What Pain Management Groups Request Before Ordering
Pain management and physical medicine practices commonly ask a prospective biologics supplier for the same core documents regardless of product family: a certificate of analysis, a donor eligibility summary where applicable, and a lot release record tied to a specific lot number.
For exosome products, practices should also expect to receive the supplier's characterization data, since analytical findings such as particle concentration and marker identification are reported per lot rather than asserted as general product claims.
San Jose
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
91- Pain Medicine
- 38
- Physical Medicine & Rehabilitation
- 53
Multi-Site and Group Practice Considerations
Pain medicine and rehabilitation groups that operate across several locations typically centralize vendor qualification and documentation storage at the group level, then distribute lot numbers to individual sites for patient-record-level tracking.
This structure is consistent with how Precision Biologics tracks each product by lot identifier from processing through shipment.
Receiving Shipments in the San Jose Area
Cryopreserved Wharton's jelly formats arrive overnight on dry ice in validated shipping containers and require transfer to -80 degree C storage promptly on receipt. Exosome and lyophilized products are shelf-stable under normal storage conditions, which can reduce receiving complexity for smaller clinics without ultra-low freezer capacity.
Verifying Standing and Opening an Account
Before ordering, a practice should confirm its own licensure and standing with the Medical Board of California or the appropriate physician licensing authority, and consult counsel on how any intended use is classified. Precision Biologics requires an NPI number for account verification and limits ordering to licensed professionals.
Verified accounts can schedule a physician-level call to review documentation questions 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 pain management clinic in San Jose request exosome product characterization data before purchase?+
Yes. Verified accounts can request the supplier's reported characterization data, including particle concentration and marker identification, for Bio Xsomes, Bio EX, and Bio AER.
Are Precision Biologics products FDA approved?+
No. FDA has stated there are no FDA-approved exosome products, and Wharton's jelly allografts are offered under the supplier's HCT/P framework; whether a specific use qualifies under 21 CFR 1271.10 is a determination for the clinic and its counsel.
Does a multi-location pain practice need a separate account for each site?+
Account verification is tied to an NPI number; group practices with multiple NPIs should contact us to discuss how documentation and lot tracking are organized across locations.