Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death...
April 28 2020 - 9:00AM
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 provided further clarification that it’s
gas-filled balloon is not the subject of the April 27, 2020 letter
issued by the FDA to health care providers warning of serious
potential risks, including deaths, associated with the use of
liquid-filled intragastric balloons.
The Obalon swallowable, gas-filled balloon system utilizes a
very different design and technology than the liquid-filled
balloons cited now in four FDA letters to health care
providers. The Obalon balloon is filled with a proprietary
patented blend of gases, not simply air, making it light and
buoyant and allowing it to reside in the upper portion of the
stomach. Additionally, the Obalon balloon is constructed of
novel, patented polymers that are designed to be semi-compliant
(less stretchy) and to maintain its initial size and shape.
“We believe the Obalon balloon continues to perform differently
than the liquid-filled balloons cited in this most recent FDA
letter to healthcare providers, due to its novel design,” said Bill
Plovanic, President and CEO of Obalon. “Since we launched the
six-month Obalon balloon in the U.S. in January 2017, we have
continued to experience a strong safety profile that is consistent
with the pre-market approval data, and we have had no reports of
deaths related to the Obalon balloon. Results from our
peer-reviewed published Commercial Registry reporting on over 1,300
patients treated at more than 100 sites demonstrated a
device-related serious adverse events rate of only 0.15%
(equivalent to 1.5 events for every 1,000 patients).
Obalon has reported to the FDA the results of the first 141
patients to complete therapy in its FDA-required Post-Approval
Study. There were no device-related serious adverse events
(0%) reported in those 141 patients. An 8.9% device-related serious
adverse event rate was reported for the Orbera® liquid-filled
balloon in their Post-Approval Study (equivalent to 89 events for
every 1,000 patients).
“Recently published data suggests that next to age, the
underlying health conditions of obesity and obesity-related health
conditions (hypertension and diabetes) are the greatest predictors
of COVID-19 hospitalizations and death in the United States. This
further highlights the serious consequences and costs of obesity,”
said Amy VandenBerg, Chief Clinical, Quality and Regulatory Officer
at Obalon. “We believe the Obalon gas-filled balloon provides
an important, non-surgical, safe and effective treatment for
obesity.”
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 http://www.obalon.com.
Cautionary Statement Regarding Forward Looking
Statements
This press release contains forward-looking statements that are
not purely historical regarding Obalon’s or its management’s
intentions, beliefs, expectations and strategies for the future,
including those related to new products and their potential
benefits. All forward-looking statements and reasons why results
might differ included in this press release are made as of the date
of this release, based on information currently available to
Obalon, deal with future events, are subject to various risks and
uncertainties, and actual results could differ materially from
those anticipated in those forward looking statements. The risks
and uncertainties that may cause actual results to differ
materially from Obalon’s current expectations are more fully
described in Obalon’s annual report on Form 10-K for the period
ended December 31, 2019 and its other reports, each as filed with
the Securities and Exchange Commission. Except as required by law,
Obalon assumes no obligation to update any such forward-looking
statement after the date of this report or to conform these
forward-looking statements to actual results.
For Obalon Therapeutics, Inc.
Investor Contact: Bill Plovanic President and Chief
Executive Officer Obalon Therapeutics, Inc. Office: +1
760 607 5103 wplovanic@obalon.com
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