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

Good morning. Thank you for joining us for Stereotaxis Fourth Quarter and Full Year 2024 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. [Operator Instructions] 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.

Thank you, operator, and good morning, everyone. It's an exciting time at Stereotaxis. We are making significant broad-based progress in establishing the attractive foundations on which to grow a substantial company. In tandem with our quarterly results, this morning, we announced in separate press releases 2 significant milestones with FDA submissions made for key catheter innovations. Stereotaxis is in the midst of a major strategic transformation. I'll discuss our progress in greater detail in a moment, but this being our annual call, I want to first step back and briefly provide context for our mission, path and strategy. Stereotaxis' overarching mission is to improve endovascular surgery with robotics to become the intuitive surgical of minimally invasive endovascular interventions. It's a huge field of medicine with tens of millions of procedures performed annually, but with essentially no robotic adoption. Unlike robots in other fields, a robot in the endovascular space must control highly flexible devices navigating through tiny delicate blood vessels. This is particularly challenging and has led to a graveyard of failed attempts to address the field with Stereotaxis left standing as the battle-tested flag bearer for this mission. It's an important mission and there is significant room to improve patient care with the precision, safety and unique mechanistic and digital capabilities of robotics. Stereotaxis approached the technical challenge of navigating the tortuous, delicate and vascular anatomy with a unique mechanism of action using precise computer-controlled magnetic fields to allow for direct control of the distal tip of specialized interventional devices. Over the years, we refined the technology and demonstrated its clinical relevance and value in robust real-world use at over 100 hospitals that have treated over 150,000 patients. While our technology was advanced and differentiated, we suffered from key structural and strategic limitations. We didn't develop or sell the catheters needed in a robotic procedure, creating unhealthy dependencies, commercial and operational stress, limited innovation and a poor razor without the razor blade business model. Our robot was never advanced to the point where it could be easily adopted, limiting access to the hospitals interested in its benefits and making rapid scaling essentially impossible. We remain focused on one specific clinical application, minimizing the platform potential of our technology to help patients with a variety of diseases. Clear-eyed and intellectually honest on these issues, a comprehensive and elegant strategy was developed to address them. It was creative and required significant innovation, but was realistic for us to accomplish while controlling technological and financial risk. It's attractive as it addresses each of our core structural issues, establishes a solid foundation for a healthy business, provides strategic independence and sets us up for commercial breakout. Most importantly, for the patients and physicians that rely on us, our innovations improve and broaden our positive impact. Our strategy rests in 4 primary pillars. First, making our robot widely available by innovating it such that it doesn't require construction and can be rapidly installed in the majority of labs. Second, building an ecosystem of catheters and integrations in our core EP ablation market, so physicians have greater choice in technologies while we reduce our dependencies and build an attractive razor blade business. Third, developing the right interventional devices so that our robot becomes a platform for endovascular surgery more broadly, providing value in several new clinical indications. And fourth, establishing a digital backbone that introduces connectivity and AI to our robot and the broader cath lab environment. Over the last decade, we've invested significant effort and many tens of millions of dollars advancing these 4 pillars. We have progressed in parallel, and we are in the late stages of bringing the strategy through key regulatory and commercial milestones. While most of this progress was done organically, we made a significant leap forward last year with the strategic acquisition of APT, which brought us in-house advanced catheter development and manufacturing capabilities to complement our internal robotic expertise. There being so many moving parts to our innovation strategy, I'll touch upon each key technology and the recent milestones and near-term regulatory and commercial expectations. The GenesisX robot received CE Mark in Europe and was submitted for U.S. regulatory approval in the third quarter of last year. Initial commercial launch in Europe required availability of a compatible catheter. And so with receipt of MAGiC catheter approval in Europe in January, we announced the first firm order for a GenesisX robot. We expect installation and first use of GenesisX at that European hospital this summer. It will be an important milestone to demonstrate the working reliably in the rigorous environment of daily clinical use. In the U.S., we received questions from the FDA in October, the majority of which were very technical and focused on cybersecurity. We decided to make software updates to enhance technology cybersecurity, have completed the development and testing of those updates and plan to imminently submit our full response to all of FDA's questions. In tandem, we've been working to enhance compatibility of the robot with various X-rays and preparing our supply chain manufacturing, installation and commercial properties processes for a full launch. Given the revolutionary ease with which we can now install a robot, we are bringing fully functional GenesisX robots to the 2 most important electrophysiology conferences in our field, the European Heart Rhythm Association Conference at the end of this month in Vienna and the Heart Rhythm Society Conference in April in San Diego. Having GenesisX at our booth and being able to navigate a portfolio of EP and vascular catheters with it is a very tangible demonstration of the dramatic technological transformation taking place. With market visibility of GenesisX at these conferences and first commercial use in summer, we are setting the stage for a successful full launch of GenesisX in both Europe and the U.S. in the second half of this year. We believe it's reasonable to expect a few GenesisX system sales this year, scaling to double-digit number of systems next year. Shifting to the portfolio of catheters. A few weeks ago, we were excited to announce European CE Mark approval of the MAGiC ablation catheter. Regulatory approval capped a significant multiyear development, clinical and regulatory effort. As I mentioned in that announcement, we are grateful for all those who contributed to advancing the catheter and look forward to the substantial impact MAGiC will have. Since the approval, we've been busy working through initial administrative