Biomerix Corporation announced today it has received two Class III Medical Device Licenses by Health Canada for its REVIVE and ASSURE Hernia Repair Meshes.
REVIVE and ASSURE surgical meshes feature the Biomerix Biomaterial, a proprietary, biointegrative, synthetic tissue scaffold. The Biomerix Biomaterial is designed to play a role similar to the body's extracellular matrix, a biological structure that supports tissue repair and regeneration. The three-dimensional, open-cell, and interconnected structure allows cells to migrate and proliferate to create new tissue. These meshes combine the strength of a synthetic material with the properties of a biologic, each offering its own set of distinctive benefits.
REVIVE is constructed with the Biomerix Biomaterial on both sides to maximize tissue ingrowth, a critical element in the repair of inguinal hernias. ASSURE is created for the repair of ventral hernias, with one side composed of the Biomerix Biomaterial to promote tissue ingrowth and the opposite side consisting of a resorbable protective film designed to minimize tissue attachment to the device in case of direct contact with the viscera.
"These regulatory approvals represent another step forward as Biomerix broadens its global reach with REVIVE and ASSURE. Both products will be distributed in Canada by Medline Industries pursuant to our exclusive distribution agreement," stated Kenneth G. Hayes, President and CEO of Biomerix Corporation.