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. Arbios Systems is developing products to replace liver function or provide support pending liver regeneration or transplantation.
The company’s SEPET Liver Assist Device 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.
This week, 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.
The approval signifies the FDA’s satisfaction with the points addressed in its previously issued conditional approval. The news is certainly welcome for Arbios investors, who, this month, saw the company’s share price deteriorate to a 52-week low of $.23.
Shawn Cain, the company’s President and CEO, commented,
“We believe that the pivotal trial, if successful, should support our filing for approval of SEPET in the United States and marketing efforts in the United States and the European Union. Further, we believe that the design of this trial will enhance physician acceptance of SEPET as a much needed tool in sustaining patients through acute life threatening episodes of liver failure, a market which we believe exceeds a billion dollars annually.”