ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2023 Earnings Call Transcript

Emily Christy: Right. Okay. Great. And just one more for me, following on that in terms of the installs. So I noticed some new placements abroad in the U.K. and in China. I’m just wondering if you can give a little bit more color on those new relationships in those markets.

Joe Burnett: Yes, it’s really from a few different places. So the sites that we have in China, for example, is a preclinical site, so a CRO similar to Charles River here in North America that we partnered with as well. This is a situation where ClearPoint equipment is now — or will be available and on-site there along with our own specialists to be able to work directly with Chinese or other pharmaceutical companies that want to do their large GLP preclinical testing over that particular site. So the same way you see some of our other preclinical centers that are based in Europe, in Canada, et cetera. This is another version of that. But it allows us to kind of plant a flag there and be able to say, hey, yes, ClearPoint here is open for business.

If you’re a pharma company, you don’t have to find another navigation or catheter or cannula technology to be able to do your development work. We can be there for you as well. And I think that’s kind of an example there versus some of the places in Europe are actually actual clinical systems at this point. So our products are approved to be used clinically in humans and under CE Mark. Many of these new hospitals are interested in doing drug and delivery cases in the future. It might be a site that is tentative to be included in a clinical trial later in this year, and we’re installing the system now so that they can get practice on the system and do some more routine laser procedures or DBS procedures or biopsy procedures today to give them five or 10 cases of experience before they do their first very elaborate and very expensive biologics patients.

So that’s kind of the thought process. But there’s a lot of different flavors of these new installs that are going into that.

Emily Christy: Great. Okay. Thanks for taking the question.

Joe Burnett: Thanks Emily.

Operator: [Operator Instructions] Our next question comes from William Wood with B. Riley Securities. Please state your question.

William Wood: Thanks so much, and congratulations on a great quarter. Just a couple from us. So curious about sort of the PRISM laser system limited release. I would love just to get a little bit extra color on how that’s been going. And then as far as the full release, I believe, in the second half of 2024, if that’s still going to be there, expected to take place in the second half and then how we should be thinking about those revenues and if they’re in the ’24 guidance already.

Joe Burnett: Yes. Sure thing, William. So just to set the stage of kind of where we are today, there’s sort of two vectors to think about, right? There’s two primary types of MRI scanners, okay? So there’s a 1.5 tesla and 3 tesla. So not a big difference between the scanners. It’s more the power. It’s the same companies like Siemens and GE, Philips, IMRIS that have access to both of those. And we kind of think the neurosurgery market is roughly split in half between hospitals that have 1.5 and hospitals that have 3 tesla, okay? So from that standpoint, we are currently only approved on these 3-tesla scanners. So that entire validation paper that we just did, incredibly robust, thorough, thoughtful science, that was published just Friday in the Journal of Neurosurgery.

That is a lot of the data that was submitted to the FDA to be able to earn clearance on the 3-tesla scanner. So if you think of it that way, we have access to about half of the hospitals today that have this 3-t scanner that’s out there. To get access to the rest of them, the worst-case scenario is we repeat the exact same study that we did. So no invention, just simply execution that would allow us to provide the FDA with the exact same data for the 1.5 tesla. So that study is currently being scheduled and planned. And our goal is to collect all of the data, do the histology, have that ready to submit by the end of this year so that sometime early in 2025, we can now unmask every hospital and say it doesn’t matter if you have 1.5 tesla or 3 tesla.

We have FDA clearance and compatibility with both, okay? So that’s one staging item, if you will. But if you heard in my prepared remarks here, we have plenty of 3-tesla opportunities out there that even if we’re not going after 1.5 tesla right now, it’s really not slowing us down. It’s really the install process and the evaluation process, the VAC committees at hospital. That’s still something we have to do, but we have plenty of shots on goal with 3 tesla. The other vector that will get us into full market release, I would say, sooner is the ability to go where the procedures are. And there’s probably 10% to 15% of all laser procedures today that are done using ClearPoint in the MRI suite. So that means 85% to 90% of these procedures are using someone else’s navigation in the operating room and then moving the patient from the operating room to the MRI to do the laser procedure.