Fremont, California -- Biomerix Corp. has received CE Mark for its Revive polyurethane-based soft tissue repair mesh, the company said in a 24 Jan statement.
The approval allows the medical and industrial material maker to market the product in all European Union member states.
Revive is constructed of Biomerix Biomaterial, a proporietary synthetic tissue scaffold, which is designed to support organised tissue ingrowth. The device is designed for repair and reinforcement in a variety of soft tissue procedures such as inguinal hernias of which over 700 000 procedures are performed each year in Europe.
"This latest approval represents another important milestone in Biomerix's plans to develop innovative products based on its proprietary materials and capabilities," said Kenneth G. Hayes, President and ceo of Fremont, California-based Biomerix. "Revive will be distributed in the EU by Medline Industries pursuant to our exclusive distribution agreement."
Biomerix created Biomerix Biomaterial - a non-resorbable, cross-linked, reticulated, polycarbonate polyurethane-urea consisting of an open-cell, three-dimensional, interconnected macroporous structure - in 2004. The Biomerix Biomaterial is designed to play a role similar to the body's extracellular matrix, through the main phases of inflammation, proliferation, and remodeling. LMH