10 News & Press Releases found
Fractyl Health News
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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 Germany to begin to negotiate payment ...
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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 improvements in blood glucose, ...
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Fractyl Health Provides Initial Clinical Update on Open-Label REVITA-T2Di
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 ...
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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 and Drug ...
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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), today announced the ...
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Fractyl Announces Tenth Trial Site Opened in REVITA-T2Di Study of Revita DMR for Type 2 Diabetes
REVITA-T2Di study is assessing potential of outpatient Revita DMR treatment to improve glycemic control and reduce or eliminate need for daily insulin – LEXINGTON, Mass., September 1, 2021 – Fractyl Health, a life sciences company ...
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Fractyl Announces First Patient Enrolled in Pivotal Study of Novel Procedural Therapy Revita® DMR for Type 2 Diabetes
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 ...
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Fractyl Announces Publication of Clinical Results from INSPIRE Study Showing Durable Insulin-Free Glycemic Control in Majority of Patients Treated
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 ...
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Fractyl Raises $55 Million in Series E Financing to Advance Revita DMR for Type 2 Diabetes
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 ...
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Fractyl Announces FDA IDE Approval to Begin Pivotal Study of Revita DMR for Insulin-Treated Patients with Type 2 Diabetes
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 ...