Evaluating a tissue and exosome supplier
Pain management and physical medicine practices often have a smaller administrative staff than a surgical group, so vendor review tends to fall to the physician owner or medical director directly rather than a dedicated compliance team. Most ask a supplier for the same baseline items: a certificate of analysis tied to the specific lot being ordered, a summary of donor screening steps, and confirmation that the ordering account's NPI has been checked against the NPPES registry.
- Certificate of analysis per lot
- Donor eligibility summary
- Lot release record
- Serology and processing description
Manchester
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
16- Pain Medicine
- 11
- Physical Medicine & Rehabilitation
- 5
Receiving cold-chain shipments
Cryopreserved Wharton's jelly formats arrive overnight on dry ice in a validated container and need to move into -80 degree Celsius storage promptly after arrival. A single-physician practice without a dedicated receiving area should plan for someone to be on-site when a shipment is scheduled to land. Lyophilized formats, by contrast, are shelf-stable and do not carry that same handling window.
Regulatory review stays with the practice
Precision Biologics does not provide clinical guidance, dosing recommendations, or protocols - those decisions sit entirely with the treating physician and the practice's own regulatory counsel. For exosome products specifically, FDA has stated there are no FDA-approved exosome products and that they are generally regulated as biologic drugs; purchasing decisions should be made with that posture in mind. New Hampshire practices can route licensure and scope questions to the New Hampshire Board of Medicine alongside their own counsel.
Account setup and ongoing support
Opening an account starts with NPI verification. From there, physicians can request a peer-level call with our team to go through lot documentation and traceability - these conversations are about paperwork and process, not clinical use. Pricing is shared only with verified accounts.
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 solo pain management practice in Manchester open an account, or is this only for larger groups?+
Any licensed physician or clinic with a verifiable NPI can open an account, regardless of practice size.
Are your exosome products FDA approved?+
No. FDA has stated there are no FDA-approved exosome products. They are generally regulated as biologic drugs, and purchase and use decisions belong to the physician and their own regulatory counsel.
How quickly does a cryopreserved order need to go into storage after it arrives?+
Cryopreserved formats ship on dry ice in validated containers and should move into -80 degree Celsius storage promptly on arrival. Lyophilized formats do not require that step.