CVRx at Jefferies London: Strategic Moves in Heart Failure Therapy

On Tuesday, 18 November 2025, CVRx (NASDAQ:CVRX) presented at the Jefferies London Healthcare Conference 2025, outlining strategic advancements in its Barostim therapy for heart failure patients. The company highlighted both the promising potential of their therapy and the challenges in market penetration. While the therapy shows significant clinical benefits, CVRx is navigating systemic barriers to increase adoption and improve patient access.

Key Takeaways

• Barostim therapy targets an annual total addressable market of $2.2 billion.
• The therapy has demonstrated an 85% reduction in hospitalizations among heart failure patients.
• CVRx revised its go-to-market strategy, focusing on deep adoption in select centers.
• The company reported Q3 worldwide revenue of $14.7 million, with guidance for Q4 set between $15 million and $16 million.
• Systemic barriers such as therapy awareness and reimbursement are being actively addressed.

Financial Results

• Q3 worldwide revenue reached $14.7 million.
• Active implanting centers increased to 250.
• Gross margin stood at 87%, with a cash balance of $85 million.
• Q4 revenue guidance is projected between $15 million and $16 million.
• Annualized revenue guidance ranges from $55.6 million to $56.6 million.
• Operating expenses are expected to be between $98 million and $99 million.

Operational Updates

• CVRx is restructuring its sales team, with 45% replaced in the last three quarters.
• Focus is on high-potential centers with experience in cardiovascular technologies.
• Efforts include building a support ecosystem with clinical champions and trained surgeons.
• The company is enhancing physician outreach and direct-to-consumer marketing.

Future Outlook

• CVRx plans to secure a permanent procedural code from January 1, enhancing reimbursement.
• The company aims to improve therapy awareness and clinical evidence to drive adoption.
• Barostim therapy is recommended for patients who remain symptomatic after conventional treatments.

Addressing Systemic Barriers

• CVRx is tackling barriers such as therapy awareness and patient access.
• The company has secured reimbursement codes, with hospitals receiving $43,000 for inpatient and $45,000 for outpatient procedures.
• A new category one procedural code will pay surgeons $560 for the procedure, effective January 1.

CVRx's presentation at the Jefferies London Healthcare Conference 2025 provides a comprehensive overview of its strategic initiatives and financial outlook. For more detailed insights, refer to the full transcript.

Full transcript - Jefferies London Healthcare Conference 2025:

Unidentified speaker, CVRx: CVRx. I've been in this role for about 20 months now, and it's my pleasure to speak to you this morning. CVRx, these are forward-looking statements available on our website. CVRx has developed the world's first neuromodulation therapy for the treatment of a cardiovascular disease. We have a $2.2 billion annual TAM, a well-defined patient population who have limited treatment options, and a highly differentiated therapy. Heart failure is a burdensome condition across the developed markets. In the United States alone, it results in over a million hospitalization visits, 1.3 million emergency room visits, 8 million physician office visits, and will reach approximately $70 billion in spending by the end of this decade. Heart failure is a progressive disease. The mortality is significant. It exceeds that of the top five cancers.

It is a condition where, over the course of the patient's disease, they increasingly present at the hospital in a decompensated state. In each case, post-hospitalization, they fail to return to their prior level of quality of life and mobility. It progresses over time, typically over 5-10 years, ultimately leading in death. When first diagnosed, patients are started on what's called quad therapy, which is a combination of four Class I guideline-indicated drugs that are prescribed in tandem. A small percentage of patients are evaluated for something called CRT, or cardiac resynchronization therapy. At the end of their disease, arguably 8-10 years later, 1% of patients receive either a left ventricular assist device or cardiac transplantation. The other 99%, unfortunately, go on to hospice. In the intervening eight years, many of these patients are home. They're debilitated.

They're presenting at the hospital regularly, and they suffer from significant diminished quality of life. The four drugs that are prescribed do, in fact, extend life by 1-6 years. However, only 1% of patients ever reach a therapeutic dose on each of those four medications. By the end of the first year, 40% of the patients discontinue at least one of the four drugs. The drugs have limited impact on quality of life. In this case, this is a meta-analysis of 18 studies comparing the impact of the four drugs, which you see across the bottom, on exercise capacity, which is a common surrogate for quality of life. You see a very limited impact on the patient's quality of life. While these drugs extend life, it leaves the patients miserable. Heart failure patients suffer from significant mobility issues.

