It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereotaxis.
Thank you, operator. Good morning, everyone. We appreciate you joining today's investor call to discuss the acquisition of Robocath. We assume you've all had the chance to read the press release that came out this morning announcing the acquisition. The press release is available on our investor relations website. I'll keep our prepared remarks relatively brief such that most of the time can be spent on Q&A. I'm taking this call from Robocath's headquarters, and we have here with me their Founder and CEO, Philippe Bencteux, who will also be available for Q&A. I'd like, though, to start with some background on Robocath and its technology, how it complements our strategic roadmap and expands our opportunity, and our intentions and expectations in the coming quarters. We are very excited to be making this announcement.
Robocath represents a highly strategic addition to Stereotaxis, amplifying and accelerating our strategy as the leading robotic platform for the broad spectrum of endovascular procedures. The combination of our technologies will more quickly allow us to deliver next-generation, fully integrated and highly capable robotic solutions for electrophysiology and even more so for interventional cardiology and neurointerventions. Let's start with some basic background. Robocath is a venture-backed private company based in Rouen, France, just north of Paris. It was founded in 2009 by Philippe, an Interventional Radiologist. The company has about 40 employees, the majority of whom are in engineering. It has raised approximately EUR 70 million to date, with the vast majority of this spent on R&D to advance its core robotic technology.
It released a first-generation robotic system, the R-One system, in 2019 after receiving CE mark receipt in Europe, and has 15 of these systems installed, predominantly in Europe and China. It has spent the last several years incorporating learnings from initial clinical use to build upon the original R-One system and develop a far more capable next-generation system. Robocath approached the topic of robotics and endovascular procedures from a very different vantage point than Stereotaxis, both in terms of technology, mechanism of action, and clinical focus. Its system is a sophisticated mechanical grasper that replicates the human hand, holding and manipulating up to five interventional guide wires and catheters simultaneously. It can be installed quickly in existing cath labs without construction and used with typical non-modified interventional devices that would otherwise be held by the physician's hand.
This differs from Stereotaxis' approach of using magnetic fields to allow for otherwise unprecedented navigation of one interventional device at a time directly from the distal tip. Robocath's mechanism is particularly important for interventional cardiology and neurointerventions, where multiple devices, wires, catheters, stents, balloons must be navigated in tandem. The closest comparison to Robocath's technology was Corindus, which was acquired for $1.1 billion by Siemens in 2019. Corindus similarly had developed a robot with a mechanical grasper mechanism of action for use in interventional cardiology. The system ultimately suffered from limited clinical value due to its immature technology, leading Siemens to pull back from the market. We believe that Robocath's technology, as it is being implemented in its next-generation system, will prove to be architecturally more capable and elegant than Corindus.
With the use of bionic fingers that provide better traction with slippery devices and more precise manipulation, and a system design that supports smoother and more efficient workflow with a better cost profile. Stereotaxis' go-alone approach to robotics in interventional cardiology and neurointervention has been predicated on developing magnetically steered guide wires and guide catheters, what we have called previously the EMAGIN family of guide wires and guide catheters, to navigate tortuous vasculature. We're still advancing that strategy and expect regulatory approvals for both EMAGIN devices later this year. The devices will address specific unmet medical needs where our unique mechanism of action, steering directly from the distal tip, can provide significant value. We always knew that to make these procedures fully robotic, where all aspects of the procedure can be done robotically and ultimately remotely, we needed a sophisticated mechanical grasper to complement our magnetic mechanism.
We had plans for how such technology could be developed internally, but simultaneously maintained an openness to an acquisition.
Ladies and gentlemen, this is the operator. I apologize, but there will be a slight delay in today's conference. Please hold and the call will resume momentarily. Thank you for your patience. Mr. David Fischel, you may resume the conference.
Sorry, everyone. I very much apologize. Somehow the phone lost connection here. Sorry for the delay. I think where we had left off, I kind of was mentioning that we had plans to develop kind of a mechanical grasper internally, in-house, but simultaneously maintain an openness to doing an acquisition if the right technology presented itself in an opportunistic fashion that accelerated and augmented what we would otherwise have done internally. We kept a close watch on the field of companies developing surgical robots, and several years ago noted Robocath's technology as something that could be of interest. Over the last year, we had the opportunity to start more detailed dialogue and deeper due diligence.
