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ENDURE II Trial

First patients implanted with ReShape Vest in ENDURE II Trial

The ReShape Vest System is an investigational, minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery

ReShape Lifesciences announced that the company has successfully implanted its first patient in the ENDURE II trial designed to support CE Marking of the ReShape Vest. The ReShape Vest System is an investigational, minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery, and is intended to enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy. The ReShape Vest is intended for morbidly obese patients with BMI of between 35 and 55.

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.

"We are very excited with the start of the ENDURE II study and expect enrolment to progress quickly with this innovative, world-class technology," said Dr Jordi Pujol, Bariatric Surgeon at the Bellvitge University Hospital in Barcelona, Spain, where he is Principal Investigator for the ENDURE II trial.

The ReShape Lifesciences ENDURE II trial is an investigative, prospective, non-randomized, multi-center study to assess the safety and effectiveness of the ReShape Vest for treatment of obese patients. The study is intended to support CE Marking of the ReShape Vest. The trial will include up to 95 subjects at up to 10 investigational sites located in Spain, the Czech Republic, Germany, Belgium and The Netherlands. Enrolled subjects will be followed for two years, with the application for CE Marking to be submitted when all patients have reached one-year of follow-up.

"It is so exciting to see this minimally invasive medical device being utilized to treat and improve the quality of life of patients," added Dr Raj Nihalani, inventor of the Gastric Vest and Chief Technology Officer at ReShape Lifesciences. "The successful implantation of the first patient with the ReShape Vest is a significant milestone as we move towards CE marking and takes the company one step closer to bringing this novel technology to the millions of patients who battle obesity."

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