CVRx, Inc.

Please stand by, your program is about to begin. If you need assistance during your conference today, please press star zero. Good day, everyone, and welcome to today's CVRX Q1 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Mike Vallee from ICR Healthcare. Please go ahead.

Good afternoon.

Thank you for joining us today for CBRX's first quarter 2025 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Kevin Hikes, and chief financial officer, Jared O'Shine. The remarks today will contain foreign-looking statements, including statements about financial guidance. These statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings. I would now like to turn the call over to CBRX's President and Chief Executive Officer, Kevin Hikes.

Thanks, Mike. Good afternoon, and thank you for joining us for our first quarter earnings call. Revenue in the quarter was $12.3 million, representing 15% growth over the prior year quarter, consistent with the preliminary results shared in early April. While we continue to make significant progress in driving Barrow-Stim to become the standard of care for heart failure, our revenue performance fell short of expectations due to two factors. The first and primary factor was our Salesforce realignment. Following the change in sales leadership in mid-2024, our new Chief Revenue Officer utilized the back half of the year to evaluate the team and the company's commercial effectiveness, concluding that we needed to strengthen our sales team. Ultimately, the depth of these necessary changes was more significant than initially anticipated and resulted in 25% of our current territory managers being hired between December and March. As with any organizational transition of this magnitude, the productivity ramp for new hires will vary significantly depending on the sales rep's background and experience, as well as whether the new hire is entering a new territory or an existing territory with established accounts. These transitions can also cause disruption at the account level, especially in dabbler accounts that have a high degree of relationship dependence, an impact that was more difficult to manage in Q1 than was anticipated. We're thrilled with the quality of the talent that we've been able to attract and we expect to see productivity improvement and account stabilization throughout the year as these representatives gain traction and experience. The second factor impacting the quarter was seasonality. In each of the last three years, our first quarter was impacted by exogenous factors, including COVID, material clinical data releases, and management changes, which masked a typical medical device seasonal trend. This year, we observed this seasonal pattern, where the first quarter typically represents the lowest quarter of the year. Even though a barostim implant isn't something that can be pushed out indefinitely, we now believe that patients and customers are actively scheduling procedures around insurance coverage and deductibles. Moving forward, we expect to see this seasonality, which is similar to other medical device companies, where Q1 takes a step down from the prior year's fourth quarter. Despite these headwinds, we continue to be very encouraged by what we hear from customers on a near-daily basis. We remain confident that barostim is a remarkable therapy with a large market opportunity and that has the potential to significantly improve the lives of heart failure patients and create significant long-term value. As a reminder, for 2025, we're executing on three key strategic priorities. We're continuing to build a world-class sales organization focused on developing sustainable Barrel Sim programs with deep therapy adoption. This includes recruiting sales representatives with strong therapy development backgrounds, strengthening our training and onboarding programs, and aligning our incentives to support program-oriented sales processes. We introduced a new compensation plan in late January that aligns with our program-focused selling approach. and that has generated strong enthusiasm and driven positive behavior change among our sales team. Second, we are targeting centers with the highest potential to develop sustainable barostem programs. We plan to systematically replicate the elements present in current barostem centers that have achieved the deepest levels of adoption. Specifically, we're targeting centers that demonstrate three key characteristics, large heart failure patient volumes, proven adoption of novel heart failure diagnostic devices, and a track record of successfully leveraging new cardiovascular therapies to strengthen their cardiovascular service offering. In these centers, we will collaborate with the clinical champions and administrative leaders who understand the potential positive impact of barostem therapy and will work with them to build a network of committed advanced practice providers, or APPs, and community-based referrers, as well as heart failure specialists. We've already seen an increase in the number of centers qualifying as sustainable barostim programs in Q1. Third, we will continue to address the fundamental barriers to adoption by improving patient access to the therapy, increasing education and awareness among physicians, APPs, and patients, and developing a more robust portfolio of clinical evidence. On the reimbursement front, we've continued our work with a coalition of companies focused on appropriate payment for technologies like barostim, Specifically, we requested that CMS create a Level 6 Neurostimulator APC within the Outpatient Prospective Payment System or OPPS. The proposed OPPS rule is now in review with the Office of Management and Budget and is expected to be released in July. Analysis of the current CMS data used for rulemaking demonstrates continued and growing rationale to support our request. We believe that given the data and procedure volumes, CMS will either propose the creation of a Level 6 neurostimulator APC or will have the technologies remain in the NewTek APC 1580 for 2026, which would allow for continued appropriate reimbursement of approximately $45,000 for barostim in the outpatient setting. Also, in connection with our expected transition from a Category 3 to a Category 1 code in January of 2026, We are awaiting the proposed Medicare physician fee schedule that will include the Category 1 numeric codes, descriptors, and proposed physician payment. We expect to see both of these proposed rules in early July. As it relates to site of service, we've continued to see an increase in the percentage of procedures being performed in an inpatient setting based on our internal reporting. As it relates to awareness, we had a presence at three major conferences during the quarter, THT, ISHLT, and the American College of Cardiology, where CVRx sponsored well-attended educational and awareness events. The company also sponsored the creation and distribution of a barostim infographic by the ACC that went to approximately 50,000 cardiologists and APPs. As part of our previously discussed strategic plan, we've significantly increased our educational and outreach efforts focused on APPs who manage the bulk of heart failure patients in the community on a daily basis and were encouraged by their engagement and interest in the therapy. Turning to our efforts to generate additional clinical evidence, we are particularly excited to highlight the data presented as a late breaker at the THT meeting in February and published simultaneously in the Journal of Cardiac Failure. This analysis was based upon data from the Premier Healthcare Database, a large all-payer database including more than 1,300 institutions. It demonstrated large and statistically significant reductions in hospital visits and length of stay in patients after barostem implantation. The analysis showed an 85% reduction in heart failure hospital visits, an 84% reduction in cardiovascular hospital visits, and an 86% reduction in all-cause hospital visits in patients following implantation. These compelling results add to our growing body of evidence, supporting the clinical and economic benefits of barostem therapy. Our increasingly robust evidence base and recent compelling real-world morbidity results have been well-received by physicians and payers. This positive reception has encouraged us to further advance our clinical evidence strategy. Based on a year-long effort that started when Dr. Phil Adamson joined CVRx as our chief medical officer in May of 2024, We've identified a number of areas for further evidence development. One such area involves a pragmatic randomized control trial design that would include patients with an ejection fraction of up to 50% and an NT-PRO BNP of up to 5,000 through a category B IDE. As part of our ongoing discussions with FDA and CMS, we intend to request that CMS cover the cost of the procedures involved in the trial should we move forward. In order to determine CMS coverage eligibility, it will be necessary to submit the proposed trial design to clintrials.gov, which we expect to do in the second quarter. We will then await their decision and would only proceed if CMS agrees to cover these costs. As currently contemplated, this trial would enroll between 1,000 and 2,000 patients at 100 to 150 centers. We believe that this trial could create significant long-term value for CVRx. allowing us to not only significantly expand our total addressable market, but to also obtain more data about the benefits of barostem therapy in our currently indicated HF-REF population. Our preliminary estimates suggest that the net costs of this trial would be approximately $20 to $25 million spread over five to seven years, with the annual cost peaking in 2029 or 2030. We will share more details about our plans for this potential trial in the future as we gain clarity around CMS coverage. In summary, we remain confident in our strategy and the fundamental strength of our business. We have a clear path forward with our strategic priorities, a talented and increasingly experienced sales force, and compelling clinical evidence demonstrating the value of barostim, including significant reductions in hospitalizations. As our newer sales representatives gain traction in their territories and with continued execution of our program-focused selling strategy, we expect to see a return to higher growth. Now I'd like to turn the call over to Jared for a financial review.

Thanks, Kevin. In the first quarter of 2025, total revenue was $12.3 million for the three months ended March 31, 2025, an increase of $1.6 million, or 15%, over the three months ended March 31, 2024. Revenue generated in the U.S. was $11.2 million for the three months ended March 31, 2025, an increase of $1.4 million, or 14%, over the three months ended March 31, 2024. Heart failure revenue in the U.S. totaled $11.1 million and $9.7 million for the three months ended March 31st, 2025 and 2024, respectively. Heart failure revenue units in the U.S. totaled $353 million and $319 million for the three months ended March 31st, 2025 and 2024, respectively. The increases were primarily driven by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of barostem. As of March 31, 2025, the company had a total of 227 active implanting centers in the U.S. as compared to 223 as of December 31, 2024. Active implanting centers are customers that have completed at least one commercial heart failure implant in the last 12 months. The number of sales territories in the U.S. decreased by three to a total of 45 during the three months ended March 31, 2025. Revenue generated in Europe was $1.1 million for the three months ended March 31, 2025, an increase of $200,000 or 23% over the three months ended March 31, 2024. Total revenue units in Europe increased to 59 for the three months ended March 31, 2025, from 44 in the prior year period. The number of sales territories in Europe remained consistent at 5 for the three months ended March 31, 2025. Gross profit was $10.3 million for the three months ended March 31, 2025, an increase of $1.2 million, or 13%, over the three months ended March 31, 2024. Gross margin was 84% and 85% for the three months ended March 31, 2025 and March 31, 2024, respectively. R&D expenses decreased $500,000, or 18%, to $2.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This change was driven by a $0.4 million decrease in consulting expenses and a $0.1 million decrease in non-cash stock-based compensation expense. SG&A expenses decreased $7.1 million, or 25%, to $21.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This change was primarily driven by an $8.6 million decrease in non-cash stock-based compensation expense, partially offset by a $1.6 million increase in compensation expense, mainly as a result of increased headcount. Approximately $8.4 million of the non-cash stock-based compensation expense for the three months ended March 31, 2024, was related to the previously disclosed modification of stock options held by the former Chief Executive Officer in connection with his retirement in the first quarter of 2024. Interest expense increased $0.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, driven by the increased borrowings under the company's term loan agreement. Other income net increased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was primarily driven by increased interest income on our interest-bearing accounts. Net loss was $13.8 million, or 53 cents per share, for the three months ended March 31, 2025, compared to a net loss of $22.2 million, or $1.04 per share, for the three months ended March 31, 2024. Net loss per share was based on 25.9 million weighted average shares outstanding for the three months ended March 31, 2025, and 21.2 million weighted average shares outstanding for the three months ended March 31, 2024. As of March 31, 2025, cash and cash equivalents were $102.7 million. Net cash used in operating and investing activities was $12.9 million for the three months ended March 31, 2025, as compared to $11.8 million for the three months ended March 31, 2024. For the three months ended March 31, 2025, the company issued 543,462 shares of common stock for the gross proceeds of $6.7 million under its at-the-market offerings. Now turning to guidance. For the full year of 2025, we now expect total revenue between $55 million and $58 million. We continue to expect full year gross margin between 83% and 84%, and we now expect operating expenses between $95 million and $98 million. For the second quarter of 2025, we expect to report total revenue between $13 million and $14 million. I would now like to turn the call back over to Kevin.

