Afternoon, everyone. I'm Robbie Marcus, the MedTech analyst at JPMorgan. Thanks for joining us today. Happy to present CVRx, our next presentation here. CEO Kevin Hykes will do some slides and presentation, followed by some Q&A. Kevin.
Thank you. Thank you, Robbie. Good afternoon. It's my pleasure to present to you today on behalf of CVRx. These are our forward-looking statements. Additional risk factors are available on our website. CVRx has developed the world's first autonomic neuromodulation therapy for the treatment of heart failure. We have a $10.5 billion prevalence-based market, a well-defined patient population, and a highly differentiated therapy, and we believe a plan that will allow us to move this therapy to standard of care for the treatment of heart failure.
Heart failure is a burdensome, life-limiting disease that affects nearly 6.7 million Americans, results in over a million hospital discharges each year, over a million emergency room visits, over eight million physician visits, and has costs that will reach almost $70 billion per year by the end of this decade. Heart failure is characterized by a progressive decline in quality of life and increasingly frequent hospitalizations.
When first diagnosed, heart failure patients are initiated on a combination of four drugs called quad therapy, today's guideline-directed class one treatment for heart failure. A limited number of those patients are also evaluated for a pacing therapy called CRT, or cardiac resynchronization therapy. It's a relatively small sliver that are eligible for that. The rest are not. At the end of their disease journey, patients, 2%, are evaluated for a left ventricular assist device or cardiac transplantation, but many are not eligible and move to hospice to finish their lives.
In the interim period, patients are left suffering with debilitating symptoms and significantly reduced quality of life. That's been the paradigm for the treatment of this disease for over 50 years. Pharmaceutical quad therapy has been shown to improve survival by one to six years when these drugs are taken compliantly and at optimal doses.
However, only 1% of patients ever reach optimal dosage on each of those four medications, and at the end of the first year, over 40% discontinue quad therapy. So while quad therapy, when taken compliantly, can extend life, it does very little for quality of life. This chart shows a meta-analysis of 18 studies comparing the impact of these four medications on exercise tolerance, which is a common surrogate for quality of life in this population. And as you can see, it shows a very modest impact, if at all, on the patient's ability to exercise.
So, the limitations of pharmacologic therapy leave the majority of patients suffering from significantly diminished quality of life, whether it's mobility problems, pain or discomfort, reduction in activity, and the ability to deal with the activities of daily living, or depression, mental health disorders.
Multiple studies in this population have demonstrated repeatedly that these patients would rather trade longevity for better quality of life. They don't want to live any longer. They want to live better. Barostim addresses this significant unmet need in the treatment continuum, and it's effectively addressing these patients in the purple window. These are the patients who the heart failure physicians themselves often refer to as the walking wounded or the forgotten middle. Those are the patients we're trying to help with our therapy, and that's the paradigm that we're trying to change.
That purple window represents a $10.5 billion TAM on a prevalence basis, and it's less than 1% penetrated today. We often describe Barostim therapy in terms of the incidence rates, and we describe a new diagnosis annual incidence of 76,000 patients, or about $2.4 billion.
We also think it's important to consider this therapy in terms of the prevalence that it addresses. Heart failure is a chronic disease state. Barostim patients are not only eligible for the therapy the year that they're diagnosed as entering our indication. They live for four or five or six years within that purple window and can be treated. So when considered on a prevalent basis, this is, in fact, 339,000 patients today who are indicated and could benefit, representing about $10.5 billion in market opportunity. So I'll share a little bit about how the therapy works and why.
Barostim targets the neurohormonal pathway, which is responsible, the proven underlying fundamental cause of heart failure. Heart failure begins with a weakened heart as a result of multiple differing insults, potential insults to the heart, ultimately reducing the cardiac output.
That reduced cardiac output results in reduced signaling from the body's natural stretch receptors, so those are called the baroreceptors. They're located at the bifurcation of the carotid artery in your neck, and they monitor each and every heartbeat for blood volume and pressure and send those signals to the brain. Effectively, it's the brain's sensor for the status of the cardiovascular system. When those sensors fire less, the brain interprets the reduced signaling as a crisis, either decompensation or a dehydration event or massive hemorrhage.
