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Safety Information

We Put Safety at the Top of The List

BIOVANCE® tissue procurement and processing practices meet the highest 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
  • Lab testing on donor blood and afterbirth for infectious diseases, including:
    • HIV 1/2 Antibodies
    • HIV NAT
    • HTLV I/II Antibodies
    • West Nile Virus NAT
    • CMV Antibodies
    • Hepatitis C Antibody
    • Hepatitis C NAT
    • Hepatitis B Core Antibody
    • Hepatitis B Surface Antigen
    • Hepatitis B NAT
    • Antibody Screen
    • Syphilis Screening Assay
    • CMV Antibody
    • Trypanosoma cruzi (Chagas) Antibody
Celularity lab technician in gown and hairnet

Certifications

Celularity adheres to the highest 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.

Click on the following links to review all our certifications and licenses:

American Association of Blood Banks
Tissue Bank License – California
Tissue Bank License – New York

Indications for Use

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 with minimized adhesion or fibrotic scarring. 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.

Connect With Celularity

For product questions, or ordering information, please contact us at customerservice@celularity.com or call us at 1-844-963-2273.

For medical inquiries, please contact us at medicalaffairs@celularity.com