Fractyl Health(US:GUTS) Globenewswire·2025-06-23 11:40Core Insights - Fractyl Health, Inc. announced positive 3-month data from the REVEAL-1 Cohort of its REMAIN-1 pivotal study, indicating that Revita may help individuals maintain or lose weight after discontinuing GLP-1 drugs, suggesting a potential for durable, drug-free weight maintenance [2][3][5] Group 1: Study Findings - In the REVEAL-1 Cohort, 12 of 13 participants either maintained or lost weight at 3 months, with 6 participants losing additional weight after stopping GLP-1 therapy and undergoing the Revita procedure [1][7] - The median weight change was stable at 0.46% (~1 pound), significantly lower than the expected 5-6% weight regain (10-15 pounds) after stopping GLP-1 therapy [1][7] - The Revita procedure demonstrated excellent tolerability, with treatment-emergent adverse effects being infrequent, mild, and transient [1][7][9] Group 2: Participant Profile - The REVEAL-1 Cohort included 22 participants, with 3-month follow-up data available for 13 individuals, averaging 49 years of age, and a gender distribution of 11 women and 2 men [4] - Participants had previously been treated with GLP-1 therapy for 5 months to 3 years, achieving a median total body weight loss of 20.9% while on therapy [4] Group 3: Future Expectations - Randomized Midpoint Cohort data is expected in Q3 2025, with pivotal cohort data anticipated in H2 2026, aimed at demonstrating Revita's potential for weight maintenance after GLP-1 discontinuation [2][9] - The company emphasizes the significant unmet need in obesity treatment, particularly the ability for patients to stop GLP-1 drugs without regaining weight [5][10] Group 4: Revita's Mechanism - Revita is designed to remodel the duodenal lining via hydrothermal ablation to reverse damage caused by chronic high-fat and high-sugar diets, addressing root causes of metabolic disease [11] - The product has received U.S. FDA Breakthrough Device designation for weight maintenance in individuals who discontinue GLP-1 based drugs [11]