The amniotic and umbilical cord material is obtained from consenting women after a scheduled C-section. No embryonic stem cells are used and no babies are harmed during the process. The material is acquired in a sterile, approved fashion and then processed at an FDA registered/certified facility.
Once processing is complete, the amniotic fluid and umbilical cord tissue is cryogenically frozen which preserves cell viability. It is kept frozen at -80 degrees Celsius until it is needed for a procedure. Shipping occurs on dry ice to keep the material frozen.
Per FDA classification as a biologic, the products fall into the minimal manipulation category. The material is rich with multiple extracellular matrix proteins, growth factors, cytokines, exosomes, stem cells and other specialty proteins.