NeuroPace (NASDAQ:NPCE) released first-quarter financial results and hosted an earnings call on Tuesday. Read the complete transcript below.
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Access the full call at https://events.q4inc.com/attendee/987387906
Summary
NeuroPace reported Q1 2026 revenue of $22.1 million, marking an 8% year-over-year growth, primarily driven by the RNS system's performance.
The company raised its full-year 2026 revenue guidance to $99-$101 million, up from $98-$100 million, reflecting expected growth in the RNS system and improved service revenue visibility.
NeuroPace is investing in its commercial organization, including adding sales representatives and enhancing sales incentives, to improve patient funnel management and increase procedural consistency.
The FDA mid-cycle review for the Nautilus PMA supplement was deemed productive, with the company expecting a mid-year determination for the IGE indication expansion.
NeuroPace continues to develop its AI tools, with the ECOCHG Assistant expected to aid clinicians in identifying seizure activity, and anticipates approval in Q2 2026.
The company reported a non-GAAP gross margin of 82.5% for Q1 2026 and a non-GAAP operating expense growth of 10%, demonstrating operating leverage.
The management highlighted the strength of the patient pipeline and the importance of community relationships in driving growth, particularly for potential IGE indication expansion.
Full Transcript
OPERATOR
Ladies and gentlemen, thank you for standing by. My name is Abby and I will be your conference operator today. At this time, I would like to welcome everyone to the NeuroPace first quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. And I would now like to turn the conference over to Scott Schaefer, head of investor relations. You may begin.
Scott Schaefer (Head of Investor Relations)
Thank you, Operator. And welcome to NeuroPace first quarter 2026 earnings conference call. Our agenda begins with Joel Becker, NeuroPace Chief Executive Officer, who will summarize our recent performance and strategic progress, followed by a detailed financial review and outlook from Patrick Williams, our Chief Financial Officer. Following our prepared remarks, we will open the call for questions. Before we begin, I would like to remind you that certain statements made on today's call may constitute forward looking statements within the meaning of federal securities laws. These statements include, among others, comments regarding our financial outlook for 2026, our commercial strategy, clinical and product development initiatives, regulatory matters, including our IGE PMA supplement, and our expectations regarding operating performance and profitability. Forward looking statements are based on management's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. The discussion of these risks and uncertainties can be found in today's press release and in our filings with the securities and Exchange Commission, including our Most recent Form 10-K and Form 10-Q. We undertake no obligation to update or revise any forward looking statements except as required by law. In addition, we will discuss certain non-GAAP financial measures on today's call, including adjusted EBITDA reconciliations of non-GAAP measures to the most directly comparable GAAP measures are included in our earnings release, which is available on the Investor Relations section of our website. With that, I will now turn the call over to NeuroPace chief executive officer, Joel Becker.
Joel Becker (Chief Executive Officer)
Thanks, Scott, Scott and good afternoon everyone. I will start with an overview of our first quarter results and how the team is executing against our strategy, followed by updates on key clinical and product development initiatives. After that, Patrick will walk through the financials and our revised outlook before we open the line for Q and A. The first quarter reflects continued execution against the priorities we outlined earlier this year. We delivered total revenue of $22.1 million in the quarter and excluding Dixie Medical, we delivered 22 million in revenue representing 8% year over year growth with RS system revenue of $21.7 million. Importantly, the underlying fundamentals of the business remain solid as we reached new all time highs in active prescribers accounts and patient pipeline during the quarter. These are leading indicators we track closely and give us confidence in the durability of demand for the RNS system. The majority of growth continues to be driven by Level 4 comprehensive epilepsy centers which remain the core of our commercial focus. In addition, we continue to see encouraging trends in the front end of the patient funnel with the rate of new patients being added to the pipeline continuing to accelerate. While the majority of procedures remain concentrated within level 4 comprehensive epilepsy centers, community relationships are increasingly serving as durable referral channels. We believe this is important not only for continued penetration of the adult focal population but also for establishing referral pathways that will be relevant as we potentially expand into IGE. Regarding guidance, we are raising our full year 2026 revenue guidance to a range of 99 million to $101 million, up from 98 million to $100 million previously. This reflects 21 to 23% underlying RNS growth from our existing adult full focal indication and does not include any contribution from idiopathic Generalized Epilepsy indication expansion. From a market development perspective, we continue to invest in the commercial organization. This includes targeted sales representative additions in key geographies, updates to our sales incentive structure to better align with growth objectives, and additional resources dedicated to helping patients navigate the funnel from identification to implant. These investments are designed to reduce friction in the patient pathway and increase procedural consistency over time. We expect them to become increasingly productive throughout 2026. Let me now turn to clinical development. During the quarter we completed our FDA mid cycle review meeting for the Nautilus PMA supplement, sometimes referred to as a day 100 meeting, which we viewed as a productive step in the overall regulatory pathway. As a reminder, the PMA supplement was submitted on December 15 and the 180 day review clock began upon acceptance of that submission. As part of the PMA supplement review process, the FDA has the ability to pause the 180 day review clock to request additional information or clarification during the quarter, the agency exercised that option to seek certain follow up information in conjunction with our mid cycle review meeting. We view this as a standard and constructive part of the review process and we were pleased with how quickly the agency provided their questions which allowed us to respond promptly and thoroughly with robust information during and following the meeting at this time, we have responded to the Agency's request and the dialogue continues to be productive. Importantly, based on our