efforts across our EU hospitals and the necessary manufacturing and supply chain activities. We expect first sales of MAGiC at multiple hospitals in March and for that to scale to approximately $1 million of MAGiC revenue per quarter in Europe by the end of this year. In the U.S., we continue working closely with FDA on the PMA regulatory submission. We appreciate FDA's constructive dialogue and a continued thorough review of our submission. In parallel, we continue to enroll patients in the ongoing study in Europe to support the specific label discussed with FDA. We believe U.S. MAGiC approval in the second half of this year to be a reasonable time line. Our pipeline of robotic EP catheter innovations goes far beyond MAGiC with high-density mapping and pulse field ablation being the most exciting and impactful efforts in our nearer-term pipeline. We're delighted this morning to be able to announce regulatory submission of MAGiC Sweep, the first-ever robotically navigated high-density mapping catheter. High-density mapping has transformed EP field and the availability of a robotic high-density mapping catheter offers new clinical benefits to our EP users, expands the value proposition of robotics as a whole and provides for significant incremental commercial opportunity. A highly prominent EP KOL, one who used us regularly but is not currently an active user, was quoted in today's press release describing the importance of the catheter and how the lack of a mapping catheter has held back overall adoption of robotics. MAGiC Sweep promises rapid and detailed electroanatomical mapping with the precision and inherent safety of our technology, the ability to map otherwise difficult to reach areas of the heart and more anatomically accurate maps by avoiding distension caused by rigid catheters. There is a substantial body of VPs who think similarly to that KOL and are excited to use the catheter. MAGiC Sweep is a 510(k) submission, and we expect regulatory approvals in both Europe and the U.S. in the third quarter. The revenue opportunity for MAGiC Sweep is similar in scale to the MAGiC ablation catheter. We expect MAGiC and MAGiC Sweep to increase our disposable revenue per procedure approximately fivefold. Having MAGiC Sweep available should also expand the pipeline of users of robotics. In PFA, we have continued to make progress with several partners in robotic PFA catheter solutions. We have an extensive preclinical testing with 3 such partners now, each an independent shot to bring a good solution to market. We expect at least one of these solutions to enter first-in-human testing this year and believe one could be available commercially in Europe within a year from now. While PFA is dramatically impacting the overall cardiac ablation market, Stereotaxis' clinical use has predominantly focused on complex VT, PVC and congenital arrhythmias in which robotics enables procedures that would otherwise be very difficult to be done successfully, safely or at all. This focus largely shields us from the competitive dynamics currently playing out in the field, those dynamics are distracting for our customers. Having a PFA solution further advanced in our pipeline will be beneficial in addressing the longer-term aspirations of our customers. In an additional press release this morning, we shared a second regulatory milestone with FDA submission of EMAGIN, our first-ever vascular catheter. Development of a family of interventional guidewires and catheters expands the benefits of our robots into multiple new endovascular indications by enabling efficient and safe navigation to otherwise difficult-to-reach vascular anatomy. EMAGIN 5F is a robotically steered 5-French catheter and the first catheter in this portfolio. There are several large medical device markets within neuro interventions, interventional cardiology and interventional radiology where we believe EMAGIN can be helpful. The catheter was a 510(k) submission, and we expect regulatory approvals in both Europe and the U.S. in the third quarter. While the short-term revenue contribution of EMAGIN will likely be modest, the strategic value is substantial. Our near-term focus following approval will be to demonstrate the clinical utility of our robot in the treatment of stroke, cancer and several cardiovascular diseases. As that clinical value is substantiated, it significantly expands the value proposition of our robots to hospitals and multiplies our addressable market. So this has already been a long set of updates. There are 2 other material innovations to discuss. In China, our partner, MicroPort, recently received regulatory approval for the Genesis robot, Magbot catheter and integrated Columbus mapping systems. Approval of this product ecosystem allows MicroPort to begin commercial efforts in China, where we see significant opportunity for our technology given the EP market size, the interest in our technology and the alignment with a large local partner with an existing EP sales force. I was in China 2 weeks ago visiting our partners there. We have good engagement and there is excitement about our opportunity, though it's difficult to estimate near-term commercial results. We have a pipeline of over a dozen hospitals with demonstrated interest and engagement in the sales process, though the macroeconomic environment and anticorruption campaigns are significant headwinds. MicroPort is also still working on nearer-term structural items that will help adoption, such as pursuing regional reimbursements for the Magbot catheter and submitting Genesis for various provincial programs. The final significant innovation effort nearing regulatory milestones is our digital surgery platform that enables operating room connectivity and smart AI capabilities in the cath lab. Synchrony and SynX digitized the various disparate systems in the cath lab, allows for seamless control of all those systems from a consolidated cockpit, offer modern cloud-based connectivity between the lab and the external world and provide attractive opportunities for smart AI features to be integrated into the operating room. The technology was originally intended for use alongside a robot has been designed also as a very attractive independent offering across non-robotic cath labs. We've been working through formal regulatory testing and software refinements to Synchrony and SynX with plans to unveil the system at HRS in April with regulatory approvals first in Europe and then in the U.S. midyear. Synchrony hardware will provide an incremental upfront capital sales opportunity, while SynX will be available with a freemium SaaS business model. The commercial impact of this technology will likely be modest this year with expectations of approximately $1 million in revenue, but we believe this will grow significantly in 2026 and beyond. As you can see, it's a particularly busy and exciting period full of meaningful regulatory and initial commercial efforts for several technologies across 3 key geographies. It will be the year in which we 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 sets us up for breakout growth as we look towards 2026. Kim will now provide additional commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A.

