Find public news by keyword, exact ticker, category and date.
Open a ticker page for its news coverage. The news search below stays a text search.
4 results loaded, newest first. End of these results. The latest changes are still being indexed. Try again shortly for updated results.
Fractyl Health said Revita showed a statistically significant reduction in weight regain versus sham (p=0.0023). The company plans a De Novo FDA submission for late Q4 2026 and expects 12-month data in Q1 2027.
Fractyl Health reported positive six-month REMAIN-1 results for Revita on October 16, 2026, showing reduced weight regain following GLP-1 discontinuation. The trial met its six-month primary endpoint; no device- or procedure-related serious adverse events were reported. A De Novo marketing application submission to the
The ongoing pivotal study reported a highly statistically significant reduction in weight regain after GLP-1 discontinuation.
The ongoing pivotal study reported a statistically significant reduction in weight regain after GLP-1 discontinuation.