Fractyl Health (NASDAQ: GUTS) has announced positive one-year results from its REMAIN-1 Midpoint Cohort reinforcing the potential of the Revita DMR System to be the first durable procedural therapy for post-GLP-1 weight maintenance.
According to Fractyl, key findings included dose-dependent durability at one-year, greatest benefit in patients with greatest need, positive weight-maintenance responder rate, and excellent tolerability. The company states that up to 84% of GLP-1 weight loss was retained with Revita versus 46% with sham at one year in patients receiving complete duodenal ablations.
In a statement, Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl, commented, “The success of GLP-1 medicines has created a new unsolved problem: what happens when patients stop. Most do stop eventually, whether because of cost, side effects, or simply not wanting to inject a drug for the rest of their lives. When they stop, the weight most often comes back.”
Dr. Rajagopalan added, “Today’s results are the first randomized, sham-controlled evidence that a single Revita procedure can keep most of the weight off for a full year after GLP-1 is stopped, without the need for ongoing medication. We eagerly anticipate an early Q4 2026 topline readout from the REMAIN-1 Pivotal Cohort with deep conviction that Revita may represent the first procedural entrant into the post-GLP-1 weight maintenance category.”
