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.

• REVITA-T2Di study is assessing potential of outpatient Revita DMR treatment to improve glycemic control and reduce or eliminate need for daily insulin –

Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, today announced the enrollment of the first patient in a pivotal clinical trial of Revita® DMR for patients with type 2 diabetes. The trial, called REVITA-T2Di, will evaluate the ability of a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable in

LEXINGTON, Mass., February 1, 2021 — Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to novel therapeutic interventions that can reverse the metabolic disease epidemic, today announced the publication of clinical results from the investigator-initiated INSPIRE clinical trial conducted in collaboration with Fractyl. The results demonstrate that a majority of patients with type 2 diabetes treated with a combination of Revita® DMR and a glucagon-like peptide-1 re

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.

LEXINGTON, Mass., August 6, 2020 – Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to novel therapeutic interventions that can reverse the metabolic disease epidemic, today announced a first close of $5

Revita T2Di pivotal study to evaluate the ability of Revita DMR, the first non-drug, non-surgical, disease-modifying therapy, to eliminate need for insulin injections in T2D; enrollment expected to begin in late 2020

LEXINGTON, Mass., June 3, 2020 — 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 pivotal study of RevitaⓇ DMR