Key Weight Loss and Safety Data Presented for the Obalon Swallowable Gas-Filled Balloon System at the 35th ASMBS Annual Meeti...
November 15 2018 - 9:15AM
Clinical results presented from over 1,300 patients
treated at 108 sites with Obalon’s non-surgical weight loss
solution in commercial setting
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 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. (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 November 2, 2018,
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
Media: Megan Driscoll EvolveMKD Office Phone: +1 646 517 4220
mdriscoll@evolvemkd.com
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