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Human Tissue Therapy Program

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The treatments described on this marketing are not considered to be standard of care for any condition or disease. Human Tissue Therapy products attempt to utilize acellular, minimally manipulated tissue allografts and are comprised of tissue allograft components intended for homologous use to supplement tissue. Tissue allografts are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. FDA recognizes that human tissue was designed, or evolved, to perform certain functions in the human body with exquisite safety and effectiveness. As an HCT/P regulated solely under the Section 361 of the PHS Act, tissue allografts are exempt from FDA pre-market review, clearance, and approval from FDA. Please consult your doctor to see if a tissue allograft is right for you. No medical advice has been offered herein. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. Results may vary.This human tissue should not be used for the treatment of COVID-19.

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