Greetings and welcome to the ClearPoint Neuro, Inc. first quarter 2026 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. 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, the company's expectations regarding the integration, performance and anticipated benefits of its recent acquisition of IRRAS Holdings, Inc., including operational efficiencies and the impact on the company's financial condition and results of operations, the company's expectation for future development, regulatory approval, timing, commercialization and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made. 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 about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K, and Form 10-Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. At this time, I would like to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead. Thank you, Shamali, and as always, thank you to all of the investors, analysts and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies, to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the, 2026 on a strong note by achieving record revenue of $12.1 million for the quarter, driven primarily by organic devices growth of 25%, which includes our historical drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems and software. This revenue was complemented by inorganic device growth from our acquisition of the new IRRAflow product line, which pushed our overall growth rate to 43% company-wide. We continued to realize meaningful revenue and cost synergies as a result of our new completed acquisition of IRRAS. With the majority of post-merger and a great drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons, and to patients globally. We believe that we are truly a unique hybrid device biotech enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow. Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications, and more than 10 partner programs that are already under some form of FDA expedited review. That is a significant head start, and through both our team and our investment into this portfolio, we intend to extend our lead. With that, I will turn the call over to Danilo D'Alessandro, our CFO, who will walk through the financial detail after which I will give a more strategic update on our progress. Danilo. Thank you, Joe, and thank you all for joining us today. Looking at the first quarter 2026 results, total revenue was $12.1 million for the three months ended March 31, 2026, and $8.5 million for the three months ended March 31, 2025, which represents 43% growth versus the first quarter of 2025 and 16% organic growth. Our revenue is made up of three components, Biologics & Drug Delivery, Neurosurgery Navigation and therapy. This increase was mainly due to an increase in product revenue of $0.1 million. B&D service revenue was in line with prior year. Neurosurgery Navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint System, the Prism laser system and IRRAflow. This revenue segment grew to $5.9 million for the first quarter of 2026, including $2.1 million in IRRAflow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our Prism laser system and ICT solution. Capital equipment and software revenue consisting of sales of our reusable hardware and software and related services increased 177% to $1.4 million in the quarter from $0.5 million for the same period in 2025, due to an increase in the placements of ClearPoint navigation system, Prism laser units and IRRAflow control units. Gross margin for the first quarter 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and obsolete inventory reserves. Research and development costs were $4.5 million for the three months ended March 31, 2026, compared to $3.4 million for the same period in 2025, an increase of $1.1 million. Sales and marketing expenses were $6.7 million for Q1, compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%. This increase was due primarily to additional personal cost of $1.9 million, an increase in travel cost of $0.5 million, resulting from the expansion of our clinical and sales teams due to the IRRAS integration, as well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for the first quarter, an increase of $0.9 million or 22%. This increase was due primarily to higher occupancy costs of $0.7 million and higher personnel cost of $0.2 million. As of March 31, 2026, we held cash and cash equivalents totaling $35.6 million as compared to $45.9 million at December 31, 2025. The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We expect the operational cash burn to decrease in the coming quarters as we complete the IRRAS integration. I'd like now to turn the call back to Joe. Thank you, Danilo. We look to build upon a successful first quarter and continue to expect 2026 revenue to be in the range of $52 million-$56 million. We are also pleased to report that our first quarter burn came in on budget from what we were expecting. As a reminder, the first quarter each year has historically been our highest burn quarter, driven by annual employee bonuses, timing of FICA taxes, additional withholdings, and several once-a-year expenses. This year, the first quarter also included a number of one-time events related to post-merger integration costs after the acquisition of the IRRAS assets. Additionally, gross margin expanded 64%. Now, although gross margin can fluctuate from quarter to quarter, it is encouraging that our first full quarter with the IRRAS technology came in slightly ahead of our pre-integration projections. As always, let's now turn to our four pillar growth strategy for a bit more detail. As a quick reminder, our four pillars consist of the following segments. Number one, pre-commercial Biologics & Drug Delivery products and services. Number two, Neurosurgery Navigation and robotics. Number three, laser therapy and access. Number four, neurocritical care and active CSF exchange. These are the four markets that we