Epitomee Medical Ltd., a leading health solutions company, has announced that the United States Food and Drug Administration (FDA) has cleared its innovative Epitomee® Capsule. This cutting-edge, ingestible medical device is designed to support weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2, alongside diet and exercise. The Epitomee® Capsule represents a significant advancement in weight management, offering a drug-free alternative to traditional treatments. This innovative approach provides a new option for millions of individuals seeking safe and effective ways to manage their weight.
The Epitomee® Capsule operates on a simple yet effective principle. Once swallowed, the capsule reaches the stomach and absorbs water, expanding into a three-dimensional matrix that occupies space in the stomach. This creates a feeling of fullness, helping individuals to feel satiated and consume fewer calories. Importantly, the Epitomee® Capsule works purely through a mechanical process, without involving any chemical activity.
The FDA clearance of the Epitomee® Capsule comes after the successful completion of the RESET study. This prospective, randomized, double-blind, placebo-controlled, multi-center trial enrolled 279 overweight and obese adults with and without prediabetes across nine sites in the United States. The study demonstrated that individuals using the Epitomee® Capsule achieved significantly better weight loss compared to those in the control group, achieving an average weight loss of over 35%. The study also highlighted the excellent safety profile of the Epitomee® treatment, with minimal patient dropouts and no serious adverse device effects. Furthermore, subjects using the Epitomee® Capsule reported improved quality of life in various aspects, indicating the positive impact of the device on overall well-being.
The company conducted a follow-up study, ELECT, in three of the original RESET study sites. In this study, participants from both the device and placebo groups continued taking the Epitomee® Capsule for an additional 24 weeks. The ELECT study further confirmed the favorable safety profile of the Epitomee® treatment over the extended 48-week period.
Shimon Eckhouse, PhD, co-founder and chairman of the board of Epitomee Medical Ltd., expressed enthusiasm for the FDA clearance, stating that it represents a significant milestone in the field of weight management. He emphasizes the innovative approach and safety of the Epitomee® Capsule, highlighting its potential to positively impact the lives of individuals seeking weight management solutions.
Dan Hashimshony, PhD, CEO of Epitomee Medical Ltd., echoed this sentiment, emphasizing the company’s commitment to tackling the global obesity epidemic. He believes the Epitomee® Capsule offers a safe, effective, and drug-free solution to individuals struggling with weight management. The company is now focused on bringing this groundbreaking product to the U.S. market and exploring strategic partnerships to maximize its commercial potential.
Epitomee Medical Ltd. is a pioneering health solutions company dedicated to advancing innovative therapies. With a strong focus on safety, efficacy, and improving quality of life, the company is committed to leading the way in transformative healthcare solutions. In addition to its flagship weight management solution, Epitomee Medical is also developing a cutting-edge platform for the oral delivery of biologics, aiming to enhance bioavailability and improve drug delivery methods.
The FDA clearance of the Epitomee® Capsule marks a significant step forward in the fight against obesity. It represents a testament to Epitomee Medical’s dedication to innovation and its commitment to providing safe and effective solutions to address the growing global health challenge of weight management.