interactions to date, we continue to believe a mid year determination remains on track. The breakthrough device designation continues to be meaningful in this process, allowing for more consistent interaction and timely feedback as the review progresses. The ongoing dialogue we are experiencing, including the ability to address clarifying questions in real time, is consistent with the intent of that program and reflects the collaborative nature of the review. As a reminder, our 2026 revenue guidance does not include any contribution from IGE indication expansion. If approved on our current timeline, contribution would begin in the second half of the year and we would provide updated guidance at the appropriate time. Once we have greater visibility into timing and reimbursement dynamics from a data perspective, we remain confident in the totality of the anodolyst clinical results As a reminder, 18 month data presented at the American Academy of Neurology Annual meeting in April demonstrated a 77% median reduction in generalized tonic clonic seizures with sustained reductions over time along with favorable safety outcomes in a highly refractory population. Additionally, reductions in absence and myoclonic seizures exceeded those observed for generalized tonic clonic seizures. Injury events also declined by approximately 30% following treatment and the use of benzodiazepines as rescue medication for generalized tonic clonic seizures was 44% lower compared with baseline. The strong physician and patient reported clinical improvement. These clinical findings are meaningful because they speak to the real world impact beyond seizure counts, including fewer seizure related injuries and reduced reliance on rescue interventions, both of which can translate into improved safety and quality of life. In parallel, we continue to build our leadership position in clinical evidence. Our three year post approval study results in drug resistant focal epilepsy were published in the journal Neurology in late April demonstrating an 82% median seizure reduction in study subjects. This publication reflects data from a rigorously conducted FDA monitored prospective study, not retrospective registry data, and reinforces the durability and strength of long term outcomes. With the RNS system now turning to product development, the roadmap we outlined on our fourth quarter call remains on track. Our priorities continue to be our suite of NeuroPace AI tools, development of a multimodal foundational model, remote care, and progress toward automated detection and next generation system development. Our EcoCHG assistant, previously known as Seizure ID, represents the first step in our NeuroPace AI suite. This is an AI enabled tool designed to assist clinicians in analyzing patients IEEG records of interest and and efficiently identify likely electrographic seizure activity upon which to focus their clinical decision making. This is a highly desired capability addressing a real workflow challenge and supports clinicians in their ability to individualize care. We're encouraged by the early performance we are seeing in internal testing and validation work of this tool. We believe this product can serve two important purposes. First, it lowers the barrier for new physicians adopting RNS by simplifying data review. Second, it deepens engagement among existing high utilizing centers by improving efficiency and allowing clinicians to manage more RNS patients within their practice. Importantly, the submission is paired with moving our clinician platform to the cloud, which improves scalability and supports faster deployment of software and data products over time. We expect ECOCHG Assistant approval in the second quarter of 2026. We are also advancing the development of a multimodal foundational model leveraging our proprietary intracranial EEG data set and the clinical experience derived from more than 8,000 patient implants across 35,000 patient years. The EEG component of this model is currently in training and although we are approximately one third of the way through the training process, early internal validation work has been encouraging. Even at this early stage, the model is outperforming prior internal algorithmic approaches we had been developing. We believe this reflects the power of scale in our data set and reinforces the strategic value of the more than 26 million intracranial EEG recordings we have accumulated. Importantly, we are uniquely positioned here. No other neuromodulation platform has a comparable depth of longitudinal intracranial EEG data linked to therapy and outcomes and leadership in this area matters as the field moves toward a data guided personalized neuromodulation approach. As the model continues to train and refine, we see meaningful opportunity to enhance treatment optimization, improve outcomes and further differentiate the RNS platform. With that, I'll turn it over to Patrick for a review of the financials and outlook. Patrick thank you, Joel.
Patrick Williams (Chief Financial Officer)
I will review our Q1 2026 performance in more detail and then discuss our updated 2026 guidance. Before I walk through the quarter, I want to clarify our reporting presentation. While we previously anticipated presenting Dixie Medical as discontinued operations beginning in the first quarter, we now expect the discontinued operations presentation to begin with our Q2 2026 results. In the meantime, we are providing supplemental non-GAAP disclosures that exclude Dixie Medical in both current and prior periods to facilitate comparability. In addition, beginning this quarter we are presenting gross margin and operating expenses on an adjusted non-GAAP basis excluding stock based compensation consistent with full year guidance given on our fourth quarter call reconciliations to the most directly comparable GAAP measures are included in today's press release. Excluding Dixie Medical, total non-GAAP revenue in Q1 2026 was $22 million or 20.1% year over year compared with $18.3 million in the prior year quarter growth was primarily driven by increased sales of the RNS System which grew 19.5% to $21.7 million versus $18.2 million in Q1 2025. As we previewed on our fourth quarter call, growth in the first half tends to moderate relative to the acceleration we see exiting the prior year and that pattern held true again. Service revenue tied to our data Collaborations in the quarter, including a new partnership totaled $314,000 excluding Dixie. Non GAAP gross margin in Q1 2026 was 82.5% compared to 83.6% in the prior year quarter. The Q1 2025 gross margin included a one time inventory revaluation benefit of approximately one hundred and twenty basis points excluding that impact. Underlying gross margin expanded year over year driven primarily by favorable pricing conversion. Total non-GAAP operating expenses for Q1 2026 were $21.5 million compared with $19.4 million in the prior year quarter and came in better than expectations driven by hiring cadence and other personnel related expenses. Non GAAP operating expense growth of approximately 10% in the quarter