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[SITUATION] · [QUIET] · [BUSINESS]
2 clusters · 2 sources · 27 days · First seen · Last updated
Fractyl Health Revita weight loss study progress
Overview
Fractyl Health has reported positive long-term data regarding its Revita endoscopic procedure, designed to help patients maintain weight loss after discontinuing GLP-1 therapy.
Initial one-year results from the REMAIN-1 study's Midpoint Cohort indicated that the Revita DMR System reduced weight regain by approximately 40% compared to a sham procedure. Specifically, patients with complete duodenal ablation of more than 14 cm maintained roughly 81% of their GLP-1-induced weight loss, whereas the sham group maintained only 48%. The company noted that 73% of Revita patients met the FDA-mandated performance goal of maintaining at least a 5% total body-weight loss.
As the company progresses with its REMAIN-1 pivotal trial involving over 300 participants, it aims to release topline six-month data from the larger pivotal cohort in early Q4 2026. Fractyl Health is also targeting a potential FDA De Novo marketing application later in that quarter.
Timeline
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about 1 month ago
[BUSINESS] 2 sourcesKornit Digital and Fractyl Health report quarterly updatesKornit Digital beat Q2 earnings estimates with $55.3 million in revenue, while Fractyl Health reported that its Revita procedure helps patients maintain weight loss after stopping GLP-1 therapy.
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about 2 months ago
[HEALTH] 3 sourcesFractyl Health reports 1‑year REMAIN‑1 data showing sustained weight loss after GLP‑1 therapyFractyl Health's REMAIN‑1 data showed the Revita system cut weight regain by 40%, with 73% of patients keeping ≥5% loss, exceeding FDA goals; no serious adverse events and shares rose 8%.
Sources
mommygearest.com · stocknews.com