The approval allows the company to market the product in the European Union and certain other countries.
Sylys surgical sealant serves as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in ileostomy reversal procedures.
Cohera Medical clinical, regulatory and legal affairs vice-president Chad Coberly said: "CE marking approval for Sylys surgical sealant, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera."
The surgical sealant will help in reducing anastomotic leakage in gastrointestinal procedures through providing additional support to the anastomosis during the first few days of healing, when the development of leaks are expected to occur.
It is applied as a viscous fluid that is claimed to create a flexible and elastic seal over the anastomosis site. The product degrades in a few weeks in-vivo and is resorbed.
Cohera Medical president and CEO Patrick Daly said: "The Sylys Surgical Sealant CE marking approval represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors."