I'm sorry, anxiety, depression, activities of daily living are difficult for them. When surveyed, they report over and over again that they would much rather live a shorter number of years but a higher quality of life than simply extend their death effectively. There is truly an unmet need in this population, and they've been expressing that openly. Barostim treats the population in the middle who are called by the heart failure community the forgotten middle or the walking wounded. It's meant to really restore quality of life in that population who are suffering. Interestingly, for 30 or 40 years, the paradigm has been to send these patients home and treat them with these medications and simply tell them that the quality of life issues are something you just have to live with. It's part of the disease.

For the first time last fall, the Heart Failure Society of America published a consensus statement that described the point of diminishing returns for these drug therapies. They said if after three to six months the patients are still symptomatic, that is the time that you should consider an intermediate therapy such as Barostim. This indication leads to a $2.2 billion annual TAM. That is the annual incidence alone. These are patients in New York Heart Association Class II and III that have an NT-proBNP, that is a marker of their heart failure stability, less than 1,600, and are suitable candidates for surgery. That yields about 76,000 new patients each year, resulting in roughly a $2 billion TAM. The actual prevalence pool is likely six or seven times that annual incidence pool. The therapy itself targets the neurohormonal pathways that underlie heart failure as a disease.

Heart failure begins with a weakened heart that can be the result of a number of different insults. It could be viral. It could be the result of a heart attack, sudden cardiac death. It results in weakened pumping function. The decreased contractility results in decreased signaling to the brain. The body's natural thermostat, or the brain, gets its information on the status of the cardiovascular system from a bundle of nerves called the baroreceptors that sit on top of the carotid artery on either side of the neck. As the heart's pumping function is diminished, those baroreceptors reduce their signaling to the brain. The brain interprets that reduced signaling as a crisis, either an acute decompensation, hemorrhage, or dehydration, a life-threatening event. The brain triggers the body's natural fight or flight response. In doing so, it increases sympathetic tone. It decreases parasympathetic tone.

Think of that as the accelerator and the brake. It triggers the release of powerful neurohormones, a storm of neurohormones by the renal angiotensin system in an attempt to rescue the body from this crisis. The challenge is there is no natural off switch for that fight or flight response. As long as the signaling remains depressed, those neurohormones are circulating in the body. Chronic exposure to the neurohormones is toxic. It damages the heart, the kidneys, and the vasculature. That is what causes the progressive nature of the disease. Today's drug therapy, the four guideline-indicated Class I drugs, are based on the concept of neurohormonal blockade. They attempt to block four or five of these 13 neurohormones that are being released to try to rescue the body.

The challenge is they can't block all the neurohormones, and they're ineffective in certain patients. Barostim effectively operates on the same mechanism, but upstream. By restoring the signaling from the baroreceptor to the brain, it effectively signals to the brain that the crisis is diminished, which then causes the brain to pull back on sympathetic tone, restore parasympathetic, and reduce these hormones that are circulating in the body, effectively backing off the fight or flight response and signaling that the patient is no longer in crisis. It operates on the same mechanism, effectively turning down the storm in concert with the drugs, which are still used to shield the end organs from the storm. A very familiar mechanism of action to physicians that treat this disease. The system itself looks very similar to a pacemaker or a defibrillator.

It has a single lead with a small button electrode that's sutured in a simple procedure onto the outside of the blood vessel on top of those baroreceptor nerves. The procedure takes about 30 minutes. It's entirely subcutaneous. There's no lead in the vasculature. It has a remarkable 97% freedom from complications. Some surgeons describe it as almost bloodless. The device itself is implanted just below the collarbone, much like a pacemaker, and the lead is then tunneled subcutaneously to connect to the device. The 24-month data that was published last year from our post-market trial, BDHF, demonstrated a significant effect on quality of life in this population. A two-times clinically meaningful improvement in exercise capacity and quality of life. 68% of patients improved their New York Heart Class functional status.

A remarkable 94% of patients responded to the therapy, which is an extremely high response rate for any pharmaceutical or device-based therapy. To put that in context, the improvement in exercise tolerance with Barostim is significantly greater, roughly three times that of the best of the four drugs. It is a significant improvement in their quality of life, even if they are on these four drugs. Although the trial was being conducted during the pandemic, which had a significant impact on the control group and made it difficult to test a number of the hypotheses, we did show a significant trend towards reduced all-cause death in the population, which was obviously encouraging. Importantly, since COVID, earlier this year, we have been publishing real-world data sets.

