FDA allows Arbios to expand trial of Sepet device for liver failure

By Lisa Kerner

Erie, Pa., March 22 - Arbios Systems, Inc. said the Food and Drug Administration allowed the expansion of the number of clinical sites and increased the number of patients in its feasibility clinical trial for its Sepet liver assist device.

Arbios can now include up to four clinical trial sites, instead of two, and as many as 20 liver failure patients with encephalopathy, up from the 15 patients originally planned, according to a company news release.

The Sepet liver assist device is used with a standard blood dialysis system to clean the blood of impurities that accumulate in the bloodstream during liver failure.

The company previously announced expansion of the Sepet clinical trial to include all clinical stages of encephalopathy resulting from liver failure.

The goal of the current clinical trial is to assess the safety of the Sepet liver assist device and its potential to serve as a blood purifier and to support liver regeneration.

Chronic liver disease, the 10th-leading cause of death in the United States, results in about $10 billion in annual health care costs, according to the American Liver Foundation. There is no satisfactory therapy available to treat patients in liver failure, the release stated.

Arbios is a medical device and cell therapy company based in Waltham, Mass.

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