Read BioDfactor Data Sht-10.24.11 text version

BIOLOGICS

BIODfactor

TM

Structural Tissue Matrix

Consider the source.

Tissue recovered from live, healthy donors during childbirth. Cyropreserved liquid allograft derived from fetal afterbirth tissue and cells. Collagen present in amnion provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body. Amnion derived extracellular matrix includes proteins, growth factors and residual multipotent cells naturally present in amnion. BioDfactor can be injected or applied directly to the surgical site. It is cryospreserved to facilitate an extended shelf life and is easy to handle in the operating room. Processed and packaged at an FDA registered tissue bank. Meets or exceeds all applicable industry standards for processing of human cellular and tissue based products. Immune Privileged. Amniotic membrane is a unique human tissue in that it rarely evokes an immune response in the human body. This unique attribute has been described in numerous clinical studies and scientific journals and has led to the characterization of the placental organ as "immune privileged." The unique biological structure of amniotic tissue, coupled with the low risk of an immune response, makes BioDfactor an ideal Choice for homologous therapeutic use.

BIOLOGICS

BIODfactor

Catalog #

BF-010025 BF-010050 BF-010125

TM

Structural Tissue Matrix

BIODfactor Structural Tissue Matrix

Product Volume

0.25 ml 0.50 ml 1.25 ml

Extracellular Matrix

Amniotic tissue is an abundant source of collagen that provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body. Collagen provides a structural tissue matrix that facilitates, among other things, cell migration and proliferation in vivo. BioDfactor was developed using a proprietary technique that morselizes the amnion in an effort to preserve its structural properties in an injectable form. This "micro-scaffold" created by the morselized tissue matrix includes the residual proteins, carbohydrates, hyaluronic acid, growth factors and other chemical compounds naturally present in amniotic fluid and tissue to provide an in vivo wound covering that is derived from those components essential for fetal growth and development. Clinicians have used amniotic tissue for over a century as a biologic dressing in a broad range of therapeutic applications.1 It has been generally recognized as a versatile wound covering with published clinical results cited extensively in the literature.2

Unique Attributes of Amnion

During pregnancy, amniotic membrane, fluid and cells act as a biologic system whose primary function is to (i) protect the fetus; and (ii) aid in fetal growth and development. In addition to its structural properties, the placental membrane and amniotic fluid have been found to contain a rich source of proteins, cytokines, growth factors and other chemical compounds, all of which are essential for fetal growth and development. Amniotic fluid also contains multipotent cells that are capable of differentiating into all three germ layers of the human body.3 Specifically, amniotic fluid derived stem cells have been shown to be broadly multipotent, capable of differentiating into adipogenic, osteogenic, myogenic, endothelial, neurogenic and hepatic cell lineages.4 While the primary function of BioDfactor is to provide a structural tissue matrix to cover and protect the wound, the presence of residual multipotent cells naturally present in amnion may provide ancillary clinical benefits by enhancing the body's natural regenerative process.

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Extracellular matrix image courtesy of Robert Mecham, Ph.D., Washington University in St. Louis. Gruss, J., et. al., Human amniotic membrane: a versatile wound dressing. CMA Journal 1978; Vol. 118: 1237-1246. 2 Id. at 1237. 3 De Coppi, P. et. al., Isolation of amniotic stem cell lines with potential for therapy. Nature Biotechnology 2007; Vol. 25, No.1: 1274-1280. 4 Id. at 1274.

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© 2011 Amedica Corporation. All rights reserved. Origin is a registered trademark of Amedica Corporation. 401021, Rev. B BioDfactor tissue is supplied by BioDlogics, Inc. Germantown, TN 38139

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