ClearPoint Neuro Q1 2025 Earnings Call Transcript

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May 13, 2025

There are 6 speakers on the call.

Operator

Please note this conference is being recorded.

Operator

Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statements may include, without limitation, statements related to anticipated industry trends the company's plans, prospects and strategies, both preliminary and projected the size of total addressable markets or the market opportunity for the company's products and services and management's expectations, beliefs, estimates or projections regarding future revenue, results of operations or the adequacy of cash and cash equivalent balances to support operations and meet future obligations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward looking statements for new information or future events. For more information, please refer to the company's annual report on Form 10 ks for the year ended 12/31/2024, which have been filed with the Securities and Exchange Commission and the company's quarterly report on Form 10 Q for the three months ended 03/31/2025, which the company intends to file with the Securities and Exchange Commission on or before 05/15/2025.

Operator

All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. I will now turn the conference over to your host, Joe Burnett, Chief Executive Officer. Thank you, Mr. Burnett. You may begin.

Speaker 1

Thank you, Joe, and thank you to all of the investors, partners and analysts joining us on today's call. 2025 is off to a terrific start here at ClearPoint Neuro as we have officially entered the third phase of our company history, a phase we refer to as fast forward. As a brief reminder, this new stage at ClearPoint has three primary tenets. First, we will extend our lead in cell and gene therapy by leveraging our complete and unique drug delivery ecosystem, including navigation hardware, predictive modeling and monitoring software, cannula based routes of administration, preclinical and clinical drug discovery services and best in class clinical field personnel. We will use this ecosystem to support our more than 60 active biopharma partners on their path to regulatory clearance and commercialization, many of which have already been selected for some form of expedited review by the FDA.

Speaker 1

Second, we will evolve our portfolio to focus not only on accuracy and precision, but also on fast, simple, predictable workflows. These new product introductions are designed to increase hospital efficiency and throughput and to create capacity for the significant demand that we believe is coming when patients learn that these new restorative therapies are available and have been proven effective. And third, we will expand our global installed base and generate scale to enable more patients around the world access to the ClearPoint ecosystem that will be used for these novel treatments. Let's remember the first of these neuro cell and gene therapies is already commercially available in The United States, The EU and beyond, and there is the potential of additional approvals in the next two years for much larger patient populations. There is no time to waste, the time to hit fast forward for us is now.

Speaker 1

As announced yesterday, despite unpredictable market conditions, we have now successfully secured the foundational funding necessary to execute on this strategy for many years to come. This capital in the form of both debt and equity has been provided by our new partner, Overland Capital, which we will discuss a bit more later on today's call. With that backdrop for context, I will now turn the call over to Danila D'Alessandro, our CFO, to discuss the financial details of the first quarter, after which I will provide additional commentary on our progress in these three fast forward initiatives. Danilo?

Speaker 2

Thank you, Joe, and thank you all for joining us today. Looking at the first quarter twenty twenty five results, total revenue was $8,500,000 for the three months ended 03/31/2025 and $7,600,000 for the three months ended March 3124, which represents 11% growth versus the first quarter of twenty twenty four. Our revenue is made up of three components Biologics and Drug Delivery, Neurosurgery Navigation and Therapy and Capital Equipment and Software. Biologics and Drug Delivery revenue includes sales of disposable products and services related to customer sponsored preclinical and clinical trials utilizing our products. Biologics and Drug Delivery revenue increased 9% to $4,700,000 in the first quarter, up from $4,300,000 in 2024.

Speaker 2

This increase was fueled by $1,200,000 increase in product revenue as numerous partners progress in their preclinical development and regulatory clinical trials. The product growth was partially offset by $800,000 decrease in Biologics and Drug Delivery Services. Neurosurgery navigation revenue consists of commercial sales of disposable products for the ClearPoint navigation system and the PRISM laser units. This revenue segment grew 70% to $3,300,000 for the first quarter twenty twenty five. This large increase is driven by higher sales for new product offerings as well as an increased customer base and adoption.

Speaker 2

Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software and of related service contracts decreased 63% to $500,000 in the quarter from 1,400,000 for the same period in 2024. This decrease is due to fewer new placements of ClearPoint navigation and Prism laser units, primarily driven by installation timing and other new product introduction priorities that occurred in the first quarter. Gross margin for the first quarter of twenty twenty five was 60%, an increase of 1% compared to 59% in Q1 twenty twenty four. Research and development costs were $3,400,000 for the three months ended 03/31/2025 compared to $2,600,000 for the same period in 2024, an increase of $800,000 or 29%. The increase was primarily due to higher product development costs as we continue to invest in expanding our product offering and extending our lead in drug delivery innovation.

