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Fractyl Health and Bariendo Sign Letter of Intent to Prepare for Potential Offering of Revita® Across its Bariatric and Metabolic Endoscopy Centers Nationwide
Globenewswire· 2025-06-04 11:00
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]