Part of SANUWAVE®’s Advanced Wound Care Solution

Derived from the human placenta with unique properties, BIOVANCE® Human Amniotic Membrane Allograft incorporates into wounded tissue to support the body’s normal ability to heal.

As decellularized, dehydrated human amniotic membrane (DDHAM) derived from the placenta, BIOVANCE is an intact, natural extracellular matrix (ECM) that acts as a wound covering that allows cellular attachment and growth factor storage.

Amnion is unique in its capacity to support human growth and development. The placenta-derived components in BIOVANCE contain key ECM proteins to support the repair of damaged tissue when applied to a wound.

In a prospective, observational, multicenter study, the safety and efficacy of BIOVANCE in supporting wound healing was compared with standard of care (SOC) in a broad, real-world patient population with a range of wound types.7

Where Does BIOVANCE Come From?

BIOVANCE is prepared from the human amnion of a healthy, full-term pregnancy. The amnion is excised from the chorion layer of the placenta, washed, and then sterilized so that it contains only what’s needed to function as a wound covering and support the body’s ability to heal.

BIOVANCE Components

BIOVANCE Components

BIOVANCE Is Easy to Use

Easy Application

  • No preparation of BIOVANCE needed: No thawing, rinsing, or soaking required prior to use
  • Flexible form: Conforms easily to irregular surfaces
  • Bidirectional orientation: Prevents the need for specific placement of BIOVANCE on the wound; can be applied with either side facing the wound
  • Adheres without sutures: Can be fastened by all surgical means if physician chooses to do so

Convenient Storage

  • Ambient room-temperature storage in a clean, dry environment: No refrigeration necessary
  • Ten-year shelf life: Eliminates the need for preordering

BIOVANCE Is Completely Decellularized, Immunologically Inert Amniotic Tissue for Maximal Benefit and Safety

Minimal Processing

  • The tissue contains no antigens,7 which further minimizes the risk of inflammatory response.
  • Tissue derived from the amniotic membrane is cleaned and preserved without altering its native matrix architecture.

Quality Assurance

Tissue used in processing BIOVANCE:

  • Has been procured, processed, and tested in accordance with standards established by the American Association of Blood Banks (AABB) and the United States Food and Drug Administration (FDA).
  • Is tested for toxicity, hemolysis, irritation, endotoxins, and pyrogenicity. Current testing cannot provide absolute assurance that the tissue will not transmit infectious diseases to the patient.
  • Utilizes a bar-code tracking system for monitoring. It is the responsibility of the practitioner to maintain sufficient records to permit prompt identification of the recipient.

For more information, including Precautions, Contraindications, Warnings, and Adverse Effects, please visit https://www.biovance.net/safety-information.html.

BIOVANCE® is a registered trademark of Celularity Inc.

BIOVANCE® Human Amniotic Membrane Allograft is manufactured for SANUWAVE Health, Inc. by Celularity Inc., 170 Park Avenue, Florham Park, NJ 07932.

References
  1. Fetterolf DE, Synder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012;24(10):299-307.
  2. Bhatia M, Pereira M, Rana H, et al. Mechanism of cell interaction and response on decellularized human amniotic membrane: implications in wound healing. Wounds. 2007;19(8):207-217.
  3. Arechavaleta-Velasco F, Marciano D, Díaz-Cueto L, Parry S. Matrix metalloproteinase-8 is expressed in human chorion during labor. Am J Obstet Gynecol. 2004;190(3):843-850.
  4. Ganatra MA. Amniotic membrane in surgery. J Pak Med A. 2003;53(1):29-32.
  5. Portmann-Lanz CB, Ochsenbein-Kölble N, Marquardt K, et al. Manufacture of a cell-free amnion matrix scaffold that supports amnion cell outgrowth in vitro. Placenta. 2007;28(1):6-13.
  6. Niknejad H, Peirovl H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-99.
  7. Smiell JM, Treadwell T, Hahn HD, Hermans MH. Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft: A Prospective, Observational, Multicenter Study of a Broad Patient Population in All Wound Types. Wounds 2015;27(6):158-169.
  8. Margolis DJ, Kantor J, Santanna J, Strom BL, Berlin JA. Risk factors for delayed healing of neuropathic diabetic foot ulcers. Arch Dermatol. 2000;136:1531-1535.
  9. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D. OASIS Venous Ulcer Study Group. Effectiveness of an extracellular matrix graft (Oasis Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5):837-843.