Arbios Receives FDA Permission to Initiate SEPET Trial

Arbios Systems has received a conditional approval from the FDA for an investigational device exemption (IDE) to begin a feasibility clinical trial for SEPET, Arbios' extracorporeal (outside the body) artificial liver assist device for blood purification for patients in acute liver failure.

SEPET is a single-use, disposable cartridge containing a bundle of hollow fibers. Blood filtration using SEPET facilitates removal of hepatic failure toxins, inhibitors of hepatic regeneration and mediators of inflammation. Blood purification using SEPET is expected to alleviate symptoms of hepatic dysfunction and support liver regeneration. The product is also designed for use with commercially available kidney dialysis units and/or plasma membrane apheresis systems, allowing for hospitals to easily use the device without any additional capital infrastructure.

The trial is designed to enroll 15 patients. The primary objective of the trial is to assess safety and tolerability of SEPET. As well, clinical efficacy data will also be collected.

Permission was granted to initiate the trial while the company responds to the FDA's request for additional information.