Providing a clear choice for your bone regeneration needs, ProteiOS possesses an array of osteoinductive, chemotactic, angiogenic and proliferative growth factors that can be added to enhance a surgeon's scaffold of choice.
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More than just a single growth factor or protein, ProteiOS contains close to 1000 proteins, including, but not limited too, established amounts of BMP-2, BMP-4, BMP-6, BMP-7, BMP-9, PDGF-BB, TGF-β and VEGF.[1]
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Sustained release of growth factors compared to the burst release of rhBMP-2 seen with Infuse.[7,8]
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Highest non-recombinant BMP-2 content on the market.[1-5]
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Allows a surgeon to use their scaffold of choice that is approved with bone graft.
Through Biologica’s proprietary processing methods, we are able to harness the relevant intracellular growth factors found within the endosteum layer of allograft bone. This layer is found lining the trabecular space and is comprised of mesenchymal stem cells (MSCs), osteoprogenitors, osteoblasts and pericytes.
Periosteum
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Cortical/compact bone
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Endosteum covering
cancellous/spongy bone
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The ProteiOS Advantage:
ProteiOS exhibits the highest amount of non-recombinant BMP-2 of any product in the orthopaedic market [1-5]
ProteiOS contains a full array of osteoinductive, chemotactic, angiogenic, and proliferative growth factor proteins [3, 5]
ProteiOS when added to a synthetic scaffold displays high growth factor binding when measured at 15 minutes [7]
ProteiOS Binding Efficiency
When bound to a synthetic scaffold, ProteiOS exhibits a long-term sustained release versus the high initial “burst release” of rhBMP-2 (Infuse®, Medtronic).[7]
A continuous long-term release has shown to be a more effective delivery system than an initial burst release.[8]
ProteiOS Elution Characteristics
ProteiOS Safety:
A Mixed Lymphocyte Reaction (MLR) is a functional assay commonly used to assess the compatibility and capacity of a product to generate an immune response.
With ProteiOS, it did not stimulate a response and had levels similar to the negative control, demonstrating non-immunogenicity.[9]
Non-immunogenic Response to ProteiOS
Additional Safety Information
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Terminally sterilized via low-dose gamma irradiation.
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Every lot tested for protein content
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Strict donor screening through an accredited (AATB) tissue bank for risk factors associated with infectious diseases and medical conditions that would rule out donation.
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Donor serology testing by CLIA certified laboratories for:
— HBsAg: Hepatitis B Surface Antigen — HIV NAT: Human Immunodeficiency Virus
— HBcAb: Hepatitis B Core Antibody — HBV NAT: Hepatitis B Virus
— HCVAb: Hepatitis C Antibody — RPR/STS or Equivalent: Syphilis
— HCV NAT: Hepatitis C Virus
— HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody
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Validated, double sterile barrier packaging.
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Packaged under nitrogen backfill to mitigate free radical formation
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Donor and lot traceability on each label.
References:
[1] Data on File, Biologica Technologies.
[2] Chnari E., et al. “Bone Morphogenetic Protein 2 (BMP-2) Levels are Predictive of the Osteoinductive Potential of Demineralized Bone Matrix,” in 56th Annual Meeting of the Orthopaedic Research Society, 2010. Poster 485.
[3] Data on File, Biologica Technologies.
[4] Schmidmaier G., et al. “Quantitative assessment of growth factors in reaming aspirate, iliac crest and platelet preparation,” Bone, vol.39 pp. 1156-1163, 2006.
[5] Data on File, Biologica Technologies.
[6]Data on File, Biologica Technologies.
[7]Data on File, Biologica Technologies.
[8]Blackwood K., et al. “Scaffolds for Growth Factor Delivery as Applied to Bone Tissue Engineering,” International Journal of Polymer Science, vol. 2012, Article ID 174942, 25 pages, 2012.
[9]Data on File, Biologica Technologies.
INFUSE® is a registered trademark of Medtronic