The body reacts to the crisis by activating the fight or flight response, so effectively, it jams on the accelerator, the sympathetic nervous system, and reduces the brake or the parasympathetic nervous system, and in doing so, it also activates the renin-angiotensin system and dumps powerful neurohormones into the bloodstream in an attempt to rescue the body from the perceived crisis.
This chronic exposure to these powerful neurohormones is what causes the progression of the disease. It's actually toxic to the heart and to the kidneys and to the vasculature. It causes the progression of the disease, and unfortunately, there is no automatic off signal. There's no switch that turns off the fight or flight response, short of restoring that signaling to the brain. So today's pharmacologic therapy, the level one guideline-directed medical therapy, is called neurohormonal blockade. So those four drugs effectively are trying to shield the end organs from the toxic effect of those neurohormones.
Barostim operates on that very same accepted pathway, but upstream, essentially restoring signaling to the brain, turning down that fight or flight response, turning down the storm that the drugs are trying to protect these end organs from.
So, it certainly doesn't replace those drugs, but it complements what they're doing already by reducing the level of circulating neurohormones. That's why Barostim works as well as it does. Heart failure has been described as metastatic heart disease. It affects not just the heart, but it's a systemic disease that affects the kidneys and the vasculature. And so, it requires a systemic solution. Barostim is a simple system, relatively speaking. It's comprised of a single carotid sinus lead and an implantable pulse generator, much like a pacemaker that has a five to six-year battery life.
It also has an external programmer that physicians use to optimize the therapy settings in the first eight to 10 weeks after implantation. Barostim is implanted in a 60-minute procedure with a 97% freedom from complications, which is remarkable.
It's implanted either on an inpatient or outpatient basis and requires a small incision in both the neck and the chest, and very importantly, it's extravascular, so there's no hardware or leads in the heart or in the vasculature, which leads to a very low complication rate, a very low infection rate. The BeAT-HF trial demonstrated at 24 months effective, predictable, and durable improvements in quality of life, showing a two-times clinically meaningful improvement in exercise capacity and quality of life.
68% of patients improved their New York Heart Association class functional status by at least one level, and a remarkable 94% of patients responded to the therapy on at least one clinical outcome. That's remarkable for medication or device therapy today. To put those improvements in exercise tolerance in context, you see a significant improvement with Barostim therapy on exercise tolerance as compared to those four guideline-directed medications.
A significant improvement in what patients can do with their lives, which describes what we see in real life as they restore their quality of life. The BeAT-HF trial also showed a positive signal in all-cause mortality, LVAD, and transplant, despite the confounding factors associated with COVID-19, which was underway at the time of the trial.
Recently published real-world evidence from the Premier Healthcare Database, one of the largest databases of real-world payer evidence data, and it represents about 1,300 hospitals in the United States, in 306 patients demonstrated a significant reduction in hospitalization before and after those patients received Barostim therapy. This was a highly statistically significant outcome. It's data that is of great interest to payers, as you can imagine, and it validated a number of single-center studies from the US and Europe that showed a very similar result.
We believe through real-world evidence, there are multiple such databases. We can fill in some of the gaps that resulted from the COVID-19 experience with the BeAT-HF trial. Turning to our commercial approach, our go-to-market strategy is focused on driving Barostim to standard of care through three key pillars. The first is improving salesforce productivity. The second is driving deep adoption in targeted centers. The third is systemically addressing the barriers to adoption of this therapy that exists in the market.
In the first case, our efforts to transform the salesforce over the last year are now largely complete. Our turnover rates have returned to near normal, and we're focusing now on onboarding and improving the productivity of our new salesforce. We're doing that through a number of ways.
The first is optimizing the span of control in the field so that our leaders in the field have the time and the bandwidth to mentor and train and improve the productivity of their new team members. The second is adding additional sales training personnel at the field level who can spend five days a week in the field riding with our teams and helping them understand the nature of the role and propagating best practices wherever possible.
We're also focusing our reps on a narrow set of opportunities, three to five accounts versus sometimes 10 to 15, where they can truly drive deep adoption and change behavior at the clinic level. This is supported by program-based selling tools and a process that is supported by our compensation system that encourages them to go deeper, not wider, in these accounts.
