Fractyl Health announced that it initiated its Revita Global Registry Program in Germany to study its diabetes reversal treatment.
On April 20, the Ethics Committee of the University of Freiburg (Germany) granted clearance for the initiation of a registry study. The study covers the Revita system in German hospitals. Patients in the registry have inadequately controlled type 2 diabetes despite guideline-directed medical therapy.
Lexington, Massachusetts-based Fractyl plans to collect data to understand the impact of Revita. This covers clinical, patient-relevant and health-economic outcomes associated with type 2 diabetes.
According to Prof. Jochen Seufert, nearly 50% of patients remain inadequately controlled with type 2 diabetes. Seufert, head of the Dept. of Endocrinology and Diabetology at University Hospital Freiburg, said a need exists for new therapeutic options.
“This registry study will enable us to collect valuable data on Revita under real-world conditions to help better understand the value it may provide to people with the disease,” said Seufert, also the principal investigator for the registry in Germany.
Fractyl plans to collect data from patients receiving the Revita procedure at Munich Municipal Hospital (Bogenhausen) and Evangelical Hospital Düsseldorf (EVK). The registry operates in collaboration with the West German Diabetes and Health Centre (WDGZ) in Düsseldorf.
Fractyl commercially launched the Revita DMR system for diabetes reversal in Germany in February.
“There is a huge, global unmet need for people with inadequately controlled T2D,” said Dr. Harith Rajagopalan, MD, co-gounder and CEO of Fractyl Health. “We believe the Revita System has the potential to offer an important new solution for patients because targeting the gut may allow us to address a root cause of the disease for the first time.”
About the Fractyl Health Revita procedure
Revita, a procedure that remodels the duodenal lining via hydrothermal ablation, has FDA breakthrough device designation. The FDA approved an investigational device exemption (IDE) trial for Revita in April 2022.
Fractyl aims for Revita to improve glycemic control and eliminate insulin needs in type 2 diabetes patients. These patients currently suffer from inadequate control on long-acting insulin. Interim data not only showed improved glycemic control but also stronger metabolic control and reduced insulin requirement.