According to a press release, Endospan has entered into strategic distribution and credit facility agreements with CryoLife. Under the terms of the agreement, CryoLife will have exclusive European distribution rights to Nexus, the first off-the-shelf endovascular stent graft system approved for the repair of both aneurysms and dissections in the aortic arch.
CryoLife will pay a total upfront payment of US$10 million. Additionally, CryoLife will provide up to US$15 million in debt financing to Endospan subject to progress on the US clinical development program for the Nexus Stent Graft System.
“We are very pleased to announce a European distribution agreement with CryoLife that allows us to leverage their company’s depth of experience and proven capabilities in the endovascular market together with our combined relationships with European opinion leaders,” said Kevin Mayberry, CEO of Endospan. “This investment also positioned Endospan to seek US Food and Drug Administration (FDA) approval for the NEXUS Stent Graft System through a premarket approval (PMA) study that is expected to start enrolling patients in 2020.”
Minimally invasive techniques are standard-of-care for treating descending aortic disease and heart disease, but highly invasive, high-mortality open surgery is still being used in the difficult-to-treat aortic arch anatomy. The Nexus Stent Graft System is uniquely engineered to address this significant area of unmet and underserved clinical need. The European market for the treatment of aortic arch disease including aneurysms and dissections is approximately US$150 million annually.