What a pain management practice should request before ordering
Pain management and physical medicine groups considering a Wharton's jelly or exosome product typically ask for the same baseline paperwork other clinical suppliers are expected to provide: a lot-specific certificate of analysis, a donor eligibility summary, and a description of recovery and release testing. Reviewing that paperwork before the first order, rather than after, is the more common approach among practices with an established compliance process.
Precision Biologics makes this documentation available to verified accounts and can walk a practice's compliance contact through what each document covers.
Fayetteville
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
42- Pain Medicine
- 24
- Physical Medicine & Rehabilitation
- 18
Account verification through NPI
An NPI number pulled from the NPPES registry, the same source behind the Pain Medicine and Physical Medicine & Rehabilitation counts above, is required to open an ordering account. This step confirms the account belongs to a licensed professional or practice before any product is released.
Lot numbers are tracked at the account level so a practice's own patient-level traceability records line up with what was shipped.
Shipping cryopreserved and lyophilized formats to the Southeast
Cryopreserved formats are stored at -80 degrees C and move overnight on dry ice inside validated shipping containers; that path to a Fayetteville address is the same one used for deliveries elsewhere in the Southeast. Lyophilized, shelf-stable formats avoid the cryogenic handling step and follow the storage and reconstitution instructions included with the lot.
Having a staff member ready to receive and log a cryopreserved shipment on the day it arrives keeps the cold chain intact until the product reaches internal storage.
Regulatory verification and getting an account set up
Exosome products carry no FDA approval; FDA has stated there are no FDA-approved exosome products, and these products are generally regulated as biologic drugs under the agency's framework, so decisions about purchase and clinical use belong to the treating physician working with their own counsel. Wharton's jelly products are offered under the supplier's HCT/P framework, and whether a specific intended use meets the criteria in 21 CFR 1271.10 is likewise a determination for the practice and its counsel, not Precision Biologics.
Practices are encouraged to verify their own standing directly with the North Carolina Medical Board. Opening an account involves NPI confirmation, basic practice details, and a documentation review; a peer-level call about that paperwork can be arranged on request.
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
Is Bio Xsomes or another exosome product FDA approved for use in a pain management setting?+
No. FDA has stated there are no FDA-approved exosome products, and these are generally regulated as biologic drugs. Purchase and any clinical use decision rests with the physician and their own regulatory counsel.
Do you work with physical medicine and rehabilitation practices as well as pain medicine practices?+
Yes. Accounts are opened for licensed pain management, physical medicine, and rehabilitation practices once NPI verification is complete, without a separate process for either specialty.
What documentation should our practice request before placing a first order?+
Ask for the lot-specific certificate of analysis, donor eligibility summary, and a description of recovery and release testing. Verified accounts can request this set directly.