Stereotaxis, Inc. (STXS)
NYSEAMERICAN: STXS · Real-Time Price · USD
1.860
-0.070 (-3.63%)
At close: Apr 28, 2026, 4:00 PM EDT
1.850
-0.010 (-0.54%)
Pre-market: Apr 29, 2026, 8:31 AM EDT
← View all transcripts

Earnings Call: Q1 2023

May 9, 2023

Operator

Good morning. Thank you for joining us for Stereotaxis's Q1 2023 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 in 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.

David Fischel
Chairman and CEO, Stereotaxis

Thank you, operator, and good morning, everyone. Our last call two months ago included a fairly comprehensive overview of Stereotaxis and our strategy. We will keep today's call more brief, focusing on a few commercial and innovation updates. Revenue in the Q1 was essentially identical to last year's Q1, barring the royalty payments that we no longer receive from Johnson & Johnson. System revenue in the quarter reflects partial revenue recognition on the shipment of one Genesis system that is completing installation as we speak. During the Q1 and subsequent to our last earnings call, we received a purchase order for a Genesis system from a U.S. hospital. We received another Genesis system order from Europe so far this quarter.

The combination of the partial system revenue recognition out of our backlog and the additional order into our backlog slightly increased quarter end system backlog to just over $50 million. Hospital construction has remained relatively slow, weighing on the speed with which backlog converts into revenue and then into installed active robots. That said, we have a fairly busy schedule of installs planned over the coming months and continue to expect the majority of our backlog to be recognized as revenue this year. Since the launch of Genesis three years ago, we have now received orders for 22 robotic systems. Building a capital sales capability, process, and infrastructure has taken time and required significant effort, but these 22 orders over three years is a dramatic turnaround from the period prior to Genesis when only one system was ordered over the same time frame.

Of the 22 robots ordered since our launch, nine have been installed and are doing procedures, five have been shipped to the hospital customer but are not yet installed or launched, and eight remain in backlog waiting to be shipped. Our orders have been broad-based geographically, with just over 50% of orders from the United States and approximately 25% each from Europe and Asia. They are also evenly split between greenfield robots and upgrades, with 11 of each. We are continuing to improve and refine our commercial capabilities and expect as we do so to see increasing orders of Genesis. Our capital pipeline looks healthy and is seeing growth across our three focus regions. We have a few dozen, approximately 50, unique opportunities in our near-term pipeline where we see a possible order over the next 12 months.

Order flow remains lumpy, the macro environment remains pressured, and we have still not fully benefited from a normalized replacement cycle. Given the engagement we see from the bottom up, there's increasing confidence in a consistent flow of orders. Most important to the adoption of robotics is the enthusiastically positive experience of the physicians who are using Genesis, along with the reliability and clinical value Genesis robots are demonstrating in the field. Engaged and happy customers who are able to provide great care to their patients and build successful practices are the best ambassadors through which to ultimately increase awareness, change historical misperceptions, and grow adoption. We are pleased with the procedure utilization we are seeing on Genesis robots, which is meaningfully higher than our average global utilization.

This is playing out both at accounts that upgraded to Genesis and with those that established entirely new robotic practices. Last month, I had the opportunity to meet physicians from two of our most recent greenfield Genesis launches, Poland's National Institute of Cardiology and Broward Health Medical Center in Fort Lauderdale, where at both we have happy and excited users who are grateful for our technology and are using it to treat patients in ways that meaningfully improve the quality of care and access to care. Discussions like those reinforce the positive impact of our technology and the relevance and importance of robotics for the field. Our overall experience with Genesis serving as the spark to restart capital adoption and to support utilization is a reminder of the significant impact innovation has on commercial results. This segues well into a few in innovation.

On our last call, we discussed in detail the key efforts in our strategic innovation plan and how they deliver meaningful clinical, commercial, and strategic value. Apart from the minority of our users who have been able to upgrade to Genesis, most existing robotic electrophysiologists have remained limited to using essentially the same ecosystem of robot, catheter, and mapping technology for over a decade. Stereotaxis' proprietary robotically navigated ablation catheter, MAGiC, is set to positively address this. Since our last call, we have made significant progress on both the EU and US regulatory paths for MAGiC. In Europe, we have been awaiting receipt of the full spectrum of technical, clinical, and microbiology questions from the EU regulator.