remained meaningfully below our revenue growth of 20%, again demonstrating underlying operating leverage as we scale. Non GAAP sales and marketing expense was $11 million up from $9.6 million in the prior year quarter reflecting headcount growth and personnel related expenses as we continue investing in the commercial team and other sales related expenses. Non GAAP research and development expense was $6.5 million compared to $6.6 million in the prior year quarter. The slight decline reflects lower clinical study spend compared to the prior year period, partially offset by personnel investments supporting our AI roadmap and next generation platform. Non GAAP general and administrative expense was $4 million, up from $3.3 million in the prior year quarter, primarily reflecting increased personnel costs. Total stock based compensation in the quarter was $2.3 million, with $2.1 million included in operating expenses and the balance and cost of goods. Non GAAP loss from operations for Q1 2026 was $3.3 million compared with a loss from operations of $4.1 million in the prior year quarter. Adjusted EBITDA loss was $3.3 million in the first quarter, an improvement compared to a loss of $4.1 million in our prior year quarter. GAAP net loss was $6.7 million for Q1 2026 compared with net loss of $6.6 million in the prior year quarter which included Dixie Medical. In both periods. We ended the quarter with $54.8 million in cash, cash equivalents, short term investments and restricted cash compared to $61.2 million at year end 2025. The sequential decrease reflects typical first quarter cash outflows primarily driven by annual corporate bonus payments. Please note that as of March 31, 2026, we had approximately $700,000 of restricted cash related to Dixie Medical. Approximately $600,000 has since been converted to cash and cash equivalents and we expect the balance will be converted by the end of Q2 2026. Turning now to our outlook for 2026, as Joel mentioned, we are raising full year 2026 revenue guidance to $99 million to $101 million, up from previous guidance of $98 million to $100 million. The $1 million increase at the midpoint is driven by 2 factors. Approximately $500,000 reflects improved visibility into service revenue and approximately $500,000 reflects improved visibility into our core RNS outlook. Our increased guidance reflects underlying RNS revenue growth of 21% to 23% and our core business and continues to exclude any potential contribution from IGE indication expansion on service revenue. Specifically, last quarter we noted that while we may generate modest service revenue during 2026, it was not included in our initial outlook given limited visibility at that time. As our planning has progressed and certain activities have become more predictable, we are now incorporating approximately $500,000 of service revenue into our updated 2026 guidance. As we have previously stated, given the underlying dynamics of a procedure based business, it can be more informative to evaluate RRNs performance over six month periods. We remain confident in our ability to deliver 20% underlying RNS focal indication growth over time and we expect the first half of 2026 to be consistent with that framework. Quarter to quarter fluctuations can occur, but our focus remains on sustained adoption and utilization trends across a broader time horizon. We continue to expect full year non-GAAP or adjusted gross margin to be between 81.5% and 82.5% reflecting continued leverage and favorable pricing. We continue to expect full year non-GAAP or adjusted operating expenses to remain in the range of $90 million to $92 million excluding approximately $10 million in stock based compensation. Consistent with prior guidance for the full year 2026, we continue to expect non-GAAP or adjusted sales and marketing expense to total between $46 million and $48 million. Sales and marketing expense growth in 2026 reflects a continued commercial investment and we expect productivity and leverage from these investments to increase meaningfully as we move through 2026 and into 2027. We continue to expect full year non-GAAP or adjusted research and development expense to total approximately $27 million R&D expense growth in 2026 reflects continued investment in our next generation platform and the development of the NeuroPace AI suite of tools designed to enhance physician workflow and drive further adoption. We remain focused on disciplined allocation of R and D capital toward programs that strengthen the platform, enhance differentiation and support long term growth. We continue to expect full year non-GAAP or adjusted general administrative expense to total approximately $17 million g and a expense in 2026 primarily reflects the infrastructure required to support a growing commercial organization and corporate systems necessary to operate at scale. We remain disciplined in managing overhead as we drive operating leverage across the organization. We now expect more favorable full year adjusted EBITDA to be a loss in the range of $8.5 million to $9.5 million, improved from a loss of $9 million to $10 million and with that
Joel Becker (Chief Executive Officer)
I'll turn it back to Joel Thanks Patrick. We are energized by the opportunity in front of us. We are executing and penetrating the adult focal market, progressing toward potential indication expansion into the IGE population and advancing a differentiated product roadmap anchored in unique proprietary data where we are developing first of its kind and unique assistive and foundational AI data analysis tools. We believe that we are uniquely positioned at the intersection of data, device and neuromodulation. We will continue to lead on product innovation and clinical evidence and we remain focused on disciplined execution and thoughtful investment to drive durable long term growth. With that operator, please open the line for questions.
OPERATOR
Thank you and we'll now begin the question and answer session. If you have dialed in and would like to ask a question, please press Star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press Star one again. If you're called upon to ask your question and are listening via speakerphone on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. To be able to take as many questions as possible, we ask that you please limit yourself to one question and one follow up and you may rejoin the queue for additional follow up questions. Again, it Is Star one to join the queue. And our first question comes from the line of Mike Kratke with Leering Partners. Your line is open.
Mike Kratke (Equity Analyst at Leering Partners)
Hey everyone, congratulations on all the progress and thanks very much for taking our questions. So first, you had some really encouraging updates on achieving new all time highs in active prescribers accounts. Patient pipeline. One of your Epilepsy competitors also recently mentioned a strengthening of the patient funnel in the US So can you just help us understand what factors seem to be most responsible for this dynamic and where specifically are you seeing this materialize?