Thank you, David, and good morning, everyone. Revenue for the fourth quarter of 2024 totaled $6.3 million, a 39% year-over-year increase compared to $4.6 million in the prior year fourth quarter. System revenue for the fourth quarter was $1.4 million compared to system revenue of $0.1 million in the prior year fourth quarter. Recurring revenue of $4.9 million reflects a full quarter's contribution from our recent acquisition of APT and compares to $4.5 million in the prior year fourth quarter. Revenue for the full year 2024 totaled $26.9 million compared to $26.8 million in 2023. Full year system revenue was $8.6 million compared to $8.7 million in the prior year, and we started 2025 with system backlog of $15.2 million. Full year recurring revenue was $18.3 million compared to $18 million with continued catheter shortages by Johnson & Johnson offset by the contribution of APT. Gross margin for the fourth quarter and full year 2024 were approximately 51% and 54% of revenue. For the full year, recurring revenue gross margin was 70% and system gross margin was 20%. Recurring margins remain negatively impacted by the accounting related to the acquisition of APT, which causes minimal accounting gross margin on the sale of acquired inventory. We expect to work through this inventory by the middle of this year and recurring margins to benefit accordingly. System gross margin continues to reflect the allocation of significant overhead expenses on low production volume. Operating expenses in the quarter of $10.8 million included $2.5 million in noncash stock compensation expense and a $1.1 million noncash mark-to-market adjustment for acquisition-related contingent earn-out consideration. Excluding these noncash charges, adjusted operating expenses were $7.2 million. Adjusted operating expenses for the full year 2024 were $27.4 million compared with $26.2 million in the prior year. Operating expenses in the fourth quarter and full year include the addition of APT operating expenses following closing of the acquisition. Operating loss and net loss in the fourth quarter of 2024 were $7.6 million and $7.5 million compared with $5.3 million and $5 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding noncash stock compensation expense and the mark-to-market adjustment were $4 million and $3.8 million compared with $2.7 million and $2.4 million in the previous year. For the full year 2024, adjusted operating loss of $12.8 million and adjusted net loss of $12.1 million compared to an adjusted operating loss of $11.3 million and an adjusted net loss of $10.2 million in the prior year. Positive free cash flow of $1.3 million for the fourth quarter reflected cash receipts on previous system revenue. Negative free cash flow for the full year was $8.5 million compared to $9.5 million for the full year 2023. At December 31, Stereotaxis had cash and cash equivalents, including restricted cash of $12.4 million and no debt. I will now hand the call back to David.

