Israel-based health solutions provider Epitomee Medical has received the US Food and Drug Administration (FDA) approval for its advanced ingestible medical device, Epitomee Capsule.
Encased in a self-administered ingestible capsule, the device supports weight management in adults with a Body Mass Index (BMI) of 25 to 40kg/m² alongside diet and exercise.
Once ingested, it absorbs water in the stomach, expanding into a three-dimensional matrix.
The matrix occupies space, creating a sensation of fullness, which helps support weight loss.
The capsule works directly in the gastrointestinal (GI) tract, through a mechanism of action that is purely mechanical and does not involve any chemical activity.
Epitomee said that its capsule represents a new prescription option in weight management, providing a drug-free alternative for health-conscious individuals in the US.
Also, the FDA approval allows the capsule accessible to a wider range of patients who are looking for tolerable and easy-to-use weight management solutions, said the medical device maker.
Epitomee Medical CEO 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.
“As we move forward, we are eager to bring this groundbreaking product to the U.S. market and seek strategic partnerships to fully realise its commercial potential.”
The US FDA approved Epitomee Capsule based on results from the RESET study, a randomised, double-blind, placebo-controlled, multi-centre clinical trial.
The study enrolled 279 overweight and obese adults with and without prediabetes at nine sites, located across nine different states in the US.
In the study, the participants were given either one capsule of Epitomee’s ingestible device or a placebo twice daily for 24 weeks, alongside diet and exercise.
The study met both co-primary endpoints, showing significantly better weight loss for the participants who received the ingestible device, compared to the control group.
In the study, Epitomee’s device was well tolerated, with fewer patient dropouts than control, and showed a favourable safety profile, with no serious adverse device effects (SADEs).
Furthermore, subjects treated with Epitomee Capsule showed superior improvement in quality of life in several items of the IWQOL-Lite-CT questionnaire.
Epitomee Medical co-founder and board chairman Shimon Eckhouse said: “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.”
