Amniotic Tissue Regeneration.

A unique alternative to invasive surgical procedures with a variety of potential applications.

What Is Tissue Regeneration?

Tissue regeneration is a unique alternative to invasive surgical procedures with a variety of potential applications that may include:

  • Tendonitis
  • Reduction of scarring
  • Chronic wound covering
  • Soft tissue or bone trauma
  • Localized inflammation

It is a non-structural de-cellularized fluid allograft intended for homologous use such as providing a cushion around a tissue. A 100 year historical use of these products in clinical applications has proven their safety and efficacy. This contains high levels of growth factors and anti-inflammatory cytokines.

Fluid is processed using an extensively tested proprietary amniotic fluid purification technology which allows for rapid retrieval of fluid without compromising protein integrity. Cells and extracellular debris are removed, yet an array of soluble cytokines and growth factors are still present.

Comprehensive Safety & Quality

Assurance Program

Donor tissue is obtained through a full-term birth consent program at IRB-approved hospital collection sites. Sterility testing is performed on every lot with the standards specified in USP. In addition, Endotoxin testing consistent with USP is utilized as a part of the release criteria for each lot. Maternal screening for infectious disease testing includes:

  • Hepatitis B core antigen (HBcAg)
  • Hepatitis C antibodies (HCVAb)
  • Human Immunodeficiency Virus 1/O/2 antibodies (HIV-1/O/2 Ab)
  • Human T-lymphotrophic virus I/II (HTLVI/II)
  • Anti-Hepatitis B core total antibodies (HBcTotal)

Regulatory

  • Processed in ISO Certified, Class100 manufacturing environments. 
  • All products are tracked in a GxP compliant tracking software using serialized inventory controls.
  • Processed and promoted under the guidance of 21 CFR 1271. Registered with the US FDA as a HCT/P establishment.
MORE INFORMATION

Protein Preservation & Characterization

Processed using an extensively tested proprietary amniotic fluid purification process that includes technology for rapid retrieval of fluid without compromising protein integrity.

Cells and extracellular debris are removed, yet an array of soluble and active cytokines, growth factors, along with other important regulatory proteins, are preserved and present.

  • Is undiluted, acellular amniotic fluid
  • DOES NOT contain a “cryopreservative” such as DMSO or Detran/Dextrose
  • The term “cryopreservation” generally refers to use of a cryopreservative and controlled freezing to minimize damage to cells
  • Is stored and shipped frozen to minimize protein degradation and loss of biologic activity

Freeze-dried amniotic fluid allograft intended for homologous use.

  • Protects & cushions
  • Provides lubrication for enhanced joint mobility
  • Modulates inflammation

Amnio Technology:

  • Flowable Tissue Matrix
  • Cryopreserved amniotic fluid with cellular components
  • Contains a “rich source of biologically active factors involved in tissue regeneration and wound healing with reported anti-inflammatory, anti-bacterial, reepithelialization, and anti-fibrotic properties”
  • Acellular Flowable Wound Matrix

The Placenta Has Many Natural Features That Contribute to Prevention of Adhesions & Scarring.

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