Vendor review, practice by practice
Smaller pain management and physical medicine groups tend to run vendor review through the physician owner rather than a dedicated procurement function. The core ask is usually the same set of documents: a lot-specific certificate of analysis, a description of donor screening and processing, and confirmation that an account's NPI has been checked against the NPPES registry before the first order is placed.
Burlington
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
17- Pain Medicine
- 12
- Physical Medicine & Rehabilitation
- 5
What arrives with a shipment
Precision Biologics ships this documentation with every order to a verified account rather than requiring a separate request each time.
- Lot-specific certificate of analysis
- Donor eligibility summary
- Lot release record
- Unique lot identifier for traceability
Cold-chain handling on arrival
Cryopreserved Wharton's jelly formats are shipped overnight on dry ice in validated containers and are stored at -80 degrees Celsius before departure; they need to reach freezer storage promptly once they land at a Burlington practice. Lyophilized formats are shelf-stable and are handled per the insert supplied with the lot, which some smaller practices find easier to manage without cold-chain equipment on site.
Regulatory posture and account setup
FDA has stated that there are no FDA-approved exosome products and that they are generally regulated as biologic drugs; Precision Biologics does not advise on clinical use, dosing, or protocols for any product, and those decisions remain with the treating physician and the practice's own regulatory counsel. Vermont practices should route licensure and scope-of-practice questions to the Vermont Board of Medicine. Accounts open once an NPI is verified, and physicians can request a direct call to review documentation 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
Is there a minimum practice size to open an account?+
No. Any licensed physician or clinic with a verifiable NPI can open a verified account.
What's the regulatory status of the exosome products you distribute?+
FDA has stated there are no FDA-approved exosome products. They are generally regulated as biologic drugs, and clinical use decisions belong to the physician and their own regulatory counsel.
How is product tracked once it reaches our office?+
Each lot carries a unique identifier, and clinics are expected to track use by lot at the patient record level on their side for traceability.