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Product approval

FDA approves Obalon Balloon System

The first swallowable, gas-filled weight loss balloon cleared for US market

The FDA has approved Obalon Therapeutics’ Obalon Balloon System, a non-surgical, 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 (BMI30-40) 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 behaviour modification programme.

“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,” said Andy Rasdal, Chief Executive Officer of Obalon. “I’d also like to recognise 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 anaesthesia 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,” said 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 ten minutes without the use of sedation or anaesthesia 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 US across fifteen clinical trial sites were randomised 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 counselling 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 in New Orleans.

“The clinical trial design for the Obalon Balloon System was highly rigorous and the system demonstrated a favorable safety profile,” said 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 programme. 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.

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