Q1 2026 Stereotaxis Inc Earnings Call

May 12, 2026

Operator 2: Good afternoon. Thank you for joining us to Stereotaxis Q1 2026 Earnings Conference Call. Certain statements during the conference call and question and answer period to follow may relate to future events, expectations, and as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company's executives may make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode.

Operator: Good afternoon. Thank you for joining us to Stereotaxis Q1 2026 Earnings Conference Call. Certain statements during the conference call and question and answer period to follow may relate to future events, expectations, and as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company's executives may make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions, and comments following the presentation.

Operator 2: 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.

Operator: 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.

Speaker #2: 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.

Speaker #2: Thank you, operator, and good afternoon, everyone. Stereotaxis has had an amazing start to this year. While our reported quarterly numbers don't yet reflect it, we're going through one of the most exciting periods in stereotaxis history, given the amount of progress, the initial commercial green shoots of success, and the clarity on the opportunity ahead of us.

David Fischel: Thank you, operator, and good afternoon, everyone. Stereotaxis has had an amazing start to this year. While our reported quarterly numbers don't yet reflect it, we're going through one of the most exciting periods in Stereotaxis' history, given the amount of progress, the initial commercial green shoots of success, and the clarity on the opportunity ahead of us. These give us confidence in our overall vision, reaching a new level of maturity in our near-term and long-term growth. In my prepared remarks, I'll touch upon the key areas of progress, the commercial green shoots, and the opportunities ahead of us. Kim will then review our Q1 results, and we will open the line to questions. The most notable achievement of the past year has been a string of regulatory approvals in the US and Europe for an entirely new foundational ecosystem of products.

Speaker #2: These give us confidence in our overall vision reaching a new level of maturity in our near-term and long-term growth. In my prepared remarks, I'll touch upon the key areas of progress, the commercial green shoots, and the opportunities ahead of us.

Speaker #2: Kim will then review our first quarter results, and we will open the line to questions. The most notable achievement of the past year has been a string of regulatory approvals in the US and Europe for an entirely new foundational ecosystem of products.

Speaker #2: While Stereotaxis has a long history, our clinical and commercial experience is nearly all with first-generation technology from 20 years ago. After spending the past eight years and over 75 million dollars rebuilding an R&D pipeline, we brought to market an entirely new foundation of products.

David Fischel: While Stereotaxis has a long history, our clinical and commercial experience is nearly all with first-generation technology from 20 years ago. After spending the past 8 years and over $75 million rebuilding an R&D pipeline, we brought to market an entirely new foundation of products. In just the past few months, we received 4 US FDA regulatory approvals for a complex surgical robot, robotically steered therapeutic and diagnostic catheters, and a digital surgery cockpit. Outside of the US, we received multiple approvals in Europe and China. These product approvals are not just incremental innovations, but rather we structurally change our opportunity. We essentially developed a fresh new startup company on the shoulders of our legacy technology and funded by our legacy business.

Speaker #2: In just the past few months, we received four US FDA regulatory approvals. For a complex surgical robot, robotically steered therapeutic and diagnostic catheters, and a digital surgery cockpit.

Speaker #2: Outside of the US, we received multiple approvals in Europe and China. These product approvals are not just incremental innovations, but rather a structurally change our opportunity.

Speaker #2: We essentially developed a fresh new startup company on the shoulders of our legacy technology, and funded by our legacy business. The streak of regulatory success that began last year continued in the first part of this year, with two essential FDA approvals.

David Fischel: The streak of regulatory success that began last year continued in the first part of this year with two essential FDA approvals. First, in January, we received PMA approval for the MAGiC cardiac ablation catheter. Just last month, we received FDA clearance for Synchrony, our digital surgery cockpit that introduces connectivity and intelligence to the operating room. MAGiC is Stereotaxis' first proprietary therapeutic catheter and is the first ablation catheter ever to be approved by FDA specifically for arrhythmia patients with complex congenital heart disease. The catheter strategically allows us to overcome our historical dependency on Johnson & Johnson and to participate robustly in the recurring revenue of each procedure. Following regulatory approval, we recently announced that we began first MAGiC procedures at multiple US hospitals. Those procedures have gone well.

Speaker #2: First, in January, we received PMA approval for the Magic Cardiac Ablation Catheter. Then, just last month, we received FDA clearance for Synchrony, our digital surgery cockpit that introduces connectivity and intelligence to the operating room.

Speaker #2: Magic is Stereotaxis's first proprietary therapeutic catheter. And it's the first ablation catheter ever to be approved by FDA specifically for arrhythmia patients with complex congenital heart disease.

Speaker #2: The catheter strategically allows us to overcome our historical dependency on Johnson & Johnson, and to participate robustly in the recurring revenue of each procedure.

Speaker #2: Following regulatory approval, we recently announced that we began first Magic procedures at multiple U.S. hospitals. Those procedures have gone well. The first patient treated with the catheter had complex congenital heart disease, was being cardioverted weekly, failed multiple attempts to be treated with manual catheters, and was now successfully treated using Magic.

David Fischel: The first patient treated with the catheter had complex congenital heart disease, was being cardioverted weekly, failed multiple attempts to be treated with manual catheters, and was now successfully treated using MAGiC. The most beautiful example for why our innovations are critical and improve lives. The physician who did that procedure later commented, and I quote, "That was the most gratifying case I've ever done. I could have never done this without robotics." Demand for MAGiC is much higher than supply. We are rolling out the catheter in both Europe and the US in line with the manufacturing ramp. While the ramp is gradual, we're seeing meaningful progress. Our contract manufacturer still expects production to top 500 catheters a month by the end of this year.

Speaker #2: The most beautiful example for why our innovations are critical and improve lives. The physician who did that procedure later commented, and I quote, "That was the most gratifying case I've ever done.

Speaker #2: I could have never done this without robotics. Demand for Magic is much higher than supply, and we are rolling out the catheter in both Europe and the US in line with the manufacturing ramp.

Speaker #2: While the ramp is gradual, we're seeing meaningful progress, and our contract manufacturers still expect production to top 500 catheters a month by the end of this year.

Speaker #2: In addition to mitigate catheter shortages, we began selling an additional catheter in Europe that we have exclusive rights to through our collaboration with Microport, and we are making meaningful progress on other efforts that expand production capacity and redundancy.

David Fischel: In addition, to mitigate catheter shortages, we began selling an additional catheter in Europe that we have exclusive rights to through our collaboration with MicroPort, and we are making meaningful progress on other efforts that expand production capacity and redundancy. For now, the still small contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson & Johnson. This transition is messy and makes it difficult in reported quarterly financials to observe the underlying ramp of our new disposable business. The green shoots of this new business model are very evident to us, though, and are very attractive. In our initial US MAGiC procedures, we are seeing disposable revenue often above $8,000 per procedure and always above $5,000.

