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Regulatory notice
Exosome material. No exosome product is approved, cleared or licensed by the FDA for any use in humans, and statements on this site have not been evaluated by the FDA. Kimera exosome material is supplied to NPI-verified licensed practitioners for topical aesthetic use on the skin surface, including after procedures, as labeled by the manufacturer, and for laboratory research and clinical research conducted under an FDA investigational new drug application. It is not supplied for injection, infusion, inhalation, intranasal, ophthalmic or any other route into the body, and it is not intended to diagnose, treat, cure, mitigate or prevent any disease. Whether, how and in what setting it is used, and whether that use complies with scope of practice and state law, is the licensed practitioner’s responsibility. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions. Research summaries describe published studies and are not claims about any product.
Compounded preparations. Compounded preparations are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed. Each preparation is compounded and dispensed by our 503A pharmacy partner, licensed by its state Board of Pharmacy, on a patient-specific prescription from a licensed prescriber; ExaVeyra Sciences does not compound, dispense or prescribe. ExaVeyra makes no claim that any preparation is safe or effective for any condition. Availability depends on the pharmacy’s license in the destination state and on whether the substance may be compounded under federal and state law. Prescribing, patient selection and scope of practice are the responsibility of the licensed prescriber. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.
Medical devices. Medical devices are sold to licensed practices for the intended use stated in each manufacturer’s labeling, with its instructions for use. The CuraCator is an FDA-listed Class I device (21 CFR 880.6430); listing is neither approval nor clearance, and it does not extend to any product applied with the device. Which product is applied, and how, is the licensed practitioner’s decision. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.