CVRx (NASDAQ:CVRX) lowered its 2026 revenue forecast after third-quarter sales fell 6.1%, as delays in insurance approvals, physician turnover and uneven sales execution continued to weigh on adoption of its Barostim heart failure therapy.
The company reported third-quarter revenue of $13.8 million, within its guidance range, and a net loss of $14.2 million, or $0.52 per share. That compared with a loss of $12.9 million, or $0.49 per share, a year earlier. Gross margin held steady at 87%.
President and CEO Kevin Hykes said the challenges facing the company had been “more impactful and more persistent” than anticipated. Although sales team tenure has improved, he said, the effect on performance is taking longer than expected.
Coverage Delays Weigh on Adoption
Hykes identified UnitedHealthcare as CVRx’s largest Medicare Advantage payer and said its approval behavior had deteriorated significantly. For prior authorizations handled directly by CVRx, the 30-day approval rate with that payer fell to about 12% from a high of 83% in 2025. The 90-day rate remained below 35%.
Hykes said UnitedHealthcare does not have a written Barostim coverage policy and is denying initial prior authorization requests and, in many cases, subsequent appeals. The company is pursuing appeals through administrative law judge hearings when necessary, a process he said can add more than 100 days after the third denial.
CVRx has limited visibility into requests handled by customers. Hykes estimated that the company’s internal system sees roughly one-third of Barostim prior authorizations, and said many customer-handled requests are likely abandoned after an initial denial.
Overall, the company’s Medicare Advantage approval rate fell to 51% at 30 days at the end of the third quarter, from 60% in the second quarter. That decline was partly offset by increased approvals for patients covered by Humana, Hykes said.
CVRx now has two written Medicare Advantage coverage policies, including one from Humana, representing a combined 21% of Medicare Advantage covered lives. Hykes said the company is hiring field-based reimbursement managers to help accounts with billing, coding and payment issues.
He also said some hospitals are pausing implants while they confirm payments across their payer mix. At one large health system, more than a dozen patients with approved prior authorizations have been on hold for multiple quarters during that process.
Sales Execution and Physician Turnover
Hykes said turnover among heart failure specialists can disrupt Barostim programs when a physician champion leaves an account. Establishing a program at a physician’s new practice commonly takes three to four quarters, he said.
Sales performance also varied across CVRx’s nine U.S. regions. Five more tenured regions were growing procedures by more than 20% on average, while four less experienced regions struggled to achieve similar growth, Hykes said.
The company appointed Paul Verrastro interim head of sales, created additional sales leadership roles and strengthened training and coaching. Hykes said third-quarter turnover fell to its lowest level in more than two years, though he cautioned that the improvement was still early.
Lower Revenue Outlook and Cost Reductions
CVRx reduced its full-year revenue forecast to $56 million to $57 million from $58 million to $60 million. For the fourth quarter, it expects revenue of $11.7 million to $12.7 million. The company maintained its full-year gross margin expectation of 86% to 87% and operating expense forecast of $99 million to $101 million.
CFO Jared Oasheim said the company had reduced staffing in non-commercial functions, paused some projects and pulled back on marketing and research spending while continuing to invest in sales and reimbursement. He did not quantify annualized savings or provide 2027 operating expense guidance.
Third-quarter U.S. revenue declined 4% to $13 million, while European revenue fell 27% to $0.9 million. Oasheim said a large customer purchase that might otherwise have occurred in the fourth quarter took place in the third quarter, affecting the fourth-quarter outlook. He declined to quantify the purchase.
CVRx ended September with $58.7 million in cash and cash equivalents, down from $64.6 million at the end of June. It raised approximately $6 million through its at-the-market facility during the quarter. Oasheim said the company believes it has at least 18 months of cash runway, excluding any additional proceeds from that facility.
Clinical Evidence and CFO Transition
Hykes highlighted data from the real-world REBALANCE study. Among 238 patients corresponding to the current U.S. commercial indication, the study showed sustained improvements in New York Heart Association functional class over 24 months and increases in average left ventricular ejection fraction of 4.8 percentage points at 12 months and 8 percentage points at 24 months, he said.
CVRx is also discussing a potential real-world evidence-based application with the Food and Drug Administration that could support an expanded indication. Hykes said the company hopes to agree on a protocol with the agency in 2027 before conducting the analysis.
John Landry, who joined CVRx in October, is set to become CFO after the company files its Form 10-Q. He will succeed Oasheim, who has been with the company for more than a decade.
About CVRx (NASDAQ:CVRX)
CVRx, Inc (NASDAQ: CVRX) is a medical device company focused on developing and commercializing neuromodulation therapies for patients with cardiovascular diseases. The company’s technology is designed to activate the body’s natural nervous system pathways to help regulate cardiovascular function.
CVRx’s primary product is the Barostim system, an implantable device that delivers electrical stimulation to baroreceptors located near the carotid arteries. By influencing signals between the cardiovascular system and the brain, Barostim is intended to reduce excessive sympathetic nervous system activity and improve symptoms and function in certain patients with heart failure.
