Wharton's Jelly and Exosome Supplier for Seattle, WA Medspas

Physician supervision and account eligibility

Medspas purchasing from Precision Biologics must operate under physician supervision, and the account is tied to the supervising or ordering physician's NPI number rather than the business entity alone. Dermatology and plastic surgery practices generally register the physician of record directly.

We ask new accounts to confirm how the supervising physician is involved in purchasing decisions before the first order is approved.

Documentation available to verified accounts

Once an account is verified, staff can request the certificate of analysis, donor eligibility summary and lot release record for any lot under consideration. Exosome products are supplied with full ingredient disclosure to verified accounts, and Wharton's jelly formats include a processing description.

Shipping and storage for aesthetic practices

Cryopreserved Wharton's jelly products ship overnight on dry ice and are stored at -80 degrees C on arrival. Lyophilized exosome and Wharton's jelly formats are shelf-stable and do not require cryogenic equipment, following the storage and reconstitution handling described in the product insert.

• Confirm lot identifier on label
• Confirm packaging integrity
• Log lot number against patient-level records

Regulatory verification and account setup support

FDA has stated that no exosome product is currently FDA-approved, and exosome products are generally regulated as biologic drugs; purchase and use decisions rest with the supervising physician and the practice's own regulatory counsel. Practices should also confirm their standing with the Washington medical board as part of their own compliance review.

Precision Biologics can set up a peer-to-peer call between a buyer's physician and ours to walk through documentation and account requirements.

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.