Regulatory & Quality

At BioTissue, we are ONE Team where quality is everyone’s responsibility. Our Quality Management System follows the highest applicable standards to deliver consistent, reliable, and high-integrity products and services. We are committed to continuous improvement, innovation, and helping our patients and providers realize the full potential of our platform technology.

The products offered by BioTissue (Prokera®, AmnioGraft®, AmnioGuard®, Neox® and Clarix®) are cryopreserved human Amniotic Membrane and Umbilical Cord. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), minimally manipulated and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1271).

Healthy mothers may be considered eligible for birth tissue donor status following natural child births or elective Cesarean Section (C-section) delivery. These mothers provide full informed consent and are put through extensive social habit screening, medical history and records review for infectious, malignant, neurological, auto-immune, transmissible diseases, and independent, serological CLIA lab testing (using FDA licensed test kits) which are non-reactive or negative for the following tests:

• HIV 1 & HIV 2, Antibody
• HIV 1 Virus (NAT)
• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (HBcAb)
• Hepatitis C Antibody (HCVAb)
• Hepatitis C Virus (NAT)
• HTLV 1 & 2 antibodies
• Syphilis (RPR)
• West Nile Virus, WNV, (NAT)

Microbial testing is also performed on the final product to ensure no growth of aerobic, anaerobic or fungal cultures. The cell activity in the tissue is inactivated using our CryoTek cryopreservation process to reduce the possibility of graft rejection, while retaining the natural biologic properties.

All tissue is deemed suitable for transplantation based on acceptable screening, serological and microbial test results. A Certificate of Compliance regarding the manufacturing, storage, shipping and tracking controls for products is available upon request.

Please see Product Use and Safety Information in the Product Insert.