Therapy Areas: Devices
Epitomee submits Weight Loss Capsule for FDA approval in US
7 March 2024 -

Epitomee (TASE: EPIT), an Israel-based health solutions company, involved in advancing innovative therapies, announced on Wednesday that it submitted its Weight Loss Capsule for FDA approval in the United States on 27 February 2024.

The company says that the Epitomee capsule offers an innovative, orally administered, drug free, and clinically proven as effective and safe solution, for adults, who are looking to lose weight. The proposed indication covers the broadest Body Mass Index (BMI) range of 25 to 40 kg/m2, even without comorbidities, when used in conjunction with diet and exercise.

The company has made the submission through the 510k regulatory pathway for medical devices. The product has already received approval in the European Union and has a CE mark. Following FDA approval, the capsule will be made available by prescription from healthcare professionals.