We have now received questions across all three of those categories and have fully responded to all the questions in what we believe to be a comprehensive and thoughtful manner supportive of CE mark. It would not be surprising to receive follow-up questions to our responses, but we believe our previously communicated timeline is reasonable and still see receipt of CE mark as most likely to occur late in the Q2 or in the summertime. In the U.S., submission of an IDE application to the FDA has been dependent on successfully completing 12 preclinical studies.

As of our call two months ago, we had established a GLP-level institutional animal care and use program and run a few pilot cases, but had not yet performed those on the record studies. We completed all the required studies since that call and will complete all the required follow-up periods within the next two weeks.

The results we have seen and physician feedback we received is very supportive of our confidence that the catheter performs well and will be enthusiastically adopted by the community of robotic users. Given this progress, we expect to make an IDE submission to the FDA in the Q3. Our other major innovation efforts, including a smaller self-shielding robot that frees us from the extensive planning and construction currently necessary to adopt robotics. A family of interventional guide wires and guide catheters that expand the benefits of our robot into new endovascular indications. A digital surgery, hardware, and software offering enabling broad operating room connectivity. And a full electrophysiology product ecosystem being built in collaboration with MicroPort. There's a significant amount of work and progress being made on each of these in parallel.

As we provided much more color on each of these during our last call, I'll just reiterate that the timelines communicated on that call stand. We have line of sight to reaching multiple significant regulatory and commercial milestones this year, with growing commercial impact from each of these technologies next year. As these technologies come to market, we will host focused innovation days to present these technologies in greater detail. While the optics of Stereotaxis' financial results are unexciting, we see ourselves as being on the cusp of a strategic transformation. We have clear line of sight to a future with strategic independence, an attractive revenue model, broad robot accessibility, and platform indication opportunity. This core product ecosystem serves as a foundation for a high-growth, high-value med tech company pioneering endovascular robotics.

Kim will now provide some commentary on our financial results. I will make a few financial comments as well before opening the call to Q&A.

Kimberly Peery
CFO, Stereotaxis

Thank you, David. Good morning, everyone. Revenue for the Q1 of 2023 totaled $6.5 million, down from $7 million in the prior year Q1, primarily due to discontinued royalties from Johnson & Johnson. System revenue of $1.8 million reflects revenue recognition on the delivery of one Genesis system. Recurring revenue for the quarter of $4.7 million was predominantly impacted by the absence of the J&J royalty, along with a smaller impact caused by J&J catheter production shortages, which pressured procedure volume. Gross margin for the Q1 of 2023 was 59% of revenue. Recurring revenue gross margin of 79% remains similar with recent quarters, with the loss of royalty impacting otherwise operational improvements. System gross margin of 7% continues to reflect significant allocation of overhead expenses over low manufacturing volumes.

Operating expenses in the quarter of $9.5 million included $2.6 million in non-cash stock compensation expense. Excluding stock compensation expense, adjusted operating expenses were $6.9 million, compared to the prior year adjusted operating expenses of $6.5 million, reflecting increased spending in R&D. Operating loss and net loss in the Q1 were $5.6 million and $5.3 million, compared to $4.1 million for both in the previous year. Adjusted operating loss and net loss for the Q1, excluding non-cash stock compensation expense, were $3 million and $2.7 million. Negative free cash flow for the Q1 was $3.2 million. At March 31st, we had cash and investments of $26.8 million. I will now hand the call back to David.

David Fischel
Chairman and CEO, Stereotaxis

Thank you, Kim. As detailed in today's press release, we are reiterating our expectation of double-digit revenue growth for the year, given our existing system backlog and the view we have into our near-term system pipeline and installation schedule. System orders are also expected to increase in 2023 compared to 2022. Genesis system revenue remains the primary driver of overall revenue growth until we start to see more meaningful commercial contribution from our innovation strategy in 2024. Our core recurring revenue business remains relatively sticky and stable, and we expect will be boosted significantly as we bring the MAGiC catheter and vascular interventional devices to market. That said, procedures and disposable revenue in the Q1 were slightly pressured by catheter shortages J&J experienced due to supply chain and production challenges.

