Fractyl Health reported favourable year-long weight loss outcomes for Revita device

Fractyl Health has announced promising outcomes for its hydrothermal ablation device, Revita, positioning it as a competitor to the growing pharmaceutical weight loss market. Data from a German real-world registry, involving 11 patients with obesity and advanced type 2 diabetes (T2D), showed significant results after 12 months. The median age of patients was 62, with a starting weight of 111kg, which reduced to 97kg—a 13% total body weight loss. Additionally, median HbA1c levels dropped by 2.4%. Most patients, who were on up to three glucose-lowering medications, either maintained or reduced their medication use, and no adverse safety events were reported.

Revita, an outpatient endoscopic procedure, resurfaces the duodenal mucosal lining, playing a crucial role in nutrient sensing and signaling. Though it has CE marking since 2016, it remains investigational in the U.S., where it recently received FDA breakthrough device designation. Fractyl is currently conducting pivotal studies, REMAIN-1 and REVITALIZE-1, to further evaluate Revita’s efficacy. As the medtech industry faces competition from popular weight-loss drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, Revita offers a potential alternative for patients with obesity and T2D, aiming to reduce chronic medication reliance and shift the treatment paradigm.