Joel Becker (Chief Executive Officer)
Thanks, Mike. And it's a great question. So for us, we're particularly pleased with the trends that we see with regard to patient pipeline. Our patient pipeline numbers are as strong as we've ever seen them. And I think a lot of that comes. Well, a lot of that comes from both our work, really three things. One, our work with our level four center traditional customers to make sure that we're doing everything we can to collaborate with them to have patients identified as they're moving through level four centers. Two, we've talked about in the past the work that we've been doing in the community and with the referral population and that's beginning to contribute nicely to, to the patient pipeline as well. And then thirdly, the investments we've made in our commercial organization, both the breadth of that organization as well as the way the leadership team is executing in the discipline systems and processes that we've put in place to make sure that we have good visibility to and are tracking well. The execution around that priority, I think are all leading toward building and really as good as we've seen it. Patient pipeline to date. Yeah.
Patrick Williams (Chief Financial Officer)
The only thing I would add to that, Mike, is we're starting to look a lot deeper into the patient pipeline in terms of analytics and tracking that differently with our commercial team. And we think about it as sort of the velocity of that patient, which we know has a long sales cycle, but better understanding where they're at within that, that healthcare continuum, we'll call it, until they actually go to a neuromodulation device. So more to come on that, but wanted to throw in there that, you know, leveraging, you know, predictive tools that are AI based, et cetera, to get a little bit smarter in that area.
Mike Kratke (Equity Analyst at Leering Partners)
Understood, very helpful. And maybe just as a follow up. But can you share any specifics in terms of what information FDA was looking for specifically as part of its mid cycle review?
Joel Becker (Chief Executive Officer)
You bet, Mike. We had a very productive and interactive meeting with the agency, a Couple of things I'd punch up there. One, we were really pleased to get the questions that we got in such a timely fashion. So it made for a good opportunity to prepare and then a robust and again interactive discussion with the agency. I would characterize the nature of the questions that we received. We really focused on folks, both clarification of and context around various aspects of the data and the associated analyses that had gone into the PMA supplement. So it's clear that they're paying good and close attention to the data, as we would expect. And again, the questions were really around clarifying some of that data, how to best understand and interpret it, and then where we had provided associated analysis, wanting to make sure that they had appropriate context for that analysis. But again, I would, in addition to those facts, I would emphasize that we thought that, you know, one, we got real good questions. We got them in a timely fashion. It resulted in a good and engaged discussion. And we have since followed up and submitted our formal responses to those and all questions that we've received until now.
Mike Kratke (Equity Analyst at Leering Partners)
So yeah, very helpful. Thanks very much.
OPERATOR
And our next question comes from the line of Priya Sachdeva with ubs. Your line is open.
Priya Sachdeva (Equity Analyst at UBS)
Hey guys, thanks so much for taking the question and congratulations on a strong start to the year. Maybe first if I could just, you know, really encouraging to see the strong growth in RNS revenues, but would love to maybe if you could parse out how much of that was deeper market penetration, increasing utilization across your, your existing centers versus new physician capture. And if there was any pricing dynamics in the quarter. I think you did call out some increasing asp. You know, if you could maybe just help us level set contributions from each and then one follow up.
Joel Becker (Chief Executive Officer)
You bet. I'll start here, Priya, and then ask Patrick if he has anything he'd like to add. So as has been the case, the growth in the business really has been centered around increasing adoption and utilization within our level four centers. So adoption you can see by the ongoing increasing number of all time high prescribers. And so we continue to be pleased with that. But then, you know, also continuing to work utilization and expansion of where the RNS system plays within those people's practices. And then the second part would be, as I mentioned earlier, the increasing contribution of patients who are identified, identified for and either implanted at or referred from community settings. So patients who are identified as good candidates for RNS in the community and either undergo the therapy there at a Level 3 or community hospital or are identified for RNS therapy and then referred in for surgical placement of an RNS device in a level four center. The third thing I'd identify here is our dtc, our direct to patient efforts as well as. Then in our Q4 call we made mention of investment in our Nurse Navigator team and that's all designed to help fill the pipeline and then move patients with increasing velocity and decreasing friction through the pipeline. And so I think our Nurse Navigator team is beginning to have a nice impact there as well. With regard to pricing, as you know, we have had consistent and good execution with regard to pricing. Pricing is somewhat of a tailwind for us here in the quarter, but the majority of the revenue is really associated with unit volume rather than than a significant price effect. But a good tailwind. Yeah.
Patrick Williams (Chief Financial Officer)
The only thing I would add on pricing, Joel articulated that well is that we do plan to take pricing as we have in prior years going forward. So this is not a one time event. And as we said, we will continue to take pricing each and every year that we can and it'll be, you know, you can expect kind of that low single digit type pricing increases that we, we would look to get.
Priya Sachdeva (Equity Analyst at UBS)
Okay, got it. That was super helpful. I mean just one more for me when we're thinking about ige and I know it's not baked into guidance for this year, but you know, when approval does come online, how quickly could we see a contribution? And then maybe if you could just remind us what the pathway from a reimbursement perspective looks like and how quickly that could come online. Thanks so much.