In terms of the second focus, driving deeper adoption, we are attempting to replicate the network of aligned stakeholders that we see in our most productive centers. And that involves, of course, a clinical champion, which is always necessary, but also includes a financial or administrative champion, a service line leader, or a hospital CFO that understands the profitability of this procedure and supports, effectively provides air cover to the team on the ground that's enrolling and treating patients.
At the prescriber level, it means not just one clinician that believes in the therapy, but two or three or four who are receiving referrals from the community and from a group of clinicians that surround the center who understand the value of the therapy. It also means having multiple surgeons available and trained to implant the system.
So where we see these networks, we see resiliency and redundancy, and we see deeper utilization and a lack. Sometimes you're exposed to career changes and retirements and physicians who go on sabbatical. If you've got a narrow network, that can shut a program down. So we attempt to build this sort of redundancy into these systems. And within that network, we're particularly focused on advanced practice providers who are the nurse practitioners and physician associates that are so critical to managing heart failure.
They play a key role in patient identification, referral, screening, and treatment, both in the community setting and in the advanced heart failure centers. They're highly focused as nurses on these patients' quality of life in a way that physicians cannot be given the time and the demands on their schedules. And they're seeking and are open to new therapies for these patients.
They're also very workflow-driven. They're algorithmic in their approach to treating disease. And so that's an important piece of how you establish a recurring cycle of treatment and deep adoption in a center. And perhaps most importantly, they see heart failure patients far more often and for much more time than the managing physician. A typical APP in a cardiology practice will see a heart failure patient every six weeks, often for 30 or 40 minutes, whereas the managing physician may see them only twice a year for 10 minutes.
So, this is really an important leverage point for us. So, aligning those stakeholders and connecting them with a workflow is the second piece of this puzzle. And workflow describes how a disease or therapy is distributed in a clinical setting.
It's a set of roles and responsibilities and work orders and processes that describe how a patient efficiently flows through a practice. In the community, this means referral physicians and clinicians and APPs understanding what a potential Barostim patient looks like and knowing who to refer that patient to at their advanced heart failure center. In the advanced heart failure center, it's clinicians who understand how to screen and evaluate and determine who the right patients truly are. Upon determining that, know who to refer that patient to for implantation.
Again, it's multiple surgeons who are trained and comfortable implanting these patients. The handoffs occur without friction at each point. The surgeons implant the device and send the patient back for optimization and ultimately back to the community to continue their life.
Where we see these aligned stakeholder networks and we have established deliberate specific workflow, we see deep adoption and positive outcomes. And those are the characteristics that drive this flywheel effect that we're trying to create at the account level that makes this part of how the disease is treated, not just an episodic thing that happens by chance or as a favor or because a patient triggers somebody's thinking of Barostim therapy.
That's really what we're trying to do here. Interestingly, even in the centers where we see that flywheel beginning to turn, if we look at the 20% of our centers who have the deepest adoption, that's 50 out of our 250 active centers, they're doing about 19 implants per year. That's about one and a half patients per month. That's helpful.
That's a bare minimum, we think, for developing this continued flywheel effect, but it leaves significant further potential in these centers. There's at least another 300 patients on average in those 52 centers who can benefit. So we believe there's a significant opportunity through deeper adoption to create a very sustainable, predictable, and valuable business. Third, we're addressing and continuing to focus on what we believe are the three primary barriers to the adoption of this therapy in the market. The first is awareness.
The second is evidence. And the third is patient access. So on the awareness front, we're continuing to focus on the physicians in the community that surround these centers. That's where most of our patients are being seen today.
In the last year, we did over 150 face-to-face local, regional, and national medical education events, helping clinicians understand what a Barostim patient looks like, who might benefit, and again, who they can refer these patients to that understand how to truly screen and refer patients for implant.
We've talked a lot about the APP, so that's a key piece of our work in the community as it is with our work in the specialty clinic, and we're spending significant time optimizing our direct-to-consumer advertising channels and our social media to connect interested patients in the community around these centers with the physicians who can evaluate them and refer them for the therapy. As it relates to evidence, you probably can never have enough evidence for a novel therapy like Barostim.
