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BIO4 is a viable bone matrix (BVM) allograft designed for the repair, replacement, or reconstruction of bone defects. It is classified as a Section 361 HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product), meaning it is a human tissue product processed to maintain the viability of endogenous bone-forming cells, including mesenchymal stem cells (MSCs) and osteoprogenitor cells. The matrix provides four essential components for bone regeneration: an osteoconductive scaffold, osteoinductive growth factors, osteogenic cells, and an angiogenic-supportive marrow-rich environment. Developed by Osiris Therapeutics and marketed exclusively by Stryker, BIO4 is primarily used in orthopedic and spinal procedures, such as Anterior Cervical Discectomy and Fusion (ACDF), to facilitate stable arthrodesis.
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