Two exosome lines. One vetted source.
Therapeutic biologics for injectable protocols and toxin-free exosomes for aesthetic and topical use — matched to your treatment, your state, and your compliance posture.
- Categories
- Two, and they are never interchangeable. ZEO ScientifiX supplies perinatal and autologous biologics for therapeutic protocols in designated states; Genovia by BioGenomics is a topical cosmetic exosome preparation for aesthetic use in all 50 states.
- Manufacturers
- ZEO ScientifiX and BioGenomics. Eventide is a distributor, not the manufacturer.
- Regulatory
- The therapeutic line is processed in an FDA-registered, ISO 7, cGMP facility compliant with 21 CFR Part 1271, and therapeutic use is limited to the states the manufacturer designates. Product availability and permitted use vary by state and by product.
- What it costs
- Quoted per line, product and volume. Certificates and third-party reports are available for every batch before you buy, not after the order.
Therapeutic or aesthetic — start where your practice is
Two different companies, two different regulatory categories. ZEO ScientifiX supplies perinatal and autologous biologics for therapeutic protocols in designated states. Genovia by BioGenomics is a topical cosmetic exosome preparation for aesthetic use in all 50 states. Most clinics end up carrying both — just never conflate them.
the certificates are available before you buy, not after the order.
Practices that already run one of the two protocols
- You run injectable regenerative protocols — orthopedic, pain, wound care, aesthetics — and practise in Florida, Utah, Georgia or Tennessee.
- You want a topical aesthetic line that ships to all 50 states and needs no cold chain.
- Your medical director asks for a Certificate of Analysis, a Certificate of Conformance and donor-eligibility records before an order, not after it.
- You would rather carry both lines from one source than reconcile two vendors' paperwork.
What the two categories cost you
- Therapeutic use is limited to the states the manufacturer designates — currently Florida, Utah, Georgia and Tennessee. Outside them, the therapeutic line is not an option at all.
- These are not drug products, are not intended for intravenous delivery, and are not interchangeable with the topical line. Conflating the two is the most common mistake we see.
- The statutory ground moves: Florida Senate Bill 1768, effective 1 July 2025, amended FS §458.3245 and §459.0127 covering orthopedic, wound care and pain indications. Confirm current requirements with your own counsel.
- Product availability and permitted use vary by state and by product, so what a colleague stocks may not be what you can.
Where it is available, it is available on unusually legible terms: a named state list, a documented category for each of the two lines, and a distributor whose job is to tell you which line your protocol actually needs before you order either.
Four questions worth asking us
- What can ship to my state, under what conditions, before anything is quoted?
- Which certificates and third-party reports come with the batch I would receive?
- Which line matches the protocol I already run, and which one does not?
- What does the donor-eligibility screening cover, and who performed it?
Two lines, and every format inside them
What each product is made from, the formats it ships in, and where providers use it. Availability and permitted use vary by state and by product — confirm both for your practice before you order.
Zeo Scientifix
Therapeutic · injectable
Orthopedic, wound care, pain, aesthetic & hair — where potency and traceability matter most.
The DayZero™ range: umbilical-cord stem cells and stem cell-derived exosomes, Wharton's jelly matrix, amniotic membrane patches and discs, high-concentration exosomes, plus two autologous lines — Patient Pure X™ and Signature X™, the personalised aesthetic exosome product. Tissue is collected within hours of delivery and processed in an FDA-registered, ISO 7, cGMP facility under 21 CFR Part 1271.
- Exosome concentration
- 25B to 500B EVs / vial
- Formats
- Cryo & lyophilized
- Sources
- Umbilical · amniotic · autologous
- Provider states
- FL, UT, GA & TN
- Range
- Stem cells · Exosomes · Amniotic membrane · PPX · Signature X
Best for injectable & regenerative protocols
Genovia by BioGenomics
Aesthetic · topical · separate company
Topical, post-procedure & microneedling — without a cold chain.
