Fractyl Health, which went public in February 2024, got some good and bad news on Monday as it secured an Investigational Device Exemption from the FDA for its Revita endoscopy system designed to maintain weight loss, but posted a $19.2 million net loss in the company’s most recent quarter.

The FDA’s Investigational Device Exemption (IDE) clears the way for a pivotal study of Fractyl’s Revita system designed to maintain weight loss after patients have stopped taking GLP-1 drugs. An outpatient endoscopic procedure, Revita targets the duodenum—which is just below the stomach—and reverse the pathology in the duodenal lining that is a root cause of obesity and type 2 diabetes.

Fractyl said that in prior studies of the device conducted on patients with type 2 diabetes, the analyses of data showed evidence to support the potential for weight maintenance after a single procedure.