Research Project
7928024
DESCRIPTION (provided by applicant): BREONICS'Exsanguineous (Bloodless) Metabolic Support (EMS) technology is a disruptive technology that could significantly alter the current paradigm in clinical organ transplantation where demand for organs far outweighs supply. It is the first technology that can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidneys. This unique ability is transformational because it changes today's limitation of recovering cadaveric kidneys from within minutes of death to within a window of several hours, thereby radically expanding organ donation criteria. Redefining the existing donor criteria is what makes the technology distinct and why it should not be confused with traditional organ preservation techniques or blood perfusion, where repair of ischemic damage has never been demonstrated. The EMS technology has been developed over the past 12-years and is protected by 12 issued &pending patents. The technology is translational to human kidneys, where canine and human kidneys tested in parallel demonstrated equivalent parameters of metabolism and function. The preclinical data, along with initial proof of concept with human kidneys, provides the basis to move forward to product development and onto pilot clinical trials. Our goal is to transition our technology, with established efficacy in preclinical testing, to the development of a prototype clinical system that will be used to perform pilot clinical trials to repair ischemically damaged kidneys at the University of Michigan and the Cleveland Clinic. This project involves a multidisciplined team consisting of nationally recognized experts in their field that will provide the needed expertise to successfully accomplish our goals. PUBLIC HEALTH RELEVANCE: Exsanguineous Metabolic Support (EMS) is a transformational technology because it changes today's limitation of recovering cadaveric kidneys from within minutes of death to a window of several hours postmortem. EMS can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidneys. The potential to redefine donor criteria is what makes EMS technology unique and why it should not be confused with traditional hypothermic preservation techniques or blood perfusion. The technology has been shown to be translational to human kidneys in several publications. We are seeking funding to take our preclinical data, along with initial proof of concept with human kidneys, to product development and on to pilot clinical trials via IRB approval at the University of Michigan and the Cleveland Clinic. It is anticipated that the data from this project will lead to an IDE and the pivotal clinical trials necessary to commercialize the EMS technology. We believe the commercialization of EMS will provide a solution to the world-wide kidney shortage.
