VENDAJE™ AC

Dehydrated human amnion/chorion membrane allograft

VENDAJE™️ AC is a structural tissue allograft composed of the amnion and chorion layer of the placental membrane. VENDAJE™ AC is intended for homologous use as a protective covering during the repair of soft tissue wounds.

VENDAJE™ AC amnion/chorion tissue allografts are applied as an anatomical barrier to help provide mechanical protection while supporting healing with endogenous growth factors. VENDAJE™ AC may be used in numerous clinical applications as a protection barrier.

VENDAJE™ AC is manufactured using BioStem's proprietary process, which helps to maintain the inherent levels of key components, including extracellular matrix, growth factors, and cytokines. VENADJE™ AC is processed in accordance with FDA regulations in our AATB® accredited facility. E-Beam sterilization provides sterility assurance level (SAL) of 10-6.

VENDAJE™ AC is available in 1x1cm, 2x2cm, 2x4cm, 4x4cm, 4x6cm, 4x8cm, and 6x6cm sizes.

The amniotic sac is the inner lining of the placenta, and it supports the fetus throughout development, so it needs to be strong, flexible, and adaptable. It’s made of two distinct but conjoined membranes, the amnion and chorion. The structural integrity of the amniotic and chorionic membranes is due to a complex, bioactive ECM that is composed of collagens, fibronectin, laminin, and proteoglycans, which are integral to tissue regeneration and wound healing1. The ECM also has a high concentration of hyaluronic acid, which promotes non-fibrotic healing and minimizes scarring2.

Multipotent amniotic epithelial and mesenchymal stem cells secrete a broad array of growth factors that support fetal development, including epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), keratinocyte growth factor (KGF), transforming growth factors alpha and beta (TGF‐α and TGF‐β), and nerve growth factor (NGF)3. Used therapeutically, these compounds have powerful healing capabilities even in chronic conditions.

The amniotic and chorionic membranes produce a number of paracrine-acting immunosuppressive cytokines, including interleukins 4 and 10 (IL-4 and IL-10) and prostaglandin E2 (PGE2), which inhibit activation and proliferation of CD4+ and CD8+ T cells and B cells and suppress differentiation of monocytes to antigen-presenting dendritic cells4. Amniotic immunosuppressors also upregulate anti-inflammatory M2 macrophage activation5 and block the release of pro-inflammatory IFN-γ from cytotoxic natural killer (NK) cells6.

The amniotic membranes have a long history in regenerative medicine7, and new applications are identified regularly. Amniotic allografts promote re-epithelialization while minimizing inflammation, making them ideal topical treatments for burns8 (even in pediatric populations9), pressure ulcers10, and other dermal wounds. Chronic conditions like diabetic ulcers are also improved with amniotic allografts11.

VENDAJE™ AC Key Points

  • Bonds with wounds by forming fibrin-elastin at the wound-dressing interface
  • Acts as a vapor barrier, preventing fluid loss from excessive evaporation from the wound surface
  • Designed for application directly to acute and chronic wounds
  • Adheres naturally via hydrostatic tension
  • No blood typing or donor matching required
  • No orientation issues, can be applied on either side
  • Contains full spectrum of growth factors
  • Bio scaffold with extracellular matrix
  • Anti-fibrotic and anti-adhesion barrier
  • High tensile strength

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(954) 380-8342

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Pompano Beach, FL 33064

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References
1. Olczyk, P., L. Mencner, and K. Komosinska-Vassev, The role of the extracellular matrix components in cutaneous wound healing. Biomed Res Int, 2014. 2014: p. 747584.
2. Nyman, E., et al., Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid: in vitro studies of re-epithelialisation in human skin wounds. J Plast Surg Hand Surg, 2013. 47(2): p. 89-92.
3. Koob, T.J., et al., Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater, 2014. 102(6): p. 1353-62.
4. Li, H., et al., Immunosuppressive factors secreted by human amniotic epithelial cells. Invest Ophthalmol Vis Sci, 2005. 46(3): p. 900-7.
5. Banas, R., et al., Amnion-derived multipotent progenitor cells inhibit blood monocyte differentiation into mature dendritic cells. Cell Transplant, 2014. 23(9): p. 1111-25.
6. Chatterjee, D., et al., Role of gamma-secretase in human umbilical-cord derived mesenchymal stem cell mediated suppression of NK cell cytotoxicity. Cell Commun Signal, 2014. 12: p. 63.
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9. Puyana, S., et al., The Use of Dehydrated Human Amniotic/Chorionic Membrane Skin Substitute in the Treatment of Pediatric Facial Burn. J Craniofac Surg, 2019. 30(8): p. 2551-2554.
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11. Haugh, A.M., et al., Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis. Plastic and reconstructive surgery. Global open, 2017. 5(4): p. e1302-e1302.
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13. Ang, J., C.D. Liou, and H.P. Schneider, The Role of Placental Membrane Allografts in the Surgical Treatment of Tendinopathies. Clin Podiatr Med Surg, 2018. 35(3): p. 311-321.
14. Vines, J.B., et al., Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg, 2016. 29(6): p. 443-50.
15. Li, Y., et al., Amniotic mesenchymal stem cells display neurovascular tropism and aid in the recovery of injured peripheral nerves. J Cell Mol Med, 2014. 18(6): p. 1028-34.
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18. Davis, A. and A. Augenstein, Amniotic Allograft Implantation for Midface Aging Correction: A Retrospective Comparative Study with Platelet-Rich Plasma. Aesthetic Plast Surg, 2019. 43(5): p. 1345-1352.
19. Andrewartha, N. and G. Yeoh, Human Amnion Epithelial Cell Therapy for Chronic Liver Disease. Stem Cells Int, 2019. 2019: p. 8106482.
20. Azargoon, A. and B. Negahdari, Lung regeneration using amniotic fluid mesenchymal stem cells. Artif Cells Nanomed Biotechnol, 2018. 46(3): p. 447-451.
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