Thank you, Jared. Before we open the line for questions, I'd like to share our outlook for the remainder of 2025. Despite the disappointing revenue performance in the first quarter, we remain optimistic about our long-term prospects. While there is a significant amount of macroeconomic uncertainty at the moment, we do not expect these trends to materially impact our business. Our exposure to the negative impact of tariffs and changing trade policy is low. We are not exposed to NIH funding cuts and we are thankfully not experiencing significant changes in our working relationships with FDA or CMS. While the realignment and strengthening of our sales force has created some short-term headwinds, we're already seeing positive signs that validate our approach. We believe our focus on attracting high-quality sales representatives with strong therapy development backgrounds will pay dividends as these representatives move through their productivity curves and gain more experience in their territories. Our strategy to focus on driving deep penetration within high-volume accounts is showing encouraging preliminary results at the account level. These centers have the patient volumes, infrastructure, and clinical expertise necessary to develop sustainable Barriston programs. We're entering the remainder of 2025 with several key advantages, improving reimbursement landscape and momentum, increasing patient and physician awareness, and a growing body of compelling clinical evidence that demonstrates both the clinical and economic benefits of barostim therapy. The recent real-world evidence showing an 85% reduction in heart failure hospitalizations is particularly compelling to both clinicians and hospital administrators who are focused on reducing readmissions and improving outcomes. As we continue to execute on our three strategic priorities throughout 2025, We believe these focused efforts will drive increased adoption of BarroStim and help us fulfill our mission of improving the lives of patients suffering from heart failure. Now, I'd like to open the line for questions. Operator?

At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. We will pause for a moment to allow questions to queue. We'll go first to Macaulay Kilbane with William Blair. Your line is open. Please go ahead.

