Stereotaxis, Inc. (AMEX:STXS) Q3 2023 Earnings Call Transcript

David Fischel: Yes.

Alex Nowak: And then on the gen three system, the mobile robot you maybe update us on the internal work. I know there’s always kind of constant improvement you can do before you submit to the FDA and kind of lock the system down. So just some of the internal work you’ve been doing there. And then just remind us when could we see a launch and the launch kind of predicated a little bit on MAGiC approval as well?

David Fischel: Sure. So, when you look at a robotic system, these are complex, complex systems with the requirement of macro hardware micro hardware electronics firmware on the boards control software, UI software, all working very, very well together. And it’s that complexity which leads to most companies not being able to really develop surgical robots. And as you’ve seen obviously in the field, there’s companies that have spent billions and billions of dollars and are still not developed as surgical robots. So, it is a tough technical hurdle to build robotic surgical systems that actually can work well reliably, robustly in the real-world environment. We’ve obviously demonstrated now that capability with for many years. We’ve gone through, as we go through kind of, when I talk about we use the, we use the word refinement, there’s various ways to refine the electronics of a system.

The tolerance of the mechanical aspects of the system, the control software where you have a system that can work very well, but as you go through more and more refinements, you find and address potential edge cases where you would otherwise have more failures in the field and you would have to work harder during the manufacturing and during the installation and during the continued maintenance phases to keep the system running well. We have — I believe, very top-tier gross margins on our service contracts as you see from our financial statements. And we want to maintain those and it’s through those kinds of refinements and continue to make the product better and better that you can have that type of good performance of the product in the field, which is obviously beneficial for our customers and beneficial for us.

And so, I think that’s the way to kind of — to think about what refinement really means. And we continue to do that also post commercialization. So, the Genesis system has gone through multiple refinements over the last few years. And so that’s kind of a healthy thing to do. From a commercial launch perspective. With a submission in the first quarter, we would expect to have CE mark very rapidly post-submission. And we would expect to have FDA 510k approval. Probably a reasonable timeline is within about six months given the experience that we had with Genesis and given our kind of comfort with overall that process. And it’s a 510k submission. And so, I think kind of that’s our overall expectation for regulatory approvals. And you are correct that we need either the MAGiC catheter or our Guidewire or guide catheter for vascular procedures that to be approved.

So, the interventional devices that we are developing are all backwards compatible with Genesis systems and AOB systems. But the new robot that is — that does not require construction, does depend on having these new interventional devices on the market. And that has led to some of the decision making on when to advance that robot towards approval towards a submission.

Operator: Your next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open.

Frank Takkinen: I was hoping you could talk a little bit to some of the events that would occur following clearance or approval of the catheter namely manufacturing capability. I believe that’s on your partner there, but are they prepared when that occurs to scale up manufacturing, if I’m right in remembering that. And then second, how should we think about any commercial organization changes after that event?