FDA Clears Epitomee, an Ingestible Device for Weight Management

The Food and Drug Administration (FDA) has cleared the Epitomee^® capsule, in combination with lifestyle modification, to support weight management in adults with a body mass index of 25 to 40kg/m².

The Epitomee capsule is a self-administered medical device that once ingested, expands in the stomach and occupies the space creating a sensation of fullness. After several hours, the device moves to the intestines where it disintegrates and passes from the body via the gastrointestinal tract.  

The FDA clearance was supported by data from the RESET trial (ClinicalTrials.gov Identifier: NCT04222322), a randomized, double-blind, placebo-controlled study that included 279 overweight and obese adults with and without prediabetes. Study participants were randomly assigned to receive the Epitomee capsule or placebo twice daily, as an adjunct to diet and exercise. 

Findings showed significantly greater weight reduction among patients who received Epitomee compared with those who received placebo (coprimary endpoint; P <.0001). Additionally, 55.5% (95% CI, 46.1-64.6) of patients in the Epitomee group were considered treatment responders (coprimary endpoint), defined as participants who lost at least 5% of baseline body weight at 24 weeks. 

The safety of Epitomee for extended use was established in the ELECT trial (ClinicalTrials.gov Identifier: NCT04994769), an open-label single-arm study that included patients who completed the 24-week treatment period with Epitomee and experienced at least a 3% weight loss during that time. Results showed a favorable safety profile in participants who used the device throughout the 48-week treatment period. 

“Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management,” said Dan Hashimshony PhD, CEO of Epitomee Medical Ltd. “As we move forward, we are eager to bring this groundbreaking product to the US market and seek strategic partnerships to fully realize its commercial potential.”

This article originally appeared on MPR