Documentation We Provide With Every Lot
Each Wharton's jelly or exosome lot we ship carries a unique lot identifier. On request, verified accounts can review the certificate of analysis, donor eligibility summary, and sterility testing summary associated with that lot.
We do not provide clinical guidance, dosing recommendations, or protocols; documentation covers product sourcing and testing, not use. These records describe sourcing, screening, and testing; they do not describe or recommend a specific clinical application.
South Bend
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
21- Pain Medicine
- 8
- Physical Medicine & Rehabilitation
- 13
Account Setup and NPI Verification
Opening an account starts with NPI verification against the NPPES registry. Pain management and physical medicine practices in South Bend with multiple providers can register a group account or set up separate accounts per provider, depending on how the practice bills and tracks inventory.
Vendor Qualification for Pain Management Practices
Pain management and physical medicine groups generally vet a new biologics supplier by checking registration status, requesting sample lot documentation, and confirming the distributor can be reached for a physician-level conversation about that documentation rather than only a sales call.
Precision Biologics offers peer-to-peer calls focused on product documentation; these conversations do not cover clinical advice or treatment decisions.
Logistics for Midwest Shipments
Cryopreserved products ship overnight on dry ice and are stored at -80 degrees C until shipment; lyophilized exosome and Wharton's jelly formats ship and store at room temperature per the included product insert. South Bend practices should plan receiving around whichever format they order, since the two formats have different storage requirements on arrival. Practices that already receive other cold-chain biologics can generally fold Wharton's jelly receiving into an existing workflow with minimal changes.
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 South Bend pain management group speak with someone about product documentation before ordering?+
Yes. Verified accounts can request a peer-to-peer call focused on documentation; we do not provide clinical or dosing advice.
Are exosome products like Bio AER regulated the same way as Wharton's jelly products?+
No. Exosome products are generally regulated as biologic drugs, while Wharton's jelly products are offered under the supplier's HCT/P framework. Ask your account manager for the documentation specific to each product line.
Does a South Bend practice need to involve its own counsel before ordering?+
We recommend it. Whether a specific intended use fits the applicable regulatory framework is a determination for the practice and its counsel, not for Precision Biologics.