How pain management groups typically vet a supplier
Pain management and physical medicine practices in this region commonly assign vendor review to a compliance lead or medical director, who requests the supplier's documentation set before any product reaches the treatment room. That review generally distinguishes between Wharton's jelly products, offered under the supplier's HCT/P framework, and exosome products, which are generally regulated as biologic drugs - the two carry different regulatory paths and are usually reviewed separately.
Baltimore
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
291- Pain Medicine
- 108
- Physical Medicine & Rehabilitation
- 183
Account setup and NPI verification
Accounts are opened for licensed professionals and verified against the NPI Registry before activation. A group practice with multiple pain management or rehabilitation providers can register under one group NPI or set up individual provider accounts, depending on how the practice prefers to track lot-level use at the patient record.
Logistics for shipments into the Southeast region
Cryopreserved Wharton's jelly and cord blood-derived exosome products are held at -80 degrees C and ship overnight on dry ice in validated containers; lyophilized exosome formats such as Bio EX and Bio AER are shelf-stable and ship without cryogenic handling. Every shipment is tied to a unique lot identifier for traceability once it reaches the clinic.
What Precision Biologics supports, and what it doesn't
Support includes access to a peer-to-peer call about product documentation and help getting an account set up and NPI-verified. It does not include clinical advice, dosing guidance, or protocol recommendations - confirm your practice's regulatory posture with the Maryland medical board and your own counsel before ordering.
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
Do Wharton's jelly and exosome products go through the same vendor review?+
Most practices review them separately, since Wharton's jelly products fall under the supplier's HCT/P framework while exosome products are generally regulated as biologic drugs; your counsel can confirm which applies to your intended use.
Can our pain management group register more than one provider under one account?+
Yes, group accounts can be verified against a group NPI number, or set up per individual provider if your practice tracks lot use that way.
What documentation should we keep on file after a shipment arrives?+
Keep the certificate of analysis and lot release record matched to the lot identifier on the shipment, and log it against the patient record for traceability.