Cohera Medical, a developer of absorbable surgical adhesives and sealants, has obtained regulatory approval to commence human clinical trials on its single-part synthetic surgical sealant in Europe.
Designed as an adjunct to standard closure techniques, Sylys surgical sealant helps surgeons performing colorectal procedures to reduce the incidence of anastomotic leakage following bowel repair and treat colonic and small bowel anastomoses.
The study, which will be conducted at two Netherlands-based hospitals, is expected to start patient enrollment in April 2013.
The safety and efficacy of surgical sealant and its effect on leakage following bowel repair and associated complications in colorectal surgeries will be investigated under the study.
Cohera Medical president and CEO Patrick Daly said, "This approval marks the first step for Cohera towards revolutionizing colorectal procedures and ultimately, improving patient outcomes."
Cohera Medical clinical, regulatory and legal affairs vice president Chad Coberly said, "Approval of this trial will move Cohera towards a regulatory approval application in Europe and a larger, U.S. based pivotal trial."
