Artivion Gains FDA Approval for NEXUS System, Secures $150M Loan to Acquire Endospan
Artivion can exercise its option to acquire Endospan within 90 days after FDA approval of the NEXUS Aortic Arch System, backed by a $150 million delayed-draw term loan. The TRIOMPHE IDE trial showed 90% survival, 90% freedom from disabling stroke and 98% freedom from reintervention at one year.
1. FDA Approval and Acquisition Option
The FDA has granted premarket approval for the NEXUS Aortic Arch System, enabling Artivion to exercise its option to acquire Endospan within 90 days of approval. This milestone unlocks a strategic pathway to integrate the off-the-shelf branched endovascular stent graft into Artivion’s product portfolio.
2. Financing via Delayed-Draw Loan
Artivion secured a $150 million delayed-draw term loan in anticipation of FDA approval to fund the potential Endospan acquisition. The financing agreement provides immediate capital availability upon drawdown and supports Artivion’s strategic expansion in aortic arch disease treatments.
3. NEXUS TRIOMPHE IDE Trial Results
The NEXUS TRIOMPHE IDE trial reported a 90% patient survival rate, 90% freedom from disabling stroke and 98% freedom from reintervention due to endoleaks at one year post-treatment. These outcomes address a high-risk patient population historically limited to invasive open-chest surgery.