Globenewswire·2025-09-26 11:00Core Insights - Fractyl Health, Inc. announced significant results from the REMAIN-1 Midpoint Cohort, indicating that the Revita procedure may be the first therapy to maintain weight loss after discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% total body weight compared to a 10% regain in sham-treated patients [2][3][10] Study Results - The REMAIN-1 Midpoint Cohort study involved 45 participants who had achieved at least 15% total body weight loss with tirzepatide, randomized to receive either Revita or a sham procedure [4][5] - At the 3-month mark, the study met its primary efficacy endpoint with a statistically significant p-value of 0.014, demonstrating the effectiveness of Revita in promoting further weight loss [8][10] - Safety and tolerability were excellent, with no serious adverse events related to Revita observed, and side effects were mild and transient [8] Future Outlook - The ongoing REMAIN-1 Midpoint Cohort is expected to provide 6-month data in Q1 2026, while the Pivotal Cohort aims to complete randomization in early 2026, with topline primary endpoint data and potential PMA filing anticipated in H2 2026 [11] - These milestones are crucial for establishing Revita as a potential first-in-class treatment for post-GLP-1 weight maintenance, opening a new therapeutic category in obesity care [11] Company Background - Fractyl Health focuses on innovative metabolic therapeutics targeting the root causes of obesity and type 2 diabetes, aiming to transform treatment from chronic management to durable disease-modifying therapies [13][15] - The company holds a robust intellectual property portfolio, including 33 granted U.S. patents and approximately 40 pending applications, positioning it well in the metabolic disease treatment landscape [13]