Fractyl Health, Inc.

Fractyl Health Strengthens Revita Patent Portfolio as It Advances Toward FDA Submission and Potential Commercialization

Fractyl Health announced new U.S. patent additions strengthening the intellectual property foundation for Revita as it prepares an FDA De Novo marketing submission for post-GLP-1 weight maintenance. The USPTO issued a catheter patent (U.S. Patent No. 12,740,821) with a term extending to November 28, 2042, and allowed an application covering Revita's thermal dosing method. These complement an existing console patent and treatment-method claims not limited to any specific energy modality. The company's IP portfolio now includes 39 granted U.S. patents, approximately 40 pending U.S. applications, and more than 50 issued international patents. The developments build on positive six-month REMAIN-1 pivotal results and patient research supporting a one-time procedural approach.

•2d ago

Fractyl Health Announces Market Research Highlighting Substantial Patient Interest in a One-Time Procedural Approach to Post-GLP-1 Weight Maintenance

Fractyl Health released company-sponsored market research showing strong patient interest in a one-time endoscopic procedure for post-GLP-1 weight maintenance, the use case targeted by its lead candidate Revita. Among nearly 300 surveyed GLP-1 users, 33% preferred stopping medication for a hypothetical procedure; among those who had already discontinued, 84% valued a one-time procedure most. The company estimates about one million U.S. patients discontinue GLP-1s monthly, with 65% of weight-loss users stopping within a year. The release reiterates REMAIN-1 six-month results in which Revita-treated participants retained roughly 80% of GLP-1-induced weight loss (p=0.0023 vs sham), with 12-month topline data expected in Q1 2027. The findings are promotional commercial-planning support rather than new clinical or regulatory news; Revita remains investigational in the U.S., with a Category III CPT code (1122T) effective January 1, 2027.

•3d ago

Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation

Fractyl Health's REMAIN-1 pivotal study met its six-month co-primary endpoint, with a single Revita procedure retaining 80% of GLP-1-induced weight loss versus 67% for sham (p=0.0023) in the 308-participant mITT population. Post hoc analyses showed a dose-dependent effect: patients receiving a complete duodenal ablation of 20 cm or more regained 3.8% total body weight versus 8.2% for sham, a 53% reduction in weight regain. Interim safety data show no device- or procedure-related serious adverse events. Fractyl plans a De Novo marketing application to the FDA in late Q4 2026, with 12-month topline data (including the second co-primary endpoint) expected in Q1 2027, a Category III CPT code effective January 1, 2027, and a potential U.S. launch in early 2028.

•16d ago