These challenges have continued into April. We are told by J&J that they will be addressed by the end of the quarter. We expect some impact from this, likely in the low hundreds of thousands of dollars during the Q2. Situations like these further reinforce the strategic, operational, and financial value of the MAGiC catheter and having control over our own destiny. As we advance our innovation strategy to market, we maintain a balanced financial posture. We are investing in the organizational infrastructure and capabilities that will allow us to drive significant revenue growth from those innovations. At the same time, we remain financially prudent to ensure that our existing balance sheet can comfortably fund all our innovation efforts and commercial launches without the need for additional financing. We look forward to now taking your questions. Operator, can you please open the line to Q&A?

Operator

Thank you. At this time, we will now conduct today's question and answer session. To ask a question, please press star then the number 1 on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. We'll take our first question from Joshua Jennings with TD Cowen. Your line is now open.

Joshua Jennings
Managing Director and Senior Research Analyst, TD Cowen

Hi. Good morning. Thanks a lot for taking the questions.

David Fischel
Chairman and CEO, Stereotaxis

Hi, Josh. Good morning.

Joshua Jennings
Managing Director and Senior Research Analyst, TD Cowen

Good morning. Thanks. wanted to ask about just the replacement cycle, channel. Are you seeing any cracks in terms of that opening up, and what do you think needs to happen for that replacement cycle opportunity to start to kick in more fully?

David Fischel
Chairman and CEO, Stereotaxis

Sure. It's been interesting because when we started this then with the launch of Genesis around 3 years ago, we were always talking about the typical traditional 10-year cycle by which capital equipment gets replaced, and by capital equipment, we mean mainly X-rays in cath labs. Clearly that has been extended over the last few years, where we now have multiple systems that are even 14, 15 years old out there in the field.

I think in the past I've mentioned that it's unclear how much of that extension of the life of X-rays is due to cyclical nature, just the macroeconomic environment and the financial pressures that hospitals have been under versus a secular change due to perhaps the reduced use of X-ray overall and so the longer life that they can exist before needing to be replaced. Probably the truth is a mix of both. Either way, we have not seen that contraction in that age where people are now starting to replace X-rays earlier. It seems like the average age of an X-ray is definitely extending in most settings beyond 10 years.

We are starting to see as some of these sites become very old, we are starting to see obviously much more of a contribution from the replacement cycle. Of the two orders that we just mentioned, one was a replacement order, one was a greenfield order. I would expect still that in our normalized level, we should probably be receiving high single-digit number of replacement systems a year. We've still not gotten to that point. We're still probably in the mid-single-digits. We probably still have a little bit of room to go to get to a more normalized level.

Joshua Jennings
Managing Director and Senior Research Analyst, TD Cowen

Understood. wanted to ask a question about potential just, you know, your drive for an open ecosystem within the EP world. Are there any potential advancements with, say, an Abbott to integrate your robotic magnetic navigation technology into the InsideX mapping platform or any other mapping system integrations that we should have on our radar for this year?

David Fischel
Chairman and CEO, Stereotaxis

Sure. We can't comment on any type of collaborative activities that we would be doing prior to them being announced. I'd say that we've talked obviously about the importance of open ecosystems more generally for progress of the medical field and for patient care and for physician choice, and then more specifically also for Stereotaxis in being able to pair the benefits of robotics broadly with a range of diagnostic and therapeutic technologies. That concept of an open EP ecosystem is an important one. I think we've made quite a lot of progress on it over the last few years, and there's obviously more progress to be made. I'd say stay tuned, and we look forward to sharing updates as we're able to.

Joshua Jennings
Managing Director and Senior Research Analyst, TD Cowen

Great. Just one last question. Sorry to sneak one more in, but You know, this pulsed field ablation race in terms of getting a commercial cath in the United States is on the major cardiac ablation catheter players, kind of teed up to get approvals over the coming, you know, 12, 18, 24 plus months. I guess how would you have investors think about the role that robotic magnetic navigation system like Genesis or GenesisX could play and could potentially enhance one of these larger players' platforms and help them, you know, win this race, this PFA race? Thanks for taking all the questions, David.

David Fischel
Chairman and CEO, Stereotaxis

Sure. We obviously see what's going on in the field and overall, view kind of what, you know, how PFA is evolving into the field. In many ways, kind of we view actually robotics as particularly well suited to be paired with PFA. We've had some experience, we've discussed in the past, some of the preclinical studies that we've done, with different PFA generators and some of the ongoing work that we are doing there. Given the constant and consistent contact that a robotically navigated catheter has with the heart tissue, there are actually particular mechanistic benefits to pairing a robot with PFA.

