FDA STEM CELL COMPLIANCE STATMENT

Last Updated: November 14, 2025

Website: https://InfiniteMedical.com

This FDA Stem Cell Compliance Statement (“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. The information below outlines how stem cell–related services, procedures, and discussions on this website comply with guidelines issued by the U.S. Food & Drug Administration (FDA).

This Statement applies to all regenerative information found on InfiniteMedical.com and to any verbal, written, or digital communication associated with our company.

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 & 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). These regulations define how stem cell and tissue products may be used, processed, stored, and delivered.

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. Products or procedures that do not meet Section 361 requirements may fall under Section 351 regulations, requiring FDA premarket approval, clinical trials, or Investigational New Drug (IND) applications.

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.

We do not state or imply FDA approval of any regenerative treatment that has not undergone FDA evaluation or clearance. 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. Patients should consult licensed clinicians about potential risks, benefits, alternatives, and investigational status before undergoing any regenerative procedure.

V. INVESTIGATIONAL NATURE OF CERTAIN THERAPIES

Many regenerative treatments offered or discussed in clinical settings across the United States may still be under investigation. These treatments may not have completed FDA-required clinical trials, and results may vary significantly among individuals.

Infinite Medical adheres to FDA restrictions on the advertisement and promotion of stem cell products that are not FDA-approved. We do 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 depending on medical history, lifestyle, severity of injury or disease, response to treatment, and other health variables. 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. The informed consent outlines the nature of the treatment, potential risks, benefits, limitations, investigational status, FDA regulatory position, and available alternatives. Patients are encouraged to ask questions and seek second opinions as needed.

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.

We do not advertise unapproved uses of stem cell products, nor do we suggest outcomes that violate FDA consumer protection policies.

IX. CLINICAL OVERSIGHT

All regenerative therapies discussed or provided by Infinite Medical are performed only under the supervision of licensed medical professionals. Treatments are administered as part of individualized care plans based on clinical assessment.

Infinite Medical ensures that any regenerative material used is sourced, processed, and handled in compliance with FDA regulations and applicable safety standards. We do not use unapproved or illegal biologic products.

X. NO SUBSTITUTE FOR MEDICAL ADVICE

This FDA Stem Cell Statement does not replace medical advice, diagnosis, or treatment from a licensed healthcare professional. Users should always consult a physician for personalized medical recommendations. Website content should not be relied upon to make decisions regarding your health.

XI. CHANGES TO THIS STATEMENT

Infinite Medical may update or modify this FDA Stem Cell Statement at any time to remain compliant with changing regulations. Updated versions will include a revised “Last Updated” date.

XII. CONTACT INFORMATION

For questions about this FDA Stem Cell Statement, contact:

Email: [email protected]

Phone: 435-772-5746

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

Media and licensing inquiries: [email protected]