MagnetOs Granules as standalone alternative to autograft:

The preliminary results are in… (and they are remarkable)

The halfway point has been reached in a patient and observer-blinded, randomized, intra-patient controlled, multi-center clinical trial evaluating MagnetOs Granules versus autograft.

The preliminary results are now in for the first 50 (of 100) subjects undergoing one to four-level instrumented posterolateral fusion (PLF) as part of this trial - and they look very promising:

Fusion rate by CT after one year:

(% subjects)

MagnetOs Granules

78.0% (39/50)

Autograft

42.0% (21/50)

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What do these interim results mean?

These are preliminary results, and the trial still has one year to run. Nevertheless...

MagnetOs Granules achieved a substantially higher fusion rate than autograft.

Autograft fusion rates have varied considerably in spinal fusion literature (between 40-80%) due to various factors, including the harvesting site; the composition and quality of the autograft bone; the assessment method for fusion; and the length of the post-operative assessment period. However, the fusion rates for autograft reported here are comparable to those reported in literature with similar study protocols (i.e., randomized, controlled, prospective, and compared to synthetic bone grafts).2

The fusion rate of MagnetOs Granules is higher than those of synthetic bone grafts reported in other studies.

This includes a β-TCP bone graft with microstructured topography, which reached a fusion rate of 55% in patients undergoing PLF2; a Silicated Calcium Phosphate bone graft, which reached a 71.4% fusion rate in patients undergoing PLF with Posterior Lumbar Interbody Fusion (PLIF)3; and a peptide bone graft, which reported a 50% fusion rate in non-instrumented PLF.4

Why did Kuros sponsor this clinical trial?

MagnetOs Granules has now been used successfully in more than 10,000 spinal procedures worldwide. To deliver the ideal bone graft, the scientists at Kuros believe in making every possible effort to obtain the highest quality & quantity of scientific evidence.

Today, there is no standard research protocol for synthetic bone graft products. This in turn, can make treatment algorithms challenging for surgeons who want to choose the best alternative to Iliac crest bone graft (ICBG) due to the sheer variability of the quality and quantity of published research.

The rationale behind this new clinical study is simple: to enhance Kuros’ portfolio of evidence by going beyond the animal research models and uncontrolled case studies used in support of many synthetic bone grafts currently on the market. As such it forms a key component of our wider Project Fusion global research program, aimed at making the unpredictable… predictable.

What are the details of this trial?

Every effort has been made to design this trial to the highest standards of clinical research, to reliably evaluate whether MagnetOs Granules is non-inferior to autograft.

The Approach:

PLF is known throughout the literature as one of the more challenging approaches for achieving spinal fusion.5 This procedure was chosen intentionally with this knowledge in mind.

The Process:
In each case, the randomized side of the graft was disclosed to the surgeon only after preparation of the fusion bed on both sides.
  • In all subjects at all levels, one side (right or left) was grafted with 10cc of autograft per level.
  • The autograft was a combination of local vertebral bone supplemented with at least 50% cortico-cancellous bone harvested from the iliac crest.
  • The other randomized side was grafted with 10cc of MagnetOs Granules without added autograft or bone marrow aspirate (standalone bone graft).

The evaluation:

Overall fusion rates were determined by two spine surgeons’ independent reads of fine-cut (<1mm) CT scans and by Oswestry Disability Index (ODI) scores at various time points. Assessment of fusion was scored in the coronal, sagittal and axial planes. A segment was fused if at least one plane showed definite fusion, and at least one other plane showed a doubtful fusion or definitive fusion.

These fusion rates were further evidenced with statistical analysis to remove co-founding variables (e.g., the presence of an interbody fusion).

group_FILL0_wght400_GRAD0_opsz48-01

50

Number of patients: 50

update_FILL0_wght400_GRAD0_opsz48-01

57

Average age: 57

wc_FILL0_wght400_GRAD0_opsz48-01

60/40

Gender breakdown: 60/40 female-male

check_circle_FILL0_wght400_GRAD0_opsz48-01

PLF

Procedure: PLF

percentage-01

62%

% of inter body fusion: 62%

equalizer_FILL0_wght400_GRAD0_opsz48-01

1-4

Number oflevels: 1-4

trending_down_FILL0_wght400_GRAD0_opsz48-01

>15

ODI score decrease at one-year: >15 points in overhalf of the patients

Case Study 1

52-year-old female one-level PLF at L3-L4.

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Case Study 2

79-year-old female one-level PLF at L4-L5.

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Case Study 3

60-year-old male two-level PLF and TLIF from L3-L5.

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Case Study 4

60-year-old male two-level PLF at L3-L5.

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Case Study 5

67-year-old male four-level PLF at L2-S1.

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Case Study 6

70-year-old female four-level PLF, with TLIF, at L1-L5.

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About MagnetOs

MagnetOs isn’t like other bone grafts. It grows bone even in soft tissue thanks to our unique NeedleGrip surface technology which provides traction for our body’s vitally important ‘pro-healing’ immune cells (M2 macrophages).*†6,7 This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft.*8-10

The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more efficient and predictable fusion.*‡10

Learn More about MagnetOs

About Project Fusion

Today, nearly 1 in 5 spinal fusions fail. So, what can we do to change this situation - for the benefit of patients, surgeons and our wider society?

This is the question that drives us at Kuros. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development & technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality & quantity of scientific evidence behind it.

Which is why Project Fusion brings together an unprecedented blend of scientific, preclinical and clinical studies – all aimed at making the unpredictable... predictable

Learn More about Project Fusion

Would you like to know more about this research?

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References: 1. Data on File. 2. Lehr, et al. Spine. 2020; 45(14):944-951. 3. Coughlan, et al. Spine (Phila Pa 1976). 2018;1-43(15):E860-E868. 4. Jacobsen MK, et al. The Spine Journal. 2020;20(5):677-84. 5. Elsamadicy, et al. J Spine Surg. 2017;3(1):31-37. 6. Van Dijk, et al. eCM. 2021;41:756-73. 7. Duan, et al. eCM. 2019;37:60-73. 8. Van Dijk, et al. JOR Spine. 2018;e1039. 9. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater. 2019;107(6):2080-2090. 10. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287.

*Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com. MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft. MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

Manufactured by Kuros Biosciences BV
Prof Bronkhorstlaan 10, Building 48, 3723 MB Bilthoven, The Netherlands.
Kurosbio.com

MagnetOs and NeedleGrip are trademarks of Kuros Biosciences.

PROMO/MAG/GL/044-21/R00 April’22