Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons
Obalon reported no device-related serious adverse events (0%) for first 141 patients completing therapy in post-approval study to FDA
SAN DIEGO, April 28, 2020 (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 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 .
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.
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