Aesthetic practice biologics supplier in Hartford, CT

Accounts under physician supervision

Products are sold only to licensed clinics, physician-supervised medspas, and physicians. For a medspa, that typically means the account is registered under the NPI of the supervising physician rather than the business entity itself, consistent with how dermatology and plastic surgery practices register as well.

Records to request before ordering

A practice evaluating a biologics vendor can request the certificate of analysis for a given lot, a donor eligibility summary, and confirmation of the quarantine and sterility testing process the lot went through before release. For exosome products, supplier-reported characterization data, including particle concentration and marker identification, is available to verified accounts.

Receiving shipments at a smaller practice

Cryopreserved formats ship overnight on dry ice in validated containers and require storage at -80 degrees C on arrival. Lyophilized formats, including both lyophilized exosome products, are shelf-stable under normal storage conditions, which can simplify logistics for a practice without dedicated cold-chain equipment.

Regulatory verification

Precision Biologics does not advise on clinical use, dosing, or procedures. Exosome products are not FDA approved, and the regulatory classification of a Wharton's jelly product for a specific intended use is a determination for the treating physician and counsel, confirmed as needed with the Connecticut medical board.

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.