Fractyl Health Virtual Commercial Strategy Day: The Potential Path to Commercializing Revita®, a Procedural Therapy for Post-GLP-1 Weight Maintenance
| DATE: | September 1, 2026 |
|---|---|
| TIME: | 11:00 AM EDT |
| LOCATION: | Virtual |
About The Event
Join Fractyl Health’s management team to discuss the potential commercial opportunity and go-to-market strategy for Revita®, following the Company’s positive one-year randomized data from the REMAIN-1 Midpoint Cohort, which showed weight maintenance one year after a single Revita procedure. The treatment effect was greatest in a pre-specified optimized population, combining complete duodenal ablation (>14 cm) with higher GLP-1-induced run-in weight loss (≥17.5%), where Revita-treated participants maintained approximately 84% of their GLP-1-induced weight loss compared to 46% in sham participants (least squares mean weight regain of 4.1% versus 13.5% of body weight; n=10 versus 8 for Revita versus sham).
An estimated 30 million U.S. adults are currently on GLP-1 therapy and Revita is designed to be their one-time procedural off-ramp when they stop. Ahead of the anticipated early Q4 2026 six-month topline readout of the REMAIN-1 Pivotal Cohort, Fractyl’s management team will discuss the potential market opportunity for Revita, its plans for bringing the therapy to patients and providers if it receives FDA marketing authorization, the reimbursement path ahead, and the Company’s potential FDA De Novo marketing application submission anticipated in late Q4 2026. Together, these milestones mark Fractyl’s transition from late stage clinical development toward commercial readiness.
A live Q&A session will follow the formal presentations.
Disclaimer
Revita® is for investigational use only in the United States and is CE marked in the European Union and United Kingdom. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. FDA pre-submission feedback is advisory and non-binding, and there is no assurance that FDA will accept a De Novo marketing application submission or that the Revita DMR System will receive marketing authorization. This page contains forward-looking statements, which are based on management’s current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations.