Bringing the progenerative power of the amnion to tissue restoration
Acute | Chronic | Mohs surgery | Burns | Trauma | Complex Surgical | Venous leg ulcers | Exposed tendon, muscle, bone Diabetic ulcers | Pressure ulcers | Arterial ulcers
The power of the amnion reengineered
for wound healing
The power of the amnion reengineered
for wound healing
The natural properties of the amniotic membrane support the
growth and development of the fetus
For 9 months, the amniotic membrane:
• Forms the innermost lining of the placenta during gestation1 • Is the tissue closest to the fetus throughout development • Serves as a barrier to minimize risk of injury to the fetus1-
The progenerative power of the amniotic membrane supports the body’s
natural ability to restore tissue1,2,4-7
• Reduces inflammation5,7 • Provides a biological barrier to infection7 • Supports tissue growth7 • Minimizes pain upon application1,5
The amniotic membrane protects against desiccation and resists proteolyctic enzymes.
BIOVANCE® is an amniotic membrane
allograft that supports healing1
BIOVANCE contains natural substances, derived from healthy
placentas, that support the body’s ability to heal1,2,7
BIOVANCE components
Function in normal dermal tissue
Basement membrane
Anchors epithelial cells; down-regulates apoptosis of epithelial cells
Collagen protein
Types I, III, IV, V, VII
Structural support and guidance of cell migration and organization
Elastin
Elasticity of tissue
Glycosaminoglycans (GAGs)
Water attraction, lubrication, and reduction of inflammation
Other proteins
Glycoproteins
Cell-binding proteins in the ECM
ElastinProteoglycans
Matrix hydration
Laminins and
fibronectin
Collagen structure regulation; migration, differentiation, phenotype,
adhesion, and survival of cells
BIOVANCE is devoid of cells, hormones, growth factors and cytokines.
Indicated for wound management for a broad set of needs:
Acute | Chronic | Mohs surgery | Burns | Trauma | Complex Surgical | Venous leg ulcers
Exposed tendon, muscle, bone | Diabetic ulcers | Pressure ulcers | Arterial ulcers
BIOVANCE® offers the potential to restore tissue to its
pre-wound state with minimal scarring*1,7
BIOVANCE used on an ischemic ulcer and surgical wound
CASE CHARACTERISTICS:• Gangrene of the great toe • Severe ischemia following recent successful bypass • Acute transmetatarsal amputation site of the toe • Full-thickness wound with moderate exudate
Baseline Day 1: First application of BIOVANCE 12.9 cm x 4.8 cm x 1 mm
Week 25: Closed
BIOVANCE evidence in a venous leg ulcer
CASE CHARACTERISTICS:• 68-year-old female • PVD and venous stasis ulcer • Left anterior shin
Baseline Day 1: First application of BIOVANCE 3 cm x 5 cm x 1 mm
Week 12: Closed after 1 application of BIOVANCE
*Best results will be found in acute and excised chronic wounds.
BIOVANCE® has been studied from
benchtop to patient8,9
BIOVANCE provides the intact extracellular matrix required for
appropriate healing and nothing more
An in vitro study demonstrated8
:
• 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 human amnion-chorion product containing nonviable cells and active growth factors limited cell attachment and initiated apoptosis. The release of bioactive molecules likely contributed to this negative effect.8
BIOVANCE® was evaluated in a real-world patient study
conducted to gain clinical and safety experience9
• 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%
Baseline Day 1: First application of
BIOVANCE 12.9 cm x 4.8 cm x 1 mm
Week 25: Closed
BIOVANCE® applied to a
second-degree burn of the leg10
A side-by-side comparison of BIOVANCE vs nanocrystalline
silver dressing*
BIOVANCE
applied to
lower half of
burn only
Nanocrystalline
silver
dressing area
VS
BIOVANCE
allograft area
5 days after 1 application of BIOVANCE (date of biopsy)
Biopsy at Day 5
*Results may vary.
Healed 16 days post-burn
29 days post-burn
Final healing (3 months)
BIOVANCE® is the easy-to-use human
amniotic membrane allograft
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
Biovance should be applied to a clean wound and covered with an appropriate secondary, non-adherent dressing.
Translucent grid
pattern is evident
on the wound until
hydration occurs
to allow view of the
wound’s progress
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
Available in multiple sizes for application exibility
Available in multiple sizes
for application exibility
1 x 2 cm Product Code: DHAM0012 2 x 2 cm Product Code: DHAM0022 2 x 3 cm Product Code: DHAM0023 2 x 4 cm Product Code: DHAM0024 3 x 3.5 cm Product Code: DHAM0035 4 x 4 cm Product Code: DHAM0044 5 x 5 cm Product Code: DHAM0055 6 x 6 cm Product Code: DHAM0066
Minimally processed to maximize natural benefits and safety
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 wound3 — 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
Contraindications, Warnings, and Precautions
BIOVANCE® is contraindicated in patients with a known hyper-sensitivity to BIOVANCE. If a patient has an adverse reaction related to the use of BIOVANCE, immediately discontinue its use. BIOVANCE should not be used on clinically infected wounds. The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize. BIOVANCE must be used prior to the expiration date on the product pouch. BIOVANCE should not be used together with a collagenase product on the wound.