Stereotaxis, Inc. (AMEX:STXS) Q4 2023 Earnings Call Transcript

We did not have a historical expertise, or experience in developing interventional devices. And that doesn’t just mean the engineering aspect. It means the quality, clinical regulatory aspects, related to interventional interbody devices. And I think that kind of, as we’ve gone through this process, both from a regulatory perspective, and now setting up the clinical trial in Europe. And all the testing processes that we went through. That all gives us more of an institutional capability, in order to replicate those again, in the future. And so, I think there was definitely a benefit, from what we’ve now demonstrated, we’re able to pull off in Europe. And depending on how the next few months go, we’ll have a feeling, on whether it’s necessary to start that in the U.S.

Alex Nowak: Okay. Great. I appreciate the update. Thank you.

David Fischel: Thank you very much, Alex.

Operator: Our next question comes from the line of Adam Maeder with Piper Sandler. Please go ahead.

Adam Maeder: David and Kim. Thank you for taking the questions here. Wanted to ask a question on the sales force. With the MAGiC launch and the mobile launch coming down the pike here, when you look to build out the sales force, to support those launches. Is that a 2025 event? Or is the plan, to kind of push forward with initial – sorry, the existing infrastructure? And then I’d follow-up? Thanks.

David Fischel: Hi, Adam. Good afternoon, thanks for the question. So, we have done a small incremental hiring in Europe already late last year, early this year in anticipation of a MAGiC launch, and ensuring that we have the ability to launch MAGiC, across our installed base, with the added level of coverage and service that, that would entail. And as discussed in the past, as we launched the catheter initially, we would plan to use our existing sales teams both in the U.S. and Europe, to cover those accounts, to launch MAGiC. They are in all of these accounts. They have the relationships. We have a good team that has good electrophysiology knowledge. And so, they’re more than capable of launching the MAGiC catheter, in a successful fashion.

And we would, though, start to reinvest, any proceeds from the catheter, back into the sales team. So that we grow the team, and can gradually evolve, to something more like, the larger players in the space, who oftentimes have one, or even more than one individual per account, per hospital customer. And so, I would see us kind of growing that sales team, but we would do it, as we’re growing the revenue, of the MAGiC catheter. Similarly, on the capital side, I would say that we are – we know that, with any new robotic system, the scaling of supply chain manufacturing and deployment of the robot, is a process that takes many months. And even with the new robot that doesn’t have the construction requirements, there are still those styles of infrastructure, kind of process improvements that play out over a period of months.

And so, I’d say that we will probably, as we gain approval, we will probably slightly increase the capital sales capability in the relevant geography. And then we’ll start to show most of the benefit, though, from having the robot, is that our existing capital sales teams should be able to be much more effective because we’ve reduced the complexity and time lines related to their sales work. And so, as we start to see that playing out as we start to see the robot being out there in the world, working successfully and well, as we’re able to scale our supply chain and manufacturing. And then again, we’ll incrementally be building the sales team. And so, I think that kind of, you’ll see most of that type, of real mind sharing effort in building the commercial team, happening in 2025, with some of the preparatory work, being done already this year.

Adam Maeder: That’s great color. I appreciate that, David. Thank you. And for the follow-up, I wanted to switch gears, and ask about mobile. If I heard correctly, regulatory submissions both in the U.S. and Europe for Q2 events. Can you just maybe share what’s left, to still be done ahead of submission, to the regulatory agencies? And just talk about what’s informing the confidence, there that you’ll be able to make, healthy submissions and ultimately garner regulatory clearance? Thank you.

David Fischel: Sure. So we are – we have the formal – the full body of formal regulatory testing that, you have to do before you can do a submission. There is still various testing that, needs to be done there. Most of it done internally with our team, some of it that is done through external testing services that, you have to do through an external testing service. And so that is all expected to play out over the next, let’s say, month to couple months. And then, you have to obviously put together, all of the documentation for the submission – and that happens concurrent with testing, but there’s always some work, after you finish the testing process. Overall, our confidence comes from the fact that we have – this is really our expertise robots.

We went through a process very, very similar to this, just about four years ago, five years ago, when we submitted the Genesis robot. And so, we have the organizational infrastructure, the muscle memory, the documentation that, we can leverage for these types of processes. And we have a skilled team that, has run this playbook before, including very recently. So that gives us the confidence. We’ve had preparatory discussions with regulators. We have clarity on what the regulatory path is, and so that gives us kind of that confidence.