In this case, we found a cohort of 306 patients in the Premier Outcomes Database, which is one of the larger real-world evidence databases in the United States. It comprises data from 1,300 hospitals. In this case, 306 patients were followed one year prior to implant and two years post-implant with the Barostim therapy. We demonstrated a remarkable 85% reduction in hospitalization. This data confirmed a number of smaller single-center studies that found roughly a similar decrease in hospitalization in these same patients before and after receiving the therapy. Despite the challenges with COVID, we're now accessing data sets that allow us to really look at morbidity and mortality and the impact on outcomes in this population.

We have been, since I joined the company 20 months ago, we've revised our go-to-market strategy and have been significantly changing the way we are introducing this therapy to the market. There are really three elements of our revised go-to-market strategy. The first is building a world-class therapeutic development sales organization. The second is really focused on adoption of the therapy. Instead of going as wide as we might as an early-stage company, we are really instead trying to drive deep adoption at the account level. Third, we're trying to address what we understand to be the systemic barriers to the adoption of the therapy, both in the United States and in Europe. In the first case, we have been gradually rebuilding our sales team over the last 18 months, principally over the last three quarters, to bring in a different type of sales rep.

Those are sales reps that understand how to introduce a novel therapy and how to change the practice of medicine and move a therapy to standard of care. This has involved replacing roughly 45% of our team in the last three quarters and over 70% since the start of 2024. A significant effort with, as you can imagine, significant focus on training and development and onboarding. That's our single greatest opportunity is to get those new sales reps up and productive as quickly as we can. Again, aligning our incentives to go much deeper, a program-oriented selling approach that drives deeper adoption in a smaller number of centers versus wider distribution of dabblers, so to speak. As part of that, we've identified a set of accounts that we think are the highest possible opportunity for the therapy.

In the United States, there are roughly 5,000 centers that can implant Barostim therapy. We've identified three characteristics that we believe describe the best centers to target. The first, along the bottom axis, is a significant number of heart failure patients, which unfortunately characterizes many hospitals in the United States. The second characteristic on the vertical axis is centers that have had experience with a device from Abbott called the CardioMEMS. That's the first diagnostic implantable device in this population. It's been available for about 10 years. Really, the only surrogate device—it's not a therapy, but it's an implantable device diagnostic in this population. Centers that have adopted that diagnostic demonstrate a progressive approach to managing this disease and appreciate that these patients need something more than being sent home for eight years on their medication.

The third axis is centers that have adopted successfully new cardiovascular technologies and have used them to build their service line and have profitably supported their hospital with the introduction of therapies like MitraClip or Watchman. In that blue box, in the United States at least, there's roughly 300-400 centers. We would estimate 200-300 patients per center in that population. That's really where we're targeting our teams today. That's a change in the way the company had targeted centers historically. What we're trying to do in those centers is build the ecosystem that we've found to exist in our most successful centers to date.

What that involves is not just a single clinical champion, which is often the case in an early-stage therapy, but also an administrative champion that understands the profitability of the procedure and the role it can play in their cardiovascular service line. It also involves not just a single heart failure specialist prescriber, but multiple prescribers with relationships in the community with multiple referrers, where many of our patients are still Class II and III and seeing a general cardiologist on a quarterly basis. The device is implanted by a cardiothoracic or vascular surgeon. Again, our best centers have multiple surgeons who are trained in the implantation of the device. These are the centers that display the deepest levels of adoption, the most sustained use of the therapy, and who have truly incorporated it into their disease algorithm.

It's part of how they treat heart failure, not just a novel new technology that they've discovered recently. This is what we're seeking to build in each of these centers. Our compensation systems for the sales team reward reps that can build a system of support just like this in these centers. The third piece of the strategy is addressing what we see as the systemic barriers to the adoption of this therapy. This is true both in the U.S. and Europe to differing degrees. In the U.S., the number one barrier is therapy awareness. The number two barrier is developing a more robust set of clinical evidence. The third barrier is clearly patient access and reimbursement and insurance coverage.

In the first case, we deployed a very significant resource into the field to really try to build referral physician outreach in the community where many of our patients are seeing their primary care physicians or general cardiologists. That involves multiple web-based educational channels, medical education, local, regional, and national outreach events, referral development events. In the last year alone, we've done well over 100 events focused on that referral community, connecting them with the heart failure specialists in the centers who can prescribe Barostim therapy. We've also significantly increased our focus on advanced practice providers who are in the United States nurse practitioners or physician's assistants. These are the advanced practice nurses who see these patients more often than the physicians do.

