Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, today announced it has entered into strategic distribution and credit facility agreements with CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease. Under the terms of the agreement, CryoLife will have exclusive European distribution rights to NEXUStm, 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 $10 million. Additionally, CryoLife will provide up to $15 million in debt financing to Endospan subject to progress on the U.S. 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 endo-vascular market together with our combined relationships with European opinion leaders," said Kevin Mayberry, CEO of Endospan. "This investment also positioned Endospan to seek U.S. 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 $150 million annually.
During the 33rd European Association for Cardio-Thoracic Surgery (EACTS) congress being held in Lisbon, Portugal, CryoLife will hold a symposium, "Future of Arch Treatment," on Friday, October 4th at 12:30pm featuring a lecture on the Endospan NEXUS Stent Graft System.
Privately held Endospan, headquartered in Herzliya (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan is the first CE endovascular off-the-shelf system to treat aortic arch disease, which includes a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website at www.endospan.com.
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