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Project Fusion: where Science and Clinical Evidence meet
Making the unpredictable… predictable
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.
The goals of Project Fusion
The evidence is clear
How are we translating the benefits of Project Fusion? We are generating a clinical data package that is superior to any other bone graft cleared for use via the same regulatory pathway. This includes:
10
clinical trials initiated.
>25
patents granted.
>320
scientific papers published.
>25000
patients treated.
Level 1
Clinical Evidence
Level I, prospective, randomized controlled trials
Level I: MAXA (Spine 2024)
A prospective, randomized, multi-center, intra-patient controlled human clinical trial of MagnetOs Granules versus autograft in instrumented posterolateral spinal fusion published in Spine.
Stempels, et al. Spine. 2024;49(19):1323-1331.
Level I: PROOF (Ongoing)
A prospective, randomized, multi-center study of MagnetOs Putty compared to DBM mixed with autograft in patients undergoing up to two-level instrumented posterolateral lumbar fusion
ClinicalTrials.gov Identifier: NCT04679844
Level I: PRECISE (Ongoing)
A prospective, randomized, multi-center study to assess the performance of MagnetOs Flex Matrix compared to a cell based allograft in patients undergoing up to four-level instrumented posterolateral lumbar fusion
ClinicalTrials.gov Identifier: NCT05037968
Additional
Clinical Evidence
Retrospective trials, case studies and white papers
Retrospective: Lumbar Interbodies ALIF/LLIF, 49% High Risk-Patient Cohort, MagnetOs
Biphasic calcium phosphate bone graft with a unique surface topography: A single-center ambispective study for degenerative disease of the lumbar spine
P. Nunley. Cureus. 2024;16(4): e58218.
Retrospective: Foot and Ankle, MagnetOs Putty
Arthrodesis of the subtalar joint using a novel biphasic calcium phosphate bone graft
T. Fusco. Foot and Ankle Surgery: Techniques, Reports & Cases. 2022;2(1).
Case Series: Cervical Posterior Fusion, MagnetOs Easypack Putty
Early radiographic and clinical outcomes of three patients undergoing open instrumented posterolateral fusion surgery with MagnetOs Easypack Putty
C. Elia, Juniper Online Journal of Case Studies. 2024;14(4).
Case Series: PLF, MagnetOs Granules and Putty
Effective use of a novel biphasic calcium phosphate with submicron surface topography in posterolateral spine fusion
A. Jones. JOJ Case Stud. 2021;12(2).
Case Series: PLF, MagnetOs Granules
Posterior thoracolumbar hemivertebra resection and fusion with a biphasic calcium phosphate bone graft with a novel submicron surface topography
F. Sandhu. JOJ Case Stud. 2021;12(2).
Case Series: Foot and Ankle, MagnetOs Granules and Putty
Clinical, radiographic, and histologic outcomes of ankle arthrodesis in a diabetic patient using a biphasic calcium phosphate bone graft with a novel submicron needle-shaped surface topography
T. Fusco. JOJ Case Stud. 2022;13(2).
Whitepaper: PLF, MagnetOs Putty
Use of a novel biphasic calcium phosphate with submicron surface topography as an extender to autograft in posterolateral spinal fusion
UCSD Orthopedic Surgery Department, CA
Preclinical Evidence
Scientific studies
Preclinical: Ovine, MagnetOs Putty
MagnetOs, Vitoss® and Novabone® in a multi-endpoint, clinically-relevant ovine model of posterolateral spinal fusion
van Dijk et al. Clin Spine Surg. 2020; 33(6):E276-E287.
Preclinical: Canine, MagnetOs Granules
Accelerated bone formation by biphasic calcium phosphate with a novel sub-micron surface topography promotes bone formation in soft tissues of canines without added cells or growth factors
Duan et al. Eur Cell Mater. 2019;28;37:60-73.
Preclinical: Ovine, MagnetOs Granules and Putty
Biphasic calcium phosphate with submicron surface topography in an ovine model of instrumented posterolateral spinal fusion
van Dijk et al. JOR Spine. 2018;e1039.
Preclinical: Lapine, MagnetOs Granules and Putty
Efficacy of a synthetic calcium phosphate with submicron surface topography as autograft extender in lapine posterolateral spinal fusion
van Dijk et al. J Biomed Mater Res. Part B: Appl Biomater. 2019; 107(6):2080-2090.
Scientific: In vitro, MagnetOs Granules
Calcium phosphate with submicron topography influences primary human macrophage response, enhancing downstream angiogenesis and osteogenesis in vitro
van Dijk et al. Journal of Immunology and Regenerative Medicine. 2023; 19 (2023).
Talk with an expert
Are you a surgeon that would like to understand more about how the body’s immune system can be modulated to eliminate non-unions? Simply book a slot with one of our scientists or surgeons below. Once signed up, you will receive an email confirming your appointment and how to join the online meeting. We look forward to speaking with you!
Dr. Katherine Sage, Senior Vice President, Medical and Clinical Affairs
United States, International
Dr. Katherine Sage is a board-certified Orthopaedic Surgeon based in Grand Rapids, MI passionate about orthopaedic implants and the science of bone grafts.
Dr. Casey Hatfield, Scientific Affairs Manager
United States
Dr. Hatfield obtained her PhD in Microbiology and Immunology from Vanderbilt University. Her PhD research focused on identifying the influence of inflammation on osteoimmunology and bone regeneration. Dr. Hatfield’s research experiences led to her passion for communicating scientific data and the clinical efficacy of advanced bone grafts to healthcare providers.
Dr. Thomas Spoonmore, Scientific Affairs Manager
United States
Dr. Spoonmore obtained his PhD in Chemical Engineering from Vanderbilt University. His PhD research focused on dual purpose bone grafts to regenerate bone tissue and eradicate biofilm infections. Dr. Spoonmore is passionate about communicating the science behind the best bone grafts for physicians to maximize successful outcomes for their patients.
Dr. Luuk van Dijk, Scientific Affairs Manager
Europe
Dr. Luuk van Dijk holds a PhD degree in calcium phosphate ceramics and a Masters degree in Regenerative Medicine and Technology, both from the University Medical Center Utrecht. He joined Kuros in 2015 and has worked for years as a researcher in the R&D department and at the University Medical Center Utrecht.
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