Stereotaxis, Inc. Q1 FY2025 Earnings Call
Stereotaxis, Inc. (STXS)
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Auto-generated speakersGood afternoon. Thank you for joining us for Stereotaxis’ First Quarter 2025 Earnings Conference Call. Certain statements during the conference call and question-and-answer period to follow may relate to future events, expectations, and as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company in the future to be materially different from the statements that the company’s executives may make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions-and-comments following the presentation. As a reminder, today’s call is being recorded. It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereotaxis. Please go ahead.
Thank you, Operator, and good afternoon, everyone. Our last call two months ago included a comprehensive overview of Stereotaxis’ strategy. We’ll keep today’s call more brief. I’ll focus our prepared remarks on a few key commercial and innovation updates. Our commercial results for the first quarter were solid, with 9% year-over-year growth. While the structural challenges of our old product ecosystem remain a significant headwind, we are starting to show commercial progress. There are three areas specifically where we are orienting our focus and seeing results. Growing recurring revenue within our Map-iT portfolio of differentiated EP catheters, starting to commercialize our recently approved MAGiC catheter in Europe, and early launch of GenesisX to expand robot adoption. Our recurring revenue growth in the first quarter reflects predominantly the contribution of the Map-iT family of differentiated diagnostic EP catheters. Our global commercial team is increasingly driving adoption of these catheters as we approach the anniversary of acquiring APT. Map-iT sales in the first quarter were over $1 million. Sales in the United States, where entering the acquisition we identified the most untapped opportunity and commercial synergy, have particularly done well, growing 30% sequentially in the first quarter from the fourth quarter. Map-iT catheters provide differentiated clinical value in the complex ablation procedures where robotics is most valued and our team most experienced, treating complex VTs and PVCs along with pediatric and adult congenital patients. The process of getting catheters adopted is gradual. There is the need to generate awareness and interest, the administrative effort to get on contract at hospitals, and the clinical support to turn initial adoption into recurring use. We’re still in the very earliest innings of working through these processes. Our first focus was existing U.S. robotic customers, a third of which have by now begun first Map-iT purchases. Our early marketing campaigns are also building awareness with measurable impact in the EP community where there is essentially no awareness of the catheters. The response to these efforts has been very positive and reinforces our confidence in the clinical value and market opportunity. We’re working through many hospital value analysis committee assessments at both robotic accounts and entirely new hospitals to translate that new awareness into first purchases. We expect a long runway for continued growth in Map-iT catheter revenue as we continue to build awareness and work through hospital approvals. The most significant driver of recurring revenue growth in the coming quarters will be the robotically steered MAGiC ablation catheter. We were delighted in the first quarter to receive European approval for MAGiC. As described on the last call, we began commercial efforts across many of our EU hospital customers. Initial adoption of MAGiC requires administrative submissions at each hospital, and for many hospitals also additional regional or national administrative efforts. We’re continuing to work through these processes across EU hospitals, regions and countries. At approximately 20% of our hospital customers, we’ve got through these initial administrative efforts and begun commercial sales. Just the initial use of MAGiC at these initial accounts should conservatively generate a couple hundred thousand dollars of revenue this quarter. We expect this revenue to ramp up significantly in the coming quarters and reiterate the expectation shared on our last call that MAGiC revenue in Europe will reach approximately a $1 million per quarter by the end of this year. Building an attractive razor, razor blade business model with portfolios of proprietary catheters is core to our overall strategy. That said, a larger installed base of robotic accounts is the critical foundation for robust recurring revenue. We spoke in detail on previous calls about how GenesisX serves as the innovation making robotics broadly accessible across cath labs. After receiving European CE Marks for GenesisX and then European approval of MAGiC, we were pleased to announce our first GenesisX purchase order in the first quarter and began an initial soft launch. The most impactful aspect of this launch was bringing GenesisX to the two largest electrophysiology conferences in our field, EHRA in Vienna in March and HRS in San Diego in April. While Stereotaxis has attended both conferences for 20 years, this was the first time we were able to install a functional robot in our booth. Doing so was a dramatic demonstration of