Surgical adhesive and sealant company, Cohera Medical, Inc.® , has announced that it has received approval to begin human clinical trials of its Sylys™ Surgical Sealant product, designed for colonic and small bowel anastomoses.
We’ve covered Cohera before, most recently last October when the company climbed a significant rung on the ladder to FDA approval for its TissuGlu® product to be used in Tummy Tucks. TissuGlu is already on the market in Europe and available on an investigational device in the U.S.
And now Cohera is targeting the gut, based on the stat that 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.
The newly announced study will investigate the safety and efficacy of Cohera’s dedicated bowel sealant, Sylys. The study will begin in April and be conducted at two hospitals in the Netherlands. It will look into the effect on leakage following bowel repair and associated complications in colorectal surgeries.
“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.”
Source: Cohera Medical, Inc.