Arbios Systems, Inc. (ABOS) Receives FDA Conditional Approval to Initiate Pivotal Clinical Trial for SEPET™
Arbios Systems, Inc. announced on February 22nd that the Company has received conditional approval from the U.S. Food and Drug Administration of an Investigational Device Exemption to be the pivotal clinical trial for SEPET™, (Arbios’ Liver assist Device). The SEPET™ Liver Assist Devise is a sterile, extracorporeal (outside of the body), disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. The SEPET™ device is for blood purification of chronically ill patients suffering from acute liver failure. Permission was granted to initiate the trial while the Company responds to the FDA’s conditions. Specifically the FDA has requested a survival primary…