Biovance

What is BIOVANCE?

BIOVANCE is an allograft—material made from donated human tissue—used to help heal a stalled chronic wound.

BIOVANCE is derived from the inner lining of the human placenta, which helps nourish a baby during pregnancy. The placentas used in the manufacture of BIOVANCE are donated by consenting women following a healthy, full-term pregnancy and live birth.

All placenta donors are tested for infectious diseases before the donation process. Once the baby of an approved donor has been delivered, the placenta is collected and sent to a Celularity lab for purification and processing. At the lab, the placenta is washed and sterilized, and all of the donor’s living cells are removed.

BIOVANCE is regulated by the United States Food and Drug Administration (FDA) and the processing facility is accredited by the American Association of Blood Banks (AABB).

How Does BIOVANCE Work?

BIOVANCE provides a natural foundation for wound healing. Key cells and proteins move into the BIOVANCE material so that tissues can regenerate and wounds can continue to heal.

How Will My Doctor Apply BIOVANCE?

1

Preparing the Wound

Your health care provider will begin by cleaning the wound thoroughly and removing any non-living tissue.

2

Applying BIOVANCE

Your health care provider will then apply BIOVANCE directly to the wound and secure it in place using adhesive strips, staples, or sutures to make sure the dressing stays in place.

3

Covering the Dressing

To help protect the wound, your health care provider will place several layers of dressing on top of BIOVANCE.

4

Keeping Your Wound Protected:

Your participation and commitment to caring for your wound, after BIOVANCESTEP4These instructions are designed to serve only as a general guideline and not to supersede your health care provider’s instructions.has been applied, is very important. Depending on the type of wound you have, your healthcare provider may require you to use special footwear or a compression dressing to make sure your wound has the best chance of healing:

Caring for Your Wound After Application

After BIOVANCE is applied, you will be asked to follow some important instructions that will help with the healing process:

Do Not Remove Your Dressings:

  • Your health care provider will provide you with specific instructions on managing your dressings. Keep all layers of the dressing ON unless your health care provider instructs you otherwise.

Keep Your Dressings Dry:

  • Avoid getting the dressings and surrounding area wet. When showering or bathing, keep your wound and dressings away from contact with water. Getting the wound area wet can lead to infection and it can also cause the BIOVANCE to detach from the wound. Call your health care provider if your dressingsget wet.

Follow All Instructions:

Be sure to follow all instructions your health care provider has provided. Contact your health care provider with any questions or concerns.

Keep All Appointments:

  • Always keep your scheduled appointments with your health care provider.

BIOVANCE contains natural substances, derived from healthyplacentas, that support the body’s ability to heal

BIOVANCE is devoid of cells, hormones, growth factors and cytokines.

BIOVANCE® offers the potential to restore tissue to its pre-wound state with minimal scarring

*Best results will be found in acute and excised chronic wounds.

BIOVANCE® offers the potential to restore tissue to its pre-wound state with minimal scarring

BIOVANCE® provides the intact extracellular matrix required for appropriate healing and nothing more

An in vitro study demonstrated:

  • Fibroblasts and keratinocytes readily attach to and proliferate on BIOVANCE
  • BIOVANCE supports the production of an insoluble fibronectin network
  • Cells attached to BIOVANCE provide G-CSF, IL-8, VEGF, and FGF which have been shown to support wound healing

BIOVANCE® is a chorion-free product. In the same study, a humanamnion-chorion product containing nonviable cells and active growthfactors limited cell attachment and initiated apoptosis. The release ofbioactive molecules likely contributed to this negative effect.

BIOVANCE® was evaluated in a real-world patient study conducted to gain clinical and safety experience

  • 244 wounds were treated at 19 different wound care sites
  • Only patients with infected wounds or those with hypersensitivity to BIOVANCE were excluded
  • • Closure rate at 8 weeks was ~50% compared to historic controls of 24%-34%

A side-by-side comparison of BIOVANCE vs nanocrystalline silver dressing

BIOVANCE® is the easy-to-use human amniotic membrane allograft

Immunologically inert 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
  • Chorion layer is removed to further support the natural healing process
    — Eliminates cellular debris
    — Avoids potential addition of MMPs to the wound
    — Prevents need for specific orientation for placement

Additional safety features

  • Tissue used in processing is procured, processed, and tested in accordance with standards established by the AABB and the FDA
  • Passed safety testing for cytotoxicity, hemolysis, irritation, endotoxins, and pyrogenicity
  • Utilizes a bar-code tracking system for optimal safety monitoring and to enhance patient and practitioner confidence

Minimally processed to maximize natural benefits and safety

Easy application and wound visualization

  • Flexible—conforms to irregular surfaces
  • Adaptable—self-adheres to wounds but can be sutured, taped, stapled, or glued, as determined by the clinician
  • Bidirectional—can be applied with either side facing the wound

Easy storage and preparation

  • 5-year shelf life eliminates need for pre-ordering
  • Room temperature storage—no refrigeration necessary
  • No thawing, rinsing, or soaking required