We've done the preclinical work and like I've mentioned, we're trying to kind of advance things in a way where we can reach a first-in-man study and provide kind of more clarity on the clinical commercial timeline. I'd say kind of overall, I would look though, when I step back and think about PFA and how it's entering the EP field. When you look at kind of all the cardiac ablation procedures more generally, and really kind of PFA is right now being targeted at paroxysmal AF. There's some thoughts in also persistent AF. We have a majority of our procedures kind of in the ventricle and certain SVT style procedures where probably it will take still 5-10 years to know the role of PFA in those settings.

There are certain procedures where PFA will likely never be particularly applicable or beneficial or safe given kind of the type of arrhythmias that you would be dealing with in certain focal arrhythmias. Even in AF, as you have probably noticed, the original view of PFA being a panacea has evolved into a more nuanced understanding of its role and its partial role in the field. I think, again, we might not be the first mover in the PFA space, but I think we're doing all the right things on kind of the backside to make sure that we have a nice offering there.

That's where, again, this open EP ecosystem does provide a lot of value in allowing us to pair the benefits of robotics with a range of other technologies that are being developed.

Joshua Jennings
Managing Director and Senior Research Analyst, TD Cowen

Excellent. Appreciate it. Thanks, David.

David Fischel
Chairman and CEO, Stereotaxis

Thank you.

Operator

Next, we'll go to Frank Takkinen in with Lake Street. Your line is now open.

Frank Takkinen
Senior Research Analyst, Lake Street Capital Markets

Great. Thanks for taking the questions. Good morning. Wanted to start with one on the construction timelines. You briefly commented on it in the prepared remarks, was hoping you could take us a little bit deeper into how the construction timelines have been trending year to date and if there's any sign of those starting to be a little bit more predictable as we look at the back half of 2023.

David Fischel
Chairman and CEO, Stereotaxis

Hey, Frank. Good morning. When I look now at kind of our guest history of these 22 orders received, since we launched Genesis, it seems kind of almost kind of a. There's a lot of variability around these averages, but almost kind of a, you know, 1 year from an order till, you know, roughly till most sites get kind of revenue recognized and installed and around 2 years until they go or revenue recognized that they get shipped and then kind of around 2 years until they get kind of installed and are starting to do procedures. There's obviously wide variability around that. We've had orders that get shipped and installed and starting doing procedures, within, you know, 6, 9 months.

We've had things where it takes two years, and you still don't recognize revenue by shipping the system. There's kind of a wide band around that, but that seems to be kind of what the average has ended up being. We are seeing more, definitely more, scheduled installations over the next, let's say nine months or the remainder of this year, with a fairly busy schedule of things. Some of those are things that have been backed up for long periods of time, and other of those are from fairly recent orders where the sites seem to be on track for meeting the timelines that they want to have for installation.

We still see many anecdotes, many cases of hospitals that have a plan, and that plan gets significantly delayed due to whatever construction issues or permitting issues they have. I still am very much looking forward to the day where we do not have the complexity and the pain of the architectural and construction timelines. At least we're seeing some movement, kind of, seemingly that is real movement for the next several months.

Frank Takkinen
Senior Research Analyst, Lake Street Capital Markets

Okay. That's helpful. For my second one, maybe speak to some of the usage patterns you've noticed from the new Genesis installs over the last couple years. What I'm hoping you can touch on is maybe where are these physicians typically starting to use the technology, what patient pool, and what's their usage patterns look like at different milestones, say 3 months, 6 months, 12 months? I'm just trying to get a better understanding of how the new Genesis users are ramping and how their usage is expanding within their patient populations.

David Fischel
Chairman and CEO, Stereotaxis

Sure. I don't have all the data in front of me to answer you in kind of in a comprehensive way with you know, three months, six months, 12 months data, but I'll Kind of let me think and kind of provide a rough answer for that. Obviously kind of across our installed base, Stereotaxis is overrepresented in the more complex ablations. That's where the mechanistic benefits of our robots are particularly pronounced. About half of our volume is in ventricular tachycardia, premature ventricular contractions, congenital patients, and those types of patients. That's also a patient population which is generally underserved, undertreated, many of them don't have an option for good therapy without the use of our robot.

