Arbios | HepatAssist

“As an academic clinician and investigator, I am continually exploring promising approaches to treat liver failure. The SEPET™ Liver Assist Device and HepatAssist™ Cell-Based Liver Support System are elegantly designed to reverse the complex medical problems caused by a failing liver. If ultimately approved, I anticipate that both approaches will have major, favorable impacts on patients suffering from liver failure.”

John M. Vierling, MD, FACP Chief of Hepatology, Baylor College of Medicine, Houston President, American Association for the Study of Liver Disease Chairman of the Board of Directors, Arbios Systems Inc.

HepatAssist™ Circuit

HepatAssist™ was the first bioartificial liver tested in FDA-approved Phase 2/3 clinical trials. A prospective, multicenter, randomized, controlled trial was conducted in 171 patients in 11 U.S. and 9 European medical centers. This trial did not achieve its primary endpoint (30-day survival) in the overall study population. However, when adjusting for the impact of disease etiology and liver transplantation on patient survival, patients with fulminant and subfulminant hepatic failure treated with the bioartificial liver had a statistically significant survival advantage compared to controls receiving standard medical care. HepatAssist™ also demonstrated a favorable safety profile. Arbios believes that a repeated pivotal trial has a high probability of success.

Arbios is currently exploring optimal ways in which this promising therapy could be advanced through to commercialization, including potential strategic partnerships with larger companies.





“As an academic clinician and investigator, I am continually exploring promising approaches to treat liver failure. The SEPET™ Liver Assist Device and HepatAssist™ Cell-Based Liver Support System are elegantly designed to reverse the complex medical problems caused by a failing liver. If ultimately approved, I anticipate that both approaches will have major, favorable impacts on patients suffering from liver failure.” John M. Vierling, MD, FACP Chief of Hepatology, Baylor College of Medicine, Houston President, American Association for the Study of Liver Disease Chairman of the Board of Directors, Arbios Systems Inc.	Arbios is developing the HepatAssist™ Cell-Based Liver Support System, a bioartificial liver that not only detoxifies the blood, but, uniquely, provides whole liver function. HepatAssist™ is intended to treat acute and acute-on-chronic liver failure patients with little to no remaining liver function. How does HepatAssist work? During therapy, blood is separated into plasma (liquid) and cellular components. The separated plasma is then passed through an absorbent activated charcoal filter to remove small molecular weight toxins, providing initial detoxification. The detoxified plasma is then oxygenated and passes through a hollow fiber cartridge housing living porcine liver cells. Importantly, the live porcine liver cells are immobilized in the cartridge by a semi-porous membrane, so that they are never administered to the patient. The porcine liver cells transform and eliminate further harmful compounds, while also enriching the plasma with albumin and other proteins and providing additional liver-specific functions. The normalized, enriched plasma is then reunited with the blood cellular components and returned to the patient. HepatAssist™ Circuit HepatAssist™ was the first bioartificial liver tested in FDA-approved Phase 2/3 clinical trials. A prospective, multicenter, randomized, controlled trial was conducted in 171 patients in 11 U.S. and 9 European medical centers. This trial did not achieve its primary endpoint (30-day survival) in the overall study population. However, when adjusting for the impact of disease etiology and liver transplantation on patient survival, patients with fulminant and subfulminant hepatic failure treated with the bioartificial liver had a statistically significant survival advantage compared to controls receiving standard medical care. HepatAssist™ also demonstrated a favorable safety profile. Arbios believes that a repeated pivotal trial has a high probability of success. Arbios is currently exploring optimal ways in which this promising therapy could be advanced through to commercialization, including potential strategic partnerships with larger companies.


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