Thank you, Kim. I'll add a few comments on how we're looking at both revenue and cash use over the coming year. With many moving parts and product launches, equity guiding revenue is changing. Throughout the prepared remarks, I provided color on how various individual product launches can impact revenue. For capital in 2025, it is prudent to expect revenue to remain approximately flat with 2024 with system revenue in any given quarter of $2 million to $3 million. This does not assume significant sales in China and reflects modest GenesisX assumptions as a full launch in the second half of this year will more significantly contribute to 2026. Recurring revenue should steadily grow throughout the year with increasing contribution from an expanded portfolio of catheters. We currently expect $5 million of recurring revenue in the first quarter growing sequentially over the course of the year to $7 million in the fourth quarter. The cumulative result of both our capital and recurring revenue expectations lead to double-digit annual growth in 2025. Regulatory milestones and early commercial efforts this year set us up for more substantial growth in 2026. From an expense and cash perspective, we expect to keep adjusted operating expenses flat over the next few quarters as our existing commercial team is well suited to manage the initial commercial rollout of our technologies. As we progress through commercial launches, we plan to continue investing in our commercial capabilities with this investment funded by the incremental profit from those new product launches. In 2024, we used about $8 million in cash. Our burn rate in 2024 was lower than 2023 despite significant costs related to the acquisition and integration of APT. With growing recurring revenue and stable operating expenses, we expect reduced cash use in 2025. We view our existing balance sheet as allowing us to reach key milestones, commercialize our innovations and profitably grow. We'll now take your questions. Operator, can you please open the line to Q&A?

[Operator Instructions] Our first question comes from the line of Frank Takkinen from Lake Street Capital Markets.

Congrats On all the progress. David, I was hoping I could start with just a little bit more color around MAGiC in the U.S. market. I know you said likely a second half approval, but maybe kind of walk us through where we are today and what needs to occur between then and now to be on time with the second half approval of MAGiC?

Sure. So we mentioned in the prepared remarks a few things. We are enrolling patients in Europe, continuing to enroll patients in Europe with specific indications that meet the unmet medical need criteria that FDA wanted for our label. And so that's kind of ongoing. And there's not a definitive number that we need to reach. So I don't think that's going to be a gatekeeper to regulatory approval, but that is helpful for the approval process, the more patients we enroll in that. And so that's ongoing in Europe. In the meantime, the FDA has been doing a very detailed review of the PMA submission. We received questions during that process. And then we kind of respond and kind of -- we respond to those questions and kind of refine the submission based on those questions. And so that's kind of ongoing in parallel. And those are kind of the 2 main bodies of efforts that are ongoing. Obviously, a regulatory review has many different sections. It's not split out the same way as it is in Europe, where you have kind of those 3 sections and you're giving questions in each one and you have to respond to each one. It's more comprehensive review of the entire submission, but those are each. There is the opportunity also for an audit of the manufacturing facility in Germany, though that's -- it's not clear that that's going to be necessary. But that's kind of -- that's something that could take place close to approval. And so those are the things that kind of are going on in parallel, and it is a substantial amount of our effort internally is to make sure we're able to respond to FDA and to kind of run that progress forward. FDA is aware of kind of some of the challenges in the field given our dependencies on Johnson & Johnson and how those have harmed some of our users and the patients that they want to treat. And so FDA is working on this in a very collaborative fashion to try to make sure it could do a thorough review in a timely fashion.

