The Epitomee® capsule is designed for oral use and stands out as a drug-free option, clinically validated to be both effective and safe for adults with a Body Mass Index (BMI) ranging from 25 to 40 kg/m^2. It is intended to be used alongside dietary adjustments and increased physical activity, catering to a wide audience without the necessity of underlying health conditions.

The application for FDA approval follows the 510k regulatory pathway, which is specific to medical devices. The product has already garnered approval within the European Union, proudly carrying the CE mark, which signals its adherence to health, safety, and environmental protection standards. Pending FDA approval, the capsule is set to be available in the United States by prescription through healthcare providers.

Prof. Donna Ryan, a revered figure in obesity research and the former president of the World Obesity Federation, praised the Epitomee® capsule for its potential to revolutionize weight management. She highlighted its efficacy in not only promoting weight loss but also in improving patients' quality of life, blood pressure, lipid levels, and waist circumference. Moreover, Prof. Ryan underscored the capsule's potential in preventing diabetes progression among individuals with pre-diabetes, attesting to its excellent safety profile and substantial benefits.

Dr. Dan Hashimshony, CEO of Epitomee Medical, expressed his enthusiasm regarding the FDA submission, viewing it as a crucial step towards the capsule's commercialization in the U.S. He looks forward to introducing this innovative solution to both healthcare professionals and consumers shortly, and aims to broaden the company's global presence through strategic partnerships.

The announcement follows the company's recent update on January 16, 2024, regarding the successful completion of the RESET pivotal clinical trial. This randomized, placebo-controlled, double-blind study assessed the safety and effectiveness of the Epitomee® capsule in conjunction with lifestyle interventions for weight reduction in overweight or obese adults without comorbidities, further solidifying the capsule's potential as a transformative tool in weight management.