Artivion (AORT) Q3 2025: Stent Graft Revenue Surges 31%, Unlocking High-Margin U.S. Growth
Artivion’s Q3 showcased a decisive acceleration in high-margin product growth, led by U.S. AMDS stent graft adoption and robust Onyx valve momentum. Margin expansion and operational investments signal a durable shift toward innovation-driven profitability, with pipeline execution and reimbursement changes positioning the company for sustained outperformance into 2026.
Summary
- AMDS Launch Drives Mix Shift: U.S. stent graft adoption and new reimbursement code fuel high-margin expansion.
- Onyx Valve Momentum Accelerates: Clinical data and cross-selling propel global share gains in mechanical heart valves.
- Pipeline Execution Remains Central: Multi-year innovation cycle and facility investments set the stage for long-term growth.
Performance Analysis
Artivion delivered a 16% constant currency revenue increase in Q3 2025, with adjusted EBITDA up 39% year over year, demonstrating clear operational leverage. The standout driver was stent graft revenue, up 31%, primarily from the early U.S. launch of AMDS, aortic dissection stent, under Humanitarian Device Exemption (HDE). Onyx, mechanical aortic valve, also posted a strong 23% revenue gain, reflecting both share gains and expanded clinical adoption.
Gross margin rose to 65.6%, a 200-basis point YoY improvement, as higher-margin AMDS and Onyx products increased their mix, offsetting flat BioGlue and modest tissue processing growth. The company’s regional performance was broad-based, with North America leading at 19% growth. Operational investments—particularly the purchase of two Austin facilities to expand Onyx manufacturing—were funded by refinancing and balance sheet strengthening, with net leverage dropping to 1.8x from 3.9x last year.
- Mix Shift to Innovation: AMDS and Onyx drove margin expansion, with legacy tissue and BioGlue businesses stabilizing.
- Operational Footprint Expansion: Facility purchases in Austin support long-term Onyx capacity and cost control.
- Cash Flow Dynamics: Opportunistic real estate buys create near-term cash outflows, but 2026 is guided to return to positive free cash flow.
Artivion’s results reflect a deliberate pivot to high-value, differentiated products, with pipeline and reimbursement catalysts supporting future growth and profitability.
Executive Commentary
"Our Q3 performance was enabled by continued growth across our product portfolio with StentGraphs and ONIC valves acting as significant growth engines... We see our StentGraph portfolio as a foundational component of our growth strategy, and we are encouraged by these strong results with AMDS."
Pat Mackin, CEO
"Gross margins were 65.6% in Q3, compared to 63.7%... due primarily to favorable mix from AMDS HDE revenues in the U.S. and the exceptional onyx growth particularly in the U.S."
Lance Berry, COO and CFO
Strategic Positioning
1. AMDS Stent Graft: U.S. Launch Momentum and Reimbursement Tailwind
The AMDS stent graft launch is transforming Artivion’s U.S. business mix, with initial stocking orders and early adoption ramping quickly. The recent establishment of DRG 209, a new CMS reimbursement code for complex aortic procedures, directly addresses hospital cost sensitivity and is expected to further accelerate AMDS penetration. Management estimates the U.S. AMDS market opportunity at $150 million annually, with limited competitive alternatives and strong clinical data validation supporting adoption.
2. Onyx Valve: Clinical Data-Driven Share Gains and Cross-Selling
Onyx’s unique low-INR indication and new mortality benefit data are fueling a mechanical valve “renaissance,” especially in patients under 65. Management cited two large studies showing significant long-term survival advantages for mechanical over bioprosthetic valves in younger cohorts. Cross-selling from AMDS launch activities is expanding Onyx’s reach, and a planned marketing push to cardiologists in 2026 could extend this growth cycle.
3. Pipeline Execution and Facility Investments
Artivion is executing a multi-year innovation cycle, with PMA (pre-market approval) filings for AMDS and Nexus, as well as the pivotal ARCEVO LSA trial. The company’s purchase of two Austin facilities secures long-term Onyx manufacturing capacity, hedges against future rent escalation, and signals confidence in sustained demand. The amended credit facility and $150 million delayed draw term loan provide flexibility for potential M&A, notably the Endospan (Nexus) acquisition option if FDA approval is secured.
