Cohera Medical has completed enrolling patients in a US clinical study of its internal TissuGlu surgical adhesive.
TissuGlu, which adheres the tissue flap created during the procedure, is designed to help eliminate fluid accumulation and the need for post surgical drains, while performing large flap surgeries such as abdominoplasty (tummy tuck).
The prospective, multicenter, randomized trial, which has enrolled 150 patients at Atlanta, Baltimore, Charlotte, St. Louis, and Washington DC, US, is designed to evaluate effectiveness of CE-marked TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries.
Hunstad-Kortesis Center plastic surgery spokesperson Dr. Joseph Hunstad said, "The trial results so far are very promising for both the surgeons and the patients."
Cohera Medical president and chief executive officer Patrick Daly said enrolling 150 patients in 90 days is a testament to the surgeons and the company’s team.
"We are encouraged by the positive feedback from the TissuGlu investigators and look forward to our work with the FDA to make TissuGlu available to surgeons and patients throughout the U.S," Daly added.
The company said the results from the study will be used for submission of TissuGlu’s premarket approval application to the FDA.