The placenta is a maternal-fetal organ that develops from the fetus and attaches to the uterus
during pregnancy. The placenta is responsible for, among other things, providing the
growing fetus with oxygen and nutrients while at the same time removing toxins.1 It also
serves as a barrier between maternal and fetal compartments. Once the baby is born, the
placenta detaches from the uterine wall and is expelled from the body. Placental tissue can be
harvested after a healthy, concluded birth and then processed into a human, placental tissue
allograft.
Acellular Placental ECM Tissue Allografts
An acellular, placental extracellular matrix allograft is a soft connective tissue graft generated
by a decellularization4 process that preserves the intact extracellular placental matrix. Upon
implantation, this structure may serve as a scaffold to support the repair, reconstruction,
replacement, or supplementation of the patient’s own tissue.
Placental Tissues are FDA Regulated
Placental-derived tissue is regulated by the FDA under 21 CFR Part 1271 and Section 361
of the Public Health Service Act.
Placental Allografts Disclaimer
Disclaimer: Certain placental allografts consist of acellular, minimally manipulated tissues intended for homologous use to
supplement patient’s own tissue. Tissue allografts are classified by the Food and Drug Administration (FDA) as Human
Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public
Health Service (PHS) Act. As an HCT/P regulated solely under the Section 361 of the PHS Act, tissue allografts are exempt
from FDA pre-market review, clearance, and approval from FDA. Please consult your doctor to see if a tissue allograft is
right for you. No medical advice has been offered herein. None of the statements in this brochure have been evaluated by the
FDA. Placental-derived allografts are not intended to diagnose, treat, cure or prevent any disease and should not be used for
the treatment of COVID-19
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