Fractyl Health announced today that it commercially launched its Revita DMR system for diabetes reversal in Germany.
Revita, an endoscopic procedural therapy, remodels the duodenal lining through hydrothermal ablation. This tackles a root cause of type 2 diabetes. Revita holds CE mark approval in Europe and established reimbursement in Germany recently.
Lexington, Massachusetts-based Fractyl performed a live demonstration of a Revita procedure on Feb. 3, according to a news release. It took place at EVK Hospital in Düsseldorf, Germany, at the 25th International Endoscopy Symposium.
Fractyl initially plans to offer Revita to patients at EVK Hospital. Senior advanced endoscopist, Dr. Torsten Beyna, will conduct procedures. Patients referred for Revita will also be managed in close collaboration with the West-German Centre of Diabetes and Health (WDGZ) in Düsseldorf by Dr. Stephan Martin, head physician and director.
“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,” said Martin. “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.”
The company said it expects to make Revita available at select hospitals in Germany at first. It plans to expand to additional centers in the future.
“We have been looking forward to the availability of Revita in Germany for quite some time,” said Beyna. “The clinical development of the technology and procedure has demonstrated the key role of the gut in metabolic diseases, and specifically in T2D.”