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AmnioMTM :
TM
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. Interstitial collagens (types I and II) form parallel bundles that provide the mechanical integrity of the membrane while collagens type V and VI form filamentous connections between interstitial collagens and the epithelial basement membrane. AmnioMTM 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. It has been generally recognized as a versatile wound covering with published clinical results cited extensively in the literature.
AmnioMTM:
Catalog #
AG-010025 AG-010050 AG-010125
Product Size
0.25 ml 0.50 ml 1.25 ml
Product Description:
Cryopreserved liquid allograft derived from fetal afterbirth tissue and cells Tissue recovered from live, healthy donors during childbirth Provides a localized wound covering or for use in filling soft tissue defects and bone voids
Product Benefits:
Liquid matrix covers and protects the wound in vivo Easy to apply at surgical site Amniotic membrane and fluid rarely evoke an immune response, Class II antigens not expressed Presence of residual multipotent cells may provide ancillary clinical benefits by enhancing bodys natural regenerative process
Quite simply, at AmnioGenix, we believe the use of live, healthy donors is a better approach to regenerative medicine.
Use of Live, Healthy Donors. AmnioMTM is a human allograft derived from amniotic tissue from live, healthy donors. It is a natural alternative to synthetic, cadaveric, or animal derived regenerative medicine products. While the primary function of AmnioMTM is to provide an extracellular tissue matrix to cover and protect the wound, the presence of the chemical compounds, growth factors and residual cells naturally present in amnion may provide ancillary clinical benefits by enhancing the bodys natural regenerative process. 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 biologic structure of amniotic tissue, coupled with the low risk of an immune response, makes AmnioMTM an ideal choice for an in vivo wound covering. Ease of Use. As a liquid wound covering, AmnioMTM can be injected or applied directly to the surgical site to cover or fill soft tissue defects or bone voids. It is cryopreserved to facilitate an extended shelf life and is easy to handle in the OR.
AmnioMTM is regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.
Regulatory References
Gruss, J., et. al., Human amniotic membrane: a versatile wound dressing. CMA Journal 1978; Vol. 118: 1237-1246. Id. at 1237. De Coppi, P. et. al., Isolation of amniotic stem cell lines with potential for therapy. Nature Biotechnology 2007; Vol. 25, No.1: 1274-1280. Id. at 1274.
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USA +1.901.457.7613
www.amniogenix.com