Biologic drug delivery company Epitomee Medical Ltd (TASE: EPIT) has announced that the U.S. Food and Drug Administration (FDA) has officially cleared its Epitomee Capsule, an innovative, drug-free weight management device. This prescription solution is designed for adults with a Body Mass Index (BMI) of 25-40 kg/m² and is intended to be used alongside diet and exercise.

The Epitomee Capsule works by creating a sense of fullness once ingested. The capsule expands after absorbing water in the stomach, reducing hunger and supporting weight loss. Its mechanism is purely mechanical, with no chemical interactions involved. This makes it a safer, drug-free alternative for weight management compared to other treatments like injectables.

Epitomee Medical's capsule was cleared following the RESET study, a randomized, double-blind, placebo-controlled trial involving 279 overweight and obese adults, some with prediabetes. The study took place across 9 sites in the U.S., and participants were either given the Epitomee® Capsule or a placebo for 24 weeks, alongside diet and exercise. The trial achieved both co-primary endpoints, with 55.5% of subjects in the Epitomee group losing at least 5% of their body weight by week 24--significantly higher than the control group.

According to the company, the Epitomee Capsule demonstrated a favorable safety profile, with no serious adverse device effects reported. In addition, the capsule was well tolerated, with better weight loss results and quality-of-life improvements in the Epitomee group compared to the placebo group.

Founded in 2005 by Shimon Eckhouse, PhD and led by CEO Dan Hashimshony, PhD, Epitomee Medical Ltd. focuses on weight management and biologic drug delivery. The company is also developing an innovative platform for the oral delivery of biologics, which enhances drug bioavailability.