Speaker #2: For now, the still small contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson & Johnson.

Speaker #2: This transition is messy, and makes it difficult in reported quarterly financials to observe the underlying ramp of our new disposable business. The green shoots of this new business model are very evident to us, though, and are very attractive.

Speaker #2: In our initial US Magic procedures, we are seeing disposable revenue often above 8,000 dollars per procedure, and always above 5,000 dollars. This robust razor blade business model benefits from our strategy to build a synergistic portfolio of catheters, including Magic, Magic Sweep, and MAP-IT.

David Fischel: This robust razor blade business model benefits from our strategy to build a synergistic portfolio of catheters, including MAGiC Sweep, and Map-iT. In Europe, just this month, we received an order for $100,000 in disposables from a single hospital for what it expects to be a month worth of procedures. These amounts are in line with the EP market but are unprecedented for us. They demonstrate the transformation that is just starting to take shape in our business model. Still at low numbers, but increasingly very material as we advance through this year and transition our installed base of robotic accounts over to this new ecosystem. By the end of this year, we expect to have substantially transitioned customers as they use up remaining inventory of J&J catheters, work through hospital approvals and tender processes, and gain experience with MAGiC.

Speaker #2: In Europe, just this month, we received an order for 100,000 dollars in disposables from a single hospital for what it expects to be a month's worth of procedures.

Speaker #2: These amounts are in line with the EP market, but are unprecedented for us. They demonstrate the transformation that is just starting to take shape in our business model.

Speaker #2: Still at low numbers, but increasingly very material as we advance through this year, and transition our installed base of robotic accounts over to this new ecosystem.

Speaker #2: By the end of this year, we expect to have substantially transitioned customers as they use up remaining inventory of J&J catheters, work through hospital approvals and tender processes, and gain experience with Magic.

Speaker #2: The structural transformation to our disposable business model is taking place as we simultaneously structurally transform our capital business. This is happening primarily through the launch of Genesis X, the new robotic system that we received FDA clearance for at the end of last year, and which doesn't require construction to be installed in existing cath labs.

David Fischel: The structural transformation to our disposable business model is taking place as we simultaneously structurally transform our capital business. This is happening primarily through the launch of Genesis X, the new robotic system that we received FDA clearance for at the end of last year and which doesn't require construction to be installed in existing cath labs. We have a healthy pipeline of physicians and hospitals that are working towards orders for Genesis X and who are prepared to be the first to demonstrate it installed rapidly in existing labs while working compatible with non-modified X-rays from major X-ray manufacturers. Compatibility testing and commercial agreements are advancing in tandem. We continue to expect to establish at least five active Genesis X programs over the course of this year. These initial adopters and their demonstrations of the technology's accessibility, interoperability, and performance will be very beneficial in expanding adoption.

Speaker #2: We have a healthy pipeline of physicians and hospitals that are working towards orders for Genesis X, and who are prepared to be the first to demonstrate it installed rapidly in existing labs while working compatible with non-modified X-rays for major X-ray manufacturers.

Speaker #2: Compatibility testing and commercial agreements are advancing in tandem. We continue to expect to establish at least five active Genesis X programs over the course of this year.

Speaker #2: These initial adopters and their demonstrations of the technologies, accessibility, interoperability, and performance will be very beneficial in expanding adoption. The second significant change to our capital business is the start of a synergistic but independent capital opportunity with Synchrony and Sync.

David Fischel: The second significant change to our capital business is the start of a synergistic but independent capital opportunity with Synchrony and Sync. As a reminder, Synchrony and Sync are our digital solutions that modernize the interventional surgical suite with enhanced workflow, remote connectivity, and smart AI capabilities. Just last month, we received FDA clearance for Synchrony. We've already received orders for multiple systems and have shipped the first systems to customers. We're very confident in our guidance of $3 million in revenue from Synchrony this year. The initial commercial green shoots from our new product portfolio are exciting. The operational and commercial friction to ramp manufacturing and implement new products makes progress gradual, but everything is moving in the right direction, and we are efficiently driving broad-based progress on many fronts in parallel.

Speaker #2: As a reminder, Synchrony and Sync are our digital solutions that modernize the interventional surgical suite with enhanced workflow, remote connectivity, and smart AI capabilities.

Speaker #2: Just last month, we received FDA clearance for Synchrony. We've already received orders for multiple systems and have shipped the first systems to customers. We are very confident in our guidance of 3 million dollars in revenue from Synchrony this year.

Speaker #2: The initial commercial green shoots from our new product portfolio are exciting. The operational and commercial friction to ramp manufacturing and implement new products makes progress gradual, but everything is moving in the right direction, and we are efficiently driving broad-based progress on many fronts in parallel.

Speaker #2: We're doing this while weaning ourselves away from the dependencies and challenges of our legacy business. It's a tough transition, but we are building a very attractive business on solid foundations.

David Fischel: We're doing this while weaning ourselves away from the dependencies and challenges of our legacy business. It's a tough transition. We are building a very attractive business on solid foundations. What is particularly exciting for me is that we aren't resting on our laurels. While the benefits of this first wave of innovation start to become operational and commercial reality, we are energetically planting the seeds for significant opportunities that will blossom over the next few years. Our vision for what Stereotaxis can and will accomplish is becoming increasingly clear and tangible. That vision can be summarized as follows: Our core mission is to pioneer robotics across endovascular surgery. That means building fantastic robots that enable what is otherwise impossible, improving patient outcomes and physician experiences. It means these robots should be fully mobile, unobtrusive, interoperable, and accessible.

Speaker #2: What is particularly exciting for me is that we aren't resting on our laurels. While the benefits of this first wave of innovation start to become operational and commercial reality, we are energetically planting the seeds for significant opportunities that will blossom over the next few years.

Speaker #2: Our vision for what stereotaxis can and will accomplish is becoming increasingly clear and tangible. That vision can be summarized as follows. Our core mission is to pioneer robotics across endovascular surgery.

Speaker #2: That means building fantastic robots that enable what is otherwise impossible: improving patient outcomes and physician experiences. It means these robots should be fully mobile, unobtrusive, interoperable, and accessible.

Speaker #2: It means robots that can do the full range of activity necessary across the breadth of endovascular procedures, EP, neuro, cardiac, and peripheral, with a matching portfolio of advanced interventional devices.

