HylaPure is a minimally manipulated, DMSO- free, cryogenically preserved human birth tissue allograft derived from the umbilical cord. These structural tissues contain extracellular matrix, such as elastin, Hylauronan, collagen fibers, and fibronectin, and naturally occurring tissue components such as growth factors, cytokines, and nanoparticles. BioXstem’s HCT/Ps are processed from bio-ethically donated human birth tissue from healthy, consenting mothers in the United States who have passed a comprehensive medical background check, blood screenings and had full term, live C-Section births.

 

BioXstem products are processed in accordance with standards established by FDA and American Association of Tissue Banks (AATB) to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493+. BioXstem products only come from a lab that is AATB accredited and Current Good Manufacturing Practices (cGMP) certified.