Based in Boston, Massachusetts, HepaLife Technologies Inc.™, is developing a cell-based bioartificial liver system called HepaMate™, as a potentially lifesaving treatment for liver failure patients. The HepaMate™ is designed to combine blood detoxification with liver cell therapy to provide whole liver function in patients with the most severe forms of liver failure. A patented liver cell cryopreservation process provides for safe and easy storing and distribution, a significant logistic and commercial advantage.
They are currently  planning a new pivotal Phase III clinical trial in the United States.

A retrospective statistical analysis of the previous pivotal Phase II/III clinical trial data, adjusted for the impact of liver transplantation on patient survival, revealed a statistically significant survival advantage for patients with fulminant and subfulminant hepatic failure when treated with HepaMate™ compared to controls receiving standard medical care alone. The inclusion of a subset of 24 patients who had undergone a prior, failed liver transplant negatively impacted the trial’s outcome. Such patients are known to have poor survival rates. Therefore, the previous Phase II/III trial was unable to achieve its primary 30-day survival endpoint in the overall study population.
Based on the retrospective statistical analysis of the clinical trial data, HepaLife expects a new Phase III clinical trial without the inclusion of failed liver transplant patients to be successful.