Regulatory Disclosure & Compliance

FDA Stem Cell Compliance Statement

Last Updated: November 14, 2025

This FDA Stem Cell Compliance Statement explains Infinite Medical's regulatory position, advertising limitations, and compliance responsibilities regarding regenerative medicine and cellular-based therapies. Infinite Medical is committed to transparency, regulatory adherence, and patient safety.

I. General FDA Notice

Many regenerative medicine treatments, including stem cell therapies, biologic products, exosomes, tissue-derived products, and growth-factor procedures, may be considered investigational. These therapies may not be evaluated or approved by the U.S. Food and Drug Administration for the specific conditions for which they are sometimes used in clinical practice.

Any reference to regenerative therapy on this website is intended strictly for educational and informational purposes and should not be interpreted as claims of safety, effectiveness, cure, or correction for any illness, disease, disability, or medical condition unless explicitly stated as FDA-approved.

II. Compliance With FDA Regulations (21 CFR Part 1271)

Infinite Medical complies with all applicable regulations under 21 CFR Part 1271, governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

HCT/Ps regulated solely under Section 361 of the Public Health Service Act are limited to products meeting FDA criteria such as minimal manipulation, homologous use, and compliance with communicable disease screening. Infinite Medical does not advertise or provide any HCT/P that requires FDA approval without proper regulatory authorization.

III. No Claims of Cure, Prevention, or FDA Approval

Infinite Medical does not claim that stem cell therapy, exosome therapy, regenerative injections, or any related biologic procedure cures, treats, or prevents any disease unless the therapy is recognized by the FDA for that specific indication.

Any therapeutic benefits described on this website are based on clinical experience, patient feedback, or emerging research and are not presented as guaranteed outcomes.

IV. Educational Use Only

All content related to stem cells, PRP, exosomes, regenerative techniques, or tissue-based therapies is provided solely for general education. These materials are not intended to substitute professional medical advice.

V. Investigational Nature of Certain Therapies

Many regenerative treatments offered or discussed in clinical settings across the United States may still be under investigation. Infinite Medical does not market investigational therapies as cures or standard medical treatments. Patients are informed of the investigational status before any procedure is performed.

VI. Individual Results May Vary

Regenerative therapies can produce different outcomes for each patient. Infinite Medical makes no guarantee of results and does not claim universal success or permanent relief.

VII. Informed Consent Requirement

Before participating in any regenerative procedure, patients must complete a comprehensive informed consent process outlining the nature of the treatment, potential risks, benefits, limitations, investigational status, FDA regulatory position, and available alternatives.

VIII. Advertising Compliance

Infinite Medical adheres to strict advertising guidelines that prohibit misleading statements, exaggerated claims, or unverified promises of treatment success. Any testimonials or patient experiences shared on this website represent individual opinions and should not be interpreted as typical results.

IX. Clinical Oversight

All regenerative therapies discussed or provided by Infinite Medical are performed only under the supervision of licensed medical professionals. Infinite Medical ensures that any regenerative material used is sourced, processed, and handled in compliance with FDA regulations and applicable safety standards.

X. No Substitute for Medical Advice

This Statement does not replace medical advice, diagnosis, or treatment from a licensed healthcare professional.

XI. Changes to This Statement

Infinite Medical may update or modify this Statement at any time. Updated versions will include a revised “Last Updated” date.

XII. Contact Information

Email: info@infinitemedical.com

Phone: 435-772-5746

Address:

491 North Bluff Street, Suite 106, St. George, Utah 84770

Media and licensing inquiries: licensing@infinitemedical.com