Cohera Medical, Inc® Receives Approval To Begin Human Clinical Trials of Sylys™ Surgical Sealant in Europe
PITTSBURGH, March 12, 2013 - Cohera Medical, Inc. (www.coheramedical.com), a leading innovator and developer of absorbable surgical adhesives and sealants, has announced today that it has received approval to begin human clinical trials of its Sylys™ Surgical Sealant product, designed for colonic and small bowel anastomoses.
The study will investigate the safety and efficacy of Sylys, and its effect on leakage following bowel repair and associated complications in colorectal surgeries. The study will be conducted at two hospitals in the Netherlands. Patient enrollment is expected to begin in April 2013.
Anastomotic leakage rates following colon resection range on average from 3-15%. Such leakage is considered the most serious complication of bowel repair, causing one third of mortalities following colorectal surgery.
“Approval of this trial will move Cohera towards a regulatory approval application in Europe and a larger, U.S. based pivotal trial,” said Chad Coberly, JD, vice president of clinical, regulatory and legal affairs of Cohera.
“There is a high clinical and economic need for a product that effectively reduces anastomotic leakage rates,” added Patrick Daly, president and CEO of Cohera Medical. “This approval marks the first step for Cohera towards revolutionizing colorectal procedures and ultimately, improving patient outcomes.”