MedLogic Global
This article was originally published in The Gray Sheet
Executive Summary
FDA approves investigational device exemption to study firm's LiquiBand topical wound closure glue in trial of 600 patients at 20 centers. Clinical endpoints include cosmesis and evidence of dehiscence, or wound opening, over a 90-day follow-up period. Based on the company's proprietary n-butyl cryanoacrylate technology, LiquiBand is intended to substitute for sutures and staples in surgical operations, "or other traditional closures in the treatment of external cuts and wounds," the company's June 15 release notes. MedLogic's proposal for a modular PMA submission also receives a nod from the agency