Obalon Completes Enrollment For U.S. Pivotal Trial of Novel Weight Loss Balloon

SAN DIEGO, June 2, 2015 /PRNewswire/ -- Obalon Therapeutics, Inc. today announced the completion of patient enrollment in a multi-center U.S. pivotal trial of the Obalon balloon, a novel, nonsurgical, fully-reversible device for weight loss. The trial utilizes Obalon's most recent technology advancement that facilitates a six-month treatment period with the gas-filled balloon. Obalon expects the data from the trial necessary to file for approval with the U.S. Food and Drug Administration (FDA) by the end of 2015.

"Most patients with obesity aren't being adequately treated with the limited options currently available. We are very excited about the potential for the Obalon balloon as a tool for meaningful weight loss in patients with obesity," said Shelby Sullivan, M.D., an investigator at Washington University in St. Louis.

Steven Edmundowicz, M.D., also an investigator at Washington University in St. Louis added, "We are impressed with the Obalon technology and its ease of use in this clinical trial thus far. We are looking forward to analyzing the final study results at our center."

Strong interest by patients and physicians resulted in full enrollment of the clinical trial in 62 days. More than 24,000 patients visited www.balloontrial.com to inquire about participation in the trial. "To have reached full enrollment with all 15 sites only four months after receiving Investigational Device Exemption (IDE) approval from the FDA is very exciting and is a testament to the commitment of the teams at our clinical trial sites and Obalon employees," said Andy Rasdal, chief executive officer of Obalon.

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.

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http://www.obalon.com