Marvin Slosman: Yes. So as we mentioned in our previous call, Adam, we had a very productive pre-sub meeting with FDA to map out our strategy for SwitchGuard and our TCAR entry into the U.S. And so we’re following their lead. We also gathered a tremendous amount of feedback from our Strategic Advisory Board and the vascular surgery community to make sure that the tool set that we’re developing addresses some of the open topics that they felt were important. We want to make sure that this is world-class next-generation technology. We like the position of a second mover advantage as long as we can take advantage of addressing some of those things. So we’ve integrated that feedback into our design and device approach and that adds the next layer of V&V [ph] and then we get into the regulatory pathway.
So the simple and short answer is we’ve identified our PIs. We’ve got a structure in place. We have to validate that with the FDA, but we hope to get started in that study late this year, and our direction in terms of availability will depend on enrollment and FDA finalizing our approach there. But I think the time lines that we’ve previously discussed remain consistent, likely late ’25 for approval.
Adam Maeder: Very good. I will hop back in queue. Thanks, Marvin.
Operator: Our next question is from Ben Haynor with Alliance Global Partners. Please proceed.
Ben Haynor: Good afternoon, gentlemen, or good day, gentlemen, I guess I should say. Thanks for taking the questions. First off for me, just on the study design, the tandem lesion15-patient study. How quickly do you expect that to enroll? It sounds like that will kick off next quarter? Any other color you can provide there?
Marvin Slosman: Hey, Ben, good to hear from you. I think the EFS, as we’ve structured it with Dr. Siddiqui, and the group at Jacobs Institute is really intended to test drive the thesis behind how CGuard performs in this acute setting, or thrombectomy and other things are being applied. We’re going to go at a pace that allows us to continue to provide data to FDA as we go along. This is not going to be a fast march to the finished event. The whole theory behind the EFS is to do things in a very deliberate manner carefully to make sure that what we believe to be the case from a safety profile perspective is true. And so I wouldn’t put any time lines to enrollment. I think what’s most important is our commitment to the neuro community and making sure that we’re acting on the feedback.
We know that there’s a lot of carotid stenting that is taking place. There’s not a dedicated label for that in some of these settings. And we think that CGuard based on the feedback from the physicians is optimally suited for that. So we’re going to take it a step at a time and use EFS as a big first step to make sure that, that thesis is validated and then we’ll go from there.
Ben Haynor: Okay. Got it. So the methodical approach there, I think its not a big surprise with you guys. That’s good. And then just any more reactions that you can share to the — from the 30-day data for C-GUARDIANS, and I know we talked about VIVA on the last call, but you know, VEITH [ph] and anything that’s kind of flowed in since then?
Marvin Slosman: Ben, overall, I think it was a remarkable presentation that I won’t say called a lot of people by surprise, but was very favorably received. From our perspective, it was consistent with our real-world experience, which was also great to have. Obviously, we have to take next steps here to flow up on the 1-year data so that we’ve got a comprehensive package to prepare and present to FDA. But so far, on the foundation of our 30-day data, there’s been a tremendous amount of confidence in our movement forward and the ability to get and secure FDA approval. So we’ll look to this next readout as the next step in that process, but excitement up to this point.
Ben Haynor: Okay. Makes sense. And then one for Craig. On the C-GUARDIANS II and just kind of the expenses they have running through R&D. How should we model that as the year goes on this year? Is there a step up in any particular quarter as you kick that thing off later this year? Or anything that we – anything in particular that we should be thinking about?
Craig Shore: Yes. I think for R&D, you should think that there’s going to be a step-up for the EFS as well as the trial for SwitchGuard C-GUARDIANS II. So yes, I would just – within the first couple of quarters already start to include a step-up.
