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Advanced UroScience Durasphere Post-Approval Study Focuses On Durability

This article was originally published in The Gray Sheet

Executive Summary

Advanced UroScience's post-approval study of its Durasphere bulking agent for treatment of female stress urinary incontinence due to intrinsic sphincter deficiency will focus on evaluating the durability of the product, the company reports.

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Advanced UroScience

Minnesota federal judge dismisses suit against the firm and founder Timothy Lawin Sept. 30. Brought by Uroplasty in August 1998, the suit alleged that Lawin had misappropriated Uroplasty's pyrolytic, carbon-coated micro-bead technology for use in the Durasphere injectable stress urinary incontinence product. Durasphere was approved by FDA Sept. 13 (1"The Gray Sheet" Sept. 27, p. 14). U.S. district court Judge Michael Davis rules that Uroplasty failed to show evidence that the firm was ever involved with the development of the technology

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