What a vendor review usually covers
Pain management and physical medicine practices that evaluate a new biologics supplier typically request a certificate of analysis for the specific lot, a donor eligibility and screening summary, and confirmation that the lot passed third-party sterility testing before release from quarantine.
Some groups also ask whether the supplier's registration and licensure documentation is available for independent review; Precision Biologics makes this available to verified accounts rather than publishing it.
Greeley
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
26- Pain Medicine
- 14
- Physical Medicine & Rehabilitation
- 12
Setting up an NPI-verified account and ordering
A practice opens an account under a licensed physician's NPI number, which is checked against the public registry before pricing or ordering access is granted. Pricing itself is never published and is shared only once an account is verified.
Cold-chain shipping and receiving in Colorado
Cryopreserved products are stored at -80 degrees Celsius and travel overnight on dry ice in validated shipping containers. Clinical staff receiving a shipment should log the lot number and confirm the container held temperature before placing product into freezer storage.
Lyophilized Wharton's jelly and exosome formats ship without a cold chain and are stored according to the insert included with each lot.
Confirming classification with Colorado's medical board
Whether a specific use is expected to meet the federal minimal manipulation and homologous use standard is a determination for the practice and its own counsel, made in consultation with Colorado's medical board as needed, not something Precision Biologics determines on a practice's behalf.
Physicians can request a peer-to-peer call focused on documentation rather than clinical application.
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 one account cover a multi-provider pain practice?+
Accounts are tied to a supervising physician's NPI number; group practices typically register under that physician and order centrally.
How is pricing handled?+
Pricing is not published publicly and is shared only with verified accounts after NPI confirmation.
Who should we ask about whether our use case fits the federal framework?+
Your own healthcare counsel, in consultation with Colorado's medical board, is the right party to make that determination.