Speaker 2

Sales and marketing expenses were $3,800,000 for Q1 compared to $3,300,000 for the same period in 2024, an increase of $500,000 or 17%. This increase was due primarily to additional personnel costs, including share based compensation as we invest in our commercial reach and in hospital support. General and administrative expenses were $4,100,000 for the first quarter, an increase of $1,300,000 or 44%. This increase was due primarily to $400,000 higher bad debt expense, dollars 400,000.0 higher personal costs including share based compensation and $400,000 higher professional service fees. As of 03/31/2025, we had cash and cash equivalents totaling $12,400,000 as compared to $20,100,000 at 12/31/2024.

Speaker 2

The cash reduction was primarily due to the operational cash burn increasing by $2,300,000 in Q1 twenty twenty five versus Q1 of twenty twenty four. This increase is mostly related to the reduction in personnel accrued expenses and its relative timing in Q1. For the full year, we continue to expect our expense growth to be lower than our revenue growth and to keep achieving operating leverage. Our March cash balance of $12,400,000 does not include the $32,000,000 net proceeds from the recently announced new credit facility and equity investment of Oberland Capital. We are very excited to have the backing of a strong long term financial partner in Oberland Capital.

Speaker 2

Our new credit facility gives us the flexibility to access an additional $25,000,000 in additional credit between now and December 2026. This credit facility has advantageous terms that suit our company's growth profile, allowing us to focus on executing our strategy in the coming years with significant flexibility. I'd like now to turn the call back to Joe.

Speaker 1

Thank you, Danilo. We are off to a great start here in 2025 highlighted most importantly by our single use consumables business more than doubling in the quarter. This 104% growth rate is driven by three key factors, including first, our biopharma partners ordering additional cannulas as their cell and gene therapy drugs progress through the regulatory pathway and into clinical trials second, our three point zero navigation software launch, allowing ClearPoint to expand beyond the MRI suite and into the operating room and third, the full market release of the PRISM laser therapy system, allowing ClearPoint penetrate the existing U. S. Laser Ablation market as a new and scalable adjacent source of growth.

Speaker 1

As always, let's dig a bit deeper into this progress with regard to our four growth pillars. Starting with pillar number one, biologics and drug delivery. Our strategy once again is to extend our lead in cell and gene therapy. Our biologics and drug delivery team continue to support more than 60 active partners in the biopharma space at all phases of development, including preclinical testing, clinical trial execution and even global commercialization. We have made substantial progress in the additional hiring of our preclinical team and continue to pursue both GLP capability and expanded capacity for preclinical services, which we plan to have operational sometime in the second half of this year.

Speaker 1

In addition, numerous partners have enrolled additional patients in global regulatory trials, including those partners that have been accepted into one of the FDA expedited review programs. In fact, just today, we submitted our five ten for the SmartFlow cannula for use with the REGENXBIO gene therapy RGX-one 21 program. This submission is once again a cross labeled combination product, which will be reviewed in parallel with the Regenexx Bio BLA, which the company announced earlier today was accepted by the FDA for review. RGX-one hundred twenty one is intended for use in children with MPS II, also known as Hunter syndrome. The PDUFA date is scheduled for November of this year.

Speaker 1

We believe that additional cell and gene therapy platforms with significantly underserved patient populations have the potential to be approved within the next two years. ClearPoint has established or is actively collaborating with multiple partners to establish strategic and commercial supply agreements to ensure readiness for the commercial launch of these new therapies. Next, let's talk about pillars number two and three, which are neurosurgery navigation and laser ablation. Our goal for this segment is to introduce new products that are not only precise and accurate, but are also fast, simple and predictable so that we can help hospitals increase throughput and create capacity for these future drug delivery patients. This segment saw our single use consumables grow 70% in the first quarter, primarily driven by the introduction of our new SmartFrame OR and three point zero operating room navigation systems, as well as gains in laser ablation market share with our Prism laser therapy system.

Speaker 1

The three point zero navigation software has been very well received during the first three months since FDA clearance. In this short time, we have seen more than 35 patients treated across 11 different neurosurgeons, all of which have communicated they plan to reorder and use the system again in the future. The product is delivering on our promise and is combining accuracy with efficiency as seen in the data collected during this limited market release. So far, we have seen average radial errors less than one millimeter and average skin to skin procedure times of around two hours, even for bilateral deep brain stimulation procedures. This is all despite the fact that these cases were often the very first experience for these surgeons with our operating room product, and we expect additional time savings with workflow familiarity and optimization.

