Israeli startup Epitomee says it has completed a pivotal clinical trial to demonstrate the effectiveness of its weight loss capsule.
The capsule is an ingestible device that when taken as a tablet expands in the stomach, applying light tension and giving the brain a feeling of being full. After a few hours, the device dissolves in the body.
The trial, which was conducted over 24 weeks in nine different centers across the US, verified the efficacy of the capsule that is meant to reduce body weight in adults who are overweight or obese.
The study found that throughout the trial, 56 percent of the 279 subjects achieved weight loss. Notably, a majority lost between 5-10 percent of body mass, with 27 percent losing up to 10 percent of their weight.
The trial was conducted to collect the data needed to secure approval from the US Food and Drug Administration (FDA).
The study also tested the safety of the product and concluded that there was no difference in risk between the control group and the experimental group.
“Epitomee is committed to delivering a premium product, tailored to health-conscious individuals, dedicated to sustainable weight loss,” said the company’s CEO Dr.Dan Hashimshon.
“We are developing a valuable addition to the weight management toolbox and seeking further international commercial partnerships to build the market presence and facilitate the successful introduction of our products,” he said.
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