Epitomee weight-loss capsule cleared by FDA for sales in US market

18 Sep 2024 --- The US FDA has cleared Epitomee Medical’s capsule to support weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2 alongside diet and exercise. The novel, drug-free, ingestible medical device provides a new option for health-conscious people in the US.

The Epitomee Capsule is encased in a standard-size, self-administered ingestible capsule. Once it’s swallowed and reaches the stomach, it absorbs water and creates a three-dimensional matrix to occupy volume in the stomach, resulting in a “sensation of fullness,” enabling weight loss. 

“We are proud to have received FDA clearance for our Epitomee weight management oral, drug-free solution. This achievement results from the innovative approach we have taken to tackle the global obesity epidemic, says Dan Hashimshony, Ph.D., CEO of Epitomee Medical. 

“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 US market and seek strategic partnerships to fully realize its commercial potential.”

Clinical trial support

The weight management capsule was cleared following a prospective, randomized, double-blind, placebo-controlled and multi-center trial, the RESET study. In this trial, 279 overweight and obese adults with and without prediabetes took one capsule of the investigational device or a placebo twice daily for 24 weeks, alongside diet and exercise. 

The researchers found that the Epitomee Capsule “demonstrated significantly better weight loss” than the placebo consumed in the control group. Over half of the participants (55.5%) taking the Epitomee product reduced their body weight by at least 5%, exceeding the threshold set at 35%. 

The majority of participants taking the capsule achieved at least 5% to 15% weight loss. In addition, 27% of participants lost at least 10% of their body weight, while 11% lost over 15%. 

Moreover, the study supported a favorable safety profile throughout the study duration. Epitomee treatment was well tolerated, and the group using this product had a lower dropout rate than the control group. The researchers also found no serious adverse side effects. 

The participants using the Epitomee Capsule also improved their quality of life. 

In a follow-up study in three of the nine sites that participated in the RESET study, participants from the device and placebo groups continued taking the capsule for another 24 weeks. This also demonstrated a favorable safety profile of the capsule throughout the 48-week period. 

Weight management solutions

The Epitomee Capsule’s mechanism is “purely mechanical,” explains the company. It does not involve chemical activities and works directly in the gastrointestinal tract. As the FDA extended its clearance to adults with a BMI starting at 25, the product is accessible to many patients looking for tolerable and easy-to-use weight management solutions. 

“The FDA clearance of the Epitomee Capsule marks a significant milestone in 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,” comments Shimon Eckhouse, Ph.D., co-founder and chairman of the board. 

Last year, Nestlé secured the distribution rights for the Epitomee Capsule as the company expanded its focus on weight management solutions, such as products that complement popular weight-loss medications. 

As the popularity of weight loss drugs continues to rise, nutrition companies are examining natural alternatives and healthy nutrition with scientific support to manage weight sustainably. For example, the supplement brand founded by Kourtney Kardashian Baker, Lemme, recently launched a supplement to boost GLP-1 hormone levels, reduce hunger and cravings and support healthy weight management.