EMS

Exsanguinous Metabolic Support

EMS consists of the solutions and equipment designed to maintain an organ, or a block of vascularized anatomy, off-line from the rest of the physiologic system. EMS has demonstrated that it is feasible to resuscitate, evaluate, maintain and repair warm ischemically damaged organs and tissue. EMS provides a means to overcome the technical barriers to expanding the organ donor pool and make available more organs for human clinical transplantation.

EMS for Clinical Transplantation

Transplantation is the therapy of choice for people with end-stage organ failure. For end-stage heart, liver and lung disease, transplantation is the only life-saving remedy. In the case of end-stage renal disease (ESRD), transplantation is generally preferred to dialysis because, if the graft is tolerated, it is the only therapy that allows the patient to lead a normal life. However, the use of transplantation as a life saving modality is severely limited by the shortage of organs. In the U.S. there are approximately 300,000 patients with ESRD for whom the number of kidneys available for transplantation rarely gets beyond 12,000 in any given year. The reason for this disparity is a combination of technical and ethical factors that limit the donor selection criteria.

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Current Methods for Organ Preservation Present-day hypothermic organ preservation technology is dependent upon excising and chilling the organ to temperatures between 4-8oC in order to suspend metabolism and limit the effects of warm ischemia (WI), the lack of oxygen normally supplied by the blood. Without the cold to suspend metabolism and without blood flow to provide oxygen the organ rapidly loses its ability to function. Complicating the procurement process is the ethical need to attain consent for donation before acquiring the organ.

Consequently, the patients who are preferred for organ donation are primarily heart-beating cadaveric donors (HBD), patients who have suffered trauma and are maintained on life support in an Intensive Care Unit (ICU) prior to declaring death by brain criteria. This accounts for approximately 5% of the trauma patient population.

Unfortunately the greatest potential for procuring more organs is in the 95 % of the trauma patient population where circulatory arrest has existed for greater than 30 minutes postmortem without any intervention. These are considered the non-retrievable donors (NRD) where WI damage would preclude organ donation by current criteria.

EMS Technology

The EMS concept is based upon BREONICS' ability to intervene during the period of WI and reverse the injury cascade by reestablishing cellular equilibrium within the vascular compartment and restoring metabolic function by providing the necessary substrates and nutrients to sustain the organ at near physiologic temperature.

Data from BREONICS pre-clinical animal studies demonstrated that the EMS could successfully resuscitate kidneys following as much as 2 hours of WI insult. When the resuscitated kidneys were implanted, they confirmed recovery of normal renal function.

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EMS presents the opportunity to alleviate the chronic shortage of organs by expanding the donor criteria for transplantation to include the NRD.

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