Our Process
Why Umbilical Cord?
Regenerative biologics can be derived from several biological sources — including bone marrow, adipose tissue, embryonic tissue, and umbilical cord. Each source carries distinct advantages and limitations. After rigorous evaluation of the science and ethics involved, Genova Biologix made a deliberate choice to work exclusively with umbilical cord-derived products.
Umbilical cord tissue is recovered immediately following birth — a process that is entirely non-invasive, ethically sound, and subject to full informed consent. Beyond its ethical profile, umbilical cord tissue consistently delivers the highest concentration of regenerative cells, growth factors, and cytokines of any available source. It is, by virtually every measure, the optimal foundation for a premium allograft product.
Bone marrow and adipose-derived products require invasive surgical retrieval and yield significantly fewer cells per procedure. Embryonic sources raise serious ethical concerns and are subject to significant regulatory restriction. For Genova Biologix, umbilical cord was not just the right scientific choice — it was the only ethical one.
Step by Step
Participating hospitals extend the option of umbilical cord tissue donation to expecting mothers carrying healthy, full-term pregnancies. Mothers who choose to participate undergo a thorough medical and lifestyle screening process. Those who meet all eligibility criteria sign comprehensive informed consent documentation, affirming their voluntary participation and understanding of how the tissue will be used.
Immediately following delivery, a specially trained clinical nurse enters the delivery room to conduct the tissue recovery procedure. The umbilical cord — tissue that would otherwise be discarded — is clamped and the cord tissue and associated biological material are carefully collected under sterile conditions. This process adds no burden to the mother or newborn and is completed within minutes of birth.
All collected tissue is transported immediately to our sterile, FDA-registered laboratory. There, each cord undergoes comprehensive screening under AATB guidelines — including infectious disease testing, viability assessment, and potency evaluation. Only tissue that passes every required test advances to the production phase. Tissue that does not meet our standards is rejected, regardless of yield or cost implications.
Validated tissue is processed in our cGMP and cGTP-compliant manufacturing environment by highly trained laboratory specialists. Cells and biological components are isolated, concentrated, and formulated into standardized product preparations. Critically, Genova Biologix extracts its products in standardized concentrations — giving physicians precise, consistent dosing with every vial, unlike many competitors whose products vary significantly between lots.
Finished products are distributed directly to licensed physicians and healthcare institutions — no intermediaries, no distribution delays. Every shipment is packaged as single-dose preparations on dry ice with temperature monitoring throughout transit to ensure maximum biological preservation. From our lab to your practice, the cold chain is never broken.
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