Expanded Clinical Data Set for the Obalon Balloon System Presented at DDW 2019

Date : 05/21/2019 @ 9:01PM
Source : GlobeNewswire Inc.
Stock : Obalon Therapeutics, Inc. (OBLN)
Quote : 0.605  0.0149 (2.52%) @ 12:46AM

Expanded Clinical Data Set for the Obalon Balloon System Presented at DDW 2019

OBALON THERAPEUTICS INC (NASDAQ:OBLN)
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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, announces that expanded clinical data from the Company’s large-scale commercial use study was presented at the Digestive Disease Week (DDW) 2019 Annual Conference, held May 18-21, 2019 in San Diego, CA. The 1,411-patient data presentation titled, Predictors of Weight Loss In Patients Treated With A Swallowable Gas-Filled Intragastric Balloon System For Six Months: Results From A U.S. Registry, continues to demonstrate the real-world utility of the Obalon Balloon System, with weight loss and safety results from 143 treatment sites in the United States.

In the presentation at DDW, average weight loss for indicated patients receiving three balloons and six months of therapy was 21.7 pounds, resulting in a 10.2% reduction in total body weight. Of note, 50.7% of patients lost ≥ 10% total body weight and 77.9% lost ≥ 5% total body weight. Weight loss in the first months of therapy was the largest predictor of success. Non-serious adverse events occurred in 10.3% of the patients with the most common being abdominal pain (3.8%), nausea (3.0%), and vomiting (1.7%). There were no serious adverse events (SAEs) reported.

“The Obalon Balloon registry is the largest endoscopic bariatric therapy registry series in the US.  The additional data collected showed significant weight loss in patients treated with this therapy in clinical practice with a good safety profile.  These results remain consistent with our previous publications,” said Shelly Sullivan, M.D. Associate Professor, Medicine-Gastroenterology, Director of the Gastroenterology Metabolic and Bariatric Program, University of Colorado School of Medicine.

About Obalon Therapeutics, Inc. Obalon Therapeutics, Inc. (NASDAQ: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.

Forward-Looking Statements

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 May 10, 2019, and in any other current and future periodic reports the Company files with the Securities and Exchange Commission.

For Obalon Therapeutics, Inc.

Investor Contact: William Plovanic Chief Financial Officer Obalon Therapeutics, Inc. Office: +1 760 607 5103 wplovanic@obalon.com

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