how far we’ve advanced the technology. We were delighted by the reception with busy booths and positive commentary from many physician visitors. Several key opinion leaders in the field from hospitals that adopted but gave up on robotics in its earliest iterations or never adopted robotics at all came by and were impressed and interested. These interactions reflect the power of innovation and an increased relevance we and many physician experts expect robotics to play in EP and endovascular surgery. We have been busy preparing for the first commercial installation of GenesisX this summer. It will be an important milestone to demonstrate the robot working reliably in the rigorous environment of daily clinical use and will serve as a pivot from which to enter into a more robust commercial effort. In tandem with working towards that installation, we’ve been working to enhance compatibility of the robot with various X-rays and preparing our supply chain, manufacturing, installation and commercial processes for a full launch. We expect a full launch in Europe and the U.S. shortly after initial commercial use and pending U.S. regulatory approval. While we viewed GenesisX as a significant driver of robotic system growth in the coming years, we continue to have a healthy pipeline of Genesis customers. We were pleased in the first quarter to receive an order for an additional Genesis system from a U.S. customer. We continue to expect a steady flow of Genesis orders in the next few quarters with additional GenesisX orders building on top of that base. We are pleased with the initial commercial impact of MAP-IT, MAGiC and GenesisX. That said, the majority of our focus remains on driving multiple innovations through key development and regulatory milestones. Realizing these milestones in our comprehensive innovation strategy sets the stage for breakout revenue growth. This will be a milestone-rich year and we’re making significant progress on multiple fronts. We discussed the full breadth of innovation efforts on our last call. It’s an amazingly busy time. We have six active regulatory reviews ongoing, key products being reviewed by either the USFDA or EU Notified Body. There are an additional five regulatory efforts ongoing for products we expect to submit for regulatory approval in the near term. This is an amazing bolus of innovation and takes a significant amount of effort to shepherd forward. I’ll share a few brief regulatory updates on the key technologies. First, MAGiC in the U.S. We submitted MAGiC to the FDA last year and continue to work collaboratively with FDA on the review of the catheter. We’ve also continued enrolling patients in our ongoing European study, which is supporting this submission, and are nearing 100 patients enrolled. Even in our interactions with the FDA, we continue to expect U.S. regulatory approval for MAGiC in the second half of this year. Second, GenesisX in the U.S. In the first quarter, we responded to the FDA’s original questions, whittling down a list of approximately 25 outstanding questions to a few final topics. We received additional feedback and questions recently from the FDA on these remaining topics. We’re working to address these and continue to view regulatory approval of GenesisX in the summer as realistic. Third, our robotically-steered high-density mapping catheter, MAGiC Sweep. We submitted this catheter for regulatory approval in the first quarter and recently received our first round of questions from the FDA. We see no significant concerns with these questions and will respond soon. We continue to see both U.S. and EU regulatory approval for MAGiC Sweep in the third quarter. Finally, our vascular guide catheter, EMAGIN, allows our robot to begin to expand its use beyond just electrophysiology. We also submitted this catheter for regulatory approval in the first quarter and similar to MAGiC Sweep, continue to expect both U.S. and EU regulatory approval in the third quarter. Beyond these products in active regulatory review, we are finalizing regulatory paperwork for our Synchrony cath lab technology with regulatory submissions still this quarter and are making good progress on our robotically-steered vascular guidewire, which we believe we will complete by the end of this year. Other R&D activities like our recently announced AI effort with NVIDIA and the multiple PFA efforts are also very exciting and are being advanced in parallel, but not expected to lead to regulatory submissions this year. It’s an exciting period seeing so much of what we’ve invested in at the cusp of coming to market. We are heads-down focused on advancing all these technologies through the development and regulatory processes and ensuring we are able to manufacture them with high quality and at scale and on commercializing the technologies with creativity. This year, we will demonstrate the tangible reality of our overall strategic transformation into a company with an easily adopted robot that can navigate a proprietary set of catheters in EP and broadly across endovascular procedures. These milestones will increasingly contribute to commercial results as we progress through the year and set us up for breakout growth as we look towards 2026. Kim will now provide additional commentary on our financial results and then I will make a few financial comments as well before opening the call to Q&A.
