Core Insights - Fractyl Health, Inc. announces strong enrollment progress in the REMAIN-1 pivotal study, indicating high demand for alternatives to GLP-1 therapy for weight maintenance [1][4][5] - Initial results from the REVEAL-1 study show promising weight maintenance outcomes after GLP-1 drug discontinuation and Revita procedure, with a patient maintaining a 15% total body weight loss one month post-procedure [3][2] - The company emphasizes the urgent need for innovative solutions in obesity management, highlighting the potential of Revita to redefine treatment approaches [2][8] Enrollment and Study Progress - Over 100 patients have been enrolled in the REMAIN-1 study across the first 8 clinical sites within less than 4 months, reflecting significant engagement from patients and physicians [4][5] - A mid-point analysis of the REMAIN-1 study is on track and expected in Q2 2025, which will provide further insights into the effectiveness of the Revita procedure [5][4] Clinical Results - Preliminary data from the REVEAL-1 cohort indicate that the first patient achieved a 15% total body weight loss with tirzepatide over 7 months, and maintained this weight loss after undergoing the Revita procedure [3][2] - Previous studies indicated an average 3% weight regain within four weeks of GLP-1 discontinuation, suggesting that the Revita procedure may offer a more effective long-term weight maintenance solution [3][2] Company Overview - Fractyl Health focuses on pioneering new approaches to treat metabolic diseases, including obesity and type 2 diabetes, aiming to transform treatment from chronic management to durable disease-modifying therapies [6][8] - The company's lead product, Revita, is designed to remodel the duodenal lining to reverse damage caused by unhealthy diets, and has received CE mark in Europe and FDA Breakthrough Device designation in the U.S. for specific indications [8][6]
Fractyl Health Announces Positive Initial Clinical Results Demonstrating Weight Maintenance Following GLP-1 Discontinuation and Revita Procedure in First Patient of the REVEAL-1 Cohort