California’s Obalon Therapeutics said it launched a pivotal trial set for as many as 15 sites across the U.S. that will test its ingestible, gas-filled weight-loss balloon.
The device is designed to be swallowed in a capsule. Once it hits the stomach, it’s inflated with gas, partially filling the stomach to help patients feel full and eat less. Additional balloons may be added to the treatment, after which they’re removed via an endoscopic procedure.
Obalon has plenty of cash to back the crucial clinical testing. In January, the company raised $30 million – a $20 million Series D financing plus a $10 million term loan – with the proceeds earmarked for the pivotal trial.
The Obalon device is approved for use in the European Union, Mexico and Middle East, but not yet in the U.S. Balloon use in approved countries is limited to 3 months, the company said.
For the purposes of the new U.S. trial, however, treatment periods will last 6 months, thanks to updates in Obalon’s technology. Researchers will pursue a randomized, sham-controlled trial, with expected completion by the end of 2015. Depending on the results, Obalon will then file for approval with the U.S. FDA.
"We are excited by this breakthrough in technology," CEO Andy Rasdal said in a prepared statement. "Our robust technology and strong R&D ensure the constant evolution and improvement of our products."