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Gynecare to commence multi-center trial of Uterine Balloon Therapy system.

This article was originally published in The Gray Sheet

Executive Summary

GYNECARE UTERINE BALLOON THERAPY SYSTEM MULTI-CENTER TRIALS will begin "very soon" in the three clinical centers at which the company has received institutional review board approval, Gynecare President and CEO William Hunter told investors in an Oct. 18 presentation at the UBS Securities life sciences conference in New York City. FDA recently granted the company an investigational device exemption for a study, expected to be conducted at 12 to 15 clinical sites, that will evaluate use of the system to treat women with excessive menstrual bleeding. "In the past two weeks since we've had approval, we've been aggressively pursuing our clinical sites to get IRB approval," Hunter said.
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