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

e subsequent commercial introduction of Polidocanol."

"For years, Polidocanol has been the worldwide standard for sclerotherapy of spider veins outside of the United States, and I am very excited about the prospect of being able to offer this treatment option to my patients in the future," said Robert Weiss, MD, President-Elect of the American Society for Dermatologic Surgery (ASDS) and Associate Professor, Dermatology at Johns Hopkins University School of Medicine, Baltimore, Maryland. "If Polidocanol becomes available in the United States, the physician community will have an important additional tool in their aesthetic treatment portfolio."

Kreussler, the company that developed Polidocanol as a sclerotherapy agent and has commercialized this product throughout the world over the past 40 years, conducted the pivotal clinical study pursuant to a special protocol assessment agreed to with FDA in 2006. The EASI study was specifically designed to provide the pivotal clinical data for the FDA related to the open New Drug Application (NDA) for Polidocanol. The final clinical study report on the EASI study has been submitted to FDA as an amendment to the existing NDA. In addition to this clinical report, Kreussler is completing manufacturing documentation for a newly expanded manufacturing facility. Consistent with the previously reported expected timeline for completion of the NDA submission, the manufacturing documentation is expected to be completed and submitted to FDA before the end of calendar year 2008.

BioForm Medical and Kreussler entered into an agreement in 2007 wherein BioForm will have exclusive U.S. rights to sell Polidocanol supplied by Kreussler upon FDA approval, and BioForm will pay Kreussler a royalty and transfer price for the supplied material, and development and commercialization milestone payments.

About BioForm Medical, Inc.:

BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, Calif
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SOURCE BioForm Medical, Inc.
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