Orthovita Gets FDA Clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute
Orthovita, Inc., an orthobiologics and biosurgery company, said that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities.
In a release, the Company noted:
Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.
As compared to Orthovita’s current Vitoss Bioactive Foam Bone Graft Substitute products, the Vitoss Bioactive Foam-2X product has the same structure and porosity but contains increased levels of bioactive glass, which in-vitro testing has shown induces two times the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties.
Antony Koblish, President and Chief Executive Officer of Orthovita, said, “Our in-vitro data indicate the increased levels of bioactive glass double the overall bioactivity of the product. Other studies have shown that increasing the concentration of bioactive glass leads to faster and more abundant bone formation. We believe that the combination of increased bioactivity and our unique scaffold design will support more effective bone formation than before. We are pleased to offer physicians and theirpatients a new, enhanced product that combines increased bioactivity with our market-leading synthetic bone scaffold technology. This is the first in a series of anticipated product innovations Orthovita expects to introduce into the market over the next 18 months.”
Vitoss Bioactive Foam-2X shares additional key characteristics with the other products in the Vitoss Foam product portfolio. For example, Vitoss Bioactive Foam-2X has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression-resistant forms, thereby providing all three key components for bone regeneration: scaffold, cells, and signals. In addition, Vitoss Bioactive Foam-2X contains Orthovita’s proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corp.’s proprietary collagen material.
Pursuant to its contract with Kensey Nash Corp., Orthovita will pay Kensey Nash to manufacture the Vitoss Bioactive Foam-2X product as well as make certain royalty payments to Kensey Nash based on the net sales of such product.
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