CVRx, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference

Good. Thank you, Bill. Good afternoon. Thank you. Appreciate the chance to address the group today about the status of CVRx. These are our forward-looking statements. Just as a little bit of background here, CVRx is commercializing the world's first autonomic neuromodulation therapy to treat heart failure. It consists of a device that looks a fair amount like a pacemaker with a single carotid sinus lead and a wireless programmer. It is implanted on the outside of the carotid artery on top of what is called the carotid baroreceptor, which is effectively the body's thermostat. It is the place where the brain senses the status of the cardiovascular system. It is implanted in a 30-minute procedure that is largely bloodless. It is extravascular and extracardiac. Our device treats a segment of the heart failure population that are commonly called the walking wounded or the forgotten middle.

When you are diagnosed with heart failure, you have roughly 8-10 years typically of longevity. The first thing they do is try to put you on as many of the four guideline-directed medications as you can tolerate. A small percentage of patients are considered for cardiac resynchronization. Otherwise, and for 50 years, patients are sent home to suffer the debilitating symptoms of heart failure, including increasingly frequent hospitalizations for decompensation. Towards the end of that journey, a very small percent of patients, less than 1%, are considered for transplantation or a left ventricular assist device. For 50 years, physicians have been treating this disease with pharmacologic therapy. We know today that only 1% of patients are ever able to tolerate all four of those medications, and at the end of the first year, 40% of them discontinue at least one of those guideline-directed medications.

The medications, if taken, can preserve life but do nothing to improve the quality of life. Barostim fits in that middle paradigm for these patients called the walking wounded. Those patients who have an NYHA Class II and III designation, so sort of the middle of the heart failure continuum with an ejection fraction less than 35% and a blood marker called NT-proBNP. That is a measure of the stability of their heart failure below 1,600, which is a bit of an artificial ceiling, but it relates to our original pivotal trial. When you take out the customary exclusions for surgical candidacy and access to healthcare, that results in about a $10 billion prevalence-based TAM in the United States. A very significant population. Interestingly, given the size of heart failure, that is only 5% of the heart failure population.

A massive chronic disease, as you well know. When I joined the company 2 years ago, we took a look at the results of the commercialization in the first 3 years and implemented a brand-new go-to-market strategy in the tail end of 2024. That involved 3 very distinct strategies. The first was to get the right sales force in place, a sales force focused on market development. The second was to develop a set of selling programs that drove deep adoption at the account level and to move from a customary sort of mile wide, inch deep approach that many early-stage companies have to start with to a much more targeted approach with the goal of driving deep, sustained, predictable adoption in the right sorts of accounts.

The third piece of the strategy was to address what we understood and validated to be the most fundamental barriers to the adoption of this therapy in the market. Those being patient access, awareness amongst clinicians and patients of the therapy and its role in the disease continuum, and evidence, right? A little bit of apple pie and motherhood. But for this therapy at least, those were the primary barriers to the adoption.

What we are seeking to do in these accounts is to drive deep adoption, and that starts with a network of aligned stakeholders, starting with a clinical champion, often with a CFO or administrative champion alongside them, and then a group of referrers in the community who understand what patients look like, patients who are candidates for Barostim, prescribers in the center that understand how to evaluate a patient, and surgeons who are partners to those prescribers who put the device in, again, in a 30-minute, very simple procedure. By developing alignment across those stakeholder groups and by implementing a workflow that lets each part of that team understand what their role is, what does the right patient look like? How do I make sure they can benefit?

How do I send them to a surgeon for implantation and then at the end of the process, send them back to their physician in the community to be followed? That is an important piece of this. If you do that well, those 2 things, you can in fact start to drive consistent utilization. This is how you change the practice of medicine, how you develop a market for a therapy that has not existed before, and only through that consistent repeat utilization do you ultimately move something towards standard of care. We have made significant progress over the last 18 months against those 3 barriers to adoption. I will talk about these in a minute, but certainly and most obviously in terms of patient access and coverage in this environment today, which is extremely difficult as you know.

Secondly, we've driven significant awareness within the medical community and in patients themselves on the role of this therapy in the treatment of heart failure. This is a novel concept to use a medical device to treat heart failure and a novel idea to do something for the patients that are in the middle of this journey, the walking wounded. On the far right, you see our evidence strategy has been producing now an increasingly steady stream of both clinical and physiologic data to support the therapy beyond that which was proven in our pivotal trial. A couple final slides. Importantly, in March of this year, we announced the initiation of a trial called the BENEFIT-HF trial. This was approved by FDA and has a CMS Category B reimbursement designation.

This will be the largest device-based therapeutic trial in the history of heart failure, almost 5 to 8 times larger than the next biggest trial. This is a leadership investment by CVRx to revisit our initial indicated population and to triple the size of our TAM by adding two adjacent populations as well. It will enroll 2,500 patients at 150 centers, largely in the U.S., looking at morbidity and mortality. As I said, it is fully covered by Medicare. That's a significant benefit for us. We expect that the trial will take roughly 3 to 5 years to enroll with a 2-year follow-up. It's a long-term investment, but one that's seen as a credible signal of our confidence in the therapy and our commitment to science. Lastly, we've made great progress in terms of reimbursement.

A third of our population, who are traditional Medicare, are now being covered at almost 100%. The seven MACs across all of the regions are covering this therapy when it's properly billed and coded. Another segment of our population, which is not advancing with this clicker. Let me try that one more time. For some reason, this slide. Witness in your minds, if you will. The bottom of this represents two populations, both commercial on the right and TRICARE, VA, Medicaid on the left, which are not a current focus of our therapy. With the Category I approval in January of this year, are now more eligible to receive this therapy than they have been in the past. The upper piece of the pie, which you can't see, represents the 33% of our population who are covered by Medicare Advantage.

Our focus is really traditional Medicare and Medicare Advantage. Within that population, those patients require a prior authorization to receive our procedure. Importantly, in May of this year, the second-largest Medicare Advantage provider and one that is notoriously difficult, Humana, issued our first written coverage policy for Barostim, and that was a huge step forward for us. It was somewhat of a welcome surprise several years earlier than we expected that that might happen. That written policy now gives us significant leverage as we work with United and Aetna and Cigna and the other Medicare Advantage payers to themselves write coverage policies for this therapy. That's a very important new step for us. It allows us to better fight for prior authorizations, to appeal rejections by the payers, and ultimately to drive for coverage.

So we can talk about that further, but I am pleased to be here. We are excited about this therapy and the impact it has on this horrible chronic disease that impacts patients' lives to such a significant degree. I will stop there. Perfect.

Thank you. All right. Well, thank you for taking the time today.