Stereotaxis , Inc. (NYSE: NYSE:STXS) has provided an update on its strategic initiatives and financial performance in its Fourth Quarter and Full Year 2023 Earnings Conference Call.
CEO David Fischel highlighted the company's approach to overcoming commercial challenges, with a focus on its proprietary MAGiC ablation catheter, a new self-shielding robot, and a suite of interventional guidewires and guide catheters.
Despite facing installation complexities and product limitations, Stereotaxis is preparing for a commercial breakout in 2025, with key developments expected in 2024. The company ended the year with a robust backlog and strong financials, anticipating increased revenue and reduced cash outflows.
Key Takeaways
- Stereotaxis aims to revolutionize minimally invasive endovascular surgery with robotics.
- The company has identified core issues, including dependency on Johnson & Johnson, complex installations, and narrow product lines.
- A comprehensive strategy has been developed, featuring the MAGiC catheter and a new robot.
- Regulatory submissions for MAGiC are underway in Europe and the U.S.
- Collaborations in China and the development of the Sync digital surgery platform are progressing.
- A Genesis robotic system order from a German hospital marked significant progress.
- 2024 outlook includes growth in orders and sales, with challenges from hospital delays and catheter shortages.
- Stereotaxis holds a strong financial position with $20 million in cash and no debt.
Company Outlook
- Commercial breakout growth expected in 2025, with key developments in 2024.
- Anticipation of increased Genesis system revenue and reduced cash outflows in 2024.
- Stable recurring revenue and double-digit growth projected for the full year 2024.
- Approximately 80% of the current $14.7 million backlog to be recognized as revenue within a year.
Bearish Highlights
- Challenges in commercializing the Genesis system.
- Hospital construction delays and catheter shortages impacting system orders and sales.
- Dependence on Johnson & Johnson for catheter supply has caused shortages.
Bullish Highlights
- New orders and growing installed base of Genesis system.
- Strong balance sheet with significant cash reserves and no debt.
- Positive clinical trial results for the MAGiC catheter.
- Collaborations and platform developments poised to drive future growth.
Misses
- Commercial struggles due to structural issues.
- Installation complexities and limited product offerings have hindered growth.
Q&A Highlights
- Focus on scaling manufacturing for the MAGiC catheter launch.
- Conversion of existing users to the integrated offering with Abbott.
- Expectation of at least one regulatory approval for MAGiC contributing to revenue by year-end.
- Preparatory discussions with regulators have provided clarity on the regulatory path.
Stereotaxis, with its strategic roadmap and financial health, is positioning itself for transformative growth in the robotics-assisted endovascular surgery market. The company's commitment to addressing its product offerings and installation processes, along with its anticipation of regulatory approvals, sets the stage for significant developments in the coming years. As Stereotaxis navigates the challenges ahead, its strong balance sheet and innovative product pipeline are expected to contribute to its success in the global market.
InvestingPro Insights
Stereotaxis, Inc. (NYSE: STXS) stands out with its strong financial position, holding more cash than debt, which aligns with the company's report of $20 million in cash reserves and no debt. This liquidity is crucial as the company navigates through its commercialization phase and invests in its innovative product pipeline. However, it's important to note that Stereotaxis has experienced a notable stock price decline over the past week, with a 10% drop in total return. This could reflect market reactions to the challenges the company faces, such as hospital construction delays and catheter shortages.
Investors should be aware that analysts have tempered expectations for the company's profitability in the near term. This is reflected in the negative P/E ratios reported, with the latest adjusted P/E ratio for the last twelve months as of Q3 2023 standing at -9.15. Additionally, the company does not pay a dividend, which may be a consideration for income-focused investors.
Despite the near-term profitability concerns, Stereotaxis has shown impressive returns over the last month, three months, and six months, with increases of 13.97%, 40.32%, and 41.85%, respectively. This suggests that there is investor confidence in the company's long-term strategy and growth potential, especially as it anticipates a commercial breakout in 2025.
