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ReShape Vest trial

ReShape begins European Trial to support CE Mark for ReShape Vest

Primary endpoints in this trial include percent total body weight loss and adverse event rates at 12 months

ReShape Lifesciences has commenced site initiation training for the first clinical trial site that will participate in the multi-centre trial of the ReShape Vest to support CE Mark approval. The trial, which will include study centres in Spain, Germany, Belgium, The Netherlands and the Czech Republic, seeks to enrol up to 95 subjects who will be followed for two years. Primary endpoints in this trial include percent total body weight loss and adverse event rates at 12 months. Enrolment is expected to begin in the third quarter of 2018.

"We have been very encouraged by the results to date with our ReShape Vest, our novel, less invasive treatment option for patients battling obesity," said Dan Gladney, Chief Executive Officer and Chairman of the Board of ReShape Lifesciences. "We look forward to beginning our CE Mark study and are excited to be one step closer to having the ReShape Vest available as a treatment option for clinical use throughout the European Union."

The GVS is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in obese and morbidly obese patients. The device wraps around the stomach, emulating the effect of conventional weight-loss surgery, and enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the US, at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Haemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38cms.

EnteroMedics acquired the Gastric Vest System through its acquisition of BarioSurg in May 2017.

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