Fremont, California -- Biomerix Corp. has received two Class III Medical Device Licenses from Health Canada for its Revive and Assure meshes for hernia repair.
These surgical meshes are made of the Biomerix Biomaterial, a proprietary, biointegrative, synthetic tissue scaffold, made of a non-resorbable, croslinked, reticulated, polycarbonate polyurethane-urea.
The Biomaterial is designed to play a role similar to the body's extracellular matrix, a biological structure that supports tissue repair and regeneration.
"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 Hayes, president and ceo of Biomerix, in a 19 April company statement.
Biomerix says such three-dimensional, open-cell, and interconnected structures allow cells to migrate and proliferate to create new tissue. The meshes combine the strength of a synthetic material with the properties of a biological one, each offering its own set of distinctive benefits.
Revive is constructed with the Biomerix Biomaterial on both sides to maximise tissue in-growth, a critical element in the repair of inguinal hernias, said the company.
Assure is for the repair of ventral hernias, with one side composed of the Biomaterial to promote tissue in-growth and the opposite side consisting of a resorbable protective film designed to minimise tissue attachment to the device in case of direct contact with the viscera.