InvestingPro Tips suggest that there are 11 additional tips available for Stereotaxis on the InvestingPro platform, offering deeper insights for those interested in the company's financial health and market performance. For those looking to explore these insights further, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - Stereotaxis (STXS) Q4 2023:
Operator: Good afternoon. Thank you for joining us for Stereotaxis' Fourth Quarter and Full Year 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 opened 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: Thank you, operator, and good afternoon, everyone. It's a very exciting, productive, busy, challenging and promising period for Stereotaxis. We are glad to be entering this year having made significant progress towards realizing our strategic transformation. Given where we stand, we have high confidence in the key puzzle pieces of this strategy coming together in the coming months putting Stereotaxis on solid strategic foundation and providing line of sight to when commercial breakouts are possible. We are driving this progress against the backdrop of various challenges which highlight the merit of our strategy. It is always helpful to view one's position in a broader context. This being our annual call, I want to use the occasion to step back and provide that perspective. I'll then share specific updates on our innovation and commercial efforts. Kim will then provide details on our financial results, and we will open the line to questions. Stereotaxis' overarching mission is to improve minimally invasive endovascular surgery with the precision, safety and unique capabilities of robotics. We are the pioneer and global leader in endovascular robotics and have demonstrated the clinical relevance and value of our technology in robust real-world use at over 100 hospitals that have treated 150,000 patients. Despite having pioneered a highly differentiated and advanced technology that works reliably in the real world and provides meaningful clinical value, Stereotaxis has a long history of commercial struggles. After joining Stereotaxis, I recognized that these struggles could be traced to structural weaknesses with our product ecosystem. These weaknesses put Stereotaxis in a challenging position with commercial disadvantages and strategic dependencies and made adoption of robotics very difficult even for our strongest advocates. We identified three key structural issues. First, in our core existing market, electrophysiology cardiac ablation procedures for the treatment of arrhythmias, we've built our business dependent on Johnson & Johnson. We were only integrated with their diagnostic mapping system, and they manufacture the ablation catheter used in every one of our procedures. That dependency limited the ability for patients and physicians to benefit from continuous innovation, created commercial challenges and provided Johnson & Johnson rather than Stereotaxis with the majority of the economic value from every robotic procedure. Second, installing our robotic system in a cath lab is a significant construction process requiring architectural planning, room shielding and reinforcement, special electrical work and hiring contractors, which all add complexity, time, effort and expense. This process leads to very long sales cycles and a high bar for adoption. The vast majority of interested potential customers ultimately never succeed in getting a system. Third, while Stereotaxis' robotic technology is designed as a platform technology, enabling the treatment of a broad spectrum of complex endovascular procedures. The company did not offer the interventional tools to allow for this expansion of indications. Being limited to one specific procedure as large and attractive as the cardiac ablation market is doesn't provide for healthy diversification and full appreciation of our opportunity. Being clear eyed and intellectually honest was the first step in improvement. We worked hard over the subsequent years to formulate a comprehensive and elegant strategy to address these weaknesses. The strategy was creative and required significant innovation but was realistic for us to accomplish while controlling technological and financial risk. It was attractive in providing strategic independence and the opportunity for substantial commercial breakout. Most importantly, it fundamentally improves and broadens our product offering for the patients, physicians and hospitals that rely on us. Stereotaxis has advanced this comprehensive innovation strategy over several years through the development process. 