ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2022 Earnings Call Transcript

This thing is not FDA cleared. We don’t have any experience. We’ve never approved a protocol with this device used before. If we — as a company can help save 3 months or 6 months of negotiation with the FDA that’s real time and real money to a pharma partner. And I think that’s one of the primary reasons they continue to come and work with us in addition to all the clinical services and things that we provide. And to answer your question, the fact that PTC has now been successful in getting a drug approved in Europe, and it’s approved as a combination device. That is definitely another feather that we can put in our hat to say, Hey, we are the one device that’s been able to navigate one of these regulatory pathways. And if it can happen here in the United States under FDA clearance as well, I think that will be another significant milestone and very significant marketing tool that we will be able to use.

Neil Chatterji: Got it. Great. Thanks for that. And then just one question on just in terms of the guidance for ’23. Just kind of curious if there’s any way to add any color in terms of just parsing out the different segments. So how do we think about the growth for BDD, functional neuro, and capital software in ’23?

Joe Burnett: Yes, it’s interesting. There’s a lot of moving parts on timing and things like that. But when we look at our model and what gave us confidence in providing that range, it really includes all three of those different buckets that Danilo presented experiencing growth. So if you think biologics and drug delivery, as far as a magnitude of gross dollars, don’t think about a percentage but an actual growth, magnitude, we do expect that to be the largest growth contributor based on POs that we’ve already received and capabilities that we can now offer. So I think that will still be the highlight one. However, we also do expect our functional neurosurgery and therapy business as well as our capital business to certainly grow in that 15% to 20% plus range as well. So we do expect all three buckets to be contributing to growth this year.

Neil Chatterji: Great. And — just one last question for me. So just curious if you could just kind of talk a little bit about your international expansion plans and just any updates for Europe or China?

Joe Burnett: Yes. So I mentioned that we’ve placed three additional systems so far this year in 2023. Actually, all three of those happen to be OUS. So two of those were placed in Europe. One was placed in Brazil, so our very first installation in South America. And we believe this is an important part now if we were just a neuro navigation company or even a laser therapy company, Brazil is probably not the first country we would go to, for example, right? It’s a massive population, but certainly a long ways away from where we are today. The support that we get from companies like PTC that have large drug potential sales opportunities in countries like Brazil and Singapore, Taiwan, a bunch of different countries, that is really helping fuel the acceleration and how quickly we would go maybe where if we were just a device company, we’d probably go a little bit slower.