OBALON THERAPEUTICS, INC. (NASDAQ:OBLN) Files An 8-K Financial Statements and Exhibits

OBALON THERAPEUTICS INC ExhibitEX-99.1 2 obalon-pressreleasexobalon.htm EXHIBIT 99.1 Exhibit FDA Grants PMA-S Approval for Obalon Touch™ Inflation SystemSAN DIEGO,…To view the full exhibit click here
About OBALON THERAPEUTICS, INC. (NASDAQ:OBLN)
Obalon Therapeutics, Inc. is a United States-based commercial-stage medical device company focused on developing and commercializing medical devices to treat obese and overweight people by facilitating weight loss. The Company’s product, Obalon balloon system, is a swallowable, gas-filled intragastric balloon designed to provide weight loss in obese patients. 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. The Obalon balloon system intends to provide patients and physicians with a reversible and repeatable weight loss solution in an outpatient setting, without altering patient anatomy or requiring surgery. The Company has received Premarket approval (PMA) for its Obalon balloon system based on the results of its United States pivotal clinical trial, referred to as the SMART trial.