Epitomee Medical Ltd. has announced that its Epitomee® Capsule, an ingestible medical device, has received FDA clearance for weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m². This prescription solution offers a drug-free alternative for individuals seeking weight management support alongside diet and exercise.
Innovative Mechanism of Action
The Epitomee® Capsule is designed to promote a feeling of fullness. Once ingested, the capsule absorbs water in the stomach, forming a three-dimensional matrix that occupies volume and creates a sensation of satiety. This mechanical action, which occurs directly in the gastrointestinal (GI) tract, aids in weight loss without any chemical activity.
Clinical Trial Results
The FDA clearance was supported by data from 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 sites in the U.S. Participants were randomized to receive either the Epitomee® Capsule or a placebo, taken twice daily for 24 weeks in conjunction with diet and exercise.
The RESET study met its co-primary endpoints, demonstrating significantly greater 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 a total body weight reduction of at least 5% at 24 weeks, significantly exceeding the pre-defined threshold of >35% (P<0.0001).
Safety and Tolerability
The Epitomee® Capsule exhibited a favorable safety profile throughout the study. The treatment was well-tolerated, with fewer patient dropouts in the Epitomee® group compared to the control group. Notably, there were no serious adverse device effects (SADEs) reported. Furthermore, subjects treated with the Epitomee® Capsule reported improvements in their quality of life, as measured by the IWQOL-Lite-CT questionnaire.
An additional study, the ELECT study, followed subjects from both the device and placebo groups for an additional 24 weeks, totaling 48 weeks of treatment. This study further confirmed the favorable safety profile of the Epitomee® Capsule over the extended duration.
Company Leadership Comments
Shimon Eckhouse PhD, co-founder and chairman of the board of Epitomee Medical, 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..."
