HepaMate™, previously known as 'HepatAssist', was clinically evaluated in a successful Phase I clinical trial. Following these results a pivotal Phase II/III prospective, randomized, controlled trial in 171 patients with fulminant/subfulminant hepatic failure and primary non-function following a failed liver transplant (86 control and 85 treated) in 11 U.S. and 9 European medical centers was conducted. The clinical trial was seen as a landmark in the area of liver support.

The inclusion of a subset of 24 patients who had undergone a prior, failed liver transplant negatively impacted the previous trial’s outcome. Such patients are known to have poor survival outcomes. Therefore, the previous pivotal Phase II/III trial was unable to achieve its primary 30-day survival endpoint in the overall study population. Based on a 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.

A retrospective statistical analysis of the 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. HepaMate™ treatment demonstrated a reduction of the risk of pre-transplant death by 47% in fulminant hepatic failure patients (n=121; p<0.043) relative to controls and by 67% in fulminant hepatic failure patients with drug or chemical induced toxicity (n=53; p=0.014). At the same time that bioartificial liver therapy improved outcomes for treated patients, it provided patients with a trend towards additional time for a liver transplant to become available (median of 2 days for all patients). HepaMate™ demonstrated clinical activity for a large majority of the enrolled patients (147 out of 171). The FDA previously approved to use identical statistical methodology employed for the retrospective analysis in any subsequent clinical trial and also previously approved to increase the liver cell dose for HepaMate™.