What we do, how it's controlled, and what we won't claim
This page contains no outcome claims. It describes process, sourcing, standards and regulation — the parts that can actually be verified.
Screened, consented donor tissue — never fetal, never taken from you
Donor material is collected at scheduled full-term births with documented donor consent. Donors are screened for infectious disease before collection, and material is discarded if any screen fails.
Nothing is taken from a patient, and nothing is taken from fetal tissue.
cGMP and ISO standards, on site
Everything administered is prepared and released in our own laboratory at the facility rather than shipped in from a third party. Each batch carries a release record covering sterility, endotoxin, mycoplasma, viability and identity.
You can ask for the batch record for anything administered to you. Patients rarely do. It exists either way.
Not FDA-approved. Administered under COFEPRIS oversight.
The FDA has not approved these treatments, and we are not going to phrase that in a way that hides it.
Treatment is performed in Mexico at licensed medical facilities regulated by COFEPRIS, under the supervision of physicians licensed in Mexico. ZignaGenix is a United States company; no treatment is performed in the United States or in our US offices.
If the absence of FDA approval is a dealbreaker for you, it should be, and we would rather you decide that now than after a deposit.
The contraindications that end the conversation
Active cancer or cancer treated within the last twelve months. Pregnancy or breastfeeding. Active untreated infection. Organ or bone marrow transplant within two years. High-dose immunosuppressive therapy.
Any one of these ends the assessment with a no. We do not work around them, and we do not ask you to travel so a coordinator can talk you out of your own medical history.
We record what happens after you go home
Structured check-ins at 30, 90 and 180 days. We record meaningful change and we record the absence of it, because a follow-up program that only captures good news is a marketing program.
Find out where you stand before anyone tries to sell you anything.
The assessment takes about two minutes, asks for no contact details until the end, and can tell you that you are not a candidate. That outcome is built in on purpose.
Check my candidacy — 2 minA physician reviewing your responses is not a diagnosis. Candidacy for any treatment is determined only after in-person assessment at our clinic in Mexico, including laboratory studies if the physician considers them necessary.