Fractyl Health(US:GUTS) Globenewswire·2026-02-26 12:00Core Insights - Fractyl Health, Inc. has completed participant randomization in its REMAIN-1 Pivotal Cohort study, which evaluates the effectiveness of Revita for weight maintenance after discontinuation of GLP-1 therapy [1][2][3] - The topline 6-month results from this study are expected to be reported in early Q4 2026, with a potential FDA marketing application submission anticipated in late Q4 2026 [1][7] - The company has reiterated its cash runway guidance, indicating sufficient funds to support operations through early 2027, beyond the pivotal data readout [1][5] Study Design and Objectives - The REMAIN-1 Pivotal Cohort is a randomized, double-blind, sham-controlled study involving adults with obesity (BMI ≥30 kg/m and ≤45 kg/m) who have lost at least 15% of their total body weight on tirzepatide [3] - Participants are randomized in a 2:1 ratio to receive either Revita or a sham procedure, with co-primary endpoints focusing on weight regain at 6 months and the proportion of participants maintaining a ≥5% weight loss at 12 months [3] Clinical and Regulatory Milestones - Fractyl Health is on track for several key clinical and regulatory milestones in 2026, including FDA feedback on the De Novo pathway for Revita expected in Q2 2026 [5][7] - The company plans to report 1-year data from the REVEAL-1 Cohort and the REMAIN-1 Midpoint Cohort randomized data in Q2 and Q3 2026, respectively [7] Product Information - Revita is designed to remodel the duodenal lining through a minimally invasive endoscopic procedure, aiming to restore nutrient sensing and signaling disrupted by chronic metabolic diseases [8] - The product has received FDA Breakthrough Device designation for weight maintenance in individuals who discontinue GLP-1 therapies and is currently for investigational use only in the U.S. [8]