May 15, 2024 - by Catie Corcoran

Fractyl Health Climbs 12% on Revita Data for Durable Maintenance of Weight Loss

15 May 2024

New York, May 15, 2024 - PRISM MarketView - Metabolic therapeutics company, Fractyl Health’s (Nasdaq: GUTS) shares rose 12% in intraday trading on Wednesday after the company shared six-month follow up data from its real-world registry study of Revita for type 2 diabetes (T2D). Revita is Fractyl’s lead product candidate and is designed to remodel the duodenal lining via hydrothermal ablation to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic disease.

Fractyl Health, Inc. Common Stock - Prism MarketView

Fractyl Health is a leader in creating innovative therapies to address the root cause of type 2 diabetes. We were founded based on groundbreaking research an

Fractyl Health Presents Clinical Update on Revita® German Real-World Registry for Patients With Advanced Type 2 Diabetes (T2D)

First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment No device- or procedure-related serious adverse events have been observed to date in any registry participant BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for

Revita has received a CE mark in Europe and reimbursement authorization through in Germany for the treatment of T2D. In the United States, Revita is available for investigational use only.

14 study participants, whose T2D had remained uncontrolled following the use of three different glucose lowering medications, completed at least 6 months of post-Revita follow up. Participants experienced an average total body weight loss of 8.1% at 6 months after the Revita procedure, with generally sustained or improved weight loss from month 1 to month 6.

Fasting blood glucose also improved after the procedure, and all patients stabilized or reduced the number of glucose-lowering medications taken. No device or procedure-related serious adverse events have been reported to date.

Fractyl said in a statement that these real-world findings further support the potential of Revita for durable maintenance of weight loss.

“Early results from our real-world registry suggest that patients who undergo Revita can experience significant improvement in blood sugar, reduction in body weight, and stabilization or reduction of medication burden."

Timothy Kieffer, Chief Scientific Officer at Fractyl Health

Fractyl is conducting a pivotal study of Revita in patients with inadequately controlled T2D, which is currently enrolling in the US and Europe. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs is anticipated to initiate in the second half of 2024.

About Fractyl Health

Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit www.fractyl.com or https://twitter.com/FractylHealth.

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