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

Adam Maeder: Got it. Okay. And maybe just to, to push a little bit more, I mean, it sounds like it’s maybe a function of just timing of capital. Is that fair or is there something on the disposable side that we should be thinking about for 4Q as well?

David Fischel: I wouldn’t expect continued pressure on the disposable side. I think on the third quarter we do have continued pressure as described in the call from the competitive situation with Johnson and Johnson and the catheter shortages that existed. But I don’t think that you should — I think you should view that as a nadir on the recurring revenue side. So, I wouldn’t expect additional pressure there. The third quarter’s also naturally light just given the summer holidays and some of the geographies. But on the capital side, I think that pace of two systems a quarter is a pace that kind of is the right one to model. I think there’s chances sometimes for upside, but I wouldn’t model that.

Adam Maeder: Okay. Very helpful thank you, for that. And I guess I wanted to flip over to the update on MAGiC and us kind of regulatory strategy. And was just hoping to get some more color on the decision to use the PMA supplement route and just ask about the level of confidence and a successful outcome that I think previously you were planning on running an IDE study, so, how did you get comfortable that this is the right strategy and that a trial is no longer needed? What can you share from your discussions with FDA that kind of led to this change in strategy?

David Fischel: It’s probably not appropriate at this stage to share much more than what we did in the prepared remarks or to speculate that much. We had mentioned previously being in dialogue with FDA on potential paths for MAGiC. Given those discussions, and we had advisors as well, consultants as well, and physician users as well. In some of those discussions, we felt it would be reasonable to submit a PMA supplement using our existing data. There is obviously no guarantee with any regulatory submission, but we believe there’s a good merit to our approach. And with a filing before year end, we will get feedback or a decision from FDA by the middle of next year, which is a relatively quick turnaround process. In the interim, we’ll obviously be collecting human data from our trial in Europe, which will enroll beyond just the number of patients needed for CE Mark submission.

So, having the three sites in Europe allows for enrollment beyond what is just needed for the CE Mark submission. And so overall, we think that the strategy is one that may significantly accelerate access to the technology for US physicians in patients. And we think it’s one that makes a lot of sense to do. So, I think kind of that’s all — that’s probably right to say at this stage.

Operator: Your next question comes from the line of Josh Jennings with TD Cowen. Your line is open.

Josh Jennings: Hi, good morning. Thanks for taking my question. I wanted to just follow up on Adam’s question and ask are you taking parallel paths looking at submission without a data set, and then also planning on the clinical trial and case that pathway is not appropriate deemed by the FDA and to be not appropriate?

David Fischel: Hi, Josh. Good morning. I think, that the data that we collect in Europe has an opportunity to be very helpful, and so there is awareness that depending on how the review of the PMA supplement goes, there are ways to enhance the PMA supplement and still keep it as a PMA supplement with enhanced data. And so, I think that that is definitely something that we have had in mind, and I think that it is something that would be reasonable and accepted. And at the end of the day, it depends on, obviously on the submission overall, and the strength of that submission. But the PMA supplement approach is one that carries a significant advantages and again, which has merit based on all of our discussions and understanding.