David Fischel: It means robots that can do the full range of activity necessary across the breadth of endovascular procedures, EP, neuro, cardiac, and peripherals, with a matching portfolio of advanced interventional devices. It means embedding these robots with the digital innovation such that they not only mechanically manipulate devices, but add intelligence, connectivity, and automation to make procedures smarter, better, and quicker. This isn't an idle vision. We established a solid foundation for it with our initial portfolio of products. We've also been advancing in the background multiple efforts to realize the full vision. A few examples. First, at the European Heart Rhythm Association conference last month, we showed off a future generation of the GenesisX robot that is fully wireless, battery-operated, and mobile. We've invested in this project for a few years, and it is moving along well.

Speaker #2: It means embedding these robots with the digital innovations such that they not only mechanically manipulate devices, but add intelligence, connectivity, and automation to make procedures smarter, better, and quicker.

Speaker #2: This isn't an idle vision. We established a solid foundation for it with our initial portfolio of products. We've also been advancing the background multiple efforts to realize the full vision.

Speaker #2: A few examples. First, at the month, we showed off a future generation of the Genesis X robot that is fully wireless, battery-operated, and mobile.

Speaker #2: We've invested in this project for a few years, and it is moving along well. In the future, all our robotic platforms will be fully mobile and wireless.

David Fischel: In the future, all our robotic platforms will be fully mobile and wireless. Second, we are busy at work with two significant AI efforts. One, for decision support AI features incorporated into Synchrony to help physicians intraoperatively benefit from the wisdom of thousands of procedures. The second, a rehaul of our automated navigation software, so a physician simply designs a procedure and the robot executes it. A specific project here is with a larger industry partner who sees the opportunity for automation to offer the most efficient and yet personalized patient-specific therapy. Finally, and most significantly and transformationally, we announced the acquisition of Robocath last month, which, as mentioned at the time, gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular device navigation.

Speaker #2: Second, we're busy at work with two significant AI efforts. One for decision support AI features incorporated into Synchrony to help physicians intraoperatively benefit from the wisdom of thousands of procedures; and the second, a rehaul of our automated navigation software so physicians simply design a procedure and the robot executes it.

Speaker #2: A specific project here is with a larger industry partner who sees the opportunity for automation to offer the most efficient and yet personalized patient-specific therapy.

Speaker #2: And finally, and most significantly and transformationally, we announced the acquisition of RoboCath last month, which, as mentioned at the time, gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular device navigation.

Speaker #2: The combination of our technologies offers a clear vision for how our robotic solution—including the full ecosystem of digital innovations—will enable remote, automated, and fully robotic treatment of stroke and cardiovascular disease.

David Fischel: The combination of our technologies offers a clear vision for how our robotic solution, including the full ecosystem of digital innovations, will enable remote, automated, and fully robotic treatment of stroke and cardiovascular disease. The puzzle pieces have come together in a remarkable fashion. We are fully focused on executing the key operational and commercial activities to reap the rewards from our recent regulatory approvals, grow revenue, and reach break even. We're simultaneously busy at work through the acquisition of Robocath, other business development activities, and in-house R&D on a robust innovation effort across robotics, interventional devices, AI, and automation. The goals, direction of the path, and stepping stones of progress along the path have become increasingly clear to us. We are energetically and enthusiastically advancing forward.

Speaker #2: The puzzle pieces have come together in a remarkable fashion. We are fully focused on executing the key operational and commercial activities to reap the rewards from our recent regulatory approvals, grow revenue, and reach break-even.

Speaker #2: We're simultaneously busy at work through the acquisition of RoboCath, other business development activities, and in-house R&D on a robust innovation effort across robotics, interventional devices, AI, and automation.

Speaker #2: The goals: direction of the path, and stepping stones of progress along the path have become increasingly clear to us. We are energetically and enthusiastically advancing forward.

Speaker #2: Kim will now provide commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A.

David Fischel: Kim will now provide commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A. Kim?

Kimberly Peery: Thank you, David. Good afternoon, everyone. Revenue for Q1 2026 totaled $6.3 million, compared to $7.5 million in the prior year Q1. System revenue of $1.3 million and recurring revenue of $5 million, compared to $2 million and $5.5 million in the prior year Q1. System revenue in the current quarter reflects revenue recognition on the installation of 1 Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue in the quarter was pressured by the transition from the Johnson & Johnson ecosystem. Gross margin for Q1 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%.

Kim Peery: Thank you, David. Good afternoon, everyone. Revenue for Q1 2026 totaled $6.3 million, compared to $7.5 million in the prior year Q1. System revenue of $1.3 million and recurring revenue of $5 million, compared to $2 million and $5.5 million in the prior year Q1. System revenue in the current quarter reflects revenue recognition on the installation of 1 Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue in the quarter was pressured by the transition from the Johnson & Johnson ecosystem. Gross margin for Q1 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%.

Speaker #2: everyone. Revenue for the first quarter of 2026 totaled $6.3 million, compared to $7.5 million in the prior year first quarter. System revenue of $1.3 million and recurring revenue of $5 million compared to $2 million and $5.5 million in the prior year first quarter.

Speaker #2: System revenue in the current quarter reflects revenue recognition on the installation of one Genesis system and partial revenue recognition of other ancillary systems. Recurring revenue in the quarter was pressured by the transition from the Johnson & Johnson ecosystem.

Speaker #2: Gross margin for the first quarter of 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%. Operating expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earnout consideration, and amortization of acquired intangibles.

Operator 1: Operating expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earnout consideration, and amortization of acquired intangibles. Excluding these non-cash charges, adjusted operating expenses were $6.7 million, similar to the prior year adjusted operating expenses of $6.8 million. Operating loss and net loss in Q1 2026 were $6 million and $5.9 million, compared with $5.9 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $2.9 million and $2.8 million, compared with $2.7 million and $2.6 million in the previous year.

Kim Peery: Operating expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition-related contingent earnout consideration, and amortization of acquired intangibles. Excluding these non-cash charges, adjusted operating expenses were $6.7 million, similar to the prior year adjusted operating expenses of $6.8 million. Operating loss and net loss in Q1 2026 were $6 million and $5.9 million, compared with $5.9 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $2.9 million and $2.8 million, compared with $2.7 million and $2.6 million in the previous year.

Speaker #2: Excluding these non-cash charges, adjusted operating expenses were $6.7 million, similar to the prior year adjusted operating expenses of $6.8 million. Operating loss and net loss in the first quarter of 2026 were $6 million and $5.9 million, compared with $5.9 million and $5.8 million in the previous year.

Speaker #2: Adjusted operating loss and adjusted net loss for the quarter excluding non-cash charges were $2.9 million and $2.8 million, compared with $2.7 million and $2.6 million in the previous year.

Speaker #2: Negative free cash flow for the first quarter was $3.5 million compared to $1.8 million in the previous year. At March 31st, stereotaxis had cash and cash equivalents of $14.6 million and no debt.

