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Press Releases

Apr 4, 2022

Fractyl Health Announces FDA IDE Approval to Begin Revitalize-2 Pivotal Study Designed for Patients with Type 2 Diabetes (T2D) Who Are Not Yet on Insulin

Revitalize-2 is the second pivotal study for the Revita DMR® system (Revita®) in Fractyl Health’s Revitalize T2D clinical development program Revitalize T2D is designed to evaluate the potential of Revita i...

Feb 8, 2022

Fractyl Health Receives Reimbursement Authorization in Germany for Revita DMR^® System

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 German...

Feb 1, 2022

Fractyl Health Publishes Two-Year Durability Data After a Single Revita DMR^® Therapeutic Procedure in Patients with Type 2 Diabetes

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 impro...

Jan 18, 2022

Fractyl Health Provides Initial Clinical Update on Open-Label REVITA-T2Di

Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today initial interim feasibility data from human clinical experie...

Jan 12, 2022

Fractyl Health Appoints Kelly Barnes to the Company’s Board of Directors

Fractyl Health, an organ editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), today announced the appointment of Kelly Barnes to the company’s board of ...

Nov 30, 2021

Fractyl Health Announces the FDA’s Authorization of Expanding the Revitalize-1 Study’s Sample Size

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...

Oct 27, 2021

Fractyl Health Announces Publication of Pioneering New Model of Intestine’s Role in Metabolism

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), t...

Sep 1, 2021

Fractyl Announces Tenth Trial Site Opened in REVITA-T2Di Study of Revita^® DMR for Type 2 Diabetes

LEXINGTON, Mass., September 1, 2021 – Fractyl Health, a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, today announced the activation of...

Jun 16, 2021

Fractyl Announces Closing of $100 Million Series F Financing to Expand Clinical Development Programs in Type 2 Diabetes

Fractyl Health today announced the closing of a $100 million Series F financing. The financing was led by new investors Maverick Capital, M28 Capital, and Population Health Partners, with participation by other new and e...

Apr 27, 2021

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 -

Fractyl Laboratories Inc. (Fractyl), a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic, today announced that the U.S. Food and Drug Administ...

The press releases contained in this section of the website are provided for historical purposes only. The information contained in each press release is accurate only as of the date each press release was originally issued. Fractyl Health disavows any obligation to update the information contained in such press releases after the date of their issuance.

Media Contact: Nancye Green, Fractyl Health,
ngreen@fractyl.com, +1 (917) 273-3536