What a pain management practice should request before ordering
Pain management and physical medicine practices generally ask a biologics distributor for the same baseline documentation regardless of specialty: a certificate of analysis for the lot, a summary of donor screening, and a description of how the product was processed. Precision Biologics makes this documentation available to verified accounts and can walk a medical director through what each document covers on a peer-to-peer call.
Because exosome products are not FDA-approved and are generally regulated as biologic drugs, practices evaluating Bio Xsomes, Bio EX, or Bio AER should route that review through their own medical director and regulatory counsel rather than relying on distributor marketing material.
Brownsville
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
10- Pain Medicine
- 3
- Physical Medicine & Rehabilitation
- 7
Setting up a verified account
Pricing is not published and is shared only with verified accounts once this process is complete.
- Provide an individual or group NPI number
- Confirm the practice is a licensed clinic or physician-supervised setting
- Complete account verification before the first order ships
Receiving shipments
Cryopreserved Wharton's jelly formats ship overnight on dry ice in validated containers and require storage at -80 degrees Celsius on arrival. Lyophilized exosome formats are shelf-stable and do not require cryogenic storage, but should still be logged by lot at receiving. Clinics in Brownsville and elsewhere in the Southwest region should confirm storage capacity and a lot-tracking process before placing a first order.
Scope of practice and regulatory review
Decisions about whether a particular use fits within 21 CFR 1271.10 or falls under section 351 as a biologic drug belong to the practice's medical director and counsel. Texas pain management and physical medicine practices should confirm their own licensure and scope with the Texas medical board before adding any new biologics vendor.
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 a physical medicine and rehabilitation practice in Brownsville open an account with Precision Biologics?+
Yes, once the practice provides an NPI number and completes account verification as a licensed clinic or physician-supervised setting.
Are exosome products like Bio Xsomes FDA-approved for pain management practices in Texas?+
No. FDA has stated there are no FDA-approved exosome products, and Precision Biologics does not make claims about their use. Review of any intended use belongs to the practice and its counsel.
What documentation is available for a pain management practice evaluating a Wharton's jelly product?+
Verified accounts can request the certificate of analysis, donor eligibility summary, and processing description for each lot.