We're continuing to invest in what we see as an increasing drumbeat of publications, really in two key areas right now. The first is evidence of improved clinical outcomes in a number of secondary outcomes that we've not had the time or the energy to publish on to date. And those are things like arrhythmias, ejection fraction, kidney function, diuresis. There are physicians, each have different hot buttons, but some of them see some of those secondary clinical outcomes as important evidence of the therapy.
And so, we're spending time developing and publishing data on the therapy's impact on those outcomes. Secondarily, there's a focus on deeper understanding of the physiologic mechanisms that underlie the therapy. The mechanism itself is widely understood and accepted. Neurohormonal blockade and the neurohormonal progression of the disease is the accepted model for heart failure with reduced ejection fraction.
But some physicians, again, want to understand in a more granular sense why exactly the therapy works the way it does. What does it do to inflammatory markers? What does it do to left ventricular ejection fraction or left ventricular mass? So again, we have now the time and the resources to start to fill some of the gaps in our evidence portfolio in these two key areas. And we'll do that in multiple channels. Real-world evidence, as I've mentioned, the Premier database is one way to get at some of that evidence. Randomized controlled trials, like one I'll mention in a minute, is another approach.
But a lot of it comes from investigator-initiated research at the center level. So single and multi-center studies, sometimes sponsored by CVRx, sometimes done completely independently. But that's really where we start to see an increasing level of publication and visibility for the therapy.
We're pleased to now start to see an example of four recent publications from single or multi-center trials looking at some of these very endpoints that are of interest to us. As I mentioned, and as was announced in our press release Monday, we received FDA approval, IDE approval for the BENEFIT-HF trial, which will be potentially a landmark randomized controlled trial in heart failure, arguably the largest device trial ever done in the field of heart failure.
This trial will seek to expand our indication from an EF cutoff of 35% to 50% and expand the NT-Pro requirement from the current threshold of 1,600 up to 5,000. That's a marker in the blood that describes the stability of a patient's heart failure. The trial will enroll 2,500 patients in approximately 150 centers in the United States and Germany.
The primary endpoint is all-cause mortality and heart failure decompensation, the hard endpoints as they're described, and we'll follow patients for two years. We believe enrollment, if approved, will begin later this year and will continue through 2030, so on the basis of the FDA approval, we've applied to CMS for what's called Category B coverage, which is a necessary condition for us to proceed with the trial. Category B coverage means that CMS will pay for the procedure and the device used in this trial.
With that coverage, we can expect the net trial cost to be between $20 million and $30 million dollars, and they will be spread over five to seven years, likely back-end loaded as is often the case with trials like this.
If successful, the BENEFIT-HF trial will expand the market opportunity from the 339 patients on a prevalence basis to over 980,000 patients on a prevalence basis, so tripling our TAM from $10 billion to over $30 billion, so a pretty significant impact on our opportunity.
What's important to note is that these patients, the patients with the higher EF above 35 and the higher NT-Pro above 1,600, are being seen every single day in the same clinics we call on by the same physicians and nurse practitioners, and the reason this trial became so compelling to us is those clinicians tell us over and over again, "I see many more patients who can benefit than I'm allowed to treat by the payers. You need to get approval to treat these patients above 35 and above 1,600 because they will benefit.
They have the same disease as the current indicated population and will benefit in the same fashion." So from a synergistic standpoint, these are highly adjacent populations that do not require us to deploy a new sales channel or a different set of evidence. We can build on the foundation that we're already developing to support the current indication to further penetrate these expanded populations. So we're very excited about this. We would anticipate hearing from CMS in the next month. We believe that there's a good chance they will, in fact, approve this trial.
And we're excited to announce in the near future the first enrollments in this trial. So the third barrier is patient access, one of the most vexing for any new therapy. We've made remarkable progress in the last year, most recently with the implementation of our Category I codes, which occurred on January 1st of this year.
The implementation of Category I means we move out of Category III experimental status, and the payers lose the ability to automatically deny prior authorizations for our therapy. It also formalizes and makes certain the physician payment for this therapy, so physicians have had in the past, as a Category III, the surgeons have had to negotiate their payment for doing the surgery.
