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Fractyl Health (GUTS) investor relations material
Fractyl Health Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
Clinical program overview
Revita is an endoscopic outpatient procedure targeting post-GLP-1 weight rebound in obesity and type 2 diabetes.
Three patient cohorts are under study: REVEAL-1 open-label, REMAIN-1 midpoint randomized, and REMAIN-1 pivotal trial.
The REVEAL-1 cohort includes real-world patients who lost ≥15% body weight on GLP-1s and then stopped medication before receiving Revita.
REMAIN-1 midpoint is a 45-patient randomized, double-blind, sham-controlled trial; pivotal REMAIN-1 includes 315 patients.
All studies use similar protocols, sites, and physicians for consistency.
Key clinical results and data updates
REVEAL-1 six-month data: 17 patients regained only 1.5% of body weight, versus expected 10%+ without intervention.
About 40% of REVEAL-1 patients lost additional weight at six months post-GLP-1 cessation.
Hemoglobin A1c remained stable (0.04% change) in REVEAL-1, indicating sustained glucose control.
REMAIN-1 midpoint: at three months, sham arm regained 8 kg, Revita arm lost 2 kg, a 10 kg (12%) treatment difference.
Six-month randomized data from REMAIN-1 midpoint (45 patients) expected in January; pivotal REMAIN-1 (315 patients) six-month data due in H2 2026.
Market opportunity and procedure adoption
20 million endoscopies are performed annually in the US; 800,000 are among GLP-1 users.
Market research suggests high willingness to undergo Revita during routine endoscopy, potentially reaching nearly 1 million patients annually.
Revita procedure is less burdensome than ongoing GLP-1 medication pickup.
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Next Fractyl Health earnings date
Q4 20253 Mar, 2026
Next Fractyl Health earnings date
Q4 20253 Mar, 2026
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Frequently asked questions
Fractyl Health Inc. is a healthcare biotechnology company dedicated to the development of innovative therapies for metabolic diseases, particularly type 2 diabetes (T2D) and obesity. The company's main therapeutic platforms include Revita DMR and Rejuva. Revita DMR is an outpatient procedural therapy aimed at modifying duodenal dysfunction—a condition influenced by a high-fat and high-sugar diet which can lead to T2D and obesity. Rejuva represents a novel gene therapy platform, delivered via adeno-associated virus, designed to achieve long-term remission of T2D and obesity by altering metabolic hormone function in pancreatic islet cells. The company is headquartered in Burlington, Massachusetts, and its shares are listed on the NASDAQ.
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