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ENDObesity II trial

BAROnova completes ENDObesity II clinical trial enrolment

TransPyloric Shuttle (TPS)
The results from this study will be used to support an FDA application for TransPyloric Shuttle approval and subsequent US commercialisation of the device

BAROnova has announced that it has completed its randomised cohort enrolment in the ENDObesity II Study, a multi-centre randomised pivotal clinical trial designed to test the safety and effectiveness of the TransPyloric Shuttle (TPS), for treating obesity. The ENDObesity II Study completed enrolment of 270 patients in nine sites in the US in December 2016.  The results from this study will be used to support an FDA application for TransPyloric Shuttle approval and subsequent US commercialisation of the device.

"This is the first non-surgical weight-loss device inserted into the stomach for a year-long residence time in US pivotal studies,” said Dr Richard Rothstein, the lead investigator of the study and the Joseph M. Huber Professor and Chair of the Department of Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH and a gastroenterologist and Chief Academic Officer at the Dartmouth-Hitchcock Medical Center. “The TPS device is easily endoscopically placed and removed. The pilot data showed that this device was well tolerated by individuals who received it with impressive weight loss results. We await the full analysis of this randomized trial to verify its safety and efficacy. The TPS device has great potential for widespread clinical use."

BAROnova's novel weight-loss device, the TransPyloric Shuttle (TPS), is inserted and removed trans-orally using standard endoscopic techniques. TransPyloric Shuttle is a non-surgical device that is delivered endoscopically to the stomach to treat chronic obesity. The TPS is deployed into the stomach to mechanically form a large spherical bulb connected to a smaller cylindrical bulb by a flexible tether. The larger bulb prevents migration from the stomach, while the smaller bulb passes freely into the duodenum during peristalsis to enable self-positioning of the TPS across the pylorus.

Once transpyloric, the larger bulb engages the pylorus directly to form an intermittent seal designed to delay gastric emptying, enhance satiety, and enable a reduction in caloric intake.

In a previous feasibility study of the TPS, patients with a BMI30-40 demonstrated an average total body loss of 14.7% after six months. Over 100M people in the United States are classified as medically obese. If approved, the TransPyloric shuttle will be the first intra-gastric device with a twelve-month dwell time in the stomach, potentially leading to additional efficacy and duration of weight-loss.

"With the completion of pivotal trial enrolment, BAROnova has achieved an important milestone.,” said David Thrower, CEO of BAROnova. “Based upon our pilot clinical results, we are optimistic that the BAROnova TPS device will prove to be a safe, effective, non-surgical treatment for obese individuals with significant advantages in efficacy and duration of treatment.  We look forward to bringing this important advancement in the treatment of obesity to market."

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