Orthopedic Biologics Distribution Serving New Haven, CT Practices

Supplier qualification for orthopedic groups

Orthopedic practices and ambulatory surgery centers in the Northeast typically run a two-step supplier review: a clinical reviewer examines processing description and donor eligibility documentation, and an administrative reviewer confirms ordering terms and account requirements.

Precision Biologics makes the certificate of analysis, donor eligibility summary, and lot release record available to verified accounts so both reviews can proceed from the same documentation set.

NPI verification and account setup

An NPI number is required to open an account, and no order is processed until that verification is complete.

Pricing is never published; it is shared directly with a verified account once an order inquiry begins.

Receiving shipments in the Northeast

Cryopreserved Wharton's jelly and exosome products are frozen by a slow-rate process, stored at -80 degrees Celsius, and shipped overnight on dry ice in validated containers to clinics throughout the Northeast.

Lot-level traceability begins at this receiving step and continues once the practice logs product use against its own patient records.

• Confirm dry ice and container condition at receiving
• Record the lot number from the shipment label
• Move cryopreserved product to -80 C storage without delay
• File the lot record against the order for traceability

Documentation review and medical director verification

Because practices in New Haven operate under Connecticut licensure and their own clinical judgment, we recommend verifying any planned use of these products with the practice's medical director, its own counsel, and the Connecticut medical board rather than relying on supplier materials alone.

Account setup support from Precision Biologics covers NPI verification, documentation requests, and access to physician-level calls about product paperwork; these calls are not a substitute for clinical or legal advice.

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.