Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (“FDA”) to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.
The study will investigate the effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
“We are pleased to have FDA approval to begin this pivotal trial that validates the biocompatibility, pre-clinical testing profile and clinical trial design of TissuGlu,” said Chad Coberly, Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “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 PMA application for TissuGlu with the FDA.”
“IDE approval of the TissuGlu study is a significant strategic milestone for Cohera and its investors,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We are encouraged by the initial positive outcomes with TissuGlu in clinical studies and commercial use outside the U.S., and we look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the United States.”
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The company plans to expand the commercial availability of TissuGlu to additional European markets in early 2012.
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