WE PUT SAFETY AT THE TOP OF THE LIST
BIOVANCE® tissue procurement and processing practices meet high safety standards.
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)
- Passed safety testing for cytotoxicity, hemolysis, irritation, endotoxins, and pyrogenicity
- Utilizes a barcode tracking system for optimal safety monitoring and to enhance patient and practitioner confidence
Donor screening and testing
- Maternal health screening, including social history
- Family medical history
- Each donor has been determined by trained, qualified, and responsible personnel to meet the screening and testing requirements of 21 CFR Part 1271 Subpart C: Donor Eligibility.
Celularity adheres to high standards of ethical practice and transparency in all aspects of our operations. Celularity is registered with the FDA as a tissue establishment and accredited by the AABB.
Indications for Use
BIOVANCE is an allograft intended for use as a biological membrane covering that provides the extracellular matrix. 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, 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.
For product information, product complaints, or adverse reaction reporting, call 1-844-963-2273.
Please refer to the BIOVANCE Package Insert for complete product information.