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To give you the most accurate information about our products and what we can do for you, we need to direct you to the right site.
In an independent, investigator-initiated Level 1 human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate of autograft in challenging Posterolateral Fusion (PLF) procedures.1,2
One-year fusion rates from the prospective, randomized, multi-center, intra-patient controlled trial in patients undergoing PLF from 1-6 levels (T10-S2) demonstrated:1
Surgeons performing procedures were blinded until bone graft application
Fine-cut CTs read by two independent, blinded spine surgeons
One-year follow-up: Fusion by CT, ODI, adverse events (safety)
Of this patient population, 19% were active smokers and 35% were former smokers; an important data point given the challenge in treating high-risk patient groups.†‡1,4
One Year Fusion (% Levels Fused) | MagnetOs Granules | Autograft |
---|---|---|
Overall1 | 79% (100/128) | 47% (60/128) |
Smokers†‡3 | 74% (20/27) | 30% (8/27) |
Based on the results of this investigator-initiated study, does 'indicated superiority' mean it's time to reassess the gold standard in PLF?
In the investigators' words: "Even though the primary aim of the current study was to demonstrate non-inferiority, our findings indicate superiority of the BCP<µm (MagnetOs) in terms of CT-determined PLF at one year."1
Ultimately, this study lends further weight to MagnetOs as the bone graft of choice for surgeons and their patients. How was this product able to achieve such compelling results?
MagnetOs grows bone thanks to its unique NeedleGripTM surface technology — which has been shown in pre-clinical studies to stimulate stem cells and form new bone across the entire graft.‡§5,6
Scanning electron microscopy (SEM) ultra-high resolution of MagnetOs at 20,000x magnification illustrates that the needles are anatomically sized to match the cells.1
Zoomed video of MagnetOs under scanning electron microscopy (SEM)
Animation of the MagnetOs NeedleGrip mechanism of action
This Level 1 human clinical trial is just one of many studies that have been (and continue to be) undertaken by the team at Kuros Biosciences.
Under the Project Fusion global research and development program, Kuros continues to generate a clinical data package that is superior to any other bone graft cleared for use via the same regulatory pathway, that includes:
10
clinical trials initiated.
>25
patents granted.
>320
scientific papers published.
The one thing a surgeon can do right now to improve fusion rates and maximize clinical outcomes is to choose a bone graft based on evidence.1-3
*MagnetOs was mixed with venous blood. †19 of initial 100 subjects were active smokers. Radiographic fusion data of the smoker subgroup were not statistically analyzed as a subgroup and were not included in the peer-reviewed publication of the study.1 ‡Results from in vivo or in vitro laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com. §For a 510(k)-cleared synthetic bone graft. For important safety and intended use information please visit kurosbio.com.
References: 1. Stempels, et al. Spine. 2024;49(19):1323-1331. 2. Yadav S, et al. Journal of Orthopaedics, Trauma and Rehabilitation. 2020;27(2):173-178. 3. Van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024. 4. Berman, et al. Int J Spine Surg. 2017;11(4):29. 5. Van Dijk, et al. eCM. 2021;41:756-73. 6. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287.