Fractyl Health, a company specializing in metabolic therapeutics, announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to its Revita System.

This designation allows for priority review by the FDA and the possibility of accelerated reimbursement decisions by the Centers for Medicare & Medicaid Services (CMS) after the successful completion of the REMAIN-1 study.

The Revita System is an outpatient endoscopic procedure designed to resurface the mucosal lining of the duodenum, the initial part of the small intestine.

This lining often becomes thickened due to high-fat and high-sugar diets, disrupting the body's ability to maintain healthy metabolism and blood glucose levels.

By addressing this thickening, Revita aims to become the first disease-modifying therapy that targets a root cause of obesity and type 2 diabetes (T2D).

Obesity, which is often linked to T2D and other cardiometabolic issues, is a widespread and complex condition. GLP-1 agonists have been crucial in treating diabetes and obesity, with over 40% of U.S. diabetes patients and over 12 million U.S. adults using them for weight loss.

However, these medications often fail to provide long-term solutions due to high discontinuation rates caused by gastrointestinal side effects, cost, and access issues. Studies indicate that up to 66% of weight can be regained within a year after stopping GLP-1 drugs.

The FDA grants Breakthrough Device Designation to technologies addressing unmet medical needs and offering the potential for more effective treatment of severe or debilitating conditions.

This program aims to expedite the development, assessment, and review of such devices while maintaining rigorous regulatory standards for pre-market approval.

Patients discontinuing GLP-1 drugs require a reliable solution to maintain weight loss, which the FDA's designation recognizes.

Data from the weight maintenance study is expected in the fourth quarter of this year, with a mid-point randomized analysis of the REMAIN-1 study anticipated in the second quarter of 2025.

These results are expected to demonstrate Revita's potential to transform the treatment landscape for patients seeking sustainable solutions for obesity.

Previous clinical studies of Revita in T2D patients in the U.S. and EU have shown promising results for maintaining weight after a single procedure.

Revita is approved in Germany for treating T2D and has received both FDA Breakthrough Device designation for insulin-treated T2D and CMS reimbursement support for study-related expenses and routine costs.

 

 

 

Source: globenewswire.com

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