Fractyl Health news
- The Revita DMR System (Revita) gains reimbursement authorization from the German Institute for Hospital Remuneration (InEK) with a NUB Status 1 designation
- NUB Status 1 entitles participating hospitals in Germany to begin to negotiate payment for Revita from statutory health insurers
LEXINGTON, MA., February 8, 2022 – Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the
- REVITA-1 was an open-label cohort study evaluating Revita® in patients with type 2 diabetes on oral anti-diabetic agents but not yet on insulin
- This is the first publication showing two-year durability of improvements in blood glucose, weight, and broader metabolic parameters with no device- or procedure-related adverse events in long-term follow-up after a single Revita procedure
- Additional ongoing and planned clinical studies o
- REVITA-T2Di is an open-label cohort evaluating Revita DMR® in patients with insulin-treated type 2 diabetes –
- Revita® in the T2Di cohort has been observed to be well tolerated and all patients previously on long-acting insulin have discontinued insulin therapy in the initial follow-up period –
- Regular updates on the extended follow-up of the REVITA-T2Di cohort in comparison to population-matched controls are planned, alongside previously announce
LEXINGTON, Mass., November 30, 2021 – Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today the United States Food and Drug Administration’s (FDA’s) authorization to expand its Revitalize-1 pivotal clinical study (formerly known as REVITA-T2Di) sample size from 288 to 420. The newly authorized Revitalize-1 pivotal study protocol amendment also allows the inclusion of a b
LEXINGTON, Mass., October 27, 2021 – Fractyl Health, a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, including type 2 diabetes (T2D), today announced the publication of an innovative new model of metabolism, the Metabolic Balance Model.
The study synthesizes multiple streams of existing evidence from molecular biology through clinical observa