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BIOVANCE®

BIOVANCE® is a decellularized, dehydrated human amniotic membrane allograft that provides a protective cover from the surrounding environment.

Celularity, Inc.

Celularity Inc. is a biotechnology company that produces cells and tissues derived from the postpartum placenta. Its portfolio of products supports the body's ability to regenerate tissue and includes BIOVANCE® Human Amniotic Membrane Allograft, Tri-Layer BIOVANCE® Human Amniotic Membrane Allograft and Interfyl® Human Connective Tissue Matrix.
Toll free:(844) 963-2273 Website: www.celularity.com
Benefits

• Provides a cover and protects from the surrounding environment
• Human amniotic membrane allograft
• Decellularized
• No orientation required
• 10 year shelf life
• Ambient room temperature storage
• Out of package ready

Indications

BIOVANCE® is an allograft intended for use as a biological membrane covering that provides the extracellular matrix while supporting the repair of damaged tissue. As a barrier membrane, BIOVANCE® is intended to protect the underlying tissue and preserve tissue plane boundaries. Indications include, but are not limited to, surgical covering, wrap or barrier, application to partial- and full-thickness, acute and chronic wounds (such as traumatic and complex wounds, burns, surgical and Mohs surgery sites; and diabetic, venous, arterial, pressure and other ulcers), including wounds with exposed tendon, muscle, bone or other vital structures.

Contraindications

BIOVANCE® is contraindicated in patients with a known hypersensitivity to BIOVANCE®.

Warnings and Precautions

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.

Adverse Effects/Reactions

Adverse reactions or outcomes that potentially involve the use of BIOVANCE® must be reported promptly to the Celularity Inc. Customer Service at 1-844-963-2273.

Storage Requirements

Store in a clean, dry environment at ambient room temperature.

How Supplied/Sizing
1cmx2cm, 2cmx2cm, 2cmx3cm, 2cmx4cm, 3cmx3(1/2)cm, 4cmx4cm, 5cmx5cm, 6cmx6cm single dehydrated sterile sheet. Disk: 10mm, 12mm, 15mm.
HCPCS Code
Product features
check_circle Assigned HCPCS code
check_circle Minimally manipulated
cancel Cryopreserved
check_circle Dehydrated
cancel Desiccated
cancel Flowable
cancel Micronized
check_circle Sheet form
cancel Requires refrigeration
check_circle Shelf life greater than 2 years
cancel Shelf life limited
check_circle Indicated for acute wounds
check_circle Indicated for chronic wounds
check_circle Indicated for diabetic ulcers
check_circle Indicated for pressure ulcers
check_circle Indicated for surgical wounds
check_circle Indicated for third-degree burns
check_circle Indicated for venous ulcers
cancel Contact manufacturer for usage guidelines
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Acute Wounds
Burns
Chronic Wounds
Cavity Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Hypertrophic Scars/Keloids
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Surgical Wounds
Superficial Wounds
Traumatic Wounds
Venous Ulcers

Mode of Use/Application

Aseptic technique. Apply topically. No specific orientation. Can secure with sutures or steri-strips. Secondary cover dressing of HCP's choice.

Additional Recommended Dressings

Cover with a non-adherent dressing.

Construction

BIOVANCE® is a decellularized, dehydrated human amniotic membrane (DDHAM). The epithelial basement membrane and collagen-rich extracellular matrix of this allograft provide a natural scaffold for cell attachment and proliferation needed for tissue repair with minimized inflammation and scarring. BIOVANCE® is an aseptically processed product and is terminally sterilized with E-beam irradiation.

Clinically Tested

Non-pyrogenic
Sterile

BIOVANCE® is tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens.
Testing for endotoxins is conducted to assure levels are below 20 EU/sheet. BIOVANCE® is non-pyrogenic.
BIOVANCE® is an aseptically processed product and is terminally sterilized with E-beam irradiation.

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