Fractyl Health surged 11.86% intraday after reporting positive 6-month REVEAL-1 clinical results for its Revita procedure. The open-label study showed participants maintained stable weight (1.5% mean change) and glycemic control six months post-treatment, outperforming third-party studies showing ~10% weight regain after GLP-1 discontinuation. The procedure demonstrated excellent tolerability, with no serious adverse events, and aligns with the company’s FDA Breakthrough Device designation for post-GLP-1 weight maintenance. Upcoming 2026 data from the REMAIN-1 trial and potential Premarket Approval (PMA) filing further bolster investor optimism. The results position Revita as a scalable, non-drug alternative for obesity management, addressing a critical unmet need in metabolic disease treatment.
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