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Regentys has completed multiple preclinical studies with ECMH showing restoration of cell barrier function, promotion of rapid tissue regeneration, reduction in clinical symptoms, and reversal of inflammation and ulceration in GI models. The company planned to start a pilot study for ulcerative colitis, with future studies and applications possible in Crohn’s disease and rectal mucositis. The product is to be regulated as a device (FDA 510K de novo pathway)[1][3].
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