AORT Q3 Deep Dive: AMDS and On-X Outperform, Pipeline and Reimbursement Bolster Outlook

Medical device company Artivion (NYSE:AORT) reported Q3 CY2025 results exceeding the market’s revenue expectations, with sales up 18.4% year on year to $113.4 million. The company’s full-year revenue guidance of $442 million at the midpoint came in 0.9% above analysts’ estimates. Its non-GAAP profit of $0.16 per share was in line with analysts’ consensus estimates.

Is now the time to buy AORT? Find out in our full research report (it’s free for active Edge members).

StockStory’s Take

Artivion delivered a Q3 marked by strong revenue growth and a positive market response, as ongoing adoption of its stent grafts and On-X heart valves fueled performance. Management highlighted particularly robust results for AMDS, with CEO Pat Mackin attributing the gains to early adoption in the U.S. and “growing early adoption and initial stocking orders.” The company also cited positive new clinical data and incremental reimbursement improvements for complex aortic procedures as supporting its value proposition. On-X continued to gain global share, underpinned by fresh clinical evidence and cross-selling momentum from the AMDS launch.

Looking ahead, Artivion’s guidance reflects confidence in continued double-digit revenue growth, driven by expanding adoption of its AMDS and On-X platforms and a robust innovation pipeline. Management sees reimbursement changes as a tailwind and anticipates new product launches, including Arcevo and NEXUS, to unlock sizable addressable markets. CFO Lance Berry emphasized, “We expect to continue to drive double-digit revenue growth with adjusted EBITDA growing at twice the rate of constant currency revenue growth,” while noting that ongoing investments in clinical trials and potential acquisition activity may influence expense trends in the coming quarters.

Key Insights from Management’s Remarks

Management attributed the quarter’s commercial momentum to AMDS adoption, On-X clinical differentiation, and operational investments to expand capacity and market reach.

• Stent graft acceleration: The stent graft portfolio, led by AMDS, saw 31% constant currency growth as initial stocking and early U.S. adoption gained traction. AMDS benefited from new reimbursement codes (DRG-209) and positive late-breaking clinical data, which management believes will support broader hospital access and patient adoption.
• On-X valve momentum: On-X mechanical heart valves grew 23% year-over-year, supported by recent clinical evidence demonstrating a mortality and reoperation benefit for patients under 65 compared to bioprosthetic valves. Management noted that cross-selling with AMDS is helping to drive new account openings and share gains.
• Operational expansion: Artivion invested in two new facilities in Austin, Texas to expand On-X manufacturing capacity, aiming to support continued growth and preempt future supply constraints. These purchases are expected to reduce long-term occupancy costs and underpin future operating leverage.
• Pipeline progress: The company is advancing pivotal trials for its Arcevo device (third-generation frozen elephant trunk) and progressing toward potential FDA approval for NEXUS, a modular aortic arch replacement system. Management highlighted that the Arcevo trial has begun enrolling patients and that NEXUS data will be presented in early 2026.
• Resilient base businesses: Tissue processing and BioGlue both returned to normalized growth rates after prior disruptions, with tissue revenues stabilizing post-cybersecurity event and BioGlue expected to post mid-single-digit growth annually, despite quarterly variability.

Drivers of Future Performance

Artivion’s outlook is built on expanding AMDS and On-X adoption, new product launches, and anticipated benefits from reimbursement and operational investments.

• AMDS adoption and reimbursement: Management expects the AMDS platform’s U.S. rollout to continue driving revenue growth, supported by the new DRG-209 reimbursement code and accumulating positive clinical trial data. Broader adoption and increased hospital access are expected as more surgeons complete required training and value analysis processes.
• On-X marketing ramp and market expansion: Artivion plans to increase marketing to cardiologists in 2026, building on recent clinical results that position On-X as the preferred choice for patients under 65. Cross-selling opportunities with AMDS and broader clinical education efforts are expected to support continued global share gains.
• Pipeline and trial investment: The company is investing in its innovation pipeline, including the Arcevo pivotal trial and ongoing development of NEXUS. Management cautioned that full-year trial costs and integration activities could slightly pressure margins in the near term, but expects these investments to unlock new U.S. market segments in the coming years.

Catalysts in Upcoming Quarters

Over the next few quarters, the StockStory team will track (1) the pace of AMDS adoption in U.S. hospitals and surgeon training completion, (2) progress on pivotal trials for Arcevo and NEXUS, including key data releases and regulatory milestones, and (3) realization of manufacturing expansion benefits and operational leverage. Additional attention will be paid to reimbursement updates and further clinical evidence supporting AMDS and On-X.

Artivion currently trades at $48.98, up from $47.60 just before the earnings. At this price, is it a buy or sell? See for yourself in our full research report (it’s free for active Edge members).

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