Medical & Legal Disclaimer

Medical & Legal Disclaimer

Stem Nova Network biologics are cosmetic-grade biologics designed for topical, post-procedural support. They are derived from 3D-cultured, umbilical cord tissue mesenchymal stem cells (UCT-MSCs) via a certified Type II Drug Master File (DMF) process.

These products are not FDA-approved as drugs or therapeutic agents for disease treatment. Any systemic or injectable use must comply with federal regulations under 21 CFR Part 1271 and be limited to homologous application or investigational research.

Effective July 1, 2025, Florida Statute § 456.47 requires full informed consent and clinical justification for use of cell- and exosome-based products in any therapeutic context. Practitioners are responsible for ensuring proper documentation, patient education, and compliance with state and federal law.

Stem Nova Network encourages the use of these biologics within IRB-approved studies, Right to Try frameworks, or strictly topical protocols to maintain legal and ethical integrity.