Adam Maeder: Hi, David. Hi, Kim. Good morning and thank you for taking the questions. I wanted to start on the MAGiC catheter, and just I guess trying to better understand time lines in Europe. So it sounds like you’re going to start the enrollment in the human study in Q4 review process from the regulatory body restarts early next year. Is midyear, or Q3 2024, just a reasonable assumption for approval and launch? So that’s question one. And then question two would be, just maybe you can flesh out the alternative regulatory route that you referenced for MAGiC when we’re talking about the US pathway? And then I had one follow-up. Thanks.
David Fischel: Okay. Hi, Adam. Good morning. So in Europe, as we described in the prepared remarks, we scrambled, there was a lot of work to be done after we learned — after we received that feedback from a notified body in Europe. There was a lot of work to be done to organize clinical trial protocol to make sure that clinical trial protocol was both very fitting with what the notified body would want to see in terms of data and very reasonable in terms of what physicians could enroll and could be done in an efficient fashion in a hospital setting. There were many documentation that are needed to gain ethics committee and national approvals that you need just to support those processes. And so the entire team here worked in a very nice fashion to organize ourselves and be able to submit documentation to hospitals in Europe.
We started engaging while we are confident that data from a single site would be sufficient for the notified body, and we didn’t want to be dependent on one side. Obviously, this is new to us to run a pre-approval trial, and so we didn’t want to be dependent on any individual site. And so we engaged with many of our users. We’ve got very enthusiastic feedback from many of our users in Europe. We’re excited to do a trial like this and fortunately, several of them have experience doing first-in-human studies in cardiac ablation. And so we’ve started submitting documentation at sites in Europe from what we’ve heard, and it’s fairly consistent at several of these centers. A review process is oftentimes couple of months, three months kind of in that type of ballpark and enrollment in this trial should be very, very rapid.
It’s all comer arrhythmias, and we’re talking about acute data. So that is something that should enroll in the time span of definitely less than a month to do full enrollment in that data. And so we think that having that data in the fourth quarter, receiving approval from the competent authorities in individual countries in Europe from the ethics committees of hospitals is very reasonable in the fourth quarter, and enrolling patients and having the acute data from them is also reasonable in that same quarter. And then we would, obviously, very quickly submit that data to the notified body so that we can restart the review of our CE Mark. Given how extensive the CE Mark review was with all the rounds of questions until they got to the point of telling us that they believe clinical data is necessary.
I believe that, that review process should be relatively shorter and streamlined. We went through rounds of questions before. But obviously, that time line of the regulatory review is outside of our control. So I think that a summer time next year sounds very reasonable. It’s obviously though outside of our control, so we can’t say for certain and hopefully, we can’t even have earlier than that. Does that kind of answer the European path for MAGiC well?
Adam Maeder: It does, David. Thank you. That’s great color. And would love additional thoughts on the path forward for MAGiC in the US, you — I think, referred to an alternative regulatory pathway. So we’d love to hear a little bit more about that. And then I have one follow-up. Thanks.
