Why practices request documentation before stocking
A pain management or physical medicine practice adding a new biologics line typically wants to see how the product was sourced and tested before it reaches inventory. For Wharton's jelly allografts, that means the donor eligibility screening summary and the lot-specific certificate of analysis. For exosome products, it means the supplier-reported characterization data, including particle concentration and the markers identified during testing.
Precision Biologics provides this documentation to verified accounts rather than publishing it broadly, since it's tied to a specific lot.
Portland
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
37- Pain Medicine
- 18
- Physical Medicine & Rehabilitation
- 19
Account setup and ordering
Opening an account starts with the ordering physician's NPI number. Multi-provider pain groups can add additional ordering physicians under one account, which is common where several proceduralists share inventory.
Pricing is not published publicly and is shared only with verified accounts.
Shipping and storage for Northeast practices
Cryopreserved products ship overnight on dry ice in validated containers and require -80 degree C storage on arrival. Lyophilized exosome formats are shelf-stable and stored per the insert included with the lot, which some practices prefer for products that move slower through inventory.
Where regulatory review fits
We don't advise on dosing or how a specific use fits the 1271.10 framework for Wharton's jelly products, and we don't characterize exosome products as 361 HCT/Ps. FDA has stated no exosome product is FDA-approved, and they're generally regulated as biologic drugs, so that determination sits with your medical director and counsel.
Confirm your practice's standing with the Maine medical board before adding a new biologic category. We can set up a peer-to-peer call to go through documentation with whoever signs off on vendor decisions at your practice.
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 multiple providers in our pain group order under one account?+
Yes. Add each ordering physician's NPI to the account during setup.
Are your exosome products FDA-approved?+
No. FDA has stated there are no FDA-approved exosome products. Ours are supplied with full characterization data on request, and use decisions rest with the treating physician.
How is traceability handled once the product arrives?+
Each lot carries a unique identifier. Your practice logs that lot number at the patient-record level to maintain traceability on your end.