Cohera Medical said Wednesday it received an expedited access pathway designation for its Sylys surgical sealant.
Sylys is a resorbable synthetic sealant designed to help prevent anastomotic leaks during gastrointestinal surgery, the Pittsburgh, Penn.-based company said. Anastomotic leaks occur between sections of surgically joined intestine, and the surgical sealant helps support anastomosis during initial healing to prevent possibly life-threatening leaks.
“I am delighted that the FDA understands the devastating impact of leaks from colorectal anastomoses and is providing a fast track for development of innovative clinical solutions,” Dr. Deborah Nagle of Boston’s Beth Israel Deaconess Medical Center said in a press release.
EAP designation was first proposed in 2014 to help reduce timeframes and costs with market authorization for products normally subject to pre-market approval or de novo registration, in cases where the product can benefit patients suffering from otherwise difficult-to-treat issues.
“The Expedited Access Program designation for Sylys surgical sealant represents the critical need for this product and demonstrates our commitment to our future customers, partners, and investors. We look forward to working with the FDA to make Sylys Surgical Sealant available to surgeons and patients worldwide as soon as possible,” CEO Patrick Daly said in prepared remarks.
Sylys won priority review status from the FDA last December, because the product addresses a significant unmet medical need, the company said.