Stereotaxis, Inc. (STXS) Earnings Call Transcript & Summary

Welcome to the Stereotaxis Innovation Day, Pioneering Endovascular Robotics. We are very happy to have so many of you online and to be able to share with you our progress and technology. We expect this event to last approximately 2 hours during which the first hour will be dedicated to a presentation by Stereotaxis' CEO and several members of our R&D leadership team, followed by a second hour dedicated to questions. Today's presentation is for informational purposes only. It is designed to provide a view into Stereotaxis innovation strategy and pipeline, and it is not designed to market any specific product. The presentation and Q&A section that follows also includes various forward-looking statements. Such statements involve risks and uncertainties that may cause actual performance in the future to be materially different. These risks are described in our public filings with the Securities and Exchange Commission. This presentation is also not an offer to sell or the solicitation of an offer to buy any securities. [Operator Instructions] You will also be able to use the Zoom control panel to write questions or remarks that you would like to be discussed in front of the audience. Our moderators will ask these questions to the presenter at an appropriate time. [Operator Instructions] Today's presentation is being recorded. Please note that making your own recordings or screen captures during this event is prohibited. Should you drop off from the event, you can always get back in using the same link. It is now time to welcome and introduce you to David Fischel, Stereotaxis' CEO and Chairman. David?

Good afternoon. Thank you, everyone, for joining us today. We're excited to host you for Stereotaxis' first Innovation Day. Over the next hour, we look forward to sharing with you several of the key innovations that we have been energetically advancing, and that we are confident will be transformative, both to Stereotaxis as a company and to the trajectory of robotics in endovascular surgery. After the presentation, we'll leave a significant amount of time for Q&A. Before we start, it's important for me to clarify that this presentation is not meant to market any specific product, but rather it's an informational presentation meant to provide you with insights on Stereotaxis' strategic path forward and how we see our technology advancing over the coming years. There are risks to any projections, and our statements must be viewed in light of the safe harbor statements on the screen and our SEC filings. Before starting, I also want to thank the many individuals that make all of this progress possible. Our highly talented team at Stereotaxis works very hard to advance the frontiers of technology and patient care. The various external partners, we are proud to collaborate with our investors who have supported us and believed in our big mission and physicians and health care professionals that educate us and motivate us. It is all of you. your commitment, your partnership, your expertise and energy that make it possible for us to advance our grand vision. So what exactly is our vision? Let me provide you some context to everything we are doing. Endovascular surgery is a miracle of modern medicine. It has allowed us to treat a wide range of diseases in a minimally invasive fashion. It has reduced invasiveness and trauma of many surgeries, expanded access to therapy for millions of patients and enabled new therapies that otherwise would never exist. We can celebrate this tremendous progress in clinical care while simultaneously recognizing that the current approach to endovascular intervention is in several ways archaic. First, navigation is backwards, performing precision surgery at one end of a flexible device with only limited control of the other end, a few feet away, may work, but it is obviously not ideal. Precision, stability, control and ultimately, patient outcomes suffer. You don't write holding on to the pencil eraser. We shouldn't force physicians to do the same when a patient's health is on the line. Second, safety is lacking, both for the patient and for the physician. The first rule of medicine is to do no harm, and yet current endovascular surgery requires us to navigate rigid devices in the most delicate vascular anatomy. And unfortunately, that sometimes leads to tragic complications. In addition, physicians perform these procedures knowing that they place their own health and safety at risk by exposing themselves to thousands of hours of radiation over the course of their careers. And lastly, the entire experience in the operating room environment just feels archaic when viewed in the context of how so many other aspects of life are being transformed with data, connectivity, automation, machine/human collaboration and a transition from physical to cognitive effort. Physicians operate standing for hours, holding their body and hands in peculiar precise positions while exposed to radiation. They have to shout out instructions to others who can control what they can see or do, and they work in operating room silos largely isolated from any external support or data. It's still stuck in the 20th century. Stereotaxis' vision is to pioneer robotics across a broad range of endovascular surgeries, and by doing so to modernize the field, address these shortcomings and meaningfully improve care. You are all aware of our robotic technology. Robotic magnetic navigation is the only robotic approach to endovascular intervention that allows for direct distal control of an interventional device. And by doing so, it overcomes the navigation and safety issues I mentioned. The safety, efficacy and efficiency of the technology has been extensively validated in hundreds of clinical publications and in the real-world experience of hundreds of physicians treating over 130,000 patients. Beyond the mechanistic benefits of robotic magnetic navigation, we have demonstrated in just the most initial ways how our robotic technology serves as a necessary foundation for true digital surgery, where the benefits of data integration, automation, connectivity and artificial intelligence can be introduced to the operating room to improve care. Now that I've provided that context, let's get into it. Stereotaxis has been advancing a strategic innovation plan designed to take what is possible, and make it very tangible, relevant and impactful. We are advancing a wide range of innovations across multiple fronts with the focus and goals of these innovations remaining consistent with what we have presented previously. Today, we want to focus on 4 specific efforts that are particularly advanced, de-risked and impactful in the short to medium term. Collectively, these efforts enable us to have the big positive impact we know we are capable of in our beachhead market of electrophysiology and more broadly across endovascular intervention. At the simplest level, a core robotic offering requires a robot that can be adopted widely, a broad range of interventional devices that work with the robot and a foundation for digital surgery. So that's precisely what we will talk about today. First, robots, second and third, a robust family of devices in EP and in new endovascular indications. And fourth, operating room connectivity. We have a lot to discuss, and we're very excited to show what we've been up to, so let's get started. To discuss the first topic, robots, it's my pleasure to introduce Brian Kidd, Stereotaxis' R&D leader and Senior Director of Product Development. Brian?

Thank you, David, and it is a pleasure to be able to speak with everyone today. Two years ago, Stereotaxis made a leap forward in robotic technology with the launch of Genesis which represented the first significant redesign of robotic magnetic navigation since Niobe system was launched over 18 years ago. It substantially reduced system size and weight, created more space around the patient in the lab, improved procedure workflow and made the robot highly responsive to physician control. By combining Genesis with the Model S X-ray system, we made establishing a robotic lab more affordable and accessible. Accessibility is important. As David has often stated, the clinical data for robotic magnetic navigation is so strong that every hospital should have a system and every patient should have access to its benefits. But sometimes great things are not easily accessible, and then the positive impact they have on the world is muted. Genesis, like Niobe before it, has great clinical value but is unfortunately not an easy system for all to adopt from a construction and planning perspective. For some hospitals, the logistics required can be very challenging. As a fixed install with significant floor loading, architectural planning with structural analysis is needed for every installation. A hospital has to have the resources available to do this, and there are many hours of planning, meetings and design work required for each system. Not every room can accommodate the weight and size and in order to keep the magnetic fields contained in the lab, almost all labs require shielding along the walls, something that also requires planning and construction. The systems power draw require special electrical work, and conduits for cables must be installed and routed between the operating room, control room and a special equipment room where the robot's computers are housed in a fairly large cabinet. Now hospitals are obviously able to do this planning. It has been done successfully many times at all of our existing hospitals. And Stereotaxis has a team that helps them along the way, but it can be a significant burden, nonetheless. And this burden has other impacts on our customers and the adoption of the technology. The significant planning process creates a long extended sales cycle during which all key stakeholders must remain engaged and supportive. A robotic lab can only be established when new lab construction or renovation is being planned, giving us only a short window of opportunity to sell a system to any given customer. Because Niobe and Genesis are fixed installations, hospitals view them as long-term commitment and permanent upping the stakes of any purchasing decision. And the Genesis is a foundational technology that will support many years of growth for Stereotaxis, and it remains a core part of our strategy in electrophysiology and beyond. But the accessibility issues are real and incongruent with the future in which robotic magnetic navigation is standard of care across endovascular surgery in every hospital. Now we are pleased to present, for the first time, a new robot that combines the long-established benefits of robotic magnetic navigation and the speed and responsiveness of Genesis in a form factor that can be easily, rapidly and broadly adopted. The new system is semi-mobile and can be set up in any operating room over a weekend. It requires no meaningful structural or architectural analysis prior to placement, no laying of cable conduits, no complicated electrical work and no lab construction or shielding of lab walls. When the robot is parked, the magnetic fields are shielded within the base of the system itself, allowing the room to be used for any nonrobotic purpose with no modifications of the lab required. And just as easily as a system can be deployed, it can be removed with no lasting impact to the lab. A robotic system like this that overcomes the recognized logistics challenges has been a dream for the company since its establishment. It is now a very tangible reality. So how did we move from pipe dream to reality? From a 30,000-foot view, the solution was relatively simple. The advanced design of our next-generation magnetic ablation catheter includes more magna material and improves navigation performance allowing us to navigate very well in a magnetic field strength half that of previous models. This advancement in catheter technology, combined with key engineering improvements we made when designing Genesis, allows us to use smaller magnets in the robot. The system is fast, elegant and has a streamlined efficient workflow. We did not just build a smaller version of Genesis. We have pushed meaningful impact innovations across every aspect of the systems design. In Genesis, we miniaturized the electronics and distributed the controls between the cabinet and the back of the robot. With our new system, we have taken that further with fully distributed electronics that are efficient and tiny in comparison. We no longer have a separate cabinet that needs to sit in its own equipment room, but instead have a small enclosure that can be placed in the operating room or control room under a table. The system is powered using traditional energy outlets so that it can be installed into any existing lab without requiring special electrical work. The cable bundles have -- of the robots in the cabinet were shrunk to the point where no construction of conduits is needed, and the cables can be laid on any floor. We designed the system so that the robot [ sides ] that on the patient's right and left sides are identical instead of mirrored. This will greatly support high-volume manufacturing, improving inventory management, assembly, maintenance and cost. And on a similar topic, we expect to ship the system completely assembled, dramatically simplifying and reducing time required for on-site installation. We still have a lot of work ahead of us to get ready for commercial use, but the project is de-risked, and we expect to submit the system for regulatory approvals in Europe and the U.S. in late 2022, and to launch the system in the first half of 2023. It will work with our new ablation catheter as that receives regulatory approvals in various geographies. And it will also work with all future interventional devices we design for electrophysiology and other applications, which Nathan will speak about in the next presentation. This new system complements Genesis, which will remain a core part of our product portfolio with a higher power of magnetic field strength for hospitals that can accommodate the construction. But it is transformational for our strategy of making robotics broadly accessible to all patients, physicians and hospitals. I'm very excited to work on this project and the impact it can have. I could talk all day, but my colleagues have much more to share.

