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REMAIN-1: Durable weight maintenance one year after GLP-1 discontinuation
Fractyl Health has announced positive one-year results from its REMAIN-1 Midpoint Cohort, reinforcing the potential of the Revita DMR System (Revita) to be the first durable procedural therapy for post-GLP-1 weight maintenance. The key findings include: Dose-dependent durability confirmed at one year: In the full modified intention-to-treat (mITT) population (N=45), a single Revita procedure reduced weight regain by approximately 40% versus sham at one year (least-squares mea
REVEAL-1: Sustained post-GLP-1 weight maintenance after a single Revita procedure
Fractyl Health has announced positive 6-month results from its open-label REVEAL-1 Cohort. The REVEAL-1 Cohort is an open-label study in individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. The REVEAL-1 data show that patients who underwent a single Revita procedure after discontinuing GLP-1 therapy maintained both stable body weight and glycaemic control through 6 mont
Fractyl Health submits of CTA module in Europe for RJVA-001
Fractyl Health has submitted the first module of its Clinical Trial Application (CTA) in Europe for the company’s gene therapy candidate...
Rejuva Smart GLP-1 pancreatic gene therapy preclinical data highlighting durable potency and safety with limited systemic GLP-1 exposure
New preclinical data from Fractyl Health’s Rejuva smart GLP-1 gene (RJVA-001’s) therapy platform, presented at the American Society of...
Early data shows Revita has potential to prevent weight regain after GLP-1 discontinuation
Fractyl Health has announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results...
Fractyl Health provides update on clinical studies priorities
Fractyl Health is prioritising its REMAIN-1 pivotal study, addressing the demand for an off-ramp to GLP-1 drugs, while advancing its...
Fractyl unveils promising preclinical data demonstrating safety and feasibility of local delivery of RJVA-001 Rejuva Smart GLP-1 Pancreatic Gene Therapy
Fractyl Health has presented new data from its preclinical Rejuva Smart GLP-1 pancreatic gene therapy program in a poster titled,...
German Real-World Registry shows meaningful and sustained weight loss for at least one year after a single Revita endoscopic procedure
Fractyl Health has announced new weight maintenance and blood sugar clinical results from the Company’s German Real-World Registry for...
FDA grants Breakthrough Device Designation for Fractyl’s Revita in weight maintenance for people with obesity who discontinue GLP-1s
The FDA has granted Breakthrough Device Designation (BDD) for Fractyl Health’s Revita System for use in the maintenance of weight loss...
Revita results in weight loss and sustained weight maintenance without weight regain at one year
The latest weight maintenance data from a pooled analysis of patients enrolled in Revita (Fractyl Health) clinical studies across the EU...
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