CVRX (CVRX) Q3 2025: Gross Margin Rises 400bps as Barostim Adoption Deepens
CVRX delivered a third quarter marked by accelerating operational leverage, expanding gross margin, and disciplined commercial execution. The company’s methodical sales transformation is translating into broader Barostim, neuromodulation device for heart failure, adoption and more productive reps, while reimbursement tailwinds are laying the groundwork for future growth. With a robust cash runway and a focused RCT, randomized controlled trial, strategy to expand its addressable market, CVRX is positioning for a pivotal 2026 as the Category 1 CPT code takes effect.
Summary
- Salesforce Productivity Shift: New hires are contributing faster, fueling deeper Barostim adoption in top centers.
- Margin Expansion Foundation: Gross margin gains driven by manufacturing scale and pricing discipline signal durable operating leverage.
- 2026 Growth Catalysts: Reimbursement clarity and a major RCT program set the stage for accelerated growth and TAM, total addressable market, expansion.
Performance Analysis
CVRX’s third quarter showcased tangible progress in scaling its Barostim franchise, with double-digit year-over-year revenue growth and a notable increase in gross margin to 87 percent. The U.S. heart failure business remains the core driver, supported by disciplined expansion into new sales territories and a growing base of active implanting centers. The company added 10 net new centers in the quarter, bringing the total to 250, and increased U.S. sales territories to 50. Europe remains a small but stable contributor, with modest revenue growth but lower unit volumes.
Gross profit outpaced revenue growth, reflecting both higher average selling prices and improved manufacturing efficiencies as volume scales. Operating expenses were well-managed, with SG&A, selling, general, and administrative, spend rising only 1 percent despite ongoing investments in commercial infrastructure. R&D, research and development, spend increased as CVRX ramps for a pivotal RCT that could triple its addressable patient population. The net loss narrowed slightly as the company balanced growth investments with margin expansion, and strong cash reserves provide ample runway for continued execution.
- Gross Margin Leverage: Manufacturing scale and higher ASPs, average selling prices, drove a 400 basis point gross margin increase, outpacing revenue growth.
- Salesforce Transformation: More reps are contributing implants than ever, with turnover normalizing and onboarding accelerating.
- Reimbursement Tailwind: CMS, Centers for Medicare & Medicaid Services, finalized a Category 1 CPT code, reducing payer friction and improving patient access from 2026 onward.
Sequential revenue growth is moderating as the company cycles through a major salesforce reset, but management signals a return to mid-teens growth in 2026 as new reps reach full productivity and reimbursement reforms take effect.
Executive Commentary
"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."
Kevin Hikes, President and Chief Executive Officer
"Gross margin for the three months ended September 30, 2025 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies."
Jared O'Shine, Chief Financial Officer
Strategic Positioning
1. Salesforce Transformation and Territory Expansion
CVRX’s multi-year salesforce overhaul is beginning to yield results, with new hires contributing faster and turnover returning to industry norms. The company is now hiring at a measured pace, focusing on onboarding and productivity rather than headcount growth. A “best practice playbook” and targeted account selection are driving deeper adoption in high-potential centers, evidenced by more than 20 percent of active centers achieving three or more implants in Q3 and top sites exceeding 10 per quarter.
2. Reimbursement and Access Momentum
Reimbursement clarity is a major strategic lever for CVRX, as CMS’s decision to assign Barostim a Category 1 CPT code eliminates the experimental label and streamlines prior authorizations. This change, effective January 2026, is expected to reduce payer denials, accelerate approval timelines, and facilitate broader physician adoption. The company is also seeing positive signals from both Medicare Advantage and commercial payers, with improved rates and fewer denials at multiple review stages.
3. Clinical Evidence and Market Development
CVRX is expanding its clinical evidence base through peer-reviewed publications from implanting centers and a planned RCT that could triple its TAM by broadening eligibility criteria. The company’s presence at major conferences and targeted education for advanced practice providers is driving awareness and referral activity, supporting deeper therapy adoption within existing and new centers.
4. Operating Leverage and Cash Runway
Margin expansion and disciplined operating expense growth are demonstrating improving operating leverage as CVRX scales. With $85 million in cash and a net loss that is narrowing, the company has the resources to invest in its pivotal trial and commercial initiatives while maintaining financial flexibility.
Key Considerations
CVRX’s Q3 reflected a business transitioning from commercial buildout to operational scaling, with foundational moves in salesforce productivity, reimbursement, and clinical strategy converging ahead of a pivotal year.
Key Considerations:
- Rep Productivity Curve: While new reps are contributing faster, full productivity typically takes six to twelve months, suggesting lagged impact on top-line acceleration.
- Account Depth vs. Breadth: Deepening adoption in top centers is driving volume, but the next phase will require scaling this playbook across more accounts.
- RCT Execution Risk: The scale and complexity of the planned 2,000-patient trial represent both a TAM expansion opportunity and a significant operational challenge.
- Reimbursement Implementation: The transition to Category 1 CPT code is not an immediate step change, but friction is expected to decline through 2026, supporting higher approval rates and shorter timelines.
- OPEX Discipline: Management expects operating expense growth to lag revenue growth in 2026, preserving operating leverage as the business scales.
Risks
Key risks include execution on the pivotal RCT, which is a multi-year, resource-intensive effort with regulatory and enrollment hurdles. Salesforce productivity gains remain partly unproven at scale, and reimbursement improvements, while positive, may not translate into immediate volume growth. Competitive neuromodulation and heart failure therapies could also pressure adoption rates if CVRX fails to maintain clinical and commercial momentum.
Forward Outlook
For Q4 2025, CVRX guided to:
- Total revenue of $15 million to $16 million
For full-year 2025, management narrowed guidance to:
- Total revenue of $55.6 million to $56.6 million
- Gross margin of 85 percent to 86 percent
- Operating expenses of $98 million to $99 million
Management highlighted several factors that will shape 2026:
- Mid-teens revenue growth expected as new sales reps reach full productivity and reimbursement reforms take hold
- Operating expense growth to remain below top-line growth, supporting further operating leverage
Takeaways
CVRX is executing a methodical commercial scale-up, with foundational moves in salesforce optimization, reimbursement, and clinical development converging ahead of a pivotal 2026. Margin expansion and cash discipline provide flexibility, but the next phase will test the scalability of the model and the company’s ability to deliver on its RCT ambitions.
- Margin Expansion as a Strategic Lever: Manufacturing efficiency and pricing discipline are driving sustainable gross margin improvements, supporting reinvestment and cash preservation.
- Reimbursement and Clinical Evidence as Growth Catalysts: Category 1 CPT code and the planned RCT could unlock new patient populations and accelerate adoption, but execution risk remains high.
- 2026 Inflection Watch: Investors should monitor rep productivity curves, RCT milestones, and the real-world impact of reimbursement changes as key drivers of the next growth phase.
Conclusion
CVRX’s third quarter demonstrates a business moving from foundational buildout to operational scaling, with margin gains and commercial execution positioning the company for a pivotal year as reimbursement clarity and clinical expansion converge. The next twelve months will be critical in proving the scalability and durability of the Barostim growth thesis.
Industry Read-Through
CVRX’s margin expansion and reimbursement wins spotlight the operational leverage available to medtech innovators as they scale. The transition to Category 1 CPT codes signals a broader trend of neuromodulation therapies gaining mainstream acceptance, with payer friction expected to decline industry-wide. Salesforce transformation and targeted account development remain essential levers for device companies seeking to move from early adoption to standard of care. The scale and ambition of CVRX’s RCT program may set a new benchmark for evidence generation in cardiovascular devices, raising the bar for both incumbents and new entrants.