ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q3 2023 Earnings Call Transcript

Joe Burnett: That’s a great question, William. The OUS is something where I’d say we’re only doing what’s required to support our pharma partners presently. So what I mean by that is if we had unlimited capital dollars, yes, we could go and hire a full commercial team across Europe and start selling navigation into centers for use in laser therapy or DDS or something like that. In the current environment where we’re being a little bit more thoughtful, pretty much what we’re saying is, hey, we’re going to respond to the pull and the needs of our pharma partners. And what that really looks like right now is a priority is one or two or five maybe pharma companies, 10 pharma companies that are interested in starting their clinical trials abroad – that pull of knowing where that site is and that they’re going to have to use our navigation and our Cannulas for this clinical trial allows us to have a strategy alongside that pharma partner to be able to work with the regulatory authorities and support it in that fashion.

That’s very different than sort of if you build it, they will come strategy of just hiring a team of folks and knocking on doors and trying to find some demand. So I think that’s an example of where I’d say we’re probably making some — probably, we have made some decisions to slow our traditional commercial efforts abroad and focused more of those efforts and resources here in the United States, where the product portfolio is a bit more complete, and we have line of sight to these new FDA submissions, which I shared are already into the FDA.

William Wood: Got it. That’s really helpful. I think I’ll leave it there. I appreciate you taking our questions. Thanks very much.

Joe Burnett: Sure. Thanks.

Operator: Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please go ahead.

Frank Takkinen: Great. Thanks for taking the questions and apologies if I am a little repetitive have been hopping between calls, but I was hoping you could talk a little bit more about the laser business. I know you spoke about some competitive pressures in that business as well as when you do end up moving for the OR and just thinking about prudently investing in those areas. But maybe just talk more about what you’re learning in that initial pilot launch and if that’s changed your strategy for when you look to a full commercial launch in that laser market, given some of the competitive factors offset by some of your cost controls that you’re speaking to?

Joe Burnett: Sure. Yes. No, I don’t — I say there’s one — let me answer the question in a few different parts here. So, the first is, I think the market is actually still a very interesting and potentially exciting market. I know the results of the actual market expansion over the past few years has been gated a little bit by COVID and certainly more growth on the tumor side than on the epilepsy side of populations. But nonetheless, I still think it’s the market certainly worthy of investment. And if you’re starting from zero, you’ve got a lot of places and existing share that can be taken, let alone the market growth itself. So, from that standpoint, I wouldn’t say that there’s a big change in the way that we’ve spoken about in the past.

From a competitiveness of our system, I think we’ve gotten some very, very good early results and been able to highlight how our particular device performs in certain patient types and be able to document that performance and collect feedback on why certain parts of the software or certain parts of the laser design or flexibility of the capital and hardware itself, how those things provide a meaningful advantage for us in the near-term. So, I feel very good about that as well. As far as an access and a speed of access standpoint, there’s two different axes that I would consider. One is one that I did mention a little bit ago, which is there’s two types of scanner powers that are out there. There’s the 3 Tesla scanners and the 1.5 Tesla. We currently only have approval for the 3 Tesla power, which you can argue is more complicated to do with the bigger system.

But nonetheless, that is where we decided to start. So, all of our installs to-date have been in 3 Tesla scanners. And for a customer that’s interested in using us but in 1.5, we have to simply say, hey, it’s on our horizon, but it’s not something that we have available to you. So, that’s kind of one axis where we only have part of the market or access department of the market. The other access is where does the entire laser procedure take place. So, in the past, we’ve talked about the laser market as ClearPoint Navigation having an inherent advantage because even if the laser catheter is placed in the operating room, the patient still has to be transported to the MRI suite because that’s where the laser is turned on inside of the MRI to give you all of the crucial heat information or the thermometry information.

So, the thought — the thought or advantage we have at ClearPoint is to say, well, if you do it with ClearPoint, you can do the entire procedure in the MRI and you don’t have to worry about transporting that patient, right? That was kind of an inherent advantage that we thought made a lot of sense. And it still makes sense. What we’ve run into practically, I would say is that some hospitals, if it’s an older diagnostic magnet and diagnostic room, it sounds a little strange, but trust me on this one. The hospital will allow you to do the ablation of the patients in the MRI, but they won’t let you do the placement of the device. So it’s almost like they say, based on the air flow of the hospital or other state-by-state parameters, they might say, “Hey, this older room is simply not designed for this.

So you’re not allowed to drill the holes or insert the catheter in the diagnostic magnet. You have to do that and — you have to do that in the operating room and then transport the patient. So I think that realization has been a little newer to us. But the reaction for us is to say, well, that’s fine. We will simply provide you next year with an option to be able to place our laser catheter in the operating room as well. We’re working on our own operating room navigation. So it’s another example instead of trying to force change of how a doctor is doing their procedure today, we’re simply going to adapt our products to fit into their existing workflow. So that’s the other access. So if you think about it, we probably today only have access to 10% or 20% of the overall patient volume as part of our limited market release.

But as we add 1.5 Tesla and as we add our operating room navigation and operating rig laser solution, we’ll go from 10% access to 80% or 90% access pretty quickly. So that’s a big part of our 2024 strategy.

Frank Takkinen: Got it. Okay. That’s helpful. And then maybe on the shift to the OR opportunity. I think we spoke about this in the past, but I think it’s worth talking about again. Just talk about once you have that entire portfolio of products in place to do those placements in the operating room. Can you just talk about how the selling process changes at that point and your excitement around when that is commercializing

Joe Burnett: Yes, I think that will help us quite a bit. First, from just a market dynamic standpoint, 95-plus percent. If you look at laser and biopsy and deep brain stimulation, the three primary procedures that stereotactic navigation is used for, more than 95% is in the operating room today. So we’re dominant in the MRI navigation, but it’s a tiny, tiny little piece of the market today. So first off, it allows us to go where the procedures are actually taking place, which is obviously an important part. I think MRI guidance will continue to grow. There are certain procedures, doctors will tell you, yes, I do some of my stuff in the OR, but when this patient comes in and needs this particular therapy, I’m doing this one in the MRI when the stakes are highest.