ReShape Medical®, Inc. today announces results of its U.S. Phase 1 investigational clinical study. This feasibility study of thirty subjects assessed the safety and effectiveness of the ReShape Duo™ in conjunction with lifestyle modification in patients with a body mass index (BMI) of 30-40. After six months of therapy, 21 study participants treated with the ReShape Duo™ achieved an average of 32% excess weight loss and maintained much of this weight loss six months after the device was removed.
The prospective, randomized study was conducted by three principal investigators: Brian Quebbemann, MD, FACS, Center for Advanced Laparoscopic Surgery, Newport Beach, California; Jaime Ponce, MD, FACS, FASMBS, Hamilton Medical Center, Dalton, Georgia; and Emma Patterson, MD, FRCS, FACS, Legacy Good Samaritan Medical Center, Portland, Oregon.
The results of the study are being presented today at the American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting during the Emerging Technologies Session by Dr. Jaime Ponce. "The study results are very encouraging. Although more extensive clinical study remains necessary, this initial feasibility data suggest that the ReShape Duo could be an attractive option for patients not ready to make a decision for surgery or a permanent implant," said Dr. Ponce.
Dr. Brian Quebbemann, the first physician in the U.S. to treat patients with the ReShape Duo, added, "ReShape Duo may have an important role in the treatment of obesity as both a six-month jump-start to weight management as well as providing a key component of longer-term therapy."
"We are pleased with our recent U.S. data and look forward to continued investigation in a U.S. pivotal study," said Ken Charhut, ReShape Medical CEO. "There is a wide gap between conventional behavior modification and invasive surgery. The ReShape Duo bridges this gap with a reversible, non-surgical approach to weight loss."
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