Wharton's Jelly and Exosome Supplier for Baltimore Medspas

Documentation to request before stocking a new product

Request the certificate of analysis, donor eligibility summary, and lot release record for the specific lot being purchased. For exosome formats such as Bio Xsomes, Bio EX, and Bio AER, also request the available characterization data and the full ingredient disclosure, since several of these formats include added peptides or growth factors alongside the exosome preparation.

Medical director review in a medspa setting

Because a medspa operates under physician supervision rather than as its own licensed tissue bank, the supervising or medical director typically reviews a new biologics supplier before any product is added to inventory. That review usually starts with the supplier's documentation set rather than marketing claims, and often includes a check with the practice's own counsel on how the product's regulatory classification applies to the practice's intended use.

NPI verification and ordering

Every account is checked against the public NPI Registry before activation, consistent with how Precision Biologics limits orders to licensed professionals. A dermatology or plastic surgery group with multiple Baltimore locations can register each site separately to keep lot traceability tied to the correct address.

Receiving shipments in the Southeast region

Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers and are stored at -80 degrees C beforehand; lyophilized exosome products are shelf-stable and store at room temperature per the product insert supplied with the lot. Confirm your practice's regulatory standing with the Maryland medical board and your own counsel before adding any product to your formulary.

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.