participate actively in today, and pretty much 100% of our current revenue is coming from these four markets. In 2026, we expect all four of these segments to each grow double digits. For clarity's sake, this does not include any revenue from the commercial launch of cell and gene therapies, which we expect to start in the years ahead upon appropriate global drug approvals. First, let's start with pillar number one, pre-commercial Biologics & Drug Delivery. The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL. This new facility will become a common starting point for our relationship with biopharma partners to perform benchtop and preclinical studies, as well as troubleshoot workflows to build custom devices and software that are drug and target specific. Despite the fact that the facility was significantly limited for most of the month of March for planned construction projects, we were still able to perform numerous studies in the first quarter, which included multiple new routes of administration, which were tested for the very first time by the ClearPoint team. This demonstrates not only our ability to co-develop new products with partners, but also shows how we expect our drug delivery portfolio will continue to grow in the future, often with new techniques and new intellectual property that we are building alongside of our partners. Additional progress was made globally, evidenced by a record number of clinical trial patients enrolled across numerous indications. We also performed our first ever commercial drug delivery procedure using ClearPoint technology in the Asia Pacific region. Our biopharma partners need to know that their therapies can reach patients anywhere in the world, and our commitment to global availability of our ecosystem delivers on exactly that. To integrate the IRRAflow product line into our portfolio. The IRRAflow dual lumen catheter is a flexible, multi-day placement catheter that we expect to address a gap in our drug delivery offerings by providing extended access to the brain, a capability that we did not have in our portfolio until now. I can say that we have already had multiple meetings with interested researchers and plan to provide updates later this year on this new option for our partners. Moving on to pillar number two, which is neuro navigation and robotics, where we have made some tremendous progress recently as well. Our successful launch of the 3.x platform continues in the U.S., and that expanded to Europe with the very first 3.x case performed there in Q1. The subsequent approval in Canada has also yielded multiple interested parties. Our first clinical cases ever performed in Canada are expected here in the near future. Numerous demonstrations of our prototype ClearPoint robotic platform, which prioritizes cranial procedures, have been extremely well received and have repeatedly highlighted our unique understanding of the cranial drug delivery space. It is important to remember that we are leveraging more than 15 years of software development focused on the brain. This historical investment into our KUKA LBR Med robotic arm. One highlight to share is that we recently performed our first-ever preclinical drug delivery case at our CAL facility using this robotic platform, and the results were better than expected. We plan to offer this system for use in preclinical biopharma studies at the CAL facility to our more than 60 active partners. For pillar number three, laser therapy and access, our biggest highlight of the quarter was the FDA clearance of the Velocity Alpha MR high-speed surgical drill system manufactured by our partner, adeor medical AG. We believe this drill will be an attractive solution for surgeons compared to our historical hand-operated twist drill. This device operates at more than 75,000 RPM, and when using our custom drill bits, we expect to meaningfully reduce procedure times. These efficiency gains were already evident during the very first-ever clinical procedure performed with the drill just a couple of weeks ago for one of our partners' cell therapy clinical trial. Additionally, we were pleased to announce just today that the drill has now received CE marking in Europe as well, which expands the system's availability beyond the U.S. and provides a scalable pathway to support neurosurgical procedures and therapy adoption globally, including across our European partnered biologic programs. Our Prism laser therapy system continues to be a highly competitive solution in the market, with multiple installs, evaluations, and purchases completed in the first quarter. As a quick reminder, our newly expanded labeling now includes both 3.0 and 1.5 Tesla scanners, which has significantly expanded our potential customer base compared to where we were a year ago. Last but not least, pillar number four, which is neurocritical care and active CSF exchange, is made up of the various IRRAflow assets included in the acquisition of the IRRAS at the end of 2025. This is a completely new market for ClearPoint, but an important one as it fits into our two-phase strategy perfectly. Number one, it adds a flexible indwelling catheter to our Biologics & Drug Delivery portfolio, a capability we've historically lacked, opening up a new potential pathway for drug delivery to the brain. In the first quarter, we have successfully merged our commercial teams together, including initial cross-training on the devices. With the sales integration now behind us, we expect to continue to grow this business in 2026 and in the years ahead. Having mapped out multiple revenue and cost synergies, we believe that the addition of the IRRAflow assets could potentially be cash neutral for ClearPoint as early as 2027 or next year. Globally, we now have more than 175 active sites using some form of ClearPoint technology and expect that number to surpass 200 by the end of 2026. This site expansion not only allows ClearPoint technology to be available to more hospitals and patients worldwide, but it also enables the scaling of our business model, including the expert clinical support for which we are very well-respected in the neurosurgical community. With that, I would like to open up the call to any questions. Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we pull for questions. Our first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question. Great. Thank you for taking the questions. I was hoping to start with one in pillar one, and kind of a two-part question and a little unrelated, so sorry if it's a little lengthy, but part one would be related to can you just give us a update from ClearPoint's standpoint, the current state of affairs or clinical backdrop at the FDA? Obviously, there's been some headlines around some leadership changes, and I'm just curious how this has impacted some of your interactions. Do you foresee maybe some of those conversations becoming a little bit more efficient in the future with different leadership and anything else that's important there? That's part one. Part two, one of your partners was acquired by UCB or pending acquisition. Just was curious if you could provide any updates related to your partner activities, ongoing there that you're able to discuss. Thanks, sorry again for the lengthy question. Frank, I expect nothing less than multi-part questions for you. Thanks for asking. The first one relative to the FDA, you know, there's two different groups at the FDA that we generally work with, which, you know, part on the devices side and then part on the combination devices side, which definitely has a component of biologics to it. On the devices side, we've seen very little change. We've seen incredible cooperation. We've hosted multiple pre-submission meetings with a team that's been pretty well intact. You know, we haven't seen anything negative at all on that side. It's been very positive, you know, for really years now at this point. That includes conversations we've had with the newly acquired IRRAS assets as well. If you think about the traditional device part of the business, we have not seen very much difference. If anything, I think it's going smooth. On the biologic side, you know, we're not always privy to each and every one of these questions, but obviously you can't read a headline today without, you know, understanding that there's been incredible confusion at the FDA, confusion on some of the feedback that had been provided across multiple ClearPoint partners, and I'm sure likely others as well. I think everyone is looking for really that confusion, I think, to halt more than anything else as the first step. My understanding is where we are with the newly selection or for both the Head of CBER as well as the Head of the FDA itself, we're still a little bit in a waiting mode here to see what that final decision is. Now certainly, any appointment to either one of those roles, from someone who, you know, is not only incredibly competent in the device, the biologic space, statistical, clinical trial design, et cetera, that would be very welcome. Of course, anyone who's, you know, gone through the gauntlet of how difficult it is to enroll these incredibly complex clinical trials, I think would also be viewed as a positive, not just by ClearPoint, but the entire community as well. You know, we're anxiously awaiting as well to see what those final decisions look like and the sort of the ability to get started. On the second question relative to, I believe you're talking about the Neurona acquisition by UCB. Again, that was, I think, a very positive. The Neurona team is still very much intact, very much working alongside us. From our standpoint, we've had a wonderful relationship with UCB for many years now as well. It's kind of two of our partners sort of coming together and getting the benefits of both teams at that time. We expect to continue to support the Neurona asset as it moves into their phase III, phase III pivotal trial as we speak. Just one quick thing I would bring up, Frank, 'cause it's a really important question too. It's kind of getting back to the FDA side of things. We need to remember that, you know, not to bucket everything together. There's sort of the rare disease side of things, which are things like Huntington's disease and, you know, a number of these very, very rare conditions that sit on sort of one side. Then there's the much higher volume, higher prevalence diseases like epilepsy, Parkinson's, et cetera. When the FDA had given guidance in the past to provide expedited review for these programs to try to accelerate their pathway to market, the larger market opportunities were always in a position where they were gonna be doing some form of a pivotal phase III study. When this sort of confusion arose to some extent where it was argued that, you know, it, some of the decisions had been changed or some of the guidance had been changed, I don't personally believe that that's impacted disorders on the other side with these rare diseases, where it's just incredibly difficult to do one of these randomized sham studies because surgeons are not necessarily comfortable enrolling patients, and patients themselves might feel like they're missing a chance to experiment with other studies if they're waiting for one in a situation where they don't even get the experimental drug. They were just given a placebo. The practicality of some of these rare disease studies is really the thing that was the biggest question that we had seen. Got it. Very helpful. Maybe for my second one, just help us through kinda low end versus high end of guidance. What are some of the key variables you're tracking that might push you towards one of those two ends? Yeah, I mean, I would say the largest factor there is really the continued investment and preparation of the preclinical services that we're providing at the new CAL facility. You know, as you've seen, you