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Fractyl Health Strengthens Revita Patent Portfolio as It Advances Toward FDA Submission and Potential Commercialization

  • Fractyl Health announced new U.S. patent additions strengthening the intellectual property foundation for Revita ahead of a planned FDA De Novo submission for post-GLP-1 weight maintenance.
  • The company's IP portfolio now includes 39 granted U.S. patents, approximately 40 pending U.S. applications, and more than 50 issued international patents.
  • U.S. Patent No. 12,740,821 covers specific design features of the Revita single-use catheter, with patent protection extending to November 28, 2042.
  • The USPTO issued a Notice of Allowance for Patent Application No. 18/988,800, which claims a thermal dosing method controlling heated & cooling fluids to regulate the thermal dose delivered to the duodenal lining.
  • U.S. Patent No. 12,471,979 includes independent treatment-method claims for duodenal tissue that are not limited to any specific energy modality, covering procedural steps like positioning & delivering energy.
  • These developments complement U.S. Patent No. 12,690,909, issued in July 2026, which covers the heater design for the Revita console.
  • Patent milestones build on positive six-month results from the REMAIN-1 Pivotal Cohort & market research showing patient interest in a one-time procedure for weight maintenance after GLP-1 therapy.
  • Revita is an endoscopic procedural therapy designed to remodel the duodenal lining to enable durable weight maintenance following GLP-1 discontinuation.
  • Revita holds FDA Breakthrough Device Designation for weight maintenance in people with obesity who discontinue GLP-1 therapies.