We were impressed with what the Robocath team had accomplished and viewed the next-generation system as the most thoughtful approach to the challenges in designing a scalable and fully capable mechanical grasper. The approach has been sharpened by their clinical experience with the R-One system, and they have an IP portfolio that will be a strong barrier of entry for any competitor. Acquiring Robocath became an actionable opportunity more recently, and we were pleased to be able to come to terms that we believe are fair and align both companies and their shareholders for long-term success. Our plan with Robocath in the near term is primarily to leverage Stereotaxis' technology and expertise to more quickly advance the next-generation robotic system towards regulatory submissions for percutaneous coronary interventions and the treatment of stroke.
Robocath's system will be enhanced with existing proprietary hardware and software embedded within GenesisX, Synchrony, and Sync, supporting advanced functionality including operating room integration, automation, and robot procedures. In tandem with bringing Robocath's next-generation system to market, we'll work to fully integrate our magnetic robot, GenesisX, with their system. The combination of these synergistic mechanisms promises the most powerful approach to improving procedural precision, efficiency, and outcomes. We see the most benefit here, obviously, in interventional cardiology and neurointerventions, but also in our existing EP market. When we launch Robocath's next-generation system, this will be fully synergistic from a commercial perspective. Our global commercial team is very well suited to sell Robocath, and being able to commercialize both technologies independently and in combination is additive in every way.
While we expect approximately $2 million in annual revenue during the first year post-acquisition, we will hold off on a full launch until the next-generation system is approved. Stereotaxis' commercial team remains fully focused in the near term on executing on our existing strategy with GenesisX, MAGiC, and MAGiC Sweep in electrophysiology. As we demonstrate our success in EP, we are already laying the foundations for future robust commercial success in the over $20 billion interventional cardiology and neurointerventional markets. A few key financial terms of the transaction, and then we'll start Q&A. The transaction consideration includes an upfront payment of $20 million, an additional contingent payment of up to $25 million tied to regulatory and commercial milestones. The regulatory milestone is FDA clearance of the next-generation Robocath system, and the commercial milestones reflect significant adoption of that technology.
All considerations, upfront, and milestones are payable in cash or Stereotaxis common stock at Stereotaxis' discretion. The upfront portion will be paid in stock at a minimum stock price of $2 per share. The acquisition will be cash flow negative initially, but is expected to become break-even by the third year post-acquisition, supported by launch of the next-generation system and commercial and operational synergies. We're also working on potential non-dilutive financings to fund the development of Robocath's technology for neurointervention. The acquisition is subject to customary closing conditions and is expected to close in mid-2026. Upon closing, Robocath will operate as a wholly-owned subsidiary of Stereotaxis. With that, Philippe and I look forward to answering any of your questions. Operator, can you please open the call to Q&A?
Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone in your device, please pick up your handset ensuring that your phone is not on mute when asking your question. Again, press star one to join the queue. Our first question comes from the line of Daniel Stauder with Citizens. Your line is open.
Yeah, great. Thanks for taking the question. I guess first, I appreciate all the color that you provided, but you talked about these being complementary technologies, and just wanted to get more of a sense of how Genesis and GenesisX and R-One would interact broadly. It sounds like these would be using the same procedures, but does R-One have the same mobile capabilities? Is there any interruption to workflow? Can they be set up at the same time? Just any more info on how these two systems will work together in the lab would be great. Thank you.
Sure. Hi, Daniel. Thanks for the question. First of all, both technologies will continue to be advanced and commercialized as independent, separate technologies, but there's definitely a significant opportunity, predominantly in interventional cardiology, neurointervention, and ultimately also in EP, to combine the technologies together. If you think about Genesis and GenesisX, we do have a small mechanical grasper, the QuikCAS device, our disposable, which sits near the access site of a patient, and the magnetic catheter clips into it, and that allows for advancing and retracting of that one catheter. That's kind of already the most simplified version of a mechanical grasper to some extent that you can have in a robotic system. As we look towards interventional cardiology and neurointerventions, we had designs on a similar type of device that could be used with a EMAGIN guide catheter or guidewire.
To allow for a fully robotic procedure and not just power steering of the tip of a magnetic device, you would want to have a more sophisticated mechanical mechanism that can move both the magnetic devices and the standard sheath, standard wire, standard angioplasty catheters. This is really kind of the combination of Robocath mechanical grasper. We won't do integration with the R-One system of Robocath. It will really be all with the next generation system of Robocath. The integration of that next generation Robocath system with GenesisX and Genesis will allow for pairing both the benefits of magnetic steering, full distal tip control, steering through tortuous anatomy, and the benefits of Robocath, which is really kind of multi-device manipulation, being able to do everything in an interventional case fully robotically.