know, throughout our history, there's always choppiness from quarter to quarter. The thing I would point out there is that we're still very much not fully operational yet and under capacity, and I view that as kind of a positive. In Danilo's comments he made, he mentioned that our preclinical services, our Biologics & Drug Delivery services were flat year-over-year. What I would point out is sort of twofold. If you think about our new facility, think of it this way. This is not a perfect analogy, at least gives you some context. We pretty much have three floors of that facility. Of those three floors, we have only taken control of one of them, and these are all three revenue generating floors for benchtop testing, for analytics, for histology, you know, you name it. To even start the quarter, we only had one third of that revenue generating space, if you will. Even if you look at the 1/3 we had, there was an entire month of March where we weren't doing studies because we were finishing completion of some of the construction there as too. If you think about estimating capacity of what that facility could do for us, you know, we still came in, you know, in the millions of dollars, but we, you could argue we were like 2/9 or 20% of, you know, what our actual capacity is. We're significantly subscale on that as well. You know, we expect if you think by the end of Q2, early Q3, we should be getting close to taking the first floor over, the second floor, if you think of it in my analogy. By Q1 of 2027, we'd have the full facility completed. It's gonna be this kind of, sort of, stable, but increase over the next year or so, maybe in the next 18 months. You know, to answer your question, when those facilities and studies get booked is really the biggest driver of that range in guidance. Got it. Okay. Very helpful. Thank you. Sure. Thank you. Our next question comes from the line of Tom Stephan with Stifel. Please proceed with your question. Great. Hey, guys. Thanks for taking the questions. Maybe as a follow-up to Frank's prior question, Danilo, maybe for you, can you talk a bit about revenue cadence for the year as we think about the guide, and notably as we consider, I'd say IRRAflow synergies that you've talked about. And then as a tack on, can you give us a sense for, you know, within your range, how much of the mix is kinda base business versus versus IRRAflow? And then I'll have a follow-up. Yeah, the way I would think about it is with sequential growth potentially quarter-over-quarter for the remainder of the year. It will be gradual, but we expect it to be somewhat consistent over the next three quarters. With regard to the IRRAflow side of things, we expect it to grow, and it still accounts for in that 20% - 25% of our total business. That's what we expect between now and the end of the year. Got it. That's great. Tom, the only thing maybe I'd add there as well is that, you know, as we mentioned at the beginning, in the first half of the year, our European extent, while the U.S. continues to kind of fire here in the first half. There could be a little bit of a lag there relative to when, sort of outside of the U.S. IRRAflow kicks in because of some of these changes. Again, it, you know, it's I wouldn't say it's just noise. I mean, I think it's real, but it's not something that's gonna change the math of our revenue for the year. Got it. That's great. Appreciate that. Then I guess moving down the P&L, if you will, sort of a two-parter again. Gross margin, really nice step up in 1Q. Joe, can you talk about kind of puts and takes specifically around IRRAflow? I know you mentioned it can fluctuate, but is this mid-60% range potentially sustainable moving forward? Then sort of similarly on OpEx, Joe, you mentioned some one-timers. How much were those? What's kind of the right OpEx run rate moving forward for 2026? Thanks. You know, quarter to quarter there's definitely gonna be some fluctuation. I mean, it could be down next quarter and then up the one after that. It's nice to get a good one under our belt for the first quarter. But we are still very much subscale in just about everything that we do, including IRRAflow. If you think about what took place in Q1, we shut down the IRRAflow factory that was in San Diego, and we moved all of their operations and employees over to our Carlsbad facility. If you think of it something that showed up on the G&A, for example, as an increase, you know, we have an empty building right now that we're in the process of subleasing, to go ahead and, you know. That's one of those very obvious cost synergies that we've already done all the work to move everything over, and now it's just finding a tenant to take over the lease. Those are the types of things. You know, multiply that times 10 or 15 different opportunities with redundant vendors, with the ability to have some sort of negotiating power with our vendors of just, you know, raw materials, putting more and more products through our factory. Even on the sales and marketing side, to be able to have our clinicals travel less because the volume has increased across our portfolio in different cities. You know, with gas prices where they are and travel expenses where they are, that's a very, very meaningful part of the strategy too that's, that doesn't hit our gross margin, but it helps, it's definitely gonna help us on the SG&A side of things. Got it. Thanks, guys. Thank you. Thank you. Our next question comes from the line of Mathew Blackman with TD Cowen. Please proceed with your question. Hey, Joe, Danilo. Thanks for taking my questions. Can you hear me okay? Yes. Yes, loud and clear. Great. Well, good to hear your voices. Clearly a lot has happened since I last had the opportunity to be on a ClearPoint call. On that theme, sort of a big picture question. You're now more evolved, four phase, five- growth pillar strategy, I think with a combined $500 million long-term revenue target. Here's