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A B ETTER A PPROACH T O R EGENERATIVE M EDICINE

A BETTER APPROACH TO REGENERATIVE MEDICINE

Enhancing Life Through Birth.

Innovative Human Cellular & Tissue- Based Wound Covering Products

 

AmnioMTM is a cryopreserved liquid wound covering derived from human amniotic tissue.

AmnioMTM TM :

 

Amniotic Multipotential Tissue Matrix

The New Standard in In Vivo Wound Covering

AmnioMTM has been developed for clinical use as a liquid wound covering or to fill soft tissue defects or bone voids. AmnioMTM can be applied directly to the surgical site to provide an easy to use wound covering offering the unique biologic structure of amniotic tissue.

Extracellular Matrix

 

AmnioMTM:

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.¹ It has been generally recognized as a versatile wound covering with published clinical results cited extensively in the literature.²

Catalog #

Product Size

AG-010025

0.25 ml

AG-010050

0.50 ml

AG-010125

1.25 ml

For Homologous Use Only

AmnioMTM is processed and packaged at an FDA registered tissue bank in accordance with CGTP standards.

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 body’s natural regenerative process

Quite simply, at AmnioGenix, we believe the use of live, healthy donors is a better approach to regenerative medicine.

Regulatory

References

Regulatory References Amniotic Multipotential Tissue Matrix Superior Solutions. Superior Outcomes. Key Features &
Regulatory References Amniotic Multipotential Tissue Matrix Superior Solutions. Superior Outcomes. Key Features &
Regulatory References Amniotic Multipotential Tissue Matrix Superior Solutions. Superior Outcomes. Key Features &
Regulatory References Amniotic Multipotential Tissue Matrix Superior Solutions. Superior Outcomes. Key Features &
Amniotic Multipotential Tissue Matrix Superior Solutions. Superior Outcomes.

Amniotic Multipotential Tissue Matrix

Superior Solutions. Superior Outcomes.

Superior Solutions. Superior Outcomes.

Key Features & Benefits

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 body’s 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.

Unique Attributes of Amnion

AmnioMTM is a liquid wound covering derived from human amnion. The collagen in amnion provides a structural tissue matrix that facilitates cell migration and proliferation in vivo. 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. As a liquid wound covering, AmnioMTM retains this protective function by providing an extracellular matrix for use in filling soft tissue defects or bone voids. 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 adi- pogenic, osteogenic, myogenic, endothelial, neurogenic and hepatic cell lineages. 4 While the primary function of AmnioMTM 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.

Donor Suitability & Safety Testing

From donor qualification to pre-release lot testing, AmnioGenix is committed to patient safety. Most human tissue products are derived from cadavers by third-party tissue banks. At AmnioGenix, all of our tissue is derived from live, healthy donors that we pre-screen during pregnancy and select based on our stringent donor selection criteria. From aseptic recovery of the tissue at childbirth to timely processing and cryopreservation, our protocols and procedures have been developed to meet or exceed all applicable industry standards for the use of human cellular and tissue-based products.

Donor Eligibility & Testing

• Donors are pre-screened through medical record review and evaluation of pre-natal tests

• Medical Director confirms eligibility through

– Behavioral risk assessment

– Review of blood test results

– Donor medical history

– Communicable disease testing

• Procurement

– Aseptic recovery technique during sterile cesarean section

– BioRecovery, LLC, an affiliate of BioDlogics, LLC, is a registered tissue bank with the FDA and performs all procurement activities

• Manufacturing

– Processed and packaged at an FDA registered tissue bank in Memphis, TN

– BioDlogics, LLC, the manufacturer of the product, is also registered with the FDA

– Culturing and toxicity testing performed prior to lot release

AmnioMTM is regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

1 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.

2007; Vol. 25, No.1:1274-1280. 4 Id.at 1274. AmnioGenix 10328 Crooked Creek Road Collierville, TN

AmnioGenix

10328 Crooked Creek Road

Collierville, TN 38017

USA +1.901.457.7613

www.amniogenix.com

contact@amniogenix.com

LITR-031-AG