Fractyl Health Announces the Initiation of a Global Registry Study of the Revita System™ in Patients With Inadequately Controlled Type 2 Diabetes (T2D)

Fractyl Health, a commercial-stage organ-editing metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D), today announces the initiation of its Revita Global Registry Program in Germany. On April 20, the Ethics Committee of the University of Freiburg (Germany) granted a clearance for the initiation of a registry study of the Revita System in German hospitals. Patients who participate in the registry will be those with inadequately controlled type 2 diabetes (T2D) despite guideline-directed medical therapy and are interested in undergoing the Revita procedure. Data will be collected to understand the impact of Revita on important clinical, patient-relevant, and health-economic outcomes associated with T2D.

“Nearly 50% of patients remain inadequately controlled with T2D, and therefore, there is a need for new therapeutic options that can improve real-world outcomes in the disease,” said Prof. Jochen Seufert, FRCPE, Head of the Department of Endocrinology and Diabetology at University Hospital Freiburg and principal investigator for the registry study in Germany. “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.”

The registry aims to collect data from patients receiving the Revita procedure at Munich Municipal Hospital (Bogenhausen) and Evangelical Hospital Düsseldorf (EVK) in collaboration with the West German Diabetes and Health Centre (WDGZ) in Düsseldorf.

“There is a huge, global unmet need for people with inadequately controlled T2D,” said Harith Rajagopalan, MD, PhD, Co-Founder 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.”