New clinical data highlight convenience, efficiency, and safety of Obalon’s proprietary Navigation and Touch Dispenser systems to achieve reliable balloon administration without the use of x-ray
SAN DIEGO, June 24, 2019 (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, announces that substantial clinical data from a study conducted with 14 clinical sites was presented at Obesity Weekend in Chicago on Friday, June 21st 2019 by the study co-primary investigator, Michael V. Seger, MD, FACS, FASMBS, Bariatric Surgeon at Bariatric Medical Institute (San Antonio, TX). The study included 397 balloon administration assessments from 155 patients with Rachel L. Moore, MD, FACS, FASMBS, Bariatric Surgeon at Surgical Specialists of Louisiana (Metairie, LA) as the study co-primary investigator.
The co-primary endpoints of the Continuous Obalon Balloon Administration Location Tracking (COBALT) Study were met, with 100% correct decision-making for administering and inflating the Obalon Balloon System using the Navigation device instead of X-ray imaging. The study data also demonstrated 100% agreement between the Navigation System assessments and x-ray images collected but not used to make any decision to initiate inflation. There were no serious adverse events observed in the study and the overall adverse event rate was 3.9% with none of the events relating to the Navigation System or Touch Dispenser.
“These results suggest that the Navigation device can be used to safely and accurately administer Obalon Balloons without the use of radiography,” said Dr. Seger. “Prior studies support the ability to achieve safe and effective weight loss with the Obalon Balloon System, and the use of Navigation can remove a key barrier to balloon administration when X-ray imaging is not accessible.”
The Obalon Navigation System provides treating physicians with the ability to place the Obalon Balloon without having to incur the costs and inconvenience of utilizing x-ray imaging. The Obalon Navigation System is a portable, easy to use, non-invasive, radiation free, self-contained imaging system that is FDA approved for dynamic tracking of the Obalon Balloon during balloon administration.
“These data demonstrate the robustness of our Navigation System, which like our gastric balloon, continues to perform well in clinical studies and in commercial use,” said Amy VandenBerg, Chief Clinical and Regulatory Officer of Obalon. “We remain dedicated to improving the performance, usability and economics of the Obalon Balloon System and making this safe and effective technology more readily available to individuals with a BMI between 30 to 40 kg/m2 who are ready to lose weight and improve their overall health.”
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. 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. Obalon Therapeutics undertakes no obligation to update or revise any forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Obalon Therapeutics' business in general, please refer to Obalon Therapeutics’ annual report on Form 10-K filed with the Securities and Exchange Commission on February 22, 2019, Form 10-Q filed with the Securities and Exchange Commission on May 10, 2019, and its future periodic reports filed with the Securities and Exchange Commission.
For Obalon Therapeutics, Inc.
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Obalon Therapeutics, Inc.
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