Obalon Announces Data Presentation at the Annual Meeting of the American Society for Metabolic and Bariatric Surgery
Results from the Pivotal Trial of Obalon Balloon System Being Presented
SAN DIEGO, CA – NOVEMBER 4, 2016 – 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, announced an oral presentation at ObesityWeek 2016, the largest international event focused on the basic science, clinical application, prevention and treatment of obesity. The annual conference is hosted by the American Society for Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS). The presentation, titled “A 6-month Swallowable Balloon System results in sustainable weight loss at 1 year: Results from a prospective, randomized sham-controlled trial” will be presented by Dr. Aurora Pryor at 8:22 am CST this morning at the meeting in Great Hall B-C.
“We’re eager for the healthcare professionals on the front lines of fighting obesity to hear first- hand the scientific rigor that exists around our clinical trial, as well as the level of efficacy that our clinical investigators and trial participants experienced with the Obalon Balloon System,” commented Andy Rasdal, Chief Executive Officer of Obalon. “Obesity Week is the premiere meeting to debut this data.”
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 Gastric Balloons are placed in the stomach within 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.
“The Obalon Balloon System, coupled with lifestyle modification, provides a new low risk option for patients struggling with obesity,” said Aurora Pryor, MD, FASMBS, study co-author and Director of the Bariatric and Metabolic Weight Loss Center at the Stony Brook University School of Medicine’s Department of Surgery. “The significant weight loss achieved with the Obalon Balloon System is typically maintained at 12 months, providing patients with an opportunity to maintain a healthier lifestyle.”
In a clinical trial, 387 patients in the United States across fifteen clinical trial sites were randomized in a double-blind, sham-controlled study. The patients in the clinical trial received either three Obalon balloons or three sham placebo-like devices that looked similar to the balloons, but were filled with sugar. The patients in both groups were given minimal diet counseling of 25 minutes every three weeks. Both co-primary weight loss endpoints were met, with approximately 65% of patients who received the Obalon balloon system experiencing clinically meaningful weight loss of at least 5% of their total body weight, which is twice as many people than in the sham-control group. Additionally, patients in the Obalon Balloon System group showed strong weight loss maintenance, with 89.5% of the mean total body weight loss maintained at one year.
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.
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.