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

NATICK, Mass.--(BUSINESS WIRE)-- Allurion Technologies, a pioneering leader in the development of innovative, scalable and trusted weight loss therapies, today announces the start of ENLIGHTEN, a United States clinical trial for the Elipse^® Balloon – the world’s first and only procedureless™ gastric balloon for weight loss.

“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,” said Jaime Ponce, M.D., Medical Director of Chattanooga Memorial Hospital Weight Management Center and Principal Investigator of the ENLIGHTEN study. “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.”

About the ENLIGHTEN Study

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: http://clinicaltrials.gov/ct2/show/NCT03261453 and http://balloontrial.com.

About the Elipse Balloon

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.

The Elipse Balloon is made of a thin, flexible polymer film. The device is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached. The balloon remains in the stomach for approximately four months, after which it opens, allowing it to empty and pass naturally from the body without the need for a removal procedure. A pilot clinical study and recent 135-patient clinical trial conducted outside the United States in overweight and obese individuals demonstrate an average weight loss of 13 to 15 kilograms (29 to 33 pounds), which equates to approximately 15% of total body weight.^1,2 Participants also saw improvements in their triglycerides, hemoglobin A1c (HbA1c) and quality of life.¹

About Allurion Technologies

Allurion Technologies is dedicated to helping people realize their full potential with innovative, scalable and trusted products. The company’s flagship product, the Elipse Balloon, is the world’s first and only swallowable, procedureless gastric balloon for weight loss. Learn more about the Elipse Balloon and Allurion online at www.allurion.com, on Facebook at www.fb.com/allurion or on Twitter @alluriontech.

References:

1. Raftopoulos and Giannakou. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13:1174-1182.
2. Al Sabah et al. The safety and efficacy of the procedure-less intra-gastric balloon. Surg Obes Relat Dis. doi:10.1016/j.soard.2017.12.001.

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