Regulatory review before ordering
Pain management practices evaluating Wharton's jelly or exosome products typically separate the two categories: Wharton's jelly allografts are offered under the supplier's human cell and tissue product framework, while exosome products are generally regulated as biologic drugs, with no FDA-approved exosome product on the market today. Practices confirm which category applies to a given product before deciding how it fits their own compliance process.
Florida practices should also know that Senate Bill 1768 (effective 2025-07-01) permits Florida-licensed physicians to use certain non-FDA-approved stem cell therapies in pain management, among other specialties, under informed consent and disclosure rules. The statute governs physician conduct under state law and does not alter any product's federal status; a practice's counsel should confirm how it applies.
Melbourne
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
66- Pain Medicine
- 28
- Physical Medicine & Rehabilitation
- 38
Account verification
An NPI confirmed against the NPPES registry is required before any account can order. This applies uniformly, whether the account belongs to a solo pain physician or a multi-site physical medicine group.
Each lot carries a unique identifier, which lets a practice maintain patient-level traceability for any product it receives, separate from Precision Biologics' own internal lot records.
Shipping into the Southeast
Cryopreserved Wharton's jelly products travel overnight on dry ice in validated shipping containers and need to move into -80 degree Celsius storage promptly on arrival. Lyophilized exosome formats, including Bio EX and Bio AER, are shelf-stable and do not require that same cold chain handling, which some practices prefer for simpler inventory management.
Setting up and staying compliant
We recommend confirming your practice's standing with the Florida medical board and reviewing SB 1768's disclosure requirements with your own counsel as part of any internal policy on these product categories, separate from anything Precision Biologics provides. Account setup starts with NPI and license verification, after which we share documentation for the product lines under consideration and can arrange a peer-to-peer call on paperwork, not treatment decisions.
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
Are exosome products like Bio Xsomes approved for pain management use in Florida?+
No exosome product is FDA approved anywhere, including Florida. We supply characterization and ingredient documentation to verified accounts; how a product fits a specific use is a determination for the physician and counsel.
Does SB 1768 let a Melbourne pain practice use any product without further review?+
No. SB 1768 sets informed consent and disclosure requirements for Florida-licensed physicians using certain non-FDA-approved stem cell therapies; it doesn't remove the need to review a specific product's federal regulatory status with counsel.
What's required to open an account as a pain management group in Melbourne?+
Submit your practice's NPI and license information. Once verified, we share lot documentation and ingredient disclosures for the products you're evaluating.