#USA #Atlanta #NEXUS #AORT #Endospan

Artivion Receives FDA Approval for NEXUS® Aortic Arch System

In an exciting development for cardiovascular medicine, Artivion, Inc. (NYSE: AORT) has confirmed that the U.S. Food and Drug Administration (FDA) has granted premarket approval for its NEXUS® Aortic Arch System. Developed in partnership with Endospan Ltd., this groundbreaking system aims to address aortic arch diseases, a challenge that doctors and patients have struggled with for years.

The Importance of the NEXUS® System

The NEXUS system represents a significant advancement in the field, particularly for those dealing with chronic aortic dissections and other aortic arch issues. Traditionally, treatment for such conditions has required invasive open-chest surgery, posing considerable risks and lengthy recoveries. The NEXUS system offers a more patient-friendly, minimally invasive alternative, potentially saving lives and improving outcomes for high-risk patients.

According to data from the NEXUS TRIOMPHE IDE trial that supported the FDA’s approval, the system demonstrated remarkable results, including:

• - 90% patient survival from lesion-related death
• - 90% freedom from disabling stroke one year post-treatment
• - 98% freedom from reintervention due to endoleaks at the one-year mark.

This strong clinical data underscores the necessity and efficacy of the NEXUS technology in improving patient care in aortic disease treatment settings.

Next Steps for Artivion

Artivion's CEO, Pat Mackin, expressed enthusiasm about the FDA approval, highlighting its implications for artivion's responsibilities towards patients with aortic arch disease. With this green light, Artivion now has the right to acquire Endospan within 90 days—a strategy that the company was preparing for in anticipation of the approval.

Artivion has secured a $150 million delayed draw term loan, aimed at financially supporting the acquisition should the company choose to pursue it. This proactive financing underscores Artivion's commitment to expanding its capabilities within the cardiac and vascular surgical fields.

As the company conducts its assessment of this acquisition option, stakeholders and shareholders alike await updates on the evolving business landscape following the NEXUS approval.

About Artivion

Artivion operates from its headquarters near Atlanta, Georgia, focusing on developing innovative solutions for cardiac and vascular surgeons facing the complexities of aortic diseases. The company markets a wide range of products, including aortic stent grafts, surgical sealants, and On-X mechanical heart valves, enhancing surgical outcomes for cardiovascular patients.

About Endospan

Based in Herzliya, Israel, Endospan Ltd. is recognized as a leader in innovating endovascular technologies, particularly the repair of aortic arch diseases. They have received CE-Mark approval to commercialize the NEXUS Stent Graft System in Europe, thus broadening access to game-changing treatments for patients typically underserved in aortic arch interventions.

For anyone interested in the future of cardiovascular treatment, the collaboration between Artivion and Endospan through the NEXUS system heralds a promising new era in patient care, emphasizing safety, efficiency, and improved health outcomes.