Thank you, David, and good afternoon, everyone. Revenue for the first quarter of 2025 totaled $7.5 million, growth of 9% from $6.9 million in the prior year first quarter. System revenue for the first quarter was $2 million and recurring revenue was $5.5 million, compared to $2.6 million and $4.3 million in the prior year first quarter. System revenue in the quarter reflects revenue recognition on the installation of one Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue growth reflects primarily the contribution from last year’s acquisition of ATT technology. Gross margin for the first quarter was 54% of revenue. Recurring revenue gross margin was 68% and system gross margin was 15%. Recurring revenue gross margins remain impacted by acquisition-related accounting that temporarily reduces disposable margins. This is an accounting treatment and not reflective of cash margins or activity. Prior to the acquisition, recurring revenue margins were approximately 75%. Following the acquisition, they dipped down below 60% and we expect recurring revenue margins to get back to a normal level by this year’s third quarter. System gross margins have been fairly consistent in the 15% to 20% range and are impacted significantly by fixed overhead allocated over low production levels. Operating expenses in the quarter of $10 million included $3.2 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earn out consideration and amortization of acquired intangible assets. Excluding these non-cash charges, adjusted operating expenses were $6.8 million, compared to the prior year adjusted operating expenses of $6.1 million. The increase in operating expenses reflects the addition of ATT operating expenses following the acquisition. Operating loss and net loss in the first quarter of 2025 were $5.9 million and $5.8 million, compared with $4.7 million and $4.5 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $2.7 million and $2.6 million, compared with $2.2 million and $1.9 million in the previous year. Negative free cash flow for the first quarter was $1.8 million, compared to $2.3 million in the previous year. At March 31, Stereotaxis had cash and cash equivalents of $10.7 million and no debt. I will now hand the call back to David.
Thank you, Kim. As mentioned in our press release, we are reiterating the revenue guidance we provided on the last call. We expect double-digit revenue growth for the full year 2025. In any given quarter, we expect system revenue to fluctuate between approximately $2 million to $3 million. Recurring revenue will continue to scale throughout the year, reaching an expected $7 million in the fourth quarter. Our revenue expectations assume only modest contributions from GenesisX in Europe this year and no GenesisX revenue from the U.S. We believe this is conservative but warranted pending regulatory clearances. These revenue expectations also assume no system revenue from China. While we viewed the recent approval of Genesis in China as a potentially significant tailwind this year, the ongoing macro situation creates substantial uncertainty as to the extent Chinese hospitals will be able to purchase Genesis systems. We and our partner, MicroPort, are continuing to work on a meaningful pipeline of Chinese customers but believe it is prudent to view this as an upside given the uncertainty. Growing recurring revenue and stable operating expenses support our expectations for reduced cash use in 2025 compared to 2024. I’m pleased with our relatively modest cash use in the first quarter, and our cash level is approximately flat with our cash balance at the end of last year’s third quarter. Tariffs, assuming current rates persist, are anticipated to cause less than a 1% increase to our expenses. We view our existing balance sheet as allowing us to reach key milestones, commercialize our innovation and profitably grow. We’ll now take your questions. Operator, can you please open the line to Q&A?
Today your first question comes from Adam Maeder with Piper Sandler. Please go ahead.
Hi. Good afternoon, David and Kim. Thank you for taking the questions and congrats on all the progress.
Thanks. Good afternoon. Maybe…
Yeah. Good to hear from you, David. Maybe just one from me to start on the capital side, multi-part question, but just wanted to dig into the backlog a little bit more and just get a better sense for how that’s shaping up, I guess, both on the Genesis side as well as the GenesisX mobile system, both in the U.S. and in Europe. One of the questions I have is, is the capital equipment environment still relatively healthy and resilient? And in the U.S. particularly, just wondering if folks are deferring purchases, waiting for the GenesisX to become available, and if that’s impacting you guys a little bit? And then I had a follow-up, and sorry for the long-winded question.
