Artivion NYSE: AORT executives said the company delivered double-digit revenue and adjusted EBITDA growth in the first quarter of 2026, while also lowering its full-year revenue outlook due primarily to softer stent graft trends and timing around U.S. AMDS account stocking.
CEO Pat Mackin said Artivion “continued to execute our strategy designed to drive long-term profitable growth” through its product portfolio, with first-quarter constant currency revenue growth of 12% and adjusted EBITDA growth of 26% year over year. COO and CFO Lance Berry said total revenue was $116.3 million, while adjusted EBITDA rose to $22.1 million from $17.5 million in the prior-year period. Adjusted EBITDA margin was 19%, up about 130 basis points, driven by SG&A leverage and gross margin improvement.
Endospan Deal Moves Forward After NEXUS Approval
A major focus of the call was Artivion’s decision to exercise its option to acquire Endospan following FDA premarket approval of Endospan’s NEXUS Aortic Arch Stent Graft system for chronic aortic dissections. Mackin described NEXUS as a branched endovascular stent graft system designed for minimally invasive treatment of aortic arch disease, where some patients otherwise have limited options beyond open heart surgery.
Mackin said data from the chronic aortic arch dissection cohort of the TRIOMPHE trial showed 93% survival from lesion-related death, 90% freedom from disabling stroke at one year and 95% freedom from intervention due to endoleaks, excluding type II endoleaks, at one year.
The company estimates the annual U.S. addressable market opportunity for both NEXUS cohorts at about $150 million, with dissections representing about $100 million. Mackin said Artivion plans to pursue a label supplement for aortic aneurysms through formal regulatory processes after the acquisition.
Berry said Artivion drew $150 million under its existing term loan facility to fund the $135 million upfront purchase price for the anticipated acquisition. The company expects the transaction to close in the second quarter of 2026, subject to customary conditions. Berry said quarterly interest expense would rise to about $8 million beginning in the third quarter if the deal closes as anticipated.
The company expects immaterial U.S. NEXUS revenue in 2026 as it works through value analysis committee approvals, builds supply and expands its U.S. sales support. Management is targeting a full U.S. launch on Jan. 1, 2027.
Stent Grafts Weigh on Guidance
Artivion reduced its 2026 revenue outlook, now expecting adjusted constant currency growth of 7% to 11%, representing reported revenue of $480 million to $496 million. Berry said the updated guidance assumes foreign exchange will provide about a one percentage point tailwind to reported revenue.
The company now expects full-year 2026 adjusted EBITDA of $100 million to $107 million excluding the planned Endospan acquisition. If the acquisition closes as expected, Artivion anticipates about $8 million in incremental 2026 expenses tied to launch costs, commercial infrastructure, operating costs, R&D and clinical expenses, reducing expected adjusted EBITDA to $92 million to $99 million.
Berry said the guidance reduction primarily reflects stent graft factors. Stent graft revenue grew 10% in constant currency during the quarter, but Mackin said that was below expectations due to lower-than-expected U.S. AMDS set sales and softer international results, especially in the Middle East. He also cited tougher European comparisons following recovery from the company’s 2024 cybersecurity event.
In response to analyst questions, Mackin said the shortfall was driven by two main areas: international stents, including Middle East weakness and supply chain challenges, and AMDS starter set sales in the U.S. Berry said the guidance reduction was roughly split between AMDS set sales and international stent grafts, with the international issue roughly split between the Middle East situation and supply chain factors.
AMDS Reorders Encouraging, Starter Sets Face Barriers
Mackin and Berry emphasized that U.S. AMDS implant and reorder activity was stronger than expected, even though initial account stocking was below plan. Mackin said Artivion is more focused on implant and reorder patterns than the immediate impact of starter set sales because reorders reflect user experience and potential long-term adoption.
Management said hospitals typically must purchase four AMDS devices for about $100,000 as an initial starter set. Berry said the company is encountering barriers to that upfront purchase, including financial considerations and the need for institutional review board processes while AMDS remains under a Humanitarian Device Exemption. Mackin said some accounts may be waiting for anticipated PMA approval rather than completing IRB-related steps.
Artivion continues to expect AMDS PMA approval around midyear 2026. Mackin said PMA approval should remove the need for new accounts to go through the IRB process, which he expects to help account conversion.
When asked whether the company would move to consignment, Berry said Artivion is not pursuing that approach now. “You can always flip to consignment, you can never flip back,” Berry said, adding that AMDS is used in emergency cases and that management believes hospitals should stock it given the product’s differentiation and reimbursement dynamics.
On-X and Tissue Processing Drive Growth
Outside stent grafts, Artivion reported stronger growth in several product areas. On-X revenue grew 17% in constant currency, which Mackin attributed to global market share gains and early traction tied to data supporting mechanical valves versus bioprosthetic valves in younger patients. Mackin said the company continues to view On-X as the best aortic valve option for patients under age 65.
Tissue processing revenue rose 23% in constant currency as tissue volumes normalized following the late-2024 cybersecurity incident. Berry said the business performed slightly above expectations in the quarter but advised investors to think of it as roughly a $24 million-per-quarter business, with normal quarterly fluctuations.
BioGlue revenue was relatively flat in constant currency. Mackin said the performance was slightly below the company’s mid-single-digit growth expectation for the full year but within normal quarter-to-quarter variability given distributor and stocking dynamics.
Pipeline Progress Continues
Mackin said Artivion has enrolled 26 patients in the ARTIZEN clinical trial for Arcevo LSA, a non-randomized trial expected to include 132 patients in the U.S. and Europe at up to 30 centers. The product is being studied for treatment of aortic dissection and aneurysm in the arch. The company expects full enrollment in mid-2027 and, assuming the trial meets its endpoints, FDA approval in 2029. Mackin said Arcevo LSA represents an incremental $80 million annual U.S. market opportunity.
Management said the pending Endospan acquisition would complete what Mackin called Artivion’s “three-pronged aortic arch portfolio,” alongside AMDS and Arcevo LSA. Mackin said NEXUS is also a platform technology with three additional PMA programs in development.
“Overall, we have near-term work to do,” Mackin said, while adding that management exited the quarter with greater conviction in Artivion’s long-term growth strategy.
About Artivion NYSE: AORT
Artivion, Inc NYSE: AORT is a global medical technology company that develops, manufactures and markets implantable tissue products and surgical devices for cardiac and vascular surgery. The company’s portfolio includes biologic implants derived from human and animal tissue, such as allografts and xenografts, as well as synthetic scaffolds and surgical adhesives. These products are designed to repair, reinforce or replace damaged cardiovascular and thoracic tissues during procedures such as aortic repair, heart valve surgery and vascular reconstruction.
Originally founded in 1984 under the name CryoLife, the company rebranded as Artivion in early 2022 to reflect its broader mission in cardiovascular innovation.
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