The Regulatory Reality of Exosome Products
Exosome and extracellular vesicle preparations do not fit the same regulatory category as minimally manipulated tissue allografts. FDA treats them as biologic drugs subject to section 351 of the Public Health Service Act, which means premarket approval pathways apply. FDA has publicly stated that no exosome product currently holds that approval.
Decisions about whether and how to purchase or use an exosome product clinically belong to the physician, made together with their own regulatory counsel. We do not advise on clinical use, dosing, or protocols for any product we distribute.
Our Exosome Product Line
We distribute three exosome formats.
Full ingredient lists and characterization data for each product are disclosed to verified accounts.
- Bio Xsomes: cord blood-derived extracellular vesicle product from a progenitor endothelial cell line, listed at 180 billion particles per mL
- Bio EX: lyophilized umbilical cord-derived exosome product, listed at 30 billion lyophilized exosomes per unit, supplied with added peptides and growth factors per the full ingredient disclosure
- Bio AER and Bio AER Plus are separately listed 1 mL presentations. Request current composition and handling instructions; do not infer storage or analytical specifications from another catalog item.
How These Products Are Characterized
The supplier reports characterization using ELISA, nanoparticle tracking analysis (NTA), and single particle interferometric reflectance imaging sensing (SP-IRIS). Exosome tetraspanin markers CD81 and CD9 have been identified, and a growth factor and cytokine panel is reported, including IGFBP-1, -2, -3, and -6, insulin, growth hormone, PDGF-AA, TGF-beta1, VEGF, and IL-1RA.
These are analytical findings describing what is present in the preparation. They are not claims about what the product does in a patient, and we do not present them that way.
What to Request Before You Purchase
Ask for the supplier-supplied literature and characterization data, the lot certificate of analysis, and the full ingredient disclosure for the product you are considering. Review the regulatory status of exosome products with your own counsel before making a purchasing or clinical-use decision.
Ordering requires account verification by NPI number, consistent with sales limited to licensed clinics, medspas operating under physician supervision, and physicians.
These products are not FDA approved or licensed for any disease or condition. Information on this page is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Is any exosome product FDA approved?+
No. FDA has stated that there are no FDA-approved exosome products. Exosome preparations are generally regulated as biologic drugs under section 351 of the Public Health Service Act.
How is an exosome product different from a Wharton's jelly allograft?+
Wharton's jelly allografts are offered under the supplier's HCT/P framework, where a minimal manipulation and homologous use determination applies. Exosome products are generally regulated as biologic drugs under section 351, a different regulatory path, and that distinction belongs in any purchasing decision.
What characterization data is available for your exosome products?+
Supplier-reported characterization includes ELISA, nanoparticle tracking analysis, and SP-IRIS, along with tetraspanin marker identification (CD81, CD9) and a growth factor and cytokine panel. Full data is available to verified accounts.
Who can purchase exosome products from Precision Biologics?+
Licensed clinics, medspas operating under physician supervision, and physicians, after NPI-based account verification. We do not sell to patients.