Acutus Medical, Inc. (NASDAQ:AFIB) Q4 2022 Earnings Call Transcript

But the way we will position this product and position the launch is very much around improving the overall ease of use with AcQMap and being able to facilitate more efficient procedures with both new and prospective customers — excuse me, new as well as existing customers especially in response to that comment that we do get from some potential users around the need to be able to use this on a more integrated basis. Because this is a product that’s already on the market in Europe, we do have a good sense of the sort of segmentation utilization. As you know, not 100% of our procedures in Europe are using AcQBlate. It’s probably hovering now in the 50% to 60% range and has been very stable at that level. It was a little bit higher at launch when we had a smaller installed base in the region.

But we do see pretty stable use at that level. In terms of the launch, we will be — typically when we launch a new product, we would be in some sort of LMR, a limited market release for an extended period of time. The reality is that because this is not a totally new to market product for us because we market it commercially outside of the United States, we would probably have a somewhat accelerated LMR process with targeted accounts likely isolated around many of our existing users but look to move pretty quickly from limited market release to full market release subsequent to when we get this on the market.

Margaret Kaczor: Okay. So maybe I’ll repeat it back to you just to make sure that we’re aligned on it. But it sounds like you’re saying three benefits. So one, you can get more system sales, replacements and contracts; two, you get the ASP increase obviously from getting more pocket share; and then three, see greater utilization I guess for certain cases that you can’t really get into today for ease of use issues. So one, is that correct? And then two, is that assumed matching guidance, if at all?

David Roman: Yes. So I think that’s a very good summary. With respect to what’s in the guidance, I would say if all three of those things materialized very well, that would put us at or above the high end of the range that we’re communicating here. Given that we are still awaiting approval and need to go through that committee, et cetera, we are taking a measured view on the contribution to AcQBlate in the guidance we’re offering here today.

Margaret Kaczor: Okay. Thank you.

David Roman: Sorry, Margaret, one last clarification just on the unidirectional versus bidirectional, when you steer with a sheath, most editions, which is a very common practice, there won’t be a materially noticeable difference.

Margaret Kaczor: Okay, that’s helpful. Thanks. And then just kind of a big picture question, I guess, you spent a lot of the frontend talking about this is this change to the R&D roadmap. So one, I guess, where did you take spend away from, and I assume it’s systems? But then more importantly, as you think about the software components, where do you see the biggest gap or capability that you guys can not only catch up on but maybe take a lead against your competition? Thanks.