What documentation looks like for this specialty
Pain management and physical medicine groups commonly ask for the same baseline records regardless of specialty: the lot-specific certificate of analysis, a donor eligibility summary, and confirmation of the sterility testing a third-party laboratory performs before a lot is released from quarantine. Precision Biologics makes this documentation available to verified accounts on request, and additional supplier characterization data is available for exosome products specifically.
Hickory
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
25- Pain Medicine
- 17
- Physical Medicine & Rehabilitation
- 8
Account setup and ordering
A new account is opened under an NPI number tied to a licensed physician or the practice itself, after which pricing becomes visible since it is never published publicly. Ordering history and lot assignment are kept so that each unit can be traced back to its release record later, which can support a practice's own patient-level traceability requirements.
- NPI-based account verification
- Pricing available only after verification
- Lot-level order history retained
Receiving shipments in North Carolina
Cryopreserved formats ship overnight on dry ice in validated containers and arrive ready for immediate transfer to -80 degree C storage, while lyophilized formats skip the cold chain and are stored per the insert included with each lot. Staff scheduling receipt of a shipment should plan around the carrier's delivery window rather than a fixed clinic hour, since dry-ice shipments need prompt handling on arrival.
Confirming regulatory fit with your own counsel
Whether a specific product and intended use falls under the minimal-manipulation and homologous-use criteria in the HCT/P framework, or is instead regulated as a biologic drug, is a determination made by the practice together with its medical director and counsel, not by the distributor. Pain management practices in North Carolina should direct that question to the North Carolina medical board and their own legal advisors rather than to a supplier.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Can Precision Biologics tell us whether a product is appropriate for a specific pain management use?+
No. That determination depends on the intended use and belongs to the treating physician and the practice's own counsel. We provide lot documentation, not clinical or regulatory advice.
What does the NPPES figure of 25 providers in Hickory actually represent?+
It is a count of individually registered NPI-1 providers whose primary location is Hickory, NC and whose primary taxonomy is Pain Medicine or Physical Medicine & Rehabilitation, retrieved 2026-10-27. It is not a list of buyers or a demand estimate.
Do exosome products carry FDA approval?+
No. FDA has stated there are no FDA-approved exosome products, and these products are generally regulated as biologic drugs. Purchase and use decisions rest with the physician and their own regulatory counsel.