ETEX' Equivabone receives additional FDA clearance for use in posterolateral spine fusion

Oct 3 2009

ETEX Corporation, an advanced biomaterials company, announced today additional FDA 510(k) cleared indications for EquivaBone®. EquivaBone was the first FDA cleared hard-setting osteoinductive material and is the only osteoinductive bone graft substitute that provides a continuous nanocrystalline calcium phosphate scaffold.

EquivaBone is now additionally indicated for use in posterolateral spine fusion, providing spine surgeons a product that combines the certified osteoinductivity of DBM with the optimal handling and hard setting characteristics of the clinically proven ETEX calcium phosphate osteoconductive scaffold.

In addition, the clearance allows EquivaBone to be mixed with autologous blood, adding greater procedural flexibility. The resultant viscous putty can then be molded and packed or injected into a defect.

Brian Ennis, President and CEO of ETEX Corporation, comments, "ETEX is pleased with the rapid expansion of clinical indications for our innovative biologic portfolio. Our product improvements and line extensions remain driven by direct surgeon feedback. This is reflected in the recent clearance of small size EquivaBone kits and the addition of blood and posterolateral spinal fusion indications to the labeling. We anticipate additional indications and platform extensions in the near term."

EquivaBone is a proprietary combination of osteoinductive Demineralized Bone Matrix (DBM) and ETEX's osteoconductive nanocrystalline calcium phosphate. ETEX is proud to offer the first combination product that is both moldable and injectable and sets hard once implanted. In addition, the osteoinductivity of the DBM is certified after sterilization, by lot, for the entirety of shelf life.