Joel Becker (Chief Executive Officer)
Maybe start us out here and then I'll ask Patrick, who's very much involved with our reimbursement team and process here to comment on that as well. So first steps first we're focused on getting the indication expansion, getting the approval from the agency. You know what that process looks like. I described it earlier here in my comments of working through that here now with the agency. In parallel with that, we are working with our internal team to make sure they are trained and well prepared for the launch. And all of our launch plans, et cetera, are moving in parallel with that as well. Once we do have approval, we will move into what is really a coverage expansion exercise. We have the device covered today, it'll be the same codes for tomorrow. And our exercise then is really going to be working with the private payers to get coverage expansion. Obviously we're going to be working to do that on an off cycle basis, but certainly we've got good visibility to contract cycles and ensuring that we're well prepared to be engaged with medical directors and health plans that at the very least it's part of an on cycle process and we intend to make sure that there's a case by case submission associated with the coverage expansion. Very important as part of that process will be the published manuscript of the Nautilus data and I'm really pleased with the progress we've been making there. We're ahead of expectations in terms of the timing of the submission and review of the Nautilus manuscript and results and so I'm encouraged by having that and the timeline it's on and being able to show the results that it shows and the early review from the editorial reviewers was very light. It was a well done manuscript and is on a good timeline there. So I think we've also been, we've also been preparing from a reimbursement perspective and here I'll hand it over to Patrick. But we have been planning and doing our research around coverage expansion and have a number of outside experts as well that we're working with up to and including even having advisory board types of discussions for how people are going to be thinking about and reacting to the data and what will be particularly, particularly important to them, et cetera. So it's approval with internal training and market development in parallel than all of the logistics, mechanics and publication associated with extending coverage from the current focal indication for the current product with the private payers. Patrick, what would you add?
Patrick Williams (Chief Financial Officer)
I think just some highlights. You asked the question to sort of cadence of when we can expect and so we're still focused on mid year approval. Thank you for pointing out that, you know we had a good quarter with rns. We did raise guidance to not only include that beat in Q1 but raise guidance on top of that above the beat. We do not have IGE indication expansion in there as we said. So the cadence on that because of what Joel just went through in detail in terms of the coverage policies with the private payers, which is, you know, close to 80% we'll call it when you include the advantage programs with Medicare Medicaid, it's going to take a little bit of time to get on there. So I would say it's definitely a back end loaded if we think about the first 12 months, let's say of launch and so you're going to see more coverage policies come on board as we move into months 7, 9, 10, 11, 12 and so forth. And so at the appropriate time we'll come back and give guidance to everyone. But I think the Takeaway for you all is that it's the same exact DRG and cpt. As Joel said, we believe we're being very proactive and being very patient advocate, focused on making sure they get this approval. And so that's really the only thing that's going to hold us back in terms of the adoption from a reimbursement standpoint.
Joel Becker (Chief Executive Officer)
I would just wrap up there, Priya. When we've had discussions on the reimbursement side, I've been impressed as to hearing the feedback for how pleased people were with the clinical data and how attuned people were that there aren't approved options for these patients. And so it's just been encouraging to hear from that constituency, from that stakeholder group, the recognition of the value of the data and the recognition of the clinical gap that exists today.
Patrick Williams (Chief Financial Officer)
We're actually augmenting our internal reimbursement with some third party, especially as we launch, to ensure that on a case by case basis basis, we can continue to advocate for those patients. And we're feeling good about it. Again, we're kind of saying a couple things. We're excited about it, but at the same time we want to be thoughtful as we do get approval and find out what that revenue cadence will look like. But we think there's a really, really good opportunity here to move things along quicker than maybe what most people may think.
Priya Sachdeva (Equity Analyst at UBS)
Thanks so much.
OPERATOR
Our next question comes from the line of Larry Beagleson with Wells Fargo. Your line is open.
Ross Osborne
Hey guys, this is Ross Osborne on for Larry. Thanks for taking our questions. So, looking at your RNS volumes, did the system as a diagnostic or a companion to surgery contribute to growth during the quarter and how do you see this evolving over time?
Joel Becker (Chief Executive Officer)
That's a great question. I think that as we think about both of those dynamics, One, the unique capability to provide the window into the brain to see what's really going on with these patients has been increasingly recognized. And as we mentioned in our prepared comments, we really see the field moving more and more toward the ability to individualize and tailor therapy for patients. And it's really that unique diagnostic capability that allows us to do that, to monitor, record, and then analyze that data and subsequently then tailor therapy. And we think part of why we see improving results over time. So, yes, the diagnostic capabilities of the device absolutely are contributing to our growth. And secondly, with regard to hybrid therapy or as a complement to resection therapy, we do hear that more and more, especially within centers that you might consider to be somewhat more, in quotes, classically trained to really look for resection first in places where either they know they can't resect or to be able to inform surgical procedures. The use of the implantation of an RNS device prior to a surgical procedure to be able to best localize where they want to resect, or if they have a clear area for surgical intervention but the disease is diffuse enough and they know they can't resect some areas of eloquent cortex, for example, they'll use an RNS device in combination as part of a hybrid therapy. So as we've talked about before, really the modern RNS story, we're going from a particularly kind of niche application within a focal patient population to multifocal disease to network stimulation to adjacent to surgical procedures is really the progression that we see and we do hear about adjacent to resection procedures more and more. Great. And then apologies if I missed this in your prepared remarks, but would you walk through your latest advances and timelines for pediatric and lgs? You did not miss it. We did not include it in our prepared comments, but I'll address both. With regard to pediatrics, as you know, we're working on a real world evidence strategy here, using retrospective metadata analysis, working with the agency itself as well as a number of external parties to really aggregate and analyze the published data that's out there. We've worked to try and prospectively enroll trials on the pediatric side, and as sometimes is the case where you have devices that are approved in the adult population, it's difficult to get people to, for understandable reasons, to get people to consent to enroll children in the trial. We think that the real world data approach is a particularly good one at this time in that if you look at the interest from the clinical, clinical and scientific community, as well as the amount of data that has been gathered and published, it is increasingly gathering momentum since 2020, for example. So in a little over the last five or maybe six years in 2020 there were about eight peer reviewed publications for pediatric use of the RNS system. Today there are 29. And so there is an increasing amount of both interest as well as published data that really supports this kind of a real world evidence analysis. So we're underway in that process. I think, as you've heard me explain before, it's a little bit inverted from a prospective trial, where in a retrospective trial you do a lot of the work on the data alignment and structure up front and then once you have that, the back end of the process can go a little bit quicker, whereas on a prospective trial you can Go a little bit quicker on the front end and then you have to do all the work downstream. So we're in the middle of that hard work now. I'm not going to quote a timeline for you, but I would want you to know that it remains a significant priority for us. And again, there's a lot of momentum and a lot of interest within the clinical and scientific community here on lgs. As folks may know, we have announced enrollment completion on our LGS trial, the first of its kind in a collaborative effort with NIH to enroll a pilot group of 20 patients in a trial looking at both safety as well as efficacy endpoints, although in a pilot trial design. More to come on the results here with regard to lgs, but we're encouraged with what we see. We're in the process of developing our plans right now for how we will engage with the agency further, but encouraged with what we see from that early data and do plan on advancing our work in lgs. And again, stay tuned. There more to come in. Not too long. But LGS is absolutely on our minds and we're encouraged with what we've seen.
