EpiFix®

EpiFix® is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. EpiFix® is a minimally manipulated, dehydrated, non-viable cellular amniotic membrane allograft that contains multiple extracellular matrix proteins, growth factors, cytokines and other specialty proteins present in amniotic tissue to provide a barrier membrane that enhances healing.

EpiFix® Amnion/Chorion Membrane Allograft for acute and chronic wound care:

  • Enhances Healing
  • Modulates Inflammation
  • Reduces Scar Tissue Formation
  • 300+ Regulatory Proteins
  • Flexible sizing
  • Room temperature storage

Unrivalled clinical and scientific evidence in placental-based allografts  – Most level 1 evidence: 7 RCTs – 40+ clinical and scientific papers

Over one million MiMedx allografts have been distributed to date with zero reported adverse reactions attributed to our products†
†As of February 1, 2018.

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EpiFix has demonstrated in previous studies very high rates of healing, with the original study showing 90%+ rates of healing in DFU wounds and 71% in VLU wounds.

With studies looking at long term follow up and the overall time to closure using weekly applications vs biweekly, MiMedx demonstrates the effectiveness of EpiFix in hard to heal/non-healing ulcers.

More on EpiFix and how it supports wound healing:

Protective Barrier

  • Protects the wound bed to aid in the development of granulation tissue

Provides a Human Biocompatible Extracellular Matrix (ECM)

  • Structural components: Collagen l,lll,lV; elastin
  • Cell binding domains: Fibronectin, collagen V, Vll
  • ECM binding domains: Proteoglycans, laminin

Retains Regulatory Proteins

  • 300+ Regulatory Proteins*

*published data on file and available on request

 

All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.

EpiFix allografts are procured and processed in the United States according to standards and/or regulations established by the American Association of Tissue Banks (AATB) and the United States Food & Drug Administration (FDA).

All tissues are recovered under full informed consent of the donors (mothers of the newborn children). The donors have consented to the transfer of the allografts to third parties. A thorough medical and social history of the donor is also obtained. The listed communicable disease testing is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

The donor is screened for:

  • HIV-1&2 Plus 0 Antibody
  • Hepatitis B Surface Antigen
  • HIV Type 1 (Nucleic Acid Test (NAT))
  • Hepatitis C Antibody
  • HTLV-1&2 Antibody
  • Hepatitis C Virus (Nucleic Acid Test (NAT))
  • Syphilis (Serologic Test)
  • Hepatitis B Virus (Nucleic Acid Test (NAT))
  • Hepatitis B Core Antibody
  • West Nile Virus (Nucleic Acid Test (NAT))*

*WNV NAT screening conducted on donors based on exposure risk per FDA Guidance for Industry.

Only tissue from donors with acceptable test results, according to the standards of MiMedx Tissue Services, LLC, as well as the standards and/or regulations of all state and federal regulatory bodies, are released.

A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers

DFU RCT overview PDF

MiMedx clinical evidence review

Application guide

The cost of treament and TIMERS

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