CVRx Eyes Barostim Growth as Coverage Gains and BENEFIT-HF Trial Launches

Key Points

• CVRx is refining its commercial strategy for Barostim by focusing on deeper adoption in selected accounts, stronger sales-force training and improved coordination among clinicians and referral partners. Management said sales challenges are concentrated in four newer regions and reflect execution issues rather than weak demand or evidence.
• Reimbursement is improving: traditional Medicare coverage reached 97% by the end of 2025, while Medicare Advantage approval rates rose above 60%. Humana’s new written coverage policy may support appeals and negotiations with other major insurers, although coverage expansion could take six to 24 months.
• The BENEFIT-HF trial has launched with plans to enroll 2,500 patients across 150 centers and assess morbidity and mortality. CVRx believes the study’s expanded patient population could potentially triple Barostim’s addressable market, but enrollment and follow-up are expected to take several years.

CVRx NASDAQ: CVRX outlined its efforts to expand adoption of its Barostim therapy for heart failure patients, emphasizing sales-force execution, payer coverage progress and a large post-market clinical trial during Canaccord Genuity’s 46th Annual Growth Conference.

President and CEO Kevin Hykes said Barostim is an autonomic neuromodulation therapy designed for heart failure patients in the middle of the disease continuum, a group the company refers to as the “walking wounded” or “forgotten middle.” The system includes an implantable device, a single carotid sinus lead and a wireless programmer. It is placed outside the carotid artery in what Hykes described as a roughly 30-minute, largely bloodless procedure.

According to Hykes, the therapy targets patients with New York Heart Association Class II or III heart failure, an ejection fraction below 35% and NT-proBNP below 1,600. After excluding patients who are not surgical candidates or lack access to health care, the company estimates the addressable U.S. market at about $10 billion on a prevalence basis. Hykes said that population represents roughly 5% of all heart failure patients.

Commercial strategy focused on deeper account adoption

Hykes said CVRx revised its go-to-market strategy in late 2024 following a review of its first three years of commercialization. The revised approach centers on building a market-development-focused sales force, targeting deeper adoption within selected accounts rather than broad but limited penetration, and addressing patient access, clinician and patient awareness, and clinical evidence.

The company’s model relies on aligning clinical champions, administrative stakeholders, community referrers, implanting surgeons and follow-up physicians around a defined patient-identification and treatment workflow, Hykes said. The goal is to drive consistent utilization and, ultimately, move the therapy toward becoming a standard part of care.

During the question-and-answer session, Hykes acknowledged recent commercial challenges but said management believes they are primarily execution-related rather than evidence or demand issues. He said five of the company’s nine sales regions, which have more seasoned leadership and limited turnover, are producing strong double-digit growth.

The other four regions have experienced a concentration of new hires and newer leaders, resulting in slower productivity ramps, according to Hykes. He said CVRx has taken a conservative stance for the remainder of the year as it focuses on making new hires “job-ready” before placing them in territories.

Management plans to tighten hiring criteria, expand training on practical account development and stakeholder workflows, and give area sales directors more capacity to coach new representatives. Hykes said the company believes it has a good team and characterized the issue as a productivity challenge that is “not everywhere.”

Reimbursement progress and payer appeals

Hykes said reimbursement has improved, particularly among traditional Medicare patients. He said all seven Medicare Administrative Contractors cover the therapy when it is properly billed and coded, and that traditional Medicare coverage had reached 97% as of the end of 2025.

Medicare Advantage remains a focus because patients generally require prior authorization for the procedure. Hykes said Humana issued CVRx’s first written Barostim coverage policy in May, a development he described as occurring earlier than the company had anticipated. The policy is intended to provide leverage as CVRx seeks coverage decisions from other large Medicare Advantage insurers, including UnitedHealthcare, Aetna and Cigna.

The company reported that Medicare Advantage approval rates overall had risen above 60%, from 46% at the end of the prior year. Hykes said Humana approval rates increased from about 10% to more than 90%, while UnitedHealthcare approvals had declined from more than 80% within 30 days to about 25% amid changes to that payer’s authorization process.

CVRx is pursuing denied cases through multiple appeal stages and, when necessary, administrative law judges, Hykes said. He noted that the process is initiated by patients, with support from the company, and can take about 100 days from the final appeal initiation to a decision. Management expects a potential “domino effect” from the Humana policy but said gaining written policies from other major insurers could take six to 24 months.

Large BENEFIT-HF study launched

In March, CVRx announced the initiation of the BENEFIT-HF trial, which Hykes said was approved by the Food and Drug Administration and received a Centers for Medicare & Medicaid Services Category B reimbursement designation. The study is expected to enroll 2,500 patients at 150 centers, primarily in the U.S., and evaluate morbidity and mortality.

Hykes described BENEFIT-HF as the largest device-based therapeutic trial in heart failure history. The trial is designed to revisit the company’s initially indicated population while adding two adjacent patient groups, which CVRx believes could triple its addressable market. Enrollment is expected to take roughly three to five years, followed by two years of follow-up.

Asked whether CVRx should reduce commercial investment and focus on the trial, Hykes said the company believes it already has sufficient evidence, reimbursement support and physician interest to commercialize Barostim today. CFO Jared Oasheim added that the company continues to view Medicare-covered patients as representing two-thirds of its estimated $10 billion market opportunity.

Hykes said CVRx remains committed to its commercial strategy despite the recent guidance revision, calling the heart failure market difficult but maintaining that Barostim has a role in treating patients with debilitating symptoms who fall between drug therapy and advanced interventions such as transplantation or left ventricular assist devices.

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.

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