Medspa and dermatology biologics supplier in Salt Lake City, UT

Physician supervision and account setup

Because our products are sold only to licensed clinics, medspas operating under physician supervision, and physicians, a medspa account is generally tied to the NPI of the supervising physician rather than the location's business license. Dermatology and plastic surgery practices typically register under the treating physician's own NPI.

What to request before adding a vendor

A practice evaluating a new biologics supplier commonly asks for the certificate of analysis for the lot being considered, a donor eligibility summary describing the screening a donor underwent, and confirmation that the lot was held in quarantine until third-party sterility testing was complete.

For exosome products, supplier-reported characterization data is also available, including particle concentration figures and the analytical methods used to generate them.

Receiving cryopreserved and shelf-stable formats

Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers and are stored at -80 degrees C until use, which is well suited to practices with existing cold-chain capacity. Lyophilized formats, including both lyophilized exosome products, are shelf-stable under normal storage and can be a simpler fit for a smaller aesthetic practice without a dedicated ultra-low freezer.

Regulatory verification

Precision Biologics does not provide clinical, dosing, or procedural guidance. Exosome products are not FDA approved, and the regulatory classification of any Wharton's jelly product for a specific intended use is a question for the treating physician and counsel, verified where relevant with the Utah medical board.

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.