Landmark Pivotal U.S. Clinical Trial for the Elipse® Balloon Commences

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Jaime Ponce, M.D., Medical Director of Chattanooga Memorial Hospital Weight Management Center and Principal Investigator of the ENLIGHTEN study said, “The start of the ENLIGHTEN clinical trial is not only a milestone for the Elipse Balloon, but also for the field of weight loss more broadly.” In addition she said, “Non-surgical weight loss therapies will help treat those who have not seen success from dieting alone. Having now treated the first patients in ENLIGHTEN, we are one step closer to having a next-generation tool to offer those in need of a solution.”

The Elipse Balloon received its European Union CE mark in 2015 and is currently available in more than 40 weight loss centers in countries across Europe and the Middle East. Over 4,000 individuals have already been treated. Unlike other weight loss balloons on the market, the Elipse Balloon is placed and removed without surgery, endoscopy, or anesthesia. It is swallowed in a capsule during a brief, outpatient office visit and remains in the stomach for approximately four months, after which it opens and passes naturally from the body.

“We are looking forward to adding to our global clinical trial experience with the Elipse Balloon,” said Ram Chuttani, M.D., Chief Medical Officer of Allurion. “Starting ENLIGHTEN is the first step toward bringing our flagship product to the United States where we can build upon the success we have had abroad.”

“The Elipse Balloon has the potential to revolutionize the way obesity is treated in the United States,” added Shantanu Gaur, M.D., Chief Executive Officer of Allurion. “Millions of Americans are struggling to lose weight, and they are calling for new options that are safe and effective. The ENLIGHTEN study is the next step in meeting this consumer need.”

ENLIGHTEN is a randomized, sham-controlled study designed to evaluate the safety and efficacy of the Elipse Balloon in 400 individuals. The study will be conducted at up to 12 sites in the United States. For more information, please visit here.

The Elipse Balloon is a procedureless weight loss device that is swallowed and removed without surgery, endoscopy, or anesthesia. The Elipse System received its European Union CE mark in 2015 and is currently available in Europe and the Middle East. It is not yet approved by the FDA and is not currently available commercially in the United States.

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