Vetting a New Biologics Line as a Pain Management or Rehab Practice
Pain management and physical medicine practices tend to ask similar questions when a new biologics vendor comes up: where the tissue is sourced, how donors are screened, and what independent testing a lot has to pass before it reaches a clinic. Recovery is performed by trained, licensed personnel, processing happens within 48 hours of recovery, and each lot is held in quarantine until a third-party laboratory completes sterility testing and the supplier's release criteria are met.
We send the certificate of analysis, donor eligibility summary, and testing record for a given lot to any verified account that requests it, rather than publishing lot-specific figures here.
Honolulu
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
75- Pain Medicine
- 27
- Physical Medicine & Rehabilitation
- 48
Setting Up Access
An NPI number is the starting point for any new account, letting us confirm the practice is an active, licensed provider or operates under one before an order is placed. After that, a practice can book a peer-to-peer call to go through documentation and processing questions with our team; we do not advise on dosing, technique, or clinical protocol in these calls.
Format Choice and Storage
Cryopreserved formats need -80 degree C storage and ship overnight on dry ice in validated containers; lyophilized formats are shelf-stable and follow the storage and reconstitution steps in the insert included with the lot. A pain management practice choosing between formats for its own workflow should weigh freezer capacity and shelf life against its receiving schedule, and can ask us for the specifics of either format at the time of order.
Where Regulatory Responsibility Sits
FDA has said directly that no exosome product is currently FDA approved, and these products are generally regulated as biologic drugs, not as section 361 tissue products. Whether a Wharton's jelly product's intended use in a given practice is minimally manipulated and for homologous use under 21 CFR 1271.10 is a determination for that practice and its counsel to make, not something we advise on.
We recommend confirming standing with the Hawaii Medical Board and with the practice's own legal counsel before adding either product family to the practice's sourcing. These products are not FDA approved or licensed for any disease or condition; nothing on this page is 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.
Frequently asked questions
Is there a minimum order size for a Honolulu pain management practice to open an account?+
Account eligibility is based on NPI verification and licensure rather than order volume; specific order minimums, if any, are confirmed at the time of account setup.
How do we confirm a lot's sterility testing before using it in our practice?+
Each lot carries a sterility testing record completed by a third-party laboratory after a quarantine hold; verified accounts can request that record along with the certificate of analysis for the lot.
Do you support both cryopreserved and lyophilized formats for accounts in Hawaii?+
Yes. Both format types ship to Hawaii accounts using the same nationwide logistics, and either can be selected based on the practice's storage capacity and preference.