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Human Amniotic Membrane Allograft “Treatment Solutions From New Beginnings” Surgical Biologics has currently made available, EpiFix

Human Amniotic Membrane Allograft

“Treatment Solutions From New Beginnings”

Surgical Biologics has currently made available, EpiFix TM , a biologic Human Amniotic Membrane implant specifically processed to offer a wide variety of surgical reconstructive options for soft tissue repair.

What is Human Amniotic Membrane ?

The human amniotic membrane comprises the innermost layer of the placenta, and lines the amniotic cavity. The amnion is composed of a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix.

Why use Human Amniotic Membrane ?

Amniotic membrane provides such functions as: a natural biological covering, an extracellular collagen matrix and helps to promote cellular migration.

The Process

Surgical Biologics uses its patent pending Purion SM process for amniotic membrane tissue. This process technology follows strict guidelines set forth by both the FDA and AATB (American Association of Tissue Banks) for allograft tissue processing. The unique Purion SM process combines cleaning, dehydration and sterilization to produce a safe, terminally sterilized product allowing for storage at room temperature.

Additional Features & Benefits Include:

FEATURES:

• Contains collagen types IV, V and VII

• Non-vascular • Intact collagen matrix • Specialized embossment marking

Human Amniotic Membrane Allograft “Treatment Solutions From New Beginnings” Surgical Biologics has currently made available, EpiFix

BENEFITS:

Promotes cellular differentiation and adhesion

Non-immunogenic and low antigenicity

Provides structure for cellular migration

Allows for correct graft placement and orientation

Human Amniotic Membrane Allograft “Treatment Solutions From New Beginnings” Surgical Biologics has currently made available, EpiFix

Consider the Possibilities

Human Amniotic Membrane Allograft “Treatment Solutions From New Beginnings” Surgical Biologics has currently made available, EpiFix
Dura Repair
Dura
Repair
Urology
Urology
Dental
Dental
ENT
ENT
Opthalmology
Opthalmology

Intact Bio-structure Means Optimal Performance

The multi-layer structure of EpiFix TM is comprised of an epithelial layer and two fibrous connective tissue layers.The Purion SM process uses minimal manipulation to maintain the structural integrity of the membrane, resulting in the unique characteristic features and benefits found in EpiFix TM .

Epithelium Basement Membrane Compact Layer Fibroblast Layer
Epithelium
Basement Membrane
Compact Layer
Fibroblast Layer

Cross section of human amniotic membrane.

Intact Bio-structure Means Optimal Performance The multi-layer structure of EpiFix is comprised of an epithelial layer

In-process inspections are performed to ensure the membrane remains intact prior to preservation.

Safety and Testing

Intact Bio-structure Means Optimal Performance The multi-layer structure of EpiFix is comprised of an epithelial layer

This microscopic view shows the amniotic epithelium layer, the dense basement membrane layer, and a layer of compact fibroblast and collagen.

Intact Bio-structure Means Optimal Performance The multi-layer structure of EpiFix is comprised of an epithelial layer

The specialized Surgical Biologics embossment allows for correct identification of the graft’s basement membrane side.

Human amniotic membrane tissues are accepted only upon obtaining informed consent from the donor during an elective cesarean section. The donor mother must also have tested negative for serological infectious diseases. The donor is screened for:

• HIV Type 1 Antibody

• Hepatitis C Antibody

HIV Type 1 Nucleic Acid Test

• HIV Type 2 Antibody

• Hepatitis B Surface Antigen

Hepatitis C Virus Nucleic Acid Test

• HTLV Type 1 Antibody • HTLV Type 2 Antibody

• Hepatitis B Core Total Antibody • • Serological Test for Syphilis

CMV Total Antibody

Test results are reviewed prior to the release of all tissue.

Intact Bio-structure Means Optimal Performance The multi-layer structure of EpiFix is comprised of an epithelial layer
Intact Bio-structure Means Optimal Performance The multi-layer structure of EpiFix is comprised of an epithelial layer
125 TownPark Drive, Ste 300 Kennesaw, GA 30144 Ph: 770-420-8487 Fax: 770-420-8486 Customer Contact: productsupport@surgicalbio.com www.surgicalbio.com
125 TownPark Drive, Ste 300
Kennesaw, GA 30144
Ph: 770-420-8487
Fax: 770-420-8486
Customer Contact:
productsupport@surgicalbio.com
www.surgicalbio.com