Fractyl Health’s Revita System Now Available in Germany

Fractyl Health has released its Revita DMR System in Germany.

Revita is an endoscopic procedural therapy that is based on emerging scientific evidence linking gut dysfunction to metabolic diseases and is designed to remodel the duodenal lining to provide a minimally invasive approach to tackling a root cause of type 2 diabetes (T2D). The Revita System has a CE Mark in Europe and has recently established reimbursement in Germany under the NUB reimbursement process.
 
Initially, Revita will be available to patients at the EVK Hospital in Düsseldorf, where procedures will be conducted by a senior advanced endoscopist, Associate Prof. Torsten Beyna, head physician of the Medical Clinic. Patients referred for Revita will be managed in close collaboration with the West-German Centre of Diabetes and Health (WDGZ) in Düsseldorf by Prof Stephan Martin, head physician and director. Revita will first be available at select hospitals in Germany with the close collaboration of clinical leaders in both endoscopy and endocrinology, with additional centers to be added in the future.
 
“We are enthusiastic about the availability of Revita in Düsseldorf for our patients with T2D who are inadequately controlled and at risk of disease progression,” Martin said. “Current medical therapies for T2D focus on treating symptoms of the disease and—despite numerous options—nearly 50% of German patients remain inadequately controlled. Revita addresses a root cause of their disease in the gut for the first time, thereby potentially enabling patients to improve their underlying disease rather than treating symptoms alone. In conjunction with an appropriate modification of diet and lifestyle, Revita may offer a crucial opportunity for a metabolic reset for patients and society.”

Revita is based on emerging scientific evidence linking gut dysfunction to the development of metabolic diseases. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. Revita has received a CE mark in Europe, and in 2022, received reimbursement in Germany through the NUB process. In the United States, Revita is for investigational use only and has received Breakthrough Device Designation from the U.S. Food and Drug Administration to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin.
 
“We have been looking forward to the availability of Revita in Germany for quite some time,” Beyna stated. “The clinical development of the technology and procedure has demonstrated the key role of the gut in metabolic diseases, and specifically in T2D. Revita is an innovation that can complement the offerings of modern interventional gastroenterology in a manner that has the potential to become an important paradigm shift in how we think about treating the disease.”
 
Fractyl Health is focused on pioneering a new approach to the treatment of T2D. Despite advances in treatment over the last 50 years, metabolic diseases in general, and T2D in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease. Fractyl Health is a private organ-editing metabolic therapeutics company based in Lexington, Mass.