In September last year, Carlsbad, Calif.-based Obalon won pre-market approval from the FDA for its ingestible, gas-filled weight-loss balloon, with plans to have it on the U.S. market in early 2017.
“It is incredibly gratifying to be shipping the Obalon balloon system to physician practices, after years of extensive development, research and testing,” CEO Andy Rasdal said in prepared remarks. “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 device is indicated for weight loss in adults 30 to 100 pounds overweight, with a body mass index of 30 to 40, who have failed to lose weight through diet and exercise. The device is designed to be swallowed in a capsule. Once the capsule reaches the stomach, it inflates with gas, partially filling the stomach to help patients feel full and eat less.
Up to 3 balloons may be added during treatment, after which they’re removed via an endoscopic procedure no longer than 6 months later.
Since 2012, a 3-month version of the device was on the market in the European Union, Mexico and the Middle East. But in Obalon’s initial IPO filing, the company said it decided in 2015 to turn toward winning U.S. approval and stopped selling the device everywhere except the Middle East.
In October, Obalon priced its initial public offering at $75 million, floating 5 million shares at $15 apiece.
OBLN shares were trading at $9.06 apiece in mid-afternoon activity, down -1.8%.