Mon Sep 16 15:12:15 UTC 2024: ## Drug-Free Weight Management Solution Gets FDA Clearance
**CAESAREA, Israel – September 16, 2024** – Epitomee Medical Ltd., an Israeli health solutions company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its innovative **Epitomee® Capsule** for weight management in adults with a Body Mass Index (BMI) of 25-40. This drug-free, ingestible medical device represents a new, non-invasive option for those seeking alternative weight loss solutions alongside diet and exercise.
The Epitomee® Capsule works by expanding in the stomach, creating a feeling of fullness and reducing hunger. This mechanical action, achieved through the capsule’s unique three-dimensional matrix, avoids any chemical interactions and is entirely safe and effective, as demonstrated in clinical trials.
The FDA clearance was based on the successful **RESET** study, a multi-center, double-blind, placebo-controlled trial involving 279 overweight and obese adults. The study showed significant weight loss among those using the Epitomee® Capsule compared to the placebo group. Notably, over 55% of participants using the device achieved a weight loss of at least 5% after 24 weeks.
The study also highlighted the safety and tolerability of the Epitomee® Capsule, with no serious adverse device effects reported.
“The FDA clearance of the Epitomee® Capsule is a major milestone in the field of weight management,” commented Shimon Eckhouse, co-founder and chairman of the board of Epitomee Medical. “This safe and effective drug-free solution opens up new possibilities for individuals striving to improve their health and quality of life.”
“We are proud to offer a safe, effective, and drug-free solution to the millions struggling with weight management,” stated Dan Hashimshony, CEO of Epitomee Medical. “We are eager to bring this groundbreaking product to the U.S. market and seek strategic partnerships to realize its full commercial potential.”
Epitomee Medical is now moving forward with plans to bring the Epitomee® Capsule to the U.S. market. The company also has a pipeline of other innovative healthcare solutions focused on weight management and biologic drug delivery.
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