That's where we provide particular clinical value. That said, there is benefits obviously across the spectrum of ablation procedures, and so there are even procedures that might be considered typically as simple procedures where we are being used because of the safety profile, and the precision of robotics and the clinical benefits that provides. There is kind of a full spectrum. When I think about kind of our Genesis install base, I generally would say that the types of procedures they perform follows that spectrum of our overall install base. We definitely have a pronounced use in the complex cases, and that is oftentimes the motivating driver for why, let's say, a greenfield account would adopt a robot.

We do see usage across the spectrum of procedures, not just in the most complex ones, at least, you know, across many of the sites. There are certain sites which might limit us only to the most more complex cases, we definitely do see across the install base, across the Genesis install base and across greenfield Genesis installs also usage kind of across the spectrum. Does that kind of partially answer you?

Frank Takkinen
Senior Research Analyst, Lake Street Capital Markets

Yes. No, that's perfect. Appreciate the color, and thanks for taking the questions.

David Fischel
Chairman and CEO, Stereotaxis

Thank you very much, Mike.

Operator

Okay. Next, we'll go to Alex Nowak with Craig-Hallum Capital Group. Your line is now open.

Alex Nowak
Partner and Director of Healthcare Research, Craig-Hallum Capital Group

Okay, great. Good morning, everyone. Maybe just expand on the J&J royalty going away. Just remind us the dynamics around that. If the royalty didn't go away, what were gonna be the consumable sales in this quarter, just so we can figure out sort of same store volume trends?

David Fischel
Chairman and CEO, Stereotaxis

Sure. Hi, Alex. Good morning. We've had obviously a very long-term relationship with Johnson & Johnson. Several years ago, that relationship was turned from an exclusive relationship into a non-exclusive relationship. There was the timeframe where it would remain a non-exclusive relationship, and then where there would be a tail supply period, where still for several years, J&J would have to continue supplying catheters to the market. That transition from the non-exclusive relationship to the tail supply period started at the beginning of this year, and J&J stopped paying us royalties at that time. We missed out on something like about half a million dollars in the quarter due to the lack of the royalties.

Alex Nowak
Partner and Director of Healthcare Research, Craig-Hallum Capital Group

Okay, that's helpful. Then how long does that tail supply agreement last till?

David Fischel
Chairman and CEO, Stereotaxis

A three-year period.

Alex Nowak
Partner and Director of Healthcare Research, Craig-Hallum Capital Group

It's three years. After the three years, there's basically no assumption that they will continue to supply catheters. Is that right? That, that'll be a timeframe we need to have MAGiC Online by.

David Fischel
Chairman and CEO, Stereotaxis

There is no legal requirement, contractual requirement, and I think it's still open to interpretation of how things will play out there, and open to kind of to seeing how things will play out. If we do our job well, there shouldn't be any reason for them to continue supplying.

Alex Nowak
Partner and Director of Healthcare Research, Craig-Hallum Capital Group

Okay. Understood. Any discussion with the FDA around the GenesisX? Just what needs to be done internally before submitting that 510(k)? You know, what could influence the timelines? What could pull it forward? What could drag it out?

David Fischel
Chairman and CEO, Stereotaxis

We have made an initial you know, we've informed FDA that this is kind of coming, so there's some awareness there, though we've not kind of submitted any documentation in you know, in a material way. There is a lot of very recent experience with FDA on a robotic magnetic navigation system. We received Genesis FDA approval just three years ago. That was a fairly extensive process. For those of you that were on the calls at the time, you may remember we had some catch-up 510s that had to be done. There were multiple steps in the process of that approval, given the long period that Stereotaxis had not been in regular dialogue with FDA.

Since that time, we have been in relative dialogue. I think kind of we keep them up to date on our progress. Overall, I think we have a fairly clear understanding of the requirements for submission. Obviously, regulatory and expectations evolve also over time. Let's say we're aware of the fact that there's generally more of a focus on things like human factors testing and on cybersecurity. You know, we know that those are things that perhaps we want to do to at least document in a more extensive fashion versus previously.

Overall, I think we feel very comfortable about the regulatory path and what needs to be done on our side, and we have the very recent experience which guides our path.

Alex Nowak
Partner and Director of Healthcare Research, Craig-Hallum Capital Group

Excellent. Thanks for the update. Appreciate it.

David Fischel
Chairman and CEO, Stereotaxis

Thank you.

Operator

Okay. Next, we'll go to Neil Chatterji with B. Riley. Your line's open.