Okay, great. I appreciate that. Just one follow-up from me, just more specifically as we think about Synchrony and R-One, when could you start to see these working together as complementary systems? I'd assume there's some compatibility process or technological integration that is needed. How complex would that be? Will R-One still use its own command unit with this new system? Just, I guess, anything there in terms of the actual system or Synchrony in the cockpit would be helpful as well.
Yeah, definitely. We view Synchrony and Syncs as we just discussed a week ago when we got FDA approval for Synchrony. We view Synchrony and Syncs as kind of a very core part of providing a great cockpit experience for the physician during a robotic procedure. It's not just that, it's not just the experience and kind of what you see visually, but the fact that Synchrony, through its software, allows for integrations and data kind of availability with many different systems in the cath lab environment. That's obviously very attractive, and so it would be a very reasonable guess to assume that we expect Synchrony to serve as part of that cockpit environment also with use with Robocath's next-generation system.
That's where there's things I've talked often in the past that someone looking at Stereotaxis and looking at robotic surgery has to think about ecosystems of technologies. Robocath has done really an awesome job in terms of building the mechanical robot. We have had much more commercial experience over many more years that has allowed us to think more holistically about an ecosystem, about software integrations, about how to take pre-op images and integrate them into the robot software, about things like telerobotics. There's a range of those capabilities that we can relatively easily bring to Robocath. I would expect as the Robocath team continues to advance the next-generation system, we will do those integrations such that the next-generation system can be launched with those capabilities.
Awesome. That's great color. I'll try to squeeze one more in here just on the financials. I guess, just as we think about the near term, how does this change your bottom line, your cash burn and cash needs as it relates to the new operating expenses with Robocath and the expectations for developing this new system and any gross margin considerations as we should think about? Thanks.
Sure. From a financial perspective, I would generally model around $5 million incremental annual operating expense from the Robocath team. We have a couple efforts ongoing or that are available, we believe, for significant non-dilutive funding to advance the technology. Hopefully over the coming months, we'll be able to discuss those as well. That's the basic way I would think about it. As we launch the technology, we would expect, definitely from a system perspective, to be gross margin accretive and from a disposable perspective, as we grow disposable revenue, it should be able to match our typical thoughts on disposable margins.
Great. Thanks for the questions, and congratulations to both teams on the acquisition. We appreciate it.
Thank you.
Our next question comes from the line of Josh Jennings with TD Cowen. Your line is open.
Hi, good morning. Congratulations on the acquisition. Thanks for taking the questions.
Thank you, Josh.
Thanks, David. Sorry for making you repeat yourself. I wanted to maybe get you to review just where Robocath stands in the FDA approval process and maybe the pathway and what the hurdle was, or it remains to be, with your clinical data that was required. Is it a 510K pathway? Again, sorry for making you repeat yourself.
Sure. I'll try to start to answer that, and then maybe if Philippe wants to add any additional color, he'll do so. Robocath received CE mark in 2019. They didn't pursue FDA approval for the R-One system. In many ways, the R-One system was not viewed as something that would undergo a broad commercial launch. Similar to some extent, the difficulties that Siemens with Corindus had in terms of launching that system broadly, it was just 1st-generation technologies in these spaces are not mature enough to really work in a broad fashion and to be commercialized very broadly.
The R-One system was really used as an initial system to gain clinical experience, to work with KOLs in the field, to learn how to refine such technology, and all of that learning went into the development of the next-generation system, which is currently still in development, but in the later stages of development. We will obviously then join in that process of refining the technology, getting it to the point of regulatory submissions, and helping the regulatory submissions. Did that answer your question?
It does. Thank you. And I was hoping to just tap in or hoping you would share your vision of robotics in coronary interventions. I think the clinical value proposition of robotics in neurovascular interventions seems more straightforward. There have been attempts for robotic solutions, as you called out in your prepared remarks, for the coronary space. But what do you think robotics needs to deliver in order for-- or your development efforts and what does Stereotaxis now need to deliver to open up that space and gain traction for your robotic solution in PCI going forward? Thanks for taking the questions.
Sure. Maybe I'll pass it to Philippe since he's thought about this for many years, and he can start to answer that.
Yes. If I may, you know that for Corindus, it was not a success because of the technology was so difficult, so complex. On our side, with our third generation, which is the first product, we learn much from the market, and even our third generation is not a success in the market. We learn much, and what is expecting the market is to be able to deal with complex lesion, which is where there is the pricing, which is where the cardiologists need for a robotic solution. They have a need for a robotic solution for this complex lesion because they stay aside the patient dealing with many devices. It's very long, it's very difficult, it's cumbersome. This is where a robot can deal with many devices and where the cardiologist may sit down with a console, working from a console.
