Startups Persevere Toward Gaining Artificial Liver Approval
This article was originally published in The Gray Sheet
Executive Summary
The potential market opportunity for an artificial liver keeps players in the game, even though many companies have tried and failed in the past
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Arbios Systems files Chapter 11
The maker of the Sepet liver assist device files for bankruptcy protection on Jan. 9, with plans to sell the company through a bid solicitation plan. In a phase I/II clinical trial, 11 out of 14 patients saw a reduction in hepatic encephalopathy. Last summer, Arbios acknowledged it would need to raise considerable capital to conduct the additional trials needed to launch the device in the U.S. and Europe (1"The Gray Sheet" June 9, 2008, p. 10). The company announced in August it had suspended all operations except fundraising efforts to support a Sepet launch or to enter into a strategic partnership
Arbios Systems files Chapter 11
The maker of the Sepet liver assist device files for bankruptcy protection on Jan. 9, with plans to sell the company through a bid solicitation plan. In a phase I/II clinical trial, 11 out of 14 patients saw a reduction in hepatic encephalopathy. Last summer, Arbios acknowledged it would need to raise considerable capital to conduct the additional trials needed to launch the device in the U.S. and Europe (1"The Gray Sheet" June 9, 2008, p. 10). The company announced in August it had suspended all operations except fundraising efforts to support a Sepet launch or to enter into a strategic partnership
Research In Brief
Drug-coated angioplasty balloon: Percutaneous treatment of femoropopliteal disease with paclitaxel-coated angioplasty balloons was associated with reduced six-month lumen loss and target-lesion revascularization rates compared to regular angioplasty balloons in the 154-patient randomized THUNDER trial sponsored by Bavaria Medizintechnologie and Schering. Results appear in the Feb. 14 issue of the New England Journal of Medicine. THUNDER is a small preliminary study and larger trials are needed to confirm the benefits of drug-coated balloons, according to authors Gunnar Tepe, M.D., University of Tübingen, et al