Got it. That's helpful. And then maybe moving over to Sweep. Can you just talk a little bit about how this is going to fit into the broader ecosystem and how it may or may not impact your relationship with Abbott and that mapping collaboration?

Sure. So MAGiC Sweep is a high-density mapping catheter. In the majority of robotic procedures now as it is in the majority of manual procedures, a physician will use a high-density mapping catheter prior to the ablation portion of the procedure. So they -- while they're standing -- even in a robotic procedure, while they're standing at the bedside, gaining access to the patient, introducing sheets, they'll -- typically, in a robotic procedure up till now, they will introduce a high-density mapping catheter, whether it's a PENTARAY or an HD grid or something similar. And they'll start to move it around manually, build out a high-density map of the heart chamber. And then once they have a high-density map, they will pull it out, insert a robotic ablation catheter, unscrub, go sit behind the computer and perform the ablation portion of the procedure robotically. So that's kind of a very typical workflow, I'd say, in the majority of our cases. It is different schools of thought in electrophysiology. There's a lot of heterogeneity in procedures though. So it isn't -- there's no kind of one workflow fits all, but that is a very common one. And there are -- there's a large body of EPs that view the mapping portion of the procedure as the most important part of the procedure, and they'll spend the majority of the time of a procedure mapping rather than ablating. And so for those physicians, doing the majority of the procedure manually and then unscrubbing and putting in a robotic ablation catheter to do a short portion of the procedure never felt worth it. And so they have kind of over the years, and this has played out really over almost 10 years already, they've kind of stopped using the robot. And so having a high-density mapping catheter that is robotically driven and that provides those same kind of core benefits of safety, of being able to reach any area you want, of being able to go to places with precision, those are core value propositions of our robotic mechanism of action, which also have a lot of pull in the mapping portion of the procedure. And so that's kind of where we see significant value. This has been something asked by us for years and years and years, and this is actually how we were first introduced with APT and why the relationship with APT originally started long before we ever imagined doing an acquisition. And so that's there. We have kind of -- our partners are fully aware of this development. It is part of a broader strategy, which includes other catheters we've not yet discussed. And so I think there's no concern or harm about how this comes out with our partners. They're well aware of everything we're doing.

Our next question comes from the line of Adam Maeder from Piper Sandler.

Congrats on the EMAGIN Vascular and EP mapping submissions. Maybe just to start on the system, the guidance, David. I just wanted to kind of unpack that. I think you said $2 million to $3 million per quarter for 2025 for system revenue, a little bit below the Street. So just maybe help us better understand that because it does feel like you have tailwinds for this segment with the GenesisX launch in Europe. You have Genesis in China, perhaps that's more back-end loaded. And then you have the system backlog, which is $15 million plus heading into 2025. So I guess the question is kind of how much of this is conservatism? Is it a revenue recognition kind of dynamic and streetness modeling? Or is there something that's kind of -- is there a headwind here that's emerged that we're not contemplating? So maybe just again, kind of walk us through all that. And then -- sorry, one clarification would just be on GenesisX commercial timing in the U.S. Did you give an update there?

