Medspa and Dermatology Biologics Distributor in Nashville, TN

Wharton's Jelly and Exosome Documentation Side by Side

Aesthetic practices evaluating our catalog are typically comparing two product families with distinct documentation. Wharton's jelly products (Bio PRP Jelly, Bio Flex, Bio Flow, Bio DPM) are offered under the supplier's HCT/P framework, with processing described as following FDA regulations and AATB and AABB guidelines.

Exosome products (Bio Xsomes, Bio EX, Bio AER) are not FDA approved. FDA has stated there are no FDA-approved exosome products, and these are generally regulated as biologic drugs rather than HCT/Ps. Verified accounts can request full ingredient disclosure and characterization data for either family.

Physician Supervision Requirements

Because our accounts are verified against an NPI number, medspas should plan to use their supervising physician's NPI during setup. Practices should also independently confirm that supervising physician's current standing with the Tennessee Board of Medical Examiners before ordering.

Precision Biologics does not determine which product or format is appropriate for a given practice; that decision, including any regulatory classification question, belongs to the supervising physician and legal counsel.

Receiving Shipments at an Aesthetic Practice

Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers and require prompt transfer to -80 degree C storage. Lyophilized exosome products are shelf-stable under normal storage conditions and do not require cryogenic equipment, which some smaller aesthetic practices find simpler to manage.

Opening and Using a Verified Account

Account verification requires an NPI number and is limited to licensed professionals and clinics operating under physician supervision. Once verified, a practice can request the certificate of analysis, donor eligibility summary, and lot release record for any product, and schedule a physician-level call focused on documentation.

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.