Fractyl Health Reinforces Intellectual Property Leadership in Metabolic Disease with Two New U.S. Patents Directed to Duodenal Resurfacing
Robust intellectual property portfolio, built over more than a decade, designed to protect core innovations for treating metabolic diseases
New U.S. patents strengthen Fractyl’s leadership in metabolic innovation by expanding its patent coverage of duodenal resurfacing, including thermal and non-thermal electrical energy applications
BURLINGTON, Mass., June 18, 2025 (GLOBE NEWSWIRE) – Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced that the United States Patent and Trademark Office has issued two new patents that further strengthen the Company’s extensive intellectual property (IP) portfolio protecting its duodenal resurfacing innovations.
Fractyl has built its patent portfolio since 2011, and its IP estate now includes 31 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign issued patents and pending applications. The two newly issued patents further reinforce the Company’s leadership position in duodenal resurfacing applications.
U.S. Patent No. 12,329,439, issued June 17, 2025, and U.S. Patent No. 12,303,185, issued May 20, 2025, both titled "Electrical energy ablation systems, devices and methods for the treatment of tissue,"are directed to ablating duodenal mucosa with various forms of energy, including thermal and non-thermal electrical energy.
“These new patents reinforce our leadership in gut-targeted therapies for metabolic disease,” said Sarah Toomey, General Counsel and Corporate Secretary of Fractyl Health. “We created this category of duodenal mucosal resurfacing more than a decade ago and continue to expand an IP portfolio that supports our vision for the Company. Revita® represents a first-in-class and potentially breakthrough treatment in this category with a compelling clinical profile in hundreds of treated patients with obesity and type 2 diabetes. As the pioneers in this field, we believe that continued innovation, along with proactive protection of our inventions, will allow us to deliver the best therapies possible to patients and physicians.”
“The idea that ablating a segment of the duodenal mucosa could drive clinically meaningful metabolic improvements emerged as a compelling and important insight from Fractyl’s early clinical studies,” said John Amatruda, M.D., Adjunct Professor of Medicine at Yale University School of Medicine. “These early findings informed foundational design principles at Fractyl that have led to a category of devices and techniques for duodenal mucosal resurfacing. This progress represents a significant step toward the creation of potentially disease-modifying metabolic therapies.”
These IP developments come as Fractyl prepares for three key data readouts from its ongoing pivotal study of Revita: REVEAL-1 Cohort open-label data expected in June 2025; REMAIN-1 Midpoint Cohort data expected in the third quarter of 2025; and 6-month primary endpoint data from the REMAIN-1 Pivotal Cohort expected in the second half of 2026. Together, these clinical milestones are designed to demonstrate Revita’s potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. The Company has a robust and growing IP portfolio, with 31 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign issued patents and pending applications. Fractyl is based in Burlington, MA. For more information, visit www.fractyl.com.
About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the Company’s insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1–based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1–based drugs, called REMAIN-1, was initiated in Q3 2024 and has completed enrollment.