As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space. At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for […]
Fractyl Health
Studies back Fractyl Health diabetes reversal procedure, gene therapy
Fractyl Health announced multiple studies supporting its programs for the reversal and treatment of diabetes. Lexington, Massachusetts-based Fractyl reported data from its Revitalize 1 pivotal study and its Rejuva program. Revitalize 1 evaluates the company’s Revita endoscopic ablation procedure to reverse diabetes. Rejuva evaluates a targeted pancreatic gene therapy. The company presented its results at […]
Fractyl Health initiates global registry for diabetes reversal treatment
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 […]
Fractyl Health launches diabetes reversal treatment in Germany
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 […]
Fractyl Health ‘encouraged’ by results from diabetes reversal study
Fractyl Health announced today that six-month data from a study of its diabetes reversal tech demonstrated improvements in glucose control. Interim data came from the human clinical experience in Fractyl’s Revita-T2Di long-term, open-label cohort. Revita, a procedure that remodels the duodenal lining via hydrothermal ablation, has FDA breakthrough device designation. The FDA approved an investigational […]
Data backs gene therapy delivery system for treating type 2 diabetes from Fractyl Health
Fractyl Health today announced positive preclinical proof-of-concept data in an animal model for its gene therapy delivery platform for treating type 2 diabetes. The company, which develops the Revita diabetes reversal procedure, evaluated its Rejuva program. Rejuva, a novel device and AAV-mediated delivery platform, delivers gene therapy directly targeting the pancreas. This potentially embeds multiple […]
Fractyl Health forms task force to understand root causes of type 2 diabetes
Fractyl Health announced today that it created the Erase T2D task force to research type 2 diabetes in the hopes of “erasing” the condition. The academic-industry scientific partnership aims to advance research on the role of the gut in metabolic disease. This, in turn, could catalyze future discoveries on understanding and erasing type 2 diabetes. […]
FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients
Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform. Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet […]
Fractyl Health touts 2-year durability study for diabetes reversal procedure
Fractyl Health today announced that it published two-year durability data from its Revita-1 clinical study in Europe and South America. Lexington, Massachusetts-based Fractyl’s trial included a two-year follow-up from 34 type 2 diabetes patients who received the company’s Revita duodenal mucosal resurfacing (DMR) procedure. According to a news release, the study observed no long-term adverse […]
Fractyl Health touts preliminary data from diabetes reversal study
Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study. Lexington, Massachusetts–based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated. The company’s Revita system resurfaces the upper intestine lining (duodenal mucosa) to treat metabolic disease in patients with insulin-treated type 2 […]
