A Solution to the Kidney Shortage: Exsanguineous Metabolic Support, From Breadbo

描述(由申请人提供)：BREONICS的失血(无血)代谢支持(EMS)技术是一项颠覆性技术，可能显著改变目前器官移植的临床范例，在临床器官移植中，器官的需求远远超过供应。这是第一项可用于在缺血损伤发生后进行干预的技术，以复苏和修复受损的肾脏。这种独特的能力具有变革性，因为它改变了今天的限制，即从死亡后几分钟内恢复身体肾脏到几小时内，从而从根本上扩大了器官捐赠的标准。重新定义现有的供体标准是这项技术的独特之处，也是为什么它不应与传统的器官保存技术或血液灌流相混淆，在传统的器官保存技术或血液灌流中，缺血损伤的修复从未得到证明。EMS技术在过去的12年中得到了发展，并受到12项已发布和正在申请的专利的保护。这项技术适用于人类肾脏，在犬类和人类肾脏的平行测试中，证明了代谢和功能的同等参数。临床前数据，以及对人类肾脏的初步概念验证，为推进产品开发和试点临床试验提供了基础。我们的目标是将我们的技术(在临床前测试中具有既定的有效性)转化为开发原型临床系统，该系统将用于在密歇根大学和克利夫兰诊所进行修复缺血受损肾脏的试点临床试验。该项目涉及一个由各自领域的国家公认专家组成的多学科小组，他们将提供成功实现我们的目标所需的专门知识。 公共卫生相关性：失血代谢支持(EMS)是一项变革性的技术，因为它改变了今天从死亡几分钟内恢复身体肾脏的限制，而不是死后几个小时的窗口。EMS可用于在发生缺血损伤后进行干预，以复苏和修复受损的肾脏。重新定义供体标准的可能性是EMS技术的独特之处，也是为什么它不应与传统的低温保存技术或血液灌流混淆。在几份出版物中，这项技术已经被证明可以翻译成人类肾脏。我们正在寻求资金，将我们的临床前数据，以及对人类肾脏的初步概念验证，用于产品开发，并通过密歇根大学和克利夫兰诊所的IRB批准进行临床试验。预计来自该项目的数据将导致集成开发环境和将EMS技术商业化所需的关键临床试验。我们相信，EMS的商业化将为世界范围内的肾脏短缺提供解决方案。

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.