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ZetaFuse is a synthetic, small-molecule-based osteoinductive biomaterial developed as a drug-device combination product for bone grafting and spinal fusion. It is designed to promote bone growth (osteoinduction), prevent bone resorption (anti-osteolytic), and inhibit tumor cell division (anti-tumorigenic). The mechanism of action involves antagonism of the opioid growth factor receptor (OGFR) pathway, targeting the management of the p21 transcript in mesenchymal stem cells to stimulate their differentiation into osteoblasts. Unlike biologic growth factors that carry higher cancer risk, ZetaFuse leverages components with established clinical safety profiles and cost-effective manufacturing. It has received FDA Breakthrough Designation for use in spinal fusion across cervical, thoracic, and lumbar regions and is being investigated for degenerative disc disease as well as metastatic cancer-related bone lesions[1][2][3][4][5][6][8].
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