CVRx (NASDAQ:CVRX) reported fourth-quarter revenue of $16.0 million and full-year revenue of $56.7 million, representing growth of 4% and 10%, respectively, as the company continued investing in its commercial organization and initiatives aimed at expanding adoption of its Barostim therapy for heart failure patients.
2025 commercial buildout and adoption strategy
President and CEO Kevin Hykes said 2025 was “a year of important and necessary investment” as the company strengthened its sales organization, refined its go-to-market approach, and focused on three strategic priorities: building a sales team for the next phase of growth, driving deeper adoption in targeted centers, and reducing barriers to adoption.
CVRx said it has narrowed rep focus to a smaller set of high-potential accounts—typically three to five—where teams can work to change clinical behavior. Hykes described the company’s “sustainable program” model as requiring: intentional targeting of high-potential centers; an aligned and redundant stakeholder network (including administrative support, multiple prescribers, and multiple implanters); and a defined workflow for patient identification, referral, screening, and implantation.
Management pointed to early signs of “more consistent utilization” at the account level. As an example, the company said the top 20% of centers had an annualized implant rate of about 19 implants in Q4, while estimating each of those centers may have roughly 300 currently indicated patients—an illustration, management said, of additional runway within existing accounts.
Reimbursement update: Category I CPT codes take effect
On patient access, Hykes highlighted the transition to Category I CPT codes effective Jan. 1, 2026. Management said the change should improve access by eliminating automatic prior authorization denials associated with Category III codes, improving reimbursement predictability, and formalizing implanting physician payment at a national average of approximately $560.
CVRx also reported progress in Medicare Advantage prior authorizations, with a 30-day approval rate reaching 46% in 2025, up from 31% in 2024. In Q&A, management said it is still early in the Category I transition, with a focus on getting codes updated across payers and resubmitting authorizations that were in process late in 2025. Hykes said the company has seen payers that historically rejected 100% of prior authorizations begin approving them, and some Medicare Advantage payers approving at higher rates and more quickly than before.
BENEFIT-HF trial initiated with CMS coverage
CVRx said it recently initiated the BENEFIT-HF trial after CMS approved Category B IDE coverage. The prospective randomized controlled trial is designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population, including patients with ejection fractions up to 50% and NT-proBNP levels up to 5,000.
Management said the study is expected to randomize 2,500 patients across approximately 150 centers in the U.S. and Germany, and described it as one of the largest therapeutic cardiac device trials ever performed in heart failure. If successful, CVRx said it would expand its prevalence-based addressable market from about 339,000 patients to over 980,000 patients, increasing the market opportunity estimate from about $10.5 billion to approximately $30 billion.
CMS Category B coverage was described as critical because it provides Medicare coverage for patients enrolled in the trial, reimbursing hospitals at approximately $45,000 per procedure, which management said is consistent with current commercial reimbursement rates. CVRx expects to begin enrollment in the second quarter of 2026.
In response to analyst questions, management said trial sites will include a mix of centers already using Barostim commercially and centers that have not yet begun commercial implantation. CFO Jared Oasheim said the trial design expects two-thirds of the 2,500 patients to be randomized to the device arm, implying roughly 1,600 to 1,700 implants and corresponding device sales over the course of the study. Hykes also said the company expects the trial to create “goodwill” and “credibility” in the heart failure community even before it materially contributes to revenue.
Management estimated the net cash impact of BENEFIT-HF at $20 million to $30 million spread over five to seven years, with most of the spend occurring in later years.
Quarterly results: margin improvement, higher operating spend
CFO Jared Oasheim reported fourth-quarter revenue of $16.0 million, up $0.7 million, including U.S. revenue of $14.9 million (478 U.S. units versus 460 a year earlier) and Europe revenue of $1.1 million (49 units versus 41). Europe maintained five sales territories during the quarter.
Gross profit in Q4 was $13.8 million, up 8%, and gross margin improved to 86% from 83%, driven by higher average selling price and lower cost per unit due primarily to manufacturing efficiencies.
Operating expenses increased year over year. R&D rose 7% to $3.0 million, driven mainly by higher compensation from increased headcount. SG&A increased 9% to $22.0 million, reflecting higher compensation, advertising, and travel, partially offset by lower consulting expense. Net loss was $11.9 million, or $0.46 per share, compared with a net loss of $10.7 million, or $0.43 per share, in the prior-year quarter.
CVRx ended 2025 with $75.7 million in cash and cash equivalents. Cash used in operating and investing activities was $40.8 million for the year, compared with $40.5 million in 2024.
Guidance and balance sheet update
For 2026, CVRx guided to total revenue of $63 million to $67 million, gross margin of 84% to 86%, and operating expenses of $103 million to $107 million. For the first quarter of 2026, the company expects revenue of $13.7 million to $14.7 million, with management noting a typical seasonal dip from Q4 to Q1 followed by expected sequential growth for the rest of the year.
On financing, CVRx said it amended its term loan with Innovatus Capital Partners in January to increase the facility by $50 million to up to $100 million, subject to milestones. At closing, the company borrowed an additional $10 million, bringing total outstanding principal to $60 million. The interest-only period was extended four years from closing (extendable to five years upon certain revenue milestones), and maturity was extended to May 2031. Oasheim said the company expects to burn approximately $30 million to $35 million in 2026 and believes it has at least two years of cash on the balance sheet, plus access to additional non-dilutive capital tied to revenue milestones. He added that the company’s shelf and ATM filing was described as “good corporate housekeeping” after a prior shelf expired.
Separately, Hykes announced Greg Morrison was appointed as the company’s new Chief Human Resources Officer, joining in March, succeeding Tanya Austin, who is stepping back for personal reasons.
About CVRx (NASDAQ:CVRX)
CVRx, Inc is a clinical-stage medical device company focused on developing a neuromodulation platform therapy for patients with cardiovascular disease. The company’s flagship product, the Barostim™ system, delivers targeted electrical stimulation to the carotid baroreceptors with the goal of modulating the body’s natural blood pressure control mechanisms. This minimally invasive, implantable therapy is designed to address unmet needs in individuals suffering from hypertension and heart failure.
The Barostim system is currently being evaluated in multiple clinical trials, including studies in resistant hypertension and advanced heart failure.
