Precision Biologics supply line for pain management practices in Cleveland

Confirming regulatory standing first

Before a pain management practice adds a Wharton's jelly or exosome product line, Precision Biologics recommends confirming current standing with the Ohio medical board and reviewing the regulatory framework that applies to the specific product with the practice's own counsel. Precision Biologics is a distributor, not a clinical or legal advisor, and does not weigh in on dosing, protocols, or how a given use is classified.

Lot documentation and sterility testing records

Each lot is tested by a third-party laboratory for sterility and is held in quarantine until it meets internal release criteria, and a verified account can request the resulting certificate of analysis along with a donor eligibility summary before ordering. Pain management practices often request this documentation product line by product line, since Wharton's jelly allografts and exosome products are processed and documented under different parts of the federal regulatory framework.

Cold-chain receiving for Cleveland-area practices

Cryopreserved products are stored at -80 degrees Celsius and shipped overnight on dry ice in validated containers; lyophilized exosome products are shelf-stable and are handled per the insert included with the lot. A practice should check the cold-chain indicator against the shipment on arrival and record the lot identifier at the patient record level, since product use is tracked by lot.

These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.

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.