A regenerative biologics partner for orthopedic surgeons in Kingsport, TN

Vendor qualification and physician oversight for orthopedic practices

Orthopedic groups adding a new biologics supplier typically confirm three things early: who the distributor is, which product family is involved — Wharton's jelly or extracellular vesicle/exosome — and what lot-level documentation exists. Precision Biologics operates as a master distributor, meaning the documentation for a given lot traces back to the supplier that processed and tested it.

Whether a specific intended use fits a practice's regulatory framework is a determination the practice's medical director makes with its own legal counsel. Precision Biologics supplies documentation to support that review but does not advise on clinical use, dosing, or procedures.

NPI-verified ordering and account setup

An NPI number tied to a licensed clinic or physician is required to open an account. Once verified, your practice can request documentation and pricing, which is available to verified accounts rather than published publicly. Precision Biologics also offers peer-to-peer calls between our team and the ordering physician, focused on product documentation rather than clinical advice.

Cold-chain delivery to northeast Tennessee

Cryopreserved Wharton's jelly products are held at -80 degree C and ship overnight on dry ice in validated containers; lyophilized formats are shelf-stable and ship without that cold-chain requirement, arriving with a product insert for the specific lot. Every lot carries a unique identifier so a receiving practice can log and track use on its own side.

Before your practice's first order, request the certificate of analysis, donor eligibility summary, and lot release record for the lot, and confirm your own licensure standing with the Tennessee medical board as part of your internal vendor review.

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.