Two product families, two review tracks
Pain management and physical medicine practices commonly treat Wharton's jelly allografts and exosome products as separate vendor-review items because they fall under different regulatory frameworks: Wharton's jelly products are offered under the supplier's HCT/P framework, while exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act. A practice's internal checklist typically confirms registration status and documentation availability for each product line independently.
Baton Rouge
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
72- Pain Medicine
- 34
- Physical Medicine & Rehabilitation
- 38
Setting up an NPI-verified account
Opening an account starts with verifying the practice's NPI number against the NPPES registry. Once verified, documentation, including certificates of analysis, donor eligibility summaries, and lot release records, becomes available, and a peer-to-peer call focused on documentation rather than clinical guidance can be scheduled. Pricing is disclosed only to verified accounts.
Cold-chain receiving in the Gulf South
Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers and must be stored at -80 degrees Celsius on arrival; lyophilized exosome products are shelf-stable and do not require cryogenic storage. A documented receiving step, confirming the shipping container's temperature indicator and matching the lot number to its certificate of analysis, should happen before any product is placed into inventory, particularly given regional shipping conditions.
Medical director and board verification
Precision Biologics does not advise on clinical use, dosing, or procedure protocol. Practices should confirm their own license status with the Louisiana State Board of Medical Examiners and consult their medical director and legal counsel on whether a given intended use fits their regulatory framework before any product reaches a patient record.
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.
Frequently asked questions
Can our pain management group and an affiliated physical medicine practice share one account?+
Accounts are tied to an NPI number, so affiliated practices with separate NPI numbers generally hold separate accounts, though billing arrangements can be discussed during setup.
What's the lead time for a cryopreserved shipment to Baton Rouge?+
Cryopreserved products ship overnight on dry ice in validated containers; your account contact can confirm scheduling specifics based on carrier availability and your receiving hours.
Does Precision Biologics recommend which product fits our patient population?+
No. Product selection and intended-use decisions are made by the practice and its own clinical and legal counsel; Precision Biologics provides documentation, not clinical recommendations.