Fractyl reports 80% weight-loss retention with Revita

• Fractyl Health reported that Revita met the six-month co-primary endpoint in its 308-patient REMAIN-1 study, with participants retaining approximately 80% of prior GLP-1-induced weight loss.
• Adjusted average weight regain was 5.1% with Revita versus 8.2% with a sham procedure (p=0.0023), while no device- or procedure-related serious adverse events were reported through September 24, 2026.
• Fractyl plans to submit an FDA De Novo marketing application in late Q4 2026, with one-year trial results expected in Q1 2027 and a potential U.S. launch in early 2028.

Fractyl Health (NASDAQ:GUTS) reported that its Revita procedure met a six-month co-primary endpoint in the 308-patient REMAIN-1 study, showing improved weight maintenance after GLP-1 treatment discontinuation.

Revita participants retained approximately 80% of their previous GLP-1-induced weight loss, compared with 67% in the sham group, with adjusted mean weight regain of 5.1% versus 8.2% (p=0.0023).

The findings build on earlier REMAIN-1 midpoint results, which Fractyl reported in July 2026, showing greater weight maintenance among participants receiving more extensive duodenal treatment.

Post hoc analyses suggested reduced weight regain with longer duodenal ablation, while Fractyl reported no device- or procedure-related serious adverse events through September 24, 2026.

Fractyl plans an FDA De Novo submission in late 2026 and targets potential authorization in late 2027, followed by a possible early 2028 U.S. launch.

Revita is an endoscopic procedure that treats the lining of the duodenum, the first section of the small intestine, to investigate whether it can help maintain weight loss after GLP-1 medications are stopped.

Fractyl completed REMAIN-1 pivotal cohort randomization in February 2026 and previously reported one-year midpoint cohort findings in July, while the pivotal study's second co-primary endpoint remains scheduled for Q1 2027.