Bariatric Medical Institute of Texas Presents Favorable Study Results for Obalon Balloon Administration Using Navigation Devi...
June 24 2019 - 8:30AM
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.
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. 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.
Investor Contact: William Plovanic President & Chief
Financial Officer Obalon Therapeutics, Inc. Office: +1 760 607 5103
wplovanic@obalon.com
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