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BioForm Medical, Inc.
338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment
September 19th, 2008
BioForm Medical, Inc. (NASDAQ:BFRM) announced that the pivotal clinical study of Polidocanol, conducted in Germany by BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler), successfully met the study primary endpoint and has been submitted to FDA as part of a New Drug Application (NDA) process. In the pivotal clinical study, named the EASI (Efficacy and safety of Aethoxysklerol compared to Sodium Tetradecyl Sulfate and Isotonic Saline) study, 338 patients with C1 varicose veins (either spider veins of <1mm diameter or reticular veins of 1-3mm diameter), were randomized to receive either Polidocanol (also called Lauromacrogol 400, European...
Source: Food & Drug Law Weekly (2008-09-19)
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