Artivion, Inc. (NYSE:AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the NEXUS® Aortic Arch System, developed by Endospan Ltd. ("Endospan"), Artivion's long-standing partner. The approval entitles Artivion to exercise its option to acquire Endospan at any time within 90 days of receiving this notice of FDA approval. Artivion has a $150 million delayed draw term loan in place, secured in anticipation of this approval, to fund a potential acquisition. The Company is actively working to complete its evaluation of the option following the earlier than anticipated approval.
NEXUS is a branched endovascular stent graft system approved in the United States for the minimally invasive treatment of aortic arch disease, including chronic aortic dissections, a patient population that has historically had little treatment option but open-chest surgery. The FDA's approval is supported by data from the NEXUS TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.
"NEXUS receiving FDA approval ahead of our expectations is an exciting milestone for patients with aortic arch disease, for our partner Endospan, and for Artivion," said Pat Mackin, Chairman, President, and Chief Executive Officer. "The TRIOMPHE data has consistently demonstrated the clinical value of this technology, and we are proud to have supported Endospan on this journey. We have proactively put the financing in place to support a potential acquisition, and we are moving diligently to finalize our considerations around the option. We look forward to updating shareholders soon.
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