And in some cases, they negotiate a payment. They have an agreement from a payer, but the payer later refuses to pay, so there has been an impact to some degree on adoption. That now goes away as of 1 January 2026. Physicians, on average, will get 11 RVUs or about $560 to do this 40-minute procedure.
And for them, that's a very attractive, predictable procedure relative to the other things they do in their day. So that's a really important transition for us. It is early in that process, but we're already starting to hear some very interesting anecdotes. And what this does is it allows us to engage at the account level much more confidently. And it gives physicians confidence that the patients they prescribe for this therapy will actually get it covered or will be more likely to get it covered by their payer. That's important.
On the payment front, we have formalized and finalized inpatient reimbursement to the hospitals of $45,000. We have, for the third year in a row, successfully defended the $43,000 outpatient payment for this therapy. We are already working with our coalition partners to petition CMS for 2027 to create a permanent Level 6 neurostimulator code.
So that work is already underway, and we believe we will eventually be successful. Finally, on the coverage front, we're seeing very encouraging results. We're seeing a greater and greater number of hospitals and health systems partnering with us and allowing us to fight the reimbursement fight on their behalf. So submit the prior authorizations, appeal the denials, and push those submissions all the way to administrative law judge review when necessary. So that's an important element of the service we provide these centers to ensure that they get paid for the work that they do.
Secondarily, we were thrilled to see our 30-day Medicare Advantage approval rates finish 2025 at 46%. That's a remarkable level for a Category III therapy. It's up almost 50% over the 31% level we saw in 2024. That's a tough payer group, as you all know, and we're thrilled that bodes very well.
Now, with Category I in place, it bodes well for our future coverage progress and interactions with the payers. So, for 2025, fourth quarter worldwide revenue was $15.9 to 16.1 million. 2025 worldwide revenue for the year was $56.5 to 56.7 million, or an 11% growth rate. We added three new US territories in fourth quarter for a total of 53 and added a net increase of two centers for a total of 252 active implanting centers.
Our cash balance at the end of the year was $75.7 million. For 2026, for the full year, we would expect worldwide revenue between $63 million and $67 million, gross margin between 84% and 86%, and operating expenses between $103 million and $107 million. For the first quarter of 2026, we expect total revenue between $13.7 million and $14.7 million.
So in closing, we believe we have the opportunity to positively impact the standard of care for a major global health condition and to address a significant unmet need in the treatment of heart failure. And in doing so, improve the quality of life for hundreds of thousands of patients who can benefit. We also believe if we are successful, we can build a transformational company that's capable of sustaining long-term growth. Thank you. I appreciate your time, and we look forward to some questions.
Great. Maybe we could kick it off with the pre-announcement that you announced just a couple of days ago. Fourth quarter beat the street by about $500,000, 2026, and first quarter roughly bracketing the street on sales. Maybe speak to some of the trends you saw in fourth quarter and how you're thinking about the building blocks of 2026.
Sure. Maybe I'll start with that, kind of, at 100,000 feet. So the themes you saw there, 2026, as we look forward, is a year of execution. We are getting the sales team that we're so proud of up to speed and productive, increasingly productive.
We saw some of that through 2025. We are obviously on the cusp of some significant reimbursement breakthroughs, which you saw with the Category I code. And we're excited about this trial. So those were all themes, obviously, in our announcement and things we're looking forward to in 2026. Jared can cover the specific financial details, but happy to dig into some of those three themes as we get further into this.
Yeah. Go ahead. Go ahead with those.
Yeah. Yeah. Happy to chime in on a couple of the numbers. Yeah. I think one of the key things that we've talked about throughout the year of 2025 is that we had a bit of a reset, right? We built this new sales force in the first quarter of 2025 and into the second and third quarter.
After building that baseline in the first quarter of 2025, we've seen sequential growth from first quarter to second quarter to third quarter to fourth quarter in the range of 8% to 10%. That's what gives us confidence to put out the guidance that includes an acceleration of growth from 2025 into 2026 because we're seeing that team come up that productivity curve at a nice clip throughout the year.
You did get a Category I CPT code, and it has a pretty substantial improvement in inpatient reimbursement. How do we think about the ability to take price now that you have a much improved reimbursement rate?
