The long-term objective of this project is the commercialization of a product(s) that enables a substantial improvement in human heart preservation prior to transplantation. The ability to significantly extend human clinical cardiac preservation, to 24 hours or more, would allow transcontinental prospective matching, with expected gain in clinical outcome for potentially thousands of transplant recipients. Phase I studies provided a proof-of-concept for the feasibility of an automated intermittent perfusion device, that used in conjunction with the preservation solution (URS) described in Phase I, successfully preserved canine hearts for at least 24 hours. Data from phase I also demonstrated that the use of URS alone, not in combination with intermittent perfusion, results in substantial extension of cardiac preservation when compared to current commercial preservation formulations. Based on these findings, it is now our strategy to introduce two products sequentially: first, URS as a stand alone product for cardiac preservation, and later, an intermittent perfusion device that will build on the first product release and offer yet further extension of cardiac preservation. In phase II we plan to demonstrate the utility of URS for 24 hour storage using post-transplant survival in animal models as an end point, and to investigate the limits of URS for the preservation of human hearts. It is our intention to use this body of data as evidence to persuade the FDA to grant clearance for 21st Century Medicine to proceed with multicenter, randomized human clinical trials to begin phase Ill. Additionally, in phase II, the development of the intermittent perfusion device as a powerful preservation modality will continue. Ultimately the device may become a second generation product as currently envisioned. However, it is also possible the data from human heart studies in phase II will demonstrate that intermittent perfusion with URS is indeed necessary to achieve the desired extension of human cardiac preservation. Should that be the case, the combination product, URS with an intermittent perfusion system, will be tested with greater priority.