Operator 1: Negative free cash flow for Q1 was -$3.5 million, compared to $1.8 million in the previous year. At 31 March, Stereotaxis had cash and cash equivalents of $14.6 million and no debt. I will now hand the call back to David.

Kim Peery: Negative free cash flow for Q1 was -$3.5 million, compared to $1.8 million in the previous year. At 31 March, Stereotaxis had cash and cash equivalents of $14.6 million and no debt. I will now hand the call back to David.

Speaker #2: I will now hand the call back to David.

Speaker #1: Thank you, Kim. I want to conclude by emphasizing that while not yet reflected in our quarterly financial results, the commercial green shoots I mentioned previously have begun.

David Fischel: Thank you, Kim. I want to conclude by emphasizing that while not yet reflected in our quarterly financial results, the commercial green shoots I mentioned previously have begun. Over the coming months, the positive impact will grow in momentum and overshadow the pressures on our legacy business. We are reiterating our revenue guidance for the year of double-digit revenue growth, with annual revenue expected to surpass $40 million. Revenue will ramp up sequentially each quarter, and we expect both the Q3 and Q4 of this year to have revenue of above $10 million a quarter. From a financial perspective, we're confident that we can advance our strategy, integrate Robocath, and grow significantly without subjecting investors to substantial dilution. Operating losses will be reduced as we grow recurring revenue, with the majority of recurring revenue dropping to the bottom line.

Speaker #1: Over the coming months, the positive impact will grow in momentum and overshadow the pressures on our legacy business. We are reiterating our revenue guidance for the year of double-digit revenue growth, with annual revenue expected to surpass $40 million.

Speaker #1: Revenue will ramp up sequentially each quarter and we expect both the third and fourth quarters of this year to have revenue of above $10 million a quarter.

Speaker #1: From a financial perspective, we're confident that we can advance our strategy to integrate RoboCath and grow significantly without subjecting investors to substantial dilution. Operating losses will be reduced as we grow recurring revenue, with the majority of recurring revenue dropping to the bottom line.

Speaker #1: We have opportunistically taken advantage of the ATM at prices significantly higher than our current valuation, with overall minimal dilution strengthening our balance sheet and bridging us through the acquisition of RoboCath and time needed to build momentum with recurring revenue.

David Fischel: We have opportunistically taken advantage of the ATM at prices significantly higher than our current valuation, with overall minimal dilution, strengthening our balance sheet and bridging us through the acquisition of Robocath and time needed to build momentum with recurring revenue. We have invested significantly in inventory that supports meaningful GenesisX and Synchrony revenue and maintain a clean balance sheet. We continue to pursue strategic opportunities for non-dilutive, non-debt financing. It is a delicate balancing act, and there is much being done in parallel, but we feel comfortable with our balance sheet, allowing us to advance our innovation strategy to market, fund a commercial ramp, and achieve profitability. We will now take your questions. Operator, can you please open the line to Q&A?

Speaker #1: We have invested significantly in inventory that supports meaningful GenesisX and Synchrony revenue, and maintain a clean balance sheet. We continue to pursue strategic opportunities for non-dilutive, non-debt financing.

Speaker #1: It is a delicate balancing act and there is much being done in parallel but we feel comfortable with our balance sheet allowing us to advance our innovation strategy to market, fund a commercial ramp, and achieve profitability.

Speaker #1: We'll now take your questions, operator. Can you please open the line to Q&A?

Speaker #3: Thank you. Yes, we will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press *1 to raise your hand.

Operator 2: Thank you. Yes. We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your question from the line of Daniel Stauder with Citizens. Your line is now open. Please go ahead.

Operator: Thank you. Yes. We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your question from the line of Daniel Stauder with Citizens. Your line is now open. Please go ahead.

Speaker #3: To withdraw your question, press *1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality.

Speaker #3: If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your question from the line of Danny Strouder with Citizens.

Speaker #3: Your line is now open. Please go ahead.

Speaker #4: Yeah, great. Thanks for taking the questions. So just for my first one, on catheters, you mentioned some initial green shoots and I know it's still early days, but for your customers that have started to use the Magic portfolio, I know you commented you were seeing revenue per procedure above $5,000 sometimes around $8,000, which is great to hear, but I was just curious if you could give us more color to your specifically in terms of how sticky utilization has been for new users of Magic and are you seeing a pretty immediate uptick following adoption?

Daniel Stauder: Yeah, great. Thanks for taking the questions. Just for my first one on catheters. You mentioned some initial green shoots, and I know it's still early days, but for your customers that have started to use the MAGiC portfolio, I know you commented you were seeing revenue per procedure above $5,000, sometimes around $8,000, which is great to hear. I was just curious if you could give us more color here, specifically in terms of how sticky utilization has been for new users of MAGiC. Are you seeing a pretty immediate uptick following adoption? Does it take time to ramp? Any more commentary would be great. Thank you.

Danny Stauder: Yeah, great. Thanks for taking the questions. Just for my first one on catheters. You mentioned some initial green shoots, and I know it's still early days, but for your customers that have started to use the MAGiC portfolio, I know you commented you were seeing revenue per procedure above $5,000, sometimes around $8,000, which is great to hear. I was just curious if you could give us more color here, specifically in terms of how sticky utilization has been for new users of MAGiC. Are you seeing a pretty immediate uptick following adoption? Does it take time to ramp? Any more commentary would be great. Thank you.

Speaker #4: Does it take time to ramp? And any more commentary would be great. Thank you.

Speaker #1: Sure. Hi, Danny. Good afternoon. So Magic adoption is right now still limited by production capacity. So we have sites that would like to transition 100% over.

David Fischel: Sure. Hi, Daniel. Good afternoon. MAGiC adoption is right now still limited by production capacity. We have sites that would like to transition 100% over. We have sites that have tried it and still have J&J catheters and are kind of, you know, for a period, would like to use both and gradually transition. We have sites that have stayed only with J&J at this point, but know that they have to transition over the coming months. Really kind of all of our sites fall into one of those three buckets. Right now we're still capacity constrained, and that is the main barrier.

Speaker #1: We have sites that have tried it and still have J&J catheters and are kind of for a period would like to use both and gradually transition.

Speaker #1: And we have sites that have stayed only with J&J at this point but know that they have to transition over the coming months. And so really kind of all of our sites fall into one of those three buckets.

Speaker #1: Right now, we're still capacity constrained, and so that is the main barrier. There will be sites where, as manufacturing continues to ramp, and it is getting better as the weeks go on, but as manufacturing continues to ramp, there will be sites that will just they've completely shifted over and every procedure they do will be with Magic, MagicSweep, MAP-IT kind of our ecosystem of catheters.

