Market Overview

Allurion Technologies Completes Enrollment in Landmark Pivotal U.S. Clinical Trial for the Elipse® Balloon


Enrollment surpasses 400-patient goal; topline results expected in
early 2019

, a pioneering leader in the development of innovative,
scalable and trusted weight loss experiences, today announces completion
of enrollment in ENLIGHTEN, a United States clinical trial for the Elipse®
Balloon –a procedureless™ gastric balloon for weight loss. Allurion
expects to use the data from this trial in its future regulatory
submission to the U.S. Food and Drug Administration (FDA).

"We have been encouraged by the performance of the Elipse Balloon thus
far," said Jaime Ponce, M.D., Medical Director of Chattanooga Memorial
Hospital Weight Management Center and Principal Investigator of the
ENLIGHTEN study. "A weight loss device that does not require surgery,
endoscopy, or anesthesia could be an appealing option for millions of
people in need of care."

The trial has been met with extraordinary interest in the United States.
More than 62,000 individuals visited the ENLIGHTEN trial website since
the first
were treated on February 1, 2018. In total, more than 400
patients were enrolled in 11 centers throughout the United States.

"Our experience to date with the Elipse Balloon underscores its
potential convenience, ease of use, and scalability," said Rachel L.
Moore, M.D., F.A.C.S. of Surgical Specialists of Louisiana in New
Orleans. "Unlike some other weight loss interventions, Elipse requires
no endoscopy, which could make it very popular with both doctors and

The Elipse Balloon received
its European Union CE mark
 in 2015 and is currently available in
more than 100 weight loss centers in countries across Europe and the
Middle East. More than 6,000 individuals have already been treated.
Unlike other weight loss balloons on the market, the Elipse Balloon can
be 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.

"The remarkable demand we observed during enrollment supports the
consumer-facing approach we took in the design of the Elipse Balloon,"
said Ram Chuttani, M.D., Chief Medical Officer of Allurion. "With
enrollment behind us, we are looking forward to receiving top-line
results early next year."

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. For
more information, please visit:

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 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

is dedicated to helping people realize their full
potential with innovative, scalable and trusted experiences. 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,
on Facebook at
or on Twitter @alluriontech.


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.

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