Adoption Economics And Cost BarriersHigh procedure-related costs and dependence on aviation logistics complicate hospital economics, potentially forcing selective device use or reliance on financing that slows broader uptake.
Exposure To Transplant Activity SwingsRevenue tied closely to U.S. transplant volumes and aviation operations creates sensitivity to declines in procedure activity, so weaker transplant trends can quickly reduce sales.
New Competitor ApprovalFDA clearance of a competing perfusion device introduces direct competitive pressure, with clinical data suggesting comparable graft outcomes that could limit share gains and pricing.