All Skye Biologics products are minimally manipulated human tissue allografts, regulated by the Food and Drug Administration (FDA) under 21 CFR Part 1271, section 361 as HCT/Ps (Human Cells, Tissues, and Cellular or Tissue-Based Products).
AMNIOTIC MEMBRANE PRODUCT INDICATION
Skye Biologics amniotic membrane products are sterile human tissue allografts intended for homologous use to cover and protect a recipient’s tissue.
PLACENTAL TISSUE MATRIX PRODUCT INDICATION
Skye Biologics placental connective tissue matrix products are human tissue allografts intended for homologous use to supplement or replace damaged or inadequate connective tissue.