Endospan, an Israeli-based, privately-held developer of the NEXUS Stent Graft System, announced today an agreement with Artivion for additional loans of up to $25M for U.S. Food and Drug Administration (“FDA”) approval of NEXUS.
“We’re excited to progress in our IDE study with the FDA and extending options for more patients with aortic arch disease through this agreement with Artivion,” Kevin Mayberry, chief executive officer of Endospan, said. “We share a commitment with Artivion to delivering minimally-invasive solutions to help surgeons address the complex challenges of this growing market.”
More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extra corporal circulation and the possibility of hypothermia, translating into reduced procedure and hospitalization time.
Endospan has developed NEXUS, the first and only approved branched endovascular system to treat aortic arch disease, including both aortic aneurysms and aortic dissections. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA), aortic arch disease patients with aneurysms or dissections who receive treatment have previously had little choice but to undergo open-chest surgery with its associated invasiveness and risks, lengthy hospitalizations, and prolonged recuperation. NEXUS transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure. NEXUS addresses a $600M global addressable market opportunity.
Endospan is currently enrolling patients in the TRIOMPHE IDE Study, a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and effectiveness of NEXUS® in treating thoracic aortic lesions involving the aortic arch. The study will enroll up to 110 patients at up to 31 sites. Earlier this year, Endospan shared 30-day results of the first 22 patients enrolled in the study. This early data aligned with results achieved during an EU clinical study, suggesting that NEXUS may provide surgeons with a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.