Neil Chatterji
Senior Analyst and Equity Research of Medical Technology and Digital Health, B. Riley Securities

Hey, guys. good morning. thanks for taking the questions. maybe just on the-

David Fischel
Chairman and CEO, Stereotaxis

Hi, Neil. Good morning.

Neil Chatterji
Senior Analyst and Equity Research of Medical Technology and Digital Health, B. Riley Securities

-on the sales funnel. Just curious how, you know, things are shaping up with the current, you know, capital spending environment and kind of ongoing hospital headwinds. Sounded like you still kind of see a pipeline of about 50. Just kinda curious to get an update there.

David Fischel
Chairman and CEO, Stereotaxis

Yeah. When we look at kind of the pipeline, I've kinda mentioned in the past that we have a more organized way to now review the pipeline and its status in each region. There's approximately two dozen, a little over two dozen in the U.S., about dozen in Europe and about a dozen in Asia that have kind of accumulated on this pipeline where the sites are talking about potentially getting an order over the next year. What I've seen generally is that there's obviously a subset of those that will get delayed. Kind of that's that's how our pipeline looks at this point.

I pair, I guess, this bottom up, relative kind of, healthy, growing pipeline, I think, as our team matures, as kind of, their efforts in the field mature, as the general marketplace, I think, sees our overall progress as a company, that helps. I see that kind of bottom up pipeline as it's growing. I pair that with kind of the top-down assessment that it still remains a relatively pressured environment. The macro environment is not what I've called in the past as still a headwind environment, not a tailwind environment.

I think with the balance of those two, we're able to do kind of some progress obviously, and we feel confident in the guidance that we've given this year. I guess kind of that's the balanced viewpoint, given this bottom up and top down, data.

Neil Chatterji
Senior Analyst and Equity Research of Medical Technology and Digital Health, B. Riley Securities

Got it. Thanks for that. Then just maybe in, on China and MicroPort, you know, the ecosystem there that's being developed, didn't sound like any huge updates on, you know, there versus last quarter or last call. Just curious, you know, how things are tracking there. You know, you obviously had Genesis, you know, submitted for approval, and the broader platform being developed. Just curious on an update.

David Fischel
Chairman and CEO, Stereotaxis

Sure. MicroPort submitted Genesis at the end of last year, and over the last two months has been submitting some supplemental information to the regulator there, to the NMPA. They, you know, and has been also working on its submission for the catheter. It has to wait until we get CE mark for MAGiC before it can submit MAGiC, given the pathway that we want to go through. But it's also working on the submission for its own variant of magnetically driven ablation catheter. And from a mapping integration perspective, we've already done very well. And so that's something that won't be a long pull in the tent at all.

As we look at kind of all of that and what MicroPort feels is a reasonable timeline given its discussions with NMPA, we're still kind of comfortable in this H1 of next year, that full ecosystem coming together. There might be certain approval that can come earlier. But I'd say that kind of that feels like the right timeline overall. Really it is that ecosystem of robot catheter mapping that should come together well in order to allow for the full launch and taking advantage of the full commercial team.

Neil Chatterji
Senior Analyst and Equity Research of Medical Technology and Digital Health, B. Riley Securities

Got it. Maybe just one last quick one. I don't know if I missed it, but just, any updates on how you're tracking for the mobile RMN, you know, clearance in Europe in the second half?

David Fischel
Chairman and CEO, Stereotaxis

Yes. We've referred to, talked about kind of in the Q3, and so I'd say we are working feverishly on multiple fronts there to be to be ready for for kind of an approval at that point in the Q3.

Neil Chatterji
Senior Analyst and Equity Research of Medical Technology and Digital Health, B. Riley Securities

Great. Thanks. That's it for me.

David Fischel
Chairman and CEO, Stereotaxis

Thank you.

Operator

Okay, next we'll go to Adam Maeder with Piper Sandler. Your line is now open.

Adam Maeder
Managing Director and Senior Research Analyst, Piper Sandler

Hi, David. Hi, Kim. Thank you for taking the questions. Two from me. The first one is on the MAGiC RF catheter. I think I heard timelines for Europe still stand late Q2 or summer. Can you talk just a little bit about kind of commercial strategy there in terms of the launch? You know, how aggressively will you be rolling MAGiC out to customers? Will you look to bolster or add sales reps prior to launching that? Just maybe flesh out the commercial strategy a little bit, and then I'd a follow-up. Thanks.