Sure. Thanks a lot for those questions. And so when we look at system guidance, I think we want to be -- we want to put in things -- as you've seen over previous quarters, there is huge volatility in any given quarter and kind of -- and difficulty in estimating correct timing of revenue recognition kind of in any quarter. And so we wanted to give kind of guidance that's based on, first, our backlog and the backlog that we are very confident of transitioning into revenue recognition, given kind of construction that's ongoing or kind of timing where we already have timing alignment with the hospital when we're shipping a system. And so that is obviously the majority of the expectation for this year is a transition of some of our Genesis backlog into revenue based on kind of what we know actually is being constructed and being shipped. And then we have, obviously, our GenesisX order that we just received, and that will also become revenue recognition soon upon shipment. And otherwise, we're being very conservative. Like I mentioned in the prepared remarks, I was in China 2 weeks ago. I was spending a lot of time with our partners. We have a pipeline of interested physician and hospital customers. There is actual engagement on sales processes, but it is tough to estimate. Should we have 1 or 2 system sales in China this year? Should we have 5 system sales in China this year? It is very, very hard to estimate that. And so it feels better not to estimate that and to let that play out, however, it does. And if we have opportunities to increase guidance in the future to beat our guidance, that sounds like a better way to play things than trying to estimate a best guess at this point. And so those are kind of some of the color, I guess, going on in our minds as we think about the guidance.

That's really helpful, David. And just the timing for GenesisX commercial approval in the U.S., do you have an update there? And then I had 1 follow-up.

Sure. So we mentioned kind of for approval of GenesisX in the U.S., we're going to be responding very, very soon to the questions that were sent to us by FDA. I don't see any real concern in those questions or in kind of the approval process for GenesisX. We went through kind of similar approval just a few years ago with Genesis. So I kind of -- I see that as a low-risk regulatory process. I think we're going to have GenesisX approved before we have either of the compatible catheters that could be used with it. And now the portfolio of compatible catheters that could be used with it kind of in order to make GenesisX useful in the U.S. would be, obviously, the MAGiC ablation catheter, but also MAGiC Sweep or the MAGiC 5F. Any of those 3 catheters could be the first one to get approved would be compatible with GenesisX and would allow for initial use of GenesisX in the U.S. And so hopefully, we'll get one of those approved in the third quarter is our expectation and at least more than one of those approved in the third quarter is our expectation. And so that's -- that would kind of allow us to start the commercial launch then.

And for the follow-up, I wanted to ask about the vascular guidance catheter, EMAGIN. So maybe just help us understand kind of what's assumed in the guidance. It doesn't sound like there's much there, but wanted to see if you could give us a little bit more color. And then in terms of the indications and pecking order, I saw neurovascular, I saw RDN, I saw complex PCI, I saw oncology kind of all listed in the press release. So just kind of help us think through kind of how you're going to prioritize that? And how do you monetize those opportunities?

Sure. So you're right that there is not any real expectation of revenue from the EMAGIN 5F catheter in our guidance. I think that even if you sell -- you have a 100 or a few hundred catheters sold, but in the end of the day, it's in the low 6 figures. So it's not something that's worth putting into guidance at this point, given also the uncertainty on regulatory -- when we're going to get regulatory approval exactly. But that is getting EMAGIN out in the real world is one of the most exciting things for me, and I think one of the biggest strategic value drivers for Stereotaxis. And we have always been a single specialty robot that is not doing justice to the potential of this technology to really become a platform broadly in endovascular surgery. And the beauty of the EMAGIN portfolio of catheters and wires and how those can enable our robot to become a multi-specialty platform robot is that we are not building the therapeutic devices themselves. We're building guidance devices, and that fits into our core value proposition of navigating tortuosity efficiently and safely. And so that kind of -- our EMAGIN catheter can enable a whole range of procedures like the ones you mentioned, and you can still use whichever therapeutic device, which the physician prefers to use. And still there's kind of enough value added, as you saw from some of the quotes in our press release, there is kind of a lot of expected value to be added in those procedures. And so it will be, I think, very, very exciting as we're able to start to demonstrate the first 10, 20 procedures done in this specific industry, treating ischemic stroke or in treating renal denervation or in treating complex coronary cases or lower limb peripheral cases or AAA graft cases. There's a series of each one of them being substantial medical device markets where we think we can add meaningful clinical value and being able to start to demonstrate that and transitioning the image of Stereotaxis out there in the world from not just being an EP robot, but being a platform endovascular robot, I think that is one of the biggest value drivers for the company possible. And I think we're going to do very nicely there over the next couple of years.