Hi, everyone. This is Macaulay. I'm for Margaret tonight. Thanks for taking our questions. I appreciate some of the commentary around the Salesforce during the quarter, but was wondering if we could get a bit more detail on how much of that was self-inflicted versus natural turnover. Was any of that a result of the new compensation plan that was implemented during the quarter? And you mentioned a significant number of new hires, Kevin, I guess. Is there more hiring to be done or have you recovered all of those territory managers already?

Yeah, thanks, Mac. I appreciate the question. Yeah, in short, the vast majority of these changes were initiated by the company. This was a result of our chief revenue officer joining us last July and taking two quarters during which turnover returned to normal levels. but over the course of those two quarters, really taking a look at our current organization, the selling challenges we faced, and the long-term skills and experience we needed in that organization to be successful. We initiated that wave of changes late in December and into January, and ultimately, as you heard me mention, ended up with a more substantive set of changes than we'd anticipated by the end of Q1. It had nothing to do with the comp plan, and in fact, The comp plan now is a true strength of this organization and sales culture and has allowed us to attract extremely strong talent as backfills for these roles that we made changes in. I guess the last point I'd make is while we're not entirely through that process, we would expect turnover to return to more typical levels within the next few quarters.

Okay, that's really helpful. And then maybe just as a follow-up, Jared, in terms of the guidance, appreciate the update to the full year in Q2 here. But, you know, looking at that 2025 guidance now, I guess what does that imply in terms of the factors between, you know, new center ads, is that high single to low double digits still the right number, as well as just overall utilization as we move through? hopefully start to get more productive. Thanks for taking the questions.

Yeah, thanks, Mac. Yeah, so, I mean, as we look to update guidance, you know, obviously, Kevin mentioned, we made some pretty significant changes within the sales organization, and it was a bit more than what we had anticipated would be necessary going into the year. At the end of the day, we're really playing the long game here, right? We want to get the right people on the bus, And we're really thrilled with the quality of the new sales hires that we've been making, but it's going to take some time for them to get fully productive. So, as we adjusted the annual guidance, we looked at, you know, the results for Q1 and are really setting that as our new baseline from which we're planning to grow from there. So, as we move forward into Q2 with the guide of 13 to 14 million dollars, and then, you know, for the full year guide of 55 to 58, It is continuing to expect on average, we'd see new center ads in high single digits, low double digits, but it's going to be a wide range, right? We're still sunsetting some of the old accounts that were more relationship driven and spending a little bit less time there and really spending more time at those centers. that have the ability to drive deep penetration, deep adoption at those centers where this therapy can become standard of care. So for the centers, I think high single digits, low double digits. As far as territories go, I think we're continuing to add to the bench. We've already rebuilt a good portion of that already to where we believe we can get back on track to adding around three territories per quarter as we go throughout 2025. And then the revenue units per center, I think the expectation is that we will continue to see that number tick up. But part of that is really dependent upon how many of the centers we are able to sunset over the next couple of quarters, the less productive ones, because that will have a direct impact on what that utilization number will come out each quarter.

Really helpful. Thanks again. Thanks.

We'll go next to Frank Tekinen with Lake Street Capital Markets. Your line is open.

Great. Hey, guys. This is Nelson Cox on for Frank. Thanks for taking the questions. I guess first I want to start with kind of following up a little bit. How much of the – help us parse out a bit more how much of the softness in the quarter was related to typical seasonality versus challenges on the rep side? I heard you say it was related primarily to a slower rep ramp, but any other additional color you can provide there to help us think about the impact of these separately?

Sure. Thanks, Nelson.

I'll take that. I think the vast majority of the softness that we saw was related to the disruption in the sales team. It was not likely a seasonality impact that played a role for sure, but it was really the fact that we had to to make a more deep set of changes than we had anticipated, even in January. And the fact, probably secondarily, we assumed, I assumed that we could maintain territory and account level performance despite the changes that we were making. And that turned out to be much more difficult than we expected. In part, because in some territories, there were a lot of these dabbler accounts who are difficult to predict and who are often, They've adopted the therapy because of relationships. They're more vulnerable to turnover because a lot of their engagement was due to a particular relationship. And so in those cases especially, even putting a relatively experienced bench TM into that territory or bringing in a very experienced new hire and putting them directly into that territory, that was not enough to sustain momentum through the quarter. And what we saw, interestingly, or perhaps not surprisingly, was that in the group of accounts that had a TM turnover, they were half as likely to have increased their business in Q1 versus Q4, and twice as likely to decrease their business in Q1 as they had in Q4. And so, obviously, we changed a lot. We changed in more places than we thought we would, and that was really the driver of the miss.

