Technology
The Bone Solutions platform is built on Magnesium, which is critical for bone health and development. Approximately 60% of Magnesium in the body resides in the bones, contributing to the structural development of bone and playing a key role in the absorption and regulation of calcium. Magnesium also controls the active transport of calcium across cell membranes and deficiency can contribute to osteoporosis.
Mg OSTEO products are a magnesium/potassium phosphate synthetic bone substitute derived from an acid/base crystallization reaction from magnesium oxide (MgO) and blend of phosphates. The MgO component serves as a binder with adhesive/cohesive properties while the phosphates promote osteoconductivity. This union allows Mg OSTEO products to set/cure in situ without migration.
The material degradation process starts immediately upon the curing of the Mg OSTEO products in vivo and continues through bone remodeling via the hydrolysis dissolution mechanism. Over time, the material will become less dense with less mineral content, as the product is remodeled through bone integration via creeping substitution. At a cellular level, magnesium ions are released, stimulating cell adhesion and proliferation, and the formation of the bone extracellular matrix by the osteoblasts – ultimately forming new bone at an optimal rate.
The optimal bone remodeling rate is what sets Mg OSTEO products apart from competitive bone growth substitutes. Magnesium phosphate combines the optimal properties of competitive materials, remaining in the body long enough to provide structural support for bone formation, but degrading once bone has formed.
Increases proliferation of marrow stromal cells
Enhances mineralization of the extracellular matrix
Stimulates proteins for enhanced bone regeneration
Improves attachment of growth of osteoblasts
Initiates apatite layer formation on scaffolds
Mg OSTEOCRETE required up to 43% greater force to completely remove the bone screw as compared to Ca-Cement and no treatment at 5 days.*
Influence of bone cements on bone-screw interfaces in the third metacarpal and third metatarsal bones of horses. Am J Vet Res. 2009;70(8):964-972. Hirvinen LJ, Litsky AS, Samii VF, Weisbrode SE, Bertone AL.
* All claims based on an equine model. It is unknown how results from the equine models compare with clinical results in humans.
Mg OSTEOCRETE demonstrated up to 58% greater extraction torque at 4 days compared to Ca-Cement and no treatment.*
Degradable magnesium based cement adheres stainless steel screws into bone. Orthopaedic Research Society; 2006; Chicago, IL. Bertone A, DeMaria M, Johnson A, Weisbrode S, Kowaleski M.
* All claims based on an canine model. It is unknown how results from the canine models compare with clinical results in humans.
Mg OSTEOCRETE improved anchoring fixation by an average of 50% fifteen minutes post injection compared to Ca-Cement.*
Use of a Novel Magnesium-Based Resorbable Bone Cement for Augmenting Anchor and Tendon Fixation. Am J Orthop (Belle Mead NJ). 2018;47(2). Roller BL, Kuroki K, Bozynski CC, Pfeiffer FM, Cook JL.
* All claims based on an canine model. It is unknown how results from the canine models compare with clinical results in humans.
Mg OSTEOCRETE remodeled nearly 4x more completely then competitive bone substitutes at 12 weeks.*
Histomorphometric Evaluation (Rabbit Femur Bone Healing) and 510k Clearances K222063 and K071004
* All claims based on an lapine model. It is unknown how results from the lapine models compare with clinical results in humans.
Radiographic Evidence of Bone Remodeling
Radiographic evidence of Mg OSTEOCRETE remodeling over one year.*