4. Legacy Business Stabilization
Tissue processing and BioGlue, legacy business lines, returned to normalized growth rates post-cybersecurity disruption, though are expected to deliver flat to mid-single-digit growth going forward. These segments provide a defendable base, but the strategic emphasis is clearly on scaling high-margin, differentiated technologies.
Key Considerations
Artivion’s Q3 marked a structural inflection toward innovation-led growth, with execution across commercial, clinical, and operational fronts. The sustainability of this momentum hinges on pipeline delivery, market access, and continued margin improvement.
Key Considerations:
- Reimbursement Impact: DRG 209 is expected to materially improve hospital adoption economics for AMDS, reducing budget constraints and validating Artivion’s complex aortic strategy.
- AMDS Ramp Dynamics: Current revenue is heavily weighted to initial stocking, but implantations are increasing monthly—true recurring demand will be the critical metric heading into 2026.
- Onyx Marketing Upside: Direct outreach to cardiologists remains untapped, offering a potential new wave of share gains as clinical data is disseminated beyond surgeons.
- Pipeline Execution Risk: Timelines for Nexus PMA and ARCEVO pivotal trial are on track, but regulatory and enrollment delays could impact long-term growth targets.
- Operational Leverage: Facility ownership in Austin locks in cost control and capacity, but near-term cash flow is temporarily negative due to acquisition payments.
Risks
Artivion faces execution risk on its pipeline, with FDA approval for Nexus and ARCEVO trial enrollment as potential bottlenecks. The AMDS U.S. launch is still in early innings, with future growth dependent on moving from stocking to high-volume clinical adoption. Reimbursement dynamics, especially in Japan and China, remain uncertain, and competitive responses in the mechanical valve market could pressure share gains if new data emerges elsewhere.
Forward Outlook
For Q4 and full-year 2025, Artivion raised guidance:
- Constant currency revenue growth: 13-14% (prior 12-14%)
- Reported revenue: $439-445 million (prior $435-443 million)
- Adjusted EBITDA: $88-91 million, with 24-28% growth and 200 bps margin expansion
Management highlighted:
- 2026 will see similar growth dynamics, but AMDS comps will be tougher as launch anniversaries roll through the year.
- Full-year clinical trial costs for ARCEVO will push R&D spend to the higher end of the 7-8% of sales range.
- Free cash flow will turn positive again in 2026 after one-time facility purchase payments.
Takeaways
Artivion’s Q3 demonstrated a decisive pivot to innovation-led, high-margin growth, underpinned by AMDS and Onyx execution, improved reimbursement, and a robust pipeline. The company is leveraging operational investments and balance sheet flexibility to sustain double-digit revenue and outsized EBITDA growth.
- AMDS and Onyx are now the clear engines of margin and revenue expansion, with reimbursement and clinical data providing tailwinds into 2026.
- Facility and pipeline investments position Artivion for sustained leadership, but execution risk remains on regulatory and commercial fronts.
- Investors should watch for AMDS implantation ramp, Nexus trial data, and Onyx cardiologist outreach as key catalysts in the next 12 months.
Conclusion
Artivion’s Q3 results confirm a structural shift toward high-value, innovation-driven growth, with AMDS and Onyx delivering both top-line momentum and margin expansion. The company’s disciplined pipeline execution and operational investments set the stage for sustained outperformance, but ongoing delivery on regulatory, clinical, and commercial fronts will be essential to realize the full potential of its differentiated portfolio.
Industry Read-Through
Artivion’s accelerating stent graft and mechanical valve growth signals a broader industry shift toward high-margin, clinically differentiated cardiovascular devices, especially as new reimbursement codes and clinical data reshape adoption curves. The success of AMDS and Onyx underscores the value of innovation and targeted clinical evidence in driving market share, while facility investments highlight the importance of supply chain control for scaling next-generation therapies. Competitors in cardiac surgery, vascular intervention, and structural heart should note the rising bar for clinical validation and economic value proposition as key factors in future market access and pricing power.