Human Amniotic Membrane Allograft Treatment Solutions From New Beginnings

Surgical Biologics has currently made available, EpiFixTM, 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 PurionSM 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 PurionSM 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 BENEFITS: Promotes cellular differentiation and adhesion Non-immunogenic and low antigenicity Provides structure for cellular migration Allows for correct graft placement and orientation

Consider the Possibilities

ENT

Dura Repair

Urology

Dental

Opthalmology

Intact Bio-structure Means Optimal Performance

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

Epithelium Basement Membrane Compact Layer Fibroblast Layer

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

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

The specialized Surgical Biologics embossment allows for correct identification of the grafts basement membrane side.

Safety and Testing

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 HIV Type 2 Antibody HTLV Type 1 Antibody HTLV Type 2 Antibody Hepatitis C Antibody Hepatitis B Surface Antigen Serological Test for Syphilis HIV Type 1 Nucleic Acid Test Hepatitis C Virus Nucleic Acid Test CMV Total Antibody

Hepatitis B Core Total Antibody

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

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