BioRegenEx is a U.S.-based supplier of pharmaceutical-grade mesenchymal stem cell (MSC) derived exosomes for physician-led regenerative medicine research.

Our quality systems are structured consistent with the requirements of Section 351(a) of the Public Health Service Act — the regulatory framework that governs FDA biologic licensure. Every lot ships with a complete Certificate of Analysis documenting particle quantification by Nanoparticle Tracking Analysis, surface marker confirmation (CD9, CD63, CD81), endotoxin per USP <85>, sterility per USP <71>, mycoplasma testing, and donor eligibility documentation per 21 CFR Part 1271 Subpart C.

We serve physicians evaluating exosome products for IRB-approved research applications.

Important regulatory information: These statements have not been evaluated by the U.S. Food and Drug Administration. BioRegenEx products are not intended to diagnose, treat, cure, or prevent any disease. References to Section 351(a) of the Public Health Service Act describe the company's stated quality and compliance approach and should not be interpreted as FDA approval or endorsement of any product.

BioRegenEx

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BioRegenEx

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