Yeah. Happy to cover ASPs as well. So I think in 2025, we saw a nice step up again in ASPs, especially on the US side of the business, where I think we saw ASPs jump from around $30,000 in 2024 to around $31,000 or $32,000 in 2025. As we move into 2026, I think our baseline model still assumes ASPs would stay flat-ish around that $31,000 mark in the US side of the business.
However, there is upside to that opportunity. Our list price is $38,500. The average reimbursement, both on the inpatient and the outpatient side, is close to $45,000. So there is enough margin there to go capture some additional increases in ASPs. But in the base case in our guidance, we're still assuming a flat ASP from 2025 to 2026.
In 2026, or 2025, you reined in expenses, and 2026, expenses are still above sales, and you have some of the interest payments at least accruing on the balance sheet. So how do we think about cash burn? What did you end up with in 2025, and how should we think about the burn in 2026?
Yeah. It's a great question, right? With the rebuild that was done in 2025, we didn't see the leverage that we had initially anticipated entering the year. I think our total cash burn is going to be in the range of around $35 to 40 million for the year. Our expectation for 2026, with the reacceleration of our top-line number, is that we will see additional leverage in this business.
Top-line number is going to be growing at a faster pace than what our overall OpEx will be growing in the year because of the fact that we're going to see more and more of those new sales reps push further and further up that productivity curve, driving that leverage that we expect to see in this business.
There were a couple of announcements along with the pre-announcement in terms of additional debt facilities, and maybe just run through it all of what happened.
Yeah. Happy to cover a couple of those items. In addition to the pre-announcing fourth quarter results, 2025 preliminary revenue, and giving the guidance for 2026, we also included a disclosure of an amendment to our loan agreement with Innovatus. Historically, we had a $50 million facility that was fully drawn. It was coming due in the fall of 2027.
Our goal with this amendment was to push out that maturity date, which we did accomplish. The new maturity date is out to 2031. So interest-only period in the range of four to five years from signing in January of 2026. But also, as part of that amendment, they offered to extend the facility to $100 million, of which we drew an additional $10 million of debt on 9 January 2026. So that brought our cash that Kevin mentioned at the end of the year from $76 million up to $86 million here in early January.
So now, with the $100 million facility, around a 9% to 10% interest rate, burning $35 to 40 million in 2026, how do you think about the building blocks to get to cash flow break-even and ultimately material profitability?
Yeah. Yeah. Thanks for that question, Robbie. So, the goal, it remains unchanged. We're working to get each one of these territories activated, fully up that productivity curve, as Kevin mentioned, with three to five active implanting centers. By driving deeper adoption, the expectation is that each one of those centers would be treating one patient a month.
So, for each territory, we would see productivity of about five implants a month or 60 implants a year. At an ASP, just to round numbers of $30,000, you'd see annual revenue generated per territory of $1.8 million if they reach these targets. It's that number that we're driving towards and seeing leverage in this model to help us achieve cash flow break-even.
So with two years plus cash on the balance sheet, there's no need for us to go out and raise any additional capital at this point in time because we're really focused on driving leverage in this model and driving that cash burn number down in the near term.
Obviously, any business, you have some reps who are highly productive, some reps who are a little less productive. That $1.8 million rep productivity, that's obviously the goal. How many of your reps are there today?
Yep. Yep. So we have many reps that have achieved that target. I think if you look at our overall average productivity for our active territories, you'll see right now productivity is about $1 million a year. And so our goal as we bring these new reps up to speed is to get more and more of them achieving that target of $1.8 million.
So Kevin, in the presentation, you talked about some of the steps, the biggest, the three barriers that you were trying to knock down to drive adoption. You're at about $1 million now. You need to almost double that. The product's been on the market for a number of years now. I imagine awareness and familiarity is a big part of it. Clinical data is there, it seems like. So from your point of view, what's the line of sight from going $1 million per rep to $1.8 million a rep? And what are you doing to make sure you get there?
Yeah. So there's a number of different things that factor into that. Obviously, number one, getting the right reps that understand program selling and moving from a relationship-based sale to one that's focused on new therapy development, that's critical. So you got to have the right DNA.
