Documentation Pain Practices Typically Request
Pain management and rehabilitation practices commonly request the same baseline documents before adding a new biologics supplier: a certificate of analysis, a donor eligibility summary, and a lot release record tied to the specific lot being purchased.
For exosome products such as Bio Xsomes, Bio EX, and Bio AER, practices can also request the supplier's reported characterization data, including particle concentration and marker identification, presented as analytical findings rather than claims about function.
Nashville
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
186- Pain Medicine
- 75
- Physical Medicine & Rehabilitation
- 111
Group Practices and Multi-Site Rehabilitation Networks
Pain medicine and physical medicine groups that operate several locations around the Nashville-Davidson metro often centralize documentation review at the group level while distributing lot numbers to each site for patient-record tracking, consistent with how Precision Biologics tracks every product by lot identifier.
Cold Chain Logistics for Southeast Deliveries
Cryopreserved Wharton's jelly formats arrive overnight on dry ice in validated containers and should be moved to -80 degree C storage on receipt. Lyophilized and exosome products are shelf-stable under normal storage, which reduces receiving requirements for smaller clinics without ultra-low freezer capacity.
Verifying Licensure Before Ordering
Before placing an order, a practice should confirm its own standing with the Tennessee Board of Medical Examiners or the relevant licensing authority and consult counsel on how a specific product use is classified. Precision Biologics requires an NPI number to verify accounts and restricts ordering to licensed professionals.
Verified accounts can schedule a physician-level documentation call and request pricing, which is not published publicly.
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 a Nashville pain management group request exosome characterization data before ordering?+
Yes. Verified accounts can request the supplier's reported analytical data for Bio Xsomes, Bio EX, and Bio AER, including concentration and marker identification.
Are these products regulated the same way as stem cell therapies?+
No. Exosome products are not FDA approved and are generally regulated as biologic drugs; Wharton's jelly products are offered under the supplier's HCT/P framework, and whether a specific use qualifies under 21 CFR 1271.10 is a determination for the clinic and its counsel.
Does a multi-site rehabilitation group need separate accounts per location?+
Verification is tied to an NPI number; groups with multiple sites and NPIs should contact us to coordinate documentation and lot tracking across locations.