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Arbios, NxStage collaborate on liver device

This article was originally published in The Gray Sheet

Executive Summary

Dialysis machine maker NxStage Medical will be exclusive manufacturer of Waltham, Mass.-based Arbios Systems' Sepet liver assist device, the firms announce Oct. 23. Arbios is seeking FDA permission to begin a controlled pivotal trial in patients with acute liver failure. Sepet is a sterile, disposable cartridge containing microporous hollow fibers designed for use with standard blood dialysis systems. The fibers cleanse a patient's blood of harmful impurities as it passes through. Other firms developing artificial liver technology include Vital Therapies, which anticipates U.S. market approval of its ELAD device by 2010 (1"The Gray Sheet" Sept. 17, 2007, p. 16)

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Vital Therapies funds artificial liver development: Start-up raises $28.1 million in a "Series C" private placement to support further development of its ELAD extracorporeal liver assist device, the firm announces Sept. 12. The San Diego company is conducting a pivotal trial of the human cell-based artificial liver in China to support a planned near-term marketing application in that country, "and to provide more safety data for U.S. registration," according to the company. The firm anticipates Chinese approval this year and a U.S. market go-ahead by the end of the decade. ELAD, which is regulated as a biologic by FDA with input from the agency's device center, is intended as a bridge-to-transplant or for potential liver recovery for patients with severe liver failure. Vital Therapies acquired the bedside-use technology in 2003 from VitaGen (1"The Gray Sheet" Oct. 6, 2003, p. 26). The recent financing round was led by Versant Ventures

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