Epitomee Medical's New Capsule Gets FDA Green Light For Weight Management

Epitomee Medical Ltd. has received clearance from the U.S. FDA for its innovative Epitomee® Capsule, an ingestible medical device aimed at helping adults with a BMI between 25 and 40 kg/m² manage their weight through diet and exercise. This groundbreaking, drug-free solution offers a fresh alternative for millions of people in the U.S. looking for effective weight management options.

The Epitomee® Capsule stands out as a prescription-based weight management solution that doesn’t rely on drugs or injections. With FDA approval for individuals with a BMI starting at 25, it offers a more accessible, user-friendly option for those seeking a manageable, non-invasive approach to weight control. Once ingested, the Epitomee® Capsule, a self-administered pill, expands by absorbing water in the stomach, forming a matrix that occupies space and promotes a feeling of fullness. This purely mechanical process aids in weight loss by directly impacting the gastrointestinal tract without any chemical interaction.

The U.S. FDA granted clearance for the Epitomee® Capsule following the successful RESET study, a large-scale clinical trial conducted across nine states in the U.S. This rigorous, multi-center study was a randomized, double-blind, placebo-controlled trial involving 279 overweight and obese adults, some of whom had prediabetes. Participants were randomly assigned to either the test group or a placebo group, taking one capsule of the Epitomee® device or placebo twice daily alongside a diet and exercise regimen for 24 weeks.

The trial met both of its co-primary endpoints. Results showed that the participants who used the Epitomee® device experienced significantly greater weight loss than those in the placebo group (P<0.0001). Additionally, 55.5% of individuals in the treatment group achieved a reduction of at least 5% in their total body weight after 24 weeks, well above the target threshold of 35% (P<0.0001).

Shimon Eckhouse, PhD, Co-Founder and Chairman of the board, stated his opinions on the approval, “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. The ability to manage weight through a simple, drug free capsule opens up new possibilities for those seeking to improve their health and quality of life.”

The study highlighted the strong safety profile of the Epitomee® treatment over the course of the trial. Participants in the Epitomee® group tolerated the treatment well, with fewer dropouts compared to the control group. Importantly, no serious adverse device effects (SADEs) were reported. Additionally, those receiving Epitomee® treatment experienced notable improvements in their quality of life, as reflected by several items on the IWQOL-Lite-CT questionnaire.

The company also conducted a follow-up study, called the ELECT study, at three of the nine sites involved in the RESET trial. In this extension study, participants from both the device and placebo groups continued taking the Epitomee® capsule for an additional 24 weeks. The results reinforced the favorable safety profile of the Epitomee® treatment, showing consistent safety over the full 48-week duration for participants in the device group.

Dan Hashimshony PhD, CEO of Epitomee Medical Ltd., mentioned “We are proud to have received FDA clearance for our Epitomee® weight management Oral, Drug-Free solution. 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. As we move forward, we are eager to bring this groundbreaking product to the U.S. market and seek strategic partnerships to fully realize its commercial potential.”