Speaker 1

Once again, this efficiency is being achieved without sacrificing accuracy and precision. Also impressive was that the total radiation dose of these efficient bilateral procedures was less than a single full diagnostic head scan. One of the surgeons even commented that with this level of efficiency and predictability, it would be possible to schedule three surgeries in a single day. Another fun anecdote from the limited market release was that for the very first time, ClearPoint Neuro had two procedures going on at exactly the same time inside a single hospital with one procedure in the MRI Suite and one in the Operating Room. These procedures were performed by two different surgeons.

Speaker 1

Similarly, our prism laser therapy system workflow got a boost with the new three point zero software making planning and imaging more compatible with both the ClearPoint navigation system and other common workflows like robotics. We have made gains in market share despite being limited to only three point zero Tesla scanners, which represents about one half of the available market today. We have now submitted the data required by the FDA to achieve compatibility with 1.5 Tesla scanners and expect to have access to the other half of the market sometime in the second half of this year. And finally, moving on to the fourth pillar of achieving global scale, we continue to make significant progress expanding our installed base and hospital support infrastructure as well as pursuing global regulatory approvals. In the first quarter, we activated two additional new sites and showed a decrease in capital revenue of 63%, which negatively impacted our overall company growth rate.

Speaker 1

For some context, Q1 of last year was by far the largest quarter we have ever had for capital sales here at ClearPoint with $1,400,000 in total sales last year. That result now acts as our baseline for comparison to Q1 of twenty twenty five, which came in at $500,000 It is important to note that for a one time capital sale, we recognize all revenue at the time of installation and title transfer, and we happen to install a substantial number of new systems in Q1 of last year. Now importantly, as I mentioned on our last two earnings calls, we have implemented a new subscription program, which we call Pathfinder and allows our hospital partners to access our latest technology and innovations by paying an annual fee, in effect acting more like a system rental than an outright capital purchase. The overall economics of a Pathfinder subscription over the course of the three or five year term is very much in line with that of a historic capital purchase. And by implementing a Pathfinder program, it allows us to continue to introduce new technologies as they become available without having to repeatedly go to a hospital capital committee for review as the rental cost is already covered in the operating budget.

Speaker 1

Now the impact to ClearPoint is important to understand because with these new contracts, we now recognize the revenue as spread out across this three to five year term instead of all at the same time of installation, which makes apples to apples comparisons more difficult. Again, for context, we were excited to sign and install four of these Pathfinder agreements here in the first quarter. However, we only recognized a small fraction of the revenue. We will now have the future benefit of recognizing the balance of the revenue in the years ahead and the overall impact of more Pathfinder agreements will be a smoothing of our capital revenue over time. It is also important to note that our sales and installation priorities in the quarter were focused around prism laser placements and upgrades to our new three point zero software, which enables ClearPoint navigation to be used in the operating room.

Speaker 1

These two strategic activities do not count as new site activations as these are meant to drive same store sales at existing ClearPoint customers. This is exactly the result we saw in the first quarter with 70% growth in disposable neurosurgery products. We continue to expect between fifteen and twenty new site activations for the full year of 2025. However, it was crucial for us to execute these new product introductions in Q1, and we were very pleased to announce our full market release at the AA and S meeting just last month. Finally, as with most companies, capital placements and revenue can always be a little choppy from one quarter to the next.

Speaker 1

Full year comparisons are more useful. For some added perspective, we are here only halfway through Q2, and we already have more capital revenue this quarter in house than we did for the entirety of Q1. Our operating expense growth in Q1 is a result of the investment that we have made to be ready to serve our pharmaceutical customers. Our biopharma partners' progress continues to give us confidence that now is the time to invest. And our just announced partnership with Overland Capital again gives us the flexibility and security to act in line with our partners' requests.

Speaker 1

We will continue to modulate investment levels very thoughtfully as these needs arise. With that, I would now like to open up the call to any questions.

Operator

Thank you. And our first question comes from the line of Matthew Blackman Please proceed.

Speaker 3

Good afternoon, everybody. Can you hear me okay?

Speaker 1

Yes, I guess you're Matt.