2024 is the year in which we expect all the key puzzle pieces to come together setting us up with multiple shots on goal for breakout growth in 2025. A few updates on the key innovation efforts follow -- in our existing cardiac ablation market, our key effort has been to address our strategic dependency, develop a proprietary ablation catheter and create an open ecosystem around our robot. We were delighted today to announce initial clinical results and regulatory submissions for the MAGiC catheter, our proprietary advanced robotically navigated ablation catheter. Following our earnings call last November, we received approvals to initiate a human clinical trial of MAGiC in both Lithuania and Denmark. Vilnius University in Lithuania enrolled its first patient at the start of this year and completed enrollment of the 20th patient in January. The results from these initial procedures were stellar and were summarized by the physicians in a manuscript recently submitted for publication in a prominent electrophysiology journal. Across these 20 patients, ranging in age from the young adults to the elderly and suffering a range of arrhythmias there was 100% acute success in treating the arrhythmias and no adverse events or device or procedure-related safety events. Additional patients beyond these 20 have been treated in both Lithuania and Denmark with consistent positive results. Beyond the stellar clinical outcomes, qualitative commentary from all the physicians who participated in the trial was very positive, reinforcing our confidence in the impact MAGiC will have on patients and physicians. We resubmitted the MAGiC catheter to the European notified body and believe the data fully addresses the request made last summer, where we were told clinical data would be necessary to be granted CE Mark under the more rigorous MDR requirements. We also submitted the MAGiC catheter for U.S. regulatory approval as a PMA supplement to the FDA. The clinical data adds to a substantial body of bench, preclinical and published clinical literature supporting the value of robotic cardiac ablation generally and the safety and effectiveness of MAGiC specifically. While there is always uncertainty with any regulatory submission, we believe we made strong submissions and have received feedback to that effect from experts in our field. We look forward to working collaboratively with the regulatory bodies in the coming months to ensure the MAGiC catheter becomes available for the patients and physicians who depend on it. The launch of MAGiC will benefit from our strong collaboration with Abbott and last year's successful launch of mapping integration with Abbott's EnSiteX mapping system. We are seeing continued expansion in the adoption of our integrated technologies in both the U.S. and Europe. This is a significant strategic collaboration in its early phases, and we are delighted with how it's progressing. The second major initiative in our innovation strategy was to address the challenges and complexities of adopting robotics. We developed a smaller self-shielding robot that significantly enhances its accessibility by removing the requirement for cath lab construction. We discussed on the last call our balanced approach to the timing of a regulatory submission, such that approval of the robot aligns approximately with market availability of MAGIC. The robot has gone through design fees and now begun formal testing. We are confident in regulatory submissions in both the United States and Europe in the second quarter and expect regulatory clearance in Europe midyear. Our experience selling Genesis gives us daily visibility into the time line shifts and hospital construction delays that slow adoption even at sites that are most motivated to build a robotic program. This experience reinforces our confidence that the availability of a smaller and more accessible robot, something that can be installed without construction will serve as a significant structural improvement to the pace and scale of adoption. Following approval, we plan to use the current year to demonstrate the reality of the robot in real-world use enhanced compatibility of the robot with various x-rays and prepare supply chain, manufacturing, installation and commercial processes for a full launch in 2025. Our third strategic innovation effort is development of a family of interventional guidewires and guide catheters that expand the benefits of our robots into new endovascular indications with five specific multibillion dollar opportunities being targeted. Neurointervention, coronary angioplasty, peripheral interventions, tumor embolization and AAA grants. The first guidewire is fully designed and in conjunction with our contract manufacturer, we have been grinding through the challenges of establishing high-quality and robust manufacturing processes. We expect to complete the manufacturing and testing of the significant number of guidewires necessary for a regulatory submission in the middle of this year and still expect commercial availability of the guidewire late in the year. Once we have made regulatory submissions, we will host an Innovation Day to allow several key physicians from multiple specialties to share their perspective and experience with where our robotic technology can add critical value in the broader field of endovascular surgery. These three innovations, MAGiC catheter, newer mobile robot and endovascular devices are our strategic response to the three structural limitations described earlier. We have line of sight to the maintaining key regulatory approvals and commencing commercialization in 2024 with growing commercial impact in 2025. Beyond these big three innovations, we were fortunate to nurture two additional opportunistic growth drivers that are synergistic and additive to our core effort. In China, we entered into a strategic collaboration with MicroPort to establish a