Fractyl Health Expands Revita Patent Portfolio Ahead Of Planned FDA De Novo Submission

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 additions to its U.S. patent portfolio that strengthen the intellectual property foundation for investigational Revita® as the Company advances toward a planned U.S. Food and Drug Administration (FDA) De Novo marketing submission for post-GLP-1 weight maintenance.

The patent developments build on positive six-month results from the REMAIN-1 Pivotal Cohort and recently announced market research identifying patient interest in a one-time procedural approach to maintaining weight loss after GLP-1 therapy. Together, these advances support Fractyl’s strategy to develop Revita as a potential new treatment option for patients seeking to preserve the weight loss they achieved with medication.

The U.S. Patent and Trademark Office (USPTO) has issued a patent covering aspects of Revita’s single-use catheter and allowed a patent application covering how the system controls thermal energy during treatment. These developments complement an existing console patent and broader issued treatment-method claims that are not limited to any specific energy modality.