Over the last decade, end users have increasingly accepted the clinical application of these bone fillers/cements as bone substitutes in trauma and orthopedic surgery. Scientists have intensively investigated Ca-phosphate compounds including tricalcium phosphates, Ca sulfates and hydroxyapatite.
Researchers are also exploring the potential of injectable Ca-based pastes as delivery vehicles for proteins such as bone morphogenetic protein (BMP) 2 for fractures. However, their slow absorption rate and non-adhesive qualities limit their utility to being carriers for other materials that may promote bone formation and providing a scaffold for bony ingrowth. Biomechanically, cements do not offer adhesive properties and are weak under tension.
"Increasing evidence shows that Mg-based implants promote bone formation during healing (osteoconduction), and may ultimately show in future FDA filings the ability of growing new bone (osteogenisis) and Mg-based alloys are being studied as orthopedic biomaterials," notes Shetty. "Looking to the future, BSI is also investigating alternative new products based on its magnesium-oriented technology, as Mg-based bone void filler may be less prone to other complications associated with Ca-based biomaterials such as the activation of clotting."
Owing to the application breadth, BSI has large, fragmented addressable markets, totaling $3 billion globally. The company is exploring licensing or joint venturing for various orthopedic applications, including trauma for synthetic bone grafts, sports medicine, extremities, maxillofacial/cranial, and dental.
Following its FDA 510 (k) clearance, BSI plans to complete a series of four additional 510(k) approvals as bone void filler for cranial applications, for maxillofacial applications, and for non-load bearing spine app
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