David Fischel: There will be sites where as manufacturing continues to ramp, and it is getting better as the weeks go on, but as manufacturing continues to ramp, there will be sites that will just, you know, they've completely shifted over and every procedure they do will be with MAGiC Sweep, and Map-iT kind of, our ecosystem of catheters. There are other sites that will likely run things side by side for a period of time. Then there's others, like I mentioned, that kind of will stay in the J&J ecosystem as long as they can. Essentially, they all know that over the coming months, probably over the next year, they essentially have to transition, given the availability of J&J catheters. So that kind of will drive a transition point.

Speaker #1: There are other sites that will likely run things side by side for a period of time, and then there's others like I mentioned that kind of will stay in the J&J ecosystem as long as they can.

Speaker #1: But essentially, they all know that over the coming months, probably over the next year, they essentially have to transition given the availability of J&J catheters.

Speaker #1: And so that kind of will drive a transition point. And so we're working really it's a ground game account by account to get them over that transition, to get them comfortable and working well with Magic, and the whole new ecosystem, and then kind of comfortable to start ordering Magic in a robust fashion.

David Fischel: We're working really it's a ground game account by account to get them over that transition, to get them comfortable and working well with MAGEC and the whole new ecosystem and then kind of the comfortable to start ordering MAGEC in a robust fashion as they've shifted over.

Speaker #1: As they've shifted over.

Speaker #4: Okay, great. And just one follow-up for me on that. Just as we look at the quarter's results and your reiteration of guidance, I was hoping you'd give us a little bit more on what is assumed in reaching that $40 million-plus number in terms of the timing of manufacturing improvement.

Daniel Stauder: Okay, great. Just one follow-up from me on that. Just, you know, as we look at the quarter's results and your reiteration of guidance, I was hoping you'd give us a little bit more on what is assumed in reaching that $40 million plus number in terms of the timing of manufacturing improvement. I know you still called out the 500 monthly catheter metric by year-end, but, you know, have you seen a meaningful shift in catheter production yield or any notable trends since the end of March? How should we be thinking about some of these headwinds in Q2? Really here, just trying to get a sense of how confident you are in the continuing improvement throughout the year on this front. Thank you.

Danny Stauder: Okay, great. Just one follow-up from me on that. Just, you know, as we look at the quarter's results and your reiteration of guidance, I was hoping you'd give us a little bit more on what is assumed in reaching that $40 million plus number in terms of the timing of manufacturing improvement. I know you still called out the 500 monthly catheter metric by year-end, but, you know, have you seen a meaningful shift in catheter production yield or any notable trends since the end of March? How should we be thinking about some of these headwinds in Q2? Really here, just trying to get a sense of how confident you are in the continuing improvement throughout the year on this front. Thank you.

Speaker #4: And I know you still called out the 500 monthly catheter metric by year-end, but have you seen a meaningful shift in catheter production yield or any notable trends since the end of March?

Speaker #4: And how should we be thinking about some of the head these headwinds in the second quarter and really here just trying to get a sense of how confident you are in the continued improvement throughout the year on this front?

Speaker #4: Thank you.

Speaker #1: Yeah. Sure. So if you think about the ASPs that are catheter portfolio provide, and you think that we're working towards 500 catheters a month by the end of this year, you can do kind of back-and-envelope math and you can see that the type of just disposable revenue that we would have in a quarter around the end of this year is higher than all of our recurring revenue right now.

David Fischel: Yeah, sure. If you think about the ASPs that our catheter portfolio provide, you think that we're working towards 500 catheters a month, by the end of this year, you can do kind of back an envelope math, you can see that the type of just disposable revenue that we would have in a quarter around the end of this year is higher than all of our recurring revenue right now.

Speaker #1: And so that's there is a lot of benefit to the shift in business model where you actually capture the revenue per procedure. And again, this is not with charging the hospital any more than what they're used to paying.

David Fischel: Benefit to the shift in business model where you actually capture the revenue per procedure. Again, this is not with charging the hospital any more than what they're used to paying. This is really just participating in the revenue that previously we didn't participate in. That's the primary driver, obviously, to revenue. You can start to model things where our recurring revenue by itself is reaching the near $10 million level as we ramp manufacturing of catheters to that level. On the system side, there's obviously this was a particularly weak quarter from a system perspective. We still have a pipeline. We still have a backlog, and we still engage with accounts both on Genesis and GenesisX.

Speaker #1: This is really just participating in the revenue that previously we didn't participate in. And so that's kind of that's the primary driver, obviously, to revenue.

Speaker #1: And so you can start to model things where our recurring revenue by itself is reaching the near $10 million or so level as we ramp manufacturing of catheters to that level.

Speaker #1: On the system side, obviously this was a particularly weak quarter from a system perspective. We still have a pipeline. We still have a backlog.

Speaker #1: We still engage with accounts both on Genesis and Genesis X. I think the majority of Genesis X accounts will be in the least-plus disposable commitment category, though there's some definite opportunities for sales there.

David Fischel: I think the majority of Genesis X accounts will be in the lease plus disposable commitment category, though there are some definite opportunities for sales there. The Genesis system is still fully a sales, that would be kind of revenue recognition upfront. That's kind of the way we're looking at the opportunity as we go through this year.

Speaker #1: But the Genesis system is still fully a sale, and so that would be kind of revenue recognition upfront. And so that's kind of the way we're looking at the opportunity as we go through this year.

Speaker #4: Your next question comes from Adam Bader with Piper Sandler. Your line is now open. Please go ahead.

Operator 2: Your next question comes from Adam Maeder with Piper Sandler. Your line is now open. Please go ahead.

Operator: Your next question comes from Adam Maeder with Piper Sandler. Your line is now open. Please go ahead.

Speaker #1: Great. Thanks. This is Kyle. I'm for Adam. I guess first to dig in a little more there on the disposable business, I was wondering if you could just kind of quantify the impact in the quarter for us, just to kind of try to help us understand where these impacts are in the quarter.

Kyle Bauser: Great. Thanks. This is Kyle. I'm for Adam. I guess first to dig in a little more there on the disposable business. I was wondering if you could just kind of quantify the impact in the quarter for us just to kind of try to help us, you know, understand where these impacts are in the quarter.

Kyle Winborne: Great. Thanks. This is Kyle. I'm for Adam. I guess first to dig in a little more there on the disposable business. I was wondering if you could just kind of quantify the impact in the quarter for us just to kind of try to help us, you know, understand where these impacts are in the quarter.

Speaker #5: Sure. So Magic and MagicSweep, the Magic portfolio, was very small in the quarter overall. And I think like we mentioned in our call in March, we had very little production in January, February because they were shifting over a process in the manufacturing line to a newer process, which improved the yield significantly.

