Endospan Receives Additional Funding From Artivion

July 2, 2024—Endospan Ltd., an Israel-based developer of the Nexus stent graft system, announced an agreement with Artivion, Inc. for additional loans of up to $25 million. The funds will be used to pursue FDA approval of the Nexus device.

Artivion is a medical device company headquartered in suburban Atlanta, Georgia. In 2019, Artivion (formerly known as CryoLife, Inc.) announced it entered into distribution and credit facility agreements with Endospan and advised it had an option agreement to purchase Endospan.

According to Endospan, Nexus is a branched endovascular system for the treatment of aortic arch disease, including both aortic aneurysms and aortic dissections. The device received CE Mark approval in 2019 and is commercially available in Europe.

The company stated that it is currently enrolling patients in the TRIOMPHE investigational device exemption study to evaluate the safety and effectiveness of Nexus in treating thoracic aortic lesions involving the aortic arch. TRIOMPHE is a multi-arm, multicenter, nonrandomized, prospective, clinical study that will enroll up to 110 patients at up to 31 sites. The commencement of enrollment was announced in January 2021.

In January 2024, Endospan announced the presentation of 30-day results of the first 22 patients enrolled in the study. This early data aligned with results achieved during a European Union clinical study, noted the company.