It's solving a huge problem here. This is what we feel that, not we feel, what we experienced is this is where we are expecting a robotic solution. Complex lesions represent half of the activity of cath labs, cardio cath labs. In neuro, only 2.8% of the world population have access to thrombectomy in emergency when having a stroke. There is a huge gap and a huge potential to improve the care of this second cause of death, and also first cause of acquired chronic disabilities such as hemiplegia and so on. There is a huge opportunity here, and this is the vision of David, who understand that market is huge and the big opportunity here.
Thank you. Maybe I'll add to that.
Thank you very much.
Yes. I'll add to that a little bit in the interventional cardiology field. I think you're very right, kind of noting the differences between interventional cardiology or coronary percutaneous interventions and neurointerventions for stroke. They are very different markets. The needs there are different in some ways. I'd say that in the coronary world, there is a kind of, you can almost think about it as a barbell approach. On the one hand, and this is really where we plan to kind of first push in the closer term with the next-generation system, is enabling complex procedures that otherwise couldn't be done or couldn't be done well or couldn't be done at most sites. That has always been Stereotaxis' core value proposition, has been enabling complex cardiac ablation procedures in the EP space. Similarly, there's room to do that with a good robot in the IC space.
I think there is also a broader benefit in the bread-and-butter IC cases, and that will really be predicated on automation. We've talked in the past about Synchrony, about some of the AI features that we've been developing with Synchrony. I've mentioned the ability to look at an X-ray feed, irrespective of which X-ray system it comes from, and to see things like catheters and wires in that feed, and to create closed feedback loops then with automation software. There are a range of kind of fun stuff happening under the hood to make that vision a reality.
With better automation, I think you definitely can also see the barbell, where the value proposition is not just enabling complex things, but it's taking away the mundane aspect of day-to-day, the 10-15 angioplasty procedures that are done in a cath lab every day, making those kind of much less mundane and much more efficient.
Super helpful. Thank you guys for the answers.
Thank you.
Thank you.
Next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open.
Great. Thank you for taking the questions. Congratulations. I was hoping I could follow up on that last string of questions. Can you just call out maybe some examples of complex procedures in the coronary that you think make the most sense? Any color on kind of starting to think about the size those markets would be interesting in the complex area?
Sure. I can give a first try, and Philippe then can add. Chronic total occlusions are one very clear one, CTOs. You have a range of times where you have to do angioplasty in a more distal, more tortuous vessel. That's kind of a second group. Sometimes you have to do it at a bifurcation of vessels. That's probably a third group. I'd say those are three categories that are clear complex ones in the PCI space. Philippe, anything you would add kind of beyond those three?
No, you told the main essential indications. What is amazing with our new generation of robot is we are able to deal with five devices with this new generation, which is unique in the world. As you mentioned, there is a technological barrier to the adoption. Again, Corindus and us with our third generation, were not able to reach this technological barrier. Now with this next generation, able to take care of at the minimum five devices, we are able to have a comprehensive approach of the whole intervention and a comprehensive approach of the whole activity of cath lab. It's a big step that we are crossing here. We are quite confident on the adoption of this next generation of the robot.
You can look at the TAM for interventional cardiology, neurointerventions in various ways. It's easily a $20 billion-$30 billion+ medical device market, just the catheters used in those procedures. We're talking about very big fields. Even if you look at just procedures that are 10% of those, it's obviously a very large market. I think given our current vantage point, we're looking to build the best technology possible, start to use it in these complex cases, and we don't have right now any concern about market size.
Helpful. I don't know if it was mentioned, apologies if I missed it, but did you guys lay out a timeline of when we could see the next-gen on the market?
We've talked about within the next couple years, we expect to do regulatory submissions.
Okay.
We had the first-in-human. We had the first cases achieved with our next generation with success. Now we are in a regulatory process.
Let me add to that. Robocath team has done first-in-human testing with that system. When Philippe says they're in the regulatory process, a submission has not been made. Testing is being done that would be related to the regulatory process, but a submission has not yet been made.
Helpful. If I could just squeeze one last one in. Can you talk about economics? How do you think about what the system might sell for? How much of the future potential do you really bake into kind of the disposable side of the equation? Obviously, that's been a big investment from core Stereotaxis to build that disposable angle. Is there investment required here that needs to catch up Robocath? Is it going to come to market with a pretty good suite of disposables to go along with the system?