Patrick Williams (Chief Financial Officer)
Yeah, I think the takeaway is that as we think about adoption dynamics in the clinical setting, not only Ige, but as well with pediatrics and LDs as Joel went through, we think those adoption dynamics are very exciting for us and much more so than what we've seen with focal over time. And so just another thing to look for in the future as we think about our clinical development efforts.
Ross Osborne
Thank you.
Joel Becker (Chief Executive Officer)
Thanks, Ross.
OPERATOR
Our next question comes from the line of Lily Lozano with JP Morgan. Your line is open.
Lily Lozano
Great. Thanks so much for taking the question. Maybe just to go back to the quarter and guidance. Like you said, you raised by more than the B. You beat by a couple hundred thousand and you're raising guidance by a million. So can you talk through your thinking behind raising the guide this early in the year and where specifically that better visibility and incremental upside is coming from, especially on the R and S side of the business?
Joel Becker (Chief Executive Officer)
Absolutely, Lee, it's a great question and I think both, you know, the performance in the quarter as well as then historically what we've seen in the business is really our basis for thinking about the business that way. If you go back over the past, I'll call it the last three years, my direct involvement here, just to to speak to it personally. If you look at 23, 24 and 25, we have seen more revenue in the second half of the year than the first half of the year. We've seen about 500 basis point increase in growth rates in the second half of the year versus the first half of the year. And that's been very consistent across that time. And so that's what the calendarization looks like. Additionally, we have a team that we are investing in commercially, both from a sales perspective and from a marketing perspective. And we expect those investments to ramp and become more productive over the year, both the people to become more productive and the programs to become more installed. And then finally, as I mentioned, the patient funnel is as strong as we've seen it. And so it's growing and robust really across the business. And so all of those factors are really dynamics within the business that put us in position to be able to make the decision to raise the guide at this point. And then finally, from more of an internal perspective, as I mentioned, we continue to really strengthen the operating system around the business and in particular the organization and the discipline around the leadership, the training, incentives, referral management, as Patrick mentioned. And so it's not that we can't, and I suspect we won't have quarter to quarter variability in some of the results, but with what we see in the business today as well as what we've seen in the business over time, those are the dynamics that we're working to reflect in the guidance.
Lily Lozano
Great, very helpful. And then just to follow up on generalized, you mentioned there's no generalized included in the guidance. I know the main gating factor from here after approval is really getting commercial reimbursement. So it sounds like that's more of a 2027 event for that to be felt more materially in the numbers. But to my understanding, you can go after that 20% of the population, that's Medicaid right off the bat. So why not include some contribution from Medicaid? Is that just conservatism or is there some other reason that's not baked into the guidance for this year? Thanks so much.
Patrick Williams (Chief Financial Officer)
Yeah, no, it's a fair question. And just to say again a little bit more on that is that again, we are anticipating approval. But to stick with how we've been doing this since, you know, back in late 2025, we have kept IGE indication expansion out of our guidance and we will continue to do so until we get approval upon that time. You are correct. We would expect that on a case by case basis with that 20% Medicare, Medicaid, we can likely move pretty quickly on that. That's why we're augmenting with third party reimbursement help Et cetera. And then we'll work with the other 80%, which is across private pay in the Advantage program. So I guess I would call it more than anything being thoughtful about waiting for an approval. That's a bit of a binary event. We feel very cautiously optimistic about when that's going to happen, and we said it, but we want to make sure we don't get ahead of ourselves. And at the point of approval, we will absolutely come back and let people know what they can expect in contribution. And I stated already that you should expect that it would be to your point, as we get those private payers on board, that it would be more of a month, 7 to 12, we'll call it impact when we cycle through all those coverage policies.
Lily Lozano
Perfect. Thank you.
Joel Becker (Chief Executive Officer)
Thanks, Lily.
OPERATOR
And our next question comes from the line of Frank Kakinen with Lake Street Capital Markets. Your line is open.
Frank Kakinen
Great. Thank you for taking the questions. I was hoping to start with one. And apologies if it already came up. I don't think it has. On the reimbursement changes for 2026, I think last year or last quarter, you spoke to the improvements in both OPPs and the physician fee schedule effective at the beginning of 2026. Any anecdotal feedback or direct feedback from the field on how that reimbursement has been received or impacted the business?