Speaker 3

Great. So Joe and Danoa, I've asked you this question before, what would you do if you had access to incremental capital and well, here we are. So I'm curious, are there initiatives that you can get after now that you perhaps have reprioritized lower on the to do list with limited capital? Is there anything from an investment standpoint that you can put to work today that could be growth enhancing for 2026 or even 2025? And then the last follow-up on that very long question is, how do we think about this runway of capital in relation to your ability to hit sustained breakeven?

Speaker 3

Does this get you all the way? Just what sort of runway does it give you? Just any thoughts on that? And I've got one follow-up on the neuro franchise.

Speaker 1

Yes. Happy to walk through a couple of these questions. Covering the first topic, yes, we absolutely see opportunities to go faster and we're actually pursuing a couple of those right now. As I mentioned, as we get closer and closer to the potential commercialization of some of these new therapeutic products, hiring terrific field support as well as hiring additional preclinical resources to do additional analytics testing. These are things that some of our pharma partners are asking us to get ready for.

Speaker 1

And like with anything, there's always a lag between when you hire sort of a new person and maybe six months later when they're fully trained, fully productive and flying solo. So we've already started this process of hiring both members of the preclinical team as well as members of the field as well. So to extend our commercial reach, We're not in a position where we're increasing guidance based on the spending because, the biggest driver between the range that we've provided this year of between 36,000,000 and $41,000,000 is really going to be the timing of our expanded capacity for preclinical. And then until we get a firm grip on exactly when we're up and operational there, we want to go ahead and kind of hold on to the guidance that we've given at this point. But there are things that I think we can accelerate, and we're actively looking to do that today.

Speaker 1

Your next question relative to the capital that we have access to through this new debt facility and kind of get us to cash breakeven, we feel that it absolutely can. Especially the fact that the interest only six year component of that provides us with quite a bit of flexibility, where we fully expect it over the next couple of years to be continuing to burn some cash. However, when these new drugs come online in the next two, three, four years with some meaningful more patient populations, at that point, we believe the company could be generating meaningful cash flow and put us in an excellent position to repay that debt when it actually does become due. So another way to think of it is some of this debt that we just took on, we will probably never touch, at least if our plans continue to work that way, which means that that debt will actually be reinvested in treasuries. So we're really only paying the interest on the spread, which given the uncertainty that's out there today, it's a good trade off for us to make because we wanted to control our own destiny in that way.

Speaker 3

Yes, makes sense. And then just on the neuro franchise, obviously, really solid first quarter. And look, I don't expect you to grow that business 70% or consumables 100% every quarter. But it does feel like and sound like the trajectory may be tracking better than at least we have modeled. I'm just interested in knowing how here in the first quarter post some of these launches, it's tracking relative to your expectations, however you want to frame that.

Speaker 3

Thank you.

Speaker 1

Yes, would say we're exactly on plan on where we expected to be in that portion. Now we had a little bit lower comparison in Q1 of last year. So that 70% is a high number, but as we shared at the very beginning of the year, we think that franchise can grow, of our business can grow significantly more than 20%, throughout the balance of the year, no matter what that comparison is. And then we also think that there's, some upside potential in there as well based on, you know, if an early approval to the 1.5 Tesla of the laser or if we continue to see the rapid adoption that we've seen with our three point zero navigation software. Just to put a little bit in perspective, last year when we launched the SmartFrame OR, we got FDA clearance and I think about three months into that period of time we had one, maybe two surgeons that had actually used the product because we had to use Medtronic as kind of an intermediary since it was on their software and, it took a little bit.

Speaker 1

Weren't fully in our own control. Here, as I mentioned earlier on the call, we've already done 35 cases across 11 different surgeons. And if that momentum keeps up, then I think we have some upside there as well.

Speaker 3

Okay. Really appreciate that Joe. Thank you so much.

Speaker 1

The

Operator

next question comes from the line of Frank Tocquelyn with Lake Street Capital Markets. Please proceed.

Speaker 4

Great. Thank you for taking the questions and congrats on all the progress in the recent financing. Wanted to start with That's okay. Yes, for sure. I wanted to start with maybe a little bit bigger picture question related to kind of MRI based procedures versus OR based procedures.

Speaker 4

My assumption, and I think I'm correct in thinking this, that vast majority is still MRI based procedures, just given three point zero is just launching now. But if we were to fast forward kind of a few years out, how do you envision the mix of procedures from MRI versus OR setting trending?

