Fractyl Health is a clinical-stage company developing one-time, device and gene therapy-based treatments for obesity and type 2 diabetes (T2D), positioning itself as a complement to GLP-1 drugs rather than a competitor. Fractyl's lead product, Revita, is an outpatient endoscopic procedure in which a physician uses a balloon catheter to perform hydrothermal ablation of the duodenal lining, which Fractyl argues is damaged by poor diet and disrupts gut-brain metabolic signaling. The procedure takes under an hour, requires no implant, and patients typically resume normal activity the next day. Fractyl has pivoted Revita's primary target indication to weight maintenance for patients who have lost weight on GLP-1 drugs but discontinued them — a population prone to rapid weight regain. The REMAIN-1 pivotal study (n=315) is fully enrolled, with topline data expected early Q4 2026 and a potential FDA De Novo application in late Q4 2026. Revita has FDA Breakthrough Device designation for this indication. If approved, Revita's revenue model would be procedure-based, with endoscopy centers purchasing a single-use catheter per procedure. Fractyl's second platform, Rejuva, is an early-stage pancreatic gene therapy delivered endoscopically, designed to reprogram beta cells to produce GLP-1 in a nutrient-responsive way. The lead candidate, RJVA-001, targets T2D remission, with first-in-human dosing expected H2 2026. Fractyl is pre-revenue and burns roughly $20-25M per quarter, with cash runway expected into early 2027.