ReShape Medical Completes Enrollment of Pivotal Clinical Trial for Weight Loss Device

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SAN CLEMENTE, Calif.--(Business Wire)--
ReShape Medical Inc announced today that it has completed enrollment in the
pivotal clinical trial for the ReShape Duo Intragastric Balloon, one of the
first non-surgical weight loss devices developed for the U.S. market. The
ReShape Duo is placed in the stomach using a standard endoscope, with no
incisions or sutures, where it takes up much of the stomach`s volume causing
patients to eat smaller portions and to feel full sooner. Over the six month
placement period, the ReShape Duo is designed to help patients consistently lose
weight while facilitating new eating and lifestyle behaviors for long-term
weight maintenance.

The eight participating sites were able to recruit and enroll 326 subjects in
less than six months. "There is tremendous patient interest in a non-surgical
approach to weight loss," said George Woodman, MD, Memphis, Tennessee, the
highest enrolling investigator involved in the trial. "We had many more
potential subjects than we could actually enroll."

The REDUCE Trial

The pivotal trial is a randomized, sham controlled design. Study endpoints
assess weight loss, responder rates and duration of effect. "This is the first
non-surgical weight loss device to be studied since the FDA announced their risk
stratified approach to weight loss products," said Jaime Ponce, MD, Dalton,
Georgia, Principal Investigator in the REDUCE trial. "We`re very enthusiastic
about its potential to help patients lose significant weight, without surgery."

The trial design included an interim analysis that allows an independent
statistician to evaluate whether the study required additional enrollment to
maintain the planned study power. "The interim analysis was recently completed
and showed that there was no need to increase enrollment," said Mary Lou Mooney,
VP Clinical, Regulatory and Quality. "We can now complete the study on time and
with greater confidence in a positive outcome."

About ReShape Medical, Inc.

ReShape Medical (www.reshapemedical.com) is a medical device manufacturer
headquartered in Southern California. The company specializes in a
dual-intragastric balloon for weight loss, ReShape Duo, to be used as an aid in
the treatment of obese or overweight patients. ReShape Duo is a non-surgical
alternative designed for those who have exhausted their efforts with diet alone
and wish to avoid or do not qualify for surgery. It comfortably occupies
existing space in the stomach for six months, serving as built in portion
control, to help patients feel full and satisfied with less food. The product
has been available in the European Union since December 2011. CAUTION:
Investigational Device. Limited by Federal (United States) law to
investigational use.

Media:
HealthSTAR Public Relations
Abhishek Basu, 646-722-8820
ABasu@healthstarpr.com

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