Speaker 1

Yes, it's a really important question for us because we're trying to fully understand not just the capability and the performance of three point zero but also the way that doctors are going to continue to use it. So as an example, and what I said in the remarks, I'll double click on that a little bit here, is that what this product allows us to do is to create capacity for these drug delivery procedures that are coming. So during the launch of many of these drug therapies, whether it's specifically indicated or not, just from a quality control standpoint, we believe that these drug procedures are going to continue to be done in the MRI at a much higher rate than say typical DBS procedures. And because these initial procedures can sometimes be a little bit longer because of the time of the infusion or the multiple trajectories, we want to make sure that the MRI scanners are as free and clear as possible to be doing these really crucial restorative therapies. So what this product allows a hospital to do is to kind of create that MRI capacity by moving some of their historic DBS procedures either out of the MRI, into the Operating Room if they're a prior ClearPoint user, or if they're a new user to ClearPoint, they can start in the Operating Room doing ClearPoint procedures with a three point o software, and in essence, they're practicing every single day on how our system, how our software works, that when these drugs become available for the MRI scanner, they've already got a head start, and the hospital has built some capabilities there.

Speaker 1

So it's, it's one of these things where I could see DBS procedures, for example, swinging, maybe definitely growing faster in the operating room than in the MRI scanner. But then two or three years down the road when these drug launches start taking place at that point the MRI mix might go up again. So it's definitely a strategy where we plan as far as we can see out that we're going be offering both of these capabilities.

Speaker 4

Got it. That's helpful. And then maybe as it relates to GLP, I think you made a brief comment that you guys remain on track for the second half of this year to be GLP certified. What's kind of left to be completed there? And then maybe talk about kind of customer interest.

Speaker 4

Is there pent up demand for once you are GLP certified to be able to kind of slot in, work in that space in a relatively short order once that is GLP certified?

Speaker 1

Yes. The primary remaining gap is really standard operating procedures and protocols that are in fact a much more sophisticated quality system is what GLP requirements need, as well as certain independent study directors and, sort of HR structural things. So the good news is none of this is invention related. It's really just hiring the right people and expanding some of the capabilities that we have. From our standpoint, the primary thing we're looking to do is to expand the capacity to a second facility that would enable us to actually do these much larger studies.

Speaker 1

So it's I think of it as kind of stepwise. Step one is going to be taking our existing capabilities and expanding that capacity. And then step two is layering on these GLP procedures on top of it. But I think certainly the expanded capacity, we plan to have this year and I'd say it's likely that we'll be in the GPL position GLP position by the end of the year as well.

Speaker 4

Okay. And then sorry, just the second part of that follow-up, just kind of pent up demand around that.

Speaker 1

Sorry. What I would say is that we have a unique conduit with many of these pharma partners, of which at least five, if not more, have communicated to us that once we're up and running, they would like to convert some of their studies our direction. Anything from discovery studies up to full GLP studies once available. I believe we're going to walk before we run. It's not like we're going to jump in the water and start doing 50 or 60 subject studies right away.

Speaker 1

However, you know, I think that's something that comes more in 2026, but I think proving, these capabilities, allowing our sponsors to be able to come visit our facility, meet the team, get to know us a little bit, you know, those are all activities that we'll be doing these pilot studies in the second half of this year. At this point we fully expect that our growth rate for biologics and drug delivery services will sort of, will grow considerably in the second half of the year, because right now just based on our current capabilities we're kind of banging up against capacity in certain months. So it's kind of limiting and we're going to remove that governor when we get into the new facility in the second half.

Speaker 4

Got it. That's helpful. Thank you.

Speaker 2

Sure. Thanks, Frank.

Operator

The next question comes from the line of Anderson Shock with B. Riley Securities. Please proceed.

Speaker 5

Hey, thank you for taking our questions and congrats on all the progress. So first on capital equipment, you activated two new sites in the first quarter. I guess, how are these sites placed? Were they full sales or rental or Pathfinder agreements?

Speaker 1

I believe they were both capital sales in the quarter. So they those were not I'm sorry, I'm confusing the issue a little bit here because, again, when we talk about a new site activation, that is a customer who has never used ClearPoint technology before. There were two new sites that, in fact, if you checked our installed base, you'd probably recognize them when they pop up on the new revised slide deck. Those are sites that have never used ClearPoint and now have access to ClearPoint. In addition to those new sites, we placed multiple new prism laser systems.

