IDE Study Approved for Novel Bone Substitute

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The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) study for a novel bone graft substitute.

What makes this novel, is that this bone graft substitute uses a dual-carrier system that employs Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP) in combination with a proprietary technology called SLOREL™ that controls the release of recombinant human bone morphogenetic protein-2 (rhBMP-2). According to the company, the system is “engineered to enhance high-density bone formation while minimizing ectopic bone growth, a common adverse effect in earlier rhBMP-2-based products.”