What a Master Distributor Does in This Category
A distributor's role is sourcing, documentation, cold chain logistics, and account verification, not manufacturing and not clinical guidance. We work from the supplier's donor screening, processing, and release records, and we pass that documentation through to verified accounts rather than generating new claims about the product.
This distinction matters because FDA has treated distributor and website content as evidence of a product's intended use in recent enforcement actions against companies in this industry. We keep our descriptions limited to sourcing, composition, and documentation for that reason.
Two Product Categories, Different Regulatory Paths
Wharton's jelly allografts (Bio PRP Jelly, Bio Flex, Bio Flow, Bio DPM) are offered under the supplier's HCT/P framework, where minimal manipulation and homologous use are relevant criteria. Extracellular vesicle products (Bio Xsomes, Bio EX, Bio AER, Bio AER Plus) are generally regulated as biologic drugs under section 351 of the Public Health Service Act, and FDA has stated no exosome product currently holds approval under that path.
Both categories require your clinic's own regulatory review before a purchasing or clinical-use decision. We can provide documentation. We do not provide that legal determination.
Donor Sourcing, Testing, and Traceability
Tissue and cord blood are donated by consenting mothers at scheduled, full-term delivery, following medical and social history review and serology testing for communicable disease. Each lot carries a unique identifier, is sampled for third-party sterility testing, and is held in quarantine until release criteria are met.
Cryopreserved products are stored at -80 degrees Celsius and shipped overnight on dry ice in validated containers. On the clinic side, use of each product is tracked by lot at the patient record level, which supports traceability if a question about a specific lot comes up later.
Working With Us
Accounts are verified by NPI number before ordering. Pricing is not published and is available to verified accounts directly.
We offer access to physician-level conversations about product documentation, such as the certificate of analysis, donor eligibility summary, and lot release record. These conversations cover documentation, not clinical advice, dosing, or protocols.
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
What does Precision Biologics distribute?+
Two categories of perinatal-derived biologics: Wharton's jelly tissue allografts and extracellular vesicle (exosome) products, across seven total formats.
Do you provide clinical guidance on how to use these products?+
No. We provide sourcing documentation, such as certificates of analysis and donor eligibility summaries. Decisions about intended use, dosing, and procedure belong to the licensed physician and their own counsel.
How do you verify buyers?+
Accounts are verified using an NPI number before any order is placed, consistent with selling only to licensed clinics, medspas operating under physician supervision, and physicians.
Is pricing published on the site?+
No. Pricing is available to verified accounts after account setup.