Got it.

Okay, that's helpful. And then, I think it might be helpful to understand the current mix of the rep tenure today a bit more. You know, if I heard you correctly, the comment was 25% of territory managers were hired between December and March. Any other color you can provide just on the remainder of the sales team in the tenure there?

Hi, Nelson. Yeah, happy to cover a bit more on the tenure. So as Kevin mentioned in the prepared remarks, About 25% of the current territory managers were hired from December to March. Another 25% were hired in the earlier months of 2024. And so you have about 50% of the total territory managers on staff today that were hired in the last 15 months. The other 50% are the folks that are in the more tenured bucket, have been here for at least the 15 months, sometimes multiple years. and are obviously the most productive of the people on the team at this stage.

Got it. Okay. Thanks, guys. I'll hop back in the queue.

We'll go next to Chase Knickerbocker with Craig Hallam. Your line is open.

Good afternoon. Thanks for taking the questions. Kevin, I want to get kind of granular here, if we can, just so you make sure we kind of understand all the specific moving pieces. So if we look at it at like the rep specific and kind of their account specific level, um, when, when, when rep turned over, um, is it mainly that most of some of their accounts, um, decreased their utilization or did they, you know, stop, um, you know, giving barostim as a treatment, um, altogether? Was it a mix? Just kind of, a little bit more specific on kind of what we saw at that granular level.

Sure. Thanks, Chase. I would say I don't know of a single instance where an account completely abandoned the therapy. The numbers we have would suggest that the utilization was down or stalled. In accounts that are only doing a few a year, if they miss an implant or they're not as productive as they typically are, then you really feel it. But we do not have a sense that we lost accounts because of the turnover. We just believe it was a decrease in productivity.

So, if we kind of look at these dabbler accounts, right, I mean, is there anything else we can do from a, you know, call it a medical education perspective to kind of have the, you know, device have a little bit more traction where, you know, the, you know, you can you can kind of lead with some additional clinical evidence that you've generated recently. I mean, is there any kind of thought there as to why these dabbler accounts kind of stay dabbler accounts after having some experience with the device?

Yeah, so I think you have to look back to a typical behavior in the early stage of a therapy like ours. And this is very typical, but you often start centers anywhere and everywhere that you can. And you do not necessarily have yet enough knowledge to identify tiers 1, 2, 3, 4 like we have now. So there are a lot of accounts who may have initiated barostem therapy with a single champion and without any of the elements around them that we know make for deep adoption. And that single champion may have continued to try to support our therapy on their own, perhaps because of a relationship with one of our team members. And that describes a fair number of those accounts. Those are the accounts on some level, if they don't happen to fit our tiered approach, if we don't think they have long-term potential, some of those accounts we're going to allow to just sunset because we're not sure the opportunity cost of supporting those dabblers is worth it. And There are other dabblers, however, that in fact are potentially Tier 1 centers that haven't been developed the right way because we didn't yet have the playbook or the recipe that helped us understand how to develop a productive, deeply adopting center. So in the case of those dabblers, we are approaching them with a full court press, and we are going back to them now with the knowledge we have on what works and how you build a sustainable program and how important the network around that initial champion is. we're reengaging them with the hope that we can make them much more productive than they have been. So sort of a tale of two cities to some degree.

No, that makes a lot of sense. Thank you for that. That does clear some things up. And then just as far as kind of what we're looking for with the right kind of rep profile, I mean, maybe just kind of what your head of sales saw in the reps that did need to be turned over and, you know, exactly, you know, who he's putting in that seat and, from a standpoint of kind of quality.

