Fractyl Health, Inc.

Fractyl Health is a clinical-stage medical device and gene therapy company developing targeted interventions for obesity and type 2 diabetes by addressing root causes in the duodenum and pancreas. The company's primary platform, Revita®, is an outpatient endoscopic procedure that resurfaces the duodenal lining to target metabolic dysfunction. Revita is currently under investigational use only in the US under Federal law. The company's second platform, Rejuva®, is a one-time gene therapy designed to enable long-term remission of obesity and type 2 diabetes by targeting pancreatic islet cells; this platform is in early development and not yet approved by any regulatory body. Fractyl has reported positive 6-month open-label results from the REVEAL-1 clinical trial demonstrating sustained post-GLP-1 weight maintenance after a single Revita procedure. The company positions its therapies as alternatives to long-term pharmacological management, seeking to break the cycle of chronic disease treatment. Fractyl's approach centers on endoscopic and molecular interventions rather than traditional pharmaceutical or implantable device solutions.