How Pain Management Groups Evaluate a New Supplier
Pain management and physical medicine practices considering a new biologics line typically ask the same opening questions a hospital-affiliated group would: where the donor tissue comes from, how it is screened, and what testing stands behind each lot. Donors are mothers who consent to donation at the time of a scheduled, full-term C-section delivery; donation does not affect their option to separately bank cord blood.
Each lot of tissue is recovered by trained, licensed personnel, processed within 48 hours of recovery, and held in quarantine until a third-party laboratory completes sterility testing and internal release criteria are met. We provide the lot certificate of analysis and donor eligibility summary to any verified account that asks.
Tucson
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
125- Pain Medicine
- 61
- Physical Medicine & Rehabilitation
- 64
Account Setup and Ongoing Support
An NPI number is required to open an account, which lets us confirm the practice is an active, licensed provider or operates under one. After setup, practices can schedule a peer-to-peer call focused on product documentation and processing questions. These calls do not cover dosing, injection technique, or clinical protocol, since Precision Biologics does not advise on clinical use.
Shipping and Storage
Cryopreserved products are shipped overnight on dry ice in validated containers and are stored at -80 degrees C once they arrive. Lyophilized formats are shelf-stable and are handled according to the storage and reconstitution instructions in the product insert included with each lot. Either way, the clinic's own tracking should record lot numbers at the patient record level for traceability.
Regulatory Review Before You Order
Exosome products do not currently have FDA approval for any use, and FDA has said so directly; these products are generally regulated as biologic drugs rather than as section 361 tissue products. Wharton's jelly products are offered under the supplier's HCT/P framework, and whether a specific intended use is minimally manipulated and for homologous use under 21 CFR 1271.10 is a determination the practice and its counsel need to make themselves.
We recommend confirming standing with the Arizona Medical Board or Board of Osteopathic Examiners and with the practice's own legal counsel before adding either product family to a pain management protocol. These products are not FDA approved or licensed for any disease or condition; nothing here is medical or legal advice.
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 Precision Biologics able to ship to a solo pain management practice in Tucson, or only to larger groups?+
Either. Account eligibility is based on licensure and NPI verification, not practice size, so solo physicians and multi-provider groups go through the same setup.
Do you offer both cryopreserved and shelf-stable formats for Tucson accounts?+
Yes. Cryopreserved Wharton's jelly products ship on dry ice and require -80 degree C storage, while lyophilized formats are shelf-stable; both ship using the same validated nationwide logistics.
Who do we talk to about exosome characterization data before ordering?+
Verified accounts can request the supplier's characterization data, including particle analysis and marker identification, and schedule a documentation call; this is provided as analytical reference material only, not as a clinical recommendation.