Epitomee Medical has gained FDA clearance for its Epitomee Capsule, an ingestible medical device designed to support weight management in adults with a BMI25–40kg/m² alongside diet and exercise. This novel, drug-free treatment provides a new option for millions of health-conscious individuals in the US, the company claims, and represents an innovative prescription option in weight management solutions, offering a drug-free alternative that differs from injectable treatments.
The Epitomee device is encased in a standard size, self-administered ingestible capsule. Once the Epitomee Capsule is swallowed and reaches the stomach it absorbs water in the stomach and creates a three-dimensional matrix designed to occupy volume in the stomach creating a sensation of fullness, enabling weight loss. The Epitomee Capsule mechanism of action is purely mechanical and does not involve any chemical activity. The capsule works directly in the gastrointestinal (GI) tract.
Epitomee Capsule was cleared by the U.S. FDA following the RESET study. This was a prospective, randomised, double-blind, placebo-controlled, multi-centre trial. The study enrolled 279 overweight and obese adults with and without prediabetes. All nine sites enrolled in the study were in the US, located across nine different states. Eligible subjects were randomised to test or placebo arms. Subjects were to take one capsule of the investigational device or placebo twice daily, alongside diet and exercise, for a period of 24 weeks. The study demonstrated that both co-primary endpoints were successfully met.
The RESET study demonstrated significantly better weight loss among the device group compared to the control group (p<0.0001). The co-primary endpoint of treatment responders was also achieved: the rate of Epitomee treatment group subjects whose total body weight was reduced by at least 5% at 24-weeks post randomisation was 55.5% (CI; 46.1-64.6), significantly exceeding the threshold of >35% (p<0.0001).
The study demonstrated a favourable safety profile of Epitomee treatment throughout the study duration. Epitomee treatment was well tolerated, with fewer patient dropouts in Epitomee group than the control group. There were no serious adverse device effects (SADEs) in the study. In addition, subjects treated with Epitomee showed better improvement in quality of life in several items of the IWQOL-Lite-CT questionnaire.
The company also performed an additional study in three out of the nine sites that participated in the RESET study, the ELECT study. In this study subjects from both the device group and the placebo group kept on taking the Epitomee capsule for an additional 24 week period. The study demonstrated a favourable safety profile of Epitomee treatment throughout the 48 weeks of the study duration for subjects in the device group.