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news.Arbios Systems has received conditional approval from the FDA to begin the pivotal clinical trial for Sepet, an extracorporeal or outside the body artificial liver assist device for blood purification of chronically ill patients suffering from acute liver failure.
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FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints.
Shawn Cain, CEO and president of Arbios, said: “We currently do not have the financial resources to fund the pivotal trial and our ability to finance the company is contingent upon, among other issues, agreement on a primary endpoint with a reasonable number of patients required for the trial.”