PITTSBURGH, May 30, 2013 -- /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its clinical trial for Sylys, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures.
Currently underway in Europe, the study is evaluating the safety of Sylys on the reduction of anastomotic leakage following bowel repair. The study included patients enrolled at two sites in the Netherlands.
"We are excited to conclude enrollment in this significant safety trial for Sylys, which has the potential to help reduce anastamotic leakage following colorectal procedures," said Dr. Consten of the Meander Medical Center, Amersfoort. "We look forward to following the enrolled patients and reporting the findings of this study."
"Cohera appreciates the fast enrollment by both Dr. Bemelman, at AMC Hospital and Dr. Consten at the Meander Medical Center" said Chad Coberly, JD, VP of Clinical, Regulatory and Legal Affairs of Cohera Medical. "We also greatly appreciate the assistance of the team at Factory CRO, in the Netherlands, to help us reach our timeline objectives on this important first in human study.
Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.
"Enrollment completion of this study is monumental for Cohera Medical, as this is our second class III product in humans," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "It is an indication of the remarkable surgeons we work with, who recognize the value of this sealant, and its ability to enhance standard closure techniques, supporting the healing process and reducing post-operative complications."
