Six manufacturing and quality controls distinguish our biologics from commodity suppliers. Every claim below is documented per lot.
Nanoparticle Tracking Analysis confirms particle count on every production lot — documented on your lot-specific COA, not estimated or derived.
3D hollow-fiber bioreactor systems. Published research documents up to 19.4x higher EV yield per cell vs. standard 2D flat culture. A manufacturing process distinction, not an outcomes claim.
Sourced from an AATB-accredited, FDA-registered tissue establishment operating under cGTP standards (21 CFR Part 1271). Facility credentials — not product approval.
Every lot is tested both in-house and through an independent third-party laboratory. Both results must meet release criteria before a lot ships.
UCT-MSC lots documented at 97%+ post-thaw viability — well above the 70% industry minimum. Confirmed by automated cell count on every lot COA.
Credential verification is required before any purchase is approved. We do not sell to unlicensed individuals or unapproved facilities.
Three steps from clinic enrollment to first delivery. Most practices are approved within 24 hours of credential submission.
Complete the credential verification form. Less than 5 minutes. Proof of medical licensure required — state medical license, NP/PA certification, or applicable jurisdictional credential.
Start EnrollmentMost applications are approved within 24 hours. Once approved, you unlock wholesale pricing, lot-specific COAs, NTA verification reports, and direct access to clinical support and Medical Director consultation.
Orders ship overnight on dry ice. Most practices receive their first order within 2–3 business days of approval. Exosome vials ship cryopreserved liquid. UCT-MSC vials require cryogenic storage upon arrival.
Every Stem Nova order ships with a lot-specific Certificate of Analysis. Practices receive new COA documentation with every shipment — not a generic master COA.
- NTA particle count (ZetaView) — where applicable to product
- Sterility — USP <71> compliant
- Mycoplasma — detection threshold compliant
- Endotoxin — LAL assay
- Total protein concentration
- Viral panel — full nine-marker panel for UCT-MSC products
- Post-thaw viability — automated cell count for UCT-MSC products
- Cell count and characterization — UCT-MSC products
Are Stem Nova Network biologics FDA-approved?
No. Stem Nova Network biologics are not FDA-approved drugs or therapeutic agents and are not intended to diagnose, treat, cure, or prevent any disease or condition. Exosome biologics are supplied for topical cosmetic use only. UCT-MSC stem cells are supplied as research-grade biologics for licensed professional use. The FDA has stated in public safety communications that there are currently no FDA-approved exosome products. Manufacturing occurs in an FDA-registered, AATB-accredited tissue establishment under cGTP-compliant standards (21 CFR Part 1271) — facility credentials, not product approval.
Who can purchase Stem Nova biologics?
Licensed medical professionals only. Credential verification is required before any purchase is approved. Eligible practitioners include MDs, DOs, NPs, PAs, dentists, chiropractors (where state law permits), and other licensed professionals with appropriate jurisdictional credentialing. We do not sell to consumers, unlicensed individuals, or unapproved facilities.
What documentation comes with each order?
Every order includes a lot-specific Certificate of Analysis covering NTA particle count (where applicable), sterility, mycoplasma, endotoxin, total protein, and where applicable viral panel and post-thaw viability. Documentation is digital and available immediately after lot release.
How are biologics shipped and stored?
All biologics ship overnight on dry ice via insured carrier in temperature-monitored packaging. Exosome biologics are cryopreserved liquid and require storage at -80°C upon arrival. UCT-MSC live cell vials require cryogenic (liquid nitrogen vapor phase or -150°C) storage upon arrival. Storage requirements vary by SKU; specific guidance ships with every order.
What is the minimum order quantity?
No minimum order quantity. Wholesale pricing applies to all enrolled accounts. Volume pricing is available for practices ordering at scale — contact your account representative after enrollment for tier details.
Lot-specific COAs, NTA-verified particle counts, and dedicated clinical support — available to licensed professionals upon credential verification. Most practices approved within 24 hours.
Products listed on this page are not FDA-approved for the diagnosis, treatment, cure, or prevention of any disease. Exosome products are positioned for topical cosmetic use only. Stem cell products are research-grade biologics. All use should be individualized under the direction of a licensed medical professional. Manufactured in an FDA-registered, AATB-accredited tissue establishment under cGTP-compliant standards (21 CFR Part 1271).