Our next question comes from Jason Wittes from ROTH Capital Partners.

I guess kind of a follow-up to the guidance, what's in the guidance. Am I right to assume there's only roughly $3 million to $4 million related to the MAGiC launch in Europe and nothing related to the U.S. launch -- potential U.S. launch in the second half for MAGiC in guidance right now?

Yes, we didn't put anything for U.S. MAGiC revenue in the guidance. We don't know exactly when the time line of approval is. So it felt safer to focus on the disposables where we do have kind of much more confidence and visibility in their timelines, which is obviously MAGiC in Europe and kind of a little bit for MAGiC Suite in Europe and the U.S. in the back half of the year.

And is there capacity constraints related to MAGiC or are you ramping up manufacturing as we speak? How do we think about that?

We're ramping up manufacturing as we speak in Europe. And so kind of the 2 big efforts are on the one side, working with every hospital to get kind of through whatever administrative processes are required at each hospital. You have to submit your pricing. You have to usually submit various regulatory documentation to the hospital. Many of them have their own questionnaires that you have to fill out and you have to just work through that administrative process. And then on the second side is the ramping of manufacturing. And so those are kind of the 2 main efforts that are -- they'll be ongoing throughout the year. Some of those will fall very quickly, and that's why we have some sales that we expect already now in this month. And then there's others that the administrative process at hospitals will take 3 months, 6 months, even 9 months sometimes, depending on if there's tenders required in those countries.

And then you mentioned the mapping catheter. Just curious in terms of -- well, 2 things related to this. One, what kind of frequency do you anticipate that being used with MAGiC or whatever other catheter they may use? And then secondly, I think you gave a number where you think that I think those 2 catheters combined should increase catheter sales fivefold. Is that the right -- I'm just curious kind of what the math is behind those assumptions.

Yes, sure. That's a great question. And it's interesting. I think that kind of in the majority of our procedures right now, high density -- a manually held high-density mapping catheter is being used in the robotic procedure. And when I say majority, it's not 55%, and it's not 85%, it's probably somewhere in between there. So I guess roughly 2/3 of the procedures, 70%, 75% probably use a high-density mapping catheter. So it's a good amount that use it. I believe that when a robotic user is doing a robotic case and there is an available robotic high-density mapping catheter, I think that will be a very attractive solution for them. And so I think you're going to see a good uptake there. We're obviously going to have to prove, right? Like everything new, you're going to have to demonstrate it and they're going to have to experience it and then they're going to have to kind of gain their internal confidence to transition on their own. But I think that that's going to be kind of an attractive offering. Again, it's something that's been asked of us for years, really years by many, many physicians to do something like this. So I think it will be exciting. And I think there will be also new users who just have always kind of seen that, let's say, even at hospitals that have a robot that have seen the robot there, they know it exists. They just say, if I'm already doing the majority of my procedure, the mapping portion manually, why should I use the robot? And I think this will allow us to engage with those physicians much better and to increase the pool of users of our robot in total. So I don't know what exactly the capture rate will be in terms of our procedures, whether it will be 50% or 70% or it could be even in some ways, kind of 1:1 if you start to have some users who start to use MAGiC Suite who weren't using otherwise our robot for ablation. So it could be kind of somewhere in that range probably in terms of the capture rate of a robotic mapping catheter. And then the ASPs are relatively similar between an ablation catheter and a high-density mapping catheter. There aren't substantial differences in different countries, it's slightly different, but they're relatively similar. And so when you look at our approximately global average ASP of $1,000 per procedure that we make currently on our disposable, the QuickCath disposable and you add on top of that expectations for MAGiC and MAGiC Sweep, it does increase our revenue per procedure by more than fivefold. And so that's where that kind of those statements came from.

There are no further questions at this time. David Fischel, I'll turn the call back over to you.

Okay. Thank you very much for the questions and for the continued support. We look forward to an exciting couple of months and speaking again in May. Thank you.

The meeting has now concluded. Thank you for joining. You may now disconnect.