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This article was originally published in The Gray Sheet

Executive Summary

FDA accepts for review the first module of a modular premarket approval application for the resorbable, carbohydrate polymer liquid designed to inhibit postsurgical scarring and adhesions following gynecological pelvic surgery. The company is conducting a pivotal trial at approximately 20 sites in more than 200 patients undergoing minimally invasive gynecological surgery. Enrollment should be complete this quarter
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