another multi-part question for you. Question one, do you have all the key pieces in place today to hit that $500 million number some, you know, time in the future, or are there still platforms or services you need to roll in to make that number achievable? Part two is there a way to get to that $500 million target faster inorganically? Are there assets out there that have technology and revenue bases that could help accelerate your pathway? How do you evaluate that pathway versus getting there organically? I do have one follow-up question. Yeah. You know, the first question was around do we have all the parts to build this spaceship and get to our destination here? And I think the answer is yes. I would say it in the way that there's still refinements in our portfolio, but we have control of the portfolio. I'll give you a perfect example of that is our robotics platform. You know, we do not have an FDA-cleared robot today. We have one that we are doing preclinical cases with for pharma partners, so it's functional in the preclinical setting. We have every confidence in this program because of the development that KUKA has put into the robotic arm development and parallel to what we have done over 15 years for our software development. It's not that we're dependent on something inorganic or dependent on something that requires invention or luck. You know, these are things that I think are execution. Once we have a robotic platform and arguably become the only company where you have one software that can be done in the MRI, using the same frame and ICT and then also with a robot as well, you know, I think that's something that, especially if our pharma partners support it as their robot of choice, I think that's gonna differentiate us and give us a right to win. If you think about other things that are out there inorganically, you know, it's interesting. If we're not gonna cross into neurovascular, and we're not gonna go out of the brain or implant something into the brain, which dramatically increase sort of complexity and costs and patient outreach and neurology call points and things like that, you know, there aren't that many assets that are out there. It's interesting because the reason for that is so few patients go through is access, improvements to reimbursement and arguably most importantly, availability, you know, final commercial availability of cell and gene therapies and other drugs that can be restorative and not ablative or not be an implant, which I think patients are very likely, from what we understand, to pursue first. You know, our focus is really getting these therapies across the finish line and then working alongside 50 or 60 pharma partners to educate neurologists, educate patients that they're available, which is something that I think will scale us quite a bit. That's why I'm saying I don't think we're dependent on something inorganic to get there. Got it. That's really helpful. The follow-up for you as well, Joe. Some of the IRRAflow catheter. Look, I appreciate it's still very early days, but feeling any interest from current or even potentially new biopharma partners in using the indwelling delivery option. Maybe Danilo, if you could, just how would the IRRAflow catheter, even if just in the roughest terms, differ from a business model or economic standpoint if it, in the future, was co-labeled with a drug versus what you have in place with the SmartFlow Cannula? Any help there? Thanks, guys. Yeah. I think, I'd say yes, we've absolutely had discussions with partners and research centers. We host a meeting called IGNITE every year, you know, we had a number of different research ideas that came out of that where they, the researcher themselves was already planning to execute a study using an off-the-shelf device called an EVD or an external ventricular drain, which is a very, very common procedure. You know, IRRAflow is arguably a next generation EVD because it's dual lumen, it allows you to actually put some sort of fluid as directed by a surgeon into the brain while it naturally drains instead of just draining and doing a sort of a bolus shot into there. You know, the product arguably for these in-path, very simple EVD studies is kind of an obvious choice to switch to this as quickly as possible. It's really an education standpoint. As you pointed out, luckily, ClearPoint Neuro ideas and these technologies out of universities and academic centers. You know, there is a product out there today that could absolutely in our current IRRAflow product line, that could absolutely become an immediate substitute in some of these studies, and I think that's a very likely case. Great. [crosstalk] Yeah. Yeah. Yeah, on the economic side, we expect IRRAflow margins to still be very healthy. Like Joe mentioned earlier, we're still pretty subscale. As it grows, we think the margins will keep expanding in that product portfolio. I think they already are, if you look at even 2026, just given the fact that we've consolidated facilities. From a business model perspective, we're gonna, you know, work with our partners. It's still very, very, very early, but we'd like to, of course, pursue similar ways of working that we've had with our, we've already tested and explored with our existing partners. Got it. Thank you, guys. Appreciate it. Yeah. Sure. Thank you. We have reached the end of the question and answer session. Therefore, I would like to turn the floor back over to CEO Joe Burnett for closing remarks. Thanks again for joining our call today. Our team feels like we have built an incredible foundation on these four pillars today, which will support an exciting future of global commercial drug delivery, which our 60+ biopharma partners are making progress towards each and every day. We are on a path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable. We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night, everyone. Thank you. This concludes today's