China-specific EP product ecosystem. MicroPort recently submitted to China's NMPA regulatory body, the robotically navigated ablation catheter we developed together. We have completed mapping integration with their Columbus mapping system, and Genesis is expected to receive Chinese regulatory approval midyear. As this core product ecosystem is available, we expect to benefit from MicroPort's substantial commercial footprint already servicing hundreds of hospitals. Our second synergistic and opportunistic venture is a digital surgery platform that enables broad operating room connectivity, both alongside our robotic platform and independently in non-robotic labs. The Sync cloud-based connectivity app has been released internally for our team in preparation for an external release. We are still finalizing remaining hardware, firmware and software efforts with the Synchrony integrated display capability, but expect to begin formal regulatory testing in the second quarter followed by submissions in summer. We will continue a soft launch of Sync till then, but plan for a full launch of Synchrony and Sync as a combined solution, enabling streamlined workflow, connectivity and collaboration broadly in any operating room. The Synchrony hardware will provide an incremental upfront capital sales opportunity, while Sync will be available with a freemium SaaS business model with premium subscriptions for hospitals, medical device sales forces and physician users. I recognize our progress has taken longer than expected and faced unforeseen challenges. With key regulatory submissions and technology developments done, we see the puzzle pieces falling into place this year. While there is risk and uncertainty with any regulatory process, our strategy is derisked with multiple shots on goal. In each of our three key geographies, the United States, Europe and China, we have the opportunity for a full ecosystem coming together and driving breakout growth. The opportunity in any individual geography can dwarf our current entire business. We are driving this innovation transformation while working hard to ensure our commercial momentum and financial strength are preserved. We continue to see signs of commercial progress with positive feedback and utilization of Genesis as well as capital interest in Genesis from both existing users and completely new customers. In the fourth quarter, we were excited to receive a Genesis order from a greenfield hospital in Germany. Germany as a country was one of the most enthusiastic earliest adopters of the first Niobe system and then also, unfortunately, the region with the strongest backlash to robotics given that the first Niobe systems were launched prematurely. To see our installed base grow with new physician users in Germany is particularly encouraging given that historical context. The order represented our 12th greenfield robotic order globally since the launch of Genesis and our 24th quarter overall. We began 2024 with $14.7 million in backlog from orders that were received but not yet shipped or installed. While we continue to see a healthy pipeline of greenfield and replacement cycle customers for Genesis, overall progress is slow. Beyond the well-understood challenges of closing a substantial capital sale for a system that requires hospital construction, several electrophysiologists have expressed their concern with the recurring catheter shortages of Johnson & Johnson and the awareness of the dependency on J&J's catheters in absence of our own MAGiC catheter as a replacement. While this has not deterred some hospitals from moving forward, it serves as an additional risk item that extends due diligence and delays purchase decisions. We believe our regulatory submissions of MAGiC will partially help and that obviously receipt of approvals will address this concern. Despite this pressure, we expect the continued pace of robotic system orders and sales with expected growth for both in 2024 compared to 2023. Our recurring revenue was also impacted by the catheter shortage from J&J, which impacted procedure volumes as well as the loss of royalty payments from J&J, which created a $2 million headwind to both our top and bottom line results. We continue to see inconsistent availability of the J&J catheter to layer up in various geographies and accounts but expect overall recurring revenue in 2024 to be consistent with 2023. Our burn rate in 2023 was lower than 2022 despite these revenue challenges. So the absolute burn rate was still higher than what we expected. Our balance sheet remained strong with approximately $20 million cash and no debt. We are cognizant of the importance of financial prudence and are confident our existing balance sheet allows us to advance our transformative product ecosystem to market and fund its commercialization. We have already invested in significant inventory and have direct commercial teams globally that are well suited to launch the new products as they become available. We expect a lower burn rate in 2024 compared to 2023, driven by increased Genesis robotic revenue and reduced cash outflows as some of the most significant R&D spending is behind us and we taper inventory purchasing. 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. Kim?
