Artivion Inc

Artivion reported second-quarter 2026 revenue of $125.8 million, up 9% on a constant currency basis, driven by growth in heart valve and stent graft products. Adjusted EBITDA rose 7% to $26.4 million, while adjusted EBITDA margin declined 90 basis points to 21% due to increased R&D investment and the Endospan acquisition. Stent graft revenue grew 12% to $46.4 million, On-X valve revenue increased 18% to $30.5 million, preservation services revenue rose 1% to $25.9 million, and surgical sealant revenue fell 2% to $19.3 million. The company received U.S. FDA premarket approval for its AMDS hybrid prosthesis in late June and completed the acquisition of Endospan during the quarter, adding the NEXUS Aortic Arch Stent Graft System. Full-year revenue guidance was reiterated at $480 million to $496 million, representing adjusted constant currency growth of 7% to 11%, and full-year adjusted EBITDA guidance was reiterated at $92 million to $99 million.

Artivion has received FDA premarket approval for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion. The approval removes the institutional review board requirement tied to the device's previous Humanitarian Device Exemption, enabling broader U.S. hospital adoption and allowing the company to pursue an estimated $150 million annual market opportunity. The device is the world's first aortic arch remodeling device for this condition and was supported by the PERSEVERE trial, which showed a 72% reduction in all-cause mortality and zero distal anastomotic new entry tears at 30 days. Artivion estimates that approximately 6,000 U.S. patients experience such dissections each year, with the approved indication covering roughly 60% of those cases. The company's shares have traded flat since the announcement, though they are down 50.7% year-to-date.

Artivion has received U.S. FDA premarket approval for its AMDS Hybrid Prosthesis, the world's first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections. The approval was supported by the PERSEVERE U.S. IDE trial, which demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events at 30 days compared to the standard hemiarch procedure, with zero distal anastomotic new entry tears. AMDS was previously available under a Humanitarian Device Exemption. The company stated that the PMA approval positions it to fully address an estimated $150 million annual U.S. market opportunity. Artivion shares rose more than 2% in pre-market trading after closing at $23.61 on Friday.