David Fischel: Sure. Magic and Magic Sweep, the Magic portfolio was very small in the quarter overall. I think like we mentioned in our call in March, we had very little production in January, February, because they were shifting over a process in the manufacturing line to a newer process which improved the yield significantly. Essentially in January and February, the entire all production was meant for validating that shift in the process. We did you know, decent production in March, but that was most of the revenue from that production comes into April, by the time it gets produced and sterilized and shipped to us, we can actually ship to customers and recognize revenue.

Speaker #5: And so essentially, in January and February, the entire all production was meant for validating that shift in the process. And then we did have decent production in March, but that was most of the revenue from that production comes into April.

Speaker #5: By the time it gets produced and sterilized and shipped to us, and then we can actually ship to customers and recognize revenue. And so there was very little revenue recognition in the first quarter from Magic and MagicSweep.

David Fischel: There was very little revenue recognition in Q1 from MAGiC and MAGiC Sweep. The primary headwind is that Johnson & Johnson has not been supplying catheters well to accounts. That, there's obviously a pressure there in our accounts from that. That's kind of where the pressure on procedures from the Johnson & Johnson catheter and behavior versus the step up in revenue from shifting procedures to the MAGiC environment. That's kind of the give and take that's happening in our disposable revenue right now. Again, the step up from the MAGiC portfolio should overshadow as we start to get meaningful numbers in Q2, Q3, should overshadow by far any pressures that we're seeing from Johnson & Johnson.

Speaker #5: The primary headwind is that Johnson & Johnson has not been supplying catheters well to accounts. And so that there's obviously a pressure there in our accounts from that.

Speaker #5: And so that's kind of where the pressure on procedures from the Johnson & Johnson catheter and behavior versus the step-up in revenue from shifting procedures to the Magic environment, that's kind of the give-and-take that's happening in our disposable revenue right now.

Speaker #5: And again, the step-up from the Magic portfolio should overshadow, as we start to get meaningful numbers in the second quarter, third quarter, should overshadow by far any pressures that we're seeing from Johnson & Johnson.

Speaker #1: Okay, great. That's helpful. And then for my follow-up, maybe on the system side, heard some of the discussion around the pipeline and where discussions are.

Kyle Bauser: Okay, great. That's helpful. For my follow-up, maybe on the system side, you know, heard some of the discussion around, you know, the pipeline and where discussions are. I was just hoping you could maybe dig in a little more. If you could just give kind of more on the qualitative measures, just what's the early feedback? What are those discussions like? Maybe that can kind of help us understand, you know, when you expect that first order to come in for GenesisX.

Kyle Winborne: Okay, great. That's helpful. For my follow-up, maybe on the system side, you know, heard some of the discussion around, you know, the pipeline and where discussions are. I was just hoping you could maybe dig in a little more. If you could just give kind of more on the qualitative measures, just what's the early feedback? What are those discussions like? Maybe that can kind of help us understand, you know, when you expect that first order to come in for GenesisX.

Speaker #1: I was just hoping you could maybe dig in a little more if you could just give kind of more on the qualitative measures, just what's the early feedback, what then, what are those discussions like, and then maybe that can kind of help us understand when you expect that first order to come in for Genesis X.

Speaker #5: Yep, sure. So maybe I'll step back a little bit and provide again context for why this is a structural change that we are working through that is very beneficial as you come out on the other side of it, but is more complicated than perhaps many people have appreciated till now.

David Fischel: Yep, sure. Maybe I'll step back a little bit and provide, again, context for why this is a structural change that we are working through that is very beneficial as you come out on the other side of it, but is more complicated than perhaps many people have appreciated till now. Historically, in our entire history, we have only sold our robot with an integrated, magnetically modified, magnetically shielded X-ray, all of our systems to date. We have built GenesisX such that it can work compatible with non-integrated X-rays.

Speaker #5: And historically, in our entire history, we have only sold our robot with an integrated magnetically modified, magnetically shielded X-ray. And all of our systems to date.

Speaker #5: We have built Genesis X such that it can work compatible with non-integrated X-rays. That is a structural change that, as you implement it, provides you a much, much bigger base of accounts and labs where you can place your robot.

David Fischel: That is a structural change that as you implement it, provides you a much, much bigger base of accounts and labs where you can place your robot, and it makes the process of installing your robot much, much easier because you're not having to always install it concurrent with a specific unique X-ray. Implementing that. Right, we did receive our first order for Genesis X last year. We shipped the system. The system is awaiting installation at an account. That was done according to the historical model, which we'll still continue to do, where we sell our robots concurrent with selling magnetically shielded and integrated X-rays. That's kind of how all Genesis sales are still being done.

Speaker #5: And it makes the process of installing your robot much, much easier because you're not having to always install it concurrent with specific unique X-ray.

Speaker #5: And so implementing that and making the right, we obviously did receive our first order for Genesis X last year. We shipped the system. The system is awaiting installation at an account.

Speaker #5: That was done according to the historical model, which we'll still continue to do, where we sell our robots, concurrent with selling magnetically shielded and integrated X-rays.

Speaker #5: And so that's kind of how all Genesis sales are still being done. That's how we did the first Genesis X shipment as well. But making Genesis X such that it can work compatibly with the broad range of X-rays from the major X-ray manufacturers is a big effort.

David Fischel: That's how we did the first GenesisX shipment as well. Making GenesisX such that it can work compatibly with the broad range of X-rays from the major X-ray manufacturers is a big effort. We've done a huge amount of that effort already. We're very confident in the assessments and testing that we've done to date. What we're really looking right now for the first few GenesisX systems, apart from that one that we've already sold, is proving the model that GenesisX can work compatible with any of the large X-ray manufacturers. That to some extent opens you up to a whole world of capital opportunity that previously was not available to us.

Speaker #5: We've done a huge amount of that effort already. We're very confident in the assessments and testing that we've done to date. And what we're really looking for right now for the first few Genesis X systems, apart from that one that we've already sold, is proving the model that Genesis X can work compatibly with any of the large X-ray manufacturers. And that, to some extent, opens you up to a whole world of capital opportunity that previously was not available to us.

Speaker #5: The first users who are going to work with us in that effort are obviously need to be physicians and hospitals who are comfortable in that type of pioneering work and in the kind of working through the uncertainty and the risk.

David Fischel: The first users who are going to work with us in that effort are obviously need to be physicians and hospitals who are comfortable in that type of pioneering work and in the kind of working through the uncertainty and the risk. We obviously, through all the kind of scientific testing, we can explain and we can document why there isn't a real risk, but there's always a somewhat of a risk when you're the first ones to demonstrate something. We're glad that we do have accounts that are kind of open and interested in working with us to demonstrate the robot working in this non-integrated fashion.

Speaker #5: We obviously, through all the kind of scientific testing, we can explain and we can document why there isn't a real risk. But there's always a somewhat of a risk when you're the first ones to demonstrate something.

