Fractyl Health, Inc. announced positive six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating the Revita® procedure for weight maintenance following GLP-1 drug discontinuation. These results were presented on January 29, 2026. The company is progressing with its U.S. regulatory strategy for Revita, seeking potential reclassification under the FDA’s De Novo pathway. Upcoming milestones include the completion of randomizations in the REMAIN-1 Pivotal Cohort in February 2026, FDA feedback on the De Novo pathway and 1-year REVEAL-1 Cohort data in the second quarter of 2026, and additional 1-year and 6-month randomized cohort data later in 2026. A potential FDA marketing application submission for post-GLP-1 weight maintenance is anticipated in the second half of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9645057-en) on January 29, 2026, and is solely responsible for the information contained therein.