Obalon Therapeutics Inc. 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. The Obalon Balloon System was approved by the Food and Drug Administration 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 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.