Medical Professionals Reference (MPR)FDA Clears Epitomee, an Ingestible Device for Weight Management

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The FDA has cleared the Epitomee® capsule for weight management in adults with a body mass index (BMI) of 25 to 40kg/m2. This self-administered medical device expands in the stomach to create a sensation of fullness, offering a non-pharmacological approach to weight loss. The clearance is based on clinical trial data demonstrating significant weight reduction compared to placebo, with a favorable safety profile for extended use. This new option in weight management combines a novel mechanism of action with lifestyle modifications.

Key Points:

• The Epitomee capsule is FDA-cleared for adults with a BMI of 25-40kg/m2, in conjunction with lifestyle changes.
• Once ingested, the device expands in the stomach, creating a feeling of fullness before disintegrating in the intestines.
• In the RESET trial, 55.5% of Epitomee users lost at least 5% of their baseline body weight at 24 weeks.
• The ELECT trial established safety for extended use over a 48-week period.
• The capsule is self-administered twice daily, offering a drug-free alternative for weight management.
• FDA clearance was supported by data showing significantly greater weight reduction with Epitomee compared to placebo.
• The device represents a new approach in the weight management field, potentially appealing to those seeking non-pharmacological interventions.

“Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management.”
– Dan Hashimshony PhD, CEO of Epitomee Medical Ltd.

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