Kimberly Peery: Thank you, David, and good afternoon, everyone. Revenue for the fourth quarter of 2023 totaled $4.6 million compared to $7.3 million in the prior year fourth quarter. System revenue was $0.1 million, and recurring revenue was $4.5 million compared to $2.2 million and $5.1 million in the prior year fourth quarter. System revenue was abnormally weak due to delays in hospital construction schedules and no shipments being made as a result. Recurring revenue was in line with recent quarters but below the prior year level due to Stereotaxis no longer receiving royalty payments from Johnson & Johnson. Revenue for the full year 2023 totaled $26.8 million compared to $28.1 million in 2022. Full year system revenue was $8.7 million compared to $6.8 million in the prior year, reflecting increased system deliveries and installations. We started 2024 with system backlog of $14.7 million. Full year recurring revenue was $18 million compared to $21.3 million reflecting the continued absence of the J&J royalties and periodic catheter shortages by Johnson & Johnson. Gross margin for the fourth quarter and full year 2023 were approximately 60% and 56% of revenue. For the full year 2023, we reported gross margins of 79% on recurring revenue and 8% for system revenue. System gross margins continue to reflect relatively low production volumes, combined with significant allocations of fixed overhead and related expenses. Operating expenses in the fourth quarter were $8 million. Excluding $2.6 million in noncash stock compensation expense, adjusted operating expenses in the current quarter were $5.4 million compared to prior year adjusted operating expenses of $6.2 million. Adjusted operating expenses for the full year 2023 were $26.2 million compared to $26.8 million in the prior year. Operating loss and net loss for the fourth quarter of 2023 were $5.3 million and $5 million compared to $4.5 million and $4.2 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding noncash stock compensation expense, were $2.7 million and $2.4 million compared to $1.9 million and $1.6 million in the previous year. For the full year 2023, adjusted operating loss of $11.3 million and adjusted net loss of $10.2 million compared to an adjusted operating loss of $8.3 million and an adjusted net loss of $7.8 million in the prior year. Negative free cash flow for the full year 2023 was $9.1 million compared to $10.8 million for the full year 2022. At December 31, we had cash and cash equivalents of $20.6 million and no debt. I will now hand the call back to David.
David Fischel: Thank you, Kim. We are cognizant that accurately guiding revenue has been challenging, and there has been significant volatility in quarterly revenue results as any individual robot sales has a significant impact on the quarter. Humbled by that experience, we are providing specific revenue guidance only for this current first quarter of 2024, in which we expect revenue of approximately $7 million. Looking at the full year 2024, we generally expect recurring revenue, to remain stable, until MAGiC can contribute to disposable revenue growth. We expect continued growth in system revenue, through conversion of our $14.7 million backlog, and new system orders, with system revenue growth driving overall double-digit revenue growth for the year. We expect our bolus of innovation, to play a decisive role in driving breakout revenue growth in 2025 and beyond. We will now take your questions. Operator, can you please open the line to Q&A?
Operator: [Operator Instructions] Our first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please go ahead.
Frank Takkinen: Great, thanks for taking the questions. Maybe to start with the MAGiC catheter submissions. On the EU submission, how should we handicap that being a resubmitted file? I assume that there's a little bit more certainty that, they'll come back with a clearance on that now that they've had a chance to already review it once. And they made their request, but maybe is there any way to kind of risk adjust that, given it's already been looked at once. And then two on the FDA side, when was that submitted? And is that, a standard 180-day review, or how should we think about the process, between now and the clearance expectation, you put out there?
David Fischel: Yes, hi Frank. Thanks for the question. So generally I want to state that, we're not going to give a lot of commentary on regulatory submissions, or the review during the review period, other than that we think, we made a strong submission. And obviously we're going to work collaboratively, with the reviewers over the coming months, and look forward to working collaboratively with them. And your commentary on the EU submission, you're correct. It is a resubmission of the vast, vast majority of the information, with just the addition of the clinical data. We are fortunate that, the reviewers are the same reviewers that, looked at the submission a year ago, and so that should support the review process, in a more efficient fashion. There's no statutory time limit of the review. So, we are obviously beholden, to the notified body, and when they're able to review things, but given the history there, and given the multiple discussions that took place last year, we are hopeful and believe it's reasonable, to assume that this will be a much more efficient process. And with the U.S. FDA, this is 180-day PMA supplement, and we expect to work collaboratively with FDA, during the review process. And it wouldn't be surprising, if during that review process, we do kind of have additional questions and discussions with FDA. So we're not, I wouldn't kind of think that, necessarily the 180 days - has to be the way it's going to play out, but overall it is 180-day PMA supplement process.
Frank Takkinen: Okay. That's perfect. And then maybe thinking about once those clearances occur, how should we think about, how quickly the uptake could occur, within the installed days? Maybe starting with, how many procedures you're doing today, would be helpful context, and then how quickly you can roll that, the MAGiC catheter into your established sites, and swap out the old catheter, for the new one?