Often, they're the primary point of contact for the patients in these practices, seeing the patients every six weeks, whereas a physician might see them only once a year. That is a really important group for us. These are clinicians who are highly attuned to quality of life and very focused on the patient's disease progression in a way that the physicians simply do not have time for. Significant focus there even over the last few quarters. Lastly, we have a significant direct-to-consumer marketing capability that we deploy, again, around these centers to try to connect patients in the community who learn of the therapy through us with experienced referrers and prescribers of Barostim. The second barrier relates to clinical evidence. Obviously, you can always use more clinical evidence. We believe we have significant evidence today, certainly enough to commercialize the therapy effectively.

There are different groups of physicians with different degrees of conservatism and different hot buttons that they focus on from an evidence standpoint. Our evidence generation work really falls into two buckets. The first is further evidence of improved outcomes. Getting beyond the high-level outcomes from our randomized control trial to really start to look one level down at arrhythmias, ejection fraction, diuretic needs, obviously hospitalizations, but really trying to understand what the secondary benefits of the therapy are in this population. On the right, we're spending significant time as well looking at the physiologic basis of the therapy and trying to understand and better describe how and why it works. That involves looking at hemodynamic function, sympathetic nerve activity, anti-inflammatory effects.

Really starting to sort of peel the onion to give more physiologically minded physicians a better sense of why, in fact, this works as well as it does. It's a little novel at first to understand that you're stimulating nerves in the neck and affecting a systemic disease. We're doing this through the development of real-world evidence, as I demonstrated earlier, randomized controlled trials, including a new trial that we're discussing today with FDA, and single-center and investigator-initiated research. We're seeing an increasingly steady drumbeat of publications in the literature. This is four publications over the last 12 months, some of them multi-center trials looking at hospitalizations. In other cases, single-center or investigator-sponsored work looking at remodeling, cardiac morphology, and ejection fraction. Again, some of those secondary endpoints that we're now being able to refocus on.

Third, we've had a significant number of milestones over the last 12 months on the patient access front. The first of those was a year ago when we secured a permanent inpatient DRG that reimbursed hospitals $43,000 for the implant procedure. The second is an outpatient code, which currently is at $45,000. We're in what's called a new tech APC, which is a temporary sort of holding code for new therapies such as ours. The inpatient and outpatient reimbursement are very similar. We've petitioned CMS three years in a row now to create a new permanent home for Barostim in what we're calling a level six neurostimulation APC. We're awaiting any day the results of this last year's process.

We do not believe that will happen this year, but we will remain in that new tech APC and can do so for as long as is necessary at that $45,000 payment level until we can secure the creation of a level six permanent neurostimulator code. Finally, on January 1 of next year, in six weeks, we will achieve a category one, a permanent procedural code. We will move from what is called a category three or a temporary or experimental code into now a permanent category one code. There are two reasons that is important. The first is that it creates formalized and specific payment for the surgeons. In our case, that is 11 RVUs or relative value units. It will pay the surgeons about $560 for the procedure. Surgeons will have for the first time certainty into what they are going to be paid. Historically, they have had to negotiate that rate.

In some cases, payers refuse to reimburse surgeons after the procedure. That has been a drag on adoption, as is the case with many new therapies. The second reason that is important is that in the U.S., category three codes are used by the payers as an excuse to deny, to automatically deny every single prior authorization on the basis of the therapy being seen as experimental. As of January 1, the payers will no longer be able to use AI to automatically deny each and every prior authorization, but will instead have to have a clinician review and make the basis of medical necessity and make a decision on the prior auth on that basis. That is, again, we believe, a step forward that will speed approvals and increase the number of approvals of the prior authorizations. For Q3, we reported results.

Worldwide revenue of $14.7 million increased from 47 to 50 US territories, increased from 240 to 250 active implanting centers, reported a gross margin of 87%, and a cash balance of $85 million. For the full year and for Q4, we are guiding to revenue between $15 million and $16 million, and worldwide annualized revenues of $55.6 million-$56.6 million, gross margins of 85%-86%, and operating expenses between $98 million and $99 million. I don't believe we're taking questions today, but I appreciate your time on a Tuesday morning at 8:00 A.M. Thank you.

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