Biomerix has received CE mark approval to market its Revive soft tissue repair mesh in all European Union member (EU) states.
The US Food and Drug Administration (FDA) approved Revive is constructed of the Biomerix Biomaterial, a biointegrative synthetic tissue scaffold and is designed to play a role similar to that of the body’s extracellular matrix, supporting organized tissue ingrowth.
The device is designed for repair and reinforcement in a variety of soft tissue procedures such as inguinal hernias.
Revive is designed to facilitate robust tissue ingrowth, while minimizing the scarring response typically associated with implantation of a mesh.
Biomerix president and CEO Kenneth Hayes said the latest approval represents another milestone in Biomerix’s plans to develop products based on its proprietary materials and capabilities.
"Revive will be distributed in the EU by Medline Industries pursuant to our exclusive distribution agreement," Hayes said.