Liver disease, in its various forms, affects 4.5 million adults in the United States with deaths exceeding 50,000 annually putting it in the top 10 most frequent causes of death. Liver transplantation is the only effective treatment currently available but there are not enough healthy donated livers to meet the need. Transplantation is expensive and, in most cases, subjects the recipient to lifelong immunosuppression which adds additional risks. Liver assist devices have been developed, but in the absence of metabolically active liver cells, these devices have shown little improvement in survival outcomes. The SRBAL combines the metabolic power of primary hepatocytes with dialysis to bridge patients in liver failure to either their own liver recovering or to give them more time to find a matching liver for transplantation. There are several indications that would benefit from such a device. Acute liver failure (ALF) is a rare presentation of severe liver dysfunction with high morbidity and mortality rates. Approximately 2,000 deaths are attributed to ALF annually. A significant number of these patients could benefit from the extracorporeal liver support provided by SRBAL.
Unmet Need