Expanded Clinical Data Set for the Obalon Balloon System Presented at DDW 2019
May 21 2019 - 4:01PM
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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