Fractyl Health, Inc. announced positive 6-month results from its open-label REVEAL-1 Cohort. The REVEAL-1 cohort is an open-label study in individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. Reproducible procedure performance: Average ablation length was approximately 16 cm (n=22), consistent with Revita European real-world experience and the ongoing REMAIN-1 Pivotal study, supporting the potential translatability of results and scalability of technique.
Revita has obtained FDA Breakthrough Device designation for post-GLP-1 weight maintenance, underscoring the urgency of the medical problem. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs.