Thank you, Brian. As Brian mentioned, our new mobile robotic platform is strategically transformative for Stereotaxis and for the broad adoption of robotic magnetic navigation in electrophysiology and across endovascular interventions. This accessibility also facilitates and plays into 2 broader themes. The move of procedural medicine to outpatient surgical centers and the use of alternative pricing models to facilitate and accelerate adoption. On the first, we have long thought that the safety benefits of our technology could play a central role in facilitating the move of cardiac ablation from expensive hospital procedures to more cost-effective and broadly distributed outpatient surgical centers. That trend has positively impacted various other procedures in medicine, and it is the natural trend for cardiac ablation. It would broaden accessibility of the therapy and improve cost effectiveness, but has to date been hampered by the risk of manual procedures and need for hospital resources immediately available in the event of a major complication. Having an advanced robotic EP lab available in a box easy to establish anywhere along with the unmatched safety of our technology, makes Stereotaxis a key party in the movement of cardiac ablation to the outpatient setting in the coming years. On the second topic, a system that can easily be placed and removed facilitates alternative financing models. This innovation will enable us to offer customers alternative pricing and adoption models, including leasing of systems and placements of the systems with disposable purchase commitments, which should enable customers much more rapid access to the benefits of robotics without sacrificing the economic value of our differentiated technology. The development of the system is really a testament to our team. In the span of less than 5 years, we have developed 2 completely novel robotic systems with all the mechanical, electrical, software and magnetic aspects that entails. These are not demo systems but robust systems that live up to the daily rigor and expectations of the most discerning customers as Genesis has proven. To put this in context, Stereotaxis previously received regulatory approval for the Niobe system in 2003, almost 20 years ago, and only had iterative improvements on the core system until Genesis. Very large companies with resources and teams in order of magnitude larger than ours have taken over a decade to develop robotic systems. The speed, quality, attention to detail and ability to develop technology of this complexity and caliber is a core strength of Stereotaxis that will continue to serve us well as we continue to push the frontiers of robotic surgery. We have much more to share, so let's move on. A robot is a necessary foundation for everything we do, but alone it is insufficient. Successful robotic procedures depend on the interplay of our robots with magnetically navigable interventional devices. Here too, we are moving from a period of long-term spaces toward a vibrant, robust family of devices in electrophysiology and in new endovascular applications. To discuss these topics, it's my pleasure to introduce Nathan Kastelein, Stereotaxis' R&D leader and Senior Director of R&D and Advanced Concepts. Nathan?

