Surgical Adhesive Technology Receives FDA Panel Recommendation
Several years ago, McGowan Institute for Regenerative Medicine faculty member Eric Beckman, PhD, George M. Bevier Professor of Engineering in the University of Pittsburgh Department of Chemical and Petroleum Engineering, and Michael Buckley, MD, oral and maxillofacial surgeon, invented a novel medical adhesive technology. The new adhesive—now known as TissuGlu®—was designed to meet a market demand for a strong, safe tissue adhesive to improve the wound closure process. The product positions tissues for optimal healing while minimizing fluid accumulation. To move the University of Pittsburgh-developed technology towards clinical use, Cohera Medical, Inc. was formed, and the intellectual property was licensed by the University to Cohera.
In August 2014, TissuGlu® received a positive recommendation from a U.S. Food and Drug Administration panel for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty. If approved, TissuGlu® will be the first internal surgical adhesive of its kind approved for large flap surgeries in the United States.
TissuGlu® is designed to meet surgeons’ needs for a strong, biocompatible, and easy-to-use surgical adhesive. The clinical data supports the safety and effectiveness of TissuGlu® as an alternative to the use of closed suction drains in large flap procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
“Today’s positive [FDA] Panel outcome is one of the final, and most critical, milestones towards the commercialization of TissuGlu® in the U.S., and is the result of a coordinated and collaborative effort by the Cohera Medical team,” said Patrick Daly, Cohera Medical president and CEO. “We are very pleased with the outcome of today’s meeting and will continue to work with the FDA to make TissuGlu® available to surgeons and patients throughout the United States.”
Illustration: Use of TissuGlu® Surgical Adhesive in abdominoplasty procedures. –Cohera Medical, Inc.