News and Events

Obalon Announces Data Presentation at the Annual Meeting of the American Society for Metabolic and Bariatric Surgery

4 November 2016

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.

Obalon Announces FDA Approval of Obalon Balloon System

12 September 2016

Obalon Announces FDA Approval of Obalon Balloon System

The First Swallowable, Gas-Filled Weight Loss Balloon is Now Available in the United States

SAN DIEGO, CA – SEPTEMBER 12, 2016 – Obalon Therapeutics, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of the Obalon Balloon System, a novel, nonsurgical, fully-reversible device for weight loss. The Obalon Balloon System 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. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.

“We’re excited to bring this novel technology to the approximately 70 million adults in the United States who are struggling with obesity. For physicians, we believe that the Obalon technology represents an important new option for both their practices and their patients who are obese and looking to lose weight,” commented Andy Rasdal, Chief Executive Officer of Obalon. “I’d also like to recognize the FDA for their efficient and interactive review of our product, which represents another option for physicians and patients in the battle against the obesity epidemic.”

The Obalon balloon system consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anesthesia required. Once the balloon reaches the stomach, it is remotely inflated with gas via a micro-catheter that is then removed, leaving a lightweight, buoyant balloon in the stomach. Over the next three months of treatment, two additional balloons are swallowed and inflated. At the end of the six-month treatment period, all three balloons are removed via an outpatient endoscopy under conscious sedation.

“We participated in the Obalon clinical trial and are excited to now have the Obalon balloon system readily available for our patients who have been frustrated by not being able to lose weight through diet and exercise alone,” stated Dr. Aurora Pryor, Director of the Bariatric and Metabolic Weight Loss Center at the Stony Brook University School of Medicine’s Department of Surgery. “The Obalon balloon is swallowable, can typically be placed in less than 10 minutes without the use of sedation or anesthesia and was well-tolerated by our patients in the clinical trial. Having now received FDA approval, we can begin treating more patients with the device.”

In the 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. The clinical trial data will be presented at Obesity Week this Fall in New Orleans.

“The clinical trial design for the Obalon Balloon System was highly rigorous and the system demonstrated a favorable safety profile,” stated Dr. Shelby Sullivan, Director of the Gastroenterology Bariatric and Metabolic Program at the University of Colorado School of Medicine. “We were also pleased to see that patients tolerated the administrations of the Obalon balloon remarkably well with no recovery time needed. This is in contrast to other currently approved intragastric balloon devices, where most patients cannot immediately return to normal activities.”

The Obalon balloon system is expected to be available in early 2017 to physicians who complete the Obalon balloon system training program. Obalon is currently in the process of identifying, hiring and training the appropriate personnel to ensure that the product can be implemented in the commercial setting with the same strong safety and efficacy profile as was demonstrated in the clinical trial. A prior generation of the Obalon balloon system indicated for three-months of treatment is currently available in select international markets, with more than 23,000 balloons having been sold internationally.

About Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc. is a San Diego-based company focused on developing and commercializing novel technologies for weight loss. The company was founded in 2008 and has a strong investor syndicate that includes Domain Associates, InterWest Partners and Okapi Venture Capital. 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.

css.php