Good evening, everyone. It's really a pleasure to be able to present to you today. Stereotaxis has amassed an immense body of scientific and real-world evidence in the field of electrophysiology. This is coupled with deep technological and clinical know-how and enthusiastic grassroots physician support. Our robotic technology has been used to treat over 130,000 patients suffering from cardiac arrhythmias. And we are very proud of the clinical data, which shows how dramatically the robot can improve patient safety, enhance outcome, and even enable therapy for some patients that would otherwise have no good treatment options. All of this clinical experience and all of this data has been generated with the original magnetic ablation catheter being offered by Biosense Webster. While the catheter's clinical performance stands up amazingly well compared to even the most modern manual ablation catheters, the catheter design by now is almost 15 years old, and innovation is overdue. The cardiac ablation field has also evolved with new energy sources and therapy approaches. Stereotaxis' strategy for developing interventional devices stands upon a guiding commitment to open ecosystems. We want the benefit of robotic magnetic navigation to be broadly combined with various therapeutic and diagnostic innovations. In order to best bring about this robust open ecosystem, we are taking responsibility for our own progress while simultaneously enabling the progress of others with an open hand for collaboration. We firmly believe that this philosophy of a nurturing open ecosystems is ultimately the best for patient care, for physician choice, for health care cost effectiveness and even for technological progress. In electrophysiology, we want to present to you today for the first time more fully, our novel robotically navigated radiofrequency ablation catheter, which is being developed in collaboration with Osypka. We will then discuss how this catheter is facilitating a subsequent wave of therapeutic catheters for a robust EP ecosystem including robotic pulsed field ablation, robotically navigated single-shot cryoablation systems and along with the potential for ablation and high-density mapping catheters. But more about those in a little bit. So let's start with our flagship catheter. It's a proprietary advanced RF catheter, we call MAGIC. MAGIC is short for Magnetic Interventional Ablation Catheter. The name reflects the magical way it can navigate using magnetic fields. There are several key design considerations with this catheter that we believe will enhance patient care and the physician's experience. Some of the more impactful design considerations are the following. First, MAGIC has a gold round tip design that is expected to have excellent ablation performance. Gold tips have been shown in multiple studies to be excellent conductors of RF energy and to maintain a more stable temperature profile with less risk of thrombus formation. A rounded tip, especially in a magnetic catheter is superior to a blunt tip. The rounded shape creates a constant surface area between the catheter and the tissue from any angle. These design considerations are important for RF energy delivery, but they're also particularly important when used with high-power, short-duration ablation. Irrigation is a standard in almost all modern ablation catheters. And the MAGIC catheter has a particularly sophisticated low-flow design. The current catheter in the field has 6 irrigation ports, and it can require up to 30 milliliters per minute of saline delivered to the tip during ablation. While this was state-of-the-art 15 years ago, more modern manual ablation catheters like the Biosense surround flow catheters require only 15 milliliters per minute at typical power settings from 30 to 50 watts. Irrigation is necessary to have a tip -- to prevent the tip from charring, but too much fluid can have a negative effect on the patient, particularly on patients who have renal issues. Since renal issues are fairly common with arrhythmia patients, we have regularly seen physicians having to balance the benefit of robotics against the risk of delivering double the amount of fluid. The MAGIC catheter has 25 small irrigation ports, and an elegant helical structure inside the tip that delivers the fluid equally to all the ports. With the excellent thermal characteristics of the gold tip, and given our bench and animal testing, we expect to pursue a label for a 10-milliliter per minute flow rate across all power settings. It is not just meant -- it's not just meeting the current standard of care for irrigation, but we're taking a leadership position. So contact force. Contact force catheters transformed the field of a manual ablation catheter several years ago. One of the benefits of robotically navigated catheters is that by design, they have very stable and constant force with the tissue even as the heart is beating. Unlike manual catheters the maximum contact force is set by the catheters design and the magnetic field. Since ablation is ultimately an electrical activity, it's not a mechanical one, the MAGIC catheter is designed to provide physicians with data on the quality of contact between the catheter and the tissue based on electrical data from the tip. This information is expected to improve the learning curve, procedure efficiency, physician confidence and make the catheter much easier to navigate. So over the years, we have become much smarter on how to design magnet placement, utilize materials such as plastics, tubings and coils, and exploit our computer simulation to optimize the catheter performance. And even though the current catheter in the field is capable of, absolutely amazing maneuvers, we have long been aware of ways that we can improve it. Certain moves today require various techniques to be learned to navigate the catheter and to be able to achieve optimal contact with certain areas of the heart tissue. This obviously doesn't negate the great clinical performance that has been documented with robotics to date, but it is a consequence of being a first-generation technology. And it does lead to a more challenging learning curve. So MAGIC has been described as what power steering was to cars, making the navigation much smoother, more capable and much more intuitive. We doubled the amount of magnet mass in the catheter tip, and we placed a string of small magnets along the shaft. We also optimized the plastics in a way that the transition from soft plastic at the distal end to more rigid plastics proximally takes place. The catheter has no discontinuities of motion, has much more consistent forces -- irrespective of the approach angle. And when navigating, it creates beautiful, rounded curves and rounded turns, including ones where the catheter can even touch its tail. We've been very pleased with the positive comments physicians have shared with us for navigating the catheter in phantoms and in animal studies. And we believe that this kind of performance will make MAGIC much more simple and much more pleasurable to drive. There are various other design considerations that we believe are beneficial from a thermocouple placed at the very tip to provide more timely, accurate temperature readings to the localization electrodes on the catheter shaft that allow mapping systems to visualize the proximal shaft. But I hope that these particular ones I've highlighted today show you the key ways that we're building a preeminent new foundation for robotic magnetic catheter design. We're currently ramping up our manufacturing of the catheter as part of our verification and validation testing, and we look forward to submitting this catheter for CE Mark an IDE clinical trial soon. But this catheter is expected to -- this catheter is expected to positively transform our commercial opportunities in electrophysiology and our clinical performance, but its development actually serves a much broader clinical strategy. We are full owners of this catheter and we have a detailed awareness of how the catheter [ is ] designed. So we can use this to facilitate a broader ecosystem of interventional devices that I spoke about previously. So using this core design of the MAGIC catheter, we are able to design other catheters that can be developed by ourselves or in collaboration with other partners. There are 3 EP catheters as part of this next wave that I would specifically like to highlight. First, Stereotaxis has begun a pulsed field ablation program. We have made a variant of our catheter called MAGIC PF. This catheter leverages the basic overall design of the MAGIC catheter with specific changes that render it particularly well suited for pulsed field energy. The catheter stability and the constant contact with the catheter walls, even in the beating heart, seem to be of high importance for pulsed field ablation.. And this is exactly where the Stereotaxis mechanism of action shines. We are very pleased to be collaborating with Acutus Medical to integrate the MAGIC PF with their advanced pulsed field generator. They've built a robust PFA team, and we are expecting to benefit from their experience and from the dozens of animal and human studies that they've conducted. MAGIC PF is also being designed to work compatibly with open-access PFA generators, which will provide additional physician choice. And we've had tangible work here as well. We've already performed initial bench and animal testing with MAGIC, and we're pleased with the results. We look forward to continuing to advance toward first-in-man with robotic pulsed field ablation cases, hopefully in about a year. The second is the single-shot ablation device to isolate the pulmonary veins. These have become a primary approach to treating paroxysmal atrial fibrillation. And many of our physician customers use the cryoballoon for simpler AF procedures and reserve robotics for more complicated procedures. They have suggested to us that robotic magnetic control of the distal tip of a single-shot device could actually improve the navigation and the orientation in the veins. We're excited to be working on a robotically navigated single-shot cryo catheter in partnership with a company -- a private company called AFreeze. AFreeze has developed, have an achieved CE Mark and commercialization with an elegant cryoablation device that's called CoolLoop. Working together, we have designed and made an initial prototype of a magnetically navigatable CoolLoop catheter. Assuming that the testing continues to move forward well, this catheter could be available in the European market by the end of 2023. And finally, one of the great benefits of our collaboration with the MicroPort EP in China is their experience and expertise in developing a broad range of EP ablation and diagnostic catheters. Since announcing our collaboration a few months ago, we have been working together on multiple fronts. The fruits of this collaboration are expected to lead to a series of magnetically driven catheters, including a range of ablation and diagnostic catheters that if successful in China, could be made available more broadly. So building this internal capability to advance a Class III therapeutic catheter is new for Stereotaxis. And we have significant work ahead of us to create this robust product ecosystem in robotic EP. But we are confident that this open strategy is fundamentally the right strategy for all of the stakeholders, and we are pleased to be advancing meaningful innovation on multiple fronts. And we're glad that we have found great partners in EP, like Osypka, Acutus, MicroPort, AFreeze and along with a few companies that we can't name yet. These companies share our vision and are helping to make this vision a reality. David?

Thank you, Nathan. The combination of highly accessible robots that can navigate a family of modern devices will allow Stereotaxis to positively transform the large and attractive field of electrophysiology. We're committed and focused on positively transforming EP, but we also recognize our technology has value beyond EP, and we have big aspirations. One of the key goals of today's Innovation Day is to transition Stereotaxis from being viewed narrowly as an electrophysiology robotics company to more broadly being seen as the pioneer and leader in endovascular robotics. As mentioned at the start of today's talk, endovascular surgery is ripe for modernization, and multiple endovascular procedures suffer from suboptimal efficacy, challenges and risk. Robotic magnetic navigation is an intrinsically powerful tool to overcome these challenges by allowing for robotic control of the distal tip of a device. And through that, allowing for navigation through complex anatomy, in an intuitive, rapid and safe fashion. To enable this type of progress, though, the right family of interventional devices is needed. We are advancing methodically in a thoughtful, strategic fashion and plan to do exactly that. Nathan, can you please continue and show what you've been doing more broadly in endovascular surgery.

Sure. Happy to do so. To understand our plan, it's important to explain how we think about unmet clinical needs, and a realistic approach to how to develop devices. These 2 are obviously closely interdependent and critical for a viable medically sound strategy. When looking at unmet clinical needs, we want to focus on large existing endovascular markets where we can provide a lot of clinical benefit. We want to focus on applications where there's complex vasculature that's difficult to navigate and where improving navigation could lead to results like better outcomes, improved safety, expanded access to therapy, more efficient procedures and reduced radiation exposure. So from a device perspective, Stereotaxis is still a small company, and we have to be prudent and focused. So our approach is to develop a small number of robotically navigated devices that are versatile and multipurpose. These magnetic devices are designed to enable and interoperate with a broad range of therapeutic devices. With that context, let me explain more specifically our clinical focus and the family of devices in development. There are 5 clinical indications that we have our sights on. The first should not come as a surprise to anyone. In neuro intervention, particularly in improving aspiration and mechanical thrombectomy for ischemic stroke patients and in the coiling of aneurysms to present -- prevent hemorrhagic stroke. Navigating through the brain's vasculature can be challenging. And for these therapies, reaching the required place quickly, safely and efficiently can mean all the difference between a successful recovery or tragedy. Physicians that we have spoken with have described both proximal challenges in accessing the arteries going up to the brain and the distal challenges navigating the tortuous vasculature higher up in the head. The second focus area is coronary angioplasty. In complex cardiac stenting, or balloon procedures, we believe that we can improve the speed, ease of access, and navigation in the coronary vasculature. Stereotaxis has experience of a few thousand procedures performed over a decade ago in this space. That experience gives us a lot of confidence in our plans, and we benefit today from that knowledge. The third is tumor embolization. The delivery of embolic agents to starve tumors of blood supply is an established therapy for hepatic cancer, other solid tumors, uterine fibroids and BPH. The challenge, however, with the embolization is that deploying the embolic agents too early in the branches of the vasculature, can damage healthy organ beyond just the tumor, but precisely targeting the more distal and multiple vessels leading to the tumor can just require an unrealistic amount of time and effort. So rapidly navigating to save locations to return to locations robotically and automatically would allow for a much more efficient and precise therapy. The fourth is peripheral artery disease, enabling angioplasty, stenting and atherectomy, particularly of clots in the lower limb, below the knee, where navigation can be really difficult. Our skill in navigating these small tortuous vessels safely and intuitively is a great benefit for these kinds of procedures. The fifth is abdominal aortic aneurysm. The repair of aortic aneurysms and guiding a wire over the iliac arch can be very challenging in these procedures, particularly in older patients where the vessels become very tortuous. Similarly, accessing the renal arteries can oftentimes require a significant amount of time and effort. And we believe our wires can make these maneuvers more efficient and more effective, and can enable therapy for some patients that otherwise have to have an open surgery. So addressing this broad range of clinical diseases with a relatively streamlined set of interventional devices, this strategy is both realistic and medically sound. It would not be realistic for us to develop therapeutic catheters like aspiration catheters or atherectomy devices or AAA graphs. That would be a complex effort well outside of our area of expertise, and it would require specialized devices for each and every therapy. Instead and in line with our open ecosystem philosophy, we want to work and interoperate with a broad range of catheters already developed by other companies and leverage our core experience in navigation to help those therapeutic catheters reach the desired location. To that end, we are developing a family of guidance devices, specifically guidewires and guide catheters. Our first family of guidance devices are magnetic microwires. The Pegasus micro guidewire is a 14,000th inch diameter wire with a tiny magnet at the tip. The wire can lead a path through the vasculature and easily bend and twist through multiple turns, the way no other wire can. Once it reaches the desired location, other manual catheters can be navigated to follow the wire. The wire will then come in a few distal configurations from more rigid to more soft so as to support the use in a wide range of vascular anatomies. We expect to file for both CE Mark and FDA 510(k) clearance for the first wire in this family in the second quarter of 2022, and to start commercializing in late 2022, with variants of the wire of varying rigidities to follow rapidly. The second family of guidance devices are microcatheters and guidecatheters. Leveraging our recent learning in the cathode design of MAGIC, we are able to make a magnetically navigated guide catheter that can cannulize vessels rapidly and efficiently and enable sheets, microcatheters and other devices to travel along the path that they've blazed. We expect to develop these devices and commercialize them later in 2023. Our magnetically robotic navigated guidewires and guidecatheters may be used alone or may be used together to enable a broad range of procedures, and we look forward to having them available so physicians across a whole range of clinical specialties can start to build clinical experience, refine the clinical value and define the best workflows. We've been fortunate to be able to work with several leading neurosurgeons and other physicians who have supported this work and have guided us in our efforts. We already have in Genesis in our next-gen system, initial software modules for vascular navigation that allow for efficient pathway planning and automated navigation, and we will continue to improve these software capabilities and think that automated navigation through complex vasculature will provide significant benefits in reducing the procedure time, complexity and in reducing radiation use. We expect our guidewires and guidecatheters to reduce the number and complexity of access devices that are otherwise currently being used in these procedures today. When taking into account the expected efficiency and outcome benefits that these products should be highly beneficial for health care systems. And as we build market awareness and penetration of robotics in these clinical specialties over the coming years, we look forward to expanding the family of robotically navigated devices for these diseases by collaborating with these other companies on versions of their therapeutic catheters. Thanks. David?

