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Obalon Announces FDA Approval of Obalon Navigation System
Eliminates the Need for X-Ray when Placing the Obalon Swallowable, Gas-Filled Balloon
SAN DIEGO, Dec. 21, 2018 (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, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of the Obalon Navigation System, which eliminates the need to use x-ray when placing the Obalon Balloon System.
“We’re very pleased about the approval of the Obalon Navigation System which is intended to make placement of the Obalon Balloon more reliable, more convenient and more accessible to physician providers and patients by eliminating the costs and logistics related to acquiring x-ray” commented Kelly Huang, Ph.D., President and Chief Operating Officer of Obalon. “I’d like to recognize the FDA for their timely review of the Obalon Navigation System, as well as the Touch Inflation Dispenser which was previously approved in the third quarter of 2018. We believe Navigation and Touch provide another step forward in helping physicians and patients battle the obesity epidemic.”
The Obalon Navigation System utilizes magnetic resonance, rather than x-ray radiation, to image the Obalon Balloon during placement and displays a dynamic, real-time image of the Balloon on a notebook computer screen. The Obalon Navigation System will be utilized in conjunction with the new, automated Touch Inflation Dispenser, and together they are intended to make placement of the Obalon Balloon more reliable, safer, easier and less expensive.
“We participated in the clinical trial for the Obalon Navigation System with the Touch Inflation Dispenser and were very impressed with the new technology to make placement of the Obalon Balloon more reliable, safer and easier,” stated Dr. Mickey Seger, founder of BMI of Texas Bariatric Medical Institute in San Antonio, Texas. “We especially appreciated the Obalon Navigation System’s dynamic 3D display during balloon placement, as opposed to the static 2D x-ray images we currently use. The automated Touch Inflation Dispenser eliminates many of the connections and valves from prior dispenser, which should reduce the potential for error during balloon placement and inflation.”
The company expects to make the Obalon Navigation System and Touch Inflation Dispenser commercially available during the first quarter of 2019 in the United States.
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.
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, among others, the uncertainties inherent in the product research, development and regulatory process and risks. Obalon Therapeutics undertakes no obligation to update or revise any forward-looking statements. For a further 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’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2018, and its current and future periodic reports filed with the Securities and Exchange Commission.
For Obalon Therapeutics, Inc.
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