Epitomee Medical Ltd. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Epitomee® Capsule, an innovative ingestible medical device designed to support weight management in adults. The capsule is aimed at individuals with a Body Mass Index (BMI) of 25 to 40 kg/m² and offers a drug-free alternative for those seeking to manage their weight alongside diet and exercise.
This FDA approval introduces a novel, non-invasive option for millions of people across the U.S. looking for effective and tolerable weight loss solutions. Unlike injectable treatments, the Epitomee® Capsule is ingested like a regular pill. Upon reaching the stomach, the capsule absorbs water, creating a matrix that occupies space, providing a sensation of fullness that aids in weight loss. Importantly, the device’s action is purely mechanical, with no chemical components involved, and it works directly in the gastrointestinal tract.
The FDA clearance is based on the results of the RESET study, a rigorous, multi-centre clinical trial. Conducted across nine states in the U.S., the study involved 279 overweight and obese adults, some of whom had prediabetes. The trial was designed as a randomised, double-blind, placebo-controlled study, with participants receiving either the Epitomee® Capsule or a placebo twice daily over a 24-week period, in addition to following a diet and exercise regimen.
The findings were conclusive: the device group experienced significantly greater weight loss compared to the control group (P<0.0001). The co-primary endpoint of treatment response was also successfully met, with 55.5% of those in the Epitomee® group achieving at least a 5% reduction in total body weight after 24 weeks – well above the pre-established threshold of 35% (P<0.0001).
The safety profile of the Epitomee® Capsule was another positive aspect of the study. There were no serious adverse effects, and fewer participants in the Epitomee® group dropped out of the trial compared to those in the placebo group. Furthermore, the study noted improvements in the quality of life for patients in the device group, as measured by the IWQOL-Lite-CT questionnaire, which evaluates weight-related quality of life.
An additional follow-up study, the ELECT trial, extended the research for another 24 weeks at three of the nine trial locations. Subjects who continued with the Epitomee® Capsule over this extended period maintained a favourable safety profile, further reinforcing the device’s long-term viability.
Epitomee’s leadership expressed pride in the FDA clearance. Shimon Eckhouse, PhD, co-founder and chairman of Epitomee Medical Ltd., called the approval a “significant milestone in the field of weight management.” He noted that the capsule’s drug-free mechanism provides “a safe and effective option for patients” seeking to improve their health.
Dan Hashimshony, PhD, CEO of Epitomee Medical Ltd., emphasised the broader impact, stating: “This achievement is the result of the innovative approach we have taken to tackle the global obesity epidemic. Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management.”
Epitomee Medical is now preparing to launch its product in the U.S. and is exploring strategic partnerships to maximise its commercial reach. For more information about Epitomee Medical Ltd., please visit Epitomee Medical
