Core Insights - Fractyl Health, Inc. announced positive six-month results from the REMAIN-1 Midpoint Cohort study, indicating that Revita® effectively supports weight maintenance after GLP-1 drug discontinuation [2][3] - Revita-treated patients showed a significant reduction in weight regain compared to the sham group, with a 70% relative reduction in post-GLP-1 weight regain for those with above median GLP-1-associated weight loss [1][8] - The company is preparing for a potential FDA filing in H2 2026 and has requested feedback on reclassifying Revita under the De Novo pathway [1][10] Study Results - The REMAIN-1 Midpoint Cohort demonstrated a 4.5% weight regain in Revita-treated patients versus 7.5% in the sham group at six months, with a p-value of 0.07 [4][8] - An exploratory analysis revealed that Revita-treated participants experienced 4.2% weight regain compared to 13.3% in the sham group, with a statistically significant p-value of 0.004 [8] - Improvements in cardiometabolic parameters were noted, including a 15.5 mg/dL increase in HDL cholesterol and a reduction in the triglyceride-to-HDL ratio [8] Safety and Tolerability - Revita demonstrated excellent safety and tolerability, with no serious adverse events related to the device or procedure reported through six months [15] - No new adverse events were observed between the 3- and 6-month follow-up periods [15] Regulatory Strategy - The company is engaging with the FDA regarding the potential for using the De Novo pathway, which may streamline the regulatory review process for Revita [10] - Feedback from the FDA is anticipated in Q2 2026, which will inform the regulatory strategy moving forward [10] Future Milestones - Fractyl Health is on track for several key clinical and regulatory milestones in 2026, including the completion of randomizations in the REMAIN-1 Pivotal Cohort and the release of one-year data from the REVEAL-1 Cohort [16] - The company plans to host an investor call and webcast to discuss these developments [11]

Core 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]