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Obalon Announces Data Presentation at the Annual Meeting of the American Society for Metabolic and Bariatric SurgerySAN DIEGO, Nov. 04, 2016 (GLOBE NEWSWIRE) -- Obalon Therapeutics Inc. (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, announced an oral presentation at ObesityWeek 2016, the largest international event focused on the basic science, clinical application, prevention and treatment of obesity. The annual conference is hosted by the American Society for Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS). The presentation, titled “A 6-month Swallowable Balloon System results in sustainable weight loss at 1 year: Results from a prospective, randomized sham-controlled trial” will be presented by Dr. Aurora Pryor at 8:22 am CDT this morning at the meeting in Great Hall B-C. “We’re eager for the healthcare professionals on the front lines of fighting obesity to hear first-hand the scientific rigor that exists around our clinical trial, as well as the level of efficacy that our clinical investigators and trial participants experienced with the Obalon Balloon System,” commented Andy Rasdal, Chief Executive Officer of Obalon. “Obesity Week is the premiere meeting to debut this data.” The Obalon Balloon System was approved by the Food and Drug Administration (FDA) in September 2016. It is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. Three (3) Obalon Gastric Balloons are placed n the stomach within three months of the six-month treatment period. The Obalon Balloon System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed six months after the first balloon is placed. “The Obalon Balloon System, coupled with lifestyle modification, provides a new low risk option for patients struggling with obesity,” said Aurora Pryor, MD, FASMBS, study co-author and Director of the Bariatric and Metabolic Weight Loss Center at the Stony Brook University School of Medicine’s Department of Surgery. “The significant weight loss achieved with the Obalon Balloon System is typically maintained at 12 months, providing patients with an opportunity to maintain a healthier lifestyle.” In a clinical trial, 387 patients in the United States across fifteen clinical trial sites were randomized in a double-blind, sham-controlled study. The patients in the clinical trial received either three Obalon balloons or three sham placebo-like devices that looked similar to the balloons, but were filled with sugar. The patients in both groups were given minimal diet counseling of 25 minutes every three weeks. Both co-primary weight loss endpoints were met, with approximately 65% of patients who received the Obalon balloon system experiencing clinically meaningful weight loss of at least 5% of their total body weight, which is twice as many people than in the sham-control group. Additionally, patients in the Obalon Balloon System group showed strong weight loss maintenance, with 89.5% of the mean total body weight loss maintained at one year. About Obalon Therapeutics, Inc. Forward Looking Statements
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