Cohera Medical announced that it submitted the 4th and final module of its FDA pre-market approval application for its TissuGlu surgical adhesive.
The 4th module is comprised of data from the Pittsburgh based-company’s ‘No Drain’ study, in which the adhesive was proven to be a “clinically superior alternative to closed-suction drains for fluid management in large flap procedures,” according to the press release.
"Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.,: CEO Patrick Daly said in prepared remarks. "The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA."
Cohera raised $17 million for the TissuGlu. The money went to expand adoption of the product in Germany & additional European markets and getting a clinical trial in U.S.