SIX STEPs
RESULTS
FACTOR HIGHLIGHTS

Problems with Chronic Wounds

The wound healing cascade is a complex process and can fail to proceed through the normal phases of wound healing due to many factors (1) Wallace, H. A., Basehore, B. M., & Zito, P. M. (2023). Wound Healing Phases. In StatPearls. StatPearls Publishing.:

  • Persistent Inflammation
  • Oxidative Stress
  • Non-migratory/hyperproliferative stress
  • Infection/ biofilm formation
  • Cellular senescence
  • Decreased angiogenesis
  • Accumulation of:
    • Pro-inflammatory signals and macrophages
    • Matrix metalloproteinases (MMP’s)
    • Proteases
  • Extracellular Matrix (ECM) and growth factor degradation

BioREtain®
The Power Of Six

The patented six-step BioREtain® process is gentle, minimally invasive, preserves the natural integrity of amniotic tissue, and optimizes retention of growth factors and cytokines found in native tissue.

Minimally invasive
Disinfection

The membrane is submerged in an effective disinfection solution.

Manual hematopoietic
Reduction

Blood and blood-producing components are removed by hand without scraping or scrubbing to preserve membrane structure.

Cold isotonic
Cleansing

A series of washes in clean, low-temperature, isotonic solution with gentle stirring remove remaining debris while minimizing tissue and growth factor breakdown.

Gentle and gradual
Dehydration

Slow drying of the membrane using physiological temperature preserves tissue structure and natural growth factors, preventing damage from freezing or high temperatures.

Precise cutting die
Placement

Precise, manual placement of cutting dies helps ensure optimal tissue quality for each individual allograft.

Low-dose E-beam terminal
Sterilization

Grafts are individually packed and terminally sterilized via electron beam, avoiding harmful byproducts or excessive irradiation associated with other methods.

*Our sterilization assurance level (SAL) is generally accepted for pharmacopeial sterilization procedures, with a probability of not more than one viable microorganism per one million sterilized items of the final product.

Factor Highlights of Amniotic Tissue

ECM Components

COLLAGEN

GLYCOSAMINOGLYCANS

Fibronectin

HYALURONIC ACID

Growth Factors

HGF – (Hepatocyte Growth Factor)

PDGF-BB  – (Platelet Derived Growth Factor)

FGF-2 – (Fibroblast Growth Factor)

Cytokines

IL-1ra – (Interleukin-1 receptor antagonist)

References

  1. Inês A Deus 1, João F Mano 2, Catarina A Custódio 3 Perinatal tissues and cells in tissue engineering and regenerative medicine- May 14, 2020
  2. Data on File
  3. Tenehaus M. The Use of Dehydrated Human Amnion/Chorion Membranes in the Treatment of Burns and Complex Wounds. Ann Plast Surg. 2017;78: S11–S13.
  4. Silini AR, Cargnoni A, Magatti M, Pianta S and Parolini O (2015) The long path of human placenta, and its derivatives, in regenerative medicine. Front. Bioeng Biotechnol.
    2015;3:162.
  5. Ramuta TZ, Šket T, Erjavec MS, Kreft ME. Antimicrobial Activity of Human Fetal Membranes: From Biological Function to Clinical Use. Front Bioeng Biotechnol. 2021;9:691522.
  6. Heckmann N, Auran R, Mirzayan R. Application of Amniotic Tissue in Orthopedic Surgery. Am J Orthoped. 2016;45(7):E421-E425.
  7. Niknejad H, Peirovi H, Jorjani M et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur. Cells Mater. 2008;15(15):88-99.
  8. Moore MC, Bonvallet PP, Damaraju SM, et al. Biological characterization of dehydrated amniotic membrane allograft: Mechanisms of action and implications for wound care. J
    Biomed Mater Res. 2020;1–8.
  9. Wassmer C-H. Berishvili E. Immunomodulatory Properties of Amniotic Membrane Derivatives and Their Potential in Regenerative Medicine. Curr. Diab. Rep. 2020;20(31).
  10. Chatterjee P, Chiasson VL, Bounds KR, Mitchell BM. Regulation of the anti-inflammatory cytokines interleukin-4 and interleukin-10 during pregnancy. Front Immunol. 2014;5(23).
  11. Moreno SE, Massee M, Koob TJ. Dehydrated Human Amniotic Membrane Inhibits Myofibroblast Contraction through the Regulation of the TGFb‒SMAD Pathway In Vitro. JID
    Innov. 2021;1:100020

VENDAJE®, VENDAJE AC® and VENDAJE OPTIC® are perinatal tissue-derived allografts. Each product is designated as a Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) by the U.S. Food and Drug Administration (FDA), minimally manipulated, and produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271) in our AATB® accredited lab.