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.
The TPS is trans-orally placed in the stomach during a standard endoscopic procedure and is intended to reside in the stomach for 12 months after which it is endoscopically removed. The TransPyloric Shuttle’s primary mechanism of action is delaying gastric emptying which is a known mechanism of weight loss. If approved by the FDA, the TPS will be the first and only intragastric implant with a 12-month duration of action available in the United States.
The PMA submission includes clinical data from its pivotal trial, the ENDObesity II study. The ENDObesity II study was a randomized, double-blinded, sham-controlled study which enrolled 302 patients from 9 sites across the United States. Primary outcomes were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of subjects in the treatment group who achieved 5% TBL or more after 12 months. The trial successfully met its endpoints in a highly statistically significant fashion. Results from the ENDObesity II Study are expected to be presented at the Obesity Week conference during November 11th-15th.
Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study said, “Obesity is on the rise in the United States and the world. Patients and physicians are searching for effective solutions for this condition and its accompanying co-morbidities. Based on the results I have seen with this device, I believe it will find a very meaningful role in clinical practice if approved by the FDA”.
David Thrower, Chief Executive Officer of BAROnova, added, “The PMA submission represents a major milestone for the company. We are pleased by the outcome of the ENDObesity II study and believe we have demonstrated best-in-class results for the TPS device. If approved, we will bring a new medical device option to physicians who treat patients with obesity and to patients who are motivated to lose significant weight and improve their health.”