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FzioMed Oxiplex Anti-Adhesion Gel Not Approvable For Spine Surgery – Panel

This article was originally published in The Gray Sheet

Executive Summary

FzioMed's Oxiplex/SP anti-adhesion gel for spine surgery is "not approvable" due to its failure to adequately demonstrate a statistically significant treatment benefit in the sponsor's randomized, pivotal trial, according to FDA's Orthopaedic and Rehabilitation Devices Panel

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