirely focused on breaking down these silos, and, again, the concept of silos, I think, is super important, whether we talk about the siloing of data, whether we talk about the geographical siloing that we all work in our own individual labs, and, you know, we have been, you know, we only have limited time, but scratching the surface of telemedicine, the ability to train folks from afar, to treat patients from afar, you know, the capabilities, the technology's been there. You know, the first case was done that way by Poponi from the podium in Boston on a patient in Italy over 15 years ago, right? Not to mention a case we showcased last year at SCRN where a patient was treated in Shanghai from the podium in Washington, D.C., where the information went to Shanghai, came back to Washington, D.C., using the hotel's free Wi-Fi with less than half a second latency, okay? So, I mean, you know, the technology's there, it's all the rest, and breaking down these silos. So, I do think that as we look toward the EP Lab of the future and breaking down all those silos, where it's information silos, geographical silos, interpersonal relationships between providers, silos, do you wanna talk more about the non-catheter movement aspects of what can be offered in this way? Sure, so I guess maybe kind of going back to this concept that when you're the physician operating on using the robot, you're, to some extent, in the cockpit, you're the pilot of the procedure, and understood fairly early on that just giving you control of just the robot was limiting, and it would be helpful to aggregate all of the procedural information, even those that are not integrated, per se, with us, but to aggregate all the procedural information on one large display in front of you, that you could have full control over every disparate input in the lab with your own mouse and keyboard, and that's kind of, there's a value proposition to that that makes the robotic experience much better, and so that's what kind of led to Odyssey at the time. Odyssey was the first generation product we, as you mentioned, we just completed development of the second generation, which is called Synchrony. Just for the audience who don't know, this is a large flat panel display that sits in your lab, but it's unique. This is not just, like everybody has their displays which show all the information, but here you actually have individual mouse control over each panel in its native system, okay, and that can be done from anywhere, so again, just to explain what that means to folks who might not be familiar, go ahead. We digitize each of the streams coming in, so without, let's say, the ultrasound system, the ECG, the recording system, the mapping system, if it's not integrated, or whether it's integrated or not integrated with us, ice imaging, kind of every disparate system in the lab, we can digitize their video streams, display it on our large integrated display, and also kind of tease off, you know, split off the mouse keyboard control so that the native monitor, native mouse keyboard isn't interrupted at all, but on this now aggregate screen, you can kind of control everything, you can move everything around, same way you would do on a Windows computer. You can resize, move it, do everything that you would want. When you take all the procedural information on one large screen, and everything's now synchronized, to some extent, you're able to see everything that's happening in the lab at the same time right there, and so the whole concept of telemedicine becomes now much more viable, right? Now all you need is the audio connection, a video connection, and sharing that native screen with high fidelity, low latency with outside world, and you can sit not just five meters away from your patient, but 5,000 miles away from your patient, and you can still kind of see everything that's going on in the lab with real time. So we've had that technology for sometimes, we've used it for remote clinical support, remote technical support. We, in the latest kind of technology implementation of it, we did it as a cloud-based, a secure, HIPAA-compliant cloud-based solution. There was a lot of work on how do you maintain high fidelity, right? 4K, large screen image, how do you maintain the high fidelity and have low latency without some of the tricks, let's say, when you do a Netflix stream, right? There's all sorts of tricks for how to transmit video images, you don't want to have, you don't want to play tricks that could lead to the recording, the ECG lines not being clear, right? You need to kind of maintain high fidelity, low latency. We accomplished that in the SYNC system, where, I mean, it depends on obviously your distance, but really something like, you know, point two seconds, point something latency, you maintain the high fidelity images, and you can see every line of recording system, and you can be remote, and that starts to kind of bring in this concept of taking a physician. Right now, when you're in a lab, you have only yourself, your nurses, your techs, your industry support that happens to be there. Maybe you can stick your head in the hallway and shout to a colleague, but you don't have anyone else. How do you kind of make it a... Yeah, it's all about breaking down silos. Absolutely, absolutely. We're down to our last couple of minutes, so I'd like to kind of go down the panel, and I think it's an opportunity for each of the physicians to tell our industry partners in one minute, you know, what key things do you want to see going forward in this next couple of years to make this leap, okay? And then from David, what are you going to do to provide those? Go ahead. Sure, so, David, I would like to walk in a room, put catheters up, have the robot essentially map the arrhythmia, tell me where to go, semi-autonomously go to that area, and ask for my permission to come on ablation. I want the robot to be watching the entire case and writing a report for me so that by the time the case is done, I just have to sign it, okay? That's my pie-in-the-sky goal. You know, beyond that, like I said- Designer and overseer of the procedure, not the executor. That's right, I'm fine, I've done enough of these six-hour ablations, I'm good. No, in general, I think, like I said at the beginning, you know, I think that, you know, there is no doubt in any of our minds that robotics is going to be a big part of the future EP lab. We have the data, we have the experience, we know best practices with current technology. You know, I'm incredibly optimistic about the timeline because of, you know, the current market forces that are favorable to robotic solutions in the surgical space spilling over to our space. I'm excited about the innovation that's in the pipeline in our space, and I'm really anticipating this inflection point, but yes, I'm looking for the pie-in-the-sky, too. Yeah, so, you know, I'll belabor the point that, you know, we talked about the improvements that we need in our own robotic technology, right, that we need in the catheter, that we need in the robot, that we're moving in that direction, the ability to do pulse field ablation, multipolar mapping robotically, which we don't currently have. That being said, we need the other players in the space to more properly integrate with this system to do it better. We need our x-ray companies, our ice companies, our mapping companies, our AI algorithm companies, all of these pieces to be able to integrate so that we can actually do this procedure the best way possible, and that's not a dig at Stereotaxis, that's a dig at the rest of the companies, and I want to see better partnership that comes across, and I've said this multiple times when I've met with each of these companies, is what is the hurdle to us getting to the next step, and it's that communication, right, talking to each other, understanding that the only way we can do this better is if we all work together in that space, and I think if we can continue to innovate on the robotic side, which we are working on, and I think it's the best it's been since I've been in this field, but also to allow the integration from all the other new technologies that are in this conference right now. David, last word. I'm in to both, and I'm fully aligned with both of your visions. Well, Dave, as you come to last seconds, that's exactly it. This is all about integration, breaking down the silos, putting everything together. We can't keep being a couple years behind, steps-wise, right, we have to be at the forefront with everything that goes on, and we really appreciate the opportunity of all the folks here in joining this conversation. Again, as we finish, much thanks to HRX. We feel very much at home here. This is a very natural synergy, and we look forward to much more in the future as far as bringing all this together. So thank you for your attention and your participation, and happy to talk afterwards, anytime. Thank you, guys. Thanks, everybody.

Pete Weiss

Society for Cardiac Robotic Navigation

SCRN

robotic electrophysiology

Heart Rhythm Society

technological adoption

Genesis X

telemedicine

data integration