About The Company
Fractyl Health has become a leader in creating innovative treatments to address the root cause of obesity and type 2 diabetes (T2D). Based in Burlington, Massachusetts, the biotech leader is pioneering disease-modifying therapies designed to move beyond chronic symptom management and deliver lasting metabolic health improvements.
Fractyl’s lead product candidate, Revita®, is an innovative therapy designed to address the gut’s role in obesity. Revita uses duodenal mucosal resurfacing (DMR) — a minimally invasive hydrothermal ablation procedure — to target the duodenal lining and restore impaired nutrient sensing and signaling disrupted by chronic high-fat, high-sugar diets. In the US, Revita is an investigational device with FDA Breakthrough Device designation for weight maintenance following GLP-1 discontinuation in people with obesity.
Fractyl is currently enrolling patients in its REMAIN-1 study, which is a randomized, double-blind pivotal study of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy, which was initiated in the third quarter of 2024. Fractyl has seen incredible patient and physician demand to participate in the study, and expects full enrollment in the summer of 2025, and a midpoint data analysis in Q3 2025.
What else has Fractyl been hard at work on? Its Rejuva® program. As T2D progression is driven by declining pancreatic function and insulin production, the Rejuva® program is particularly groundbreaking as it utilizes an Adeno Associated Virus (AAV)-based gene therapy platform designed to enable local and durable production of therapeutic proteins by the pancreas. In January 2024, Fractyl announced the nomination of RJVA-001 as the first clinical T2D candidate. This milestone marks the company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D. Additionally, Fractyl introduced RJVA-002 as its first dual GIP/GLP-1 pancreatic gene therapy candidate for obesity, further expanding its pipeline. The company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in T2D to regulators in H1 2025, and if the CTA is authorized, expects to report preliminary data in 2026.
In addition to its strides in medicine, Fractyl Health began trading on the Nasdaq in February 2024 under the symbol GUTS, raising $110 million from the IPO.
Wolf Greenfield & Fractyl Health
Wolf Greenfield has been helping Fractyl develop a patent strategy and effectively protect its IP assets including both the Rejuva® and Revita® programs, as they undergo clinical development. In addition to managing Fractyl’s patent portfolio, the Wolf Greenfield team has also helped the company evaluate and navigate relationships with third parties and assisted the company with IP diligence related to its IPO.
