A NOVEL HOMOGRAFT HEART VALVE PRESERVATION PROCESS

DESCRIPTION (provided by applicant): Approximately 60,000 heart valve replacement surgeries are performed each year in the U. S. alone with nearly 4,500 of these being allograft tissue valves. Current available technology for procurement of allografts involves the use of antibiotic storage solutions and cryopreservation techniques. These methods require the added complication and expense of specialized storage and transport systems. We have developed a process referred to as D-Hydro(TM) technology for the treatment, lyophylization and sterilization of allograft valve tissue. Preliminary studies in sheep indicate that this treatment provides a nonimmunogcnic, intact collagen tissue matrix that becomes a "living tissue" allograft through host cell rehabitation. We will evaluate-processed homografts for competency in the orthotopic position, induction of host immune response, and validation of the sterilization process and effect of sterilization on tissue integrity. Since the process does not require that harvested homografts contain viable cells, extension of tissue procurement time will be studied. Our plan is to commercialize this process and implement it through existing valve banks in the U. S. as well as other parts of the world should the proposed studies support our preliminary observations. PROPOSED COMMERCIAL APPLICATION: The goal of Philogenesis, Inc. is to license the D-Hydro(TM) technology to an organization that procures, processes and distributes donor tissues such as the Red Cross and possibly to companies currently involved in cryopreservation of homograft valves. If the process proves successful in human clinical trials it will be expanded to include other tissue sources.