Epitomee Medical has received approval from the US Food and Drug Administration (FDA) for the Epitomee Capsule, an ingestible device aimed at supporting weight management.
The device is intended for use by adults with a Body Mass Index (BMI) of 25kg/m²–40kg/m², in conjunction with diet and exercise.
This approval introduces a drug-free alternative to the weight management market, potentially benefiting millions of individuals in the US.
The Epitomee Capsule is a prescription-based innovation that stands out from existing injectable treatments. It is designed for a wide range of patients seeking manageable weight management solutions.
Encased in a standard-sized capsule, the device operates mechanically without any chemical interaction, expanding in the stomach to create a sensation of fullness.
Once ingested, it absorbs water and expands to form a three-dimensional matrix in the stomach, which aids in weight loss by promoting a feeling of satiety. It targets the gastrointestinal (GI) tract directly.
Epitomee Medical CEO Dr Dan Hashimshony said: “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.”
The FDA's clearance was based on the results of the prospective, randomised, double-blind, placebo-controlled, multi-centre RESET trial.
This study involved 279 overweight and obese adult subjects, including those with prediabetes, across nine different states in the US. Participants were divided into test or placebo groups, with the regimen including two capsules daily alongside diet and exercise over 24 weeks.
The RESET study's findings were significant, demonstrating that the device group experienced notably better weight loss compared to the control group.
Additionally, the co-primary endpoint of treatment responders was met, with 55.5% of subjects in the Epitomee treatment group achieving at least a 5% reduction in total body weight at 24 weeks post-randomisation, surpassing the >35% threshold.