Yeah, so that's another good question. You know, and again, I think not specific to CBRX, but in general, in the early stages of these therapy development efforts or any new medical technology, you need reps who have relationships, who can get themselves in the door with a brand new therapy that may not yet be fully understood or appreciated or reimbursed, right? So it's a certain sort of profile that's very necessary in those early stages. We've moved beyond that stage, and we now know that what we need are our sales reps that understand how to introduce novel therapies. That's a very different process than a relationship cell or a slightly better peripheral vascular catheter, for example. We need reps that understand how you build a coalition of physicians and administrators in an account, how you deal with reimbursement and coding and billing complexity, how you grow awareness in a community around an account. That's a different set of skills. So increasingly, the folks we are now recruiting and attracting to the venture have that program or therapy development experience. Many of them also have cardiovascular experience and bring some level of relationships to our company. But even so, they need to understand and learn our business. And that's why even a really good new hire with a cardiovascular background and perhaps relationships on the ground, they don't understand our therapy or our technology or our clinical data or our reimbursement well enough to be productive in the first six or even nine months. So even those really strong hires who will ultimately be very productive take a similar amount of time to sort of get to understand what's happening in their territory, refresh relationships, and understand how to best support our particular therapy.

Got it. And just as we kind of model sales territories, has turnover, you know, normalized already at this point? Are we still turning over some territories? Or should we be kind of modeling from here kind of three territories per quarter?

Yeah, I think you should begin modeling three territories per quarter. There is still some level of change that I would anticipate, but we're through the bulk of it. Again, we had to go deeper than we expected, but a lot of that has played out, and we think that the turnover levels will return to normal over the next few quarters.

Got it. Thank you, guys.

Our last question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is open.

Ross Osborne, your line is open. Please go ahead. Hi. Can you guys hear me? We can.

Oh, great. I guess starting off, as you work to deepen utilization in existing centers, Are there specific K types or patient segments where barostem adoption has started to show good signs of penetration?

No, that's a good question. I would say no. We are, the data we have generated in support of the therapy is undifferentiated. If you meet the indication, you can expect a 94% responder rate and a 97% freedom from complication. There are certainly differences in some centers. where depending on physician conservatism, they may wait longer to prescribe barostim and try harder to make the medicines work. In other cases, physicians that understand, there's actually a very interesting consensus statement published late last year by the Heart Failure Society of America that for the first time put a time domain around when you should give up on medical therapy and consider an implantable device like barostim. And they said, if after three to six months a patient is still symptomatic on guideline-directed medical therapy, it's time to consider an intermediate heart failure device like barostim. So, you know, there's some difference there in terms of conservatism and the degree of patient, you know, titration on meds, but really no difference in the type of patient themselves. It's more the type of physician, frankly. Okay.

Got it. That's super helpful color. And then just one more from me on a potential RCT. Would you just remind us of what the near-term timelines would look like for that? And then can you just remind us about the expected patient enrollment numbers as well as centers? Thank you.

Sure. Yep.

So as I mentioned, it's sort of a two-part process. Part one and we're materially engaged in part one, is the discussion with FDA around a potential protocol, a trial design, and the populations that we would include. And so we are meaningfully involved in that process. We hope that we would reach an agreement, if we can, in the next month or two, and that we would then have a trial design that we could take to CMS. Part two of the process is petitioning CMS to reimburse patients reverse hospitals for the procedures that are done on patients as part of the trial. And you can't do the second without the first. So we're talking about it today, even though we haven't yet committed to running the trial. If, in fact, we have FDA approval in the next few months, we will post that document on clinicaltrials.gov so that we can then engage CMS. And we didn't want to surprise the investor community with that information out of the blue in advance of our next earnings call. So that's sort of the process. We'd expect an answer from CMS and the ability to make a decision on moving forward later this calendar year. What we did communicate was the size of this trial, given the populations of interest and, frankly, the statistical plan necessary to deliver a successful trial, we'd expect it to be north of 1,000 patients, maybe as many as 2,000 patients. And to enroll that many patients, you need to engage 100 to 150 centers based on commonly seen enrollment rates. So, this will be a sizable trial. It will be a landmark trial in many instances. We think it demonstrates our continued commitment to developing evidence to support this therapy, to leading the adoption of devices in this forgotten middle population. And it'll be a great way for us to raise our profile and engage centers that up until now may not have yet had experience with Barrelston therapy. But again, we need to get through both part one and part two before we make that decision and decide to move forward.

Yep, understood. Thanks for taking the questions, guys. Thank you.

This does conclude today's question and answer session. I will now turn the program back over to Kevin Hikes for closing remarks.

Thank you, Operator. Thanks again to everyone for joining us for our first quarter earnings call today. We appreciate your ongoing support, and we look forward to updating you on our progress at our next update. Thank you.

This does conclude today's program. Thank you for your participation. You may disconnect at any time.