Relevant Medical Need for Our Technology
American Heart Association (AHA) reports that 100,000 heart valve replacements are performed in the U.S. annually, a $1.7 billion burden. Current underdiagnosis and undertreatment of heart valve disease, combined with the aging population, is expected to dramatically expand clinical heart valve replacement volumes.Deficiencies of current replacement heart valves led the National Heart, Lung, and Blood Institute (NHLBI) Cardiac Surgery Working Group to recommend increased funding for heart valve prosthesis biomaterial research. Due to their native tissue ECM composition, structure, and function, xenogeneic tissues (e.g., BP) have potential to serve as ideal heart valve prosthesis biomaterials. However, as noted by the NHLBI Xenotransplantation Working Group, recipient graft-specific adaptive immune responses towards xenogeneic tissue antigens are the primary barrier to expanded use of xenogeneic tissues and organs in clinical practice.
