What Artivion, Inc. told the SEC could break it.

Artivion has pervasive single- and sole-source supplier dependence across its flagship product lines. For BioGlue, the molded-plastic delivery devices are made by a single supplier using resin from a different single supplier, and the bovine protein and cross-linker come from a small number of qualified suppliers. It purchases grafts for its On-X aortic anatomical prosthesis (AAP) from a single supplier, and various other On-X valve components come from single-source suppliers; the manufactured collagen suspension and heparin suspension each rely on a single external supplier. Because medical-device supplier changes can require an FDA PMA supplement before manufacturing can resume — Artivion abandoned its CardioGenesis cardiac-laser business in 2023 after a supplier's manufacturing-location change forced a PMA-S — these are concrete, hard-to-replace single points of failure. A high-severity, multi-product sole-source exposure.

“The delivery devices are manufactured by a single supplier, using resin supplied by a different single supplier. We purchase grafts for our On-X AAP from a single supplier and various other components for our On-X valves come from single-source suppliers.”

Artivion manufactures its aortic stent grafts — a key, fast-growing revenue driver — only at its primary European facility in Hechingen, Germany (≈156,000 sq ft of leased manufacturing/lab/warehouse space). 96% of its international long-lived assets are located in Hechingen. With this product line concentrated at a single overseas site, a disruption there (operational, regulatory under EU MDR, labor/Works Council, or geopolitical/energy) would be a single-point-of-failure for the aortic stent-graft business. A specific single-facility, single-country manufacturing concentration.

“Our primary European facilities, located in Hechingen, Germany, consist of approximately 156,000 square feet of leased manufacturing, administrative, laboratory, and warehouse space where we manufacture aortic stent grafts.”

Artivion's preservation-services business — about 22% of 2025 revenue ($95.5M of $441.3M) — depends entirely on the donation of cardiac and vascular tissues from deceased human donors by donor families. This is a structurally constrained, non-substitutable raw-material supply: unlike a manufactured component, donated human tissue cannot be sourced from an alternate vendor or scaled on demand, so a decline in donations, procurement-organization disruption, or tightened tissue-banking regulation directly limits the tissues Artivion can process and sell. A genuine, segment-specific supply dependence unique to its tissue-preservation business.

“Our preservation services business and our ability to supply needed tissues is dependent upon donation of tissues from human donors by donor families.”