Fractyl Health’s Revita System Wins FDA Breakthrough Designation

Fractyl Health, Inc. (GUTS) has provided an update.

Fractyl Health, Inc. has announced a major milestone as their Revita System received the FDA’s Breakthrough Device Designation for its role in sustaining weight loss post GLP-1 drug treatment. Additionally, the company is in the midst of their REMAIN-1 pivotal study, with results expected to start rolling out in the last quarter of 2024. This development represents a significant step for Fractyl Health, potentially impacting the stock as investors watch for the study’s outcomes.

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