Thank you, Nathan. I know there has been anticipation and many questions on how Stereotaxis was going to address new endovascular applications. I hope our presentation helps clarify our strategy by describing a realistic family of interventional guidance devices, and the unmet clinical needs they are designed to address. The strategy is elegant, realistic and medically sound and combined with a robot that can be easily adopted, we believe will be transformative for the field. I know that this has already been a long discussion, but we have one more innovation to discuss. It's very different than what we have presented so far, but it is highly complementary to all we do. And I'm excited to invite John Platt, Senior Director of Project Management and Systems Software, to share it with you. John?

First, let me provide some context. When we use the term digital surgery, we're referring to adding information and intelligence to the operating room. Robots have been used so far across the spectrum of surgeries, primarily for their mechanistic benefits, enhancing the mechanical skills of surgeons to execute procedures successfully. But there are 2 big skills a surgeon has to have to operate effectively, mechanically using the tools at their disposal, and cognitively they need to understand the disease and design a procedure that best treats the patient. Both are critical, but if we look at the evolution of society, the trend is for us as humans to become more thinkers and designers versus just mechanics. Digital surgery is the introduction of improved information, insights, connectivity and intelligence to the surgical theater. As a field, we are just in the earliest phases of making digital surgery a reality, but robotics serves as a necessary foundational platform for full digital surgery. We are advancing digital surgery in multiple ways with improved integration of preoperative and interoperative patient-specific data presented intuitively to the physicians by developing automation algorithms, which allow physicians to design therapy and then direct the robot to perform those maneuvers, by collecting procedural data with the goal of ultimately harnessing artificial intelligence to better inform care, and by advancing operating room connectivity. Today, I want to talk about a very tangible new technology being developed for operating room connectivity. Operating rooms currently live as isolated silos. When physicians have a challenge, they must rely on the expertise and support that happens to be available physically next to them in the same room. The telecom revolution of the last decades have transformed all our lives with immediate access to a world of information and connection to our friends and colleagues irrespective of physical distance. It's archaic that the same access to information and communications is not available in the OR, and that reality hurts patient care and makes health care highly inefficient. A few examples of how increased connectivity could help are: improve technical and clinical support by industry whenever an issue emerges, and with the right network of support and expertise, not just the industry support person who happens to be in the room; collaboration between physicians and guidance for mentors during challenging procedures or key moments of a surgery, giving patients access to the world's best experts irrespective of geographical limitations; education and training of physicians on a new technology or new techniques in a highly efficient and real-world setting; and enabling remote procedures where patients in underserved communities can benefit from the best care rapidly when needed. Interconnecting operating rooms, while maintaining patient privacy and IT security would be a major advance for procedural medicine. We believe the operating room connectivity or collaborative surgery is a core value, not just in robotic labs, but all labs, and we believe that we are best positioned to make connected ORs a reality. We have this confidence because we have a head start. As part of our robotic technology, we previously developed a large integrated display, our Odyssey system, which aggregates the disparate procedural information in the operating room and allows a physician to seamlessly control the information using a single mouse and keyboard. Once all procedural information is aggregated on 1 screen, it's a small additional step to share it remotely. We have previously showcased how our existing connectivity solution enables secure remote support, remote collaboration and even remote long-distance procedures. But while Odyssey is already in use at over 100 hospitals globally, and has shown great performance in both robotic and nonrobotic labs, it does not easily facilitate broad adoption. The hardware of Odyssey is large with a 350-pound cabinet, almost 5 feet tall. Installation requires routing fit cable bundles, hundreds of feet between various systems in the operating room, control room and equipment rooms. Installation requires an operating room to be closed for over a week, and our cost of goods sold requires the device to be priced as a premium offering. The current connectivity solution requires manual software installs on a PC, manual administration of accounts and privileges, and significant maintenance. We have worked hard to achieve a solution that extends operating room connectivity across clinical specialties and makes it highly accessible, scalable and impactful. This solution enhances the value of our robotic ecosystem, but beyond that can be viewed as an entirely new and independent business venture incubated within Stereotaxis that looks to broadly pioneer operating room connectivity. I am proud to present Synchrony, our next-generation integrated display and Synx, a mobile and browser-based app for lab connectivity. Synchrony maintains and improves upon the core architectural elegance of Odyssey, but it is designed to be broadly adoptable. Instead of a 350-pound cabinet that must be stored in a special cabinet room, Synchrony uses more advanced electronics and fits in a tiny enclosure that would just be placed under a table. We no longer need to route cable bundles through ceilings and floors but instead only a few individual cables are needed to connect the equipment. Our system is able to automatically reconfigure itself as video sources are added and removed. All of this leads to a system that can easily be deployed into any existing operating room rapidly and cost-effectively. This leads me to Synx. While Synchrony will be sold as capital equipment whose core value is improving the lab environment, the long-term value of this platform is in building a network in a Software-as-a-Service business model with Synx. Synx is a modern app that allows for broad connectivity between Synchrony systems and users logged in through web browsers, Android and iOS devices. It's built to be scalable, secure and cloud-based. Synx is inspired by services like Zoom, LinkedIn and Uber, but with significant thought given to tailoring the experience for the operating room, ensuring privacy and security, while encouraging connectivity and collaboration. Synx will be available by invitation and referral to physicians and health care professionals at no charge, and we look forward to building a robust network of operating rooms with Synchrony and users using Synx. We have a pipeline of premium features planned that will allow for broader Software-as-a-Service business model from our installed base. We expect to start limited rollout of Synchrony and Synx at the end of 2022, and to commercialize the technology fully in 2023. Let me now hand it back to you, David.