David Fischel: Sure, so we've talked before, about doing under 10,000 procedures a year, with approximately 40%, 45% of that volume in Europe, 40%, 45% of that volume in the U.S., and about 10%, 20% of that volume in Asia. And so that's kind of the overall install base. So, we have several thousand procedures a year, each in both Europe and the US. And we've talked about previously, the structural barriers in Europe where in certain geographies, certain countries, certain regions, you do pursue then, local tenders after you have CE mark while in others, really the only structural barrier is a contract, with the hospital and setting a price, with the hospital. And generally, I would expect given also the fact that, we are gaining a real world clinical experience, with the catheter currently through the clinical trial, I would expect a relatively, quicker ramp in catheter adoption, as it becomes available. The things that we have to do in tandem with gaining regulatory approval is scaling of manufacturing, and building of sufficient stock for a commercial launch. And then also the work that we are doing with Abbott, to convert existing users, which historically were predominantly, using Johnson & Johnson's mapping system, to using the current integrated offering with Abbott, that will also be beneficial in accelerating adoption. So those are the things we think about, as we think about adoption, but I overall expect to see a relatively rapid transition over, let's say, a handful of quarters.
Frank Takkinen: Okay. That's helpful. I'll stop there. Thanks for taking the questions.
David Fischel: Thank you.
Operator: Our next question comes from the line of Jason Wittes with ROTH MKM. Please go ahead.
Jason Wittes: Hi. Thanks for taking the questions, and congrats on the submission here. In terms of - you just kind of highlighted this a little bit, but in terms of this year's outlook, should we expect anything from MAGiC this year, or is this really a 2025 event?
David Fischel: We didn't discuss - and thanks for joining us, Jason. I'm glad to have you on the calls again. We didn't incorporate any revenue from MAGiC in the commentary we provided, in terms of how we generally think about this year's revenue. That said, it would be surprising, if we do not generate some revenue from MAGiC, in the back half of this year. And it will really be dependent on the timing of regulatory approval in terms of how much to expect. And so, I think until we don't have that approval in hand, it's hard for us to estimate how much to contribute. But I would definitely expect that we get at least one approval prior to the end of this year with the chance for MAGiC to start to contribute to recurring revenue.
Jason Wittes: Okay. That's helpful. Thanks. And also, I appreciate the backlog information of $4.7 million. I mean, roughly, what is the expectation in terms of how long those take to get placed in a hospital?
David Fischel: Sure. So just - it is $14.7 million.
Jason Wittes: Okay. If I said that wrong, I apologize, yes.
David Fischel: No, it's fine. And then, and so overall, we would estimate - and I'm looking at Kim right now, she wants to correct me - that typically you would estimate that approximately 80% percent of that will be recognized as revenue. I'm getting a thumbs up, so that seems correct. About 80% of that should be recognized within a given year. We have seen scenarios where hospitals that were planning, to take delivery at a specific date, push back that date, due to their own challenges. And so, there is - there's not guarantees, of that playing out, as we've seen even up, till the fourth quarter obviously, in the results of our fourth quarter. But generally, that 80% within one year for backlog, is a general rule that holds.
Jason Wittes: Okay. That's helpful. Then last question. Just in terms of supply issues with the current catheter. Are there any updates from your supplier? Or is there any change in outlook? Or how should we be thinking about this for 2024?
David Fischel: Yes. So just to be clear, the catheter shortages are not from a supplier of ours, nor from a company that we have any control over. This is all related to the dependency, which I described before, where Johnson & Johnson independently manufactures, sells and supplies the magnetic ablation catheters that, are used alongside our robot. And so, we do not have control over them, or even influence over them in the same way that, we would have influenced with a supplier that, we have hired and worked with. We have seen - these cropped up over a year ago now, about a year and a half ago. We have seen continued shortages that flare up in various specific geographies, various accounts. And there is a randomness to it, though it does definitely pressure the physicians, and hospitals that rely on our technology, and create disturbances to their normal practices. And so, I think given where we stand right now, it seems like the intensity and distribution of those flare-ups, doesn't seem worse than it was a year ago. And so, it seems like overall, the numbers this year, should look similar to last year, but there is an aspect of dependency there. And that again speaks, to how valuable and important having MAGiC on the market will be.
