Epitomee Medical Ltd. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Epitomee® Capsule, an ingestible medical device designed to support weight management in adults. This innovative, drug-free treatment offers a new option for individuals with a Body Mass Index (BMI) of 25–40 kg/m², intended for use alongside diet and exercise.
Mechanism of Action
The Epitomee® Capsule is designed as a prescription weight management solution, providing a drug-free alternative to other treatments. Suitable for adults with a BMI starting at 25, the capsule is self-administered and, upon reaching the stomach, absorbs water to create a three-dimensional matrix. This matrix occupies volume in the stomach, promoting a sensation of fullness and facilitating weight loss through a purely mechanical action within the gastrointestinal (GI) tract, without any chemical activity.
Clinical Trial Results
The FDA clearance was supported by the RESET study, a prospective, randomized, double-blind, placebo-controlled, multi-center trial. The study involved 279 overweight and obese adults, some with prediabetes, across nine U.S. sites. Participants were randomized to receive either the Epitomee® Capsule or a placebo, taken twice daily with diet and exercise, over 24 weeks.
The RESET study met its co-primary endpoints, demonstrating significantly better weight loss in the device group compared to the control group (P<0.0001). Additionally, 55.5% of subjects in the Epitomee® treatment group achieved at least a 5% reduction in total body weight at 24 weeks (CI; 46.1-64.6), significantly exceeding the pre-defined threshold of >35% (P<0.0001).
Safety and Tolerability
The study also highlighted a favorable safety profile for the Epitomee® Capsule, with good tolerability and fewer dropouts in the device group compared to the control group. No serious adverse device effects (SADEs) were reported. Furthermore, subjects treated with the Epitomee® Capsule reported improvements in quality of life, as measured by the IWQOL-Lite-CT questionnaire.
An additional study, the ELECT study, was conducted at three of the RESET study sites, where subjects continued taking the Epitomee® capsule for an additional 24 weeks. This study confirmed the favorable safety profile of the Epitomee® treatment over the extended 48-week period for subjects in the device group.
Leadership Perspective
Shimon Eckhouse PhD, co-founder and chairman of the board, stated, "The FDA clearance of the Epitomee® Capsule marks a significant milestone in the field of weight management. Its innovative approach offers a safe and effective option for patients..."
Dan Hashimshony PhD, CEO of Epitomee Medical Ltd., added, "We are proud to have received FDA clearance for our Epitomee® weight management Oral, Drug-Free solution..."
Epitomee Medical is also developing a platform for the oral delivery of biologics, aimed at enhancing drug bioavailability.