Speaker 1

We upgraded numerous sites to the three point zero software. So we don't count those as new site activations because they already had access to ClearPoint, and now they have access to additional technology and additional revenue streams for ClearPoint. So the two new sites, I believe, were both capital placements, but a lot of the prism systems that we put out, for example, those fell into that Pathfinder bucket. Hopefully it was clear on how I was describing the Pathfinder work. So if you sign a five year Pathfinder agreement and you install that system March first of this year, instead of in the past how we would recognize that entire transaction in the first quarter, in this example, we would have only recognized one out of sixty months in that particular quarter.

Speaker 1

So again, it's the placements, the capital going out the door is actually kind of same as it's always been. However, the recognized revenue doesn't quite follow. And I think it's also important to note that it doesn't necessarily mean there's a huge cash sort of discrepancy or delay either. These hospitals certainly have the right to continue to pay on a whether it's a quarterly basis or an annual basis. However, in some cases they actually pay for the entire three to five year term upfront.

Speaker 1

We've seen that happen too. There's a little bit of a disjointed effort between revenue recognition and the rest of reality. But like I said, I think we're probably going to get closer in the future to possibly even 50% Pathfinders, and that will smooth out our capital revenue because those will show up on a monthly basis as opposed to be kind of choppy based on the installation timing. Hopefully that makes sense.

Speaker 5

Okay, got it. That's helpful. And then on OpEx, OpEx grew 29% in the quarter. I guess, how should we think about this and especially R and D trending going forward now that you've secured funding to accelerate the development and launch of Duplex?

Speaker 1

Yes, it's somewhat similar and if not even reversed from the capital side of things is that there are certain investments that we have to make that we don't get an immediate return on, but we wouldn't be making them if we didn't see that return coming. So I gave a couple of examples on expanding these preclinical services and GLP capability. Obviously, don't have that capability yet. We're not selling it, but we're hiring the people, we're training, we're building the processes. So that's sort of an accelerated investment.

Speaker 1

Similarly, when we want to if we see the demand coming for our three point zero software and we know it's going to drive case volume, we have to hire now for these people that will be ready in Q3 and Q4 of this year to absorb some of these additional procedures and provide support. So again, that's a little bit of an accelerated investment that we wouldn't make if we didn't believe it was coming. The third example I would give you is that we have many of our pharma partners that are actually hiring us to build custom routes of administration for them. So a slightly different actuator or cannula or surgical needle or something else to work with our software and deliver a drug to a specific portion of the brain. That's another example where we might have a contract where we don't recognize the revenue until it's done, but we hire an additional engineer or two now to be doing that work that we know the revenue is going to follow.

Speaker 1

So to Danilo's comments, we continue to believe that for the full year, our revenue growth is going to outpace our expense growth. And Q1 is just one where it's a little bit flipped upside down because we're sort of prepaying and pre hiring some of these roles.

Speaker 5

Okay, got it. Thank you for taking our questions.

Speaker 1

Yes, sure thing, Anderson.

Operator

Thank you. There are no further questions at this time. I'd like to hand the call back to Joe Burnett for closing remarks.

Speaker 1

Well, thanks again to everyone for joining today's call. We have spent the last ten years building a strong foundation, and 2025 is again where we hit the fast forward button to get the market ready for this exciting future of cell and gene therapy. We are very excited to be in a position where we can directly impact many patient lives, often being in the room for the very first patient ever treated. Good night, everyone, and thanks again.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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Key Takeaways

  • ClearPoint entered its third “Fast Forward” phase, focusing on leveraging its complete drug delivery ecosystem for cell and gene therapy, streamlining workflows, and expanding global scale, supported by new debt and equity financing from Overland Capital.
  • Q1 revenue rose 11% year-over-year to $8.5 million, with Biologics & Drug Delivery up 9% to $4.7 million, Neurosurgery Navigation up 70% to $3.3 million, and Capital Equipment & Software down 63% to $0.5 million.
  • The single-use consumables business more than doubled (104% growth) driven by increased cannula orders from biopharma partners, the launch of the 3.0 navigation software, and the full market release of the PRISM laser system.
  • The 3.0 operating room navigation and PRISM laser solutions saw rapid early adoption—over 35 cases across 11 surgeons achieved under 1 mm radial error and average bilateral procedure times of around two hours.
  • ClearPoint is expanding preclinical services and aiming for GLP certification by H2 2025, while its new “Pathfinder” subscription program smooths capital revenue recognition and bolsters recurring income.
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Earnings Conference Call
ClearPoint Neuro Q1 2025
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