Fractyl’s Revita maintains most GLP-1 weight loss in six-month trial
Fractyl Health reported that its Revita DMR System met the six-month co-primary endpoint in the 308-participant REMAIN-1 study. In the modified intention-to-treat population, patients retained approximately 80% of GLP-1-induced weight loss after Revita, versus 67% with a sham procedure; mean weight regain was 5.1% and 8.2%, respectively. Fractyl said it intends to file a De Novo application with the FDA in late Q4 2026, report 12-month data in Q1 2027, and pursue a potential U.S. launch in early 2028.
Why it matters
The result provides Fractyl with clinical support for Revita as a potential post-GLP-1 weight-maintenance treatment, but commercialization remains subject to FDA authorization. A dedicated CPT code takes effect January 1, 2027, before the company’s potential launch window.
Key facts
- 1REMAIN-1 is a randomized, double-blind, sham-controlled study involving 308 participants with obesity. stocktitan.net
- 2At six months, Revita patients retained approximately 80% of their GLP-1-induced weight loss versus 67% for sham, with mean weight regain of 5.1% versus 8.2% in the modified intention-to-treat population. stocktitan.net
- 3The six-month endpoint result had p=0.0023. stocktitan.net
- 4As of the September 24, 2026, data cutoff, no device- or procedure-related serious adverse events had been observed. stocktitan.net
- 5Fractyl expects to submit the De Novo application in late Q4 2026 and plans to report one-year data in Q1 2027. stocktitan.net
- 6Dedicated CPT code 1122T for the Revita procedure becomes effective January 1, 2027, ahead of a potential U.S. launch in early 2028. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.