Okay. I would rather not comment right now about that first part of the question. We've obviously looked at things like the da Vinci robot as a good yardstick for the Stereotaxis robot in that kind of one and a half to two million dollars range. There's other robots on the market in orthopedics that are sometimes lower than that. I think we'll definitely be shooting for a seven-figure number, and generally want to do a little bit of exploration about what the best pricing will be. Give us a little bit of time to plan for that. I think we should be able to have a healthy price and a healthy margin on this. In terms of the disposable part, there is definitely an opportunity in the interventional cardiology, neurointerventional field to think more expansively about disposables like Stereotaxis had in electrophysiology.
I would say that in the initial iteration of Robocath's technology, you should think about the revenue model much more similarly to what Stereotaxis has been historically. With the one exception being obviously when our two robotic mechanisms are paired together, there will be a magnetic guidewire, magnetic guide catheter that would be used in the procedure, and so that would be kind of an added disposable revenue.
Got it. Very helpful. Thank you for taking the questions.
Thank you.
Next question comes from the line of Adam Maeder with Piper Sandler. Your line is open.
Hi, this is Kyle on for Adam. Thanks for taking the questions and congrats on the acquisition. I guess first to follow up on the impacts to the model. See that you expect $2 million annual revenue contribution here from Robocath. Just trying to kind of map it out. Should we assume about $1 million contribution for the second half of this year? Didn't see any mention of kind of the previous fiscal 2026 guidance of about $40 million total revenue. Are you still kind of standing by that figure? Is it correct to maybe assume an additional $1 million here from the acquisition?
Hi, Kyle. Thanks for the question. We stick with our obviously proof. We haven't updated our previous guidance. We stick with our previous guidance. I would say we plan to close the acquisition in the middle of this year. Don't kind of flatline that $2 million. I would put more of it into the beginning of next year versus the end of this year.
Sure. Okay. Got it. That makes sense. I guess, kind of more broadly, just curious to get your thoughts, why right now made sense for doing this acquisition, kind of given you just got the full product portfolio together for the U.S., a lot of approvals. How do you plan to manage or prioritize resources going forward, making the commercial push with GenesisX and MAGiC versus now also balancing the development of this 2nd-gen Robocath system?
Great question. What I'd say is that kind of from a commercial perspective, our commercial teams are fully focused on what's in front of them. As you mentioned, we've been blessed with many regulatory approvals over the last few months. It's been a multi-year effort to get to this stage where we have that. We know very clearly what is our key goal for this year. As mentioned on the call a month ago or so, in our March year-end call, we talked about the key goals for this year. Those four key goals kind of are imprinted in everyone here. One of those key goals was to demonstrate a more robust strategy in kind of beyond electrophysiology in the endovascular space. This was one of those activities that we were obviously thinking about and working on at the time. There's another one which is.
It's not an acquisition. The other one would provide for significant non-dilutive funding to Stereotaxis in the tens of millions of dollars to advance technology in this field. This is part of that promise of our 2026 annual goals, is creating a pipeline which allows us to be much more robust in the broader endovascular space. I'd say that our R&D team, regulatory team, obviously there's still a lot of activity to do. We have a robust in-house development effort. Obviously coming on the heels of completing GenesisX and getting MAGiC approved and all of those successes and getting Synchrony approved, there is an ability to start to think about where do we want to orient our engineering regulatory focus over the next couple years, few years. I think that the expansion into a multi-specialty robot is a very good strategic way to advance.
This obviously sets us up. We're blessed. The Robocath team has a good engineering team across also all the specialties of engineering, and so it's not like they're going to need Stereotaxis' team immediately to get things running, but we'll be able to gradually ramp up the participation of the Stereotaxis team with them over the next year or so. In terms of the timing, just sorry, to more specifically answer that also. It's somewhat also just opportunistic. Opportunities present themselves, and when you find great opportunities to advance a company, you take them and you move forward. The timing was right from Robocath's side, and I think that given the success we had on all the regulatory approvals recently, the timing also felt right on our side.
Perfect. It's all super helpful. Thanks, David.
Thank you.
Again, if you would like to ask a question, press star then the number one on your telephone keypad. There are no further questions at this time. I would like to turn the call back over to Mr. David Fischel for closing remarks.
Okay. Thank you very much for joining us. We're excited to be pushing forward aggressively on all fronts and look forward to speaking with you again soon. Thank you.
Thank you.
Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect.