"The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit, as well as to allow the clinical investigators to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. To date, three patients have been enrolled and implanted in the clinical trial. Data from these patients have allowed clinical investigators to propose surgical modifications in an effort to address conduit patency and vascular supply. As planned, Tengion has submitted the surgical modifications and additional clinical data from the trial to the U.S. Food and Drug Administration (FDA). The Company expects to gain more clarity during the third quarter of this year from the FDA on the path forward for the trial and anticipates providing a trial and enrollment update by the time of its next quarterly update."