Speaker #5: And so we're glad that we do have accounts that are kind of open and interested in working with us to demonstrate the robot working in this non-integrated fashion.

Speaker #5: But that's really what we're doing with these first kind of pioneering accounts that are going to start using Genesis X and serving as kind of the showplaces where Genesis X works in existing labs.

David Fischel: That's really what we're doing with these first kind of pioneering accounts that are gonna start using GenesisX and serving as some of the showplaces where GenesisX works in existing labs.

Speaker #2: Your next question comes from Joshua Jennings with TD Cowen. Your line is now open. Please go.

Operator 2: Your next question comes from Joshua Jennings with TD Cowen. Your line is now open. Please go ahead.

Operator: Your next question comes from Joshua Jennings with TD Cowen. Your line is now open. Please go ahead.

Joshua Jennings: Hi. Thanks, David and Kim. Appreciate taking the questions. Wanted to just ask about some of the Johnson & Johnson turbulence and just thinking about the MAGiC integration at these centers. You know, what mapping platform are electrophysiologists using today when they integrate MAGiC into a blation case? Could there be any turbulence going forward? I mean, should we be thinking that MAGiC will be used with CARTO as well, as this catheter supply relationship ends with J&J?

Speaker #3: Hi. Thanks, David and Kim. Appreciate you taking the questions. Wanted to just ask about some of the Johnson & Johnson turbulence and just thinking about the Magic integration at these centers.

Speaker #3: And what mapping platform are electrophysiologists using today when they integrate Magic into ablation case? And could there be any turbulence going forward? I mean, should we be thinking that Magic will be used with CARTO as well as this catheter supply relationship ends with J&J?

Speaker #5: Sure. Good afternoon, Josh. So we've been committed to the concept of open ecosystems around our robot where you can pair the benefits of our robot with the broad range of diagnostic and therapeutic technologies out there.

David Fischel: Sure. Good afternoon, Josh. We've been committed to the concept of open ecosystems around our robot, where you can pair the benefits of our robot with the broad range of diagnostic and therapeutic technologies out there. That has been kind of one of our commitments from the beginning to our physicians. It's the right thing for patients, for physicians, for hospitals, and overall for the progress of medicine. As part of that, we integrated with Abbott's EnSite X system, its latest mapping technology, and we're fully integrated with EnSite, and that has been the predominant mapping system that is being used with MAGiC. There are some ways to make MAGiC work also with CARTO, and we also obviously have a full integration with a MicroPort mapping system, Columbus.

Speaker #5: And that has been kind of one of our commitments from the beginning to our physicians. It's the right thing for patients, for physicians, for hospitals, and overall for the progress of medicine.

Speaker #5: And as part of that, we integrated with Abbott's NSAID X system. It's the latest mapping technology. And we're fully integrated with NSAID. And that has been the predominant mapping system that is being used with Magic.

Speaker #5: There are some ways to make Magic work also with CARTO, and we also obviously have a full integration with a microport mapping system, Columbus, that is not available in the US, but that is available in Europe.

David Fischel: That is not available in the US, but that is available in Europe and in China, obviously. There are kind of some others, but in the majority of cases, and definitely in the US and mostly in Europe, you're seeing EnSite X being used with MAGiC, Abbott's EnSite X system.

Speaker #5: And in China, obviously. And so there are kind of some others, but in the majority of cases, and definitely in the US and mostly in Europe, you're seeing NSAID X being used with Magic, Abbott's NSAID X system.

Speaker #3: Thanks for those details. And also, at HRS, in the robotics symposium, I think two topics we were impressed with. I mean, one, just some of the progress on the PFA development.

Joshua Jennings: Thanks for those details. Also at HRS, you know, in the robotics symposium, I think two topics, we were impressed with. I mean, one, just some of the progress on the PFA development. If you could just share any incremental progress today. Then also, there seemed to be optimism from some electrophysiologists that are already involved in the cardiology ASCs or cardiology ambulatory procedure centers, that robotics could be incorporated. Sorry for two questions in one, but maybe you could touch on both of those topics and how you see the PFA evolving on the robotic platform and integrating in the MAGiC catheter, then also, just the opportunity in ASCs. Thanks for taking the questions.

Speaker #3: If you could just share any incremental progress today. And then, also, there seems to be optimism from some electrophysiologists that are already involved in the cardiology ASCs or cardiology ambulatory procedure centers.

Speaker #3: That robotics could be incorporated. Sorry for two questions in one, but maybe you could touch on both of those topics and how you see the PFA evolving with robotic platform and integrating in the Magic catheter and then also just the opportunity in ASCs.

Speaker #3: Thanks for taking the questions.

Speaker #5: Sure. Thanks a lot. And yeah, and I'll definitely touch upon both PFA and ASC setting. And maybe before that, just since you mentioned HRS and the Society for Cardiac Robotic Navigation Symposium that happened at HRS, I mean, that was a beautiful demonstration of how the fact that we are innovating and bringing new solutions to the market does create a different level of excitement in the field.

David Fischel: Sure. Thanks a lot. I'll definitely touch upon both PFA and the ASC setting. Maybe before that, just since you mentioned HRS and the Society for Cardiac Robotic Navigation symposium that happened at HRS, I mean, that was a beautiful demonstration of how the fact that we are innovating and bringing new solutions to the market does create a different level of excitement in the field. With all of the challenges and all of the messiness to the transition, we had at HRS about, I don't know, it was a huge room and probably about 200 or so people who came. At the far end, you had to walk all the way at the end of the hallway in order to get to the room of SCRN.

Speaker #5: With all of the challenges and all of the messiness to the transition, we had at HRS about, I don't know, it was a huge room and probably about 200 or so people who came at the far end.

Speaker #5: You had to walk all the way at the end of the hallway in order to get to the room of SCRN. And right, you had probably about 200 or so people who attended that session with fantastic talks from multiple physicians.

David Fischel: Right, you had probably about 200 or so people who attended that session with fantastic talks from multiple physicians, KOL physicians. That was kind of a really nice event, and I think it's reflective generally of the type of interest. We're still a small player in the EP field, but there is a renewed interest from many physicians who long had thought that robotics was an old technology and a stale technology, and are interested and kind of starting to recognize that the technology that they remembered is not anymore how it is today, and the opportunity is there for them to actually engage with us in a much more meaningful way.

Speaker #5: KOL physicians. And so that was kind of a really, really nice event. And I think it's reflective generally of the type of interest we're still a small player in the EP field, but there is a renewed interest from many physicians who long had thought that robotics was an old technology and a stale technology, and are interested and kind of starting to recognize that the technology that they remembered is not anymore how it is today.

