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Polarean’s technology is for research use only

Regulatory Filling Support

Polarean products can be used in human subjects for investigational use only. If you are a new site preparing your regulatory documents (Institutional Review Board protocols or the equivalent in your region) in order to conduct imaging research on human subjects using hyperpolarized gases, Polarean can support your regulatory filing process. Polarean has active IND’s (in USA) and DMF’s (in Canada) for both HP 129Xe and HP 3He as inhalant contrast agents in humans which can be cross-referenced by your own institution IND/DMF filing to streamline and expedite the regulatory filing process. Please contact us to learn more about the regulatory access process and to discuss the options in regions other than North America.