On May 11, 2017, Obalon Therapeutics, Inc. (the “Company”) announced that it received notification that it has obtained the necessary regulatory approvals in select Middle East markets to commercialize the Obalon six-month balloon and the associated inflation dispenser. The Company intends to fulfill an initial order to its Middle East distributor, Bader Sultan, during the second quarter of 2017.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding when the Company intends to fulfill an initial order to its Middle East distributor, Bader Sultan. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to achieve or sustain profitability; the Company’s ability to predict its future prospects and forecast its financial performance and growth; the rate at which physicians and patients adopt and use the Company’s balloon system; the effect of adverse events or other negative developments involving other companies’ intragastric balloons or other obesity treatments; the Company’s ability to educate physicians on safe and proper use of the Obalon balloon system; the rate at which patients may experience serious adverse device events as the result of the misuse or malfunction of, or design flaws in, the Company’s products; the Company’s ability to obtain FDA approval or other regulatory approvals for its future products and product improvements; the Company’s ability to adequately protect its proprietary technology and maintain its issued patents and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

About OBALON THERAPEUTICS, INC. (NASDAQ:OBLN)

Obalon Therapeutics, Inc. is a United States-based commercial-stage medical device company focused on developing and commercializing medical devices to treat obese and overweight people by facilitating weight loss. The Company’s product, Obalon balloon system, is a swallowable, gas-filled intragastric balloon designed to provide weight loss in obese patients. The Obalon balloon system is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed six months after the first balloon is placed. The Obalon balloon system intends to provide patients and physicians with a reversible and repeatable weight loss solution in an outpatient setting, without altering patient anatomy or requiring surgery. The Company has received Premarket approval (PMA) for its Obalon balloon system based on the results of its United States pivotal clinical trial, referred to as the SMART trial.

OBALON THERAPEUTICS, INC. (NASDAQ:OBLN) Recent Trading Information

OBALON THERAPEUTICS, INC. (NASDAQ:OBLN) closed its last trading session down -0.11 at 11.18 with 100,227 shares trading hands.