Thank you very much, John. We are excited by the Synchrony, Synx project as it is highly synergistic with the robotic experience, but also opens us up to an entirely adjacent incremental opportunity beyond robotics. Synchrony and Synx will be included with every robotic system we sell, but we also expect to market the combined Synchrony and Synx technology to nonrobotic operating rooms across clinical specialties, using our own team, and potentially through strategic collaborations. Depending on the adoption trajectory of Synx, it may even warrant being spun out as a separate entity in the future. We've shared quite a lot over this past hour, and we'll have time to discuss everything further during Q&A. So I want to wrap things up with just a few closing comments. Stereotaxis may have a long history but we are just in the earliest innings of pioneering endovascular robotics. Over the past 4 years, we have made significant investment in advancing a robust, elegant and impactful innovation strategy. The strategy incorporates the maturity and realism of taking responsibility, and being self-sufficient with idealism that open ecosystems and broad collaboration is possible, and the right thing to pursue. Our innovations overturn and transform long-held assumptions on the abilities and limitations of robotic magnetic navigation. On the slide next to me is a summary of the innovation pipeline we discussed today. We have a clear path towards a near-term future with a highly accessible robot that can be adopted broadly and rapidly, a family in pipeline of catheters in electrophysiology interventional devices that broaden our clinical value to new endovascular indications beyond EP, and a leading platform for operating room connectivity. It's very exciting to stand at the cusp of reaping the benefits of this strategy. We still have significant work ahead of us to bring this bolus of innovations to market and then to prove them commercially, but it should be very clear how over the next 2 to 4 years, we should emerge as a very different company. Our evolution from being only electrophysiology-focused without our own catheter to more broadly pioneering into vascular robotics takes us from a total addressable market historically of approximately $2 billion to a steady-state addressable market of greater than $10 billion annually. This $10 billion TAM is in just the specific endovascular specialties we discussed today with just the product portfolio discussed on this call. This TAM does not include approximately $20 billion in upfront robotic system sales that would occur as endovascular labs transition to robotics. I want to thank again everyone who makes this progress possible. The fantastic Stereotaxis team, our many partners, our physicians and hospital customers and our investors. We will continue working hard to realize our grand mission of modernizing and improving health care by pioneering endovascular robotics. With that, let's move on to Q&A.

[Operator Instructions] If you prefer, you can also use the chat function in the Zoom control panel. Our moderator will pose your question on your behalf. We are giving you, our audience, a moment to submit your questions or raise your hand virtually before we go back to the Stereotaxis' team.

Welcome back. We look forward to taking your questions. I hope you enjoyed the last hour. I see that the first question comes from Josh Jennings, and so we should be able to open your line and hear you.

Congratulations on all the innovation progress and thanks for hosting this event, very informative. I wanted to start just on the next-generation robot, you detailed how to solve many of the challenges and accessibility including the alternate pricing that will be made available. I just wanted to better understand and should we be thinking about ASPs remaining consistent? Or are COGS coming down significantly because the magnet is smaller? Were you able to offer these alternate pricing models with this system? Or is it also just the timing of robotic catheter development where you'll be able to place some of these systems with disposable purchase commitments? Sorry for the long-winded first question. But just wanted to learn a little bit more about your pricing strategy for this next-generation robot.

Sure. So I'd call it the mobile robot because both the mobile robot and Genesis will continue to live together and be available for customers. And with the mobile robot really providing broad accessibility and an easier entry point to robotics while the Genesis system offering higher-powered magnetic fields. And so both will live together. And I think that the economic value of robotics broadly in the field of surgery has been fairly well established. We wouldn't expect any real economic difference between both systems. But the fact that the system can be easily placed and easily removed without an impact on the lab does allow you to be more creative in how you can deploy a mobile robot in ways that you couldn't be as creative with a fixed permanent install. So I think that's the type of creativity that I was looking to talk about and to kind of to convey during the prepared remarks.

Understood. And I'll throw one more in. There's a lot of angles to pursue here with so much -- with such a big download. But just wanted to follow up on the topic from the SCRN meeting. PFA -- it's some maximalist sort of thing significantly disrupted the rate of frequency catheter market. But just hearing at that conference about the potential important role that RMN could play with PFA procedures, most importantly being that the need for stability of the catheter, whether you need tissue contact or not. It seems like you need to really have stability of catheter in place when you're delivering the pulse frequency ablation. So I wanted to just hear some follow-up thoughts on that just really your outlook on -- outside of 1-year catheter development, outside of that, but just really RMN's role in PFA in the future and your vision there.

Sure. So maybe let me make 2 comments kind of around that topic and then also, Nathan, if you have anything you want to add.

Sure.

So 2 comments. One is that what you describe as stability and consistent contact with the beating heart being important, it's important for radio frequency ablation, but it seems to be particularly important for pulsed field ablation. And that has been -- that comment has been shared with us by multiple physicians and technologists in the field many of which have much more experience than us in pulsed field ablation and have really pioneered it over the last years. And so I think that kind of that does serve us well, and we for that feedback from companies that we have been working with on pulsed field ablation and from physicians in the field. So I hope and expect that we'll start to see that also in the clinical data as that accumulates. The second point I just wanted to make is that when we look at -- oftentimes, if I think about some of the previous earnings calls or the discussions with the investment community, oftentimes people think about our development of our own proprietary ablation catheter as kind of its own individual product. And when looking at it through that narrow lens, you lose focus again of the broader strategy behind a lot of our innovations. And you saw it, for example, with Genesis. The innovation of Genesis served as also a beautiful steppingstone in some ways to the development of a mobile system. And similarly, with the MAGIC catheter, while the MAGIC catheter has a lot of value and can have a significant positive impact on its own, the development of our own proprietary ablation catheter has helped seed multiple other projects, including the pulsed-field ablation catheter, including some of our collaborations like what we've said with them with A3s or with MicroPort and including even in some of the vascular navigation guide catheters. And so I think kind of viewing it in that context is helpful. And again, innovation has to be a continuous, consistent push forward. And I think you can see that we have much more below the surface than what necessarily gets shared at any given time. And then -- so there is that robust effort, and that's what allows us to also do things in pulsed field. I don't know if, Nathan, you have something else you'd like to add?

Right. I guess I'd just emphasize sort of the comment that was already made there. But certainly, the mechanism of action of the magnet system and the stability of the catheter with the magnetic field holding the catheter in a very stable position is really a very important part of pulsed-field energy delivery, because the energy delivery only takes a few seconds. And if the catheter is moving in a sliding or slipping manner due to the rigidity of the catheter, then over that few seconds, those high-energy pulses are distributed around the tissue and don't have the effect they're intended to. But if the catheter is stably positioned on the tissue, when that energy delivery takes place in those few seconds, the -- all of the energy is dumped into the same location. So it has the effect that's intended to. So it is a very unique aspect of the magnetic system's stability in this catheter. So -- and we've seen that kind of thing in our work so far.

I see kind of the next person with their hand up is Adam from Piper Jaffray -- Piper Sandler.

Congratulations on all the progress here and a great update. Certainly, a lot of exciting things in development. So wanted to start with the mobile robot that was discussed. The first question that I have is really what needs to happen from now until when you submit for approval in late 2022. Are you at a point where you have design lock? Maybe just talk through the level of confidence in the design and the performance of the system at this point in time.

Okay. So let me make also just a brief comment, and then Brian will continue. So we have a -- we very recently went through the development, testing, regulatory process for a significant robotic innovation in Genesis. And so we've all just lived through it. We've experienced it. We have a relatively good feel for how that type of development looks like. And what I'd say with then the mobile system is we have, let's say, there's various parts of the system. So you have the magnets themselves. You have a lot of the mechanical superstructure. You have the electronics. You have the control software. You have the user interface software. We benefit from a lot of what we've done already. So things like user interface software don't change dramatically. They do change when you add new endovascular applications, but they don't change kind of in a broad sense with a new robot offering. In things like the magnets themselves, we have magnets in-house. We've tested them they were manufactured and have the -- generate the magnetic fields exactly as modeled, as planned, as desired. And so certain things are completely done. Other things we've done extensively where you have good prototypes that have been tested, where you feel extremely confident and others, we've prototyped more crudely, and then you are waiting for a more refined prototype to arrive. And so given kind of all of that, it is a very, very derisked project and kind of we think those time lines make sense given the supply chain out there and given kind of where we are.

Yes, you're exactly right. Really, in the state of the world today right now, the supply chain lead times have drifted out a little bit. So that is impacting us really just from kind of building those initial [ B&V ] units. But from -- really the design is pretty much set. We've got some work to finish up. But after that, it's really building our [ B&V ] systems, conducting the formal testing and then submitting.

Okay. Understood. And great to hear. And maybe just a follow-up on the mobile side, and perhaps not a fair question on the mobile robot. But if you were to venture a guess, in 2025, I mean, how do you think about the system, install mix between Genesis and the mobile system? I guess what I'm really trying to understand, and I hear that they're complementary, they can coexist. But which customers gravitate towards the mobile system? Which ones gravitate towards Genesis? Is it primarily site of care? Just any flavor there would be helpful, David.

