CVRx, Inc.

Greetings and welcome to the CVRX third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Valli from ICR Healthcare. Thank you, sir. You may begin.

Good afternoon. Thank you for joining us today for CBRX's third 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 forward-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 CVRX's President and Chief Executive Officer, Kevin Hikes.

Thanks, Mike. Good afternoon, everyone, and thank you for joining our third quarter earnings call. Q3 was a strong quarter for CVRX. We grew revenue by double digits year over year and expanded our commercial footprint. Our newer reps are hitting their stride, driving procedure volumes, and building productive relationships with the physicians and APPs that manage heart failure patients in the community. Let me remind you of our three strategic priorities for 2025. Our first priority is building a world-class sales organization that develops sustainable Barrelston programs with deep therapy adoption. Our Salesforce transformation is progressing well, and turnover is returning to more normal levels. The first wave of the sales reps hired earlier this year are getting up to speed and making meaningful contributions. We will continue hiring high-quality talent, but at a more measured pace that aligns with our territory expansion plans, rather than the accelerated hiring that was needed to support the transformation. With this foundation in place, we're now concentrating on onboarding the new reps and accelerating their path to productivity. We are targeting centers with the highest potential for sustainable programs and implementing a best practice playbook to drive deep therapy adoption. Our refined approach to account targeting guides our expansion strategy, focusing on high potential Tier 1 and Tier 2 accounts. That being said, we're also selectively pursuing pragmatic opportunities in Tier 3 and 4 accounts where we see committed physician champions, administrative support, and the right fundamentals. We added 10 net new centers this quarter and are seeing traction with this approach. Our top accounts are demonstrating the deepening adoption that is the hallmark of an established barostim program. More than 20% of our active implanting centers achieved three or more implants in Q3, and our highest performing sites are now implanting more than 10 patients per quarter. This demonstrates what is possible when committed physician champions and strong institutional support come together. Our third priority is addressing the primary barriers to the adoption of barostim therapy by improving patient access, expanding therapy awareness, and building out our portfolio of clinical evidence. As it relates to patient access, we are making headway on multiple fronts. In July, CMS proposed maintaining barostim in new technology APC 1580 with payment of approximately $45,000 for procedures performed in the outpatient setting. The second rule proposed in July and finalized on October 31st is our transition to a Category 1 CPT code effective January 1 of 2026. The Category 1 designation eliminates the experimental and investigational denials regularly seen with Category 3 CPT codes, improves prior authorization predictability and throughput, and ensures that physicians are paid fairly and consistently for the procedure. On the coverage front, we are continuing to see encouraging trends and positive support from Medicare, Medicare Advantage, and commercial payers. Taken as a whole, these reimbursement advancements are creating an increasingly solid foundation for patient access and facilitate our work to move barostim towards standard of care. Our awareness efforts are focused on educating clinicians on the appropriate role of barostim therapy in the treatment of heart failure. We are engaging more deeply with the networks of referral physicians that surround our targeted centers through expanded national, regional, and local medical education programs. Beyond these physician-focused programs, we've continued to expand our engagement with advanced practice providers, or APPs, with a significant number of APP-specific educational programs completed year-to-date. These events are driving substantial interest and awareness in barostem therapy among community-based APPs, who manage most of our indicated heart failure patients on a day-to-day basis. During the quarter, we also had a significant presence at the Heart Failure Society of America meeting, one of the largest global heart failure conferences, where we hosted a multidisciplinary symposium with over 125 attendees. Our clinical evidence portfolio supporting barosem therapy continues to grow, and we are seeing an increasing flow of independent peer-reviewed publications being submitted from our implanting centers and reporting positive patient outcomes. Recently, we've seen single-center studies showing significant improvements in barostim patients, including a reduction in hospitalizations, reduced arrhythmia burden, and a positive impact on the ability to up-titrate and optimize guideline-directed medical therapy. Also, our discussions with FDA around a potential new randomized controlled trial are progressing positively. We submitted our IDE application in mid-October and expect to receive feedback from FDA in late November. If we can reach agreement with FDA on the IDE protocol, we will then approach CMS to apply for Category B IDE coverage, a second and necessary condition in order for us to move forward with the trial. We're pleased with our third quarter performance. The momentum we're building reflects our investments in team development and go-to-market execution. with an increasingly broad and strong contribution across our account and territory base. In fact, in the third quarter, we had more sales reps contributing implants than in any quarter in the company's history. We're seeing the consistent methodical progress needed to establish barostim as a standard of care for heart failure patients. Now, I'd like to turn the call over to Jared for a financial review.