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Our aim is to deliver decreased complications, advanced functional rehabilitation and to eliminate non-unions for spine surgeons and their patients
With more than 150 years of combined research experience, we feel well-established as leaders in orthobiologics, but we’re never content with resting on our laurels. Instead, we continue to forge beyond the accepted solutions for spinal fusion.
Our focus is on revolutionizing the field of orthobiologics by developing bone grafts that deliver both targeted and controlled bone healing.
We recently launched MagnetOs, a unique bone graft with submicron surface topography, that harnesses the power of osteoimmunology to deliver uniform, solid and stable spinal fusions.
The U.S. Food and Drug Administration (FDA) has approved an IND for the investigation of our Fibrin-PTH (KUR-113) product candidate; the first ever drug-biologic combination for spinal interbody fusion. Fibrin-PTH (KUR-113) is entering a Phase 2a clinical trial in the U.S.
Alpesh A. Patel, MD is the Director of Orthopedic Spine Surgery at Northwestern and a spine surgeon with fellowship training in both Orthopedic Spine Surgery and Neurosurgery. Dr. Patel specializes in cervical spine surgery and minimally invasive spine surgery.
Director of Orthopedic Spine Surgery, Northwestern Medicine, Chicago, IL
Andrew Sama, MD is Co-Chief of HSS Spine where he specializes in the management of all traumatic, degenerative, and deformity-related conditions of the cervical, thoracic, and lumbosacral spine. Dr. Sama also serves as an Associate Professor of Clinical Surgery, Weill Medical College of Cornell University.
Co-Chief of HSS Spine, New York, NY
Kornelis Poelstra is board certified in orthopedic spine surgery. He specializes primarily in long-construct minimally invasive spine surgeries, adult spinal deformity, oncologic conditions, spinal fracture treatment and cervical disc replacements. He is one of the world leaders in Robotic Spine Surgery.
Orthopedic Spine Surgeon, OrthoNorthCal, Los Gatos, CA
W.R. Walsh, PhD is a Professor in the Prince of Wales Clinical School, Division of Surgery at University of New South Wales in Sydney, Australia, and Director of Surgical & Orthopaedic Research Laboratories, Prince of Wales Hospital. His research lies at the interface between implanted materials and the connective tissues of the body.
Professor, Division of Surgery at University of New South Wales, Sydney, Australia
Faheem Sandhu, MD, PhD, is Director of Spine Surgery at MedStar Georgetown University Hospital and Professor of Neurological Surgery at Georgetown University Medical Center. He specializes in minimally invasive and complex spinal surgery.
Director of Spine Surgery, MedStar Georgetown University Hospital, Chevy Case, MD
Richard (Todd) Allen, MD, is board-certified orthopedic surgeon with expertise in complex adult reconstruction procedures for deformity/scoliosis and tumors. He also specializes in complex disorders of the upper cervical spine and in degenerative, traumatic, and post-traumatic conditions.
Associate Professor of Orthopaedic Surgery, UC San Diego Health, San Diego, CA
MagnetOs is an advanced bone graft with a porous trabecular structure that mimics human cancellous bone and a unique submicron surface topography that harnesses the power of macrophage polarization and osteoimmunology to form bone instead of scar tissue.3*
This effect is so potent that MagnetOs can form bone in soft tissues without added cells or growth factors,4*¥ meaning in preclinical studies bone is formed simultaneously throughout posterolateral spine defects.1,2,5
Watch to find out how its needle-shaped submicron feature promotes attachment and spreading of macrophages, leading to uniform, solid and stable spine fusions.1-3*
In preclinical studies, MagnetOs has been shown to direct bone formation even in soft tissue, without the need for added cells or growth factors.4*¥
Using clinically-relevant animal models, multiple fusion endpoint analysis at the 12-week mark showed MagnetOs’ performance was equivalent to autograft, the gold standard.2,3*
In validated preclinical tests, MagnetOs is radiographically, biomechanically and histologically superior to the category leaders Vitoss BA2X and Novabone Putty.5*
Our Fibrin-PTH technology, is based on the well-established mechanism of action of parathyroid hormone – or PTH as it is commonly known – and the natural healing matrix fibrin.
It promotes controlled bone formation at the site of implantation through the induction of osteoprogenitor cell differentiation, enhancement of osteoblast proliferation and by increasing the life-span of bone-forming cells.6*
Fibrin-PTH (KUR-113) is the first ever investigational drug-biologic product candidate being evaluated for spinal fusion.#
Demonstrated for Fibrin-PTH (KUR-113) in preclinical animal studies of spinal fusion.7*#
Excellent flowability and setting properties for Fibrin-PTH (KUR-113) shown in preclinical studies.8*#
Effective for bone healing with a promising safety profile in two Phase 2 orthopedic trauma trials.9,10
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GET IN TOUCHSuggested Reading
References And Disclaimers
Find the latest data on posterolateral spine fusion rates for each category of bone graft on Pubmed.gov
MOREDiscover more of our research for MagnetOs bone graft on Pubmed.gov
MORESee selected articles for parathyroid hormone (PTH) on Pubmed.gov
MORESee our clinical research for MagnetOs and Fibrin-PTH on Clinicaltrials.gov
MORE1. Van Dijk LA, et al. JOR Spine 2018;e1039.
2. Van Dijk LA, et al. J Biomed Mater Res B Part B 2019:9999B:1-11.
3. Data on file, 2019.
4. Duan R, et al. Eur Cell Mater 2019;37:60-73.
5. Walsh W et al., NASS 2019 annual meeting, oral presentation; van Dijk et al. Clin Spine Surg; 2020; Feb [Epublication].
6. Kraenzlin ME, et al., Nat Rev Endocrinol. 2011 Jul 12;7(11):647-56.
7. Data on file, 2011.
8. Data on file, 2019.
9. Data on file, 2011; Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF), ClinicalTrials.gov Identifier: NCT00533793.
10. Data on file, 2011; Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting, ClinicalTrials.gov Identifier: NCT00409799.
11. “Kuros Biosciences Announces U.S. FDA approval of IND Application to Initiate Fibrin-PTH Phase 2a Clinical Trial in Spinal Fusion”, press release, Kuros Biosciences, September 2019.
* Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans.
¥ MagnetOs is not cleared by FDA as an osteoinductive bone graft.
# Fibrin-PTH (KUR-113) is an investigational drug/biologic combination product candidate. Firbin-PTH (KUR-113) has been evaluated in animals for use in lumbar interbody fusion. The safety & efficacy of Fibrin-PTH (KUR-113) has not yet been evaluated for spinal fusion in humans.
Please refer to the Instructions for Use for a full list of indications, contraindications, warnings and precautions.