David Fischel: So the traditional path in the US is a filing for an IDE trial and running a pivotal US study and obviously, the mission of a PMA application to FDA. We have done most of the work to be ready for that and to do that submission we — given what we are doing in Europe and given some of the discussions we’ve had, we believe there might be a reasonable likelihood that we gain an alternative path, which would be attractive. And it is obviously very important for us and for the physician community that relies on robotics and for the patients they treat that MAGiC is available for US physicians and patients as early as possible. And so we are cognizant of that importance. We’re grateful that we’ve had the opportunity to have meaningful discussions with FDA.
And at this point, there’s not much more that I should say, but I believe that at the next quarterly earnings call, I’ll definitely — I should be able to provide much clearer guidance on our path forward in the US.
Adam Maeder: Okay. Great. Totally understand. And then for the follow-up, I wanted to pivot over to the mobile robotics system. And I guess the Genesis of the question is just trying to better understand the strategy and timing here. I think I heard you say the plan now is to submit for 510(k) and CE Mark at year-end, so a little bit of a push out there. I guess my question is, why not submit earlier for approval, get across the regulatory goal line, but just not launch it until you have approval for the MAGiC catheter in hand. So hopefully, that makes sense. And would love any color there. Thank you.
David Fischel: No pun intended on the Genesis of the question comment there, right? So we feel good with how we’ve been developing and the testing process that — for the next-generation system, there is a balancing act where – and as we pursue approval first system, oftentimes even post approval, you continue to do some improvement, some modifications in a robotic system. It’s different than something like an interventional device and we’ve continued to improve the Genesis system over time. And so there’s a balancing act between when do you want to pull the lever on pursuing regulatory approval versus continuing to do that refinement and then pulling the regulatory lever, our team has been laser-focused on the MAGiC regulatory process these last several weeks.
And there isn’t value in gaining approval for the robot prior to either MAGiC or Guidewire being on the market. And so I think we’re taking a very just a balanced approach where we definitely want to gain like you say, approval for the robot prior to the interventional devices being on the market in order to derisk that dependency and to make sure it is available. On the other hand, we feel very confident with the regulatory path that exists for the robot even given that we did Genesis very recently and given that we’ve had discussions with the regulators in both the regions recently on that regulatory path again. And so we feel confident in the regulatory path there. And we want to balance also not getting approval for a robot six, nine months before we actually can do anything with it and then continuing to make iterative improvements in that meantime.
And so that’s really kind of the calculus going on. I think that kind of this is a reasonable balance and we’ll be flexible if we sense that we have acceleration anywhere else in the program, then we’ll poll to trigger quicker.
Adam Maeder: That’s helpful color. Thank you.
David Fischel: Thank you.
Operator: Our next question comes from Alex Nowak from Craig-Hallum Capital. Please go ahead, your line is open.