Number two, they got to understand the right centers to call on and how to develop that sort of flywheel that I did describe. They will get more productive as they're successful at getting these centers to start to do this under their own power, right? That's what we're trying to achieve is the proper placement of this therapy in the disease continuum so that if a patient shows up that looks like a Barostim patient, that triggers somebody's mind and they know who to send the patient. So it's sort of who you're selling to and how you sell.
But it's obviously, if you look at those three barriers, the most significant is probably always reimbursement, right? No one can escape that. In our case, that's one of the three. I think the remarkable results that, from what we understand, the sort of rule of thumb for prior authorization approvals at 90 days for Medicare Advantage and commercial payers is about 30% or the mid-30s. So the fact that we're at 46% at 30 days is pretty impressive, we think. And we think that's a fantastic platform to build from.
So, the other piece that will get these reps productive is physicians being confident that the patient they refer is going to get it covered and in doing so then be willing to refer more and more patients because physicians are fatigued, right? And they feel personally responsible when they refer a patient, get them excited about Barostim, refer them for the treatment, and the payer won't cover it. So, we're hopeful. There's probably not one of those things that's going to be the single driver of productivity improvement. It's a multitude of factors that thankfully are now all moving in the right direction.
Now, with the CPT one code, do you think a lot of the reimbursement headwinds gets pushed away?
Yeah. Yes. Not completely, of course, but it's a significant reducer of the friction in the system and the amount of pain and suffering that the physicians and patients go through to get the therapy. So there are many examples in our industry of that being a catalyst for accelerated growth. We think we'll see that. It's too early to tell that now, but that's a significant step forward. And we're already seeing, as I said, anecdotes in the first 13 days of payers behaving differently than they did. And it'll take a couple of quarters to get through that.
Payers are notoriously slow to update their codes. That's helpful to them. So we're working payer by payer to identify those that haven't yet updated their systems and trying to make sure that that transition is as smooth as possible and that we don't lose any patients who were submitted in December under the old regime, canceled, and somehow don't get resubmitted under the new regime.
You had the, let's call it the reset in 2025. How would you grade the progress since then? And do you feel like you're completely out on the other side?
Yeah. I would say this was a very necessary reset. It obviously involved a significant change in our organization, up to 70% of our sales team since I've joined this organization, much of it in 2025. It involved a completely revised go-to-market strategy. The foundation is in place. We've got the right people.
We think we have the right strategy. We have the right reimbursement support here and a growing body of evidence. So we are moving into an execution phase here. We don't need a lot of additional tools or support. We need to get these people productive and sort of get that flywheel going in as many of these centers as we can.
Obviously, tripling the addressable market would be fantastic. It's going to be a long trial. It's going to be a number of years before we see results. What were some of the clinical science or the data that you have in hand today that informed you to set up the trial? And how do you feel about the odds of success?
Yeah. So maybe I'll take that in reverse order. So, we feel really good about the way this trial has been designed. It is the largest such trial we believe in heart failure devices. So, we have designed it with a very conservative statistical plan that we think, and an improved understanding of event rates, both in our indicated population, which we've studied in the past, and in this extended, they call it heart failure with moderately reduced ejection fraction, MREF, from 35 to 50. That's the same disease as the under 35s. It's not as advanced.
There aren't as many events, but we have a much better understanding today than we could have seven or eight years ago about the behavior of those two populations. And so, we think we have a world-class scientific advisory board. We think we have a trial here that we can be successful with.
Of course, it requires CMS to agree to pay for it, but we think it will be a leadership signal to our industry and will generate a ton of goodwill. Physicians already, there's almost a sense of FOMO, right? This is a massive trial.
Even those that aren't yet ready to start using Barostim commercially are telling us they will participate in the trial. This is a major sort of seminal event if we're successful in how heart failure is treated. So we're excited about that. It will be a gradual start, as they always are. We're not building any of the revenue from those units.
Much of the units in the trial will be a population that we don't treat today. So those will be incremental. But I think there'll be a significant sort of goodwill tailwind that benefits our commercial business today as we get into this trial.
Great. Unfortunately, we're just about out of time. I want to thank you for a great discussion, and thanks to everybody for joining.
Thank you.
Thank you.