BEI's HydroThermAblator
This article was originally published in The Gray Sheet
Executive Summary
Phase III study of the treatment for excessive uterine bleeding is scheduled to begin in September and include 276 patients at 11 U.S. sites, BEI Medical Systems announces Aug. 18. The system will be compared to electrosurgical rollerball ablation. The company reports that in six-month follow-up of patients in a Phase II trial, 58% experienced a complete cessation in menstrual bleeding and 37% reported either reduced or normal menstrual flow