The FDA has cleared the Epitomee Capsule, a new ingestible medical device for weight management in adults with a body mass index of 25 to 40 kg/m², intended for use alongside diet and exercise. Epitomee Medical Ltd. developed this prescription device as a drug-free alternative to existing weight management therapies.

The Epitomee Capsule works by absorbing water in the stomach, forming a three-dimensional matrix designed to occupy volume and induce a sensation of fullness. Its mechanism of action is mechanical, without any chemical activity.

The capsule was evaluated in the RESET study, a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Researchers enrolled 279 adult patients with overweight and obesity, including those with prediabetes, across nine U.S. sites. The patients were randomly assigned to receive either the investigational device or placebo, taken twice daily for 24 weeks. 

Among the key findings were:

• Greater weight loss: significantly greater weight reduction in the treatment group compared with the control (P < .0001).
• High response rate: 55.5% of the patients in the treatment group achieved ≥ 5% total body weight reduction at 24 weeks (95% confidence interval = 46.1–64.6, P < .0001).
• Safety: no serious adverse device effects were reported.
• Improved quality of life: patients in the treatment group showed significant improvements in several items of the IWQOL-Lite-CT questionnaire.

In the extended ELECT study, conducted at three of the original nine sites, the researchers demonstrated a favorable safety profile throughout an additional 24-week treatment period for the device group.

The manufacturer is now seeking strategic partnerships to bring the capsule to the U.S. market.