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 endpoint, which could have potential to increase the total number of patients required for the trial. Arbios is requesting a meeting with the FDA to talk over the issue and to confirm the overall design of the trial.
Shawn Cain, CEO and President of Arbios stated, “While we are pleased to have received FDA permission to start the SEPET pivotal trial, we will work diligently with FDA with the hope of identifying a mutually acceptable primary endpoint. We currently do not have the financial resources to fund the pivotal trial and our ability to finance the Company is contingent upon, among other issues, agreement on a primary endpoint with a reasonable number of patients required for the trial.”
Dr. John Vierling, M.D. FACP Chairman of Arbios and Professor of Medicine and Surgery and Chief of Hepatology at the Baylor College of Medicine noted, “Hepatic encephalopathy (HE) represents on of the most frequent complications of cirrhosis mandating hospitalization and a two-stage improvement of HE has significant clinical benefits to patients. Specifically, patients with grade 3 or 4 HE are incubated in the intensive care unit to prevent lethal aspiration pneumonia and can be transferred out of the ICU after a reduction of 2 grades of HE, unless other complications require continued ICU care. Similarly, reduction of HE to grade 0,1 usually permits discharge from the hospital and management as an outpatient, reducing exposure to antibiotic-resistant organisms in hospitals and eliminating risks associated with medical errors.”
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