Speaker #5: And the opportunity is there for them to actually engage with us in a much more meaningful way. So that was one of the highlights, obviously, of the last few weeks as the whole HRS conference and era conferences and then specifically the SCRN session there.

David Fischel: That was one of the highlights, obviously, of the last few weeks is the whole HRS conference, neuroconferences, and then specifically the SCRN session there. If we look at PFA specifically, I know I didn't include any discussions about that in the prepared remarks, not because there's anything negative, just because we're continuing as we've discussed in the March call, and we had enough other things to speak about on this call. We're still working, obviously with CardioFocus. We have the announced collaboration. We're working on the effort of getting compatibility between MAGiC and CardioFocus' generator, PFA generator approved in Europe. We've done kind of meaningful work and started actually the kind of regulatory engagement with a notified body. That's kind of clearly underway.

Speaker #5: If we look at PFA specifically, I know I didn't include any discussions about that in the prepared remarks, not because there's anything negative, just because we're continuing as we've discussed in the March call and we had enough other things to speak about on this call.

Speaker #5: We're still working obviously with cardio focus. We have the announced collaboration. We're working on the effort of getting compatibility between Magic and cardio focus is generator PFA generator approved in Europe.

Speaker #5: We've done kind of meaningful work and started actually the kind of regulatory engagement with notified body. And so that's kind of clearly underway. We also have kind of another collaboration, one of those that we've kind of not mentioned the name, but discussed over the last couple of years.

David Fischel: We also have kind of another collaboration, one of those that we've kind of not mentioned the name, but discussed over the last couple years. That is also overall a clear opportunity for leveraging a variant of MAGiC with their generator. We continue to view that kind of as an exciting space. I think during the talks, the physician talks at the SCRN symposium, there was a few kind of where the speakers were noting how despite all of the enthusiasm for PFA, there is still various safety signals that things like stability of the catheter with the tissue are particularly important for PFA, both efficacy and safety. Our stability of the catheter is one of our hallmarks of our catheter and a great benefit there.

Speaker #5: And that is also overall clear opportunity for leveraging a variant of Magic with their generator. And so we continue to view that kind of as an exciting space.

Speaker #5: I think during the talks, the physician talks at the SCRN symposium, there was a few, kind of—the speakers were noting how, despite all of the enthusiasm for PFA, there are still various safety signals, that things like stability of the catheter with the tissue are particularly important for PFA—both efficacy and safety.

Speaker #5: Our stability of the catheter is one of our hallmarks of our catheter and a great benefit there. And that as you start to think about PFA in the ventricle, we have an ability to obviously get anywhere in the ventricle to stay steady on that tissue and so we're probably in a very, very good position.

David Fischel: As you start to think about PFA in the ventricle, we have an ability to obviously get anywhere in the ventricle to stay steady on that tissue. We're probably in a very, very good position. Some of the speakers there weren't part of our animal studies, so they, I don't share data from those animal studies in their presentations. On the ASC side, the ASC side is fascinating. It's obviously still a minority, right? The vast majority of cardiac ablation procedures are still done in the hospital setting. You've seen in several states, ASC starting to get set up to do cardiac ablation procedures.

Speaker #5: And some of the speakers there weren't part of our animal studies. And so they I believe shared data from those animal studies in their presentations.

Speaker #5: On the ASC side, the ASC side is fascinating. It's obviously still a minority. The vast majority of cardiac ablation procedures are still done in the hospital setting, but you've seen in several states ASCs starting to get set up to do cardiac ablation procedures.

David Fischel: There's obviously the precedent in many other areas of medical devices where ASCs have kind of become a dominant setting for procedures. We think and believe that the robot, the Stereotaxis robot should be very well suited for the ASC, particularly because of our safety profile. That's obviously one of the biggest risks from moving from the hospital setting to the ASC setting, is that you don't have the same safety net in terms of all of the hospital resources around you. We think that our robot can provide a big benefit there. The vast majority of procedures currently being done in the ASC setting are paroxysmal AF. That's not where our robot shine.

Speaker #5: There's obviously the precedent in many other areas of medical devices where ASCs have kind of become dominant setting for procedures. We think and believe that the robot, the Stereotaxis robot, should be very well suited for the ASC, particularly because of our safety profile.

Speaker #5: And that's obviously one of the biggest risks from moving from the hospital setting to the ASC setting is that you don't have the same safety net in terms of all of the hospital resources around you.

Speaker #5: And so we think that our robot can provide a big benefit there. The vast majority of procedures currently being done in the ASC setting are paroxysmal AF.

Speaker #5: That's not where our robot shines. Our robot can shine in things like PVCs and in various other areas where stability and safety and navigation is more challenging.

David Fischel: Our robot can shine in, you know, things like, you know, PVCs and in various other areas where, you know, stability and safety and navigation is more challenging. I, you know, I very much hope, believe that one of those Genesis X installations this year will be in the ASC setting, and that will start to demonstrate also the financial and clinical merit of having a robot in the ASC setting. Again, this is small. This is something that will be a long term, will have a long term tailwind to it in the US. Definitely think there's merit to us being there early on and starting to demonstrate the value there.

Speaker #5: And so I very much hope, believe that one of those Genesis X installations this year will be in the ASC setting and that will start to demonstrate also the financial and clinical merit of having a robot in the ASC setting.

Speaker #5: Again, this is small. This is something that will be a long-term will have a long-term tailwind to it in the US, but definitely we think there's merit to us being there early on and starting to demonstrate the value there and hopefully that will give us another opportunity over the next few years to grow kind of and to help the ASC setting grow as a field for cardiac ablation.

David Fischel: Hopefully that will give us another opportunity over the next few years, to grow kind of and to help the ASC setting grow as a, as a field for cardiac ablation.

Operator 2: There are no further questions at this time. I will now turn the call back to David Fischel for closing remarks.

David Fischel: There are no further questions at this time. I will now turn the call back to David Fischel for closing remarks.

Speaker #1: There are no further questions at this time. I will now turn the call back to David Fischel for closing remarks.

Speaker #3: Okay. Thank you very much for your questions and for your continued support. We look forward to hosting any investors visiting our office on Thursday for our annual shareholder meeting.

David Fischel: Okay. Thank you very much for your questions and for your continued support. We look forward to hosting any investors visiting our office on Thursday for our annual shareholder meeting. We will continue working hard for your benefit and look forward to speaking again soon. Thank you very much.

Speaker #3: And we will continue working hard for your benefit and look forward to speaking again soon. Thank you very much.

Operator 2: This concludes today's call. Thank you for attending. You may now disconnect.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

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Q1 2026 Stereotaxis Inc Earnings Call

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Q1 2026 Stereotaxis Inc Earnings Call

Tuesday, May 12th, 2026 at 8:30 PM

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