Press Release: BAROnova : BAROnova Announces Submission of Premarket Approval (PMA) Application to the U.S. FDA for the TransPyloric Shuttle® (TPS®) Device Intended for the Treatment of Obesity

SAN CARLOS, Calif., July 17, 2018 /PRNewswire/ -- BAROnova, Inc., announced today that it has submitted a Pre-Market Approval (PMA) application for the TransPyloric Shuttle device intended for the treatment of obesity to the Food and Drug Administration (FDA). Obesity is a worldwide epidemic with over 40% of adult Americans suffering from obesity and its attendant co-morbidities. The investigational TransPyloric Shuttle device is a novel, non-surgical, weight-loss solution intended for patients with a BMI between 30-40 kg/m2. Based upon best-in-class pivotal trial outcomes, the company has filed a PMA submission with the FDA.