Jason Wittes: Great, thanks. I'll jump back in queue.
David Fischel: Thank you very much, Jason.
Operator: Our next question comes from the line of Alex Nowak with Craig-Hallum. Please go ahead.
Alex Nowak: Okay. Great. Good afternoon, everyone.Continuing the manufacturing question there. Just with regards to MAGiC, if you get the approvals, let's just say, second half of this year for both Europe and U.S., how quickly can you ramp up manufacturing?
David Fischel: Hi, Alex, thanks and good afternoon. So overall, that is something that we've been working with Osypka, our contract manufacturing partner in Germany, to improve. They have significant experience, manufacturing thousands of units, of various interventional devices. And so, they have the organizational capabilities to do that. With every product, there is its own scaling effort during the formal regulatory testing of MAGiC, we did produce - I believe it was near 1,000 units of the catheter. So, they demonstrated their capability to scale manufacturing to those - to that type of level. We are working with them, have been working with them. We'll continue working with them, so that they can scale, to the point where we're able to service the entire European, and U.S. installed base. I think that probably reaching that level still, over the course of this year is probably aggressive, but that's what we're shooting for, and there are all sorts of incentives in place, to increase that manufacturing.
Alex Nowak: Okay. That is great to hear. Maybe expand on the qualitative commentary, with the physicians who are using MAGiC in the European study. Just, what do they like about it, versus the J&J device specifically?
David Fischel: Sure. So, I had the good fortune of being able to actually watch eight procedures, when I visited Vilnius University in January. And I think that kind of obviously, you recognize that the financial, the strategic, the independence benefits of having a catheter, the fact that the catheter serves, as the enabling technology for our mobile robot. So all of those, are kind of the more strategic, aspects from our side. From a clinician's perspective, how does the catheter benefit the patient and the physician. I'd say that some of the main benefits that were described by the physicians. One was an observation that, the stability of the catheter was particularly nice. And we are - magnetic catheters are known that, one of their key benefits is stability. Oftentimes, that stability is dependent on your approach towards, the tissue. And they felt that, irrespective of how they approach the tissue with the catheter, they had very, very good stability, beyond what typically they consider very good stability, with the existing magnetic catheters. That was one thing that was particularly called out. The ease of navigation, and how that was more intuitive than what they were used to was the second observation that was called out. And then the fact that reduced fluid is required, to cool the catheter that should benefit patients that, have renal issues, or longer procedures, and that just generally creates a reduced fluid load, for patients. And so, some of those, were some of the things that I remember, from a visit and from the discussions with physicians. I think kind of those are, some of the key, key benefits, both for patients and physicians, as they switch to MAGiC.
Alex Nowak: Okay. Great. And then just last question. Are you teeing up any U.S. studies just in case the supplement, the FDA comes back and request additional U.S. data? Just how quickly could you turn something like that around?
David Fischel: I believe in the coming months, we will have a much clearer feeling - coming few months, we'll have a much clearer feeling for the regulatory path in the U.S., given what we've done in Europe that, has been very helpful in educating us, and giving us certain infrastructure, to run clinical trials more broadly. If you step back, and think about Stereotaxis as a company, we have a very, very unique and kind of a special capability, in terms of building robots - that's something that, almost no other company has, very few companies have demonstrated the capability, to build robots that, can actually be deployed in a real-world clinical setting, and can work robustly and reliably there. We have that capability in-house. We did not have a historical expertise, or experience in developing interventional devices. And that doesn't just mean the engineering aspect. It means the quality, clinical regulatory aspects, related to interventional interbody devices. And I think that kind of, as we've gone through this process, both from a regulatory perspective, and now setting up the clinical trial in Europe. And all the testing processes that we went through. That all gives us more of an institutional capability, in order to replicate those again, in the future. And so, I think there was definitely a benefit, from what we've now demonstrated, we're able to pull off in Europe. And depending on how the next few months go, we'll have a feeling, on whether it's necessary to start that in the U.S.
