Manufactured in compliance with 351(a) and GMP requirements

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We represent a line of exosomes which have been manufactured in accordance with current regulatory guidelines under 351(a). These more stringent regulations require more research and clinical trials. 

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All testing for these products is performed on a batch by batch basis by third party laboratories and the manufacturing processes for the product has been reviewed by appropriate regulatory agencies.  As a result our products are able to be purchased for any independent research or investigational purposes.  Additionally, we are working with our manufacturer to seek a drug approval via an Investigational New Drug Application so that our products may be used and billed for specific clinical indications.

 

There are currently no clinically approved exosome products in the US.

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