Cohera Medical begins human trials of surgical sealant

Cohera Medical has announced it is to begin trials of its Sylys Surgical Sealant product, which is designed for colonic and small bowel anastomoses.

The research will look into the safety and efficacy of Stylus and the effects it has on leakage following bowel repair and complications of colorectal surgeries, with the work set to be carried out at two hospitals in the Netherlands.

Patient enrolment is set to begin in April 2013, as anastomotic leakage rates following colon resection differ from three to 15 per cent, with such incidents found to be the most serious complication of bowel repair, resulting in one-third of mortalities after colorectal surgery.

Chad Coberly , vice president of clinical, regulatory and legal affairs of Cohera, said: "Approval of this trial will move Cohera towards a regulatory approval application in Europe and a larger US based pivotal trial."

Patrick Daly , president and chief executive of Cohera Medical, said: "There is a high clinical and economic need for a product that effectively reduces anastomotic leakage rates.

"This approval marks the first step for Cohera towards revolutionizing colorectal procedures and ultimately, improving patient outcomes."

Cohera Medical develops a number of absorbable surgical adhesives and sealants, with the company's TissuGlu Surgical Adhesive, which is used for a number of large flap surgeries, including abdominoplasty.

Recently, Cohera Medical investigated the use of TissuGlu in the reduction of wound drainage, post-operative seroma and related complications in abdominiplasty patients without using drains,

Patrick Daly, president and chief executive officer of Cohera Medical, said: "We’re thrilled to kick off the first no-drain trial in the US bringing us one step closer to facilitating a more natural healing process in large flap procedures.

"By eliminating post-surgical drains, our product has the ability to significantly impact how millions of patients recover from surgeries throughout the world."

Posted by Ben Evans