Alex Nowak: Okay. Great. I appreciate the update. Thank you.
David Fischel: Thank you very much, Alex.
Operator: Our next question comes from the line of Adam Maeder with Piper Sandler. Please go ahead.
Adam Maeder: David and Kim. Thank you for taking the questions here. Wanted to ask a question on the sales force. With the MAGiC launch and the mobile launch coming down the pike here, when you look to build out the sales force, to support those launches. Is that a 2025 event? Or is the plan, to kind of push forward with initial - sorry, the existing infrastructure? And then I'd follow-up? Thanks.
David Fischel: Hi, Adam. Good afternoon, thanks for the question. So, we have done a small incremental hiring in Europe already late last year, early this year in anticipation of a MAGiC launch, and ensuring that we have the ability to launch MAGiC, across our installed base, with the added level of coverage and service that, that would entail. And as discussed in the past, as we launched the catheter initially, we would plan to use our existing sales teams both in the U.S. and Europe, to cover those accounts, to launch MAGiC. They are in all of these accounts. They have the relationships. We have a good team that has good electrophysiology knowledge. And so, they're more than capable of launching the MAGiC catheter, in a successful fashion. And we would, though, start to reinvest, any proceeds from the catheter, back into the sales team. So that we grow the team, and can gradually evolve, to something more like, the larger players in the space, who oftentimes have one, or even more than one individual per account, per hospital customer. And so, I would see us kind of growing that sales team, but we would do it, as we're growing the revenue, of the MAGiC catheter. Similarly, on the capital side, I would say that we are - we know that, with any new robotic system, the scaling of supply chain manufacturing and deployment of the robot, is a process that takes many months. And even with the new robot that doesn't have the construction requirements, there are still those styles of infrastructure, kind of process improvements that play out over a period of months. And so, I'd say that we will probably, as we gain approval, we will probably slightly increase the capital sales capability in the relevant geography. And then we'll start to show most of the benefit, though, from having the robot, is that our existing capital sales teams should be able to be much more effective because we've reduced the complexity and time lines related to their sales work. And so, as we start to see that playing out as we start to see the robot being out there in the world, working successfully and well, as we're able to scale our supply chain and manufacturing. And then again, we'll incrementally be building the sales team. And so, I think that kind of, you'll see most of that type, of real mind sharing effort in building the commercial team, happening in 2025, with some of the preparatory work, being done already this year.
Adam Maeder: That's great color. I appreciate that, David. Thank you. And for the follow-up, I wanted to switch gears, and ask about mobile. If I heard correctly, regulatory submissions both in the U.S. and Europe for Q2 events. Can you just maybe share what's left, to still be done ahead of submission, to the regulatory agencies? And just talk about what's informing the confidence, there that you'll be able to make, healthy submissions and ultimately garner regulatory clearance? Thank you.
David Fischel: Sure. So we are - we have the formal - the full body of formal regulatory testing that, you have to do before you can do a submission. There is still various testing that, needs to be done there. Most of it done internally with our team, some of it that is done through external testing services that, you have to do through an external testing service. And so that is all expected to play out over the next, let's say, month to couple months. And then, you have to obviously put together, all of the documentation for the submission - and that happens concurrent with testing, but there's always some work, after you finish the testing process. Overall, our confidence comes from the fact that we have - this is really our expertise robots. We went through a process very, very similar to this, just about four years ago, five years ago, when we submitted the Genesis robot. And so, we have the organizational infrastructure, the muscle memory, the documentation that, we can leverage for these types of processes. And we have a skilled team that, has run this playbook before, including very recently. So that gives us the confidence. We've had preparatory discussions with regulators. We have clarity on what the regulatory path is, and so that gives us kind of that confidence.
Adam Maeder: It's helpful. Thank you.
David Fischel: Thank you.
Operator: This concludes today's question-and-answer session. I would now like to turn the call over to David Fischel for closing remarks.
David Fischel: Okay. Thank you very much, for all your thoughtful questions and for your continued support. We look forward to working hard on your behalf this year, bringing about the transformations we promised, and speaking again in a couple months. Thank you.
Operator: This concludes today's call. You may now disconnect.
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