Obalon Announces Initial Commercial Patient Placements of the First and Only Swallowable, FDA-Approved Balloon System for Weight Loss

SAN DIEGO, Calif., Jan. 13, 2017 (GLOBE NEWSWIRE) — Obalon Therapeutics Inc. (OBLN), a vertically integrated medical technology company, announced that it has begun U.S. commercial shipments of the Obalon Balloon System, the first and only FDA-approved swallowable, gas-filled intragastric balloon system for weight loss. The first patients have been treated by physicians in key metropolitan markets across the United States. Candidates for Obalon are adults 30 to 100 pounds overweight and willing to follow a diet and exercise program.

“It is incredibly gratifying to be shipping the Obalon Balloon System to physician practices, after years of extensive development, research and testing,” commented Andy Rasdal, Chief Executive Officer of Obalon. “We are looking forward to playing a role in helping the 86 million adults that are currently struggling with being obese to regain control of their health. The Obalon Balloon System will be a powerful tool for our physician partners in fighting the obesity epidemic.”

The Obalon Balloon System was approved by the Food and Drug Administration (FDA) in September 2016. It is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. Three (3) Obalon Balloons are placed in the stomach within the first three months of the six-month treatment period. 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.

“I have been eagerly anticipating the Obalon Balloon System and am excited to finally be able to offer it to our patients. This system, coupled with lifestyle modification, provides a new, ideal option for patients struggling with obesity,” said Moses K. Shieh, D.O., FACOS and Founder of the Surgical Healing Arts Center, a center focused on bariatric and body contouring surgery in Florida. “I decided to bring the Obalon Balloon System into my practice because of the superior clinical trial results, as well as the safety and convenience it offered to my patients.”

About Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc. (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.

Forward Looking Statements
This press release 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 the benefits of the company’s product. 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 press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

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The Obalon Balloon System is intended for adults with a body mass index (BMI) of 30 to 40 kg/m2 willing to follow a diet and exercise program. All Obalon balloons must be removed in 6 months. Patients with prior weight loss surgeries are not eligible. The most common side effects reported were mild abdominal pain and nausea which typically resolved within two weeks. You must take daily acid-blocking medicine prescribed by your doctor. For full Important Safety Information click on Safety Information and Patient Labeling.