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BIOLOGICS

The ultimate goal of fusion is to restore disc height, alignment, and stability. In order for new bone to form, three critical elements are required: osteoconductive scaffold (or a surface for bone to grow on, in, and through), osteogenic cells (the cells that produce bone), and osteoinductive signals (proteins/molecules that tell the cells what to do).

BACTERIN

Bacterin products are engineered to provide superior handling characteristics for the surgeon.

The OsteoSponge® allograft is compressible, OsteoWrap® is flexible, and OsteoSelect® DBM Putty features a consistency that allows it to stay in place even in wet surgical environments.

While Bacterin could stop at aseptic processing and rely on tissue decontamination processes to ensure safety, they take safety to the next level by providing a sterility assurance level of 10-6 via low-dose gamma irradiation. Research over the past 20 years has shown that low-dose gamma irradiation provides an additional means of allograft safety while not significantly compromising the natural integrity or biologic performance of the allograft. Presently, Bacterin test DBM processed from every donor for osteoinductive potential AFTER low-dose gamma irradiation.

OsteoSponge®

OsteoSponge® was created by Bacterin with the patient and the physician in mind. The product consists of 100% human cancellous bone that has been demineralized to provide a value-added benefit over other allografts. The demineralization process assists with two functions:
It makes the product compressible so it is ideal for surgeons to obtain a press-fit, precise placement of the graft and it exposes the native growth factors and bone morphogenic proteins that are essential to induce new bone formation.
OsteoSponge® also maintains the natural interconnected porosity of cancellous bone providing an ideal scaffold for cellular infiltration and bone formation. While OsteoSponge® is DBM by definition, it is distinct from other DBM products on the market in that it does not contain an added carrier material like putties and gels.
OsteoSponge® comes in various shapes and sizes to better meet surgical needs for specific applications. After placement, OsteoSponge® will stay in the surgical site and will not ooze or migrate, even upon direct irrigation.
OsteoSponge® is regulated and approved for homologous use as a bone void filler and may be used for any non-structural bone grafting applications and it is fully compatible for use in conjunction with orthopedic hardware.

OsteoWrap®

OsteoWrap® is 100% human cortical bone demineralized through a proprietary process that makes the graft flexible while maintaining allograft integrity. In addition to its unique handling characteristics, OsteoWrap® can be easily sized with a scalpel or scissors, and it may be sutured in place. The versatility of the OsteoWrap® allograft makes it an ideal scaffold for use in spinal, neurological, cranio-maxillofacial, reconstructive, and general orthopedic surgical procedures.
100% human demineralized cortical bone
Osteoconductive
Osteoinductive potential
Flexible handling characteristics
Easily contours to patient anatomy
Radiolucent to allow for accurate follow-up
Proven clinical outcomes

OsteoSelect ®

OsteoSelect® DBM Putty is in a class of its own. Maintaining Bacterin’s core competency of developing scaffolds based upon surgeon feedback, this putty is provided sterile with proven osteoinductivity and provides exceptional handling. Unlike many putties on the market, OsteoSelect® DBM will not dissipate or migrate upon direct irrigation, and does not adhere to surgical gloves–making precise product placement much easier to achieve.
Proven Osteoinductivity
Osteoinductivity of the final product is assessed in a validated athymic rat model. The osteoinductive potential of each lot is tested after low-dose gamma irradiation of the final product.
Device-Level Sterility (SAL 10-6)
Exceptional Handling Characteristics
Will Not Dissipate Upon Direct Irrigation
Contains 74% DBM by Dry Weight

Nuvasive-Osteocell Plus & Formagraft

Osteocel © Plus is a novel biologics solution for use in various musculoskeletal applications, including spine procedures, to facilitate fusion. An allograft cellular matrix containing viable mesenchymal stem cells, it mimics the biologic profile of autograft and contains all three natural components for bone healing: osteogenic cells, osteoconductive scaffold, and osteoinductive signals. Osteocel Plus is a complete bone graft that provides an advanced solution for restoring quality of life.

FormaGraft © supplements the biologics offering as a scaffold for new bone growth. A synthetic biologic comprised of minerals naturally occurring in the body (hydroxyapatite and beta-tricalcium phosphate) and bovine collagen, when combined with bone marrow aspirate, FormaGraft offers the three necessary components for fusion.

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