Orthopedic Biologics Supplier Serving Albuquerque, NM

NPI Verification Comes First

Before any order ships, Precision Biologics confirms the account against an NPI number, the same number buyers can look up on the public NPPES registry themselves. This standard applies to every orthopedic account regardless of region.

Shipping to the Southwest

Cryopreserved Wharton's jelly products such as Bio PRP Jelly ship overnight on dry ice in validated containers at -80C. Longer ground or air transit segments common to Southwest deliveries make scheduled, attended receiving important, so a shipment isn't held past its validated dry ice window. Lyophilized Bio DPM is shelf-stable and removes that constraint for practices that prefer it.

Documentation Orthopedic Groups Can Request Before Ordering

Recovery is performed by trained, licensed personnel, and processing is completed within 48 hours, described as following FDA regulation and AATB and AABB guidelines. Each lot carries a unique identifier and is held in quarantine until third-party sterility testing and internal release criteria are complete.

• Certificate of analysis
• Donor eligibility summary
• Lot release record
• Description of recovery, screening, and processing practices

Confirming Fit With Your Medical Director and Counsel

Whether a given product and intended use is appropriately classified, for example under 21 CFR 1271.10 for Wharton's jelly products, or under section 351 for exosome products, for which FDA has stated no product is currently FDA-approved, is a determination for the practice's medical director and legal counsel. Practices are encouraged to verify their internal policy with the New Mexico Medical Board and counsel before formalizing a new vendor relationship.

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.