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Press Releases

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 -

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Feb 1, 2021

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 -

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Aug 6, 2020

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 date.

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Jun 3, 2020

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

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Mar 30, 2020

Fractyl Announces New Clinical Data on the Mechanism of Revita DMR in Type 2 Diabetes

Data presented at ENDO 2020 from the randomized, sham-controlled REVITA-2 study verifies that improvements in blood glucose control (HbA1C), insulin sensitivity, and other metabolic measures seen after one Revita treatment are also associated with improved pancreatic beta-cell function. Revita is the first non-drug, non-surgical, disease-modifying therapy in clinical trials in the U.S. and commercially available in the U.K. for the treatment of type 2 diabetes.

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