CVRx, Inc. reported preliminary fourth‑quarter 2025 revenue of $15.9 million to $16.1 million, a 4% to 5% increase over the $15.3 million earned in Q4 2024. The lift was driven by stronger demand in the U.S. market, where the company’s Barostim implant system saw a 12% rise in new implantations, offsetting a modest decline in the international segment due to supply‑chain constraints.
Full‑year 2025 revenue is projected at $56.5 million to $56.7 million, up 10% to 11% from the $51.3 million recorded in 2024. The growth reflects a 15% increase in U.S. implant volume and a 5% rise in pricing from the newly effective Category I CPT codes that began on January 1, 2026. The company’s gross margin is expected to remain strong at 84% to 86%, a slight improvement from 82% to 84% in 2024, thanks to higher mix of high‑margin implant sales and modest cost inflation.
Operating expenses for Q4 2025 rose to $21.9 million, up 8% from $20.3 million in Q4 2024. The increase is largely attributable to expanded sales and marketing spend aimed at scaling the Barostim footprint, including the addition of 12 new implanting centers and 3 new U.S. sales territories. While operating expenses are higher than revenue for 2026 guidance, the company expects the investment to accelerate market penetration and generate incremental revenue in the coming years.
The company disclosed a $20 million to $30 million investment in the BENEFIT‑HF randomized controlled trial, with costs spread over five to seven years. A $50 million term‑loan amendment increased the debt facility to $100 million, with $60 million outstanding after a $10 million draw on January 9, 2026. The company has secured FDA approval for the BENEFIT‑HF IDE in November 2025 and has applied for CMS Category B coverage, a critical step that could unlock reimbursement for the trial and broaden the addressable market for Barostim.
For 2026, CVRx expects first‑quarter revenue of $13.7 million to $14.7 million and has raised full‑year revenue guidance to $63 million to $67 million, a 11% to 18% increase over the 2025 outlook. Operating‑expense guidance of $103 million to $107 million exceeds revenue, reflecting continued investment in sales, marketing, and the BENEFIT‑HF trial. The company’s debt facility was increased by $50 million, extending the interest‑only period to five years contingent on revenue milestones. Investors reacted negatively, citing the high operating‑expense guidance, increased leverage, and pending CMS approval as headwinds despite the strong revenue trajectory.
CEO Kevin Hykes emphasized that the company is “well positioned for accelerated growth in 2026” thanks to the new CPT codes, a maturing sales organization, and a strengthened balance sheet. He noted that the BENEFIT‑HF trial is a strategic catalyst that could triple the addressable market for Barostim, but acknowledged that the trial’s success depends on regulatory and reimbursement approvals.
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