Sure. Sure. No. It’s a great question. And I think when you look at the capital environment overall, you do really have to look at the three key geographies independently, because there is very much its own dynamic in each of the three. And just in terms of our product ecosystem and kind of what we’re working within, I’d say that our experience is probably not necessarily reflective of broader macroeconomics. I don’t know. We’re still such a small fish that it’s very hard to say that what we experience is reflective of the broader capital equipment environment because again, we’re kind of a small fish in a huge ocean. And I think that irrespective of how the macro goes, we’re going to be mainly driven by our own swimming capabilities. That said, if we look at kind of the three regions, in the U.S., we have still the least advanced of an ecosystem in that we don’t yet have MAGiC approved. We don’t have the catheter approved. And so it’s kind of a tougher capital environment for us. We do have various interested customers on the Genesis side. As kind of we announced, we had one Genesis order from a U.S. customer in the first quarter. So obviously there continues to be a pipeline there. There continues to be activity, but I’d say that’s probably one of our most challenged markets until we get GenesisX on the market and have kind of some of the catheters that are critical for GenesisX also approved. We do have hospitals that are very much, and kind of you probably saw some of them at HRS, there are hospitals that are very much interested and engaging with us in understanding how GenesisX could fit into their labs. They like the fact that they don’t have to necessarily think about a major construction project for it. And so there is kind of a group of interested hospitals there, but obviously kind of we’re waiting towards later in the year when we have approval both for GenesisX and MAGiC to view that as being really actionable. In Europe, we have a more kind of robust pipeline in that we have both on the Genesis side and on the GenesisX side. I’d say that the Genesis side is still in some ways a larger pipeline than GenesisX just because there are physicians and hospitals that have interacted with us for the last couple years and have advanced interest in that over the years. And if they’re already planning to do construction or they’re building out new wings of hospitals, their baseline assumption is to use Genesis just because that’s what’s been in their mind all along. We are starting now to also build a separate pipeline of physicians that would be most interested in GenesisX. I recognize that the investment community already counts it as a given that GenesisX works, and I give it as a given. Obviously, we had it at the conference. We were able to show it. That is very helpful. But there is something with physicians and hospitals. I think a natural conservatism which wants to see things actually working in the real world, treating patients before they are fully onboard and fully confident to jump. And so there is more of that market confidence in Genesis, given that people have seen it working now at many hospitals, consistently treating thousands of patients than there is still on GenesisX. And it’s up to us over this coming year as we install the first system, maybe a second system, that we kind of demonstrate GenesisX working well, and that will kind of increase the confidence and allow us to grow there. But again, I expect relatively consistency, and we should have almost every quarter at least one or two Genesis orders coming out of Europe. And then China is its own dynamic. We obviously just got regulatory approval. MicroPort is a great partner with us in China. They are pushing aggressively, despite the macro noise, to start to build or to start to convert the pipeline that we have into actual orders. And the whole tariff situation and what that would mean in terms of the price of Genesis for a Chinese hospital customer is obviously a little bit challenging and there’s uncertainty there. The news today is probably somewhat more helpful in that, but that uncertainty does kind of raise questions, and that’s why we’re viewing that all as upside. That’s not part of our guidance, but definitely kind of there should be upside there, particularly if the macro situation is improved versus what it was last week. I hope that helps, and if there’s any follow-up, I can obviously talk a bit more about it.
No. That’s great color, David. Thanks so much for all of that. And for the follow-up, just pivoting over to the catheter side, your MAGiC RF inflation catheter, I guess just wanted to kind of get a better understanding of the feedback from your European customers that have adopted that catheter. How is the catheter performing? Is it being used predominantly in SVT and VT, or is it really across a garden variety of cases? And as you think about that 20%, I think you said of customers that are now using MAGiC and kind of through the VAC process, just how should we think about that scaling over the course of the next couple quarters? And thanks again for taking the questions.