Sure. So I've previously discussed wanting to put in place all the infrastructure and the capability to really have a company that can sell hundreds of systems a year. And I think that's really what the mobile system is meant to enable, is that type of future where you're going to have hundreds of robots being sold and placed a year and broad adoption across clinical specialties. And the Genesis system remains a more powerful system in terms of the magnetic field it can create. And so while all of the interventional devices that we discuss today, both in electrophysiology and in other new clinical applications, vascular clinical applications, will all work on both products. And things like the MAGIC catheter's navigation in the mobile system will still perform better than what the current ablation catheter that's available performs in Genesis. They will all navigate better in the Genesis environment, just by nature because of the stronger magnetic field. And so what I think will emerge is that the mobile system will be easier to adopt more broadly, and by its nature, then be more use, more adoption of that system. But hospitals that have -- that know that they want the robot and that are using it consistently, when they have opportunities to do lab replacements, they should gravitate probably towards the Genesis system. And if you're able to do the lab construction that remains the more powerful system. And that's why, again, I think that the -- both systems work well together in this ecosystem.

Okay. Very helpful. And I'm going to push my luck here and try for a third question, and appreciate the time. So this one is on endovascular expansion. And I guess I wanted just to better understand. I think you put out 5 new potential indications there. Ischemic and hemorrhagic stroke, I think, went first in the pecking order there. So am I right to assume that that's kind of the first indication that you're going to go after outside of EP?

Sure. So I'd say that, that is probably the indication, which has the biggest unmet medical need overall, as an industry, as a society. There are -- the vast majority of stroke patients don't get therapy, don't get access to interventional therapy. And when we speak to physicians, it's not just a question of efficiency or radiation exposure. There's truly large number of patients that require multiple different access sites and multiple attempts and not a few minutes, but tens of minutes, or hour of kind of trial and error, trying to access areas that are needed. And so there, there is a very significant unmet medical need. And in the other ones that also are unmet medical needs, you sometimes then err on kind of uncertain subsets of interventional cardiology peripheral, AAA patients, embolization patients where it's kind of -- it's less of this broad, broad unmet medical need. And so that's kind of where -- that in our mind, that's kind of the most attractive place to put our focus. What's nice and what I hope was kind of conveyed in the presentation is that just to kind of say we want to target a clinical application isn't sufficient. We need to have a realistic plan for how to do so. And the concept of these guidance devices, a series of guide wires, guide catheters, microcatheters that are relatively simpler devices, they don't have a therapeutic or diagnostic capability, it's really a guidance capability, that allows you to actually, with relatively small variance between the devices, to target a broad range of vasculature. And so that's really kind of the approach is that, yes, there will be variants of the guidewire, for example, of different rigidity, and certain variants will be better tailored towards soft, more delicate, more torturous neurovasculature, certain will have a more rigid body to enable kind of more rigid catheters to ride upon them. But overall, these are variants of exactly the same device, and they have broad applicability across endovascular applications.

I guess the only other thought to add there is that the Pegasus Guidewire is the guidewire that we've had regulatory clearance on. And so it's a natural thing for us to bring that wire back into the exact indications that it was used for previously. So bringing it back in the coronary and peripheral space is very natural because we have experience and indications already in that space. And then like David said, these other areas are very strategic and have a huge opportunity. So they'll definitely be a high priority in the near term as well.

I see the next hand raised is from Frank from Lake Street.

Can you hear me all right?

Yes, Frank.

Perfect. Congrats on all the progress. Wanted to start with the guidewire and guide products. So I'm sure there's some uniqueness across different clinical applications, but I was kind of hoping you could dive into the thought process. If it's going to be more a stronger utilization of the installed base? Or if it's meant to spur another avenue of new capital equipment sales into new end users and just kind of the overlap between new users versus using the already established installed base.

Sure. So all of the guidewires, guide catheters that we're going to develop will work on Genesis systems, on Niobe systems. So they will be backwards compatible, and they'll obviously also work with the mobile system. And they're -- what I'd kind of think about in terms of how it will drive utilization or system adoption is that there are certain applications even that actually electrophysiologists do. So last week, I was in Arizona, meeting with multiple electrophysiologists. And they discussed certain EP procedures where using a magnetically driven guidewire would be very beneficial for them. And there are some labs, some hospitals where electrophysiologists use their lab exclusively, and no one else uses their lab. And so you won't have other clinical applications in that lab, in the Genesis lab, for example, because it's just -- it is an EP lab. But you have many hospitals. My guess would be it's still the majority where interventional cardiologists and electrophysiologists share a lab or share multiple labs, and you can have both types of procedures in the same room. And so in those cases, you would expect additional utilization in the existing robotic lab. There are fewer labs or relatively few places where, let's say, interventional neurologists and then -- and EPs use the same lab to treat their own procedures. And so in cases like that, our adoption in neuro intervention will likely take place really kind of in new -- by new systems being sold and placed into new labs, and that will really be the way that kind of will start to drive utilization. And so I think it is a mix of both. Some increased utilization in existing installs and probably kind of to a bigger extent, adoption in new labs.

Okay. Perfect. Wanted to shift over to the mobile robot a little bit more. Help us just understand what this does to the market for you. I mean, I'm sure it's a little bit hard to put your finger on it, but just how much larger does this make the market? Things that you're explaining all make sense entirely. But is it -- is there a large case of folks out there who just won't adopt because of these things that previously weren't available mobile, easy install and those things where you think you could be expanding the actual market of adopters by 2x, 3x, 4x? Just how does it really play into the market expansion?

Order of magnitude plus. It has been particularly painful over the last few years, seeing how many times we meet physicians that are very enthusiastic with our technology. Either just because they learned about it or because they used it at a previous hospital and they moved hospitals, or they used it during fellowship and then they graduated, got hired somewhere else. They love our system. They love the benefits of it, and the pain which you have to go through to get it adopted is immense. And there's always an effort to adopt new technology. But the fact that it is an installation that is pretty much permanent and fixed, and the fact that there's construction requirements. And even though the construction isn't more difficult than an MRI or a CT system, it weighs less, it's easier than an MRI or CT system. It's just different. Every hospital knows how to install an MRI system. Every hospital knows how to install CT system. For every hospital that's installing our system, it's pretty much the first time they're going through it, and there's a learning curve and there's an effort involved with that. And so really kind of being able to overcome those challenges and to being able to tell a hospital administrator who might be -- who might understand the benefits but be nervous about moving forward because they don't know if that physician who's the champion is actually going to stay there for more than the next 3 years, and they don't know if they want to make a 10-year commitment. Or they're not sure that they have the -- they have the financial resources to buy a robot, but they're not sure that they have the space to do the construction or the -- even the desire to go through the process of architectural planning and construction. Now you have a way to actually address and engage them in a relatively -- potentially, if they'd like in a low-risk environment for them where they can pay as they go, they can use it as they go. And if for whatever reason, robotics doesn't play out as they expect and they're disappointed, then so be it, they've taken no incremental risk. And so I think kind of in that sense, it really does. It's a game changer in that sense.

Perfect. Really helpful. Last one from me. Wanted to ask one on Synchrony. I think you said over 100 systems right now have Odyssey. Is there -- what's the main excuse for transitioning from Odyssey to Synchrony, or is there one? It sounds like a lot of the Odyssey investment is upfront, but just kind of put those 2 side by side and explain to us the case for upgrading to the Synchrony from Odyssey?

Sure. So I'm glad someone was asking about that. So it wasn't being ignored entirely. We're -- it's an interesting, right? I can -- I mentioned as I was introducing John, that it's -- on the one hand, very different than everything else we discussed today. But it is both very complementary and it's almost kind of -- it's seeding an entirely new business opportunity that even I could see at some point, if it evolves as we expect it should, being spun out as its own company. The Odyssey is very nice in the field. Users of it call it a premium kind of first-class product in terms of the way it integrates all of the disparate systems in the lab. It presents it to the physician. It allows the physician to interact with it in a very user-friendly fashion. And like with many of our technologies, as you see, there's this kind of continued theme that great things need to be accessible. You can build something great, but if it's not easily accessible, its benefit on the world is muted. And that's really kind of, again, the effort with Odyssey, Odyssey Cinema environment shifting to Synchrony Sync is making what is overall functionally good, accessible and built to scale. We could not, for example, manage a network of connectivity with hundreds of users, thousands of users. It just wouldn't be feasible, right? And yet Zoom and many of the networks and kind of the networks that we're used to from our consumer lives, right, can scale to hundreds of thousands, millions of users without any major technical challenge. And that's, to some extent, what we're doing with Synchrony and Sync. So I wouldn't expect someone who has Odyssey already will be actually able to join the Sync network, the connectivity network. But I wouldn't expect someone who was Odyssey to necessarily shift to Synchrony. But Synchrony, again, will make it that much more easy and accessible to establish and to make a lab kind of a fully integrated connected lab and part of this kind of connected network.

