What LeMaitre Vascular, Inc. told the SEC could break it.

Biologic offerings represented 53% of LeMaitre's 2025 sales (52% in 2024, 51% in 2023), spanning bovine/porcine vascular grafts and patches and human cadaver-tissue allografts (RestoreFlow processing/cryopreservation of veins, arteries, cardiac valved conduits). The company states its reliance on sole-source and limited-source suppliers — including suppliers of biologic and tissue-based products — exposes it to supply disruptions. Animal-tissue and donor-tissue inputs are constrained, hard to qualify second sources for, and subject to disease/contamination and donor-availability shocks; a disruption at a sole tissue supplier would directly impair over half of revenue. A material biologic/tissue sole-source supply dependence.

“Our reliance on sole-source and limited-source suppliers, including suppliers of biologic and tissue-based products”

LeMaitre's RestoreFlow human-tissue allografts are subject to extensive FDA regulation under 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products) promulgated under Section 361 of the Public Health Service Act, with its Fox River Grove facility accredited by the American Association of Tissue Banks and subject to periodic inspections by regulators and notified bodies. Its Artegraft biologic vascular graft is a pre-amendment Class III device (outside the 510(k) pathway). Tightening of human-tissue/biologic regulation, an adverse inspection, or loss of accreditation would constrain a distinctive, high-margin slice of its portfolio. A specific tissue/biologic regulatory exposure beyond ordinary 510(k) device risk.

“Our allografts are subject to extensive regulation by the FDA under Title 21 of the Code of Federal Regulations, Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products).”