Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients Revita procedure demonstrated excellent safety and tolerability to date, consistent with prior clinical studies Results validate pivotal study design and reinforce Revita’s potential to be the first therapy for post-GLP-1 weight maintenance Company to host investor call and webcast to ...

Core 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]

Core Insights - The collaboration between Fractyl Health and Bariendo aims to develop a scalable clinical pathway for the Revita procedure, which is intended for weight maintenance after discontinuation of GLP-1 drugs, pending FDA approval [1][5][6] - There is a growing demand for endoscopic alternatives to GLP-1 drugs, as many patients experience rapid weight regain after stopping these medications [5][6] - Revita is positioned as a potential first disease-modifying therapy targeting the root causes of obesity by resurfacing the duodenal lining [3][8] Company Overview - Fractyl Health focuses on innovative metabolic therapeutics that address the root causes of obesity and type 2 diabetes, aiming to transform treatment from chronic management to durable therapies [7] - Bariendo is a direct-to-consumer platform that offers advanced endoscopic weight loss procedures and aims to provide long-term solutions to obesity without ongoing medication [9] Clinical Development - Fractyl is preparing for three key data readouts from its pivotal study of Revita: open-label data from REVEAL-1 expected in June 2025, midpoint data from REMAIN-1 in Q3 2025, and primary endpoint data from REMAIN-1 in the second half of 2026 [2] - The collaboration will focus on pre-commercial preparation, including clinical workflow design, provider education, and health economic analysis [5] Market Context - The increasing use of GLP-1 drugs has highlighted the need for effective solutions to maintain weight loss after discontinuation, creating an urgent market opportunity for Revita [5][6] - Bariendo's holistic approach to obesity care aligns with the goals of Revita, emphasizing the importance of integrating metabolic endoscopic solutions into clinical practice [4][6]