Documentation pain management and physical medicine practices request
Practices in these specialties commonly ask the same set of questions before adding a biologics line: how donors are screened, how quickly tissue is processed after recovery, and what third-party sterility testing was performed on the specific lot. We supply the certificate of analysis, donor eligibility summary, and lot release record directly to verified accounts rather than describing them only in a sales conversation.
Wichita
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
38- Pain Medicine
- 18
- Physical Medicine & Rehabilitation
- 20
Why exosome and Wharton's jelly products are documented differently
Because FDA has stated there are no FDA-approved exosome products and treats them as biologic drugs, documentation for Bio Xsomes, Bio EX, and Bio AER includes supplier characterization data, such as particle concentration and marker identification, rather than any claim of FDA clearance. Wharton's jelly products are offered under our supplier's HCT/P framework, and whether a specific intended use qualifies under 21 CFR 1271.10 is a determination for the practice and its counsel.
Account setup and shipping into the Midwest
Accounts open only after NPI verification against the NPPES registry. Once verified, a practice can order cryopreserved formats, which are stored at -80 C and shipped overnight on dry ice in validated containers, or lyophilized formats, which are shelf-stable and handled per the included product insert. Every lot carries its own identifier for tracking once it reaches the practice.
Confirming regulatory standing
We recommend any practice confirm its standing with the Kansas medical board and its own counsel before adding a new biologics line, since the regulatory determination for a specific intended use is theirs to make, not ours. Physician-level calls are available to review documentation in detail; they are not a substitute for that counsel.
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 pain management practice in Wichita order exosome products from Precision Biologics?+
Yes, provided the practice is licensed and its account is verified against an active NPI. Exosome products are not FDA approved, and purchase decisions rest with the practice and its own regulatory counsel.
What is included in the documentation for Wharton's jelly products?+
Verified accounts can request the certificate of analysis, donor eligibility summary, and lot release record for the specific lot being considered.
How quickly are tissue lots processed after donation?+
Tissue is recovered by trained personnel and processed within 48 hours of recovery, following a sterility testing and quarantine process before release.