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24 articles with Fractyl Health
Fractyl Health Publishes Two-Year Durability Data After a Single Revita DMR® Therapeutic Procedure in Patients with Type 2 Diabetes
Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes, announced the publication of two-year durability data from its REVITA-1 clinical study conducted at centers in Europe and South America.
REVITA-T2Di is an open-label cohort evaluating Revita DMR ® in patients with insulin-treated type 2 diabetes.
Fractyl Health today announced the appointment of Kelly Barnes to the company’s board of directors.
Fractyl Health, a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, including type 2 diabetes, announced the publication of an innovative new model of metabolism, the Metabolic Balance Model.
Fractyl Announces Closing of $100 Million Series F Financing to Expand Clinical Development Programs in Type 2 Diabetes
Fractyl Health, a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, announced the closing of a $100 million Series F financing.
Fractyl Announces FDA Breakthrough Device Designation for Revita® DMR in Insulin-Treated Type 2 Diabetes
Fractyl Announces FDA Breakthrough Device Designation for Revita ® DMR in Insulin-Treated Type 2 Diabetes - REVITA-T2Di study is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing or eliminating the need for insulin -
It was a busy week for clinical trial updates. Here’s a look.
Fractyl Announces Publication of Clinical Results from INSPIRE Study Showing Durable Insulin-Free Glycemic Control in Majority of Patients Treated
- Revita ® DMR, combined with GLP-1RA medication, enables 53% of patients with type 2 diabetes to discontinue and remain off insulin for 18 months - - Results are published in peer-reviewed journal Gastrointestinal Endoscopy -
Revita® DMR is the first and only procedural therapy for type 2 diabetes; Revita DMR has been shown to durably improve blood sugar control without the need for escalating drug therapy and to reduce liver fat in NAFLD/NASH in clinical studies to date.
Fractyl Announces FDA IDE Approval to Begin Pivotal Study of Revita DMR for Insulin-Treated Patients with Type 2 Diabetes
Fractyl Laboratories Inc. ( Fractyl ) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin a pi
This Clinical Catch-Up has been split into three sections: COVID-19-Related Clinical Trials; Non-COVID-19-Related Clinical Trials; and Trials Affected by the COVID-19 Pandemic. Here’s a look.
Fractyl Announces Positive Topline Results in the Revita-2 Clinical Trial in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Successful completion of Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR to support EU commercial launch and inform U.S. pivotal clinical trial
Fractyl’s Revita DMR Same-Day Therapeutic Procedure Could End Daily Insulin Injections for Type 2 Diabetes Patients
Interim clinical data to be presented at ADA 2019 show that approximately 85 percent of patients are insulin-free at six months after Revita DMR outpatient therapy
Fractyl Announces New Clinical Data Showing Same-Day Procedure Can Benefit Both NAFLD/NASH and Type 2 Diabetes
Minimally invasive therapy lowered hepatic fat by 36% and Hb1AC levels by 1% in patients with non-alcoholic fatty liver disease and type 2 diabetes
These additions come as Fractyl is preparing for commercialization efforts outside the U.S. and has started the company’s first U.S. clinical trial for its lead product candidate Revita™ DMR for the treatment of type 2 diabetes and fatty liver disease.
Fractyl uses Helix ALM to achieve medical compliance with FDA and ISO regulations in record time
Proceeds from the financing will be used towards continued development of Fractyl's Revita DMR technology for patients with type 2 diabetes.
Fractyl Appoints Senator William W. Bradley and Dr. John Amatruda to the Company's Board of Directors
Fractyl today announced the appointment of Senator William W. Bradley and Dr. John Amatruda to the company's board of directors.
Fractyl Announces Initiation Of Multicenter Clinical Trial To Evaluate A Novel Medical Procedure For Poorly Controlled Type 2 Diabetes