Arbios Systems has suspended operations and laid-off employees while it focuses on raising additional funds. If the company fails to secure financing by the end of August, Arbios will consider liquidating its assets.
Last May, Arbios began a pivotal trial for its SEPET liver assist device. The company received an Investigational Device Exemption from the FDA allowing the company to begin a pivotal clinical trial for SEPET in acutely ill patients suffering from chronic liver disease.
SEPET is a blood purification therapy designed for use with a standard blood dialysis system. It uses a sterile, single-use, disposable cartridge containing microporous hollow fibers that filter a patient’s blood and remove harmful impurities like ammonia. These substances would otherwise accumulate in the patient’s bloodstream during liver failure, accelerating damage to the liver and other organs.
Liver and biliary diseases affect 25 million Americans, whose annual healthcare costs exceed $10 billion. Unfortunately, there are no direct treatments available for liver failure and patients must receive a liver transplant or endure prolonged hospitalization with significant mortality.