Obalon Initiates U.S. Pivotal Trial of Novel Weight Loss Balloon

SAN DIEGO, March 24, 2015 /PRNewswire/ -- Obalon Therapeutics, Inc. today announced the initiation of patient enrollment in a multi-center U.S. pivotal trial of the Obalon balloon, a novel, nonsurgical, fully-reversible device for weight loss. Patients will participate in the randomized, sham-controlled trial in approximately 15 sites across the country. Obalon expects to complete the trial by the end of 2015 and use the data to file for approval with the U.S. Food and Drug Administration.

The pivotal trial will utilize advancements in Obalon's technology that facilitate a six-month treatment period with the gas-filled balloon. "We are excited by this breakthrough in technology, which now allows physicians to extend weight loss treatment from three months to six months," said Andy Rasdal, chief executive officer of Obalon. 

The Obalon balloons that are commercially available in select markets outside the U.S. are limited to a three-month treatment period.

The company announced in January the completion of a $20 million Series D private equity financing and a $10 million term loan to support the pivotal trial and fund the continued development of Obalon's product pipeline. "Our robust technology platform and strong R&D ensure the constant evolution and improvement of our products. We intend to bring forward a continual stream of new product and procedure advancements," said Rasdal.

The Obalon balloon is designed to jump-start weight loss by partially filling the stomach and helping to induce a feeling of fullness to help people eat less. The patient simply swallows a capsule containing a balloon that is then inflated with gas in the stomach. Additional balloons are placed to continue to facilitate weight loss during the treatment period and are removed at the end in a short endoscopic procedure.

The Obalon balloon is not approved in the U.S. and is available for investigational use only. The Obalon balloon is approved for sale in the European Union, Mexico and the Middle East.

According to the World Health Organization, 500 million people are obese. Bariatric surgery is costly, irreversible and used in less than one percent of the eligible population. Physicians, patients and payers all agree there is a compelling need for new products and technologies to address this gap.

About Obalon Therapeutics
Obalon is a private medical technology company based in San Diego, California focused on developing innovative, high-quality gastric balloon technology for weight loss therapy. www.obalon.com.

SOURCE Obalon Therapeutics, Inc.

Related Links

http://www.obalon.com