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Fractyl Health, Inc. shares important news about its weight loss study results.

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Fractyl Health said Revita users regained less weight than sham users at 6 months, meeting the study's main goal. No serious device-related events or deaths were reported, but the study continues and FDA acceptance of a future application is not assured.

GUTS · Fractyl Health, Inc.

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These results give Fractyl stronger evidence that one Revita treatment may help people keep weight off after stopping GLP-1 drugs. Revita participants regained less weight than sham participants, and the study met its main goal. No serious device- or procedure-related events or deaths were reported by the data cutoff. Still, the study is ongoing, and the filing says early FDA feedback is nonbinding and acceptance of a future application is not assured.

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