REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham
32% of Revita® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)
Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6 (nominal p=0.003)
Revita has been generally well-tolerated with no device- or procedure-related serious adverse events
Revita received FDA Breakthrough Device Designation for Post-GLP-1 weight maintenance; De Novo marketing application submission to the FDA planned for late Q4 2026; anticipated topline one-year data from the REMAIN-1 Pivotal Cohort and second co-primary endpoint planned for Q1 2027
Dedicated CPT code 1122T for the Revita procedure takes effect January 1, 2027, well ahead of a potential U.S. launch in early 2028
Investor webcast today at 8:00 a.m. ET
BURLINGTON, Mass., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced positive topline six-month results from the Pivotal Cohort of its ongoing REMAIN-1 study (Pivotal Cohort), a 308-participant, multicenter, randomized, double-blind, sham-controlled study of the Revita DMR System (Revita) for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy. REMAIN-1 met its pre-specified six-month co-primary endpoint of weight loss retention, as patients treated with a single Revita procedure demonstrated a highly statistically significant reduction in weight regain compared to sham (p=0.0023). The second prespecified co-primary endpoint, the percentage of participants who maintain 5% or greater total body weight loss, will be assessed at 12 months. We believe these 6-month results reinforce the potential of Revita to be the first durable procedural therapy for post-GLP-1 weight maintenance and support the Company’s planned De Novo marketing application submission in late Q4 2026.
Key Findings
Six-month co-primary endpoint met: In the modified intention-to-treat (mITT) population (N=308), Revita participants maintained approximately 80% of their GLP-1-induced weight loss after a single treatment at six months, compared with 67% in sham participants (least-squares mean weight regain of 5.1% versus 8.2% of body weight; n=176 versus 74), with high statistical significance (p=0.0023). 32% of Revita participants were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation (14 cm of duodenal ablation), the higher run-in weight loss population (at least 17.5%), and the Optimized population (both). Per the pre-specified statistical analysis plan, key secondary endpoints are formally evaluated for statistical inference following assessment of the 12-month co-primary endpoint. The REMAIN-1 program also includes the open-label REVEAL-1 Cohort and the randomized, sham-controlled Midpoint Cohort (N=45), which reported one-year results in June and July 2026, respectively. Topline 12-month data from the Pivotal Cohort are expected in Q1 2027.
About Revita
The Revita® DMR System is Fractyl’s lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.
About Fractyl Health
Fractyl is a clinical-stage metabolic therapeutics company advancing two differentiated candidates designed to target the root causes of obesity and T2D: Revita, an endoscopic procedural therapy in pivotal development for post-GLP-1 weight maintenance with positive pivotal six-month data, and Rejuva, an AAV-based gene therapy platform with its lead candidate RJVA-001 entering first-in-human clinical studies. Fractyl’s goal is to change the course of metabolic disease, advancing treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding: the promise and potential impact of our clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation and its potential to be the first procedural therapy for post-GLP-1 weight maintenance; the translatability of results and scalability of technique related to Revita; the design, initiation, timing and results of clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort , including 12-month data; the potential launch or commercialization of any of our product candidates or products; our regulatory strategy, including the timing of any potential De Novo marketing application submission and the potential use and benefits of the De Novo pathway (FDA pre-submission feedback is advisory and non-binding, or as to the timing of any such authorization); coding, coverage and payment for Revita, including the effectiveness and use of Category III CPT code 1122T and eligibility for or timing of Medicare transitional pass-through payment or other coverage, which are subject to AMA and CMS review and are not assured; the potential treatment population or benefits for any of our product candidates or products; our strategic and product development objectives and goals; and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that are discussed more fully in our filings with the Securities and Exchange Commission (the SEC), including the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents we subsequently file with or furnish to the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 10, 2026. These forward-looking statements are based on management’s current estimates and expectations. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Contact
Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@fractyl.com, 951.206.1200
