Orthopedic Biologics Distributor Serving Portland, Maine

Logistics for Northeast shipments

Cryopreserved Wharton's jelly products ship overnight on dry ice in validated shipping containers and arrive ready for -80 degree C storage. For practices in the Northeast, that means planning freezer capacity and staff availability around overnight delivery windows rather than same-day pickup.

Lyophilized formats, including the lyophilized Wharton's jelly and exosome products, are shelf-stable and don't require cryogenic storage, which gives surgery centers a lower-maintenance option for products used less frequently.

Documentation review before your first order

Surgery centers typically request the certificate of analysis for the specific lot, the donor eligibility summary, and the sterility testing result from the third-party lab before approving a new biologics vendor. Precision Biologics provides these on request to any verified account.

• Lot-specific certificate of analysis
• Donor eligibility summary
• Sterility testing result
• Supplier characterization data for exosome products

Setting up an NPI-verified account

Account setup requires the ordering physician's NPI number and basic practice details. Once verified, pricing and ordering access open; pricing itself is not published and is shared directly with verified accounts.

Surgery centers with more than one ordering physician can register multiple providers under the same account.

Confirm your regulatory posture before you order

Whether a specific use of a Wharton's jelly allograft meets the minimal manipulation and homologous use standard in 21 CFR 1271.10 is a determination for your practice and its counsel. Exosome products carry a separate regulatory posture: FDA has stated there are no FDA-approved exosome products, and they are generally regulated as biologic drugs.

We recommend confirming your facility's licensure standing with the Maine medical board before introducing a new biologic category, and we're glad to schedule a peer-to-peer call to walk your medical director through product documentation.

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.