Clinical results presented from over 1,300 patients treated at 108 sites with Obalon’s non-surgical weight loss solution in commercial setting
SAN DIEGO, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Obalon Therapeutics, Inc. (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, announces that clinical data from a large-scale commercial use study was presented at the American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting at Obesity Week 2018 by Rachel Moore, M.D., Bariatric Surgeon and Weight Loss Specialist. The presentation of the 1,300+ patient data set titled, The First Year of Commercial Experience with a Swallowable, Gas-filled, 3- Balloon System, demonstrates the real-world utility of the Obalon Balloon System, with weight loss and safety results from 108 treatment sites in the United States.
Average weight loss data on patients receiving three balloons and six months of therapy was 21.7 pounds, resulting in a 9.9% reduction in total body weight and a 3.5 point decrease in BMI compared to baseline values. Of note, the top quartile of those patients lost an average of 39 pounds, resulting in a 16.8% reduction in total body weight and a 6.2 point decrease in BMI compared to baseline values. Consistent with prior controlled clinical trial results, the rate of serious adverse events (SAEs) reported was 0.14%, with SAEs occurring in two of the 1,343 patients evaluated for safety. No deaths were reported. Non-serious adverse events occurred in 14.3% of patients, also consistent with prior controlled clinical trial results.
88% of patients treated received three balloons and achieved weight loss that was statistically higher than patients receiving only one or two balloons. 82% of patients completed all six months of therapy and 97% completed at least three months of therapy.
“This large real-world data set validates the Obalon Balloon System as an important tool for battling the obesity epidemic,” said Dr. Moore. “The clinically meaningful weight loss and excellent safety profile can provide clinicians and patients with an important weight loss option for patients who may not qualify for or will not consider bariatric surgery.”
About Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc. (OBLN) is a San Diego-based company focused on developing and commercializing novel technologies for weight loss. The Obalon management team has over 150 combined years of experience in developing and commercializing novel medical technologies with a track record of financial and clinical excellence. For more information, please visit www.obalon.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Obalon Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause Obalon Therapeutics' future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include those risks described in “Risk Factors” and elsewhere in the Company’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2018, and in any other current and future periodic reports the Company files with the Securities and Exchange Commission.
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Obalon Therapeutics, Inc.