Patrick Williams (Chief Financial Officer)
Yeah. Hey, Frank, you know, 2026 was still a good year for us from a reimbursement standpoint. A lot of the legwork that we did in 25 came to fruition in 26. So I would say overall, when you don't hear news and pushback from your field team, that's a good thing. As we go into 27, you know, we'll keep everyone posted on that. But at this point, we're in comment period, et cetera. We're not anticipating, nor have we, you know, obviously given 2027 guidance yet. But rest assured, you can expect us to continue to push hard on making sure that we not only advocate for patients, but that the hospital accounts are being reimbursed appropriately to make sure that that doesn't become a impediment to installing our neuromodulation device.
Joel Becker (Chief Executive Officer)
The only thing I'd add there, Frank, is that we did have a positive development from an OPPS perspective. As you mentioned, the replacement cycle for us is still a small amount of the business. But I know I don't need to emphasize for this group that that's on its way. And so that's something that we believe will hold us in good stead here. As those RNS320 devices increasingly come back around for replacement, we'll be in a positive and improved reimbursement position with regard to outpatient device replacement as that cycle increases.
Frank Kakinen
Got it. That's helpful. And then maybe just a bigger picture question on Project Care. I think we're about two years into when that initiative was kicked off. Joel, maybe give us a review. I mean puts and takes what has surprised positively, maybe what's been proven to be more challenging in this setting. Anything on utilization, if that's what's been driving some improvement, if it's new site activations, just any kind of big picture commentary that you've noticed over the last two years on that would be great. Thanks.
Joel Becker (Chief Executive Officer)
Thank you, Frank. I think, you know, things we've learned. We have learned and you've heard me comment on some of this previously, is that there are a number of different segments that exist in the community or referral population and having the flexibility to be able to address the needs of those different segments is important. One, we have some centers, community centers, level three centers, who really they've got the patient population, they've got the epileptologists and neurologists there, they've got the functional neurosurgeons with capacity, the surgical equipment, capital equipment requirements are there and maybe there's a software package that is required in a contracting activity. But other than that, they're really ready to go and we can turn them into an implanting center where they can self sustain and that's great. There are others that will eventually look like that. But since they hadn't had access to the technology, it wasn't something that they were planning for. And so it takes some time then to develop those centers. And as you know, with capital cycles and trainings and everything else that goes on at the hospital level that takes a little longer. But that's all a very important and viable segment for us, especially as we think about the idiopathic generalized population and not needing the phase two monitoring that requires someone to be transferred to a level four center for invasive emu seg monitoring that can abrogate the referral pathway. Timing the third segment has been interesting and that is centers that have all of the patient population and the neurology and epileptology capability and management infrastructure. And they don't really want to have the patients implanted at their center. Not that they don't want patients implanted at their centers, but they would like to prioritize management of the patients. And so they're happy to have a connection made and a referral relationship developed that puts them in a position where they feel like their patients are going to be taken care of. Remember, these are patients that have multi year relationships with their clinicians as they proceed through medication management and their disease progression. So to have a relationship developed where they can have somebody hand it off and make sure they can get them back and then we can do the training and the support around programming those patients, that's a third segment that exists and really works out quite well. And so I think we had maybe thought going into it it'd be a little more homogeneous than that. But those have been some learnings I think. Maybe not a negative. I guess maybe I'd characterize it a little bit as a negative. There's just, there's a lot of awareness building and development to do. And so on the one hand that's work that needs to be done and is a little bit of a air quotes negative surprise and you can't assume that people are aware of things. On the other hand, we found it to be just a great opportunity and to be able to get out in the community the way we are now on an increasing basis and be able to make people aware of and understand recent developments in and the data associated with as well as referral opportunities for again all associated with learning and why. I think overall to your point on big picture, from a big picture perspective, staging things the way that we have, where we got the PMA supplement to permit expansion beyond Level 4 centers with the focal indication and doing that work has allowed us to learn about that dynamic and the referral population even more. And then we think that will skate rather nicely into here the work that we're doing for indication expansion with IGE and beyond a little bit of a long way around, but hopefully that that answers your question.
Frank Kakinen
No, that's perfect. Comprehensive. Thank you very much.
Joel Becker (Chief Executive Officer)
Thank you, Frank.
OPERATOR
And our next question comes from the line of Anthony Petrome with Mizuho. Your line is open.
Anthony Petrome
Thanks for fitting us in here and congrats on the progress so far in 26. Maybe just come back to two reimbursement questions. One on the new APC mapping for vagus nerve stimulators. There it was a shift for new patient implants, APC 1580, that was a 48% increase for the category. And then end of service shifted from level four to level five and that was also roughly a 47, 48% uplift. So it just seems like from the Medicare level on an outpatient basis, there's receptivity to good healthy levels of reimbursement for epilepsy. So is there any kind of read through from what we've seen in vagus nerve, you know, kind of transferred over to the RNS system once we get there for generalized and then I think, I believe there's no wiser program exposure here. But just to confirm that that the RNS system is not seeing any kind of prior authorization impact in those six states from the WISA program. Thanks.
Joel Becker (Chief Executive Officer)
Thank you, Anthony. And I'll start here and then Patrick can help me. The first point is with regard to end of service and moving from four to five, we had the same improvement in what I mentioned earlier with regard to the replacement cycle and the OPPs increase in reimbursement. So that's absolutely the case. And I agree with your comments 100% that when we saw those increases in reimbursement we were encouraged not only because of the effect on RNS replacement reimbursement obviously, but that overall and generally the reimbursing bodies are seeing the value associated with neuromodulation and are open to making sure that there's good access for hospitals and clinicians to be able to access the technology. So one, also fortified in an improvement in OPPs. Two, I share the view on it's good news when people are investing in neuromodulation broadly and three, there is no impact with regard to wiser for us and we're not included.