Yes. The only thing I would add to that really is that Odyssey is limited somewhat as to the sheer -- the bandwidth or the number of pixels that we can put through the system. As more and more third-party systems are coming out with 4K displays, Odyssey is not really going to be an option there. Whereas, the newer system, Synchrony, is designed really to handle the higher bandwidths right from the get-go.

And maybe that's an important point. All of these innovations, when I say, making things more accessible, they are also improving performance, right? And so we're mixing this improvement of performance and really building a foundation also for the future. And thinking about what does it take to make something broadly kind of adopted and a real commercial product that can be commercialized at scale. There's other things, let's say, we've talked about. If you really want to have a network effect, it'd be great if you could de-identify patient information and build kind of that patient confidentiality by design into the system. There are certain other things that kind of we were limited of in the past where in the new environment, we can kind of -- we can do it. And so there's various things like that, like what John mentioned in kind of these ways to try to improve the product offering.

Okay. David, we another question in that same area. Would I be allowed to pose the question right away? It is the question, can you walk us through how Sync and Synergy could work in non-robotic labs? So the question is, can it be used in non-robotic labs as well?

Sure. So we do actually have Odyssey currently installed in some non-robotic labs. Where -- a hospital, for example, in Helsinki that you're all aware that Helsinki adopted the Genesis system by now about 15, 16 months ago, with an Odyssey system in the Genesis Lab. And a few months after that, they decided to adopt an Odyssey system in a non-robotic manual lab that they had in the same department. And it was really and that won out over other integrated display offerings by very large companies because of the way it performs, just the fundamental performance and user friendliness of the system. We have not built a sales capability to really pursue that effort of kind of commercializing Odyssey broadly in non-robotic accounts because of the limitations to adoption, the challenge with broad commercial adoption and to some extent, also the commercial model. And so when you have a system that, again, requires -- it's a significant effort. The lab has to be down for a week, 1.5 weeks. And even though that doesn't sound like a lot, there's a lot of money that's lost for a hospital from that. It requires an installation team of ours to fly out and to spend time there and to do a lot of effort in the field. And then when the revenue model is an upfront system sale and a little bit of service revenue a year and that's, to some extent, the extent of it, that's not a fantastic area to spend strategically a lot of your effort. When you have a system that can be deployed relatively easily, to the point where perhaps even you charge a little bit extra for installation, but you can provide the instructions for how to install for local biomeds at the hospital to install in their own, and you have a system that can be shipped, placed. It doesn't need cable routing between multiple rooms around the lab. You can kind of be sitting under a table, the cabinets and the electronics. And then when you have a revenue model, which is a software-as-a-service revenue model, so really, the capital sale of it or the service revenue of it is relatively -- yes, kind of you do generate some revenue there. But really kind of the economic value is having this network and having a series of services that are provided through software, through the Sync application. That becomes something much more attractive. And so I think, again, you'll see that we'll commercialize the system initially just with our existing sales team to robotic labs, to the adjacent labs around the robotic lab where there's an easy opportunity to sell the system. But potentially with potential collaborators and kind of beyond that. And if things go as we think it can and should, it might be worth in a few years to think about spinning out Sync as a separate stand-alone company. There are other companies in this field that I think have technology that is while perhaps elegant in certain ways, is, I think, fundamentally less capable of what we have developed and have received funding rounds in the tens, even hundred million-dollar range. And so I think that it is -- it has an opportunity to be really a significant stand-alone business.

Any further questions from Mr. Frank Takkinen, perhaps?

If not, I see that there's been several kind of written in the Q&A. [Operator Instructions] And otherwise, we can look through some of the Q&A. And so maybe if we start from the top of the Q&A at the written-in questions.

I see the first question came in from MedTech Ventures. You may have covered this, but what is your schedule for filing new FDA indications over 2022?

So maybe to recap a bit. In terms of the mobile robot, we've discussed a filing towards the end of 2022. On the electrophysiology side, we expect to file for an IND -- for an IDE study for the MAGIC catheter earlier next year. And -- when it comes to the vascular devices, we expect to file for guidewire in the second quarter, a magnetic guidewire in the second quarter. And then to follow on variants of that guidewire and of guide catheters kind of subsequent to that in relatively rapid succession. And on the Synchrony and Sync side, we expect to start to do an initial rollout later in 2022 with the full commercialization 2023.

Then we move to the next question.

I see a question. What is the profile of a current Genesis model versus the new mobile system? I don't know exactly how to answer that, but we did share during Brian's presentation, there were pictures and those were to scale accurate representations of the system together. Do you have a sense of, let's say, the difference in kind of size or...

Yes. I mean as far as the magnet goes itself, which really drives everything, it's about half the size. Now from the images you saw though, you probably noticed that the basis looks a little bit larger than half of what Niobe was or whatever. And a lot of that is driven because we've addressed the challenges of the room construction in the shielding. So rather than put that shielding in the room itself, that has migrated to the face of the system to allow it to be self-shielding. So I mean overall, the system is probably -- I know it's about 40% less weight than the Niobe system before it. So -- but again, some of that room shielding has wound up in the face itself.

Probably the pod kind of from a patient perspective, the surface area, I would assume it's something less than 50%.

It's probably around -- right around 50%, yes.

We're moving to the next question from Charlie Nettleton from HealthCor. How do you move the core user group of docs? Ischemic stroke is different doctor core point. So when new catheter launches in 2023, how do you drive penetration?

Okay. So I guess kind of the question is more on how do you start to approach new clinical applications and physicians in new clinical indications. And I kind of say that we -- our intention is to follow a model similar to Intuitive Surgical, where they have one sales team that covers the broad range of clinical applications, both on the system sales side and on the clinical adoption and engagement side. So that's a model that exists kind of we have a feeling for how that model would be very applicable also in what we do. And so I'd say that kind of as we start to think about how do we engage with these new users, the first thing that you do, which has already, to some extent, been done, but obviously will be done more and more in kind of in a growing fashion as we lead up to the launch, if you engage with physician users who can be real KOLs and champions of the technology. And so we've been fortunate, particularly on the neuro intervention side. And I had to work with kind of more than a handful of physicians from more than a handful of hospitals that have been really engaged with us. And many of them actually reached out to us directly. So we've received over the years, direct cold call e-mails to our info mailbox and from physicians who have somehow come across what we've done and have said, "That's really kind of -- this will be really, really beneficial for my patients." And so -- and as you kind of engage with them, certain ones really shine in terms of being particularly helpful and particularly engaged and able to advance. And we also think about these KOL partners as both how can we work together on the core technical improvements, how can we assess technology, how can we learn from each other on how to best design devices, how to best design software for those procedures. But then we also think about, what could their impact be on broader adoption? Do they -- which presentations do they generally give? Which societies are they a part of? And so we are already kind of in the midst of those types of discussions. And I hope that actually perhaps as we get close to launching neuro intervention, my thought is probably we'll host an Innovation Day or an Investor Day like this, and we'll have some of the physicians up to talk about their experience to date and their experience without robotics and where they see kind of the most benefits.

I see we have MedTech Ventures also reposing their question on filing new FDA indications for 2023. Any additional comments you want to make?

I think we shared it broadly. So we can talk kind of through things later.

Let's move on to the next one. Does the mobile version work with every environment or with the [ C-arm ] or any EP lab with any x-ray?

So the mobile system will work with the Model S x-ray, and we expect it to work in various operating room environment, so EP labs and interventional cardiology labs and neuro interventional labs. So yes, it's designed to fit in a broad range of operating rooms. Really, again, the goal of having something that can be broadly adopted means that it doesn't have specific peculiarities that are necessary in the room in order to place the system.

Let's move on to the next question from [ Mr. and Mrs. Parsons ]. Can you speak to patents held or being developed for all the new developments announced?

So we've done some work on the most recent interventional devices. We benefit from a range of patents still on robotic magnetic systems as a whole. And also on Odyssey, there's a range of patents that will apply also to the Synchrony ecosystem. I don't know if there's anything else kind of you guys would...

I would say that as we go through this development process and bring things up, we're very keen to recognize when there's intellectual property-related discoveries along the way. And so we're diligent about pursuing and documenting those as they come up. We're also going into environments where there's also a lot of ground has been plowed already. And so these innovations and stuff, we certainly keep an eye out for them when they come about.

