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

of side effects, most commonly local tissue reactions near the injection site, was generally lower for patients treated with Polidocanol than for patients treated with STS.

"We are very pleased that the EASI study successfully demonstrated the safety and the efficacy of Polidocanol for the treatment of spider and reticular veins," said Professor Eberhard Rabe, President of the International Union of Phlebology (UIP) and the German Society of Phlebology (DGP) and Professor at the Department of Dermatology, University of Bonn, and the principal investigator in the study. "Polidocanol has been used successfully to treat spider and reticular veins in Europe for over 40 years, and we are pleased to participate in this clinical evaluation to evaluate Polidocanol. These results scientifically confirm our every day experience in clinical practice, and the high patient satisfaction seen with Polidocanol, as compared to STS."

The EASI Study results will be presented at several scientific congresses in the coming weeks by Professor Eberhard Rabe, the principal investigator in the study. Planned presentations include September 8, 2008, at the Australasian College of Phlebology meeting in Australia, November 7, 2008, at the American College of Phlebology, and November 9, 2008, at the American Society of Dermatologic Surgery late-breaking results session.

"We are delighted with the results of this clinical study," said Steve Basta, Chief Executive Officer of BioForm Medical, Inc. "We believe that bringing Polidocanol into the U.S. market will allow physicians in the United States to use what has been regarded internationally as the gold standard product for sclerotherapy, and that the lower rate of local tissue reactions evidenced in this trial versus the leading competing product, combined with the high success rate of this treatment may be the basis of significant future growth in sclerotherapy procedure volume in the United States upon FDA approval and th
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SOURCE BioForm Medical, Inc.
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