EXSANGUINOUS METABOLIC SUPPORT (EMS)
BREONICS, is a biomedical research & development company applying its novel bioengineering technologies to create innovative medical products for the clinical kidney transplantation markets. BREONICS’ Exsanguinous Metabolic Support (EMS) enables continued oxidative metabolism and function in kidneys while isolated from the rest of the human body providing a number of unique opportunities for medical application. The EMS technology is distinct from today’s state-of-art kidney preservation technology where metabolism is instead inhibition by preserving kidneys at a temperature just above freezing.
EMS for Clinical Transplantation
Transplantation is the therapy of choice for people with end-stage kidney disease (ESRD). In the case of (ESRD), transplantation is the only life saving therapy, that allows the patient to lead a normal life once again. However, transplantation is severely limited by the chronic, world-wide shortage of transplantable kidneys. In the U.S. there are approximately 786,000 patients with ESRD for whom the number of deceased donor kidneys available for transplantation rarely gets beyond 24,000 in any given year. The reason for this disparity is a combination of technical and ethical factors that limit the donor selection criteria.
State-of-art hypothermic kidney preservation technology is dependent upon maintaining kidney allografts at a temperature between 4-8°C in order to inhibit metabolism. Inhibiting metabolism limits the effects of warm ischemia (WI), a damage mediated by the lack of oxygen normally supplied by the blood. Without the cold to inhibit metabolism with the cessation of blood flow that occurs upon death, the kidney rapidly loses its ability to function. Complicating the procurement process is the ethical need to obtain consent for donation before recovering the kidney. Consequently the patients who meet the criteria for kidney donation are primarily deceased heart-beating donors (DBD). These are 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 fatality population. Unfortunately, the greatest potential for procuring more kidney allografts is in the 95% of the trauma patient population where cardiac arrest has existed for greater than 30 minutes postmortem without any intervention. These are considered the uncontrolled Deceased by Cardiac Death (DCD) patients where WI damage would preclude kidney donation by current criteria.
The EMS technology is based upon the ability to intervene during the period of WI and reverse the injury cascade by resuscitating oxidative metabolism. EMS restores metabolic function by providing the necessary substrates and nutrients to sustain the kidney at near physiologic temperature. Data from BREONICS’ pre-clinical animal studies demonstrated that 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.
The translational ability of the preclinical data to human kidney allografts has been established in >100 human kidneys. The work with human kidneys, that were too damaged to be transplanted, confirmed the ability to resuscitate oxidative metabolism of sufficient magnitude to restore synthetic functions that in turn was the basis of regeneration in human kidney allografts.
EMS Development
By addressing the dynamic and technical barriers associated with overcoming warm ischemic injury, EMS will be the first technology that can be used to intervene after ischemic damage has occurred to resuscitate and repair damaged kidney allografts. This unique ability of EMS is transformational because it changes today’s limitation of recovering deceased donor kidneys from within minutes of death to within a window of several hours postmortem. EMS’ potential to redefine the existing donor criteria is what makes the technology distinct and why it should not be confused with traditional organ preservation techniques.