Artivion Q3 Revenue Rises 9% as Margins and Cash Flow Weaken

Artivion Inc. (NYSE: AORT) reported higher third-quarter revenue as its On-X heart valves and stent grafts delivered double-digit constant-currency growth, but lower margins, increased spending and acquisition-related payments weighed on earnings and cash flow. The medical-device company narrowed its full-year 2026 outlook to revenue of $484 million to $492 million and adjusted EBITDA of $93 million to $98 million.

Revenue for the quarter ended September 30 rose 9.2% year over year to $123.8 million, equivalent to 9% growth in constant currency. On-X revenue increased 13% on both a reported and constant-currency basis, while stent-graft revenue grew 12%. Preservation services and surgical sealant revenue were unchanged from a year earlier.

Artivion attributed On-X growth to market-share gains following the product’s low-INR label for aortic-valve patients, recent clinical data and cross-selling. Stent-graft growth came despite what the company described as a challenging comparison and was supported by its differentiated product portfolio and an increase in AMDS implants from the second quarter.

Growth was broad across regions. Revenue increased 8% in North America, 11% in Europe, the Middle East and Africa, and 8% in Asia-Pacific on both a reported and constant-currency basis. Latin American revenue rose 9% as reported and 5% in constant currency.

Margins and cash flow weaken

GAAP gross margin declined 420 basis points to 61.4% from 65.6% a year earlier. Artivion recorded a GAAP net loss of $7.9 million, or $0.16 per diluted share, compared with net income of $6.5 million, or $0.13 per share, in the prior-year quarter.

On a non-GAAP basis, diluted earnings were $0.08 per share, down from $0.16. Adjusted EBITDA fell 8.4% to $22.5 million from $24.6 million.

Operating cash flow was negative $4.6 million, compared with positive $22.3 million a year earlier, while free cash flow was negative $17.6 million versus positive $17.7 million. The company said free cash flow included a $13.3 million portion of the AMDS premarket-approval milestone payment that was classified as operating cash and about $2 million of Endospan integration expenses. Excluding those items, remaining free cash flow was relatively neutral as Artivion invested in its On-X manufacturing facility, operated the acquired Endospan business and prepared the U.S. launch of NEXUS.

U.S. aortic-arch portfolio advances

U.S. AMDS implants increased sequentially following premarket approval. Artivion expects set sales to build as it works to reduce barriers associated with the roughly $100,000 upfront investment required for starter sets.

The company also said it remains on track to begin the U.S. commercial launch of the NEXUS system in January 2027. Preparations include building inventory, obtaining value-analysis committee approvals, expanding the U.S. sales team and training surgeons.

Enrollment is continuing in the ARTIZEN pivotal trial for Arcevo LSA. As of November 2026, 56 patients had entered the study, which is designed to enroll as many as 132 patients across up to 30 centers in the U.S. and Europe. Artivion expects enrollment to be completed in mid-2027 and anticipates premarket approval in 2029.

Full-year outlook

Artivion’s full-year revenue range of $484 million to $492 million represents expected constant-currency growth of 8% to 10% from adjusted 2025 revenue of $443.6 million. The prior-year figure excludes the impact of estimated Italian payback obligations recorded in the fourth quarter of 2025 for fiscal years 2019 through 2025.

Management identified continued demand for On-X and aortic stents, clinical data supporting AMDS and On-X valves, and further U.S. adoption of AMDS as the principal revenue drivers. The adjusted EBITDA forecast of $93 million to $98 million includes about $8 million of previously disclosed Endospan-related expenses expected through 2026.

The company expects operating leverage to come from gross-margin expansion and its existing global sales and general-and-administrative infrastructure. Those expectations remain subject to risks involving international operations, regulatory developments, clinical trials and approvals, commercialization, market opportunities and the integration of acquired operations.