Overall, the feedback has been very positive, which doesn't surprise us since we conducted a clinical study prior to the launch. As a result, several physicians already had experience with MAGiC. The catheter offers various improvements that enhance both the experience and performance. The outcomes we observed in the clinical study are now being reflected in the initial commercial adoptions. It has been utilized across a variety of procedures, including SVTs, AF procedures, VTs, PVCs, and congenital patients, showing its versatility. However, similar to our overall volume, we see a greater tendency to use it for VTs and PVCs, where we can provide the most value, aligning with our procedural volume. We are gradually increasing the number of hospitals and physicians adopting MAGiC. We estimate that MAGiC in Europe will reach about a $1 million run rate by the end of this year, translating to an annual revenue of approximately $4 million. While this reflects a solid penetration, it is still less than half of what we anticipate overall from our European customers. Historically, I've mentioned that we expect a two-year timeframe to fully transition the market, and we believe we are on track to achieve that.
Great color. Thanks again.
Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please go ahead.
All right. Thanks for taking the questions. Congrats on all the progress. I was going to start with one on MAGiC, just to continue that conversation a little bit. How have ordering patterns looked for the 20% that are now active? Have they essentially started to use it and maybe they’re testing a few units before they fully implement it and use MAGiC exclusively or are they getting confidence kind of right up front to switch over all of their RF magnetically-driven catheters to MAGiC?
Sure. Hi, Frank. Good afternoon, and it’s a great question. Generally, when we see the first order, we see an order for five or 10 catheters, kind of in a box of five or 10. They’ll work through those. We make sure our trainers are on-site. We make sure that kind of there’s real discussion. It’s not that they just pull it out and use it one day without any discussion. We want to make sure their experience is good. There are differences, right? You’re given an analogy that kind of all of us can remember. You have a car that you’ve driven for 15 years, 20 years, and suddenly you have a new car. Even if it’s a better-handling car, there are differences in the experience. So it’s useful kind of to both discuss those before they do the first drive and then to kind of be with them on the first drive and make sure it’s going well and they’re enjoying it. We’ve gotten very positive feedback. We’ve had some now kind of second orders after that first order, this, even, I think, a third order from a couple. So we’re starting now to get into some repeat orders from some of the hospitals, and otherwise are working through those initial batches. Sometimes in some hospitals, there are multiple physicians. So you’ll see kind of one who will take the flag and say, I want to be the one to do the first few. They’ll talk about it with their colleagues and then other colleagues want to do it. So every hospital has its own little dynamic, but overall kind of that’s the way it’s playing out. We have kind of multiple hospitals, obviously, where we’re in certain aspects of either the hospital review or the national review to get it in, and so it’s kind of a grind just working through these processes, but overall we’re very happy with kind of the physician reception.
Got it. That’s helpful. And then maybe just MAGiC in the U.S. I heard the updated comments that you’re working collaboratively with the FDA. What’s kind of left on the docket as you look at that submission process? Is there anything specific that they’re waiting to see or is it more just in their court and related to timing of when they can get to the file?
Overall, despite various news articles suggesting a negative outlook, the FDA appears to be putting in significant effort, conducting thorough reviews, and maintaining responsiveness. It's been encouraging to witness this in practice, and it seems that the negative press hasn't impacted our interactions with them. In relation to our FDA review of MAGiC, we have received very detailed questions and comments regarding different aspects of our submission. We have either addressed these or are conducting additional biocompatibility or sterility tests to support our earlier findings. Most of this work is completed, although a few tests are currently being run at third-party labs to enhance our submission. As we continue to enroll patients in Europe, we're not targeting a specific number but focusing on patients with complex congenital conditions that are best suited for FDA evaluation. We're gathering all relevant data and sharing it with the FDA for their review. The key tasks ahead involve answering the remaining questions, ensuring thorough review of the clinical data from the European study, and making sure the FDA is confident in our findings. There is a possibility of an onsite audit of the manufacturing facility, but it's uncertain whether that will be necessary.
Got it. That’s helpful. I’ll stop there. Thank you.
Maybe one other comment, just kind of similar to your first question, but more fitting with the second one, the U.S. is obviously the U.S. doesn’t have as many administrative complexities as Europe. Generally, I would expect U.S. adoption of MAGiC post-approval to be quicker. You obviously don’t have any of the national or regional registrations. You still have to work through VAC committees in the U.S., but we’ve had now quite a lot of experience with VAC committees with the MAGiC catheters in the U.S. And sometimes that goes slowly, but when a physician is vocal about it, that can move over all very quickly. That’s, I think, kind of we have good experience now with that and that will help us with the MAGiC program in the future.
