What we have seen over the past 20-years medical devices, it’s a little bit more complicated than this and FDA has to rely on the totality of evidence before the issue adjustment on whether it’s approved or not. In our case, our device is already approved to benefit outweigh the risk according to FDA. So what you’re looking here is, what does the device do in other elements that FDA would allow us to tell physicians that yes, . And that’s why it’s a little bit more complicated than the usual situation. And even if we don’t meet the primary endpoint per se, but to meet another secondary, or ancillary endpoint, we still believe that there is a net-net positive, not as positive as meeting the primary endpoint, but positive above our base case right now.
William Plovanic: Thank you.
Operator: Thank you. One moment for our next question. That will come from the line of Alex Nowak with Craig-Hallum. Your line is open.
Alex Nowak: Okay, great. Good afternoon, everyone. And perhaps I missed this, but can you expand on what is happening in the background collecting all the morbidity data to move the readout from the first half to first quarter? You must be seeing something or hearing something to give you that confidence it’s going to come this quarter, rather than more in the first half of the year?
Nadim Yared: Hey, Alex. This is Nadim. Nice hearing from you. it’s actually not the data, but the rate of collection of the data and the rate of monitoring of the data. So we’re just identifying the trend of monitoring of sites to ensure that we will have all of the data monitored as required by FDA before we are and based on the synergistic that we see, we are able and we’re able to narrow the timeline for their blinding showing that now it’s a very strong likelihood that this will happen in Q1, not in Q2.
Alex Nowak: Okay. Understood. And then would Okay, yes, understood. That makes sense. You’re all good. When you think about the rate of new center ads in 2023, you more than doubled that number in 2022. I’m just going to throw it out — double the number again in 2023? Or what are you thinking about what the ramping sales can do this year?
Jared Oasheim: Yes, Alex, maybe I’ll just kind of baseline on that guidance again. So for the U.S. heart failure business, the midpoint of the range, the expectation is that we’ll be seeing ads of around 10 to 12 active implanting centers on a quarterly basis going forward. Continuing to see those longer-term accounts continue to ramp up the productivity level similar to rates we saw in the past. And then as I just look to the hypertension business in the U.S., it’s still flat, right, it’s a set patient population. And then just one more piece on the European side of it. We still haven’t necessarily cracked the code over there at this point. And so our base case, the middle of the road of the guidance is that it would stay consistent at around that $1 million or so per quarter.
We saw a bit of a uptick there in the fourth quarter, but some of that was distributors stocking up some shelves — shelf units there for the first half of 2023. So we don’t expect that to be repeated here in the first quarter. So overall, the vast majority of that growth coming from the U.S. heart failure business, but most of that revenue is coming from those centers that have already signed up have already been activated in 2022 and then adding that 10% to 12% per quarter going forward.
Alex Nowak: Okay, understood. That makes sense. And maybe on that last point, what do you need to happen for Europe to really ramp. Is it just you need to put a little bit more focus on it? You’re just focusing too much on the U.S., probably for good reason. Is it a reimbursement dynamic? Just how are you thinking about Europe?