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MagnetOs Clinical Whitepaper

Favorable preliminary results of MagnetOs as standalone alternative to autograft in a prospective, multi-center, randomized, intra-patient controlled trial

Introduction
Pseudoarthrosis after spinal fusion is a challenging complication that is estimated to generate 92,000 revision spine surgeries in the United States in 2022.1-3 Surgeons face several challenges when performing complicated arthrodesis surgeries, one of which is having an adequate supply of autograft available, especially in complex or multi-segment procedures. Iliac Crest Bone Graft (ICBG) is considered the gold standard, but there are known disadvantages to using ICGB including limited availability and an additional procedure for harvesting the graft; as such, many surgeons turn to local bone in place of, or to augment, ICBG.4 Furthermore, evidence suggests significant variability in autograft bone due to age, metabolic disease, or donor co-morbidities.5

Because of the disadvantages in obtaining ICBG, multiple substitutes to autograft bone have been developed for bone grafting in spinal arthrodesis surgery. These alternatives include allograft, demineralized bone matrices (DBMs), cell-based matrices (CBMs), and synthetic bone grafts.6 Each of these categories comes with a unique set of risks and benefits. Synthetic bone grafts have quickly come to the forefront as a reasonable alternative to autograft bone because of their cost-effectiveness and notable safety profile. Formulations include Calcium Sulfate, Hydroxyapatite (HA), β-Tri Calcium Phosphate (β-TCP), Biphasic Calcium Phosphate (BCP), Bioglass, and Silicated Calcium Phosphate (Si-CaP).6 Because there is significant variability in the quality and quantity of clinical evidence for synthetic bone grafts, it can be challenging for surgeons to identify the best options in terms of efficacy, safety, and cost-effectiveness.

Biphasic Calcium Phosphate (BCP)
In recent years, research on BCP as bone graft substitute, has led to increased utilization in spine arthrodesis surgery. BCP is cost-effective, has been proven to have an appropriate safety profile, and has a low incidence of reaction or material-related complications.7,8 Interestingly, a novel BCP with submicron needle-shaped surface features, MagnetOs (MagnetOs; Kuros Biosciences BV, The Netherlands), has been shown to promote bone formation even in soft tissue, without the need for added cells or growth factors.9 MagnetOs is designed to mimic the porous, trabecular structure of cancellous bone, and has a resorption profile equal to anatomic bone due to an optimal ratio of HA to β-TCP. The needle-shaped submicron surface features of MagnetOs triggers bone formation propagating from the core of the graft, while also supporting bony ingrowth through osteoconduction. MagnetOs, therefore, does not solely rely on bone formation via creeping edge repair, as is the case for conventional synthetic bone grafts. Thus far, MagnetOs has led to uniform, solid, and predictable fusions in clinically relevant animal studies and in one retrospective evaluation of cervical and lumbar spinal arthrodesis cases.* However, the current report describes the first clinical results for MagnetOs obtained in an ongoing prospective randomized controlled trial of posterolateral fusion.10-12

Conclusion
This interim analysis found a 78% fusion rate of MagnetOs Granules by subject, and a 76.1% fusion rate of MagnetOs Granules by level. The results of this ongoing, prospective study aiming to determine the non-inferiority of MagnetOs Granules used standalone as compared to autograft are promising. Ongoing studies with more subjects are forthcoming.

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