Biologics Supplier for Medspas and Dermatology Practices in San Jose

Physician Supervision and Medical Director Verification

Medspas operating under physician supervision should confirm that any biologics supplier will only open an account tied to a licensed physician's NPI number, since this is the basis Precision Biologics uses to verify eligibility. Aesthetic practices should also independently confirm their medical director's current standing with the Medical Board of California.

We do not advise medspas on which product or format fits a particular offering; that determination, including any regulatory classification question, belongs to the supervising physician and legal counsel.

Comparing Wharton's Jelly and Exosome Product Documentation

Aesthetic practices evaluating our catalog typically compare two product families with different documentation profiles. Wharton's jelly products (Bio PRP Jelly, Bio Flex, Bio Flow, Bio DPM) are offered under the supplier's HCT/P framework, with processing described as following FDA regulations and AATB and AABB guidelines.

Exosome products (Bio Xsomes, Bio EX, Bio AER) are not FDA approved; FDA has stated there are no FDA-approved exosome products, and these are generally regulated as biologic drugs. Full ingredient disclosure and characterization data are available to verified accounts for both families.

Cold Chain and Shelf-Stable Receiving

Cryopreserved Wharton's jelly formats ship overnight on dry ice and require -80 degree C storage on arrival, which medspas should plan for if staff do not regularly receive cold chain shipments. Lyophilized exosome products are shelf-stable under normal storage and do not require cryogenic equipment.

Account Setup for Aesthetic Practices

Opening a verified account requires an NPI number and is limited to licensed professionals and clinics operating under physician supervision. Once verified, a practice can request a certificate of analysis, donor eligibility summary, and lot release record for any product under consideration, along with scheduling a physician-level documentation call.

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.