The SEPET™ Liver Assist Device is a novel blood purification therapy designed for use with a standard blood dialysis system.  It comprises a sterile, single-use, disposable cartridge containing microporous hollow fibers with unique permeability characteristics.  When a patient’s blood is passed through these fibers, blood plasma of specific molecular weight and size is expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins such as ammonia, as well as various mediators of inflammation and inhibitors of hepatic regeneration).  These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, accelerating damage to the liver and other organs, including the brain and kidneys, and suppressing the ability of liver cells to function and to proliferate or regenerate.

SEPET™ is further designed to retain in the circulating bloodstream numerous larger, beneficial molecular weight blood proteins, including a powerful promoter of liver regeneration, Hepatocyte Growth Factor (HGF), various immunoglobulins, such as IgG, IgM, and others, and various complement species that are important for retaining active immune protection against infection (which often exacerbates liver failure). SEPET™ also retains most of the blood clotting factors, which are important for preventing bleeding—another common and potentially lethal complication of liver failure.

SEPET™ is currently demonstrating favorable outcomes in a U.S. clinical feasibility trial in patients experiencing acute exacerbation of chronic liver disease (so-called “acute-on-chronic” liver failure) caused by hepatitis B, hepatitis C or alcoholic cirrhosis.  Arbios believes these encouraging interim results provide validation of the potential for SEPET™ and is continuing to enroll patients in this important first-in-man clinical trial, with additional trials planned in Europe and Asia.

Arbios believes that SEPET™, if ultimately approved, could provide the following critical benefits:

• Accelerate and improve probability of successful recovery from liver failure
• Accelerate and improve probability of successful recovery from septic shock
• Reduce frequency of or prevent liver failure in patients with chronic liver disease
• Enhance medical outcomes in patients eligible for liver transplantation
• Enhance eligibility and outcomes from surgery for liver cancer
• Reduce duration of intensive care stays and overall hospitalization
• Enhance overall cost effectiveness of medical care for liver failure and septic shock

For more information on ongoing clinical trials, please visit the Patients/Clinicians section of this website.