Adipose-derived stem cell exosomes at approximately 2 billion per mL, stabilised with sodium hyaluronate and trehalose. A patented culture step using a natural stimulant is reported to raise exosome secretion more than fourfold, which keeps cell passage counts low; the product is 0.2 µm filtered, characterised by nanoparticle tracking analysis and immunoblotting, then cryogenically freeze-dried at −80 °C — so no cold chain.
- Exosomes per vial
- 2 Billion
- Kit
- 50mg / 5mL + activator
- Yield vs. standard
- +362%
- Storage
- No cold chain
- Range
- Toxin-free · PDRN · Glutathione · FDA / KFDA / GMP
Best for topical & aesthetic add-on revenue
| Product | Source | Formats | Where providers use it |
|---|---|---|---|
| DayZero™ Stem Cells | Umbilical cord | 10M & 20M cells (2 mL) vials; 100M, 120M & 150M IV bags | Orthopedic, pain & wound |
| DayZero™ Stem Cell-Derived Exosomes | Umbilical cord | 25B and 200B EV (1 mL) | Aesthetics, therapeutics |
| DayZero™ Wharton's Jelly Matrix | Amniotic mix | 50B & 100B EV (2 mL); 200B EV (1 mL) | Aesthetics, therapeutics |
| DayZero™ High-Concentration Exosomes | Amniotic fluid | 250B & 500B EV (1 mL); 150B EV 3-vial box; 25B and 50B EV 5-vial boxes | Aesthetics, therapeutics |
| DayZero™ Amniotic Membrane | Amniotic membrane | 12 mm optical discs; 2×2 cm and 2×4 cm patches; custom sizes by cm² | Wound care |
| Patient Pure X™ (PPX™) | Autologous — patient's platelets | 100B, 200B & 400B EV vials | Therapeutic protocols |
| Signature X™ | Autologous — patient's platelets | Per-patient; ships with a Total Cell Counter report | Aesthetic — skin, hair, post-procedure |
| Genovia™ | Adipose-derived stem cells | ~2 billion exosomes / mL, lyophilised | Topical aesthetic, microneedling, post-procedure |
ZEO ScientifiX products are processed in an FDA-registered, ISO 7, cGMP facility compliant with 21 CFR Part 1271. They are not drug products, are not intended to prevent, treat or cure any disease or diagnosed condition, and are not intended for intravenous delivery. Therapeutic use is limited to the states the manufacturer designates — currently Florida, Utah, Georgia and Tennessee. Florida Senate Bill 1768, effective 1 July 2025, amended FS §458.3245 and §459.0127 covering orthopedic, wound care and pain indications; confirm current requirements with your own counsel.
Where providers work with these products
Categories where practices in our network apply regenerative and aesthetic products. These are provider-directed use areas, not statements of efficacy — licensed providers determine appropriate use for each patient.
- Application areas
- Aesthetic & skin · Post-procedure care · Microneedling adjunct · Hair & scalp · Topical protocols · Regenerative practice · Orthopedic & sports · Wound & recovery
- 33
- Patents behind the Genovia line
- 57
- Peer-reviewed publications
- 400B
- Peak exosome EVs per Zeo vial
- 1 donor
- 1 batch, 3 passes, no recycled cells
Documented sourcing, manufacturing, and testing
Every record this category is sold on is a record about process — where a product was made, what was in the lot, who may use it. None of them is a clinical endpoint, and the third column says so on every row.
| Source | What it says | What it does not establish |
|---|---|---|
| Manufacturing records | The therapeutic line is produced in FDA-registered facilities under cGMP with ISO7 cleanroom standards and 21 CFR Part 1271 compliance; the aesthetic line comes from FDA/KFDA/GMP cell-and-gene manufacturing. | A registered facility and a compliant process describe how a product was made. Registration is not approval, cGMP is not a clinical finding, and neither names an indication. |
| Lot documentation | A Certificate of Analysis and Certificate of Conformance for every batch, third-party certified reports, donor-eligibility screening records, and full lot traceability — the paperwork your medical director will ask for, available before you buy. | Certificates establish identity, conformance and traceability for one lot. They do not establish efficacy, safety in use, or a result for any patient. |
| State licensure | Product availability and permitted use vary by state and by product. We confirm what can ship to your state — and under what conditions — before anything is quoted, so there are no surprises after the order. Therapeutic use is limited to the states the manufacturer designates — currently Florida, Utah, Georgia and Tennessee. | A state statute governs who may use a product and where. It is not a federal approval and it is not evidence that the product works. |
| Patents and publications | The manufacturer profile records 33 patents behind the Genovia line and 57 peer-reviewed publications. | A patent is a property right, not a finding, and a publication count is not a result. Neither names an indication, a population or an outcome. |
| Provider use areas | The eight categories listed above are where practices in our network apply these products. | These are provider-directed use areas, not statements of efficacy — licensed providers determine appropriate use for each patient. |
Nothing on this page claims a result for any patient, and no row above is offered as one.
How this category is actually regulated — and where it is going
Most of what is written about biologics collapses three separate things into one word. They are not one thing, and knowing which is which is most of the compliance work.
- Injectable use is a state question first
- There is no single federal permission that makes an injectable biologic available to a practice. What exists is a growing set of state statutes. Florida’s CS/CS/SB 1768 took effect 1 July 2025 and permits physicians to administer stem cell therapies that have not been approved by the FDA, limited to orthopedics, wound care and pain management, and conditioned on sourcing from an accredited FDA-registered facility, signed informed consent, and a specific advertising notice. Utah’s S.B. 199 (2024) did the same for placental tissue. Georgia signed HB 1275 on 11 May 2026 and Tennessee signed HB 2246 on 26 May 2026, Tennessee’s reaching across all specialties rather than a named list. For a practice, the first question is therefore not what a product is — it is whether your state has a statute, and what that statute asks of you before a patient is treated.
- A state statute is not federal cover
- These laws govern the practice of medicine inside their own borders. They do not change federal law, and the FDA has continued to act against unapproved regenerative products throughout the same period. Anyone who tells you a state statute makes a product federally lawful is selling you something. We will tell you which states have a framework and what it requires; your healthcare attorney tells you what to do with that.
- Registration is not approval — and the regulation says so
- 21 CFR 1271.27(b) puts it in the regulator’s own words: FDA acceptance of an establishment registration and HCT/P listing “does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA.” There are currently no FDA-approved exosome products, and exosomes intended for the treatment of disease in humans are regulated as drugs and biological products subject to premarket review. Every facility statement on this page — ours and the manufacturers’ — describes how a product was made. A competitor presenting “FDA-registered” as a quality badge is using the phrase in a way the FDA itself calls misleading.
- Topicals travel a different road entirely
- Under the FD&C Act, cosmetic products and ingredients — colour additives excepted — require no FDA approval before they go on the market. The Modernization of Cosmetics Regulation Act of 2022 (P.L. 117-328) then built the first real structure around them since 1938: facilities register, products are listed, safety substantiation must be on file, serious adverse events must be reported, and the FDA gained mandatory recall authority. That is a registration-and-listing pathway, not a clearance and not an approval — the FDA describes it as “neither a cosmetic approval program nor a promotional tool” and issues no certificates for it. What decides whether a topical is a cosmetic or a drug is intended use, established by the claims made on the label, in advertising and online. That is precisely why the wording on the Genovia page is as careful as it is: the category is held by what you say about a product, not by what is in it.
- What the direction of travel means for an operator
- Five states now carry frameworks of this kind — Utah (S.B. 199, 2024), Florida (CS/CS/SB 1768, effective 1 July 2025), Montana (SB 535, signed 12 May 2025, with rules final 25 July 2026), Georgia (HB 1275, signed 11 May 2026) and Tennessee (HB 2246, signed 26 May 2026) — and the scope has widened as they have come: from a single tissue source, to a named list of clinical indications, to Tennessee reaching all specialties and Montana licensing experimental treatment centres outright. That is a category being written into statute rather than tolerated at the edges of one. Practices built around regenerative, longevity and performance medicine are being handed more room to operate in than they had two years ago. The ones positioned to use it are the ones whose sourcing records, consent forms and advertising language are already in order — and that documentation is the part we can put in your hands today.
Sources for this section: FDA, Public Safety Notification on Exosome Products (6 December 2019); 21 CFR 1271.10(a) and 1271.27(b); FDA, Is It a Cosmetic, a Drug, or Both?; FDA, Modernization of Cosmetics Regulation Act of 2022; Florida CS/CS/SB 1768 (2025), Utah S.B. 199 (2024), Montana SB 535 (2025), Georgia HB 1275 (2026), Tennessee HB 2246 (2026). Each was verified against its own legislature’s record; where a bill number could not be confirmed from a primary source, no bill is named. Read as of 7 August 2026 and reviewed on the 90-day compliance interval. This is general regulatory information for licensed providers, not legal advice.
What it takes to carry these lines
Every question a compliance-conscious buyer raises on a first call, answered on the page — because in this category, silence reads as risk.
- FDA-registered facilities
- cGMP, ISO7 cleanroom, and 21 CFR Part 1271 compliance across the therapeutic line; FDA/KFDA/GMP cell & gene manufacturing for the aesthetic line.
- Full lot traceability
- Certificate of Analysis, Certificate of Conformance, and third-party certified reports available for every batch, plus donor-eligibility screening.
- State-licensed use
- Therapeutic use is limited to the states the manufacturer designates — currently Florida, Utah, Georgia and Tennessee, each of which has its own statute and its own conditions. Aesthetic exosomes are positioned for topical application. We confirm what can ship to your state, and under what conditions, before anything is quoted.
- Toxin-free production
- Patented filtration yields pure exosomes with no additives — single donor, single batch, three passes, no recycled cell lines.
- Who supplies it
- These lines are made by ZEO ScientifiX and BioGenomics. Eventide is a distributor, not the manufacturer, and handles sourcing, documentation, state matching and support.
- Who it is sold to
- This is a business-to-business page. Both lines are sold to licensed medical providers and the practices they operate, not to consumers, and nothing here is directed at patients. We support clinics in all 50 US states.
What buyers ask before the first order
Are exosome or biologic products FDA-approved?
No. Biologic and exosome products are not FDA-approved to diagnose, treat, cure, or prevent any disease, and no clinical outcome is claimed or guaranteed. That's exactly why documentation and sourcing discipline matter in this category.
What documentation comes with each order?
A Certificate of Analysis and Certificate of Conformance for every batch, third-party certified reports, donor-eligibility screening records, and full lot traceability — the paperwork your medical director will ask for, available before you buy.
How are the products manufactured?
The therapeutic line is produced in FDA-registered facilities under cGMP with ISO7 cleanroom standards and 21 CFR Part 1271 compliance; the aesthetic line comes from FDA/KFDA/GMP cell-and-gene manufacturing.
Can my clinic order in my state?
Product availability and permitted use vary by state and by product. We confirm what can ship to your state — and under what conditions — before anything is quoted, so there are no surprises after the order.
What's the difference between the therapeutic and aesthetic lines?
The therapeutic line is sourced for provider-directed protocols with state-licensed sourcing requirements; the aesthetic line covers topical exosome and PDRN products used around aesthetic procedures. Most practices start with the line that matches services they already run — we help you choose on a short call.
Biologic and exosome products are not FDA-approved to diagnose, treat, cure, or prevent any disease. No clinical outcome is claimed or guaranteed. Product availability and permitted use vary by state and by product; we help you match compliant options to your license and jurisdiction.