Cohera Medical said it’s won a date with an FDA advisory panel in August for its TissuGlu surgical adhesive.
Cohera said the FDA’s General & Plastic Surgery panel is slated to convene August 1 to review its pre-market approval application for TissuGlu, which is designed "for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty."
"The scheduling of the FDA panel meeting represents a significant milestone towards the commercialization of TissuGlu in the U.S. and demonstrates the commitment we have to our future patients, partners, and investors," president & CEO Patrick Daly said in prepared remarks. "We look forward to the panel meeting and working with the FDA during the remainder of the approval process to make TissuGlu available to surgeons and patients throughout the United States."
"The advancement of the PMA to the panel meeting stage represents a large accomplishment – and 1 of the final steps – in the approval process by the company," added vice president of clinical, regulatory & legal affairs Chad Coberly. "Over the last several months the FDA has largely finalized its review of our modular PMA submission, as well as its review of the company and its major manufacturing and clinical partners. To date, all have passed the FDA preapproval inspections related to manufacturing, quality, and clinical trials, marking a great achievement in the PMA process."
Early this year Cohera closed on a $26 million Series D round, saying it plans to use the proceeds to advance TissuGlu through the PMA process and to secure CE Mark approval in the European Union for Sylys, another surgical sealant designed for intestinal anastomosis procedures. A clinical trial of Sylys closed in December 2013.