- FAQs
Frequently Asked Questions
Exosomes are tiny extracellular vesicles (30–150 nm) naturally secreted by mesenchymal stem cells (MSCs). They carry proteins, RNA, and growth factors that promote cellular repair, regeneration, and communication.
No. Exogenix exosomes are cell-free and derived from cultured MSCs obtained from Wharton’s Jelly (umbilical cord tissue). They contain no DNA, no cells, and no replication potential.
No. Exogenix exosomes are intended for research use only and are not approved by the U.S. Food and Drug Administration (FDA) for the diagnosis, treatment, or prevention of any disease.
While NuYou+ does not make any therapeutic claims, many licensed providers use exosomes for investigational or off-label applications. We recommend consulting with your regulatory advisor and remaining up to date on FDA guidelines.
NuYou+ is an authorized secondary distributor of Exogenix products. We do not repackage, rebrand, or white-label. Instead, we supply Exogenix exosomes with full documentation, ensuring transparent access to high-quality regenerative solutions.
Yes. Every batch is tested by third-party labs for:
- Sterility
- Endotoxins
- Protein concentration
- Particle size and concentration
- Surface markers (CD9, CD63, CD81)
Certificates of Analysis (COAs) are available for each lot.
Exosomes are shipped frozen on dry ice and can be stored as follows:
- Cryogenic freezer: up to 18 months
- Home freezer: up to 4 months
- Refrigerator (4°C): 10 days
- Room temperature: 24 hours after thawing
Topical exosome products are shelf-stable for up to 14 months.
No. NuYou+ works exclusively with licensed healthcare providers, clinics, and research institutions. We do not sell directly to consumers or patients.
Please visit our [Contact Page] or submit a request through our secure [Order Inquiry Form]. Our team will guide you through product availability, documentation, and delivery timelines.
Please visit our [Contact Page] or submit a request through our secure [Order Inquiry Form]. Our team will guide you through product availability, documentation, and delivery timelines.
- Regulatory Disclosure
Important Notice:
The Exogenix products available through NuYou+ are not drugs or biological products approved by the FDA for any medical indication. These exosomes are for research use only, and any off-label application is the sole responsibility of the licensed provider.
NuYou+ does not promote or claim:
- The prevention, treatment, or cure of any disease or condition
- The use of exosomes in FDA-regulated therapies
- That these products are suitable for use outside a research or investigational setting
Providers are responsible for ensuring compliance with all local, state, and federal regulations when using these products in practice.
- Why We Do It
FDA Guidance Reference
As per FDA’s updated statement on regenerative products (Section 351 vs. Section 361 of the PHS Act), exosomes must not contain living cells and are classified as Human Cell and Tissue Products (HCT/Ps). Exogenix meets these criteria but is not exempt from regulation for medical use.
We encourage all providers to review the official FDA Guidance on HCT/Ps.
- Ethical & Quality Commitment
Safety. Quality. Transparency
NuYou+ is committed to:
- Ethical sourcing of umbilical cord tissue (donor-consented, screened)
- Transparency in documentation and labeling
- Ongoing regulatory awareness to protect both provider and patient safety
Still Have Questions?
Our team is here to help you navigate the science and compliance landscape. Reach out for personalized support.