Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced that its Sylys Surgical Sealant has received expedited access pathway (EAP) designation and priority processing status from the US Food and Drug Administration (FDA).
Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.
Anastomotic leakage, which occurs in three to twenty-three percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, and frequently results in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death.
At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.
The FDA has designated Sylys Surgical Sealant as an Expedited Access Pathway device due to its potential to address the unmet need related to gastrointestinal leaks. According to the FDA, "…the device is intended to treat or diagnose a life threatening condition… and there are no appropriate alternative approved products."
"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," said Deborah Nagle, MD,Chief, Division of Colon and Rectal Surgery,Beth Israel Deaconess Medical Center,Boston, MA.
The Expedited Access Pathway is a recently finalized (April 13, 2015) program at the FDA designed to help patients gain more timely access to critical medical devices by expediting their development, assessment, and review.
"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," said Patrick Daly, Cohera Medical President and CEO. "We look forward to working with the FDA to make Sylys Surgical Sealant available to surgeons and patients worldwide as soon as possible."
Cohera Medical is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers.