Bone Substitute Materials
Not all calcium phosphates are created equal!
There are several different compounds of calcium phosphates that are either used independently or in combination to develop a bone substitute material (BSM). The performance of a calcium phosphate BSM in-vivo depends highly on its chemical composition as well as other physical characteristics such as structure, crystal and particle size, specific surface area, and porosity. The chemical structure, low crystallinity and high porosity of ETEX’s calcium phosphate technology have been shown to have a perfect physical and chemical resemblance to the mineral content of natural bone. These characteristics create osteoconductive bone substitute materials that are replaced by bone cells with new bone over time.
Research projects are currently underway to develop formulations with varying properties such as compressive strength, resorbability self-setting and composite materials composed of therapeutic agents, such as cells, demineralized bone matrix (DBM) and bone morphogenetic proteins (BMPs) to meet the needs of orthopaedic and spine surgeons.
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Carrier for Cells and Therapeutic Agents
Clinical delivery of cells and bioactive therapeutic agents such as bone growth factors is dependent upon a chemically compatible carrier that can provide localized retention and offer a predictable release rate after implantation.
ETEX is in collaboration with Wyeth Biotech to develop customized carriers for delivering recombinant human Bone Morphogenetic Protein-2 (rhBMP-2), for various applications in orthopaedics. RhBMP-2 is an osteoinductive protein that stimulates bone formation.
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Resorbable Orthopaedic Devices
ETEX has developed resorbable calcium phosphate based materials adaptale to orthopedic applications such as bone plugs, fixation screws and interbody spacers. These materials are manufactured using ETEX's calcium phosphate technologies and resorbable polymers. The similarity of the ETEX calcium phosphate to bone mineral gives the material excellent bone bonding, remodeling and mechanical properties. In vitro and in vivo testing has demonstrated the biocompatibility of the material and the feasibility to provide primary mechanical stability. ETEX is actively engaged in studies to determine optimum material design and to establish material safety and efficacy.
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Implant Surface Angstrom Coatings
ETEX has developed a patented thin coat plasma process using a calcium phosphate film at ambient temperatures. This method may not only enhance cellular in-growth improving bone apposition, but also enable potential delivery of desirable therapeutic or anti-microbial agents. This technology can be used on metal or polymer implants without generating the byproducts associated with traditional methods. Several preclinical studies involving canine total hip replacement, canine dental screw implant and sheep interbody stabilization have been performed.
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