David Fischel
Chairman and CEO, Stereotaxis

Sure. Hi, Adam. Good morning. Yeah. The timeline, obviously it still remains somewhat of a black box. You respond to questions, then you kind of sit and wait, but everything is now kind of back on their court. We are very pleased that we got at least the first set of questions from them across all three categories and that we were able to respond in a timely fashion. When we look at kind of the commercial... Assuming we get approval at some point this summer, the overall commercial strategy is we have invested somewhat in our team in Europe, we have kind of two people more than what we have had historically.

That was done in anticipation of kind of MAGiC coming to market and the opportunity that would present itself. We are, we have kind of done fairly detailed reviews of every one of our 30-some hospitals in Europe that have a robot. In each one, understanding both the logistics of bringing the catheter to market. Is there a tender? Is there not? What, you know, a hospital application needs to be filled in just on the logistics side. On the financial side, what should pricing look like? On the kind of clinical side, what are the motivations of the physicians? What do they think about the catheter? What would be the drivers of adoption, the risks to adoption? Which I think we have a fair. We have a good clarity.

The team there has worked kind of now for a fairly long time. They've had to work on these business plans. We have a fairly good plan site by site what we want to do. We have designated a few sites, a handful of sites as those that will participate in a limited market release phase. While the catheter has kind of shown itself to be robust and working well across kind of many of the you know, many studies now, there is a type of also art to cardiac ablation procedures.

You do want good physicians who are interested in being the pioneers, who are interested in doing the early procedures to have a first shot at things to learn some of the tips and tricks that can only really be learned in that setting, and then to be available to share their experience and help also train others. I would think about an LMR period of probably kind of several weeks, you know, a few number of months, a couple months perhaps.

We're really focused on those sites and making sure that they use the catheter across a range of cases and can kind of document and refine best practices, at which point then we would move into a full launch across all the 30 accounts in Europe. I think about it as a relatively with that kind of limited market release period, you know, post that being a relatively quick adoption across our installed base. I've talked in the past that there are certain countries in Europe where you do have tenders or other kind of administrative hurdles which don't allow you to fully kind of convert an account just based off of commercial agreements and just based on kind of the physician's desire.

There are some of those places, countries like France, some of the Scandinavian ones, where you do have kind of other logistical barriers, which will just take kind of a, you know, over the course of probably a year or so, you can overcome the vast majority of those. There are some of those that will slow adoption at certain accounts as we work through them.

Adam Maeder
Managing Director and Senior Research Analyst, Piper Sandler

Okay, great. Very helpful color, David. Thank you for that. For the follow-up, just wanted to ask about HRS, which is scheduled for later this month. I saw in the press release, you know, something about, you know, the potential to share meaningful updates on the innovation strategy at that conference. I was hoping you could just expand on that a little bit. You know, what do you have planned, either from a clinician standpoint or Wall Street perspective? Just any more details on HRS would be great. Thanks for taking the questions.

David Fischel
Chairman and CEO, Stereotaxis

Thanks, Adam. Stay tuned. We at this point won't share much more, but as kind of it's appropriate and as we're able to share more, we look forward to sharing some news at HRS that we think will be impactful for the EP community and also impactful obviously for the company and for the investor base. We look forward to sharing it there. More generally at HRS, we're excited for our showing there. There is a special session, a joint session of the Society for Cardiac Robotic Navigation and HRS at the conference. That will be a nice session in which robotics is obviously kind of front and center.

Again, apologies I can't share much more at this point, but we look forward to sharing news, in less than two weeks.

Adam Maeder
Managing Director and Senior Research Analyst, Piper Sandler

Okay, perfect. We'll stay tuned there. Thank you.

David Fischel
Chairman and CEO, Stereotaxis

Thanks, Adam.

Operator

There are no further questions at this time. I'll now turn the call back over to David Fischel, Chairman and CEO of Stereotaxis, for any additional or close remarks.

David Fischel
Chairman and CEO, Stereotaxis

Okay. Thank you very much for all your questions. We look forward to sharing the updates at the Heart Rhythm Society meeting next week and working hard for, on your behalf, in the coming months. We'll speak again in a quarter. Thank you.

Operator

This concludes today's conference call. You may now disconnect.

Powered by