The FDA awarded priority review status to Cohera Medical‘s surgical sealant Sylys because the product addresses a significant unmet medical need.
Updated August 4, 2014 at 11:30 a.m. with comments from panel members.
The FDA’s General & Plastic Surgery Devices Advisory Panel today narrowly recommended approval for Cohera Medical‘s polyurethane-based TissuGlu adhesive for the approximation of tissue layers to bind subcutaneous dead space between the tissue planes in large flap surgical procedures, including abdominoplasty.
June 10, 2014 by Arezu Sarvestani
Cohera Medical said it’s won a date with an FDA advisory panel in August for its TissuGlu surgical adhesive.
April 25, 2014 by Brian Johnson
Cohera Medical closed its Series D financing round, bringing in $26.3 million which will be dedicated to securing FDA clearance for its TissuGlu surgical adhesive and CE Mark approval for the Sylys surgical sealant.
Cohera Medical put a bow on the clinical trial for its Sylys surgical sealant, saying that it confirmed the safety of the leakage-preventing product.
Sylys is a synthetic sealant "specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures," used in conjunction with standard anastomotic closure techniques. Sylys supports anastomosis during the 1st few days of healing, when leaks are most likely to occur.
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.