CVRx, Inc. (NASDAQ:CVRX) Q3 2023 Earnings Call Transcript

Nadim Yared: Good evening, Matt. And by the way, thank you for joining us. I know it’s been a busy week for you with DCT and everything going on. Listen, no. Actually, we have not looked at statistics of the past in here to be exact. I don’t have a percentage. But the vote is non-binding. This is a pattern very similar to the FDA panel. FDA can follow the recommendation and they can just ignore it. We do not have any indications to believe it’s going to go one way or the other, except to note that the chances of getting it has increased. That’s all I can say right now, Matt.

Matthew O’Brien: Okay. That makes total sense. And then the follow-up is just on the label expansion. Just talk maybe a little bit about where you’re at with that process, and then maybe when we can get an update there? Thank you.

Nadim Yared: Yes. So under the MDUFA, the Medical Device User Fee Agreement number 5, which is the current agreement that is in place between FDA and the industry. FDA has 180 days to respond in 95% of the PMA supplement. So, we hope that we are among those 95%, is where FDA will meet the 180 days clock. When we do the count of all of the stoppage days that happened during this interactive session between when FDA give us feedback and we respond to the feedback, when we add all of those stoppage, we still have time to get to the 180 days in this year, before end of December. But again, it’s no guarantee that we fit within the 95% committed numbers of PMA supplement that FDA commits to do within 180 days.

Matthew O’Brien: Understood. Thanks so much.

Nadim Yared: Thank you, Matt.

Operator: The next question comes from the line of Margaret Kaczor Andrew with William Blair. Please proceed.

Margaret Kaczor: Hi, good afternoon guys. Thanks for taking the questions. I wanted to maybe start on utilization. I know you guys have been pretty vocal about new center utilization. Maybe doing one or two patients upfront and then waiting for a few months, and maybe progressing until they get to 24 months plus. But you’ve added quite a few of these centers. Maybe there’s a bigger cohort within that six to 12 months. Any trends that you guys can walk us through? Or is it a pretty large scatter plot within that group?

Jared Oasheim: Hi, Margaret, thanks for the question. Yes, I think the trends have continued to be what we’ve seen in the past, where we saw a lot of those centers coming on board, treating a handful of patients, and then waiting for the results both for the reimbursement, because of the complexity of the add-on payment, that TPT, but then also wanting to see the impact on their patients themselves. No matter how much clinical data there is, they still want to see how it works in their patients. And then after about six, seven months of waiting to see what those answers are, then they start treating more and more patients over time. And the trend has continued, where the longer an account is active, the more patients they’re treating on average. And so, we’ve seen that trend continue here into the third quarter.

Margaret Kaczor: Okay. That’s helpful. And then you also referenced previously in quarters that you did see kind of this high level of interest at your booth following some of the data presentations earlier this year. Has that continued? Has there been follow-through, and not only follow through of continued interest, but maybe making their way through the hospital processes to get Barostim on board?