Your next question comes from the line of Jason Wittes with ROTH Capital Partners. Please go ahead.
Hi. Thanks for sharing the questions. First off, I assume if MAGiC gets approved in the U.S., that would potentially be some upside in the numbers if we got it, say, early in the second half, or is that not the right way to think about it?
Hi, Jason. Yeah. We didn’t include MAGiC in our guidance for $7 million of recurring revenue in the fourth quarter. That doesn’t include MAGiC revenue in the U.S.
And in terms of just penetration in Europe, and I think you sort of spoke to it in the U.S., what’s your kind of timeline that you think before it can be sort of fully converted or fully set, maybe not saturated, fully converted to MAGiC in the U.S. and Europe?
The general statement I’ve made is that I’d expect a full conversion to play out over a period of approximately two years. So that would say in Europe, you should expect at some point in the course of 2026 that really, substantially all of the usage has converted to MAGiC. The U.S. would probably have a quicker timeline than that, but it’s obviously starting later.
I understand. For GenesisX, it seems you are already engaging in discussions on the ground. While it's good that there is no need for major construction, have you explored alternative financing options? I recall you mentioning before the possibility of leasing or placing these systems. Has that been part of the conversations, or is it something you're planning to address later?
It's a great question. In Europe, we are actively discussing the commercialization of GenesisX and working on building a pipeline. In the U.S., it hasn't been approved yet, and we are incorporating it into our innovation strategy, but we are not commercializing or quoting it in the U.S. Currently, we are focused on ramping up manufacturing and supply chain. There is demand for acquiring systems, but we're not pushing anything at this point. In the coming quarters, we plan to present hospitals with three options: a purchase model, a leasing model, and a placement model with disposable revenue and capital commitment. We aim to present these options to hospitals concurrently without favoring any one model, which should help streamline adoption. At this stage, we are primarily discussing the sales model, but in certain situations with key opinion leaders, a leasing model might be appealing to encourage them to try the robotics system, as it would help raise overall awareness in the field. While our focus is still on the sales model, as we increase manufacturing and supply chain capabilities and move toward a full commercial launch, we will become more flexible between the three models. The main objective is to accelerate growth from having a base of 100 robots to 1,000 robots. Leveraging a good portfolio of catheters can make financing options like leasing or disposable commitments financially attractive and viable.
Great. I appreciate all the cover. I’ll jump back into you.
Your next question comes from Josh Jennings with TD Cowen. Please go ahead.
Hi. Good afternoon. Thanks, David and Kim. I wanted to ask David just as you’re building out your catheter portfolio, if we think about the commercial era where you have the MAGiC RMN ablation catheter, MAGiC Sweep high-density mapping catheter, and the Map-iT portfolio. I mean, how do you envision the case mix for robotic magnetic navigation cardiac ablation procedures evolving? Do you think the percentages of ventricular versus atrial, and I think you guys described in some of the cases that MAGiC catheter is being used in terms of your case mix? Would you expect that to change? Do you expect the platform to be utilized in more atrial ablations as well?
Thank you for the question, Josh. That’s a good one. To begin, you may have noticed at HRS the section of our booth where we showcased all the catheters, which was also included in our investor slide. It’s notable that a year ago we weren’t selling any catheters, and now we have 10 displayed, with eight of those expected to be commercial this year. Most of them are already in commercial use in at least one of the key regions. This marks a significant strategic shift for Stereotaxis. With 20 years of commercial experience, we’ve never sold our own catheter before, making this a substantial milestone for us. As for the case mix, we’re addressing all sides, and each of our portfolios, Map-iT, MAGiC, and EMAGIN, will lead to significant catheter revenue. Currently, most of our procedures involve VTs, PVCs, and congenital patients in electrophysiology, and we anticipate that trend will continue as we roll out our catheter portfolio. Our robotic magnetic mechanism of action provides the most value in complex cases where traditional manual catheters struggle with navigation, stability, or safety, which is our strength. This advantage helps us establish relationships with individual physicians. Once we gain rapport and they appreciate our offerings, we see increased adoption in SVTs and some atrial fibrillation cases. At this stage, we believe there is potential for significant growth, possibly 30 times larger in the VT, PVC, and congenital sectors, which is a lucrative niche for us. As we establish a presence, there is always the possibility to expand into other procedures. I think avoiding the intense competition in the AF market right now is also beneficial for our commercial team’s focus, allowing us to make a more substantial impact with the easier opportunities in complex ablations.
