Development and Commercialization of Nanostructured Resorbable Urogenital Grafts

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Abstract Bladder cancer is the fourth most common cancer among men and the seventh most common cancer in women with a life expectancy of only five years after diagnosis. Repair of advanced bladder cancer requires removal of the bladder and construction of a neo bladder or urinary conduit using autologous bowel. These reconstructions have high chronic complications and cost. Complications stem from donor sight morbidity, mucus secretion and continued absorption of metabolites, drugs and other toxins by the bowel tissue. Metabolic imbalances, calculi formation, and severe diarrhea are common and malignancy and perforation are also reported. Allograft or xenograph materials do not have the absorptive properties of bowel tissue but are believed to have insufficient mechanical properties potentially leading to a life threatening perforation. With the support of a Phase I grant from the NCI, the team previously developed and tested a regenerative bladder graft in adult minipigs achieving bladder tissue regeneration and bladder capacity comparable to use of autologous bowel segments, and achieved supportive in vitro data. To build on these encouraging results the team proposes to apply the previously tested graft nanotechnology to generate a viable and durable urinary conduit in a porcine model that performs as well as a urinary conduit constructed from autologous bowel tissue but that has the potential for reduced complications, surgery time and expense. If this proposed program is successful, the team under Nanovis' infrastructure and financial support plans to commercialize the nanostructured urinary conduit.