Endospan Gets Extra $25M from Artivion for Nexus FDA Approval

Endospan Ltd. (Endospan), an Israeli-based developer of the NEXUS® Stent Graft System, has announced a new agreement with Artivion, Inc. (Artivion) that provides additional loans of up to $25 million. The funds will support Endospan's efforts to secure U.S. Food and Drug Administration (FDA) approval for NEXUS.

Kevin Mayberry, CEO of Endospan, expressed enthusiasm about the progress being made in their Investigational Device Exemption (IDE) study with the FDA. This new agreement with Artivion aims to extend treatment options for patients suffering from aortic arch disease. "We share a commitment with Artivion to providing minimally-invasive solutions to help surgeons address the complex challenges of this growing market," Mayberry said.

Approximately 120,000 patients in the USA and Europe suffer from thoracic aortic arch disease annually, yet only about 25% are diagnosed or treated. Despite advances in medical technology, open surgical repair for the aortic arch still comes with high mortality and morbidity rates. Patients who are not suitable for surgery due to high perioperative risks or anatomical factors have limited treatment options. Anatomical complexity and the lack of approved devices have historically hindered endovascular repair, complicating treatment decisions for many patients. Minimally invasive alternatives reduce the need for extra corporeal circulation and hypothermia, leading to shorter procedure and hospitalization times.

Endospan’s NEXUS is the first approved branched endovascular system designed to treat aortic arch disease, which includes both aneurysms and dissections. While minimally invasive endovascular repair has become the standard for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA), patients with aortic arch disease have previously had little choice but to undergo invasive open-chest surgery. This type of surgery poses significant risks and often results in lengthy hospital stays and long recovery periods. NEXUS transforms complex surgical repairs into minimally invasive procedures, addressing an estimated $600 million global market opportunity.

The TRIOMPHE IDE Study is currently enrolling patients to evaluate the safety and effectiveness of NEXUS in treating thoracic aortic lesions involving the aortic arch. This multi-arm, multi-center, non-randomized, prospective clinical study aims to enroll up to 110 patients across 31 sites. Earlier this year, Endospan shared 30-day results from the first 22 patients enrolled in the study. These early findings were consistent with results from an earlier EU clinical study, indicating that NEXUS could offer surgeons a reliable, minimally invasive solution for aortic arch repairs, providing consistent procedural results and improved patient outcomes.

Endospan, headquartered in Herzelia (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease, including aneurysms and dissections. The company has received CE-Mark approval to commercialize NEXUS in Europe. This system is the first off-the-shelf endovascular solution for aortic arch disease, which affects a significantly underserved patient group with dilative lesions in or near the aortic arch. While other areas of aortic disease have benefited from minimally invasive endovascular repair, patients with aortic arch conditions have had limited options, often resorting to high-risk open surgery.

Artivion, Inc., based in suburban Atlanta, Georgia, focuses on developing solutions for cardiac and vascular surgeons facing challenges in treating aortic diseases. Artivion’s product range includes aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. The company markets and sells its products in over 100 countries worldwide.