Makes sense. Thanks. I wanted to follow up on EMAGIN. I know you’ve been interacting with neurovascular physician experts over the years, and understanding that there’s some buzz that you’ve generated. I was hoping you could walk us through, I know this may be a review, but walk us through 510(k) approval of EMAGIN, 510(k) approval of GenesisX. Maybe how do you see the neurovascular community engaging and potentially adopting robotic magnetic navigation using the EMAGIN guide catheter, guidewire for some of the neurovascular cases over the next 12 months to 24 months? Thanks a lot.
Sure. Thanks. That’s a great question too. Our EMAGIN portfolio will initially have the EMAGIN 5F guide catheter. It’s a 5-inch guide catheter. We hope to submit by the end of this year also the 014 guidewire, which is a much, much smaller kind of, almost like the diameter of a piece of hair and a little wire. Those are kind of the two key families and each one of them will have kind of a family of devices that are relatively similar, but slightly different. The guide catheter has already been submitted, and so as we gain approval, there are certain procedures that are better suited for a catheter and others that are better suited for a wire. Let’s say in the neuro field, one of the areas where we expect the guide catheter to provide a lot of value is just navigating up the carotid. I think I might’ve mentioned on some previous calls, some of the feedback we were receiving from neuro-interventionalists was navigating from the aorta into the carotid and up the carotid in a subset of patients, whether it’s 15% or 20% of patients can be very, very difficult. They’ll spend 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes trying to do so, and sometimes they’ll fail completely. During that whole time they’re on X-ray, and obviously, if it’s a stroke case, that amount of time is critical for the outcome of the patient. Similarly, there are other cases that would be useful for the guidewire that are just kind of different or other parts of a case where a guidewire could be helpful. As we get the guide catheter approved, I would say that the guide catheter can work obviously with GenesisX, but can also work with Niobe and Genesis. The quickest, easiest adoption of the guide catheter will be in existing labs where they already have a robot, and an interventional cardiologist or radiologist wants to step into the lab and kind of try it in some complex cases. Essentially, every EP department is part of the interventional cardiology department. Even if you have a room that is a dedicated EP room, usually the cardiologists are literally right next door and able to use those labs. It’s probably more difficult for neuro-interventionalists to use an EP lab just because the other tools they have in a neuro lab are different. That would probably only take place in an existing Niobe or Genesis lab. If it was really part of a series of cases that were particularly difficult that they wanted to move into the EP rooms for that process. I’d see a slower but kind of good interest adoption in the neuro field, and probably that’s going to be predicated also on having GenesisX available. Also on some of our efforts that I kind of touched upon in some of the preferred remarks on making GenesisX compatible with various other X-rays in the field. We’re working on that in tandem. There are physicians in the U.S. from various hospitals who are very interested in the clinical value that Imagine can provide. As we get that on the market and as GenesisX is on the market, I expect we’re going to be able to establish GenesisX at a couple of hospitals at least and start to demonstrate the clinical value in the neuro world. You’re probably going to see more value being shown in interventional cardiology and interventional radiology just from existing installed base.
Understood. I appreciate that. Thanks, David.
Thank you, everyone. That concludes our Q&A session for today. I will now turn the call back over to David Fischel for closing remarks.
Okay. Thank you very much for all your questions and for the continued support. We look forward to working hard on your behalf over the coming quarter and speaking again soon. Thank you.
Ladies and gentlemen, that concludes today’s call. You may now all disconnect. Thank you for joining. Have a nice day ahead.