Yes. There's work that we've had some creative ways for how to best design magnetic, guide catheter-types devices. There's a range of things that we've been working on there. And I'd say, again, that IP can be viewed just through the lens of patents or can be -- also be viewed through the lens of know-how. And one thing that I think everyone who has watched the robotic surgical space has realized over the last years is that even with immense amount of capital and immense amount of personnel, building a robotic system that works in the real-world environment and the rigors of the real world is extremely difficult. And many companies have struggled immensely to build competitive systems. I'm talking more about laparoscopic surgery, where there's been kind of much more of an effort. And so I think that we benefit significantly from having a robot that works reliably in the real world at scale, 130,000-plus procedures already, and thousands of procedures a year. And that is a major, major barrier is just the know-how that has accumulated over years amongst our team and in our technology.

So we have another question coming from Chris. You have previously guided to an approximate doubling of Genesis sales in 2022 from 2021. Do you see any impact to that outlook given the pending commercial launch of the mobile robot in early 2023?

So we're obviously aware of the mobile robot being developed when we provided that guidance. So the guidance for an approximate doubling of system revenue in 2022 versus 2021 still stands. And then I think really kind of -- there's a few things again to recognize. The mobile robot and the Genesis system work together in -- they coexist in the ecosystem together. If you think about the types of customers who would be best suited for Genesis, it is those who are either existing users of us where it's natural that they would shift from Niobe to Genesis rather than to a mobile robot, they already have a lab, they have everything placed. Or obviously, if a hospital is looking to buy a system in the very near term, and we had enough confidence to put them as part of our guidance for next year, it is likely that they already have designated a room, that they already have awareness of the construction aspect. It isn't that that's coming to them as a surprise. There's already been some engagement there. And so again, I think that there -- really what the mobile robot is meant to do is to provide a path towards selling hundreds of systems a year and visibility to how that becomes a feasible undertaking in a very realistic way.

I have received one more question. It's a 2-part question, I think. Can you elaborate on the value of smaller magnets? And how were you able to miniaturize the robots? I'm not sure if -- it should be 1 or 2 questions, but perhaps you can comment.

Can you repeat it again?

Can you elaborate on the value of smaller magnets? And how were you able to miniaturize the robots?

Sure. So yes, I think the core of it was basically the better performance or the increased performance of the MAGIC catheter is really what allowed us to reduce the magnet size and the robots themselves. Also, we've done some work internally to show that for a lot of kind of our interventional device concepts and ideas, we can still navigate at the lower field strength as well. But really, the key was the improvements in the MAGIC catheter.

And let's say development of -- in the Genesis system, we have a magnet that rotates along its central axis. That was very beneficial, and that's carried on in the mobile system. And so yes, it was -- there -- and then there's many other improvements. Again, it's not just the magnets. The magnets impact many things kind of downstream from it. But like you saw in one of the slides, in one of my favorite slides, is the miniaturization and distribution of all the electronics, right? That's really kind of an amazing effort by our electrical engineering team to be able to do that and to reduce the cable bundles from things of this sort to -- in Genesis, things of this sort to in the mobile system, things of this sort. There are kind of a series of innovations. If we just wanted to make a mobile system, but not and not -- and just have smaller magnets, that would have been one thing. But if you want true broad accessibility, you need to address, and you should address, kind of a wide range of things that all have their own little impact and then the ability to use normal power outlets. So you don't have to have specialized kind of electricians coming into the hospital and installing special equipment. There's a series of things here, a series of innovations that each one is a relatively significant effort on its own, collectively that would cause this transformative impact on our technology.

We've received another question in the chat. It's from Guy. Does the success of the guidewire and microcatheter business absolutely require buy-in from existing access device companies for the guidewires, microcatheters to add value? And what are your assumptions regarding the needs for partners?

Sure. So if you think about our product development strategy, and I hope we were trying to convey this in Nathan's discussion, is that you want to have open ecosystems where your technology can work synergistically and beneficially for the patients and the physicians with other technologies that have already been developed. You also need to be able to operate independently. And so there's that kind of dual nature of the open ecosystem environment, which we're really pursuing. And so what that means, practically, is that the guidewires, guide catheters that we're developing can work interoperably with a range of therapeutic devices that are out there, whether it's stents or aspiration catheters or coil devices, without needing to necessarily have any integration or work with them. And that's what actually happens in vascular, endovascular procedures all the time, you'll have a guidewire from one company and a microcatheter from another and a therapeutic catheter from another, and they're all being used in the procedure. And so we're designing our devices in that same vein to work alongside things. And that's how you can benefit from the navigational capabilities of robotic magnetic navigation, while not having to give up on the therapeutic benefits of company A or company B or company C's thrombectomy system or atherectomy device or embolization technology for cancer. And so that's really kind of the effort.

We definitely benefit from the fact that in a lot of these interventions, the sizes of different categories of devices have sort of been set by the nature of the procedure and the tools that are out there. So the physician is able to select guidewires independently, microcatheters independently, therapeutic devices. And because the sizes are sort of established on each of these categories, they can interplay with each other. And so we benefit definitely from the fact that we can create devices that are in certain categories with certain sizes and performance characteristics, and by virtue that we automatically then interplay with all of the devices designed around that kind of intervention.

So taking it from the catheters, I now have also a question from [ Rudy Boito ]. I hope pronounced correctly. There is 3 questions. I'll start with the first one. From a hospital decision-maker perspective, what are the financial concerns preventing or encouraging a switch to Stereotaxis? And then I'll come back with the other 2 questions.

Okay. I think -- so obviously, we have the most experience in electrophysiology. And there, I'd say that the financial kind of considerations that generally drive the decision-making to adopt the robotic system is our ability to help a hospital and physicians treat patients that otherwise they wouldn't be treating, usually more complex patients that either because of the complexity of the procedure, the risk of the procedure, the hospital and the physicians decide they don't want to do manually, but they feel comfortable doing robotically. And given the economic value of any cardiac ablation procedure for a hospital, relatively few of those procedures need to be done incrementally to make it a very attractive financial consideration for the hospital. And the second thing would be the safety to the patient. If a hospital has one adverse event, it can cost easily in the 6 figures. And if they get sued because of it, it can cost easily in 7 figures. And so that by itself pays back for a system. And I think there's quite a big body of evidence that has demonstrated the safety benefits of robotics in electrophysiology. So I think kind of those are probably the 2 biggest financial considerations for a hospital. Obviously, the things that kind of prevent adoption are that naturally hospitals are cost conscious. They are circumspect on new technology and investments of new technology. And so physician champion needs to be sufficiently persuasive and sufficiently kind of relentless in their pursuit of adoption of the technology to actually move a process forward at a hospital. And that gets a little bit again to the mobile robot where the lower the risk is for the hospital. If things don't work out and the physician leaves, or the physician's promises that they're going to be able to treat 50 additional patients a year don't work out, and the hospital doesn't believe that it ultimately was a successful investment, to some extent, the risk was very much muted. They're not making a 10-year decision. And so again, I think that's kind of -- that makes it much easier to reduce the concern and to highlight the benefits.

And then in that same stream, we've got another question from [ Rudy ] as well. What are the medical community's concerns preventing or encouraging a switch to Stereotaxis? So more towards the medical community's pros and cons.

Again, I think kind of these are broad questions. I'd say that generally, for the adoption of any new transformative technology, medicine evolves slowly. It changes slowly. There's obviously many positives to our technology. We've discussed many of them here. We've discussed them in previous calls. And -- but like in everything, change is something that many people are afraid of and many people just are hesitant of. They've spent years and years and years honing their craft and they have a very amazing craft. And to just switch is not an easy thing for many physicians. And that's why medicine generally, not just in our case, evolves very slowly.

And then what would a patient advocate advising a patient, say regarding going old style or manual versus Stereotaxis, would they say?

I would say, given the propensity of the data available, I would be -- I'd be happy to debate the merits of not -- of going old style as it's written with a patient advocate. But again, like in everything, we're still a young company, we're still a very small one in the field. And so we will continue to build the clinical evidence that supports the safety and efficacy benefits of robotics.

Then we have another question from Guy. Does the strength of the magnets impact the ability to do more complicated cardiac ablations, meaning that Genesis is likely to be the workhorse in the cardiac lab, while the mobile robot would be used for the neuro market?

No, that's not the case. Both systems will be able to be used for the broad range of clinical applications.

Well, I think we have handled or answered all the questions that we have in chat. [Operator Instructions]

Okay. Again, want to thank you very much for joining us today. I hope you're pleasantly surprised by the breadth of innovations that we're advancing and by the strategy that we have really kind of put in place here at Stereotaxis. We look forward to advancing all of these over the coming months, and so again, to having a broad positive impact on the evolution of endovascular medicine. Thank you very much for joining.

Thank you for spending time with us. We wish you a very nice continuation of your evening, and we will be disconnecting now. Goodbye.