The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) approval to Cohera Medical's TissuGlu Surgical Adhesive.
Based on the IDE approval, the company will start pivotal clinical trial for TissuGlu Surgical Adhesive in the US.
The multicenter, prospective, randomized trial is designed to study the safety and effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries.
Cohera Medical Clinical, Regulatory and Legal Affairs vice president Chad Coberly said they are pleased to have FDA approval to begin the pivotal trial that validates the biocompatibility, pre-clinical testing profile and clinical trial design of TissuGlu.
"Initiation of this study is planned in the first quarter of 2012 and will be conducted at five clinical sites with 150 patients, and upon favorable conclusion will allow the company to complete a premarket approval (PMA) application for TissuGlu with the FDA," Coberly said.
Cohera Medical president and CEO Patrick Daly said they are encouraged by the initial positive outcomes with TissuGlu in clinical studies and commercial use outside the US.
The company received CE mark approval for TissuGlu and plans to expand the commercial availability of TissuGlu to additional European markets in early 2012.