OPERATOR
And our next question comes from the line of Michael Pollark with Wolff Research. Your line is open.
Michael Pollark
Hey, good afternoon. On the topic of generalized with the fda, Joel, I'm curious. Just as you assess their interest in the data questions that you've received and answered, how much focus are how much focus have they placed on the primary endpoint in the Nautilus study, which did not meet significance versus all of the supplemental analysis. I'm just trying to envision, you know, in light of the kind of headline squish in the trial and all the constructive data underneath, how they may kind of are they wrestling with that, how they might conclude and what a label may or may not look like. Thank you.
Joel Becker (Chief Executive Officer)
Thanks, Mike. As you might imagine, and I won't speak on FDA's behalf, but I will give you my observations. My observations would be as you might expect. They're focused on the totality of the data. They're looking at all of it. The primary safety, which did meet, the primary efficacy as you mentioned, which didn't, and the pre Specified secondaries. The that again we think are particularly impactful and clinically relevant. And so I would say that they're taking a comprehensive and appropriate view of the totality of the evidence. With regard to label, it's our interest to pursue a label that is aligned with the study population and the inclusion exclusion criteria in the study. And that's really been our approach.
Michael Pollark
I appreciate that Joel, thank you. I have one other reimbursement question. Conviction in this question is not sky high, but I believe the RNS first time implant is on the so called inpatient only list maintained by Medicare. And I think over the years to come it may come off and could trigger the creation of the level 6 outpatient APC. Now it may be most of if not all the cases would still be inpatient but by virtue of Medicare cleaning up this inpatient only list and you know you would have, they would have to provide a pathway for the RNS system and some other devices in the outpatient setting and given the cost of the cases a lot higher that that would necessitate and maybe pull forward and finally make come to fruition this level 6 creation. I'm sorry for the long winded ramp, but it's a very, you know, it's been a topic in Neurostin that's been discussed for a while and I'm curious you agree or disagree strongly with anything I just said there. Thank you
Joel Becker (Chief Executive Officer)
Mike. What I would tell you, and there are a lot of moving parts there associated with that is that we have been very engaged with regard to virtually all aspects of reimbursement from inpatient to outpatient to physician reimbursement, the move from 4 to 5, the maintenance of the DRG categorization, change from the proposed rule to the final rule, the improvement in CPT rates, you know, really across all fronts. We've been both pleased with and highly engaged from a reimbursement perspective. I think at this point to talk further about going from five to to six and kind of the secondary dependency for what may or may not happen with the inpatient is a couple of degrees removed from where I feel like I could credibly comment. I would leave you with. We're very engaged in, you can see from the results associated with and are highly involved with reimbursement across all fronts. And again back to the question that was asked earlier. I think it's encouraging for us to see the payers signaling a general openness to recognizing the value both clinically as well as economically. So I can't answer the five to six potentialities specifically given where we sit today. But I like where general trends are headed from a reimbursement perspective around neuromodulation.
Patrick Williams (Chief Financial Officer)
Yeah. And I would just add, because this is a, you know, appreciate the question, but I want to be crystal clear with everyone. We feel very good about the reimbursement that we advocated for our patients through 25 that came into effect in 26. We feel good about the pricing that we have as we move forward. And as Joel said, we continue to see the payers advocate on behalf of these patients that need this intervention in order to get their lives back and have some life changing outcomes. And so we're not in the game of speculation, but rest assured we are doing everything we can, including advocacy at the Hill Society, advocacy, et cetera. And so this will not be a headwind for us in our minds, we will continue to advocate on behalf of patients on the reimbursement side.
Michael Pollark
Helpful color. Thank you both. Thanks.
Joel Becker (Chief Executive Officer)
Thanks Mike.
OPERATOR
And our final question comes from the line of Yee Chen with H.C. wainwright. Your line is open.
Kayte
Hi, this is Kayte on for yi. Just real quick to wrap us up. Could you give us an idea of how many implants were replacements versus new implants this quarter? Do you think that's kind of a typical mix of what we should expect going through the rest of 2026?
Joel Becker (Chief Executive Officer)
We asked Patrick to comment here, but we did see an increase in replacements. It's still a small number, but we did see a mild increase in replacements. You know, again, remember the RNS 320s have got a nominal battery life of 11 years. And so we should be right at the kind of the front edge here of that replacement cycle, but still not seeing meaningful volume in the, in the last quarter. Would you.
Patrick Williams (Chief Financial Officer)
Yeah, I agree. And what we talked about historically, we've said we're less than 5% of our revenue is replacement over time. At this point, a little less than 10% as well on the unit side. And that's because when we do a replacement, we don't have to replace the leads, we just replace the 320 device. So there's less of an ASP that we incur the account. So I think the point here for everyone is that we're excited about the replacement revenue that will become a bit of a recurring revenue stream as we go forward. But we're in the very early stages of that. But it'll become more meaningful as we move throughout this year and certainly as we get into 27, 28 and beyond.
OPERATOR
And ladies and gentlemen, that is all the time we have for questions today. I will now turn the conference back over to Mr. Joel Becker for closing remarks.
Joel Becker (Chief Executive Officer)
Thank you. Thank you all for your time and attention today. 2026 is a year with transformational potential for NeuroPace, and we are well on our way to executing on this potential while building on the momentum in our current business. We look forward to keeping you up to date throughout the year as we continue to execute our strategy and progress toward these significant opportunities. And thanks again for your interest in and support in NeuroPace.
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