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338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment
Date:9/4/2008

SAN MATEO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM) today 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 tradename, Aethoxysklerol(R)), Sodium-tetradecyl-sulfate (STS or Sotradecol(R), an effective control), or Isotonic saline (a placebo control). Patients were followed for 26 weeks (6 months) with standardized photography of a defined 10x10 cm area of the leg at baseline, 12 weeks and 26 weeks. These photographs were rated by the treating physicians and two blinded evaluators, which served as the basis for efficacy assessment.

The EASI study successfully met its primary efficacy endpoint with demonstrated statistically significant superiority (p<0.0001) of Polidocanol versus placebo. The treatment success rates for Polidocanol were 96% and 95% at 12 and 26 weeks, compared to STS (92%, 91%) and placebo (8%, 6%). A secondary endpoint analysis demonstrated that significantly more patients were satisfied or very satisfied with Polidocanol at 12 or 26 weeks (88%, 84%), compared to STS (63%, 64%; p<0.0001) or placebo (13%, 11%; p<0.0001). Polidocanol was found to be safe and well tolerated in the study. The incidence
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SOURCE BioForm Medical, Inc.
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