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Flowable tissue allografts derived from human amniotic fluid


Two configurations available

  • Cryopreserved (Amnio- Maxx™)
  • Ambient temperature (Amnio-Maxx™RT)

Amniotic fluid is a versatile, powerful tissue which supports the development of the fetus in utero. The properties of amniotic fluid which benefit the fetus also make it an ideal material for covering wounds,1-3,6 and contributing to an environment conducive to the regeneration of healthy tissue.4-6

Allogenic human birth tissues, including amniotic fluid, can be utilized in a variety of surgical and clinical settings.

Published literature shows that amniotic fluid contains important growth factors,1,2,5 extracellular matrix2,5 molecules, hyaluronic acid,1,4,5 fibronectin,2 laminin,4 prostaglandins,3 and cells.6

Benefits of amniotic fluid may include:

  • A safe, natural covering for wounds1-6
  • Decreased inflammation3
  • Reduced fibroses, scarring, and adhesion at the surgical site4

Intended for topical application as a covering over wounds or areas of localized inflammation.

Birth tissues are recovered during planned cesarean sections and processed aseptically in a manner to preserve it’s inherent properties.

Handling & Storage Guidelines:
  • Store at -70°C or colder. Thaw only prior to use.
  • Allow product to thaw by standing at room temperature and apply directly to the wound or area of inflammation
  • See instructions for use for more details
Part # Description Volume
AM-05 Amnio-MAXX™ Cryopreserved Liquid Amnion 0.5 ml
AM-1 Amnio-MAXX™ Cryopreserved Liquid Amnion 1.0 ml
AM-125 Amnio-MAXX™ Cryopreserved Liquid Amnion 1.25 ml
AM-2 Amnio-MAXX™ Cryopreserved Liquid Amnion 2.0 ml
Handling & Storage Guidelines:
  • Store at ambient temperature (59-86°F/15-30°C) until ready for use
  • Provided as a sterile, ready to use, flowable graft with no thawing or preparation required
  • Apply directly to the wound or area of inflammation
  • See instructions for use for more details
Part # Description Volume
AMRT-05 Amnio MAXX™ RT Acellular Liquid Amnion 0.5 ml
AMRT-1 Amnio MAXX™ RT Acellular Liquid Amnion 1.0 ml
AMRT-2 Amnio MAXX™ RT Acellular Liquid Amnion 2.0 ml
Tissue Safety
  • Placental donors go through a rigorous prescreening qualification and are tested according to FDA guidelines for infectious disease
  • Collection of the donor tissue is performed during planned cesarean section delivery by appropriately licensed personnel
  • Tissue is processed in accordance with the standards and guidelines established by Bone Bank Allografts, who follow the American Association of Tissue Banks (AATB)
References
  1. Nyman E, Huss F, Nyman T, Junker J, Kratz G. (2013 Apr) 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. 47(2):89-92
  2. Adzick NS, Lorenz HP. (1994 Jul) Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound repair. Annals of Surgery. ;220(1):10-18.
  3. Gao X, Devoe LD, Given KS. (1994 Aug) Effects of amniotic fluid on proteases: a possible role of amniotic fluid in fetal wound healing. Annals of Plastic Surgery. 33(2):128-134; discussion 134-135.
  4. Bolat E, Kocamaz E, Kulahcilar Z, Yilmaz A, Topcu A, Ozdemir M, Coskun ME. (2013 Dec) Investigation of efficacy of mitomycin-C, sodium hyaluronate and human amniotic fluid in preventing epidural fibrosis and adhesion using a rat laminectomy model. Asian Spine J. 7(4):253-9.
  5. Ozgenel GY, Filiz G, Ozcan M. (2004 Jul) Effects of human amniotic fluid on cartilage regeneration from free perichondrial grafts in rabbits. Br J Plast Surg. 57(5):423-8. 6. Rosner M, Hipany K, Shanmugasundaram B, Lubec G, Hengstschläger M (2012 Jun) Amniotic Fluid Stem Cells: Future Perspectives. Stem Cells Int. 2012: 741810.
For more information, contact Royal Biologics Allografts at 201.333.8114